Aetna considers coil embolization medically necessary in the treatment of arterio-venous malformations (AVMs)/aneurysm and splenic artery aneurysm.
Aetna considers endovascular embolization is an acceptable treatment modality for an extracranial AVM or fistula.
Aetna considers vascular embolization medically necessary for the treatment of type I/type II endovascular leak.
Aetna considers renal artery embolization/angioinfarction, as a pre-operative adjunct to nephrectomy, medically necessary in the treatment of persons with large, hypervascular renal cell carcinomas.
Aetna considers transcatheter embolization (embolotherapy) medically necessary in the treatment of intractable or recurrent severe posterior epistaxis when conservative measures have failed.
Aetna considers tumor embolization or pre-operative tumor embolization to reduce intra-operative bleeding prior to surgical resection medically necessary in the treatment of hypervascular tumors or metastases from hypervascular tumors.
Aetna considers alcohol embolization or sclerotherapy and/or surgery medically necessary for symptomatic venous malformations as evidenced by pain, swelling, ulceration, or hemorrhage.
Aetna considers coil embolization and occlusion of the hypogastric veins for the prevention or treatment of deep vein thrombosis (DVT) experimental and investigational.Background
Splenic artery aneurysms account for 60 % of all visceral arterial aneurysms. They are the only aneurysms that are more common in women, with a female-to-male ratio of 4:1. The development of aneurysms in the splenic artery has been attributed to systemic arterial fibrodysplasia, portal hypertension, and increased splenic arterio-venous shunting that occurs in pregnancy. Splenic artery aneurysms are most often asymptomatic. Symptomatic patients exhibit vague left upper quadrant or epigastric discomfort and occasional radiation of pain to the left shoulder or subscapular area. Only 2 % of splenic artery aneurysms result in life-threatening rupture.
Coil embolization is a catheter-based procedure that allows precise closure of abnormal blood flow in a blood vessel. A catheter with a metallic occluding coil is inserted into an artery, usually in the groin (the femoral artery). It is then advanced to the abnormal blood vessel. Once properly positioned, the metal coil is released, springing into position within the vessel. It remains firmly in place by the expansion of the metal coils. A blood clot will form on the coil, completely obstructing the abnormal blood flow beyond the coil. Eventually a scar will form, creating a permanent seal.
Although the individual study numbers are small, the total studied over several years is significant and the evidence has demonstrated that coil embolization in the treatment of splenic artery aneurysms is safe and effective and may induce less morbidity than open surgery, in particular by preserving the spleen.
Leffroy et al (2008) evaluated the outcomes of endovascular treatment of splenic artery aneurysms and pseudoaneurysms. From April 2002 to May 2007, 17 patients (mean age of 55.2 years, range of 17 to 82) with splenic artery aneurysms (n = 7) or pseudoaneurysms (n = 10) underwent endovascular treatment. Six patients were asymptomatic, 3 had symptomatic nonruptured aneurysms, and 8 had ruptured aneurysms. Lesions were in the proximal splenic artery (n = 5), intermediate splenic artery (n = 3), splenic hilum (n = 6), or parenchyma (n = 3). Embolization was with microcoils by sac packing (n = 8), sandwich occlusion of the main splenic artery (n = 4), or cyanoacrylate glue into the feeding artery (n = 4). Computed angiotomography was done within the first month and magnetic resonance angiography (MRA) after 6 and 12 months, then yearly. Mean follow-up was 29 months (range of 1 to 62). Exclusion of the aneurysm was achieved in 16 (94.1 %) patients. One patient with an intra-parenchymal pseudoaneurysm underwent splenectomy after failed distal catheterization. No major complications occurred. Post-embolization syndrome developed in 4 patients, who had radiographic evidence of splenic microinfarcts. The authors concluded that transcatheter embolization of splenic artery aneurysms/pseudoaneurysms is safe and effective and may induce less morbidity than open surgery, in particular by preserving the spleen. Coil artifacts may make MRA preferable over computed tomography for follow-up.
