Endovascular Repair of Aortic Diseases
Number: 0651
Table Of Contents
PolicyApplicable CPT / HCPCS / ICD-10 Codes
Background
References
Policy
Scope of Policy
This Clinical Policy Bulletin addresses endovascular repair of aortic diseases.
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Medical Necessity
Aetna considers the following interventions medically necessary:
- Endovascular repair of infra-renal abdominal aortic or aorto-iliac aneurysms with a Food and Drug Administration (FDA)-approved fenestrated, branched or non-fenestrated endovascular stent graft;
- Endovascular repair of descending thoracic aortic aneurysms with an FDA-approved endoprosthesis;
- Endovascular stenting (with a FDA-approved stent) for the treatment of aortic coarctation in persons with body weight of 1.5 kg (3.3 lbs) or more, and who exhibit systemic arterial hypertension and resting arm-leg pressure gradient of greater than 20 mmHg;
- Computed tomography (CT) surveillance after endovascular (stent) aortic repair at 1 month, 6 months, and 12 months following repair, then every year;
- Endovascular treatment for pulmonary artery stenosis and/or hypoplasia in a child.
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Experimental, Investigational, or Unproven
Aetna considers the following interventions experimental, investigational, or unproven because the effectiveness of these approaches has not been established:
- Bifurcated-bifurcated aneurysm repair of aorto-iliac aneurysms;
- Endovascular aneurysm sealing system (Nellix device) for the treatment of abdominal aortic aneurysms (including failed endovascular aneurysm repairs);
- Endovascular repair for the treatment of non-dissected ascending aortic diseases;
- Fabric/mesh wrapping of abdominal aortic aneurysms;
- GORE EXCLUDER thoraco-abdominal branch endoprosthesis for the treatment of thoraco-abdominal aortic aneurysms;
- Implanted wireless pressure sensors for detection of endoleaks in the aneurysmal sac following endovascular repair;
- Intra-operative CT for endovascular aneurysm repair;
- Pre-operative embolization of the inferior mesenteric artery to reduce the rate of type II endoleak following endovascular abdominal aortic aneurysm repair;
- Total endovascular aortic arch repair for the treatment of aortic arch disease.
Background
Aortic aneurysms can develop anywhere along the length of the aorta, but 3/4 are located in the abdominal aorta. Thoracic aortic aneurysms, including those that extend from the descending thoracic aorta into the upper abdomen (thoraco-abdominal aneurysms), account for 1/4 of aortic aneurysms.
Abdominal aortic aneurysms (AAAs) are the most common form of aortic aneurysm, and are a potentially life-threatening condition. It is estimated 1 to 4 % of persons over age 50 years are affected (O'Connor, 2002). Rupture of an AAA is the 13th most common cause of death in the United States.
Abdominal aortic aneurysm is usually the result of degeneration in the media of the arterial wall, resulting in a slow and continuous dilatation of the lumen of the vessel. In fewer than 5 % of cases, AAA is caused by mycotic aneurysm of hematogenous origin. Abdominal aortic aneurysms are usually asymptomatic until they expand or rupture. Presence of a pulsatile abdominal mass is virtually diagnostic but is found in less than 50 % of cases. Rupture is uncommon if aneurysms are less than 5 cm in diameter, but ruptures are dramatically more common for aneurysms greater than 6 cm in diameter. Without prompt intervention, ruptured aneurysms are often fatal. Thus, elective surgical repair is usually recommended for all aneurysms greater than 6 cm unless surgery is contraindicated (Beers et al, 1999). In patients who are good surgical risks, elective repair is generally recommended for aneurysms between 5 and 6 cm (mortality, about 2 to 5 %).
- diameter of aneurysm is greater than 5 cm; or
- diameter of aneurysm is 4 to 5 cm and has increased in size by 0.5 cm in the past 6 months; or
- diameter of aneurysm is twice the diameter of the normal infra-renal aorta.
Current endovascular graft stents require an infra-renal non-aneurysmal neck length of at least 15 mm; however, there are case reports that describe the use of a fenestrated stent graft (Zenith, Cook, Inc., Bloomington, IN) customized to meet the anatomic needs of the individual patient. The Zenith fenestrated graft, which is not FDA-approved, is based on Cook's FDA-approved Zenith AAA endovascular graft design. It incorporates scallops at the top and openings in the graft wall called fenestrations that allow it to be implanted precisely in the aorta across adjacent blood vessels without blocking blood flow through those vessels. Accurate placement of a fenestration over the orifice of a target vessel is feasible, but long-term maintenance of position is dependent on secure graft fixation (Stanley, 2001).
Verhoeven et al (2004) used a customized fenestrated graft based on the Cook Zenith composite system on 18 patients who had the following criteria: abdominal aneurysm at least 55 mm in diameter, a short neck (less than 15 mm), and contra-indications for open repair (cardiopulmonary impairment or a hostile abdomen). Additional stents were used to ensure apposition of the fenestrations with the side branches. Of the 46 targeted side branches, 45 were patent at the end of the procedure. At follow-up (mean of 9.4 months), all of the remaining targeted vessels stayed patent. The authors concluded that by customizing fenestrated stent-grafts, it is possible to position the first covered stent completely inside the proximal neck, thus achieving a more stable position. This technique may become a valuable alternative for patients with a short infra-renal non-aneurysmal neck length; however, more patients with longer follow-up are required to determine the long-term safety and effectiveness of the device.
Verhoeven and colleagues (2009) noted that recent developments with fenestrated and branched stent grafts have opened the way to treat complex aortic aneurysms involving the visceral arteries. Early reports on endovascular treatment of thoraco-abdominal aneurysms have demonstrated the feasibility of the technique. Given the sparse literature, its safety has not been established yet. These researchers performed a literature review and also presented the results of their own series of 30 patients treated with a custom-made Zenith device with fixed branches are presented. Most of the patients were refused open surgery mainly for the extent of the disease combined with co-morbidity, which included in most patients a combination of several risk factors. The mean aneurysm size was 70 mm and the extent of the aneurysm was type I in 8 cases, type II in 5, type III in 12 and type IV in 5 patients. Technical success in the authors' series was achieved in 93 % (28/30). Two out of 97 (2 %) targeted vessels were lost. In 1 patient, a renal artery ruptured during insertion of the bridging stent graft. In a second patient, a celiac artery could not be catheterized and was lost. The 30-day mortality was 6.7 % and corroborated with 5.5 % in the largest series reported so far. The 6-month and 1-year survival were 89.3 % and 76.0 %, respectively. The authors concluded that the results of fully endovascular repair of selected thoraco-abdominal aneurysms are promising. A learning curve should be expected. Anatomical limitations such as extremely tortuous vessels and access problems should be taken into account, as well as the quality of the targeted side branches. Although longer-term results need to be awaited, it is likely that endovascular repair of thoraco-abdominal aneurysms will become a preferential treatment option for many patients in the future.
The Zenith Alpha thoracic endovascular graft was approved by the FDA on September 15, 2015. It is indicated for the endovascular treatment of patients with isolated lesions of the descending thoracic aorta (not including dissections) having vascular anatomy suitable for endovascular repair, including:
- Iliac/femoral anatomy that is suitable for access with the required introduction systems; and
- Non-aneurysmal aortic segments (fixation sites) proximal and distal to the thoracic lesion:
- with a length of at least 20 mm, and
- with a diameter measured outer wall to outer wall of no greater than 42 mm and no less than 15 mm.
Monahan and Schneider (2009) stated that open surgical repair of complex aortic aneurysms, such as juxta-renal or thoraco-abdominal aortic aneurysms, is a highly demanding procedure. They frequently require major surgical exposure through both the thoracic and the abdominal cavities, supra-renal or supra-celiac aortic cross-clamping, and exposure of the visceral and renal arteries. Endovascular aortic repair and thoracic endovascular aortic repair have become the mainstay of treatment for infra-renal AAAs and descending thoracic aneurysms. However, the obvious need to maintain perfusion of the visceral and renal arteries has limited application of endovascular techniques to treatment of more complex aneurysms. Fenestrated and branched stent grafts are being developed to address this need and enable repair of complex aneurysms involving branch vessels exclusively using minimally invasive techniques. Although these devices remain investigational in the United States, they have recently become commercially available in other countries and play an increasing role in the management of complex aortic aneurysms.
Amiot and associates (2010) evaluated the medium-term outcomes following aortic aneurysm repair using fenestrated endografts performed in 16 French academic centers. A retrospective analysis of prospectively collected data was carried out. This study included all patients treated with fenestrated endografts in France between May 2004 and January 2009. Patients were judged to be at high-risk for open surgical repair. Fenestrated endografts were designed using computed tomography (CT) reconstructions performed on 3-dimensional work-stations. All patients were evaluated with CT, duplex ultrasound and plain film radiograph at discharge, 6, 12, 18 and 24 months, and annually thereafter. A total of 134 patients (129 males) were treated over the study period. Median age and aneurysm size were 73 years (range of 48 to 91 years) and 56 mm (range of 45 to 91 mm), respectively. A total of 403 visceral vessels were perfused through a fabric fenestration, including 265 renal arteries. One early conversion to open surgery was required. Completion angiography and discharge CT scan showed that 398/403 (99 %) and 389/394 (99 %) respective target vessels were patent. The 30-day mortality rate was 2 % (3/134). Pre-discharge imaging identified 16 (12 %) endoleaks: 3 type I, 12 type II and 1 type III. After the procedure, transient or permanent dialysis was required in 4 (3 %) and 2 (1%) patients, respectively. The median duration of follow-up was 15 months (range of 2 to 53 months). No aneurysms ruptured or required open conversion during the follow-up period. Twelve of 131 patients (9 %) died during follow-up (actuarial survival at 12 and 24 months: 93 % and 86 %, respectively). Median time from procedure to death was 15 months. None of these deaths were aneurysm related. Aneurysm sac size decreased by more than 5 mm in 52 %, 65.6 % and 75 % of patients at 1, 2 and 3 years, respectively. Three (4 %) patients had sac enlargement within the first year, associated with a persistent endoleak. During follow-up, 4 renal artery occlusions were detected. A total of 12 procedure-related re-interventions were performed in 12 patients during follow-up, including 6 to correct endoleaks, and 5 to correct threatened visceral vessels. The authors concluded that the use of endovascular prostheses with graft material incorporating the visceral arteries is safe and effective in preventing rupture in the medium-term. A predictable high mortality rate was depicted during follow-up in this high-risk cohort. Meticulous follow-up to assess sac behavior and visceral ostia is critical to ensure optimal results.
An evidence report from the Agency for Healthcare Research and Quality (Wilt et al, 2006) on treatment options to repair AAA found that more research is needed to evaluate the long-term benefits and harms of endovascular repair versus open surgical repair. According to this report, in patients medically fit for surgery and with an AAA of 5.5 cm or more, endovascular repair is a less invasive procedure, requires a shorter length of stay, and is associated with lower 30-day morbidity and mortality that open surgical repair. However, studies have not shown improved quality of life beyond 3 months or survival beyond 2 years, according to the report. Endovascular repair is associated with more complications, increase need for re-intervention, more long-term radiological monitoring, and greater costs when compared with open surgical repair. A 4-year study of 166 endovascular repair patients medically unfit for surgery found that endovascular repair did not confer any survival benefit compared with no intervention. The authors concluded that research is needed to evaluate the cost-effectiveness of endovascular repair in the United States (Wilt et al, 2006). Research is also needed to evaluate whether the outcomes of endovascular repair procedures are influenced by either hospital volume or the surgeon's experience.
Lee and Faries (2007) noted that the increasing use of endografts to treat AAA has prompted the need for improved post-operative imaging and surveillance. Although patients benefit from decreased morbidity with endovascular repair compared with open AAA repair, the long-term outcome of stent repair has yet to be fully determined.
Jonk et al (2007) performed a systematic review of the cost-effectiveness of AAA repair. Of the 20 eligible articles, there were 3 randomized controlled trials (RCTs), 12 case series, 4 Markov models, and 1 systematic review. Regardless of time frame, all studies found that endovascular repair costs more than open surgery. Although the high cost of the endovascular prosthesis was partially offset by reduced intensive care, hospital length of stay, operating time, blood transfusions, and peri-operative complications, hospital costs were still greater for endovascular than open surgical repair. For patients medically fit for open surgery, mid-term costs were greater for endovascular repair with no difference in overall survival or quality of life. For patients medically unfit for open surgery, endovascular repair costs more than no intervention with no difference in survival. The authors stated that although conclusions regarding the cost-effectiveness of AAA treatment options are time dependent and vary by institutional perspective, from a societal perspective, endovascular repair is not currently cost-effective for patients with large AAA regardless of medical fitness.
On the other hand, Brewster and colleagues (2006) reviewed a 12-year experience with endovascular AAA repair (EVAR) to document late outcomes. During the interval between January 7, 1994 and December 31, 2005, a total of 873 patients underwent EVAR utilizing 10 different stent graft devices. Primary outcomes examined included operative mortality, aneurysm rupture, aneurysm-related mortality, open surgical conversion, and late survival rates. The incidence of endoleak, migration, aneurysm enlargement, and graft patency was also determined. Finally, the need for re-intervention and success of such secondary procedures were evaluated. Kaplan-Meier and multi-variate methodology were used for analysis. Mean patient age was 75.7 years (range of 49 to 99 years); 81.4 % were male. Mean follow-up was 27 months; 39.3 % of patients had 2 or more major co-morbidities, and 19.5 % would be categorized as unfit for open repair. On an intent-to-treat basis, device deployment was successful in 99.3 %. Thirty-day mortality was 1.8 %. By Kaplan-Meier analysis, freedom from AAA rupture was 97.6 % at 5 years and 94 % at 9 years. Significant risk factors for late AAA rupture included female gender (odds ratio [OR], 6.9; p = 0.004) and device-related endoleak (OR, 16.06; p = 0.009). Aneurysm-related death was avoided in 96.1 % of patients, with the need for any re-intervention (OR, 5.7; p = 0.006), family history of aneurysmal disease (OR, 9.5; p = 0.075), and renal insufficiency (OR, 7.1; p = 0.003) among its most important predictors. A total of 87 (10 %) patients required re-intervention, with 92 % of such procedures being catheter-based and a success rate of 84 %. Significant predictors of re-intervention included use of first-generation devices (OR, 1.2; p < 0.01) and late onset endoleak (OR, 64; p < 0.001). Current generation stent grafts correlated with significantly improved outcomes. Cumulative freedom from conversion to open repair was 93.3 % at 5 through 9 years, with the need for prior re-intervention (OR, 16.7; p = 0.001) its most important predictor. Cumulative survival was 52 % at 5 years. The authors concluded that EVAR using contemporary devices is a safe, effective, and durable method to prevent AAA rupture and aneurysm-related death. Assuming suitable AAA anatomy, these data justify a broad application of EVAR across a wide spectrum of patients.
Frank et al (2007) performed a systematic review and meta-analysis of 12 years of EVAR. A total of 163 studies pertaining to 28,862 patients undergoing EVAR were identified as relevant for the review and meta-analysis. The pooled estimate for operative mortality was 3.3 % (95 % confidence interval [CI]: 2.9 to 3.6 %). The pooled estimate for type 1 endoleaks was 10.5 % (95 % CI: 9.0 to 12.1 %), with an annual rate of 8.4 % (95 % CI: 5.7 to 12.2 %). The pooled estimate of type 2,3 and 4 endoleaks was 13.7 % (95 % CI: 12.3 to 15.3 %), with an annual rate of 10.2 % (95 % CI: 7.4 to 14.1 %). The pooled estimate for primary conversion to open repair was 3.8 % (95 % CI: 3.2 to 4.4 %), and for secondary conversion to open repair 3.4 % (95 % CI: 2.8 to 4.2 %). The pooled estimate for post-operative rupture was 1.3 % (95 % CI: 1.1 to 1.7 %), with an annual rupture rate of 0.6 % (95 % CI: 0.5 to 0.8 %). Multi-variate meta-regression analysis showed that rates of operative mortality, post-operative rupture and total number of endoleaks all fell significantly (p < 0.05) over time. The authors concluded that this study demonstrated a low mortality and a gradual reduction in vascular morbidity and mortality associated with EVAR since it was first introduced.
In a systematic review, Lederle et al (2007) compared the effectiveness of treatment options, including active surveillance, open repair, and endovascular repair, for unruptured AAAs. Randomized trials that compared open or endovascular AAA repair with another treatment strategy and published clinical outcomes were included. Two trials compared open repair with surveillance for small AAAs (n = 2,226). Repair did not improve all-cause mortality (relative risk, 1.01 [95 % CI: 0.77 to 1.32]) or AAA-related mortality (relative risk, 0.78 [CI: 0.56 to 1.10]). Four trials compared open repair with endovascular repair (n = 1,532). Endovascular repair reduced 30-day mortality (relative risk, 0.33 [CI: 0.17 to 0.64]) but not mid-term (up to 4 years) mortality (relative risk, 0.95 [CI: 0.76 to 1.19]). One trial compared endovascular repair with observation in 338 patients who were unfit for open repair. Endovascular repair did not reduce all-cause mortality or AAA-related mortality, but high cross-over and procedural mortality rates complicate interpretation of results. The authors concluded that repairing AAAs smaller than 5.5 cm has not been shown to improve survival. Endovascular repair is associated with lower operative mortality than open repair, similar mid-term mortality, and unknown long-term mortality and has not been shown to improve survival in patients unfit for open repair. They stated that long-term trial data comparing endovascular repair with open repair are needed, as is another trial comparing endovascular repair with observation in high-risk patients.
Thoracic aortic aneurysms (TAAs) may be idiopathic and have been associated with congenital connective tissue disorders (e.g., Ehlers-Danlos syndrome, Marfan's syndrome). Tertiary syphilis is an uncommon cause of aneurysms. Thoracic aneurysms may become huge while remaining asymptomatic. Symptoms relate to pressure against or erosion of adjacent structures by the enlarging aorta, such as pain, cough, wheezing, hemoptysis, dysphagia, or hoarseness. Thoracic aneurysms generally should be resected if greater than or equal to 6 cm (Beers et al, 1999). However, aneurysms in patients with Marfan's syndrome are prone to rupture, so elective surgical repair is recommended for aneurysms 5 to 6 cm. Surgical repair consists of resection of the aneurysm and replacement with a synthetic conduit. Some surgeons use a homograft of the proximal aorta and aortic valve instead of synthetic materials.
Following diagnosis, untreated patients with TAAs have a 2-year survival rate of less than 30 %, with 50 % of all deaths caused by aneurysm rupture. Complications of conventional repair include post-operative paraplegia (25 %), renal failure (20 %), bleeding, stroke, and prolonged ventilator dependence. In addition, the operative mortality of the open procedure has been reported to be about 10 %.
Endovascular repair of TAAs is one of the most recent technological advancements in vascular surgery. The current technique and available technology allow the repair of TAAs distal to the left subclavian artery (Najibi et al, 2002). This less-invasive approach has the potential to reduce the morbidity and mortality associated with the traditional open operative repair of TAAs. In addition, high-risk patients who would not be considered for open repair and would not be treated may now be candidates for this minimally invasive procedure.
- adequate iliac/femoral access;
- aortic inner diameter in the range of 23 mm to 27 mm; and
- less than or equal to 2 cm non-aneurysmal aorta proximal and distal to the aneurysm.
The graft is made of expanded polytetrafluoroethylene (ePTFE) with an outer self-expanding nitinol support structure and is inserted into the diseased area of the aorta through a catheter inserted in the groin.
Gore's non-randomized pivotal study compared TAG (n = 140) with open surgery (n = 94) in 17 U.S. sites. The control group included patients who already had undergone open-surgical repair of aneurysms in the thoracic aorta (n = 50) as well as concurrent patients (n = 44), some of whose aneurysm neck length made them unsuitable for the device cohort, and some of whom were TAG-eligible. Gore conducted a confirmatory study (n = 51) after the graft was re-designed to avoid fracture. Study results reported the TAG group was associated with reduced aneurysm-related deaths compared to the surgical group. The proportion of subjects who experienced at least 1 major adverse event (e.g., bleeding, hematoma, renal failure) through 1 year post-treatment was 42 % for the TAG group versus 77 % for the control. One major adverse event was reported between months 12 and 24. In the confirmatory study, the proportion of subjects who experienced at least 1 major adverse event was 12 % of the 51 TAG patients versus 70 % of the control. No deaths were reported for the TAG group during the first 30 days compared with 6 % of the surgical control. In addition, Gore reported that the median stay in intensive care was 1 day for the TAG group versus 3 for the control group and median length of hospital stay was 3 days for TAG versus 10 for surgery patients. The TAG group also experienced less median blood loss and returned to normal daily activities sooner.
The Interventional Procedures Advisory Committee of the National Institute for Clinical Excellence (NICE, 2005) is examined endovascular stent-graft placement in TAAs. Provisional recommendations from the Committee state that it is a suitable alternative to surgery in properly selected patients; however, the Committee emphasizes that these recommendations are provisional and subject to change.
A systematic review of the published evidence on this procedure that was commissioned by NICE (2004) identified a total of 29 studies of endovascular stent-grafting for TAAs: 27 case series and 2 comparative observational studies. In 1 comparative study, the technical success rate was 100 % (67/67 patients). The systematic review reported that the overall technical success rate was 93 % over 18 studies (16 case series and 2 comparative studies).
The systematic review reported that the rate of conversion to open repair varied from 0 % (0/26 patients) to 7 % (1/14 patients). The proportion of patients who experienced an increase in aneurysm size varied from 0 % (0/18) to 7 % (2/29) of patients. In the study with the largest number of patients, the aneurysm increased in size (by = 5 mm) in 5 % (4/84) of patients. The proportion of patients who experienced a decrease in aneurysm size varied from 100 % of patients (18/18) to 17 % (5/29) of patients. The 30-day mortality rate varied from 0 % (in several studies with a combined population of 94 patients) to 14 % (2/14) of patients. The overall mortality ranged from 3 % (1/37 patients) to 24 % (11/46 patients) across 17 studies over a mean follow-up of 14 months.
The most commonly reported complication following TAA stent-graft placement was endoleak (incomplete sealing of the aneurysm). Nineteen studies reported at least 1 patient with an endoleak, with a mean incidence of 13 % over 12 months (the total number of patients in these studies was 752; follow-up ranged from 3 to 25 months). Five studies with a total of 83 patients reported that there were no cases of endoleak during a mean follow-up period of 12 months. Injuries to the access artery were reported in 9 case series, and included iliac artery dissection in 4 % (1/26 patients), perforation of the iliac artery in 4 % (1/27 patients) and dissection/rupture of the femoral artery in 6 % (2/34 patients). One case series reported stent fracture in 13 % (11/84) of patients, and 6 cases of stent migration were reported over 15 case series. Other reported complications included wound complications in 25 % (8/32) of patients, stroke in 19 % (8/43), renal failure requiring dialysis in 11 % (2/19), and paraplegia in 7 % (3/43) of patients. The NICE Interventional Procedure Advisory Committee noted that there is a lack of long-term data on the durability of TAA stent-grafts.
Gore is conducting a post-approval study to evaluate all-cause mortality, aneurysm-related mortality, morbidity and device-related adverse events at 30 days and 1 year post-procedure. Another condition of approval is the completion of a 2-day training program as a prerequisite for ordering TAG.
Other endoprosthesis for TAAs under clinical investigation in the United States include the Talent (Medtronic Inc., Sunrise, FL), Valiant with the Xcelerant delivery system (Medtronic Inc., Sunrise, FL), and Zenith TX2 (Cook, Inc., Bloomington, IN).
Surgically repaired abdominal aortic aneurysms have a risk of rupture due to leakage around the graft. Patients are periodically monitored with contrast enhanced computed tomography (CT) after stent graft placement for endoleak and sac dilation which indicate increased risk of rupture.
In order to reduce the risks of rupture, endosensors are being developed to monitor abdominal aortic aneurysm pressure after endovascular repair. One manufacturer is developing a wireless radiofrequency endosensor (e.g., CardioMEMS Endosensor, CardioMEMS, Inc., Atlanta, GA). Once implanted into the aneurysm, the endosensor measures the pressure inside the sac. The pressure measurements transmitted via radiofrequency to a device held over the patient's body, where pressure readings are recorded. The device may reduce the necessary frequency of periodic monitoring of the aneurysmal sac with contrast-enhanced CT. Clinical studies of the CardioMENS Endosensor are currently ongoing.
Another endosensor, the Impressure AAA Sac Pressure Transducer, is being developed by Remon Medical, and consists of a piezoelectric membrane, which when actuated by ultrasound waves from a hand-held probe charges a capacitor. Once charged, the transducer measures ambient pressure, then generates an ultrasound signal, which is relayed to the probe. The data can then be down-loaded and exported as an Excel data file consisting of pressure measurements and the corresponding times at which the measurements were taken.
Ellozy et al (2004) reported on the first clinical experience with the use of the Impressure permanently implantable, ultrasound-activated remote pressure transducer to measure intra-sac pressure after endovascular repair of abdominal aortic aneurysms. Over 7 months, 14 patients underwent endovascular repair of an infra-renal AAA with implantation of the remote pressure transducer fixed to the outside of the stent graft and exposed to the excluded aortic sac. Twelve patients received modular bifurcated stent grafts, and 2 patients received aorto-uniiliac devices. Intra-sac pressures were measured directly with an intravascular catheter and by the remote sensor at stent-graft deployment. Follow-up sac pressures were measured with a remote sensor and correlated with systemic arterial pressure at each follow-up visit. Mean follow-up was 2.6 +/-1.9 months. The investigators reported "excellent" concordance between catheter-derived and transducer-derived intra-sac pressure intra-operatively, with a Pearson correlation coefficient for systolic, diastolic, and pulse pressures of 0.97, 0.97, and 0.96, respectively (p < 0.001). Pulsatile waveforms were seen in all functioning transducers at each evaluation interval. One implant ceased to function at 2 months of follow-up. In 1 patient a type I endoleak was diagnosed on 1-month CT scans; 3 type II endoleaks were observed. The investigators reported that those patients with complete exclusion of the aneurysm on CT scans had a significant difference in systemic and sac systolic pressures initially (p < 0.001) and at 1 month (p < 0.001). Initial sac diastolic pressures were higher than systemic diastolic pressures (p < 0.001). The investigators reported that the ratio of systemic to sac systolic pressure increased over time in those patients with complete aneurysm exclusion (p < 0.001). Four of 6 patients with no endoleak and greater than 1-month follow-up had diminution of sac systolic pressure to 40 mm Hg or less by 3 months. The investigators concluded that additional clinical follow-up will be necessary to determine whether aneurysm sac pressure monitoring can replace CT in the long-term surveillance of patients after endovascular repair of aortic aneurysms.
Ohki et al (2007) stated that complete exclusion and de-pressurization of the aneurysm sac is the prime goal of EVAR of AAAs. Thus, any EVAR that results in a type I or III endoleak has been classified as a technical failure. The current method to detect endoleaks uses intra-operative aortography. However, aortography is limited by its subjective nature, inability to quantify the significance of the endoleak, and artifacts such as bowel gas that may mimic an endoleak. In addition, repetitive contrast injection may impair renal function. To increase the safety and effectiveness of intra-operative endoleak detection, a wireless pressure-monitoring system has been developed and tested in the clinical setting. The APEX trial (Acute Pressure Measurement to Confirm Aneurysm Sac EXclusion) is a prospective, multi-center/international trial sponsored by CardioMEMS to evaluate the safety and effectiveness of the EndoSure wireless pressure sensor for EVAR. The 30 x 5 x 1.5-mm sensor contains no battery and is powered externally with radiofrequency energy. The sensors are extremely stable, operate over the full physiological range of pressures, and have a resolution of 1 mm Hg. A total of 90 patients were enrolled at 12 sites, 76 of whom were eligible for analysis. The sensor was implanted via the contralateral femoral artery at the time of EVAR. The sac pulse pressure was measured with both an angiographical catheter and the sensor after deployment of the main endograft but before the deployment of the contralateral limb (type I endoleak equivalent). Sac pressure was again measured with the sensor after deployment of the contralateral limb and completion of the EVAR. Data were collected in a prospective manner. In all of the eligible patients (n = 76), the initial sensor pressure measurement agreed closely with the angiographical catheter pressure measurement of the type I endoleak equivalent. At the completion of the procedure, there was agreement between the sensor measurement and angiography regarding the presence or absence of a type I or III endoleak in 92.1 % (n = 70) of the measurements. Overall, the sensitivity was 0.94 and the specificity was 0.80 for detecting type I or III endoleaks. Final pulse pressures decreased significantly compared with baseline measurements. The authors concluded that implantation of the wireless pressure sensor is safe, and remote aneurysm sac pressure sensing is feasible. It was a valuable guide in evaluating the completeness of the EVAR procedure. Moreover, they stated that long-term study will be needed to prove its effectiveness for post-operative surveillance.
Fabric wrapping for abdominal aortic aneurysms entails wrapping aneurysms with cellophane or fascia lata. Karkos et al (2002) stated that "whether external wrapping does alter the outcome in patients with unresected AAAs and a gain in longevity for the individual can be achieved is unclear …. the question whether one could justify employing this old-fashioned technique, as a last resort, to delay rupture in selected poor-risk patients unfit for open repair, with large aneurysms that extend above the renal arteries and those unsuitable for endovascular surgery remains unanswered".
Fabric wrapping for abdominal aortic aneurysms has not been demonstrated to prevent eventual rupture. In extremely rare instances, external wall reinforcement may be indicated when the current accepted treatment (excision of the aneurysm and reconstruction with synthetic materials) is not a viable alternative, but external wall reinforcement is not fabric wrapping. It should also be noted that of fabric wrapping of abdominal aortic aneurysms is not covered by Medicare (2001).
Guidance from the National Institute for Health and Clinical Excellence (NICE, 2009) concluded that endovascular aortic stent-grafts are not recommended for patients with ruptured aneurysms except in the context of research.
Foster et al (2010) examined whether a policy for endovascular repair as the primary mode of treatment for ruptured abdominal aortic aneurysms (rAAAs) would improve outcomes. A total of 1,328 papers were found; of these, 24 presented represent the best evidence to answer the clinical question. The author, journal, date and country of publication, patient group studies, study type, relevant outcomes, results, and study weaknesses of these papers were tabulated. The majority of data available derives from level 2b evidence, with only 1 single level 1b and no level 1a studies available. Appraisal of theses studies was constrained by limited patient numbers, selection bias and heterogeneity in treatment protocols between the reported series. The sole prospective, RCT comparing open and endovascular treatments found a 53 % mortality among patients treated by either modality. This study was, however, under-powered and contrary to numerous cohort series that show reduced mortality with EVAR. The largest body of evidence was found in a co-operative multi-center cohort study spanning 49 institutions that showed superiority of EVAR over open repair in terms of 30-day mortality. The authors concluded that, within the limitations of the published literature to date, endovascular repair as the primary treatment for rAAA is achievable and appears to be associated with favorable mortality over open repair with appropriate case selection.
On the other hand, other published studies indicated that EVAR is not an established procedure in treating ruptured aneurysms. Vetrhus and associates (2009) noted that repair of AAAs is performed in more than 800 patients annually in Norway. Open repair is an established procedure, but an increasing number of patients have undergone endovascular repair during the last decades. This paper delivered an updated discussion of infra-renal AAA repair. A systematic search was performed in PubMed and literature containing the search terms "abdominal aortic aneurysm" and "mortality" (from 2004 to 2009) was retrieved. The review was based on randomized, multi-center and registry studies examining complications and mortality in endovascular and open repair. Peri-operative mortality is lower in endovascular repair. The initial survival benefit is not sustained over time. The mortality rate is still high in ruptured AAAs, but endovascular repair may improve mortality in selected patients. The authors concluded that even though peri-operative mortality associated with endovascular repair is lower than that of open repair, questions concerning benefit and selection of patients are still left unanswered.
- single-center series,
- systematic reviews, and
- population-based studies.
In order to validate EVAR, this technique was compared to the conventional open repair. These studies were heterogeneous, and often failed to demonstrate any significant difference between EVAR and open repair. More recently, some population-based studies from the United States suggested that there are advantages of EVAR over open repair with regard to 30-day mortality and morbidity. Some bias have influenced the reported results including criteria for choice of EVAR varied across the studies according to the policy of the authors. Therefore, any meta-analysis should be interpreted with caution. Patients' conditions have directed the authors towards a technique instead of the other, namely, pathophysiological factors of the patients, and anatomical conditions of the AAAs. The authors concluded that according to the current literature, the role of EVAR in the management of rAAAs must be further checked; RCTs could provide the evidence to define adequate indication to EVAR.
Karkos et al (2009) documented mortality after endovascular repair of rAAAs. Articles that reported data on mortality after endovascular repair of rAAAs were identified. Only patients with true ruptures were included. Additionally, information on mortality after concurrent open repair was sought. One of the authors reviewed all of the studies and extracted appropriate data. A total of 43 articles were identified, 14 of which were excluded. A total of 29 articles with 897 patients who underwent endovascular repair met the inclusion criteria. Of the patients with available information, 86 % were men; 29 % had been operated on under local anesthesia; 28 % were hemodynamically unstable; 17 % required intra-aortic balloon occlusion; 48 % received bifurcated stent grafts; 6 % had endovascular procedures converted to open repair intra-operatively; and 5.5 % developed abdominal compartment syndrome. In-hospital and/or 30-day mortality ranged between 0 % and 54 % in different series, whereas the pooled mortality after endovascular repair was 24.5 % (95 % CI: 19.8 % to 29.4 %). In 19 studies reporting results of both endovascular and concurrent open repair from the same unit, the pooled mortality after open repair was 44.4 % (95 % CI: 40.0 % to 48.8 %), and the pooled overall mortality for rAAA undergoing endovascular or open repair was 35 % (95 % CI: 30 % to 41 %). The authors concluded that endovascular repair of rAAAs is associated with acceptable mortality rates. They stated that additional studies are needed to verify these promising results and precisely define the role of endovascular treatment as an additional therapeutic option for rAAAs.
Hinchliffe and colleagues (2009) performed a systematic literature review of EVAR of rAAA from 1994 to 2009. The literature analyzed included systematic reviews and population-based studies of rAAA. A total of 7 systematic reviews were identified, all demonstrating from published data that patients with EVAR of rAAA had significantly reduced mortality compared with controls. Six recently published population-based studies from the United States demonstrated low mortality rates associated with EVAR; however, only a small proportion of rAAAs were treated by EVAR. Systematic reviews and population-based studies both raised concerns about patient selection and publication bias. Two RCTs are in progress, and 1 is due to commence 2009. The authors concluded that the outcome of EVAR in a non-selected patient population remains unknown. One or more definitive RCTs could provide the level I evidence to resolve these issues.
In a systematic review, Chambers et al (2009) examined the clinical effectiveness and cost-effectiveness of EVAR of AAAs in patients at varying levels of risk. The following bibliographic databases were searched (2005 to February 2007): BIOSIS Previews, CINAHL, Cochrane Central Register of Controlled Trials, EMBASE, ISI Proceedings, MEDLINE, MEDLINE In-Process & Other Non-Indexed Citations, Science Citation Index and Zetoc Conferences. A systematic review of the clinical effectiveness of EVAR was performed using standard methods. Meta-analysis was employed to estimate a summary measure of treatment effect on relevant outcomes based on intention-to-treat analyses. A second systematic review was undertaken to identify existing cost-effectiveness analyses of EVAR compared with open surgery and non-surgical interventions. Two new decision models were developed to inform the review. A total of 6 RCTs were included in the clinical effectiveness review; 34 studies evaluated the role of patients' baseline characteristics in predicting risks of particular outcomes after EVAR. The majority were based on data relating to devices in current use from the EUROSTAR registry. Compared with open repair, EVAR reduces operative mortality (OR 0.35, 95 % CI: 0.19 to 0.63) and medium-term aneurysm-related mortality (hazard ratio 0.49, 95 % CI: 0.29 to 0.83) but offers no significant difference in all-cause mortality. Endovascular aneurysm repair is associated with increased rates of complications and re-interventions, which are not offset by any increase in health-related quality of life. EVAR Trial 2 comparing EVAR with non-surgical management in patients unfit for open repair found no differences in mortality between groups; however, substantial numbers of patients randomized to non-surgical management crossed-over to receive surgical repair of their aneurysm. The cost-effectiveness systematic review identified 6 published decision models. Both models considered relevant for the decision in the United Kingdom concluded that EVAR was not cost-effective on average compared with open repair at a threshold of 20,000 pounds per quality-adjusted life-year (QALY). Another model concluded that EVAR would be on average more cost-effective than no surgical intervention in unfit patients at this threshold. The Medtronic model concluded that EVAR was more cost-effective than open repair for fit patients at this threshold. The York economic evaluations found that EVAR is not cost-effective compared with open repair on average at a threshold of 30,000 pounds per QALY, with the results very sensitive to model assumptions and the baseline risk of operative mortality. Exploratory analysis to evaluate management options in patients unsuitable for open surgery suggested that the cost-effectiveness of EVAR may be sensitive to aneurysm size and patient's age at operation. Indicative modelling suggests that EVAR may be cost-effective for small aneurysms in some patient groups. Ongoing RCTs will provide further evidence relating to these patients. The authors concluded that open repair is more likely to be cost-effective than EVAR on average in patients considered fit for open surgery. Endovascular aneurysm repair is likely to be more cost-effective than open repair for a subgroup of patients at higher risk of operative mortality. These results are based on extrapolation of mid-term results of clinical trials. Evidence does not currently support EVAR for the treatment of ruptured aneurysms.
Jonker et al (2010) stated that thoracic EVAR offers a less invasive approach for the treatment of ruptured descending thoracic aortic aneurysms (rDTAA). Due to the low incidence of this life-threatening condition, little is known about the outcomes of endovascular repair of rDTAA and the factors that affect these outcomes. These investigators retrospectively investigated the outcomes of 87 patients who underwent thoracic EVAR for rDTAA at 7 referral centers between 2002 and 2009. The mean age was 69.8 +/- 12 years and 69.0 % of the patients were men. Hypovolemic shock was present in 21.8 % of patients, and 40.2 % were hemodynamically unstable. The 30-day mortality rate was 18.4 %, and hypovolemic shock (OR 4.75; 95 % CI: 1.37 to 16.5; p = 0.014) and hemothorax at admission (OR 6.65; 95 % CI: 1.64 to 27.1; p = 0.008) were associated with increased 30-day mortality after adjusting for age. Stroke and paraplegia occurred each in 8.0 %, and endoleak was diagnosed in 18.4 % of patients within the first 30 days after thoracic EVAR. Four additional patients died as a result of procedure-related complications during a median follow-up of 13 months; the estimated aneurysm-related mortality at 4 years was 25.4 %. The authors concluded that endovascular repair of rDTAA is associated with encouraging results. The endovascular approach was associated with considerable rates of neurological complications and procedure-related complications such as endoleak. Further improvements of current endovascular devices are needed to reduce the endograft-related complications and deaths during follow-up.
In an editorial that accompanied the study by Jonker et al, Coselli and Gopaldas (2010) stated that "[a]lthough the current use of TEVAR for ruptured thoracic aneurysms remain off label, the success demonstrated by Jonker and colleagues and by several others establishes a strong foundation that would support the use of TEVAR as the primary modality for treating ruptured DTAA in the near future".
A scientific statement on "Surgical management of descending thoracic aortic disease: Open and endovascular approaches" from the American Heart Association (Coady et al, 2010) noted that "[t]reatment of acute aortic syndromes that affect the descending thoracic aorta continues to evolve with the development of new technologies and management strategies. Although data presented in this summary have highlighted current outcomes of endovascular stenting compared with conventional open repair, it must be stressed that there have been no prospective randomized trials to compare these treatment strategies on a head-to-head basis. In addition, although endovascular stenting offers a minimally invasive method of treatment, its long-term durability is still largely unknown. Ongoing experience and national and international registries will continue to define precise roles for both surgical and endovascular therapy".
Huddle et al (2009) determined what laboratory values predict the prognosis of patients following EVAR. MEDLINE and Cochrane Library databases were searched. This resulted in 13 relevant articles. Data were pooled, and meta-analyses were performed. A meta-analysis including 5,655 patients showed that pre-operative serum creatinine greater than 1.5 mg/dL was a significant risk indicator for increased 30-day mortality (relative risk 3.0, 95 % CI: 2.3 to 4.1; p < 0.0001). Four other studies showed that other cut-off values of creatinine or glomerular filtration rate (GFR) can predict mortality and complications following EVAR. One study suggested that reduced pre-operative hemoglobin is a risk indicator for reduced long-term survival. Increased serum creatinine, reduced GFR, and reduced hemoglobin are significant and strong predictors of mortality and complications after EVAR. The authors concluded that current evidence remains limited, and further research is needed to determine conclusively additional laboratory values that may predict the outcome of patients following EVAR.
Linsen et al (2012) performed a systematic review of the current literature to analyze the immediate and follow-up results of fenestrated EVAR (FEVAR) in patients with para-renal AAAs. The Medline, Embase, and Cochrane databases were searched to identify all studies reporting FEVAR of para-renal AAAs published between January 2000 and May 2011. Two independent observers selected studies for inclusion, assessed the quality of the included studies, and performed the data extraction. Studies were selected based on specific pre-defined criteria. Outcomes were technical success (successfully completed procedure with endograft patency, preservation of target vessels, and no evidence of type I or III endoleak at post-procedural imaging), 30-day mortality, all-cause mortality, branch vessel patency, renal impairment, and secondary interventions. Between-study heterogeneity was calculated using I(2) statistics. Pooled estimates were calculated using a fixed-effects (I(2) < 25 %) or a random-effects (I(2) > 25 % to < 50 %) model. A total of 9 studies were included reporting 629 patients who underwent FEVAR for a para-renal AAA, of which 1,622 target vessels were incorporated in an endograft design. Between-study heterogeneity was less than or equal to 41% for all outcomes. The pooled estimate (95 % CI: was 90.4 % (87.7 % to 92.5 %) for technical success, 2.1 % (1.2 % to 3.7 %) for 30-day mortality, and 16 % (12.5 % to 20.4 %) for all-cause mortality. Follow-up was 15 to 25 months. The pooled estimate (95 % CI) during follow-up was 93.2 % (90.4 % to 95.3 %) for branch vessel patency, 22.2 % (16 % to 30.1 %) for renal impairment, and 17.8 % (13.5 % to 22.6 %) for secondary interventions. The authors concluded that promising immediate and mid-term results (up to 2 years) support FEVAR as a feasible, safe, and effective treatment in a relatively high-risk cohort of patients with pararenal AAAs.
Cross et al (2012) stated that FEVAR is a technically challenging operation. The duration, blood loss, and risk of limb ischemia, contrast-induced nephropathy and re-perfusion injury are likely to be higher than after standard EVAR. Benefits of FEVAR over open repair may be less than those seen with standard infrarenal EVAR. These investigators performed a meta-analysis of observational studies of all published data for FEVAR, with the aim to high-light current issues around the evidence for the potential benefit of FEVAR. A search was performed for studies describing FEVAR for juxta-renal AAAs. Small series of fewer than 10 procedures and studies describing predominantly branched endografts or FEVAR for aortic dissection were excluded. Authors of included papers were contacted to eliminate patient duplication. A total of 11 studies were identified describing a total of 660 procedures. Definitions of aneurysm morphology were variable, and clear inclusion and exclusion criteria were not always documented. Double fenestrations were more common than triple or quadruple fenestrations. Target vessel perfusion rates ranged from 90.5 to 100 %. Eleven deaths occurred within 30 days, giving a 30-day proportional mortality rate of 2.0 %. Morbidity was poorly reported. The authors concluded that FEVAR for repair of supra-renal and juxta-renal aneurysms is a viable alternative to open repair. However, there is no level 1 evidence for FEVAR, and current evidence is weak with many unanswered questions.
In a Cochrane review, Filardo and colleagues (2012) compared long-term survival in patients with AAAs of diameter 4.0 to 5.5 cm who received immediate repair versus routine ultrasound surveillance. For this update the Cochrane Peripheral Vascular Diseases Group searched their Specialized Register (February 2012) and CENTRAL (2012, Issue 1). Reference lists of relevant articles were checked for additional studies and the searches were supplemented by hand-searches of recent conference proceedings and information from experts in the field. Randomized controlled trials in which men and women with asymptomatic AAAs of diameter 4.0 to 5.5 cm were randomly allocated to immediate repair or imaging-based surveillance at least every 6 months. Outcomes had to include mortality or survival. Two authors abstracted the data, which were cross-checked by the other authors. Due to the small number of trials, formal tests of heterogeneity and sensitivity analyses were not conducted. Four trials with a combined total of 3,314 patients, the UK Small Aneurysm Trial (UKSAT), the Aneurysm Detection and Management (ADAM) trial, the Comparison of Surveillance Versus Aortic Endografting for Small Aneurysm Repair (CAESAR), and the Positive Impact of Endovascular Options for treating Aneurysms Early (PIVOTAL) fulfilled the inclusion criteria. The 4 trials showed an early survival benefit in the surveillance group (due to 30-day operative mortality with surgery) but no significant differences in long-term survival (adjusted hazard ratio (HR) 0.88, 95 % CI: 0.75 to 1.02, mean follow-up 10 years (UKSAT); HR 1.21, 95 % CI: 0.95 to 1.54, mean follow-up 4.9 years (ADAM); HR 0.76, 95 % CI: 0.30 to 1.93, median follow-up 32.4 months (CAESAR); HR 1.01, 95 % CI: 0.49 to 2.07, mean follow-up 20 months (PIVOTAL)). The meta-analyses of mortality at 1 year (CAESAR and PIVOTAL only) and 6 years (UKSAT and ADAM only) revealed a non-significant association (Peto odds ratio at one year 1.15, 95 % CI: 0.59 to 2.25; Peto odds ratio at 6 years 1.11, 95 % CI: 0.91 to 1.34). The authors concluded that these findings from the 4 trials to date demonstrated no advantage to early repair (via open or endovascular surgery) for small AAA (4.0 to 5.5 cm) and suggested that "best care" for these patients favors surveillance. Furthermore, the more recent trials focused on the efficacy of EVAR and still failed to show benefit. Thus, both open and endovascular repair of small AAAs are not supported by currently available evidence.
Brown and associates (2012) evaluated the effectiveness of EVAR against standard alternative management in patients with large AAA. These researchers examined 2 national, multi-center randomized trials – EVAR trials 1 and 2. Patients were recruited from 38 out of 41 eligible United Kingdom (UK) hospitals. Men and women aged at least 60 years, with an AAA measuring at least 5.5 cm on a CT scan that was regarded as anatomically suitable for EVAR, were assessed for fitness for open repair. Patients considered fit were randomized to EVAR or open repair in EVAR trial 1 and patients considered unfit were randomized to EVAR or no intervention in EVAR trial 2. The primary outcome was mortality (operative, all-cause and AAA-related). Patients were flagged at the UK Office for National Statistics with centrally coded death certificates assessed by an Endpoints Committee. Power calculations based upon mortality indicated that 900 and 280 patients were required for EVAR trials 1 and 2, respectively. Secondary outcomes were graft-related complications and re-interventions, adverse events, renal function, health-related quality of life and costs. Cost-effectiveness analyses were performed for both trials. Recruitment occurred between September 1, 1999 and August 31, 2004, with targets exceeded in both trials: 1,252 randomized into EVAR trial 1 (626 to EVAR) and 404 randomized into EVAR trial 2 (197 to EVAR). Follow-up closed in December 2009 with very little loss to follow-up (1 %). In EVAR trial 1, 30-day operative mortalities were 1.8 % and 4.3 % in the EVAR and open-repair groups, respectively: adjusted odds ratio 0.39 [95 % CI: 0.18 to 0.87], p = 0.02. During a total of 6,904 person-years of follow-up, 524 deaths occurred (76 AAA-related). Overall, there was no significant difference between the groups in terms of all-cause mortality: adjusted hazard ratio (HR) 1.03 (95 % CI: 0.86 to 1.23), p = 0.72. The EVAR group did demonstrate an early advantage in terms of AAA-related mortality, which was sustained for the first few years, but lost by the end of the study, primarily due to fatal endograft ruptures: adjusted HR 0.92 (95 % CI: 0.57 to 1.49), p = 0.73. The EVAR procedure was more expensive than open repair (mean difference of £1,177) and not found to be cost-effective, but the model was sensitive to alternative assumptions. In EVAR trial 2, during a total of 1,413 person-years of follow-up, a total of 305 deaths occurred (78 AAA-related). The 30-day operative mortality was 7.3 % in the EVAR group. However, this group later demonstrated a significant advantage in terms of AAA-related mortality, but this became apparent only after 4 years: overall adjusted HR 0.53 (95 % CI: 0.32 to 0.89), p = 0.02. Sadly, this advantage did not result in any benefit in terms of all-cause mortality: adjusted HR 0.99 (95 % CI: 0.78 to 1.27), p = 0.97. Overall, EVAR was more expensive than no intervention (mean difference of £10,222) and not found to be cost-effective. The authors concluded that EVAR offers a clear operative mortality benefit over open repair in patients fit for both procedures, but this early benefit is not translated into a long-term survival advantage. Among patients unfit for open repair, EVAR is associated with a significant long-term reduction in AAA-related mortality but this does not appear to influence all-cause mortality.