Ikeda and colleagues (2008) described their experiences with the treatment of visceral artery aneurysms (VAA) by transcatheter coil embolization and proposed indications for treating VAA by this method. A total of 22 patients with VAA were treated by coil embolization; 9 had splenic-, 7 renal-, 4 pancreaticoduodenal arcade-, and 2 proper hepatic artery-aneurysms. The transcatheter coil embolization procedure included coil embolization and coil-packing of the aneurysmal sac, preserving the native arterial circulation. Transcatheter coil embolization with aneurysm packing was technically successful in 16 (72.7 %) of the 22 patients and the native arterial circulation was preserved. Post-procedure angiograms confirmed complete disappearance of the VAA. In 4 of the 9 splenic artery aneurysm patients, the native arterial circulation was not preserved. In 1 renal artery aneurysm patient, stenosis at the aneurysmal neck necessitated placement of a stent before transcatheter coil embolization. Magnetic resonance angiographs obtained during the follow-up period (mean of 27 months) demonstrated complete thrombosis of the VAA in all 22 patients. Infarction occurred in 1 splenic- and 2 renal artery-aneurysms patients; the latter developed flank pain and fever after the procedure.
Yamamoto et al (2008) published the findings of a small study evaluating the clinical results and technical problems of transcatheter coil embolization for splenic artery aneurysm. Subjects were 16 patients (8 men, 8 women; age range of 40 to 80 years) who underwent transcatheter embolization for splenic artery aneurysm (14 true aneurysms, 2 false aneurysms) during the period January 1997 through July 2005. Embolic materials were fibered coils and interlocking detachable coils. Embolization was performed by the isolation technique, the packing technique, or both. Technically, all aneurysms were devascularized without severe complications. Embolized aneurysms were 6 to 40 mm in diameter (mean of 25 mm). Overall, the primary technical success rate was 88 % (14 of 16 patients). In the remaining 2 patients (12.5 %), partial re-canalization occurred, and re-embolization was performed. The secondary technical success rate was 100 %; 7 (44 %) of the 16 study patients suffered partial splenic infarction. Intra-splenic branching originating from the aneurysm was observed in 5 patients. According to the authors, transcatheter coil embolization should be the initial treatment of choice for splenic artery aneurysm.
Piffaretti and associates (2007) assessed the endovascular embolization of splenic artery aneurysms and false aneurysms with special consideration given to post-operative complications in 15 patients (11 women; mean age of 56 years; range of 39 to 80 years) with splenic artery aneurysm (n = 13) or false aneurysm (n = 2) treated with coil embolization. The lesion was asymptomatic in 9 patients, symptomatic in 5 patients, and ruptured in 1 patient. The mean aneurysm diameter was 33 +/- 23 mm (range of 15 to 80 mm). Post-operative follow-up evaluation included a clinical visit and spiral computed tomography at 1, 4, and 12 months, and yearly thereafter. Endovascular treatment was possible in 14 patients (93 %) (1 failure: neck cannulation). Peri-operative mortality was not observed. Morbidity included post-embolization syndrome in 5 patients (30 %). Neither pancreatitis nor spleen abscess occurred. The mean follow-up period was 36 months (range of 3 to 60 months). During follow-up evaluation 1 sac reperfusion was detected that was sealed successfully with additional coils. Surgical conversion or open repair was never required.
Tulsyan et al (2007) studied the outcomes of the management of VAA with catheter-based techniques. Between 1997 and 2005, 90 patients were identified with a diagnosis of VAA. This was inclusive of aneurysmal disease of the celiac axis, superior mesenteric artery (SMA), inferior mesenteric artery, and their branches. Surveillance without intervention occurred in 23 patients, and 19 patients underwent open aneurysm repair (4 ruptures). The endovascular treatment of 48 consecutive patients (mean age of 58, 60 % men) with 20 VAA and 28 visceral artery pseudoaneurysms (VAPA) was the basis for this study. Electronic and hardcopy medical records were reviewed for demographic data and clinical variables. Original computed tomography (CT) scans and fluoroscopic imaging were evaluated. The endovascular treatment of VAA was technically successful in 98 % of 48 procedures, consisting of 3 celiac axis repairs, 2 left gastric arteries, 1 SMA, 12 hepatic arteries, 20 splenic arteries, 7 gastroduodenal arteries, 1 middle colic artery, and 2 pancreaticoduodenal arteries. Of these, 29 (60 %) were performed for symptomatic disease (5 ruptured aneurysms). Coil embolization was used for aneurysm exclusion in 96 %. N-butyl-2-cyanoacrylate (glue) was used selectively (19 %) using a tri-axial system with a 3-F microcatheter for persistent flow or multiple branches. The 30-day mortality was 8.3 % (n = 4). All peri-operative deaths occurred in patients requiring urgent or emergent intervention in the setting of hemodynamic instability. No patients undergoing elective intervention died in the peri-procedural period. Post-procedural imaging was performed after 77 % of interventions at a mean of 16 months. Complete exclusion of flow within the aneurysm sac occurred in 97 % interventions with follow-up imaging, but coil and glue artifact complicated CT evaluation. Post-embolization syndrome developed in 3 patients (6 %) after splenic artery embolization. There was no evidence of hepatic insufficiency or bowel ischemia after either hepatic or mesenteric artery aneurysm treatment. Three patients required secondary interventions for persistent flow (n = 1) and recurrent bleeding from previously embolized aneurysms (n = 2).