Di and colleagues (2013) noted that the development of endovascular technology has led to the introduction of FEVAR to treat para-renal abdominal aortic aneurysms (PRAAAs) that have been deemed unsuitable for standard endovascular repair. These investigators performed a systematic review and meta-analysis of data from the literature to determine the outcomes of the fenestrated technology. The Medline, Embase, and Cochrane databases were searched to identify all studies published in English between January 1996 and May 2011 that reported on FEVAR for PRAAAs. Separate meta-analyses were performed for primary outcomes (i.e., 30-day mortality, technical success rate, primary target vessel patency rate, and 12-month patency rate) and secondary outcomes (i.e., re-intervention rate, target renal artery occlusion rate, and post-operative permanent dialysis rate). Subgroup analyses were performed to determine whether there were differences in outcomes between varying types of studies (prospective or retrospective). Regression analyses were performed to explore associations between outcomes and varying factors (i.e., mid-date of study, study size, and procedure time). A total of 12 studies conducted between 2006 and 2011 and consisting of a total of 776 cases of FEVAR were enrolled. The pooled estimate for 30-day mortality was 2.52 % (95 % CI: 1.55 to 4.08). Technical success was measured to be 92.8 % (95 % CI: 87.5 to 96.0). Primary target vessel patency was 98.3 % (95 % CI: 97.4 to 98.8). Twelve-month target vessel patency was 94.5 % (95 % CI: 92.1 to 96.2). The post-operative re-intervention rate was 17.6 % (95 % CI: 12.0 to 25.1). The target renal artery occlusion rate was 6.1 % (95 % CI: 4.1 to 8.8). The post-operative permanent dialysis rate was 2.6 % (95 % CI: 1.5 to 4.4). Subgroup analyses found no significant differences between the major outcomes of the retrospective studies and the prospective studies. Regression analyses suggested that large series had higher 12-month target vessel patency rates than small series. The authors concluded that this study revealed that FEVAR treatment for PRAAAs has acceptable early and mid-term outcomes.
Dijkstra et al (2014) noted that in the past decennium, the management of short-neck infra-renal and juxta-renal aortic aneurysms with FEVAR has been shown to be successful, with good early and mid-term results. Recently, a new fenestrated device, the fenestrated Anaconda (Vascutek, Renfrewshire, Scotland), was introduced. These researchers presented the current Dutch experience with this device. A prospectively held database of patients treated with the fenestrated Anaconda endograft was analyzed. Decision to treat was based on current international guidelines. Indications for FEVAR included an AAA with unsuitable neck anatomy for EVAR. Planning was performed on computed tomography angiography images using a 3-D work-station. Between May 2011 and September 2013, a total of 25 patients were treated in 8 institutions for juxta-renal (n = 23) and short-neck AAA (n = 2). Median AAA size was 61 mm (59 to 68.5 mm). All procedures except 1 were performed with bifurcated devices. A total of 56 fenestrations were incorporated, and 53 (94.6 %) were successfully cannulated and stented. One patient died of bowel ischemia caused by occlusion of the superior mesenteric artery. On completion angiography, 3 type I endoleaks and 7 type II endoleaks were observed. At 1 month of follow-up, all endoleaks had spontaneously resolved. Median follow-up was 11 months (range of 1 to 29 months). There were no aneurysm ruptures or aneurysm-related deaths and no re-interventions to date. Primary patency at 1 month of cannulated and stented target vessels was 96 %. The authors concluded that initial and short-term results of FEVAR using the fenestrated Anaconda endograft are promising, with acceptable technical success and short-term complication rates. Moreover, they stated that growing experience and long-term results are needed to support these findings.
Raux et al (2014) stated that the benefit of FEVAR compared with open surgical repair (OSR) of complex AAAs (CAAAs) is unknown. These researchers compared 30-day outcomes of these procedures from 2 high-volume centers where FEVAR was undertaken for high-risk patients. Patients undergoing FEVAR with commercially available devices and OSR of CAAAs (total supra-renal/supra-visceral clamp position) were propensity-matched by demographic, clinical, and anatomic criteria to identify similar patient cohorts. Peri-operative outcomes were evaluated using uni-variate and multi-variate methods. From July 2001 to August 2012, a total of 59 FEVAR and 324 OSR patients were identified. After 1:4 propensity matching for age, gender, hypertension, congestive heart failure, coronary disease, chronic obstructive pulmonary disease, stroke, diabetes, pre-operative creatinine, and anticipated/actual aortic clamp site, the study cohort consisted of 42 FEVARs and 147 OSRs. The most frequent FEVAR construct was 2 renal fenestrations, with or without a single mesenteric scallop, in 50 % of cases. An average of 2.9 vessels were treated per patient. Uni-variate analysis demonstrated FEVAR had higher rates of 30-day mortality (9.5 % versus 2 %; p = 0.05), any complication (41 % versus 23 %; p = 0.01), procedural complications (24 % versus 7 %; p < 0.01), and graft complications (30 % versus 2 %; p < 0.01). Multi-variable analysis showed FEVAR was associated with an increased risk of 30-day mortality (OR, 5.1; 95 % CI: 1.1 to 24; p = 0.04), any complication (OR, 2.3; 95 % CI: 1.1 to 4.9; p =0 .01), and graft complications (OR, 24; 95 % CI: 4.8 to 66; p < 0.01). The authors concluded that FEVAR, in this 2-center study, was associated with a significantly higher risk of peri-operative mortality and morbidity compared with OSR for management of CAAAs. These data suggested that extension of the paradigm shift comparing EVAR with OSR for routine AAAs to patients with CAAAs is not appropriate. Moreover, they stated that further study to establish proper patient selection for FEVAR instead of OSR is needed before widespread use should be considered.
In a Cochrane review, Jackson et al (2014) compared the clinical outcomes of percutaneous access with standard femoral artery access in elective bifurcated abdominal EVAR. The Cochrane Peripheral Vascular Diseases Group Trials Search Coordinator searched their Specialized Register (last searched July 2013), CENTRAL (2013, Issue 6) and clinical trials databases. Reference lists of retrieved articles were checked. Only RCTs were considered. The primary intervention was a totally percutaneous endovascular repair. All device types were considered. This was compared against standard femoral artery endovascular repair. Only studies investigating elective repairs were considered. Studies reporting emergency surgery for a rAAA and those reporting aorto-uni-iliac repairs were excluded. All data were collected independently by 2 review authors. Owing to the small number of trials identified, no formal assessment of heterogeneity or sensitivity analysis was conducted. Only 1 trial met the inclusion criteria, involving a total of 30 participants, 15 undergoing the percutaneous technique and 15 treated by the standard femoral cut-down approach. There were no significant differences between the 2 groups at baseline. No mortality or failure of aneurysm exclusion was observed in either group. Three wound infections occurred in the standard femoral cut-down group, whereas none was observed in the percutaneous group. This was not statistically significant. Only 1 major complication was observed in the study, a conversion to the cut-down technique in the percutaneous access group. No long-term outcomes were reported. One episode of a bleeding complication was reported in the percutaneous group. Significant differences were detected in surgery time (percutaneous 86.7 ± 27 minutes versus conventional 107.8 ± 38.5 minutes; p < 0.05). The included study had a small sample size and failed to report adequately the method of randomization, allocation concealment and the pre-selected outcomes. The authors concluded that only 1 small study was identified, which did not provide adequate evidence to determine the safety and effectiveness of the percutaneous approach compared with endovascular aneurysm repairs. This review has identified a clear need for further research into this potentially beneficial technique. One ongoing study was identified in the search, which may provide an improved evidence base in the future.
Glebova et al (2015) noted that a recent prospective study found that FEVAR was safe and effective in appropriately selected patients at experienced centers. As this new technology is disseminated to the community, it will be important to understand how this technology compares with standard EVAR. These researchers compared the outcomes of FEVAR versus EVAR of AAAs. The American College of Surgeons-National Surgical Quality Improvement Program database from 2005 to 2012 was queried for AAAs (International Classification of Diseases, ninth Revision code 441.4). Patients were stratified according to procedure (FEVAR versus EVAR). A bi-variate analysis was done to assess pre-operative and intra-operative risk factors for post-operative outcomes; 30 -day post-operative mortality and complication rates were described for each procedure type. Multi-variable logistic regression was performed to assess the association between the type of procedure and the risk of post-operative complications. A total of 458 patients underwent FEVAR and 19,060 patients underwent EVAR for AAA. Patients undergoing FEVAR were older (p = 0.02) and less likely to have a bleeding disorder (p = 0.046). Otherwise, the incidence of co-morbidities in both groups was similar. Fenestrated EVAR was associated with increased median operative time (156 versus 137 minutes; p < 0.001), and average post-operative length of stay (3.3 versus 2.8 days; p = 0.03). There was a statistically significant increase in overall complications (23.6 % versus 14.3 %; p < 0.001) and post-operative transfusions (15.3 % versus 6.1 %, p < 0.001) and trends toward increased cardiac complications (2.2 % versus 1.3 %; p = 0.09) and the need for dialysis (1.5 % versus 0.8 %; p = 0.08) in the FEVAR group. Mortality (2.4 % versus 1.5 %; p = 0.12) was not statistically different. On multi-variable analysis, FEVAR remained independently associated with the need for post-operative transfusions when operative time was less than 75th percentile (adjusted OR, 1.72; 95 % CI: 1.09 to 2.72; p = 0.02) as well as when operative time was greater than 75th percentile for respective procedures (adjusted OR, 5.33; 95 % CI: 3.55 to 8.00; p < 0.001). The authors concluded that patients undergoing FEVAR are more likely than patients undergoing EVAR to receive blood transfusions post-operatively and are more likely to sustain post-operative complications. They noted that although mortality was similar, trends toward increased cardiac and renal complications may suggest the need for judicious dissemination of this new technology. They stated that future research with larger number of FEVAR cases are needed to determine if these associations remain.
Capoccia and Riambau (2015) stated that inflammatory AAA (IAAA) is a rare but potentially life-threatening condition that is characterized by marked thickening of the aortic wall, peri-aneurysmal and retro-peritoneal fibrosis, and dense adhesions of adjacent abdominal organs. The pathogenesis of IAAA remains an enigma. The principal objective of invasive or surgical therapy of AAAs is prevention or correction of aortic rupture. Prevention or treatment of AAA rupture by open or endovascular repair is proven by numerous studies published in the literature. However, treatment of IAAA poses a different challenge to surgeons compared with traditional atherosclerotic AAA because of the potential for iatrogenic injury in open repair or, alternatively, potential increased inflammatory response to endoprosthesis implantation. These investigators evaluated the effects of elective endovascular versus open repair for IAAA. The Cochrane Peripheral Vascular Diseases Group Trials Search Co-ordinator (TSC) searched the Specialised Register (April 2015) and the Cochrane Register of Studies (CRS) (Issue 3, 2015). The TSC searched trial databases for details of ongoing and unpublished studies. The authors sought all published and unpublished RCTs, quasi-RCTs and controlled clinical trials comparing results of elective endovascular or open repair of IAAAs without language restriction. Both review authors independently assessed studies identified for potential inclusion in the review. They planned to conduct data collection and analysis in accordance with the Cochrane Handbook for Systematic Review of Interventions. These researchers identified no studies that met the inclusion criteria. The authors concluded that they found no published RCTs, quasi RCTs or controlled clinical trials comparing open repair and elective endovascular repair for IAAA, assessing immediate (30-day), intermediate (up to 1-year follow-up) and long-term (more than 1-year follow-up) mortality or complications rates. They stated that high-quality studies evaluating the best treatment for inflammatory abdominal aneurysm repair are needed.
Walker et al (2015) reported their long-term experience with type II endoleaks (T2Ls) management in a large multi-center registry. Between 2000 and 2010, a total of 1,736 patients underwent EVAR, and these investigators recorded the incidence of T2L. Primary outcomes were mortality and aneurysm-related mortality (ARM). Secondary outcomes were change in aneurysm sac size, major adverse events, and re-intervention. During the follow-up (median of 32.2 months; interquartile range [IQR] of 14.2 to 52.8 months), T2L was identified in 474 patients (27.3 %). There were no late AAA ruptures attributable to a T2L. Overall mortality (p = 0.47) and ARM (p = 0.26) did not differ between patients with and without T2L. Sac growth (median of 5 mm; IQR of 2 to 10 mm) was seen in 213 (44.9 %) of the patients with T2L. Of these patients with a T2L and sac growth, 36 (16.9 %) had an additional type of endoleak. Of all patients with T2L, 111 (23.4 %) received re-interventions, including 39 patients who underwent multiple procedures; 74 % of the re-interventions were performed in patients with sac growth. Re-interventions included lumbar embolization in 66 patients (59.5 %), placement of additional stents in 48 (43.2 %), open surgical revision in 14 (12.6 %), and direct sac injection in 22 (19.8 %). The re-intervention was successful in 35 patients (31.5 %). After patients with other types of endoleak were excluded, no difference in overall all-cause mortality (p = 0.57) or ARM (p = 0.09) was observed between patients with T2L-associated sac growth who underwent re-intervention and those in whom T2L was left untreated. The authors concluded that in their multi-center EVAR registry, overall all-cause mortality and ARM were unaffected by the presence of a T2L. Moreover, patients who were simply observed for T2L-associated sac growth had aneurysm-related outcomes similar to those in patients who underwent re-intervention. They stated that their future work will investigate the most cost-effective ways to select patients for intervention besides sac growth alone.
An UpToDate review on "Endovascular repair of abdominal aortic aneurysm" (Chaer, 2015) states that "Contraindications – Endovascular repair of AAA is contraindicated in patients who do not meet the anatomic criteria required to place any of the available endografts. Adverse anatomic features include suprarenal or juxta-renal AAA, small caliber vessels, circumferential aortic calcification, and extensive tortuosity. Depending upon the location of the main and accessory renal arteries, endovascular repair may also be contraindicated for the management of AAA associated with horseshoe kidney. A variety of next-generation devices are being developed to treat suprarenal and juxt-arenal abdominal aortic aneurysms. A relative contraindication to endovascular aneurysm repair (EVAR) is the inability to comply with the required post-EVAR surveillance. Whether younger patients (less than 60 years of age) who are not at high risk for open surgery should undergo open surgical repair versus EVAR remains controversial. Surveillance over an extended period of time exposes the patient to greater levels of cumulative radiation, and EVAR does not completely eliminate the risk of future aortic rupture. Guidelines from major medical and surgical societies emphasize an individualized approach when choosing endovascular repair, taking into account the patient's age and risk factors for perioperative morbidity and mortality".
CT Surveillance after Endovascular (Stent) Aortic Repair
MedSolutions guidelines recommend CT surveillance after endovascular (stent) aortic repair at 1 month, 6 months, and 12 months following repair, then every year.
Multi-Branched Stent-Grafts
- JRAAAs and
- TAAAs.
Resources were searched from inception to October 2013, including Medline (OvidSP), Embase (OvidSP) and the Cochrane Central Register of Controlled Trials (Wiley) and, additionally, for cost-effectiveness, NHS Economic Evaluation Database (NHS EED; Wiley) and EconLit (EBSCOhost). Conference abstracts were also searched. Studies were included based on an intervention of either fEVAR or bEVAR and a comparator of either OSR or no surgery. For clinical effectiveness, observational studies were excluded only if they were not comparative, i.e., explicitly selected on the basis of prognosis. For clinical effectiveness, searches retrieved 5,253 records before de-duplication. Owing to overlap between the databases, 1,985 duplicate records were removed. Of the remaining 3,268 records, based on titles and abstracts, 3,244 records were excluded, leaving 24 publications to be ordered. All 24 studies were excluded as none of them satisfied the inclusion criteria – 16 studies were excluded on study design, 6 on intervention and 2 on comparator; 5 out of 16 studies excluded on study design reported a comparison. However, all of the studies acknowledged that they had groups that were not comparable at baseline given that they had selectively assigned younger, fitter patients to OSR. Therefore, these studies were considered "non-comparative". For cost-effectiveness, searches identified 104 references before de-duplication. Owing to overlap between the databases, 34 duplicate records were removed. Of the remaining 70 records, 7 were included for the full assessment based on initial screening. After a full-text review, no studies were included. Because of the lack of clinical effectiveness evidence and difficulty in estimating costs given the rapidly changing and variable technology, a cost-effectiveness analysis (CEA) was not performed. Instead a detailed description of modelling methods was provided. The authors concluded that despite a thorough search, no studies could be found that met the inclusion criteria. All studies that compared either fEVAR or bEVAR with either OSR or no surgery explicitly selected patients based on prognosis, i.e., essentially the populations for each comparator were not the same. The authors recommended that at least 1 clinical trial to provide an unbiased estimate of effect for fEVAR/bEVAR compared with OSR or no surgery. This trial should also collect data for a CEA.
Michel and co-workers (2015) compared 30-day outcomes and costs of fEVAR, bEVAR and OSR for the treatment of complex AAA and TAAA. The multi-center, prospective, registry WINDOW Trial was designed to evaluate fEVAR/bEVAR in high-risk patients with para-renal AA (PRAA)/JRAAA, and infra-diaphragmatic and supra-diaphragmatic TAAA. A control group of patients treated by OSR was extracted from the national hospital discharge database. The primary end-point was 30-day mortality; secondary end-points included severe complications, length of stay, and costs. Mortality was assessed by survival analysis and univariate and multivariate Cox regression analyses using pre- and post-operative characteristics. Bootstrap methods were used to estimate the cost-effectiveness of fEVAR/bEVAR versus OSR. A total of 268 cases and 1,678 controls were included. There was no difference in 30-day mortality (6.7 % versus 5.4 %, p = 0.40), but costs were higher with fEVAR/bEVAR (€38,212 versus €16,497, p < 0.001). After group stratification, mortality was similar with both treatments for PRAA/JRAAA (4.3 % versus 5.8 %, p = 0.26) and supra-diaphragmatic TAAA (11.9 % versus 19.7 %, p = 0.70), and higher with fEVAR/bEVAR for infra-diaphragmatic TAAA (11.9 % versus 4.0 %, p = 0.010). Costs were higher with fEVAR/bEVAR for PRAA/JRAAA (€34,425 versus €14,907, p < 0.0001) and infra-diaphragmatic TAAA (€37,927 versus €17,530, p < 0.0001), but not different for supra-diaphragmatic TAAA (€54,710 versus €44,163, p = 0.18). The authors concluded that fEVAR/bEVAR did not appear justified for patients with PRAA/JAAAA and infra-diaphragmatic TAAA fit for OSR; but may be an attractive option for patients with PARR/JRAAA not eligible for surgery and patients with supra-diaphragmatic TAAA.
Eagleton and colleagues (2016) evaluated the technical and clinical outcomes of fEVAR/bEVAR for extensive type II and III TAAA. Data from 354 high-risk patients enrolled in a physician-sponsored investigational device exemption (IDE) trial (2004 to 2013) undergoing fEVAR/bEVAR for type II and III TAAA were evaluated. Technical success, peri-operative clinical outcomes, and mid-term outcomes (36 months) for branch patency, re-intervention, aneurysm-related death, and all-cause mortality were analyzed. Data are presented as mean ± standard deviation (S.D.) and were assessed using Kaplan-Meier, univariate, and multivariate analysis; fEVAR/bEVAR incorporating 1,305 fenestration/branches were implanted with 96 % of target vessels successfully stented. Completion aortography showed 2.8 % patients had a type I or III endoleak. Procedure duration (6.0 ± 1.7 versus 5.5 ± 1.6 hours; p < 0.01) and hospital stay (13.1 ± 10.1 versus 10.2 ± 7.4 days; p < 0.01) were longer for type II TAAA. Peri-operative mortality was greater in type II repairs (7.0 % versus 3.5 %; p < 0.001). Permanent spinal cord ischemia (SCI) occurred in 4 % and renal failure requiring hemodialysis occurred in 2.8 % of patients; 27 branches (7.6 %) required re-intervention for stenosis or occlusion; and celiac artery, superior mesenteric artery, and renal artery secondary patency at 36 months was 96 % (95 % CI: 0.93 to 0.99), 98 % (95 % CI: 0.97 to 1.0), and 98 % (95 % CI: 0.96 to 1.0), respectively. A total of 80 endoleak repairs were performed in 67 patients, including 55 branch-related endoleaks, 4 type Ia, 5 type Ib, and 15 type II endoleaks. At 36 months, freedom from aneurysm-related death was 91 % (95 % CI: 0.88 to 0.95), and freedom from all-cause mortality was 57 % (95 % CI: 0.50 to 0.63). The treatment of type II TAAA (p < 0.01), age (p < 0.01), and chronic obstructive pulmonary disease (p < 0.05) negatively affected survival. The authors concluded that fEVAR/bEVAR is a robust therapeutic option for patients at increased risk for conventional repair of extensive TAAAs. Technical success and branch patency were excellent, but some patients will require re-intervention for branch-related endoleak. Aneurysm extent portends a higher risk of peri-operative and long-term morbidity and mortality. They stated that additional efforts are needed to improve outcomes and understand the utility of this therapeutic option in the general TAAA population.
In a systematic review and meta-analysis, Hu and colleagues (2016) evaluated the available literature on endovascular repair of TAAA and para-renal aortic aneurysm (PRAA) using multi-branched stent-grafts. Medline, Embase, and Cochrane databases were searched between January 2001 and June 2015 to identify articles related to the use of multi-branched stent-grafts for the treatment of TAAA and PRAA. Articles with less than 4 cases and those on juxta-renal aortic aneurysms were excluded. Meta-analyses were conducted to evaluate 30-day mortality, all-cause mortality, SCI, renal insufficiency, endoleak, target vessel patency, and re-intervention. Of 370 articles screened, only 4 articles encompassing 185 patients (mean age of 71.1 years; 137 men) were aligned with the inclusion criteria. There were 23 PRAAs; the mean aneurysm diameter was 64.5 mm. The Crawford TAAA classification was 10 type I, 47 type II, 37 type III, 58 type IV, and 9 type V; there was 1 Stanford type B dissection in association with a large TAAA. Results of the meta-analyses are reported as proportions and 95 % CI. Pooled analysis indicated a technical success rate of 98.9 %. As study heterogeneity was significant, random effects models were used for meta-analysis. The rate for 30-day mortality was 9 % (95 % CI: 3 % to 19 %), for all-cause mortality 27 % (95 % CI: 17 % to 38 %), endoleaks 10 % (95 % CI: 1 % to 25 %), target vessel patency 98 % (95 % CI: 95 % to 99 %), SCI 17 % (95 % CI: 1 % to 26 %), irreversible SCI 6 % (95 % CI: 3 % to 10 %), renal insufficiency 15 % (95 % CI: 0.8 % to 41 %), and re-interventions 21 % (95 % CI: 4 % to 47 %). The authors concluded that use of multi-branched stent-grafts in the treatment of TAAAs and PRAAs appeared to be feasible and safe based on satisfactory early outcomes in the limited literature available to date. Moreover, they stated that long-term surveillance and further studies are needed to determine the durability of this technique.
Furthermore, an UpToDate review on "Endovascular repair of abdominal aortic aneurysm" (Chaer, 2016) states that "Advanced devices and techniques – When aneurysmal disease is more extensive, involving the visceral vessels proximally or associated with common or hypogastric artery aneurysms, the complexity of the required endovascular or open repair increases. Fenestrated and branched graft technology is under investigation to manage more challenging anatomy without the need for surgical debranching. The early results using these endografts have been promising, with high rates of successful exclusion of juxta-renal and thoracoabdominal aneurysms, but with an increased risk of visceral artery or stent-branch occlusion".
Intravenous Heparin During Ruptured Abdominal Aortic Aneurysmal Repair
Lammy and colleagues (2016) noted that there have been enormous advances in the screening, diagnosis, intervention and overall prognosis of AAAs in the last decade, but despite these, rAAAs still cause around 3,500 to 6,000 deaths in England and Wales each year. Open repair remains standard treatment for rAAA in most centers but increasingly EVAR is being adopted. This has a 30-day post-operative mortality of 40 %, which has remained static despite surgical, anesthetic and critical care advances. One significant change to current practice for elective repairs of AAAs, as opposed to emergency repairs of rAAAs, has been the introduction of intravenous heparin. This provides a protective effect against cardiac and thrombotic disease in the post-operative period. This practice has not gained widespread acceptance for emergency repairs of rAAA even though a reduction in mortality and morbidity has been demonstrated in elective repairs. In a Cochrane review, these researchers examined the effect of intravenous heparin on all-cause mortality in rAAA management in patients undergoing an emergency repair. The secondary objectives were to evaluate the effect of intravenous heparin in rAAA management on the incidence of general arterial disease (e.g., cardiovascular, cerebral, pulmonary and renal pathologies) in patients undergoing emergency repair. The Cochrane Vascular Information Specialist (CIS) searched the Specialized Register (December 2015). In addition the CIS searched CENTRAL;2015, Issue 11). The CIS searched clinical trials registries for details of ongoing or unpublished studies. These researchers sought all published and unpublished RCTs and controlled clinical trials (CCTs) of intravenous heparin in rAAA repairs (including parallel designs). Two review authors independently assessed studies identified for potential inclusion in the review. They used standard methodological procedures in accordance with the Cochrane Handbook for Systematic Review of Interventions. They identified no RCTs or CCTs that satisfied the inclusion criteria. The authors concluded that they identified no RCTs or CCTs of intravenous heparin in rAAA repairs (including parallel designs). Thus, they were unable to evaluate the effect of intravenous heparin on all-cause mortality and incidence of general arterial disease in patients undergoing an emergency repair. They stated that a RCT is needed to address this question in rAAA management as there is no high quality evidence.
Pre-Operative Inferior Mesenteric Artery Embolization to Reduce the Rate of Type II Endoleak Following Endovascular Abdominal Aortic Aneurysm Repair
Brown and associates (2016) stated that type II endoleaks are the most common endovascular complications of EVAR; however, there has been a divided opinion regarding their significance in EVAR. Some advocate a conservative approach unless there is clear evidence of sac expansion, while others maintain early intervention is best to prevent adverse late outcomes such as rupture. There is a lack of Level I Evidence in this challenging group of patients, and due to a low event rate of complications, large numbers of patients would be needed in well-designed trials to fully understand the natural history of type II endoleak. These investigators noted that due to a lack of evidence regarding the natural history of type II endoleaks and their association with adverse outcomes such as sac expansion and rupture, intervention is typically offered for persistent endoleaks and for those which demonstrate sac expansion (greater than 10 mm) or increased intra-sac pressure. Unfortunately, optimal thresholds are not clear. Moreover, they stated that future studies should aim to compare not only different approaches to the treatment of type II endoleak, but also different embolents. More focus is needed on long-term outcomes and complications rather than technical success alone. A multi-center registry of type II endoleak intervention and outcomes would be ideal to uncover solutions to some of the remaining challenges in the management of this challenging group of patients.
- those who did not undergo IMA embolization (control) before EVAR, and
- those who did.
Rates of type II endoleaks, aneurysm sac regression, and secondary interventions were analyzed. A total of 620 patients from 6 studies were analyzed, including 258 patients who underwent an attempted IMA embolization before EVAR with a cumulative success rate of 99.2 % (range of 93.8 % to 100 %). There was 1 fatality associated with IMA embolization. A meta-analysis showed that pre-operative IMA embolization protected against type II endoleaks compared to the control group (OR, 0.31 [0.17 to 0.57]; p < 0.001, I2 = 43 %). Furthermore, the rate of secondary intervention was significantly lower in the treatment group (OR, 0.12 [0.004 to 0.36]; p < 0.001, I2 = 0 %). After IMA embolization, type II endoleak resulted from patent lumbar arteries in all 62 patients with persistent endoleak. The authors concluded that pre-operative embolization of the IMA protected against the development of type II endoleaks and secondary interventions and may potentially lead to a rapid aneurysm sac regression. The procedure can be performed with a high technical success rate and minimal complications and should be considered in patients with IMA greater than 3 mm before EVAR. Moreover, they stated that a randomized trial is needed to clearly delineate the clinical significance of this technique.
Fenestrated Prosthesis for Repair of Abdominal Aortic Aneurysms
Graves and Jackson (2015) noted that endovascular abdominal aortic aneurysm repair (EVAR) provides an attractive alternative to traditional open techniques. Endovascular repair is frequently limited by aortic aneurysm neck angulation, the absence of an adequate infra-renal neck, and the need for internal iliac preservation. Several devices have been created to incorporate visceral artery segments as well as preserve the internal iliac artery, thus broadening the patient population suited for endovascular repair. These researchers reviewed the current literature regarding fenestrated devices, branch devices, off-the-shelf devices, and physician-modified devices. They also highlighted the iliac branch stent grafts currently on trial for internal iliac artery preservation. The authors concluded that data thus far have suggested that these devices will be both a safe and effective option for anatomically challenging abdominal aortic aneurysms (AAAs). They noted that fenestrated and branched stent grafts have greatly broadened therapeutic options for aortic aneurysmal disease and their clinical use will expand as technologies are advanced
Glorion et al (2016) stated that despite technical advances of fenestrated and branched endografts, endovascular exclusion of aneurysms involving renal, visceral, and/or supra-aortic branches remains a challenge. In-situ fenestration (ISF) of standard endografts represents another endovascular means to maintain perfusion to such branches. These investigators reviewed current indications, technical descriptions, and results of ISF. A review of the English language literature was performed in Medline databases, Cochrane Database, Web of Science, and Scopus using the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) guidelines. A total of 67 relevant papers were selected; 33 papers were excluded, leaving 34 articles as the basis of the present review. Most experimental papers evaluated ISF feasibility and assessed the consequences of ISF on graft fabric. Regarding clinical papers, 73 ISF procedures have been attempted in 58 patients, including 26 (45 %) emergent and 3 (5 %) bailout cases; 65 (89 %) ISF were located at the level of the arch, and 8 (11 %) in the abdominal aorta. Graft perforation was performed by physical, mechanical, or unspecified means in 33 (45 %), 38 (52 %), and 2 vessels (3 %), respectively. ISF was technically successful in 68/73 (93 %) arteries. At 30 days, 2 (3.4 %) patients died in the setting of an aorto-bronchial fistula and an aorto-esophageal fistula, respectively. No post-operative death, major complication, or endoleak was seen as secondary to the ISF procedure. With follow-up between 0 and 72 months, 4 (6.9 %) late deaths were noted, unrelated to the aorta; 1 (1.7 %) LSA stent was stenosed without symptoms. The authors concluded that although there may be publication bias, multiple techniques were described to perform ISF with satisfactory short-term results. Long-term data remain scarce. They stated that aortic endograft ISF is an off-label procedure that should not be used outside emergent bailout techniques or investigational studies. These researchers stated that a comparison with alternative techniques of preserving aortic side branches is needed.
Blankensteijn et al (2017) noted that the fenestrated Anaconda endograft (Vascutek, Renfrewshire, Scotland) was introduced in 2010 and showed promising short-term results with high technical success and low morbidity rates. These researchers presented the mid-term results, with a minimum of 12 months follow-up, for all patients treated with the fenestrated Anaconda endograft in the Netherlands. Patients treated with the fenestrated Anaconda endograft between May 2011 and February 2015 were included. Follow-up consisted of computed tomography angiography at 1 month and 1 year, and duplex ultrasound yearly thereafter with additional computed tomography angiography if indicated using a standard protocol. A total of 60 patients were included; 48 patients (80.0 %) were treated for juxta-renal aneurysms, and 12 (20.0 %) were short-neck infra-renal aneurysms. Mean aneurysm size was 64 ± 9 mm. A total of 140 fenestrations were incorporated. Median follow-up was 16.4 months (inter-quartile range [IQR], 11.9 to 27.4). The 30-day mortality was 3.4 % (n = 2). Kaplan-Meier estimates for 1-year, 2-year, and 3-year survival were 91.4 %, 89.5 %, and 86.3 %, respectively, without aneurysm-related mortality during follow-up. Main body primary and secondary endograft patencies were 98.3 % and 100 %, respectively. Target vessel primary and secondary patencies were 95.0 % and 98.6 %, respectively. Early type IA endoleaks occurred in 7 patients (11.7 %) and spontaneously resolved in all patients. At 1-year follow-up 4 (6.7 %) type II endoleaks persisted; 1 patient experienced aneurysm rupture because of a late type III endoleak attributable to a dislodged renal stent and subsequently underwent successful conversion to open surgery. The authors concluded that fenestrated Anaconda is a viable therapeutic option for complex abdominal aortic aneurysms. Acceptable mortality and morbidity and low re-intervention rates contribute to good mid-term results. Occurrence of early type I endoleak was relatively common, but these resolved spontaneously in all patients. Long-term follow-up data are needed.
Timaran et al (2017) stated that fenestrated endovascular aneurysm repair (FEVAR) is an alternative to open repair of complex aortic aneurysms. Despite promising short-term results, the technical complexities of this procedure remain a considerable challenge. The risk of technical failure with loss of visceral or renal arteries is ubiquitous even in the most experienced hands, and thus many patients with unfavorable anatomy are frequently denied FEVAR. These researchers have adopted a new technique for FEVAR that involves retrograde brachial artery access and step-wise deployment of the endograft during target vessel catheterization, overcoming many anatomic limitations encountered from a trans-femoral (TF) approach. This technique, termed sequential catheterization amid progressive endograft deployment, has become the authors’ preferred approach for FEVAR. Moreover, these investigators noted that currently available Food and Drug Administration-approved fenestrated endografts may not be amenable to sequential catheterization amid progressive endograft deployment as this technique requires pre-loaded wires incorporated into the endografts.
Falkensammer et al (2017) FEVAR allows an extension of the proximal sealing zone above the renal arteries to an adequate, healthier segment of the aorta. This feature makes FEVAR an option to treat patients with a diseased aortic neck or type Ia endoleak after EVAR. These investigators presented a single-center experience with FEVAR for patients with an abdominal aortic endograft in-situ compared with primary FEVAR. A prospectively held database on FEVAR patients treated with the fenestrated Anaconda device (Vascutek/Terumo, Inchinnan, Scotland, United Kingdom) at the authors’ institution was screened for individuals who had previously undergone EVAR. Between April 1, 2013, and July 31, 2016, a total of 94 fenestrated Anaconda devices were implanted at the authors’ institution; 12 patients with prior EVAR were treated for pathology of the proximal neck: type I endoleak (n = 7), for stent migration with aneurysm progression but no visible endoleak (n = 2), and progressive aortic disease at the level of the visceral segment (n = 3). When re-do cases and primary FEVARs were compared, primary technical success rates were 58.3 % and 87.8 % (p = 0.02) and primary functional success rates were 91.7 % and 95.1 %, respectively (p = 0.62). Peri-operative rate of major deployment-related (14.6 % and 16.7 %) and systemic complications (8.5 % and 8.3 %) as well as 30-day mortality (6.1 % and 0 %; p = 0.5) were comparable between groups. After an average follow-up interval of 10 months (range of 0 to 43 months), no late occlusions of connecting stents were observed. The late re-intervention rates were 11.0 % and 16.7 %, respectively (p = 0.57). The authors concluded that the risk of a failure to cannulate 1 or more visceral arteries through the respective fenestrations was increased in patients who had previously undergone EVAR. This was most likely caused by increased friction between the fenestrated endograft and the failing graft in-situ, which may impair the adaption of the unsupported Anaconda device to the aortic wall. As a consequence, fenestrations may not line up perfectly at the respective openings of the visceral or renal arteries, and folding of the fabric may be increased, making cannulation of the fenestrations more difficult.
Georgiadis et al (2017) noted that the establishment use of fenestrated and branched devices to treat complex aortic aneurysms as a first-line management option has been previously reported. These researchers reviewed the current literature of the use of fenestrated devices to treat complex abdominal and thoraco-abdominal type IV aortic aneurysms as a first-line management option. A literature search was performed. This review particularly focused on all the aspects of the use and results of fenestrated stent-grafts (SGs) in patients with complex abdominal and type IV thoraco-abdominal aortic aneurysms and summarized the available evidence. The use of fenestrated SGs for complex aortic aneurysm disease has grown enormously the last years; SGs with fenestrations, scallops and occasionally branches have to be customized to each patient's anatomy and precisely deployed in-vivo. Bridging covered stents between the main graft and the target vessels eventually exclude the aneurysm preserving blood flow to vital organs. Multiple device morphologies have been used incorporating the visceral arteries in various combinations. High technical success rates and satisfactory peri-operative outcomes were described as well as mid- and long-term success and durability including target vessel and branch stent perfusion, data emerging mainly from high volume specialized centers. Percentage of target vessel successfully perfused was reported between 90.5 and 100%; 30-day mortality was reported between 0 % and 4.1 % while the lowest type 1 or type 3 endoleak rates were 2.5 % and 1.3 %, respectively. Migration rates were kept below 3 %. Renal failure was the most frequent complication reported. Advances in SG technology have reduced but not eliminated secondary interventions. Outcomes depend mostly on proximal extension of the disease which increases also the complexity of the repair. High level of expertise and organizational facilities are required for better mid- and long-term outcomes. The authors concluded that fenestrated EVAR (fEVAR) has been shown to be safe and effective in the short and mid-term follow-up. Remaining issues including secondary interventions and the need for follow-up are still within the range of those reported for EVAR. These, continue to plague fEVAR for complex abdominal or type IV thoraco-abdominal aortic aneurysms.
Farber et al (2017) reported prospective data of an off-the-shelf fenestrated endograft (Zenith p-Branch; Cook Medical, Bloomington, IN) from 4 centers for the treatment of patients with para-renal AAAs. Data were combined from 4 single-center investigational studies conducted in the United States and Europe. The p-Branch endograft consists of a proximal off-the-shelf component incorporating a scallop for the celiac artery, a superior mesenteric artery fenestration, and 2 conical pivot fenestrations to preserve flow to the renal vessels. The device is available in 2 configurations, a left renal fenestration at the same (configuration A) or lower (configuration B) longitudinal position than the right to accommodate varied anatomy of the patients. Between August 2011 and September 2015, a total of 76 patients (82 % men; mean age of 72 years; 65 elective and 11 emergent) were enrolled, with 55 % implanted with option A and 45 % with B. The device was deployed successfully in all patients, and stents were placed in all target vessels except in 3 cases (1 elective, 2 emergent): a left kidney was sacrificed in 1 patient, and a right renal artery was left un-stented in 2 patients during the index procedure. There was no 30-day mortality. During follow-up (mean of 25 ± 13 months), 10 late deaths occurred (6 elective, 4 emergent; none related to device or procedure), and there were no ruptures or conversions to open repair; 2 patients experienced bowel ischemia; 1 case resolved with non-operative treatment and 1 required superior mesenteric artery and celiac artery angioplasty and stent placement. Renal artery occlusion occurred in 8patients (11 %) and was deemed procedure related in 63 % (5/8) of these patients; 4 of these were successfully intervened on with preservation of renal function. The overall renal insufficiency incidence was 7 % (5/76); 1 patient developed renal failure requiring dialysis. The authors concluded that early results incorporating learning curves for physicians with a new device and delivery system indicated that the use of the Zenith p-Branch device is feasible and safe; long-term follow-up is needed to assess the effectiveness and durability of this treatment strategy and to refine the indications for use.
Oderich et al (2017) examined outcomes of manufactured fenestrated and branched endovascular aortic repair (F-BEVAR) endografts based on supra-celiac sealing zones to treat para-renal aortic aneurysms and thoraco-abdominal aortic aneurysms (TAAAs). A total of 127 patients (91 men; mean age of 75 ± 10 years old) were enrolled in a prospective, non-randomized, single-center study using manufactured F-BEVAR (November 2013 to March 2015). Stent design was based on supra-celiac sealing zone in all patients with greater than or equal to 4 vessels in 111 (89 %). Follow-up included clinical examination, laboratory studies, duplex ultrasound, and computed tomography imaging at discharge, 1 month, 6 months, and yearly. End points adjudicated by independent clinical event committee included mortality, major adverse events (any mortality, MI, stroke, paraplegia, acute kidney injury, respiratory failure, bowel ischemia, blood loss of more than 1 L), freedom from re-intervention, and branch-related instability (occlusion, stenosis, endoleak or disconnection requiring re-intervention), target vessel patency, sac aneurysm enlargement, and aneurysm rupture. There were 47 para-renal, 42 type IV, and 38 type I-III TAAAs with mean diameter of 59 ± 17 mm. A total of 496 renal-mesenteric arteries were incorporated by 352 fenestrations, 125 directional branches, and 19 celiac scallops, with a mean of 3.9 ± 0.5 vessels per patient. Technical success of target vessel incorporation was 99.6 % (n = 493/496). There were no 30-day or in-hospital deaths, dialysis, ruptures or conversions to open surgical repair. Major adverse events (AEs) occurred in 27 patients (21 %). Paraplegia occurred in 2 patients (1 type IV, 1 type II TAAAs). Follow-up was greater than 30 days in all patients, greater than 6 months in 79, and greater than 12 months in 34. No patients were lost to follow-up. After a mean follow-up of 9.2 ± 7 months, 23 patients (18 %) had re-interventions (15 aortic, 8 non-aortic), 4 renal artery stents were occluded, 5 patients had type Ia or III endoleaks, and none had aneurysm sac enlargement. Primary and secondary target vessel patency was 96 % ± 1 % and 98 % ± 0.7 %, respectively at 1 year. Freedom from any branch instability and any re-intervention was 93 % ± 2 % and 93 % ± 2 % at 1 year, respectively. Patient survival was 96 % ± 2 % at 1 year for the entire cohort. The authors concluded that endovascular repair of para-renal aortic aneurysms and TAAAs, using manufactured F-BEVAR with supra-celiac sealing zones, was safe and efficacious; however, long-term follow-up is needed to assess the impact of 4-vessel designs on device-related complications and progression of aortic disease.
Zeinali et al (2018) state that "more complex thoracoabdominal and juxta-renal abdominal aortic aneurysms can now be treated with new stent grafts and techniques. Fenestrated endovascular aortic aneurysm repair (FEVAR) with fenestrated stent grafts was commenced in our center after hundred cases of endovascular aortic repair, and so far 4 serial complex cases deemed inoperable (2 juxta-renal abdominal aortic aneurysms, 1 thoracoabdominal aneurysm, and 1 thoracoabdominal pseudoaneurysm) have been treated with FEVAR. All these patients needed custom-made stent grafts, which were designed and implanted successfully under general anesthesia in the catheterization laboratory. They were followed up for more than 1 year, with a median follow-up period of 23.0 months. There were no major in-hospital or short-term complications. Only 1 patient had midterm unilateral iliac artery thrombosis, which was successfully managed interventionally. Computed tomography angiography at 1 year’s follow-up showed that the stent grafts were patent and their visceral branch cover stents had no endoleak." Due to the limited number of procedures and variety in patients’ conditions and clinical settings, reporting the outcome of every procedure is still demanding. This study was conducted at a single-center with limited number of cases in Iran.
Oderich from the Mayo Clinic (2018) stated that "Endovascular repair of complex aneurysms involving the visceral arteries has become a reality. Fenestrated stent-grafts are increasingly utilized to treat para-renal and thoraco-abdominal aneurysms. The technique is safe, effective, and can be performed with high technical success and low risk of complications by experienced physicians. More than 8,000 patients have been treated by fenestrated and branched stent-grafts and more than 5,500 by iliac branch devices. Based on results of single-center reports, systematic reviews, and the U.S. prospective trial, technical success is high (greater than 98 %) with low rates of type I and type III endoleak, migration, aneurysm rupture, and conversion to open repair. Branch patency averages greater than 95 % with covered stents. These results should serve as a benchmark for comparison with alternative endovascular techniques of branch vessel incorporation, including debranching, snorkel, and physician modified grafts. Long-term comparison with open surgical repair is still required".
Wang et al (2018) stated that the Zenith Fenestrated (ZFEN; Cook Medical, Bloomington, IN) aortic stent graft system was approved for commercial use by the Food and Drug Administration (FDA) in April 2012. These researchers report their single-center experience of 100 consecutive patients treated with the ZFEN platform from October 2012 to March 2017. A retrospective review of their prospectively maintained fenestrated endovascular aneurysm repair (FEVAR) database at a tertiary care academic institution located in the Midwest United States was performed for descriptive analysis. All continuous variables were reported as a mean ± standard deviation and compared using 2-sided Student t-tests. Categorical variables were compared using 2-sided Fisher exact tests. All but 1 of the procedures were elective in nature. Overall intra-operative characteristics included a mean blood loss (estimated blood loss) of 388 ± 385 ml, fluoroscopy time of 63 ± 30 minutes, radiation dose of 437 ± 272 rad, contrast material volume of 99 ± 36 ml, and operative time of 236 ± 87 minutes. Average number of visceral arteries stented was 2.1 ± 0.5. Technical success was achieved in 98 % of the patients. Statistically significant (p < 0.05) improvement in estimated blood loss (2.1-fold) was observed in the second half of their series. Interestingly, no improvements were made in terms of fluoroscopy time, radiation exposure, contrast material use, or operative time. However, procedural difficulty increased in the last half by number of visceral arteries stented as a surrogate (1.9 versus 2.2; p < 0.05). Mean length of stay (LOS) was 3.6 ± 4.3 days. Peri-operative mortality at 30 days was 2 %. Peri-operative morbidity included a 5 % incidence of any bowel ischemia, 1 % of spinal cord ischemia, 3 % of renal failure requiring hemodialysis, 1 % of stroke, and 4 % of myocardial infarction (MI). Average follow-up was 1.7 ± 1.4 years. Re-intervention during the follow-up phase was 20 %. Of the 209 visceral arteries stented, these investigators noted 6 instances of stent thrombosis, 6 of kinking or stenosis, and 1 of stent fracture in follow-up. Endoleak, most commonly type II, was present or could not be excluded in 15 % of all FEVARs at last available computed tomography angiography (CTA). The authors concluded that in their experience, FEVAR with the ZFEN system continued to be safe and effective; there was a significant rate of re-intervention observed, and close monitoring is fundamental to maintaining good clinical results. The main drawbacks of this study were its retrospective design, a single center study and mid-term results; well-designed studies with long-term follow-up are needed to validate these findings.
Also, an UpToDate review on "Endovascular repair of abdominal aortic aneurysm" (Chaer, 2018a) states that "Advanced devices and techniques – When aneurysmal disease is more extensive, involving the visceral vessels proximally or associated with common or hypogastric artery aneurysms, the complexity of the required endovascular or open repair increases. Fenestrated and branched graft technology is under investigation to manage more challenging anatomy without the need for surgical debranching. The early results using these endografts have been promising, with high rates of successful exclusion of juxta-renal and thoracoabdominal aneurysms, but with an increased risk of visceral artery or stent-branch occlusion".
An UpToDate review on "Endovascular devices for abdominal aortic repair" (Chaer, 2018b) states that "Fenestrated and branched grafts are available for clinical use in Europe, but are considered investigational devices in the United States and are still undergoing clinical trials. The Zenith Fenestrated AAA Endovascular Graft is the most studied device. Several other device manufacturers are currently working on off-the-shelf designs of branched and fenestrated grafts with clinical trials underway … When aortic disease is more extensive and involves branch vessels, the complexity of the repair and risk of complications increases. Approaches to manage more complicated anatomy include debranching procedures and the use of fenestrated and branched endografts. These endografts preserve blood flow into specific aortic branches depending upon the level of repair, but are available only for investigational use in the United States".
Armstrong et al (2014) noted that patients with large abdominal aortic aneurysms (AAAs) are usually offered reparative treatment given the high mortality risk. The investigators stated that there is uncertainty about how to treat juxta-renal AAAs (JRAAAs) or thoracoabdominal aortic aneurysms (TAAAs). Endovascular repair of an abdominal aortic aneurysm (EVAR) is often seen as safer and easier than open surgical repair (OSR). However, endovascular treatment of JRAAAs or TAAAs requires specially manufactured stent grafts, with openings to allow blood to reach branches of the aorta. The investigators explained that commissioners are receiving increasing requests for fenestrated EVAR (fEVAR) and branched EVAR (bEVAR), but it is unclear whether or not the extra cost of fEVAR or bEVAR is justified by advantages for patients. The investigators conducted a systematic evidence review to assess the clinical effectiveness, safety and cost-effectiveness of fEVAR and bEVAR in comparison with conventional treatment (i.e. no surgery) or OSR for two populations: JRAAAs and TAAAs. The systematic evidence review was funded by the National Institute for Health Research Health Technology Assessment Programme. Resources were searched from inception to October 2013, including MEDLINE (OvidSP), EMBASE (OvidSP) and the Cochrane Central Register of Controlled Trials (Wiley) and, additionally, for cost-effectiveness, NHS Economic Evaluation Database (NHS EED; Wiley) and EconLit (EBSCOhost). Conference abstracts were also searched. Studies were included based on an intervention of either fEVAR or bEVAR and a comparator of either OSR or no surgery. For clinical effectiveness, observational studies were excluded only if they were not comparative, i.e. explicitly selected on the basis of prognosis. For clinical effectiveness, searches retrieved 5253 records before deduplication. Owing to overlap between the databases, 1985 duplicate records were removed. Of the remaining 3268 records, based on titles and abstracts, 3244 records were excluded, leaving 24 publications to be ordered. All 24 studies were excluded as none of them satisfied the inclusion criteria. Sixteen studies were excluded on study design, six on intervention and two on comparator. Five out of 16 studies excluded on study design reported a comparison. However, all of the studies acknowledged that they had groups that were not comparable at baseline given that they had selectively assigned younger, fitter patients to OSR. Therefore, these studies were considered 'non-comparative'. For cost-effectiveness, searches identified 104 references before deduplication. Owing to overlap between the databases, 34 duplicate records were removed. Of the remaining 70 records, seven were included for the full assessment based on initial screening. After a full-text review, no studies were included. Because of the lack of clinical effectiveness evidence and difficulty in estimating costs given the rapidly changing and variable technology, a cost-effectiveness analysis CEA) was not performed. Instead a detailed description of modelling methods was provided. The investigators concluded that, despite a thorough search, no studies could be found that met the inclusion criteria. All studies that compared either fEVAR or bEVAR with either OSR or no surgery explicitly selected patients based on prognosis, i.e. essentially the populations for each comparator were not the same. Despite not being able to conduct a CEA, the investigators have provided detailed methods for the conduct if data becomes available. The investigators recommended at least one clinical trial to provide an unbiased estimate of effect for fEVAR/bEVAR compared with OSR or no surgery. This trial should also collect data for a CEA.