Gabelmann et al (2002) conducted a review of their 10-year experience with endovascular embolization of VAA. A total of 25 patients (13 men; mean age of 52.1 years, range of 31 to 80) presented with VAAs of varying locations and etiologies: 10 splenic, 3 gastroduodenal, 2 pancreaticoduodenal, 3 hepatic, 3 superior mesenteric, 2 celiac, 1 left gastric, and 1 jejunoileal. Ten patients were asymptomatic; 7 aneurysms were ruptured. Transcatheter coil embolization was the treatment of choice in all patients. Coil placement was initially (less than 7 days) successful in 23 (92 %) patients. One superior mesenteric artery aneurysm remained perfused, and recurrent bleeding occurred 2 days after intervention in 1 case, but repeated embolization excluded the aneurysm. One patient with necrotizing pancreatitis died from sepsis 10 days after endovascular treatment and surgery (4 % 30-day mortality). Long-term follow-up revealed excellent results after an average 48.7 months (range of 14 to 75) with only 1 recurrence after 12 months.
Guillon et al (2003) assessed the endovascular treatment of 12 patients (mean age of 59 years, range of 47 to 75 years) with splenic artery aneurysm (n = 10) or false aneurysm (n = 2). The lesion was asymptomatic in 11 patients; hemobilia was observed in 1 patient. The lesion was juxta-ostial in 1 case, located on the intermediate segment of the splenic artery in 4, near the splenic hilus in 6, and affected the whole length of the artery in 1 patient. In 10 cases, the maximum lesion diameter was greater than 2 cm; in 1 case 30 % growth of an aneurysm 18 mm in diameter had occurred in 6 months; in the last case, 2 distal aneurysms were associated (17 and 18 mm in diameter). In 1 case, stent-grafting was attempted; 1 detachable balloon occlusion was performed; the 10 other patients were treated with coils. Endovascular treatment was possible in 11 patients (92 %) (1 failure: stenting attempt). In 4 cases among 11, the initial treatment was not successful (residual perfusion of aneurysm); surgical treatment was carried out in 1 case, and a second embolization in 2. Thus, in 9 cases (75 %) endovascular treatment was successful: complete and persistent exclusion of the aneurysm but with spleen perfusion persisting at the end of follow-up on CT scans (mean of 13 months). An early and transient elevation of pancreatic enzymes was observed in 4 cases.
Arterio-venous malformation (AVM) is a disorder of the blood vessels that is characterized by a complex, tangled web of abnormal arteries and veins connected by 1 or more AV fistulas (abnormal communications); AVMs of the hemangioma type are congenital. While they can occur anywhere in the body and have been found in the arms, hands, legs, feet, lungs, heart, liver, and kidneys; 50 % of these malformations occur in the brain, brainstem, and spinal cord. Arterio-venous malformations of the intestine, also referred to as angiodysplasias, are distinct from hemangiomas and true congenital AVMs. They are thought to be acquired degenerative lesions secondary to progressive dilation of normal blood vessels within the submucosa of the intestine. An arteriovenous malformation may hemorrhage, or bleed, leading to serious complications that can be life threatening.
Endovascular embolization is the therapeutic introduction of various substances or other materials, into the circulation, to occlude blood vessels. This is intended to either arrest or prevent bleeding, or devitalize a structure, tumor or organ by occluding it’s blood supply.