O'Donnell et al (2020) compared outcomes of fenestrated (FEVAR) and open repairs of complex abdominal aortic aneurysms (cAAA). The investigators noted that FEVAR has emerged as an alternative to open surgery for treating cAAA, but direct comparisons are limited. The investigators studied all repairs of intact or symptomatic cAAA in the Vascular Quality Initiative between 2012 and 2018, excluding chimney/snorkels and any devices implanted under Investigational Device Exemption studies. The investigators compared open repairs, commercially available FEVAR devices and physician-modified endografts (PMEG) using inverse probability weighting. As a secondary analysis, the investigators compared PMEG separately. The investigators identified 3253 cAAA repairs: 2125 open (65%), 877 FEVAR (27%), and 251 PMEG (8%). Patients undergoing FEVAR were older, with larger aneurysms, and more comorbidities. Propensity-weighted perioperative mortality was similar between open repair and FEVAR (4.7% vs 3.3%, respectively, P = 0.17), but open repair was associated with higher rates of myocardial infarction (5.0% vs 3.0%, P = 0.03), acute kidney injury (25% vs 16%, P < 0.001), and new dialysis (4.3% vs 2.1%, P = 0.003). However, propensity-weighted long-term mortality was higher following FEVAR [Hazard Ratio (HR) 1.7 (1.1-2.6), P = 0.02]. Although outcomes of commercially available FEVAR and PMEG were similar, there was a trend toward higher long-term mortality with PMEG compared to FEVAR [HR 1.7 (0.9-3.1), P = 0.09). The investigators concluded that, in patients undergoing cAAA repair, open surgery was associated with higher overall survival than FEVAR and similar perioperative mortality, but longer lengths of stay, and higher rates of postoperative renal dysfunction and MI. PMEG were associated with similar perioperative results as commercially available FEVAR, but further study is needed to establish their long-term durability.
Li et al (2016) noted that juxta-renal aortic aneurysms (JAA) account for approximately 15 % of abdominal aortic aneurysms. Fenestrated endovascular aneurysm repair (FEVAR) and chimney endovascular aneurysm repair (CH-EVAR) are both effective methods to treat JAAs, but the comparative effectiveness of these treatment modalities is unclear. The authors searched the PubMed, Medline, Embase, and Cochrane databases to identify English language articles published between January 2005 and September 2013 on management of JAA with fenestrated and chimney techniques to conduct a systematic review to compare outcomes of patients with juxta-renal aortic aneurysm (JAA) treated with the two techniques. The authors compared nine F-EVAR cohort studies including 542 JAA patients and 8 CH-EVAR cohorts with 158 JAA patients regarding techniques success rates, 30-day mortality, late mortality, endoleak events and secondary intervention rates. The authors stated that the results of this systematic review indicate that both fenestrated and chimney techniques are attractive options for JAAs treatment with encouraging early and mid-term outcomes.
Yaoguo et al (2017) reviewed data pertaining to fenestrated endograft technique and chimney stent repair of complex aortic aneurysm for comparative analysis of the outcomes. A comprehensive search of relevant databases was conducted to identify articles in English, related to the treatment of complex aortic aneurysm with fenestrated endovascular aneurysm repair and chimney stent repair, published until January 2015. A total of 42 relevant studies and 2264 patients with aortic aneurysm undergoing fenestrated endovascular aneurysm repair and chimney stent repair were included in the review. A total of 4413 vessels were involved in these processes. The cumulative 30-day mortality was 2.4% and 3.2% (p = 0.459). The follow-up aneurysm-related mortality was 1.4% and 3.2% (p = 0.018), and target organ dysfunction was 5.0% and 4.0% in fenestrated endovascular aneurysm repair and chimney stent repair, respectively ( p = 0.27). A total of 156 vessels showed restenosis or occlusion after primary intervention (3.6% and 3.4% in fenestrated endovascular aneurysm repair and chimney stent repair, respectively, p = 0.792). The cumulative type I endoleak was 2.0% (38/1884) after fenestrated endovascular aneurysm repair compared with 3.4% (13/380) after chimney stent repair ( p = 0.092), and the type II endoleak was 5.4% (102/1884) and 5.3% (20/380), respectively ( p = 0.905). Approximately, 1.1% and 1.6% increase in aneurysm was observed following fenestrated endovascular aneurysm repair and chimney stent repair, respectively ( p = 0.437). The re-intervention frequency was 205 and 19 cases after fenestrated endovascular aneurysm repair and chimney stent repair, respectively (11.7%, 5.6%, p = 0.001). The authors concluded that fenestrated endovascular aneurysm repair and chimney stent repair are safe and effective in treating patients with complex aortic aneurysm. A higher aneurysm-related mortality was observed in chimney stent repair while fenestrated endovascular aneurysm repair was associated with a higher re-intervention rate.
Rao et al (2015) observed that open repair is the gold standard management for juxta-renal aneurysms. Fenestrated endovascular aneurysm repair (FEVAR) is indicated for high-risk patients. The long-term outcomes of FEVAR are largely unknown, and there is no Level I comparative evidence. The authors conducted a systematic review and meta-analysis of case series to compare elective juxta-renal aneurysm surgery by open repair and FEVAR. A systematic literature search was conducted for all published studies on elective repair of juxta-renal aneurysms by FEVAR and open repair. The MEDLINE, EMBASE, and Cochrane databases were searched from 1947 to April 2013. The exclusion criteria were case series of <10 patients or ruptured aneurysms. The primary outcomes were perioperative mortality and postoperative renal insufficiency. The secondary outcomes were secondary reinterventions and long-term survival. The authors identified 35 case series with data on 2326 patients. Peri-operative mortality was 4.1% in open repair and FEVAR case series (odds ratio for open repair with FEVAR, 1.059; 95% confidence interval, 0.642-1.747; P = .822). Post-operative renal insufficiency was not significantly different (odds ratio for open repair with FEVAR, 1.136; 95% confidence interval, 0.754-1.713; P = .542). FEVAR patients had higher rates of secondary reintervention, renal impairment during follow-up, and a lower long-term survival compared with open repair patients. The authors concluded that FEVAR and open repair have similar short-term outcomes but have diverging long-term outcomes that may be secondary to the selection bias of FEVAR being offered to high-risk patients. FEVAR is a favorable option in high-risk patients, and open repair remains viable as the gold standard.
Ou et al (2015) said that fenestrated endovascular repair is an alternative to open repair in the management of juxta-renal aortic aneurysms and short-neck abdominal aortic aneurysms (AAAs). The investigators sought to examine the evidence in published literature on the use of fenestrated endovascular stent grafts in the treatment of juxta-renal and short-neck AAAs. A systematic review was formulated under the instruction of Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guideline. Articles published from January 1996 to October 2014 in English language were included. Published studies on fenestrated endovascular stent grafts in treating juxta-renal and short-neck AAAs were systematically searched and reviewed through a computerized search of PubMed and Ovid MEDLINE and cross-referenced. Title key words include "fenestrated", "juxta-renal", and "short neck". All relevant published articles up to first October 2014 were reviewed. A total of 529 nonduplicated publications were identified but only 15 articles were eligible for our qualitative analysis, with 763 patients and 2,040 target vessels. Twelve studies were included in cohort studies with a short or medium follow-up period (median range, 6-67 months). The mean 30-day and late follow-up mortality were 1.7% (range, 0-4%) and 20.1% (range, 4-50%), respectively, with 5.3% aneurysm-related late deaths. A total of 74 target vessels (3.6%) were lost in all the studies with 65 of them (87.8%) lost postoperatively. Overall, 28.8% patients endured renal dysfunction postoperatively, whereas 2.5% of patients required dialysis. Target vessel events and endoleaks were the 2 major indications for reintervention, accounting for 63.8%. Fourteen aneurysm sacs (1.8%) were enlarged continuously during follow-up and a half were due to type II endoleaks. Migration of the proximal fenestration component was reported with 3.0%. One registry study reported 4.1% of early mortality, higher than any cohort studies, whereas the target vessel loss was relatively low (1.6%). Freedom of late secondary intervention decreased from 90% at year 1 to 70% at year 3. Two nonrandom controlled comparative studies showed no definitive superiority of fenestrated repair over the open surgery. The authors concluded that contemporary published literature does not produce a high enough level of evidence that leads to a change in treatment guidelines for juxtarenal or short-neck aneurysm. Fenestrated endovascular repair is a safe and efficacious treatment, particularly for those deemed surgically high risk. Growing experience and innovation of stent graft are essential for the advancement of fenestrated grafting.
Kamman et al (2015) stated that the optimal management strategy for chronic type B aortic dissections (CBAD) is unknown. Therefore, the authors systematically reviewed the literature to compare results of open surgical repair (OSR), standard thoracic endovascular aortic repair (TEVAR) or branched and fenestrated TEVAR (BEVAR/FEVAR) for CBAD. EMBASE and MEDLINE databases were searched for eligible studies between January 2000 and October 2015. Studies describing outcomes of OSR, TEVAR, B/FEVAR, or all, for CBAD patients initially treated with medical therapy, were included. Primary endpoints were early mortality, and one-year and 5-year survival. Secondary endpoints included occurrence of complications. Furthermore, a Time until Treatment Equipoise (TUTE) graph was constructed. Thirty-five articles were selected for systematic review. A total of 1081 OSR patients, 1397 TEVAR patients and 61 B/FEVAR patients were identified. Early mortality ranged from 5.6% to 21.0% for OSR, 0.0% to 13.7% for TEVAR, and 0.0% to 9.7% for B/FEVAR. For OSR, one-year and five-year survival ranged 72.0%-92.0% and 53.0%-86.7%, respectively. For TEVAR, one-year survival was 82.9%-100.0% and five-year survival 70.0%-88.9%. For B/FEVAR only one-year survival was available, ranging between 76.4% and 100.0%. Most common postoperative complications included stroke (OSR 0.0%-13.3%, TEVAR 0.0%-11.8%), spinal cord ischemia (OSR 0.0%-16.4%, TEVAR 0.0%-12.5%, B/FEVAR 0.0%-12.9%) and acute renal failure (OSR 0.0%-33.3%, TEVAR 0.0%-34.4%, B/FEVAR 0.0%-3.2%). Most common long-term complications after OSR included aneurysm formation (5.8%-20.0%) and new type A dissection (1.7-2.2%). Early complications after TEVAR included retrograde dissection (0.0%-7.1%), malperfusion (1.3%-9.4%), cardiac complications (0.0%-5.9%) and rupture (0.5%-5.0%). Most common long-term complications after TEVAR were rupture (0.5%-7.1%), endoleaks (0.0%-15.8%) and cardiac complications (5.9%-7.1%). No short-term aortic rupture or malperfusion was observed after B/FEVAR. Long-term complications included malperfusion (6.5%) and endoleaks (0.0%-66.7%). Reintervention rates after OSR, TEVAR and B/FEVAR were 5.8%-29.0%, 4.3%-47.4% and 0.0%-53.3%, respectively. TUTE for OSR was 2.7 years, for TEVAR 9.9 months and for B/FEVAR 10.3 months. The authors statted that they found a limited early survival benefit of standard TEVAR over OSR for CBAD. Complication rates after TEVAR are higher, but complications after OSR are usually more serious. Initial experiences with B/FEVAR show its feasibility, but long-term results are needed to compare it to OSR and standard TEVAR. The authors concluded that optimal treatment of CBAD remains debatable and merits a patient specific decision. TUTE seems a feasible and useful tool to better understand management outcomes of CBAD.
An international assessment by Health Technology Scotland (2018) found higher perioperative morbidity with open surgical repair, but higher reintervention rates with fenestrated\branched grafts compared to open surgical repair. Most data are from retrospective case series, with only one prospective comparative study identified. They also noted the paucity of long-term data for the fenestrated grafts. Based upon the single prospective comparative study, there were no significant differences in 30-day mortality in a prospective study comparing open surgery to fenestrated/branched stent grafts.
An international evidence review by NICE (2018) found, based on "low quality evidence," that complex endovascular repair of aortic aneurysms was associated with a shorter hospital stay than open surgical repair, and that, based upon "very low quality evidence," they could not differentiate differences in 30-day mortality between complex EVAR and open surgical repair, and could not differentiate between rates of hemodialysis, pneumonia, stroke and reintervention rates between patients treated by complex EVAR and those treated by open repair. These conclusions were based upon the only prospective comparative study of complex EVAR, which followed 90 patients for a mean follow-up of 15.2 months. The assessment also found, based upon modeling, that endovascular repair of complex aortic aneurysms to be dominated by no intervention, meaning that complex EVAR resulted in higher costs and fewer QALYs than no intervention. The report concluded: "The committee noted that the evidence comparing complex EVAR with open surgical repair was extremely limited in quantity and quality. No RCTs were identified and the single non-randomised comparative study that met this review’s inclusion criteria was small in size and only assessed mortality rates at 30-day follow-up. The results of the study, coupled with results from a new health economic model developed for this population (discussed below), led the committee to conclude that there was no evidence that complex EVAR yields a net advantage over open surgery. However, the committee were mindful that longer-term evidence from large RCTs could clarify the clinical utility of complex EVAR, and inform future health economic modelling. Thus, they recommended that the procedure should not be performed outside the confines of an RCT."
Bifurcated-Bifurcated Aneurysm Repair of Aorto-Iliac Aneurysms
Shin and Starnes (2017) noted that up to 40 % of AAAs have co-existent iliac artery aneurysms (IAAs). In the past, successful endovascular repair required internal iliac artery (IIA) embolization, which can lead to pelvic or buttock ischemia. These investigators described a technique that uses a readily available solution with a minimally altered off-the-shelf bifurcated graft in the IAA to maintain IIA perfusion. From August 2009 to May 2015, a total of 14 patients with AAAs and co-existing IAAs underwent repair with a bifurcated-bifurcated approach. A 22-mm or 24-mm bifurcated main body device was used in the IAA with extension of the "contralateral" limb into the IIA. Intra-operative details including operative time, fluoroscopy time, and contrast agent use were recorded. Outcome measures assessed were operative technical success and a composite outcome measure of IIA patency, freedom from re-intervention, and clinically significant endoleak at 1 year. Technical success was achieved in 93 % of patients, with successful treatment of the AAA and IAA and preservation of flow to at least 1 IIA. The procedure was performed with a completely percutaneous bilateral femoral approach in 92 % of patients; 3 patients had a type II endoleak on initial follow-up imaging, but none was clinically significant. There were no cases of bowel ischemia or erectile dysfunction; 1 patient had buttock claudication ipsilateral to IIA coil embolization (contralateral to bifurcated iliac repair and preserved IIA) that resolved by 6-month follow-up; 2 patients required re-interventions; 1 patient presented to his first follow-up visit on post-operative day 25 with thrombosis of the right external iliac limb ipsilateral to the bifurcated iliac repair, which was successfully treated with thrombectomy and stenting of the limb. This same patient presented at 83 months with growth of the preserved IIA to 3.9 cm and underwent coil embolization of the aneurysm. Another patient presented for surveillance 44 months after his original repair with component separation of the mating stent and the iliac bifurcated stent grafts. This was treated with a limb extension and endo-anchors to fuse the endografts. Of the 13 patients who underwent bifurcated-bifurcated repair, 100 % of the preserved IIAs remained patent at last follow-up. The composite outcome measure of IIA patency and freedom from re-intervention and clinically significant endoleak at 1 year was 92 % (n = 12/13). The authors concluded that in this small retrospective review, bifurcated-bifurcated aneurysm repair of aorto-iliac aneurysms with preservation of perfusion to the IIA was technically feasible and safe with good short-term and mid-term results in male patients. These preliminary findings need to be validated by well-designed studies.
Endovascular Aneurysm Sealing (e.g., the Nellix Device) for the Treatment of Abdominal Aortic Aneurysms
Bockler and associates (2015) noted that despite improvements in endograft devices, operator technique, and patient selection, endovascular repair has not achieved the long-term durability of open surgical aneurysm repair. Persistent or recurrent aneurysm sac flow from failed proximal sealing, component failure, or branch vessel flow underpins a significant rate of re-intervention after endovascular repair. The Nellix device (Endologix, Irvine, CA) employs a unique design with deployment of polymer-filled EndoBags surrounding the endograft flow lumens, sealing the aneurysm sac space and potentially reducing complications from persistent sac flow.
Bockler et al (2015) reported on a retrospective analysis represented the initial experience in consecutive patients treated with the device in real-world practice. This study was performed at 6 clinical centers in Europe and 1 in New Zealand during the initial period after commercialization of the Nellix device. Patients underwent evaluation with CT and other imaging modalities following local standards of care. Patients were selected for treatment with Nellix and treated by each institution according to its endovascular repair protocol. Clinical and imaging end-points included technical success (successful device deployment and absence of any endoleak at completion angiography), freedom from all-cause and aneurysm-related mortality, endoleak by type, limb occlusion, aneurysm rupture, and re-intervention. During a 17-month period, a total of 171 patients with AAAs were treated with the Nellix device and observed for a median of 5 months (range of 0 to 14 months). The 153 men and 18 women with mean age of 74 ± 7 years had aneurysms 61 ± 9 mm in diameter with an average infra-renal neck length of 28 ± 15 mm and infra-renal angulation of 37 ± 22 degrees. Technical success was achieved in all but 2 patients (99 %); 1 patient had a type Ib endoleak and another had a type II endoleak. Through the last available follow-up, type Ia endoleak was observed in 5 patients (3 %), type Ib endoleak in 4 patients (2 %), and type II endoleak in 4 patients (2 %). There were 8 limb occlusions (5 %), among which 7 were evident at the 1-month follow-up visit. Aneurysm-related re-interventions were performed in 15 patients (9 %). There were no aneurysm ruptures or open surgical conversions. The authors concluded that this first multi-center post-market report of the Nellix device for infra-renal AAA repair demonstrated satisfactory results during the initial learning phase of this new technology. The rate of aneurysm exclusion was high, and frequency of complications was low. They stated that more definitive conclusions on the value of this novel device await the results of the ongoing Nellix EVAS FORWARD Global Registry and the EVAS FORWARD investigational device exemption trial.
Carpenter and co-workers (2017) stated that the Nellix EndoVascular Aneurysm Sealing (EVAS) System (Endologix, Inc., Irvine, CA) is a novel approach to AAA treatment whereby polymer is used to fill the AAA sac. These researchers reported 1-year results of the IDE pivotal trial. Eligible patients were treated at 30 sites in the U.S. and Europe. Inclusion criteria required an asymptomatic infra-renal AAA, with a neck length of greater than or equal to 10 mm and less than or equal to 60° angle, iliac artery blood lumen diameter of 9 to 35 mm, access artery diameter of greater than or equal to 6 mm, and serum creatinine of less than or equal to 2 mg/dL. Follow-up included CT angiography scans at 30 days, 6 months, and 1 year that were evaluated by a core laboratory. The primary safety end-point was 30-day major adverse events (MAEs), which were compared with a performance goal of less than 56 % (the Society for Vascular Surgery open repair control group rate). The primary effectiveness end-point was treatment success at 1 year, which was compared with a performance goal of greater than 80 %. Treatment success required procedural technical success and absence of AAA rupture during follow-up, conversion to open surgical repair, endoleak (type I or III) at 1 year, migration of greater than 10 mm causing complications or requiring secondary intervention, aneurysm enlargement, or secondary procedures through 1 year for resolution of endoleak, device obstruction or occlusion, or device defect. Of 150 treated patients, 149 (99.3 %) completed 1-year follow-up. The MAEs rate at 30 days was 2.7 % (95 % CI: 0.7 % to 6.7 %), satisfying the primary safety end-point (less than 56 %). The 1-year treatment success was 94 % (95 % CI: 88.6 % to 97.4 %), achieving the primary effectiveness end-point (greater than 80 %). At 1 year, key secondary outcomes included 6.7 % MAEs, 4.7 % serious device-related events, 1.3 % AAA-related mortality, 3.7 % secondary interventions, and 0.7 % surgical conversions; MAEs through 1 year included death (n = 6), stroke (n = 3), bowel ischemia (n = 2), renal failure (n = 2), respiratory failure (n = 2), and myocardial infarction (n =1). One iatrogenic AAA rupture occurred and 1 AAA rupture was reported during follow-up. AAA sac enlargement (greater than 5 mm) was 1.5 % at 1 year. Endoleaks were present in 4 patients (3.1 %) at 1 year (1 type Ib and 3 type II). Migration of greater than 10 mm occurred in 3 patients (2.3 %), but none required secondary intervention. The authors concluded that outcomes with this novel endovascular therapy for AAA, the Nellix EVAS System, were encouraging. The primary safety and effectiveness end-points have been met. Moreover, they noted that low morbidity, low mortality, and high procedural and treatment success were achieved despite the inevitability of a learning curve and unique risks associated with a new device and technique; long-term follow-up is in progress.
Youssef and associates (2017) examined the technical success and clinical outcome of re-interventions using the Nellix EVAS System to treat complications after EVAR. A total of 15 consecutive patients (mean age of 79 years; 14 men) with prior EVAR were treated with EVAS between March 2014 and December 2015 at 2 institutions. The failed prior EVARs included 13 bifurcated endografts, 1 bifurcated graft plus fenestrated cuff, and 1 tube endograft. Endoleaks were the predominant indications: type Ia in 10 and type III in 5 (3 type IIIa and 2 type IIIb). All patients presented with progressive aortic aneurysms (median of 7.85-cm diameter; range of 6.5 to 11); 8 patients were treated on an urgent or emergency basis (6 symptomatic aneurysms and 2 contained ruptures). All patients underwent Nellix relining of the failed stent-graft; 10 had chimney (Ch) procedures in combination with EVAS (chEVAS) because the proximal landing zones were inadequate. Technical success was 100 %. All endoleaks were successfully sealed, and no additional intervention was needed. No further endoleak after EVAS or chEVAS was recorded. Endobag protrusion occurred in 1 case without sequelae. One elderly patient with ruptured aneurysm died from multiple organ failure 2 months post-operatively. One renal artery guide-wire injury led to nephrectomy because of active bleeding. No re-interventions, aneurysm-related mortalities, graft thrombosis, endoleaks, or chimney graft occlusions were observed during a median follow-up of 8 months (range of 3 to 24). The authors concluded that the present preliminary experience demonstrated that the use of EVAS/chEVAS was feasible for treatment of failed EVAR. Moreover, they stated that this technique may be used as bailout or an alternative treatment when other established methods are infeasible or not available.
Unlu and colleagues (2017) stated that despite improvements in endograft design, operator skills, and patient selection, late EVAR associated complications and need for re-interventions remains the Achilles heel. These complications erode the early benefit over open aneurysm repair during long-term follow-up. The recently introduced endovascular aneurysm sealing (EVAS) is an innovative technology with the intention to lower these EVAR related complications. These investigators reviewed the EVAS technique, indications, and possible applications, and provided a critical appraisal of clinical outcomes. The authors concluded that EVAS is a promising technique for treating AAAs, and early efficacy data were encouraging in very suitable straight forward anatomy. Moreover, they stated that the Nellix device is still in development; long-term results are needed.
Brown and co-workers (2017) noted that there has been a clear move towards endovascular repair of AAAs owing to better peri-operative outcomes compared with open surgical repair. However, follow-up has continued to reveal relatively high rates of endoleaks and re-interventions. Improvements in endovascular stent-grafts aim to decrease these complications. In a systematic review, these investigators determined the early outcomes of AAA sealing. Standard PRISMA guidelines were followed. They performed a literature search extract any publication related to the endovascular aneurysm sealing device. The total number of patients in this systematic review of 11 studies was 684, with a mean age of 73.2 years, and 587 (88.0 %) were men. The majority were undergoing elective procedures (n = 606, 91.0 %), the remainder as emergencies (n = 30, 4.5 % as ruptures; n = 30, 4.5 % as symptomatic). Technical success rate including emergency cases was 99.1 %; 30-day mortality rate was 2.6 % (n = 17) including all cases, and 1.0 % (n = 6) including elective cases only; 30-day endoleak detection rate was 4.7 % (n = 31) including all cases, and 4.8 % (n = 29) including elective cases only; 30-day aneurysm-related re-intervention rate was 5.7 % (n = 38) including all cases, and 4.6 % (n = 28) including elective cases only. There was no conversion to open surgery within 30 days post-op in the elective cases. There were 3 delayed conversions to open surgery within 30 days and 1 report of stent migration causing rupture in the emergency setting. The authors concluded that this novel endovascular aneurysm-sealing device for AAA repair has shown respectable early outcomes. Good technical success rates, in both elective and emergency settings, low rates of all-type endoleaks and low re-intervention rates have all been demonstrated. They stated that endovascular aneurysm sealing is proving to be a safe alternative to open and endovascular aneurysm repair; however, longer term follow-up results are needed to evaluate the safety and effectiveness of the device in the long-term.