Various embolization devices and several types of embolic agents have been approved by the U.S. Food and Drug Administration (FDA). The currently available embolic agents include liquid embolitics, particulate materials, metallic coils, and detachable balloons. There are numerous liquid embolic agents, the most commonly used being absolute alcohol (100 % ethanol) and various tissue adhesives, including the cyanoacrylates and Onyx (EV3 Neurovascular). Two commonly used particulate materials are Gelfoam and polyvinyl alcohol (PVA).
There are 2 broad categories of metallic coils: coils that are pushed from a catheter with a metal coil pusher or guidewire, and coils that are released by breaking a bond between the coil and the pushing wire.
Based on the clinical evidence, endovascular embolization is an acceptable treatment modality for an extra-cranial AVM or fistula.
Renal cell cancer accounts for 90 to 95 % of malignant neoplasms arising from the kidney. Gross or microscopic hematuria is the most common presenting sign, followed by abdominal pain and a flank or abdominal mass.
Renal artery embolization is a non-surgical technique. Using x-rays (angiography), a catheter is directed into the renal artery by a specially trained radiologist (Interventional Radiologist). Material is injected through the catheter into the artery causing the blood to clot and block blood flow to the kidney. Nephrectomy is the surgical procedure to remove a kidney.
Based on the clinical evidence, renal artery embolization/angioinfarction, as a pre-operative adjunct to nephrectomy, is an acceptable alternative in the treatment of patients with large, hypervascular renal cell carcinomas.
Epistaxis is bleeding from the nose or nasal hemorrhage and is classified as anterior or posterior. Approximately 90 % of epistaxis events are idiopathic. Transcatheter embolization (embolotherapy) is the intentional occlusion of a vessel by deposition of thrombogenic materials directly into the vessel via an angiographic catheter. Based on the clinical evidence, transcatheter embolization (embolotherapy) is an acceptable alternative in the treatment of intractable or recurrent severe posterior epistaxis when conservative measures have failed.
A hypervascular tumor is a tumor characterized by an abnormal increase in blood vessel growth in the area. These vessels feed the tumor cells, and may be characterized by abnormal connections between veins and arteries. Hypervascular tumors may be benign (meningiomas, osteoblastomas, chondromas), malignant (renal cell carcinoma, thyroid carcinoma, hepatocellular carcinoma, glomus tumor) or metastatic tumors from these primary sites (list is not all-inclusive).
Tumor embolization is defined as the blockage of the vascular supply to a tumor. Embolization is the therapeutic introduction of various substances into the circulation to occlude vessels, either to arrest or prevent hemorrhaging, to devitalize a structure tumor or organ by occluding it’s blood supply or to reduce blood flow an arteriovenous malformation. The occlusion is usually performed via an endovascular approach, transcatheter embolization (embolotherapy) by deposition of thrombogenic materials directly into the vessel via an angiographic catheter or by direct percutaneous injection of embolic agents into the tumor. The goals of embolization may be adjunctive, curative, or palliative. The procedure is usually performed in a single session, simultaneously with diagnostic arteriography, but may also be performed in multiple staged sessions. Pre-operative embolization is also performed.
Tumor embolization or pre-operative tumor embolization to reduce intra-operative bleeding prior to surgical resection may be considered medically necessary in the treatment of hypervascular tumors or metastases from hypervascular tumors.
Coil Embolization for the Treatment of Arterio-Venous Malformations (AVMs)/Aneurysm:
Koebbe and colleagues (2006) reviewed the clinical and angiographic outcomes for 1,307 patients undergoing endovascular treatment of intracranial aneurysms. This analysis focused on posterior circulation and middle cerebral artery aneurysms, as well as cases of stent-assisted coil embolization. They reviewed their procedural protocol and patient selection criteria for endovascular management. Several large clinical trials have demonstrated the safety and effectiveness of endovascular treatment of intracranial aneurysms. The International Subarachnoid Aneurysm Trial provides Level I evidence demonstrating a significant reduction in disability or death with endovascular treatment compared with surgical clipping. The most common procedural complications include intra-procedural rupture and thromboembolic events; avoidance strategies were also discussed. Vasospasm after subarachnoid hemorrhage causes neurological morbidity and mortality and can be successfully managed by early recognition and interventional treatment with angioplasty, pharmacologic agents, or both. The authors concluded that long-term studies evaluating experience with aneurysm coil embolization during the past decade indicated that this is a safe and durable treatment method. The introduction of stent-assist techniques has improved the management of wide-neck aneurysms. Future technology developments will likely improve the durability of endovascular treatment further by delivering bioactive agents that promote aneurysm thrombosis beyond the coil mass alone. It is clear that endovascular therapy of both ruptured and un-ruptured aneurysms is becoming a mainstay of practice in this patient population. Although not replacing open surgery, the continued improvements have allowed aneurysms that previously were amenable only to open clip ligation to be treated safely with durable long-term outcomes.
Bruno and Meyers (2013) stated that arterio-venous malformations (AVMs) of the brain are rare, complex, vascular lesions that can result in significant morbidity and mortality. Modern treatment of brain AVMs is a multi-modality endeavor, requiring a multi-disciplinary team with expertise in cerebrovascular neurosurgery, endovascular intervention, and radiation therapy in order to provide all therapeutic options and determine the most appropriate treatment regimen depending on patient characteristics and AVM morphology. Current therapeutic options include microsurgical resection, radiosurgery (focused radiation), and endovascular embolization. Endovascular embolization is primarily used as a pre-operative adjuvant before microsurgery or radiosurgery. Palliative embolization has been used successfully to reduce the risk of hemorrhage, alleviate clinical symptoms, and preserve or improve neurological function in inoperable or non-radiosurgical AVMs. Less frequently, embolization is used as “primary therapy” particularly for smaller, surgically difficult lesions. Current embolic agents used to treat brain AVMs include both solid and liquid agents. Liquid agents including N-butyl cyanoacrylate and Onyx are the most commonly used agents. As newer embolic agents become available and as micro-catheter technology improves, the role of endovascular treatment for brain AVMs will likely expand. The authors noted that embolization under these circumstances should be used to treat specific high-risk AVM angio-architectural features such as aneurysms.
Lanzino et al (2013) performed a meta-analysis of prospective controlled trials of clipping versus coil embolization for ruptured aneurysms. These researchers performed a search of the English literature for published prospective controlled trials comparing surgical clipping with endovascular coil embolization for ruptured intracranial aneurysms. Data were abstracted from the identified references. Outcomes of interest were the proportion of patients with a poor outcome at 1 year and episodes of re-bleeding from the index treated aneurysm after the allocated treatment. There were 3 prospective controlled trials eligible for inclusion. These studies enrolled 2,723 patients. Meta-analysis of these studies showed that the rate of poor outcome at 1 year was significantly lower in patients allocated to coil embolization (risk ratio, 0.75; 95 % confidence interval [CI]: 0.65 to 0.87). This relative effect is consistent with an absolute risk reduction of 7.8 % and a number needed to treat of 13. The effect on mortality was not statistically different across the 2 treatments. Re-bleeding rates within the first month were higher in patients allocated to endovascular coil embolization. The authors concluded that on the basis of the analysis of the 3 high-quality prospective controlled trials available, there is strong evidence to indicate that endovascular coil embolization is associated with better outcomes compared with surgical clipping in patients amenable to either therapeutic strategy.
Morales-Valero et al (2014) performed a comprehensive literature search for reports on contemporary endovascular treatment of internal carotid artery (ICA) bifurcation aneurysms from 2000 to 2013, and these investigators reviewed their experience. They extracted information regarding peri-procedural complications, procedure-related morbidity and mortality, immediate angiographic outcome, long-term clinical and angiographic outcome, and re-treatment rate. Event rates were pooled across studies by using random-effects meta-analysis. Including their series of 37 patients, 6 studies with 158 patients were analyzed. Approximately 60 % of the aneurysms presented as un-ruptured; 88.0 % (95 % CI: 68.0 % to 96.0 %) of aneurysms showed complete or near-complete occlusion at immediate post-operative angiography compared with 82.0 % (95 % CI: 73.0 % to 88.0 %) at last follow-up. The procedure-related morbidity and mortality were 3.0 % (95 % CI: 1.0 % to 7.0 %) and 3.0 % (95 % CI: 1.0 % to 8.0 %), respectively. The re-treatment rate was 14.0 % (95 % CI: 8.0 % to 25.0 %). Good neurologic outcome was achieved in 93.0 % (95 % CI: 86.0 % to 97.0 %) of patients. The authors concluded that endovascular treatment of ICA bifurcation aneurysms is feasible and effective and is associated with high immediate angiographic occlusion rates. However, re-treatment rates and procedure-related morbidity and mortality were non-negligible.