Cerebrospinal Fluid Drainage During Endovascular Aortic Aneurysm Repair
Suarez-Pierre and associates (2019) noted that spinal cord ischemia is among the most devastating complications of thoracic endovascular aortic repair (TEVAR). Spinal fluid drainage has been proposed as a viable means to reduce spinal cord ischemia, but few data exist to support its routine use. These investigators examined the association of pre-operative spinal fluid drainage with the risk of spinal cord ischemia following TEVAR. The Vascular Quality Initiative (VQI) TEVAR module was queried for adult patients (greater than or equal to 18 years) undergoing TEVAR (coverage of zones 0 to 5) between September 2014 and March 2018 (inclusive). Patients with pre-operative spinal mal-perfusion, aortic rupture on presentation, and connective tissue disorders were excluded. One-to-one propensity matching was used to balance patients on 44 separate dimensions by the nearest neighbor principle to compare those with vs those without pre-operative spinal drainage. The primary end-point was spinal cord ischemia still present at the time of discharge; secondary outcomes were 30-day mortality and prolonged intensive care unit (ICU) stay (greater than 7 days). Among 4,287 patients who underwent TEVAR (mean age of 67.1 [standard deviation [SD], 13.7] years; 1,665 [38.8 %] women and 2,622 [61.2 %] men), 2,076 had a spinal drain placed. Propensity matching yielded 1,292 pairs with adequate co-variate balance (all 44 absolute standardized differences of less than 0.1). In the 2,584 propensity-matched patients, spinal drain placement was associated with a reduced risk of spinal cord ischemia (1.5 % versus 2. 5%; risk-adjusted OR, 0.47; 95 % CI: 0.24 to 0.89; p = 0.02). The rates of 30-day mortality (4.5 % versus 5.0 %; risk-adjusted OR, 0.67; 95 % CI: 0.44 to 1.01; p = 0.05) and prolonged ICU stay (7.0 % versus 5.7 %; risk-adjusted OR, 1.10; 95 % CI: 0.84 to 1.45; p = 0.48) did not differ on the basis of spinal drain placement. The cross-over rate was 10 % (127/1,292), and those with post-operative drain placement had a 20 % (26/127) spinal cord ischemia rate on discharge. The authors concluded that among patients undergoing thoracic and thoraco-abdominal endovascular aortic repair, pre-operative placement of a spinal drain, compared with no drain, was associated with reduced risk of spinal cord ischemia. These researchers stated that cerebrospinal fluid drainage (CSFD) as a rescue measure does not provide the same protection offered by routine pre-operative placement. They stated that further investigation, including RCTs, is needed to more definitively determine the role for spinal drainage in TEVAR.
The author stated that this study was subject to unexpected confounders because of its observational design; despite extensive risk adjustment, these findings may be considered only associative in nature. Large multi-institutional data sets are subject to variability in data entry and miscoding; however, the end-points examined in this study were concise and interpreted universally across practices. Participation in the VQI registry was voluntary; however, centers that did participate were required to submit 100 % of their cases to avoid selection bias. In the multi-variable model, left subclavian artery re-vascularization did not demonstrate an association with decreased rate of spinal cord ischemia; this may be a reflection of the substantial proportion of patients (approximately 30 %) who had missing values. Avoidance of hypotension, intra-operative neuromonitoring for signs of spinal cord ischemia, peri-operative hypothermia, technique of drain placement, pressure thresholds for CSF evacuation, and duration of use were not standardized in this multi-institutional study. Complications specific to pre-operative CSFD were not examined.
Malloy and colleagues (2020) noted that spinal cord injury (SCI) is a known complication of aortic aneurysm repair. Previous reports indicated that CSFD may reduce incidence of SCI during open aortic aneurysm repair but its utility in endovascular repair remains poorly understood. In a systematic review, these investigators examined the protocols and outcomes of CSFD in patients undergoing endovascular aortic aneurysm repair. The PRISMA guidelines were employed to carry out a systematic literature review. PubMed, Scopus, Ovid, Cochrane, and Embase were searched for articles published since 2016 using search terms "(cerebrospinal fluid diversion OR CSF diversion OR lumbar drain OR subarachnoid drain OR spinal) AND (aortic aneurysm AND thoracic AND endovascular OR TEVAR)". A total of 92 articles were identified and screened by 2 independent reviewers, and 23 studies met criteria for full-text review after initial screening. A total of 8 studies met full inclusion criteria for final analysis; 6 studies reported incidence of SCI in patients with CSFD and 2 compared SCI incidence between patients with and without CSFD. Protocols for drainage most commonly included draining to a target pressure intra- and post-operatively, between 8 and 12 mm Hg. Incidence of SCI ranged from 0 % to 17 % in patients with CSFD, and from 0 % to 50 % in those without CSFD. Rates of CSFD-related complications ranged from less than 1 % to 28 %. The authors concluded that there may be a protective benefit of CSFD in preventing SCI, but there remains significant variation in drain placement protocols; and significant potential bias exists in the reviewed data. These researchers stated that higher quality studies on the role of CSFD in endovascular aortic aneurysm repair are needed.
Karkkainen and co-workers (2020) examined the rates and risk factors of complications related to CSFD during first stage and completion fenestrated-branched endovascular aortic repair (F-BEVAR) of para-renal and thoraco-abdominal aortic aneurysms. These investigators reviewed the outcomes of 293 consecutive patients enrolled in a prospective, non-randomized study to examine outcomes of F-BEVAR between 2013 and 2018. Patients who received CSFD during first-stage thoracic endovascular aortic repair, index F-BEVAR, or completion of temporary aneurysm sac perfusion procedures were included in the analysis. CSFD complications were graded as severe or moderate if they were life-threatening, escalated the level of care, or prolonged the hospital stay. Presence of substantial degenerative lumbar disease (DLD) was identified based on review of pre-operative CT. End-points included technical difficulties during CSFD placement and CSFD-related complications. A total of 187 patients (mean age of 73 ± 8 years; 70 % men) treated for 20 para-renal and 167 thoraco-abdominal aortic aneurysms received CSFD in 240 procedures, including 51 first-stage thoracic endovascular aortic repairs, 184 index F-BEVARs, and 5 completion temporary aneurysm sac perfusion procedures; 19 patients (10 %) had 22 CSFD-related complications after 21 aortic procedures (9 %). Complications were graded as severe-to-moderate in 17 patients (9 %). There were 12 patients (6 %) with intra-cranial hypotension, including 3 (2 %) who had intra-cranial hemorrhage and 9 (5 %) with post-dural puncture headache requiring blood patches in 6. Another 6 patients (3 %) developed spinal hematomas resulting in paraplegia in 2 (1 %) and transient paraparesis in 2 (1 %); 1 patient had CSF leakage from the puncture site (no intervention required); 4 patients had bleeding during attempted drain placement, which required postponement of F-BEVAR. Technical difficulties were observed in 57 drain insertions (24 %), more often in patients with DLD than in those without DLD (35/113 [31 %] versus 22/121 [18 %]; p = 0.03). Fluoroscopic guidance was used in 44 drain placements (18 %) with a lower rate of technical difficulties compared with the blind approach (9 % versus 28 %; p = 0.01). There was a statistically non-significant trend toward more complications in patients with technical challenges (14 % versus 7 %; p = 0.10). Of 13 study patients who developed SCI during aortic procedures, 4 (31 %) were attributed to CSFD. The authors concluded that although CSFD was widely used to prevent ischemic SCI during complex aortic repair, the risk of major CSFD-related complications is not negligible and should be carefully weighed against its potential benefits; 1/3 of SCIs were caused by CSF drain placement. The use of fluoroscopic guidance may decrease the risk of CSFD-related complications.
The authors stated that the main drawback of this study was the retrospective nature of collecting CSFD-related data. Although the note template for spinal drain insertion procedure was fairly well-structured in the authors’ electronic medical record, there was a possibility of variation in reporting between neuro-radiologist and anesthesiologist because these specialists used different note templates. The association between CSFD and intra-cranial hemorrhage was often obscure, and causality could be difficult to establish; these investigators agreed on the etiology of 2 intra-cranial hemorrhage and 1 remained inconclusive; CT scans were often reported in a standardized fashion by the radiologists; however, DLD was not well-defined in this retrospective study because it mostly relied on the radiology report, and it was very common in middle-aged to older individuals. Furthermore, the numbers of end-point events were too small to perform meaningful multi-variable analyses.
Early Repair Versus Surveillance with Repair on Subsequent Enlargement in Individuals with Asymptomatic Abdominal Aortic Aneurysms
Ulug and colleagues (2020) noted that AAA is an abnormal ballooning of the major abdominal artery. Some AAAs present as emergencies and require surgery; others remain asymptomatic. Treatment of asymptomatic AAAs depends on many factors, but the size of the aneurysm is important, as risk of rupture increases with aneurysm size. Large asymptomatic AAAs (greater than 5.5 cm in diameter) are usually repaired surgically; very small AAAs (less than 4.0 cm diameter) are monitored with ultrasonography (US). Debate continues over the roles of early repair versus surveillance with repair on subsequent enlargement in individuals with asymptomatic AAAs of 4.0 cm to 5.5 cm diameter. In an updated Cochrane review, these researchers compared mortality and costs, as well as quality of life (QOL) and aneurysm rupture as secondary outcomes, following early surgical repair versus routine US surveillance in individuals with asymptomatic AAAs between 4.0 cm and 5.5 cm in diameter. They searched Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialized Register, CENTRAL, Medline, 2 other databases, and 2 trials registers to July 10, 2019. These investigators also hand-searched conference proceedings and checked reference lists of relevant studies. These researchers included RCTs where individuals with asymptomatic AAAs of 4.0 cm to 5.5 cm were randomly allocated to early repair or imaging-based surveillance at least every 6 months. Outcomes had to include mortality or survival. Three review authors independently extracted data, which were cross-checked by other team members. Outcomes were mortality, costs, QOL, and aneurysm rupture. For mortality, they estimated risk ratios (RR) (endovascular aneurysm repair only), hazard ratios (HR) (open repair only), and 95 % CI based on Mantel-Haenszel Chi2 statistics at 1 and 6 years (open repair only) following randomization.
These investigators found no new studies for this update; 4 trials with 3,314 participants fulfilled the inclusion criteria. Two trials compared early open repair with surveillance and 2 trials compared early EVAR with surveillance. They used GRADE to access the certainty of the evidence for mortality and cost, which ranged from high to low. They downgraded the certainty in the evidence from high to moderate and low due to risk of bias concerns and imprecision (some outcomes were only reported by 1 study). All 4 trials showed an early survival benefit in the surveillance group (due to 30-day operative mortality with repair); but no evidence of differences in long-term survival. One study compared early open repair with surveillance with an adjusted HR of 0.88 (95 % CI: 0.75 to 1.02, mean follow-up 10 years; HR 1.21, 95 % CI: 0.95 to 1.54, mean follow-up of 4.9 years). Pooled analysis of participant-level data from the 2 trials comparing early open repair with surveillance (maximum follow-up of 7 to 8 years) showed no evidence of a difference in survival (propensity score-adjusted HR 0.99, 95 % CI: 0.83 to 1.18; 2,226 participants; high-certainty evidence). This lack of treatment effect did not vary to 3 years by AAA diameter (p = 0.39), participant age (p = 0.61), or for women (HR 0.84, 95 % CI: 0.62 to 1.11). Two studies compared EVAR with surveillance and there was no evidence of a survival benefit for early EVAR at 12 months (RR 1.92, 95 % CI: 0.73 to 5.06; 846 participants; low-certainty evidence). Two trials reported costs. The mean U.K. health service costs per participant over the first 18 months after randomization were higher in the open repair surgery than the surveillance group (GBP 4,978 in the repair group versus GBP 3,914 in the surveillance group; mean difference (MD) GBP 1,064, 95 % CI:796 to 1,332; 1,090 participants; moderate-certainty evidence). There was a similar difference after 12 years. The mean U.S. hospital costs for participants at 6 months after randomization were higher in the EVAR group than in the surveillance group (USD 33,471 with repair versus USD 5,520 with surveillance; MD USD 27,951, 95 % CI: 25,156 to 30,746; 614 participants; low-certainty evidence). After 4 years, there was no evidence of a difference in total medical costs between groups (USD 48,669 with repair versus USD 46,112 with surveillance; MD USD 2,557, 95 % CI: -8,043 to 13,156; 614 participants; low-certainty evidence). All studies reported QOL; but used different assessment measurements and results were conflicting. All 4 studies reported aneurysm rupture. There were very few ruptures reported in the trials of EVAR versus surveillance up to 3 years. In the trials of open surgery versus surveillance, there were ruptures to at least 6 years and there were more ruptures in the surveillance group, but most of these ruptures occurred in aneurysms that had exceeded the threshold for surgical repair.
The authors concluded that there was no evidence of an advantage to early repair for small AAA (4.0 cm to 5.5 cm), regardless of whether open repair or EVAR was used and, at least for open repair, regardless of patient age and AAA diameter. Therefore, neither early open nor early EVAR of small AAAs is supported by currently available evidence. These researchers stated that long-term data from the 2 trials examining EVAR are not available; thus, they could only draw firm conclusions regarding outcomes after the first few years for open repair. Research regarding the risks related to and management of small AAAs in ethnic minorities and women is urgently needed, as data regarding these populations are lacking.
Endovascular Versus Surgical Repair of Abdominal Aortic Aneurysms
Yokoyama and colleagues (2020) stated that although EVAR for the treatment of AAAs significantly decreases peri-operative mortality compared with open surgical repair (OSR), they have not concluded superiority between EVAR and OSR beyond the peri-operative period. In a meta-analysis, these investigators compared phase-specific survival following EVAR versus OSR. The review was carried out according to the PRISMA guideline. Embase and Medline were searched up to November 2019 to identify RCTs and propensity score-matched studies that examined greater than or equal to 2-year all-cause mortality (primary outcome) following EVAR versus OSR for intact infra-renal AAA. For each study, the HR with 95 % CI of mortality for EVAR versus OSR was calculated using survival curves for the following specific phases: early term (0 to 2 years following repair), mid-term (2 to 6 years following repair), long-term (6 to 10 years following repair), and very long-term (greater than or equal to 10 years after repair). The risk ratio (RR) in the peri-operative (in-hospital or 30-day) period was also extracted. Phase-specific HRs or RRs were separately pooled using the random effects model. Sensitivity analyses were carried out by removing 1 study at a time to confirm that these findings were not derived from any single study. Funnel plot asymmetry was also examined using the linear regression test. The search identified 4 RCTs and 7 propensity score-matched studies enrolling a total of 106,243 AAA patients assigned to EVAR (n = 53,123) or OSR (n = 53,120). The mortality following EVAR compared with OSR was significantly lower in the peri-operative period (RR, 0.39; 95 % CI: 0.29 to 0.51; p < 0.00001) and similar in the early-term period (HR, 0.93; 95 % CI: 0.84 to 1.03; p = 0.16). Notably, significantly higher mortality was observed in the EVAR group compared with the OSR group in the mid-term period (HR, 1.15; 95 % CI: 1.03 to 1.29; p = 0.01). However, similar mortality was observed between the EVAR group and the OSR group in the long-term (HR, 1.06; 95 % CI: 0.96 to 1.17; p = 0.27) and very-long-term (HR, 1.17; 95 % CI: 0.93 to 1.47; p = 0.19) periods. In sensitivity analyses, the significant benefit of EVAR in the peri-operative period and that of OSR in the mid-term period were not changed. No funnel plot asymmetry was identified in all analyses. The authors concluded that compared with OSR, EVAR was associated with lower peri-operative mortality and higher mortality in the mid-term period for intact infra-renal AAA. The superiority of EVAR was absent in the early-term period, and the inferiority of EVAR in the mid-term period disappeared in the long-term and very long-term periods.
Endovascular Stent Grafting Versus Open Surgical Repair for the Treatment of Arch/Descending Thoracic Aortic Aneurysms
In a systematic review and meta-analysis, McCarthy and colleagues (2021) compared the effectiveness of endovascular stent grafting (ESG) against OSR for the treatment of chronic arch or descending TAAs. Medline, Embase, CENTRAL, World Health Organization (WHO) International Clinical Trials Routine data collection, current controlled trials, clinical trials and the NIHR portfolio were searched from January 1994 to March 2020. All identified studies that compared ESG and OSR, including RCTs, quasi-randomized and non-RCTs, comparative cohort studies and case-control studies matched on main outcomes were sought. Participants had to receive elective treatments for arch/descending TAAs. Studies were excluded where other thoracic aortic conditions (e.g., rupture or dissection) were reported, unless results for patients receiving elective treatment for arch/descending TAAs were reported separately. Data were extracted by 1 reviewer and checked by another. Risk of Bias was examined using the ROBINS-I tool. Meta-analysis was carried out using random effects. Where meta-analysis was not appropriate, results were reported narratively. A total of 5 comparative cohort studies met inclusion criteria, reporting 3,955 ESG and 21,197 OSR patients. Meta-analysis of unadjusted short-term (30 day) all-cause mortality favored ESG (OR 0.75; 95 % CI: 0.55 to 1.03)). Heterogeneity identified between larger and smaller studies. Sensitivity analysis of 4 studies including only descending TAA showed no statistical significance (OR 0.73, 95 % CI: 0.45 to 1.18)), moderate heterogeneity. Meta-analysis of adjusted short-term all-cause mortality favored ESG (OR 0.71, 95 % CI: 0.51 to 0.98)), no heterogeneity. Longer-term (beyond 30 days) survival from all-cause mortality favored OSR in larger studies and ESG in smaller studies. Freedom from re-intervention in the longer-term favored OSR. Studies reporting short-term non-fatal complications suggested fewer events following ESG. The authors concluded that there is limited and increasingly dated evidence addressing the comparison of ESG and OSR in the management of elective arch and or descending thoracic aorta aneurysms. These investigators stated that further high-quality evidence is needed. Although large RCTs may not be possible in this relatively rare condition, future studies should use strong methodological study design to control for potential confounders and reduce potential biases. Furthermore, given the current conflicting evidence, it is important that comparisons of OSR and ESG are carried out in both the short-term and the long-term.
The authors stated that the findings of this systematic review and meta-analysis were limited by the number and potential for confounding of the 5 included studies, so that definitive conclusions are not possible. The adjustment for confounders was likely to be only partial and some bias in the estimates of differences in mortality and complications may persist, despite attempts to reduce bias in the larger studies identified. Statistical analysis of non-fatal complications was not possible due to limited and inconsistent reporting.
One- Versus Two-Stage Hybrid Repair of Thoraco-Abdominal Aortic Aneurysms
Wang and colleagues (2021) noted that for TAAAs, it is unclear if it is better to perform hybrid repair in 1- (single) or 2-stage (staged). In a meta-analysis, these researchers compared the clinical outcomes of single versus staged hybrid repair of TAAA. Medline, Embase, and Cochrane Databases (January 1, 1994 to May 11, 2020) were searched for studies on hybrid repair of TAAAs. Cohort studies and case series reporting outcomes of single and staged hybrid repair of TAAAs were eligible for inclusion. The Newcastle-Ottawa scale and an 18-item tool were used to examine the risk of bias. The primary outcome was 30-day mortality, and the secondary outcomes included post-operative complications, overall survival (OS), and other mid-term events. A random effects model was used to calculate pooled estimates. A total of 37 studies was included in the meta-analysis. The quality assessment of the included studies suggested low or moderate risk of bias. The pooled estimates for aneurysm rupture and death during stage interval were 2 % (95 % CI: 0 % to 4 %, I2 = 0 %) and 4 % (95 % CI: 2 % to 7 %, I2 = 0 %), respectively. Single repair was associated with a significantly higher 30-day risk of death when compared with patients who completed staged procedures successfully (OR 2.64, 95 % CI: 1.36 to 5.12, I2 = 0 %). Staged repair also had lower incidence of major adverse cardiac events (MACE) (single: 10 %, 95 % CI: 5 % to 16 %; staged: 2 %, 95 % CI: 0 % to 5 %) and intestinal complications (single: 15 %, 95 % CI: 8 % to 25 %; staged: 3 %, 95 % CI: 1 % to 6 %). For mid-term outcomes, single and staged repair had comparable 12-month OS, aneurysm related mortality, rate of re-intervention, and graft patency. The authors concluded that 2-stage hybrid repair may represent a better choice for patients with controlled risk of aneurysm rupture, because it could provide lower 30-day mortality risks, MACE, and intestinal complications, as well as comparable mid-term outcomes. Moreover, these researchers stated that RCTs are needed to determine the effect of repair staging in patients for elective TAAAs.
Intra-Operative Computed Tomography in Endovascular Aneurysm Repair
Hansrani and colleagues (2020) examined the ability of computed tomography (CT) to identify technical complications intra-operatively during EVAR. Frequency of complications identified by CT and their sequelae was compared with conventional completion angiography. These researchers carried out a systematic review that adhered to the PRISMA guidelines. They considered studies reporting on the effectiveness of intra-operative CT during EVAR. The literature search yielded 6 studies that met criteria for inclusion. In general, these showed intra-operative CT to be superior to completion angiogram at detecting intra-operative complications during EVAR. Despite concerns regarding irradiation, the use of intra-operative CT was found to expose patients to an overall lower radiation dose, since post-operative CT angiography was no longer needed. Moreover, no adverse effect on renal function has been demonstrated as a result of the increased intra-operative contrast usage when CT was used. The authors concluded that the current body of evidence suggested that intra-operative CT was superior to completion angiography at detecting clinically important EVAR complications and incurred a lower total radiation dose with no added risk of contrast-induced renal impairment. Moreover, these researchers stated that more research is needed to determine the full benefits that can be offered by intra-operative CT before recommendations can safely be made.
The authors stated that there is great potential in this new technology to provide reassurance in how the graft has been deployed, and whether it can change follow-up regimes. They stated that larger, prospective cohort studies comparing matched cases and controlled clinical trials would be helpful in adding to the limited evidence available. Moreover, such studies should include a range of outcome measures, including hospital LOS, mortality, morbidity and patient satisfaction. These investigators stated that further research determining whether intra-operative CT could provide long-term improved outcomes by reducing secondary intervention, future complications would also be needed.
Endovascular Stenting for the Treatment of Aortic Coarctation
Kische and colleagues (2010) noted that surgical treatment of aortic coarctation (AC) has increased life expectancy and reduced mortality. Unfortunately, the average lifespan after repair remains only 35 to 50 years, and significant morbidity persists as a result of aneurysm formation, hypertension, accelerated coronary disease, and stroke. Follow-up studies have revealed re-stenosis rates of 30 % and persistent hypertension at rest and during exercise, sometimes with compromised cardiac function. The less invasive nature of non-surgical repair using transcatheter therapies has led to balloon angioplasty (BA) and, recently, stent implantation as an emerging concept for the treatment of AC.
Jha and associates (2016) noted that patients with functional aortic interruption of the descending thoracic aorta at the isthmus due to severe coarctation in association with atretic lumen are extremely rare in the adult population. The management is challenging and carries high morbidity and mortality. These investigators described successful percutaneous reconstruction using a covered stent in a similar patient who was doing well 2 years after intervention. These researchers carried out a literature search to examine management strategies and their long-term outcomes. The authors concluded that this report was an attempt to highlight the role of minimal invasive approach in the management of rare, severe AC in adult patients to avoid morbidity and mortality associated with more invasive procedures. These investigators noted that the initial percutaneous approach in the treatment of AC was BA; however, endovascular stent placement is gaining wider acceptance recently. The incidence of early and late aneurysm following BA has been reported to be 5 % to 11 %. This has led to the development of balloon-expandable stents and presently there are covered stents available in the market as a further advancement. These stents provide support to the vessel wall, prevent aneurysm formation and amenable to re-dilatation.
Salcher and colleagues (2016) stated that there is no systematic assessment of available evidence on effectiveness and comparative effectiveness of balloon dilatation and stenting for AC. These investigators systematically searched 4 online databases to identify and select relevant studies of balloon dilatation and stenting for AC based on a priori criteria. They synthesized results for each intervention from single-arm studies and obtained pooled estimates for relative effectiveness from pairwise and network meta-analysis of comparative studies. The primary analysis included 15 stenting (423 participants) and 12 balloon dilatation studies (361 participants), including patients of greater than or equal to 10 years of age. Post-treatment blood pressure (BP) gradient reduction to less than or equal to 20 and less than or equal to10 mm Hg was achieved in 89.5 % (95 % CI: 83.7 to 95.3) and 66.5 % (44.1 to 88.9) of patients undergoing balloon dilatation, and in 99.5 % (97.5 to 100.0) and 93.8 % (88.5 to 99.1) of patients undergoing stenting, respectively. Odds of achieving less than or equal to 20 mm Hg were lower with balloon dilatation as compared with stenting (OR, 0.105 [0.010 to 0.886]). Thirty-day survival rates were comparable. Numerically more patients undergoing balloon dilatation experienced severe complications during admission (6.4 % [2.6 to 10.2]) compared with stenting (2.6 % [0.5 to 4.7]). This was supported by meta-analysis of head-to-head studies (OR, 9.617 [2.654 to 34.845]) and network meta-analysis (OR, 16.23, 95 % CI: 4.27 to 62.77) in a secondary analysis in patients greater than or equal to 1 month of age, including 57 stenting (3,397 participants) and 62 balloon dilatation studies (4,331 participants). The authors concluded that despite the limitations of the evidence base consisting predominantly of single-arm studies, the findings of this review indicated that stenting achieved superior immediate relief of a relevant pressure gradient compared with balloon dilatation.
Beckmann and Jassar (2018) stated that AC is one of the most common congenital cardiac pathologies. Repair of native AC is nowadays a common and safe procedure; however, late complications, including re-coarctation and aneurysm formation, are not uncommon. Both bare metal stents and covered endografts have been used to treat AC. Endovascular stent graft placement offers the benefit of a less invasive approach and a potentially quicker recovery. The procedure can be performed with a low peri-operative risk. Stent implantation has replaced BA for discrete coarctation in adolescents and adults in most centers nowadays. Stent implantation is generally not advised in patients of less than 25 kg of body weight. In these patients, there is an increased risk for potential femoral artery rupture due to the sheath size. Furthermore, the native aorta is relatively small and may out-grow the stent; thus, requiring re-intervention for transcatheter dilation of the stent. The re-coarctation rates appeared to be comparable with open surgical approaches. However, aneurysm formation has been observed in 6 % of cases following stent graft placement. Previously, it has been suggested that bare metal stents might have a tendency towards future development of (pseudo) aneurysms; however, a more recent study comparing the 2 stent types did not observe any significant difference.
Price et al (2019) noted that AC is a common congenital abnormality causing significant morbidity and mortality if not corrected. Re-coarctation or re-stenosis of the aorta following treatment is a relatively common long-term problem and the optimal therapy has not been elucidated. These investigators identified the challenges associated with and the optimal management for recurrent AC and the most appropriate therapy for different patient cohorts. Open surgery provides a durable long-term aortic repair, however, given the complex nature of the procedure, has a somewhat higher rate of serious complications. Endovascular repair, although less invasive and relatively safe, has limitations in treated complex anatomy and is more likely to require repeat intervention. The authors concluded that open surgical repair is more appropriate for infants who have not been intervened on; and endovascular therapy should be reserved for older children and adults and those that require repeat intervention.
In a retrospective, single-center study, Hatoum and co-workers (2020) examined the safety and efficacy of endovascular stenting for AC and determined the effect of clinical parameters and stent characteristics on outcomes. Clinical data of all patients with AC who had attempted transcatheter stenting between 2004 and 2019 were retrospectively reviewed. Eligible patients had native or recurrent AC with systemic arterial hypertension and resting arm-leg pressure gradient of greater than 20 mmHg. Exclusions included distance between take-off of cervical arteries and stenotic aortic lesion of less than 10 mm, contraindication to anti-thrombotic therapy, body weight of less than 25 kg, and secondary hypertension. A total of 20 patients (75.0 % with native lesions) were included with a mean age of 18.4 years and a mean body weight of 59.2 kg. Procedure was successful in 90.0 % of cases with an immediate drop in the invasive pressure gradient across lesions. On a median follow-up of 12 months (range of 8 to 144.9 months), coarctation recurred in 5 patients, but 4 of them required intervention after a median of 104.4 months with successful outcomes. Cheatham Platinum stents were significantly associated with lower rates of re-coarctations and re-interventions. At the latest follow-up, 3 out of 6 patients with persistent hypertension had no re-coarctation. Analysis showed that the need for anti-hypertensive therapy was not influenced by clinical parameters, aortic arch geometry, or stent characteristics. The authors concluded that treatment of AC with stent implantation was a safe and successful procedure; and the use of Cheatham Platinum stents appeared to be associated with better outcomes.
Rossi et al (2020) stated that AC in adults is generally recognized via systemic arterial hypertension associated with a pressure gradient between the upper and lower extremities. Precise vascular imaging (multi-detector CT or magnetic resonance imaging) is mandatory for a complete evaluation of the thoracic aorta, its branches, and possible collateral vessels. Criteria for invasive treatment in adult patients include translesional pressure gradient (greater than 20 mm Hg) and/or evidence of significant collateral vessels. Choice between open surgery versus percutaneous endovascular treatment should be determined by a team of surgeons, interventional radiologists, and cardiologists.
Agasthi et al (2020) stated that the hallmark finding of AC is upper extremity hypertension, and for this reason, AC should be considered in any young hypertensive patient, justifying measurement of lower extremity BP at least once in these individuals. The presence of a significant pressure gradient between the arms and legs is highly suggestive of the diagnosis. Early diagnosis and treatment are important as long-term data consistently demonstrate that patients with AC have a reduced life expectancy and increased risk of cardiovascular complications. Surgical repair has traditionally been the mainstay of therapy for correction, although advances in endovascular technology with covered stents or stent grafts allow non-surgical approaches for the management of older children and adults with native AC and complications. Persistent hypertension and vascular dysfunction can lead to an increased risk of coronary disease, which, remains the greatest cause of long-term mortality. Therefore, BP control and periodic re-assessment with transthoracic echocardiography and three-dimensional (3D) imaging (CT or cardiac magnetic resonance) should be carried out regularly as cardiovascular complications may occur decades after the intervention.
Boe et al (2021) noted that stent implantation (SI) is more effective than BA for the treatment of AC. Due to technical factors, BA is more commonly performed in small patients. In a retrospective, single-center study, these researchers examined outcomes of percutaneous adult sized SI for the treatment of AC in small patients. This trial included patients of less than or equal to 20 kg who underwent percutaneous adult sized SI for native or recurrent AC from 2004 to 2015. A total of 39 patients (20 patients less than or equal to 10 kg) were identified, with 28 (71.8 %) having recurrent AC and 22 (56.4 %) previously failed BA. At the time of SI, the median (range) patient age and weight were 1.1 (0.3 to 7.9) years and 10 (5.5 to 20.4) kg, respectively. SI resulted in significant improvements in the median gradient (26 mm Hg [IQR, 18 to 42] to 0 mm Hg [IQR, 0 to 2]; p < 0.05) and median minimum diameter (3.6 mm [IQR, 2.4 to 4.8] to 7.7 mm [IQR, 6.5 to 9.4]; p < 0.05); 7 patients (18 %) had procedural AEs; 27 (69 %) patients underwent elective re-intervention at a median time of 49.3 (IQR, 26.5 to 63.2) months from SI, with 8 (21 %) stents requiring repeat SI for stent fracture. Over a median follow-up of 67.2 (IQR, 33.8 to 116.1) months, 25 patients (69 %) were without hypertension or BP gradient; 3 (11 %) patients developed femoral arterial occlusion. The authors concluded that adult sized SI was an alternative to surgical intervention for small patients with AC. SI carried a risk of access-related complications, which may improve with the development of lower profile stents with adult sized maximum diameters.
The Cleveland Clinic’s webpage on “Aortic Coarctation” (2021) states that “Twenty years ago, surgery was the only treatment available for aortic coarctation. Surgery is still considered the gold standard, but today treatment options for adults with this condition also include balloon angioplasty, stenting, stent grafting, or hybrid repair (a combination of open surgery and stent grafts). The choice of treatment is based on the individual's overall health, the size and severity of the coarctation, associated aneurysm or valve disease, and its precise location”.
Furthermore, an UpToDate review on “Management of coarctation of the aorta” (Bacha and Hijazi, 2021) states that “Aortic aneurysm or pseudoaneurysm is generally treated surgically. Alternatively, endovascular stent grafts have been used to repair aortic aneurysms at the site of prior CoA repair. In one case series of six adult patients with aortic aneurysm following CoA repair (age range 31 to 68 years), placement of a stent graft was successful in all cases with no related morbidity or mortality at one-year follow-up after intervention. In a second case series of nine patients, endovascular stenting was successfully performed without any major complications at a mean follow-up of 24 months”.
Chimney/Snorkel Endovascular Repair for the Treatment of Symptomatic and Ruptured Abdominal Aortic Aneurysms
Jernigan et al (2021) noted that symptomatic and ruptured AAAs are increasingly being managed with EVAR. In a retrospective, cohort study, these researchers examined the outcomes of patients with symptomatic and ruptured AAAs who had undergone EVAR with a chimney or snorkel technique (ChEVAR). This trial was carried out using the Vascular Quality Initiative registry from March 2013 to July 2019. All patients with symptomatic and ruptured AAAs with a proximal aortic zone of disease from 6 to 9 who had undergone ChEVAR were included. The outcomes were analyzed in accordance with the Society for Vascular Surgery reporting standards for EVAR. ChEVAR was carried out in 77 patients (ruptured, 35 [45.5 %]; symptomatic, 42 [54.5 %]). The median age was 73.0 years (IQR, 67.0 to 81.0 years), and 54 patients (70.1 %) were men. The median maximum aneurysm diameter was 67.5 mm (IQR, 54.5 to 83.3 mm). All patients had American Society of Anesthesiologists (ASA) class greater than or equal to III. For the patients with ruptured AAAs, the mean lowest pre-operative systolic BP (SBP) was 95.3 ± 29.3 mm Hg. The fluoroscopy time was 57.4 mins (IQR, 41.2 to 79.0 mins). The proximal aortic zone of disease was zone 6 in 9 (11.7 %), zone 7 in 21 (27.3 %), zone 8 in 36 (46.8 %), and zone 9 in 11 (14.3 %) patients. ChEVAR involved more than 1 vessel in 55 patients (71.4 %). No significant difference was found in 30-day mortality between the patients with ruptured versus symptomatic AAAs (11.4 % versus 7.1 %; p = 0.695). Re-intervention was needed for 10 patients (13.0 %) at a median of 9 post-operative days, 2 (20.0 %) of whom died. Post-operatively, 31 patients (40.3 %) had experienced a major complication. A type I endoleak had occurred in 9 patients (11.7 %), 2 (22.2 %) of whom died. Long-term follow-up data were available for 38 patients (49.4 %) at a median of 406.5 days (IQR, 326.8 to 602.0 days) post-operatively. Of the 18 patients with long-term radiographic data, sac growth was detected in 4 (22.2 %). A total of 14 patients had died at a median of 26.5 days (IQR, 3.0 to 468.5 days). The authors concluded that ChEVAR for symptomatic and ruptured AAAs could be performed with acceptable rates of morbidity and mortality. Moreover, these researchers stated that long-term data are needed to determine the durability.
The authors stated that this study was limited by the inherent structure of rigid definitions and pre-populated data entry choices set forth by a national database. Accordingly, the data became less granular, making it difficult to examine the course of an individual patient. This was compounded by the lack of strict guidelines to define urgent, emergent, and semi-urgent cases of AAA. Furthermore, meaningful variables were missing data, making it challenging to fully characterize the true rate of many of the complications and the management of the various endoleaks encountered in this trial. It was possible that some of the complications observed in this patient population were not included, given that participation in the VQI database was not mandatory at many centers. As such, it was difficult to examine if the morbidity rates found in the present study were artificially low. Although the present study was the largest of its type, the small number of patients could also have resulted in an under-estimation of these complications. Unreported surgical turn-down rates and a non-standardized patient selection process among the centers in the VQI, combined with the absence of a control group, made it difficult to draw firm conclusions from the present data series.
Viabahn Balloon-Expandable Stent Versus Self-Expandable Covered Stents for Branched Endovascular Aortic Repair
Motta et al (2021) compared the performance between the Viabahn balloon-expandable stent (VBX; Viabahn [W. L. Gore & Associates, Flagstaff, AZ]) and a covered self-expandable stent (SES; Fluency [Bard Peripheral Vascular, Tempe, AZ]) used as bridging stents for directional branches during fenestrated or branched endovascular aneurysm repair of complex aortic aneurysms. Patients with thoraco-abdominal aortic aneurysms (type I to IV) or pararenal aortic aneurysms either at high risk for open repair or unsuitable for endovascular repair with commercially available devices were prospectively enrolled in a physician-sponsored IDE trial. Descriptive statistics of the cohort included demographics, risk factors, and anatomic and device characteristics. Individual branches were grouped as either VBX or SES and had data analyzed for primary patency, branch-related type I or type III endoleaks, branch instability, branch-related secondary intervention, and branch-related aortic rupture or death. Categorical variables were expressed as total and percentage, and continuous variables were expressed as median (IQR). Kaplan-Meier curves were used to estimate long-term results. Groups were compared with the log-rank test; and p value of < 0.05 was considered statistically significant. During the period from July 2012 through June 2019, there were 263 patients treated for complex aortic aneurysm (thoraco-abdominal aortic aneurysm) with fenestrated or branched endografts. The devices used were either custom-manufactured devices or off-the-shelf p-Branch or t-Branch (Cook Medical, Bloomington, IN) devices. The median age was 71 years (IQR, 66 to 79 years); 70 % were men, and 81 % were white. The most common cardiac risk factors were smoking (92 %), hypertension (91 %), hyperlipidemia (78 %), and chronic obstructive pulmonary disease (COPD; 52 %). The total number of vessels incorporated into the repair was 977, with branches representing 18.4 % (179 branches). Among these 179 branches, the celiac artery, superior mesenteric artery, right renal artery, and left renal artery received 54 (30 %), 56 (31 %), 38 (21 %), and 31 (18 %) branches, respectively. VBX and SES groups represented 96 (54 %) and 81 (46 %) of the branches implanted. The celiac artery, superior mesenteric artery, right renal artery, and left renal artery received VBX as a bridging stent in 40 %, 46.7 %, 33.8 %, and 32.2 % respectively. The overall cohort survival rate was 78.5 % at 24 months. There was no branch-related rupture or mortality. Primary patency at 24 months (VBX, 98.1 %; SES, 98.6 %; log-rank, p = 0.95), freedom from endoleak (VBX, 95.6 %; SES, 98.6 %; log-rank, p = 0.66), freedom from secondary intervention (VBX, 94.7 %; SES, 98.1 %; log-rank, p = 0.33), and freedom from branch instability (VBX, 95.6 %; SES, 97.2 %; log-rank, p = 0.77) were similar between groups. The authors concluded that this initial experience with VBX stents demonstrated excellent primary patency and similarly low rates of branch-related complications and endoleaks, with no branch-related aortic rupture or death. These findings demonstrated that in a high-volume, experienced aortic center, the VBX stent was a safe and effective bridging stent option during branched endovascular aortic repair. Moreover, these investigators stated that multi-center studies with a larger cohort and longer follow-up are needed to validate these findings.
Chimney Versus Fenestrated Endovascular Versus Open Repair for Juxta/Pararenal Abdominal Aortic Aneurysms
In a systematic review and meta-analysis, Zlatanovic et al (2023) compared the short-term results of FEVAR, ChEVAR, and open surgery for patients with juxta/pararenal AAA (JAAA/PAAA). Medline, SCOPUS, and Web of Science were searched from inception to July 1, 2022. Any comparative studies examining the results of 2 or 3 treatment strategies (ChEVAR, FEVAR, or open surgery) on clinical outcomes for patients with JAAA/PAAA were included. Analyzed outcomes were 30-day mortality, acute kidney injury (AKI), bowel ischemia (BI), and MACE. A total of 22 studies with 8,853 patients were included in the analysis. FEVAR (OR = 0.58, 95 % CI: 0.36 to 0.82) and ChEVAR (OR = 0.56, 95 % CI: 0.28 to 1.02) were associated with lower 30-day mortality than open surgery. FEVAR (OR = 0.54, 95 % CI: 0.33 to 0.85) was associated with lower risk of AKI than open surgery. FEVAR (OR = 0.43, 95 % CI: 0.20 to 0.89) and ChEVAR (OR = 0.34, 95 % CI: 0.10 to 0.93) compared to open surgery were associated with lower rates of BI. FEVAR (OR = 0.67, 95 % CI: 0.49 to 0.90) and ChEVAR (OR = 0.61, 95 % CI: 0.35 to 1.02) were associated with lower 30-day MACE risk than open surgery. FEVAR was associated with a higher rate of SCI compared to open surgery (OR = 4.90, 95 % CI: 1.55 to 19.17). The authors found a clear benefit for FEVAR and ChEVAR versus open surgery in terms of reduced 30-day mortality, BI, and MACE, as well as AKI for FEVAR suggesting that higher-risk patients might benefit from endovascular treatment of JAAA/PAAA. Moreover, these investigators stated that this approach should be applied in clinical practice with caution, since long-term outcomes were outside of the scope of this review.
Celiac Artery Coverage During Thoracic Endovascular Aortic Repair
In a systematic review and meta-analysis, Hanna et al (2022) examined the clinical impact of celiac artery (CA) coverage during TEVAR. This study was carried out according to the PRISMA guidelines. Electronic databases were searched from 1989 to 2020 for studies reporting visceral ischemia, spinal cord ischemia (SCI), 30-day in-hospital mortality, endoleaks, re-intervention, and caudal stent graft migration following CA coverage in patients undergoing TEVAR. Meta-analysis was performed using random effects modelling. The quality of the evidence was graded using the Grades of Recommendation, Assessment, Development and Evaluation (GRADE) approach. A total of 15 observational studies with 236 patients (108 men, age range of 61.3 to 79 years) were included. The pooled visceral ischemia rate was 13 % with significant heterogeneity between studies (95 % CI: 4 to 24; I2 = 72 %, p < 0.001). The SCI rate was 5 % (95 % CI: 2 to 9; I2 = 0 %); the 30-day in-hospital mortality was 4 % (95 % CI: 1 to 7; I2 = 0 %); the overall endoleak rate was 21 % (95 % CI: 13 to 29; I2 = 35 %) with a 5 % (95 % CI: 0 to 13; I2 = 38 %) rate of type Ib and 2 % (95 % CI: 0 to 8; I2 = 43 %) rate of type II endoleak from retrograde CA flow. The re-intervention rate was 13 % (95 % CI: 6 to 22; I2 = 54 %); the caudal stent graft migration rate was 3 % (95 % CI: 0 to 9, I2 = 0 %). The certainty of the body of evidence was judged to be very low for all outcomes. The authors concluded that CA coverage during TEVAR was associated with high rates of visceral ischemia, spinal cord ischemia, 30-day in-hospital mortality, endoleaks, and re-intervention. These investigators stated that although the literature is of poor quality and questions remain over effects estimates, there is evidence that CA coverage should be avoided if at all possible, during TEVAR.
Argyriou et al (2022) TEVAR has emerged as an attractive alternative option in the treatment of TAAA diseases, reporting lower morbidity and mortality rates compared with open or hybrid repair. A challenging situation arises when the aneurysm involves the CA, precluding a safe distal landing zone. In a systematic review and meta-analysis, these investigators examined the safety and effectiveness of CA coverage in the treatment of complex TAAA diseases during endovascular management. They carried out a review of the literature in accordance with the PRISMA guidelines. The electronic bibliographic sources searched were Medline and SCOPUS databases. Primary outcomes of interest were peri-operative and 30-day mortality. Any type of endoleak, mesenteric ischemia, peri-operative SCI, and re-intervention rates were secondary endpoints. A random-effects meta-analysis was conducted. Summary statistics of event risks were expressed as proportions and 95 % CI. A total of 10 observational cohort studies published between 2009 and 2020, reporting a total of 175 patients, were eligible for quantitative synthesis. Indications for TEVAR were primary TAAAs in 82 % of patients, aortic dissection in 14 % of patients, type Ib endoleak after previous endograft deployment in 3 % of patients; and penetrating aortic ulcer in 1 patient. Re-intervention rate was 9 % (95 % CI: 4 % to 20 %) and SCI was 7 % (95 % CI: 4 % to 12 %). Type II endoleak was the predominant type of endoleak in 10 % of patients (95 % CI: 4 % to 22 %), followed by type I endoleak in 5 % of patients (95 % CI: 2 % to 12 %) and type III endoleak in 1 % (95 % CI: 0 % to 16 %) of patients. Mesenteric ischemia occurred in 6 % of patients (95 % CI: 3 % to 10 %); 30-day mortality was 5 % (95 % CI: 2 % to 13 %) and the pooled estimate for overall mortality was 21 % (95 % CI: 14 % to 31 %). The authors concluded that CA coverage during TEVAR was a challenging but feasible option for the treatment of TAAA diseases, providing acceptable morbidity and mortality rates. Demonstration of adequate visceral collateral pathways before definitive CA coverage was necessary for the success of the technique.
Elective Endovascular Versus Open Repair for Elective Abdominal Aortic Aneurysm in Patients Age 80 Years or Older
In a systematic review and meta-analysis, Wang et al (2023) examined available evidence on clinical outcomes among octogenarians (aged 80 years or older) with AAA managed by elective endovascular repair, compared to conventional open repair. PubMed, Embase, and Scopus databases were systematically searched. Studies that were either observational or RCTs were considered for the review. Included studies were carried out in elderly subjects (80 years or older) with AAA, and clinical and mortality outcomes were compared between endovascular and open surgical repair. Those reporting on outcomes of patients with urgent repair were excluded. The primary outcomes of interest were mortality and risk of complications. The pooled effect sizes were reported as OR for categorical outcomes and weighted mean difference (WMD) for continuous outcomes. STATA software was used for statistical analysis. The meta-analysis included 15 studies. Compared to those undergoing open repair, patients receiving endovascular repair had significantly reduced risk of immediate post-operative mortality (OR 0.23, 95 % CI: 0.20 to 0.27), overall complication (OR 0.30, 95 % CI: 0.20 to 0 .44), cardiac (OR 0.23, 95 % CI: 0.16 to 0 .35), renal (OR 0.29, 95 % CI: 0.18 to 0.46), pulmonary (OR 0.14, 95 % CI: 0.09 to 0.21) and bleeding related (OR 0.59, 95 % CI: 0.42 to 0.83) complications. The risk of mortality at latest follow-up (at 36 months and 60 months) was similar in the 2 groups. The total blood loss (ml) (WMD 1,126.47, 95 % CI: 1,497.81 to 755.13), operative time (min) (WMD 29.40, 95 % CI: 56.19 to 2.62), length of ICU stay (days) (WMD 2.27, 95 % CI: 3.43 to 2.12) and overall hospital stay (days) (WMD -6.64, 95 % CI: 7.60 to 5.68) was significantly lower in those undergoing endovascular repair. The authors concluded that endovascular repair appeared to be better than open repair of AAA in this high-risk, frail population, with respect to short-term outcomes. The benefits of reduced risk of short-term mortality, complications, and better peri- and post-operative outcomes may be considered when making a choice between these 2 surgical approaches. Moreover, these researchers stated that RCTs are needed to provide reliable evidence on the effect of EVAR on long-term survival.
Total Endovascular Aortic Arch Repair
Basha et al (2023) stated that total endovascular aortic arch repair (TEAAR) represents an emerging alternative for the treatment of aortic arch disease in patients at prohibitive risk for open surgery. In a systematic review, these investigators examined the early outcomes with this new technology. All studies (excluding single-patient case reports) of CE-certified "custom made" or "off-the-shelf" zone 0 stent graft deployments were included. The primary search of Medline, Embase, CINAHL, and the Cochrane CENTRAL registry was supplemented with searches of Web of Science, ClinicalTrials.gov, and conference abstracts (within last 3 years), and a hand-search of citations within relevant articles. Studies underwent 2-stage screening by 2 independent reviewers before inclusion. A total of 15 relevant studies were identified. Indications for TEAAR were chronic arch dissection with degenerative aneurysmal disease (54 %, 148/273), pure arch aneurysm (41 %, 112/273), penetrating atherosclerotic ulcer (2 %, 5/273), and type IA endoleak from a zone 2 thoracic endograft (1 %, 3/273). Double-branch (70 %, 192/273), triple-branch (19 %, 53/273), and single-branch (into innominate artery; 10 %, 28/273) devices were used. Adjunct left carotid-subclavian bypass occurred in 90 % of double- and single-branch procedures. Procedural success with TEAAR was 93 % (95 % CI: 85.8 % to 96.3 %). The proportion of all-cause mortality was 16 % (95 % CI: 8 % to 26 %), stroke 14 % (8 % to 24 %), peripheral vascular events 7 % (1 % to 33 %), and MI 4 % (2 % to 7 %). Endoleaks were identified in 13 % (7 % to 25 %) of the study population. The authors concluded that TEAAR represents an emerging option for the management of aortic arch disease with high procedural success rates and acceptable early outcomes in a high-risk patient population.
Wong et al (2023) described the feasibility and outcomes of endovascular repair of distal aortic arch aneurysms using a patient-specific stent graft with a pre-loaded single retrograde left subclavian artery (LSA) branch stent graft. These investigators examined the clinical data and outcomes of consecutive patients enrolled in an ongoing prospective, non-randomized, physician-sponsored IDE study to assess the outcomes of endovascular aortic arch repair using patient-specific arch branch stent grafts between 2019 and 2022. All patients received a design with triple-wide scallop and a single retrograde LSA branch with a pre-loaded catheter. There were 5 men with median age of 77 years (72 to 80) treated using the single LSA branch stent graft. Technical success was achieved in all patients. Median operating time, fluoroscopy time, and total radiation dose area product were 103 (78 to 134) mins, 26 (19 to 39) mins, and 123 (71 to 270) mGy/cm2, respectively. There were no 30-day or in-hospital mortality, neurological or other MAEs. During median follow-up of 21 (20 to 27) months, all patients were alive with patent LSA branches, except for 1 who died of COVID-19 complications. There was no branch instability or secondary interventions. The authors concluded that this early feasibility study showed successful endovascular repair of distal aortic arch aneurysms using a patient-specific stent graft with single retrograde LSA branch without technical failures, mortality or neurological events. Moreover, these researchers stated that larger clinical studies with longer follow-up are needed to ascertain the effectiveness of this approach in patients who need endovascular repair with proximal extension into Zone 2.
Endovascular Repair for the Treatment of Non-Dissected Ascending Aortic Diseases
Plichta and Hughes (2018) stated that TEVAR of the ascending aorta (AA) is a developing alternative treatment strategy, which currently is specifically aimed at patients who are too high risk for open surgery. TEVAR has been used in patients with a variety of pathologies of the AA including type A dissection, intra-mural hematoma, penetrating ulcers, aneurysm, and pseudoaneurysm. These investigators discussed the available evidence regarding the use of TEVAR for the AA as well as the latest techniques and pitfalls of the procedure. They noted that the challenges of this modality are considerable, and the techniques that have been employed drew from the many facets of endovascular experience. The authors concluded that there was limited literature on the use of stent grafts in the AA, and the pool of patients currently considered appropriate candidates for the procedure is small. These researchers stated that this is an evolving intervention that warrants further investigations and the development of devices specifically engineered to meet the anatomical and physiologic challenges of the AA.
Preventza et al (2022) noted that different pathologies of the AA, including aneurysms, acute and chronic dissections, and pseudoaneurysms, have been treated with open surgical repair with very good results, especially at aortic centers of excellence; however, there is a subset of patients for whom open surgery is considered to pose high or prohibitive risk These patients could benefit from a less invasive approach with catheters and wires, percutaneous techniques and stent grafts. The existing technology was developed to treat descending thoracic aortic pathologies; it is not approved for use in the AA by the FDA. The devices used for the descending thoracic aorta (DTA) have certain size and design limitations that make their use to the AA cumbersome at times. As a result, custom-made endografts have been used to treat pathologies in the AA, although their use is feasible only in elective procedures. Furthermore, the AA has specific anatomic and physiologic characteristics that raise concerns regarding the long-term durability of the current technology. Moreover, these researchers stated that although endovascular repair is a promising new direction for the treatment of AA, the main barrier to widespread use is the lack of devices designed and approved specifically for treating the AA. Although several centers have used improvised devices off-label for compassionate use, a device and delivery system specific to the AA would be invaluable. Furthermore, a TEVAR device for AA interventions would be designed with the unique flow characteristics of the AA in mind, which could enhance the device’s durability and improve long-term outcomes.
In a systematic review, Huo et al (2023) examined the effectiveness of endovascular repair for the treatment of non-dissected diseases of the ascending aorta. Data sources included PubMed, Embase, and SciELO. These investigators carried out a search on the PubMed, Embase, and SciELO databases for all cases of ascending aortic endovascular repair included in the literature published between January 2007 and July 2023, excluding type A aortic dissection. This reviewed entailed 56 case reports and 7 observational studies assessing the techniques, equipment, procedural steps, and results. These researchers summarized the age, complications, follow-up time, and access route. This review included 63 studies reporting 105 patients (mean age of 64.96 ± 17.08 years) who received endovascular repair for non-dissected ascending aortic disease. The types of disease include aneurysm (n = 16), pseudoaneurysm (n = 71), penetrating aortic ulcer (n = 10), intra-mural hematoma (n = 2), thrombosis (n = 2), iatrogenic coarctation (n = 1), and rupture of the aorta (n = 3). The success rate of surgery was 99.05 % (104/105). Complications included endoleak (10.48 %, 11/105), stroke (5.71 %, 6/105), post-operative infection (1.91 %, 2/105), acute renal failure (0.95 %, 1/105), aortic rupture (0.95 %, 1/105), thrombosis (0.95 %, 1/105), and splenic infarction (0.95 %, 1/105). A total of 5 patients required conversion to open surgery, 2 patients underwent endovascular re-intervention, and 4 of these 5 patients underwent surgery due to endoleak. Early mortality was 2.86 % (3/105). The authors concluded that while the viability and results of endovascular repair for the treatment of ascending aortic diseases were acknowledged in some circumstances, further investigations are needed to ascertain the safety and effectiveness of endovascular treatment for ascending aortic disease. These researchers stated that there is still a need for large clinical trials; and technical problems must be solved.
Ferraresi et al (2024) stated that the number of vascular centers performing endovascular repair of AA disease is constantly increasing. Accordingly to the guidelines, open surgical repair remains the gold standard for these pathologies; however, about 25 % of patients are deemed unfit for open surgery. These investigators described 3 cases of ascending TEVAR carried out at the authors’ center. All the patients were deemed unfit for open surgery by the aortic team – 2 patients had an ascending aortic pseudoaneurysm, and the 3rd had a focal type A aortic dissection. In 2 cases, these researchers used 2 abdominal aortic cuffs deployed from zone 0B to zone 0C, with no need for supra-aortic trunk debranching. In 1 case, these investigators conducted a "reverse" extra-thoracic debranching, and they deployed a thoracic endograft from zone 0B to zone 2. Complications included 1 minor stroke and 1 inguinal hematoma. In 1 patient with an infected pseudoaneurysm, these investigators carried out ascending TEVAR as a bridge strategy for open repair. This patient developed a type Ia endoleak; however, clinical stabilization and infection control were obtained, and he was able to undergo heart surgery successfully. He underwent a 2nd re-intervention to treat superior mesenteric embolic occlusion. At 2-year follow-up, all 3 patients were alive. The authors concluded that their preliminary experience with 3 high-risk patients unfit for open surgical repair showed the technical feasibility and clinical appropriateness of ascending TEVAR for selected ascending aortic pathologies using standard, commercially available endografts. Moreover, these researchers stated that long-term results must be confirmed. The choice to treat the AA using endovascular techniques must be discussed in the context of an aortic team and being clear that the gold standard continues to be open surgery. However, the introduction of specifically designed devices will aid in standardizing the procedure of ascending TEVAR, establish appropriate indications, and ensure good clinical outcomes.
Furthermore, an UpToDate review on “Overview of open surgical repair of the thoracic aorta” (Burke, 2024) states that “Repair of the ascending aorta, whether for acute type A dissection, aortic aneurysm, or aortic intramural hematoma, is approached in a similar manner, with cardiopulmonary bypass including cardioplegia. Aortic root replacement is sometimes required … During ascending aortic and arch repairs, deep hypothermic circulatory arrest, retrograde cerebral perfusion, and selective antegrade cerebral perfusion techniques are used alone, or in combination, to minimize brain injury. Repair of pathologies affecting the ascending aorta or aortic arch may involve the aortic root, which necessitates coronary artery reimplantation and may or may not require aortic valve replacement or repair. For patients without significant aortic root dilation, valve-sparing aortic root replacement is recommended”.
GORE EXCLUDER Thoraco-Abdominal Branch Endoprosthesis
Spath et al (2023) noted that PRAAAs require complex endovascular aortic repair or open surgical repair with supra-renal clamping. Custom-made devices (CMD), including fenestrated and branched endovascular aortic repair (F/B-EVAR) or off-the-shelf (OTS) multi-branched devices, are available therapeutic options. In a retrospective, single-center study, these researchers examined the additional healthy aortic coverage using an OTS multi-branched endograft versus a CMD for the treatment of PRAAAs. Consecutive patients with PRAAAs requiring a proximal landing zone above the CA, planned and treated with CMDs (Zenith Fenestrated) between January 2017 and December 2021 were included in this trial. Treatment with supra-celiac coverage using available OTS multi-branched devices was simulated using available pre-operative images: T-Branch; E-nside; and TAMBE. Study endpoints included the need for additional proximal aortic coverage, and the number of the segmental arteries additionally covered proximally from the CA for OTS devices compared with CMDs. A total of 83 patients with PRAAAs were treated with CMDs (all FEVAR), including juxta-renal AAAs (n = 46; 56 %), supra-renal AAAs (n = 20; 24 %), and short-neck AAAs (n = 17; 20 %). In this study, treatment with 249 (3 × 83) OTS endografts was simulated. When compared with CMDs, OTS devices required a mean of 74 ± 19 mm of additional proximal healthy aortic coverage from the CA (CMD: 33 ± 19 mm versus OTS: 108 ± 6 mm; p ≤ 0.001), as well as an average sacrifice of 2.5 additional segmental arteries (CMD: 1.3 ± 0.8 versus OTS: 3.8 ± 0.9; p ≤ 0.001). In 94 % of patients, at least one of the available multi-branched endografts could have been implanted in accordance with instructions for use. The authors concluded that despite not requiring customization time, OTS endografts for the treatment of PRAAAs resulted in more extensive healthy aortic coverage, as well as an average sacrifice of 2.5 additional segmental arteries, compared with CMDs. When compared with OTS devices, CMDs appeared to limit the extent of unnecessary aortic coverage and the theoretical subsequent risk of spinal cord ischemia.
The authors stated that this study had several drawbacks, such as its retrospective, single-center design, with assumptions based on CTA scans and without clinical data from all patients treated with a CMD graft. One of the key drawbacks was that all PRAAA patients were treated with a single fenestrated CMD platform. Furthermore, there was no control group to compare clinical data, and safety and morbidity considerations were based on a large amount of available data from the literature.
Chen et al (2023) carried out a meta-analysis to examine the safety and effectiveness of T-Branch OTS multi-branched endograft for the treatment of TAAA. Data sources included PubMed, Embase, and Web of Science. Online databases were searched from June 2012 to March 2023. Data were pooled using a random-effects model of proportions. Overall outcomes included technical success, spinal cord ischemia, target vessel occlusion, type I or III endoleak, re-intervention, early mortality (30-day), and mid-term outcomes. Subgroup meta-analyses and meta-regression were conducted to examine variation among studies. A total of 15 studies containing 1,238 patients were included in the meta-analysis. The overall study quality assessment was found to be moderate-to-good. The pooled technical success was 97.0 % (95 % CI: 95.5 % to 98.6 %, I2 = 53.01 %, 1,185/1,238 cases, 15 studies). Overall, early mortality was 7.3 % (95 % CI: 4.4 % to 10.1 %, I2 = 74.48 %, 124/1,238 cases, 15 studies). Early spinal cord ischemia was 13.4 % (95 % CI: 9.6 % to 17.2 %, I2 = 67.24 %, 160/1,238 cases, 15 studies), and early type I or III endoleak was 6.0 % (95 % CI: 3.4 % to 8.5 %, I2 = 53.71 %, 68/1,032 cases, 9 studies). Mid-term outcomes showed target vessel occlusion was 4 % (95 % CI: 1.4 % to 6.5 %, I2 = 65.18 %, 28/528 cases, 10 studies, 5 to 21.2 months), type I or III endoleak was 4.7 % (95 % CI: 2 % to 7.5 %, I2 = 49.74 %, 38/512 cases, 10 studies, 5 to 21.2 months), re-intervention was 11.2 % (95 % CI: 8.1 % to 14.3 %, I2 = 31.06 %, 85/650 cases, 10 studies, 5 to 21.2 months), and pooled mortality was 13.9 % (95 % CI: 7.2 % to 20.7 %, I2 = 76.32 %, 84/550 cases, 11 studies, 5 to 21.2 months). Meta-regression found a significant linear association between higher technical success and earlier publication year (p = 0.014) and studies with anatomic inclusion criteria (p = 0.037). Urgent patients (p = 0.021) and later publication year (p = 0.048) were significantly associated with higher early mortality. The authors concluded that the use of the OTS T-Branch multi-branched endograft for elective or urgent endovascular TAAA repair was associated with high technical success rates and proved to be safe and effective at early and mid-term follow-up. However, these researchers stated that the heterogeneity between the included studies was high, and prospective, randomized clinical trials along with future larger studies with long-term follow-up are needed.
In a prospective, non-randomized, multi-center study, Farber et al (2024) reported the 30-day outcomes of the primary arm of the GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis (TAMBE) pivotal trial for complex AAA repair. This trial included patients who were enrolled in the primary study arm of extent IV TAAA and PRAAs. Technical success and major AEs were analyzed per the Society for Vascular Surgery (SVS) guidelines. A total of 102 patients of the primary arm who underwent endovascular repair using the TAMBE device were a mean age of 73 ± 6.4 years (range of 58 to 82 years), and 84 (84.2 %) were men. The mean body mass index (BMI) was 28.3 ± 5.0 kg/m2; 59 patients (57.8 %) were treated for extent IV and 43 (42.2 %) pararenal aneurysms; the mean maximum diameter of the aneurysms was 59.4 ± 7.8 mm. A prophylactic cerebrospinal fluid (CSF) drain was used in 10 patients (9.8 %). Technical success was achieved in 99 % of patients, with the single failure owing to unsuccessful cannulation of the left renal artery. Mean procedure time was 315 ± 103 mins (range of 163 to 944 mins), estimated blood loss (EBL) was 300 ± 296 ml (range of 10 to 2,000 ml), and contrast administration was 153.6 ± 73.5 ml (range of 16 to 420 ml). The ICU-LOS was 58.7 ± 52.7 hours (range of 1 to 288). In 28 patients (27.5 %), a total of 32 additional endovascular components were deployed to manage procedural complications including aortic and target vessel dissections and injuries not related to access. Bridging stent grafts were deployed to incorporate 407 target vessels (mean of 1.6/per vessel; range of 1 to 4). Post-operative transfusion was required in 14 patients (13.7 %). Major AEs occurred in 7 patients (6.9 %) through 30 days. Events included respiratory failure (n = 2), disabling stroke (n = 1), new-onset renal failure requiring dialysis (n = 2), and paraplegia (n = 2). At 30 days, there was 1 patient with intra-operative rupture; no severe bowel ischemia or lesion-related/all-cause mortality were reported. The Core lab-reported patency was 100 % in the aortic component, superior mesenteric artery, and celiac artery, and 95.9 % in the left renal and 99.0 % in the right renal branch components through 30 days of follow-up. Re-interventions through 30 days were carried out in 9 of 96 patients (9.4 %) and were all minor. The authors concluded that the Early TAMBE device outcomes showed a high technical success rate, no 30-day lesion-related mortality, and a low rate of safety events within 30 days of the index procedure. Moreover, these researchers stated that this procedure was not without risks, including paraplegia, renal failure, and the need for adjuvant stenting to resolve complications both intra-operatively and in follow-up. They stated that long-term data are needed to determine where this treatment strategy will fit in the management of patients with TAAA and PRAA.
The authors stated that this study had several drawbacks. First, aneurysm suitability was determined by an experienced screening committee. Patient selection has a significant impact on outcomes and device applicability may not reflect real-world experience. Second, protocol development occurred in 2016, before the updated SVS reporting standards were published in 2021; thus, it was not possible to plan data collection to allow for reporting of outcomes to completely align with the updated SVS reporting standard definitions for technical success and major AEs. Third, in this study, endoleaks reported from the Core lab analysis were not always concordant with the site-reported data (e.g., type II and/or indeterminate endoleaks reported by the Core lab in patients that sites reported as type I or III endoleak). Endoleak determination by the Core lab follows a uniform, validated protocol and is independent of clinical information available to site investigators, such as physical examination, operative observations, arteriography, and trans-esophageal echocardiography (TEE). The Core lab does not always have access to the full body of the data (clinical and imaging); thus, limiting their complete assessment of all events. Site physicians, by contrast, have non-uniform and different site definitions and criteria of imaging findings, and sites may have different thresholds for when an imaging finding warrants AE reporting. They may be more likely to assess and report clinically significant observations that were congruent with reported AEs. Physicians may determine both the presence and type of endoleak, based on their best medical judgement, through the evaluation across multiple images sets and image modalities.
DiBartolomeo et al (2024) stated that fenestrated-branched endovascular aortic repair (FB-EVAR) has shown favorable outcomes for repair of complex aneurysms and thoraco-abdominal aortic aneurysms. Physician-modified endo-grafting (PMEG) and the Gore thoraco-abdominal multi-branch endoprosthesis (TAMBE) provide custom and off-the-shelf devices for FB-EVAR, respectively. In a retrospective, single-center study, these researchers compared the outcomes of TAMBE and PMEG. They reviewed medical records of patients who underwent TAMBE as part of the multi-center, pivotal trial or PMEG as part of a prospective, physician-sponsored IDE trial at a single institution between 2020 and 2022. Patient demographics, characteristics, as well as peri-operative and mid-term outcomes were compared. A total of 68 patients were included, with 12 in the TAMBE group and 56 in the PMEG group. Baseline characteristics were comparable between groups. Aneurysm type was most often thoraco-abdominal aortic aneurysm in both groups (58 % TAMBE and 52 % PMEG). TAMBE had a higher rate of upper extremity access (100 % versus 63 %; p = 0.013) and longer mean procedure time (247 ± 36 mins versus 189 ± 49 mins; p < 0.001). Other intra-operative metrics were similar between groups. Technical success was 100 % in TAMBE and 95 % in PMEG (p = 0.412). There was no 30-day mortality in either group. No major AEs occurred with TAMBE, whereas in PMEG cases, 2 % had respiratory failure, 2 % required dialysis, and 4 % experienced spinal cord ischemia. Although the overall endoleak rates were similar (50 % of TAMBE versus 41 % of PMEG; p = 0.57), type-II endoleaks accounted for all of the endoleaks in the TAMBE group, whereas type-I or type-III endoleaks were observed in 11 % of PMEG patients. At a median follow-up of 26.7 months for the TAMBE group and 21.2 months for the PMEG group, target vessel instability was observed in 10.4 % of TAMBE, and 6.9 % of PMEG targeted branches (p = 0.401). Re-intervention was required in 33 % of TAMBE patients and 27 % of PMEG patients (p = 0.646). Estimated freedom from re-intervention rates at 3 years were similar (56 % TAMBE versus 62 % PMEG, log-rank p = 0.910). Freedom from visceral renal target vessel instability at 3 years was 89 % for both groups (log-rank p = 0.459). The Kaplan-Meier 3-year estimated survival was 100 % for patients in the TAMBE group and 77 % for patients in the PMEG group (log-rank p = 0.157). The authors concluded that both TAMBE and PMEG showed high technical success rates and similar 3-year outcomes, marked by high re-intervention rates. The introduction of TAMBE presented a promising advancement that may aid in streamlining the treatment of complex aortic pathologies. These researchers stated that further investigations via real-world clinical experience are needed to examine the comparative durability of TAMBE and PMEG in patients undergoing FB-EVAR.
The authors stated that this trial was limited by its selection bias owing to strict adherence to the center’s treatment algorithm, resulting in patients with more favorable anatomy being included in the TAMBE group. In addition to a small sample size, these findings may not be generalizable to extent I, II, and III TAAA and post-dissection TAAA as most of the TAMBE patients included in this study were enrolled in the primary arm of the multi-center pivotal study (extent IV TAAA or pararenal abdominal aortic aneurysm). Albeit these differences, these results demonstrated that similar outcomes were attained at the authors’ aortic center while incorporating TAMBE into complex EVAR therapeutic options.
Karaolanis et al (2025) stated that during the last years a great progress has been noted in device technology and operator experience in treating complex aortic aneurysms. Fenestrated and branched CMDs require detailed pre-operative planning and production time that can take 12 weeks or less. During this awaiting period, aortic-related mortality is increased. To overcome this limitation, OTS standardized multi-branched devices were launched in the market for the treatment of PRAAs and TAAAs. In a systematic review and meta-analysis, these investigators examined all the published studies of OTS endografts for the treatment of PRAAs and TAAAs. They carried out a systematic review to identify all the eligible studies that reported outcomes to the OTS with inner or outer multi-branched devices and then conducted a qualitative synthesis and meta-analysis of the results. The main outcomes were technical success, mortality, target visceral vessel instability, major AEs, and re-intervention rates. These researchers estimated pooled proportions and 95 % CIs. A total of 1,605 study titles were identified by the initial search strategy, of which 13 (8 T-Branch, 3 E-nside, 1 We-Flow, and 1 TAMBE) were considered eligible for inclusion in the meta-analysis. A total of 595 patients (70 % male) were identified among the eligible studies. In terms of procedures, 64.4 % were elective, 19.2 % (13.4 % outer multi-branched group [OMG]; 6.1 % inner multi-branched group [IMG]) were emergent, and 16.4 % (15.6 % OMG; 0.8 % IMG) were urgent. The pooled technical success was 92.1 % (95 % CI: 83.8 % to 96.4 %) and 96.9 % (95 % CI: 92.5 % to 98.8 %) for the outer and inner multi-branched endografts, respectively. The pooled 30-day mortality was 10.4 % (95 % CI: 6.6 % to 16.1 %,) and 4.2 % (95 % CI: 2.0 % to 8.6 %) for the OMG and IMG, respectively. The pooled 30-day and late target visceral vessel instability for the OMG was 3.5 % (95 % CI: 2.0 % to 6.1 %) and 6.2 % (95 % CI: 4.7 % to 8.0 %) and for the IMG 10.4 % (95 % CI: 4.5 % to 22.5 %) and 1.6 % (95 % CI: 0.7 % to 3.3 %) respectively. The authors concluded that this pooled analysis indicated good technical success and mortality rates for both devices despite the high rate of urgent procedures; PRAAs and TAAAs can be treated safely using the included devices. Moreover, these researchers stated that further investigations are needed to draw additional conclusions for the IMG owing to the small sample size.
Furthermore, an UpToDate review on “Endovascular devices for thoracic aortic repair” (Chaer, 2024) states that “Fenestrated grafts -- The use of fenestrated-endovascular aneurysm repair (FΕVAR) to manage more challenging aortic anatomy continues to evolve. The Zenith Fenestrated AAΑ Endovascular Graft is the only device approved device for use in the US and specifically for the treatment of pararenal abdominal aortic aneurysm (AAA). Other branched devices to treat thoracoabdominal aneurysms are under investigation. Enrollment was recently completed in the early feasibility study evaluating the Gore Excluder Thoracoabdominal Branch Endoprosthesis (TAMBE) for the treatment of aortic aneurysms involving the visceral branch vessels. The TAMBE is designed to be the first complete off-the-shelf solution for the treatment of this complex disease and was approved for commercial use by the US Food and Drug Administration (FDA)”.
Endovascular Repair in Children
Aortic coarctations or congenital pulmonary artery stenosis can be a serious condition in children with hemodynamic complications. In the past, stents were not recommended for this group as fixed stents will not grow with the child. Then existing large caliber of adult arterial stents were approved for patients greater than 25 kgs. Thus children with hemodynamic complications due to aortic coarctations or pulmonary artery stenosis have been left with only surgical options and requiring repeat surgeries as they grow.
Gibb, et al. (2024) presented the medium-term outcomes for stenting of aortic coarctation (CoA) (native or re-coarctation) with newer generation low-profile stents (Valeo, Formula, and Begraft stents) in children under 30 kg. The investigators conducted a retrospective review of patients weighing under 30 kg who had percutaneous stent treatments for coarctation between 2012 and 2021. Clinical and procedural data were collected; 19 patients were included. The median age at the time of procedure was 5.1 [4.1-6.4] years and median weight 21.0 [17.3-22.3] kg. One patient had a history of re-coarctation. Thirteen (68%) patients were on anti-hypertensives pre-procedure. Different types of stents were used (14 Valeo™, 4 Formula® 535, 1 BeGraft), which can all be dilated to 18 mm or larger. One patient required a 9 F sheath, all others required a 7 F sheath. The narrowest diameter in the aorta increased from a median of 3.5 [3.0-4.5] to 9.4 [8.9-9.8] mm, p < 0.001; there was a reduction in the median pressure gradient across the coarctation from 35.0 [30.0-43.0] to 5.0 [0-10.0] mmHg, p < 0.001. There were no intra-procedural complications. Follow-up was for a median of 56.0 [13.0-65.0] months. Five (26%) of patients underwent re-intervention after a median time frame of 40.0 [39.5-52.0] months; four had balloon dilation, one had repeat stent implantation. Five (26%) patients were on anti-hypertensive agent(s) post-intervention. Our single center experience demonstrates that percutaneous stenting for coarctation of aorta in children under 30 kg, with low-profile stents, had no significant complications during the median follow-up time of 56 months. This study demonstrated that the procedure is safe and effective for short and medium-term therapy in this group of patients with a 26% re-intervention rate. A quarter of patients remained on anti-hypertensive medication post stenting, emphasizing the importance of long-term follow-up.
Berman, et al. (2024) stated that stent implantation has become standard of care in older children and adults for treatment of branch pulmonary artery stenosis (BPAS) and coarctation aorta (CoAo). There are no stents approved or available for infants that have the potential to be dilated to adult diameters. The Minima stent was designed to fulfill this unmet need. The investigators reported a multicenter, prospective, nonrandomized early feasibility study evaluating safety and effectiveness of the Minima stent for treatment of BPAS and CoAo. Primary endpoints included: (1) successful deployment across lesion, (2) stenosis relief defined by an increase in angiographic diameter of >50% and (3) freedom from stent explant, embolization or migration at 30 days and 6 months. Between 2/2022 and 5/2022, 10 pts underwent Minima stent implantation with a median age and weight of 9 months (4-43 months) and 7.6 kg (5.1-16.9 kg). Procedural success and predefined stenosis relief was achieved in all cases (CoAo [n = 4], BPAS [n = 6]). Adverse events occurred in 3 pts: transient diminished lower extremity pulse (n = 2), distal stent on-balloon displacement successfully managed in the catheterization suite (n = 1). There were no deaths or major adverse events. All patients were free from stent explant and migration at 30 days and 6 months with no evidence for significant restenosis at latest follow-up. The investigators concluded that implantation of the Renata Minima stent was safe and effective for the treatment of BPAS and CoAo in this small cohort of infants and young children during early follow-up. Based on these early results, an expanded study with longer follow-up is warranted.
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