Turfe et al (2015) stated that endosaccular coil embolization and parent artery occlusion (PAO) are established endovascular techniques for treatment of cavernous carotid aneurysms. These researchers performed a systematic review of published series on endovascular treatment of cavernous carotid aneurysms to determine outcomes and complications associated with endovascular coiling and PAO of cavernous carotid artery aneurysms. In September 2013, these investigators conducted a computerized search of MEDLINE and EMBASE for reports on endovascular treatment of intracranial cavernous carotid aneurysms from January 1990 to August 2013. Comparisons were made in peri-procedural complications and outcomes between coiling and PAO patients who did not receive bypass. Event rates were pooled across studies using random effects meta-analysis. A total of 20 studies with 509 patients and 515 aneurysms were included in this systematic review. Aneurysm occlusion rates at greater than 3 months after operation were significantly higher in the PAO without bypass group (93.0 %, 95 % CI: 86.0 to 97.0) compared with the coiling group (67.0 %, 95 % CI: 55.0 to 77.0) (p < 0.01). Re-treatment rates were significantly lower in the PAO without bypass group (6.0 %, 95 % CI: 2.0 to 12.0) compared with the coiling group (18.0 %, 95 % CI: 12.0 to 26.0) (p = 0.01). Coiling patients had a similar morbidity rate (3.0 %, 95 % CI: 2.0 to 6.0) compared with PAO without bypass patients (7.0 %, 95 % CI: 3.0 to 12.0) (p = 0.13). Coiling patients had a similar mortality rate (0.0 %, 95 % CI: 0.0 to 6.0) compared with PAO without bypass patients (4.0 %, 95 % CI: 1.0 to 9.0) (p = 0.68). the authors concluded that evidence from non-comparative studies suggested that traditional endovascular options are highly effective in treating cavernous sinus aneurysms. PAO is associated with a higher rate of complete occlusion. Peri-procedural morbidity and mortality rates were not negligible, especially in patients receiving PAO.
An UpToDate review on “Extracranial carotid artery aneurysm” (Kirkwood, 2015) states that “Options for endovascular repair include bare metal stent placement with or without trans-stent coil embolization of the aneurysm sac, exclusion of the aneurysm using a stent-graft, or endovascular occlusion of the carotid artery. Features favoring an endovascular approach include pseudoaneurysm related to trauma, aneurysm of the distal internal carotid artery, and hostile neck anatomy”.
Furthermore, guidelines on “The management of patients with unruptured intracranial aneurysms” from the American Heart Association/American Stroke Association (Thompson et al, 2015) support treatment of intra-cranial aneurysms if they are enlarging. The guidelines note that endovascular coiling is an effective treatment for select unruptured intracranial aneurysms (UIAs) that are considered for treatment (Class IIa; Level of Evidence B); endovascular coiling is associated with a reduction in procedural morbidity and mortality over surgical clipping in selected cases but has an overall higher risk of recurrence (Class IIb; Level of Evidence B).
Vascular Embolization for the Treatment of Endovascular Leak:
Lu and colleagues (2010) analyzed a single-center experience of fibrin glue sac embolization to eliminate type I endoleaks after endovascular aneurysm repair (EVAR), assessing the feasibility and effectiveness of the technique in long-term follow-up. A retrospective study was conducted involving 783 EVAR patients treated between August 2002 and February 2009. Under a standardized protocol, 42 (5.4 %) patients (37 men; mean age of 73 ± 8 years) underwent intra-operative transcatheter fibrin glue sac embolization to resolve type I endoleak persisting after initial intra-operative maneuvers to close the leak or in necks too short or angulated for cuff placement. Intra-sac pressure was measured before and after glue injection. Computed tomographic angiography was performed to assess the outcome after 3, 6, and 12 months and annually thereafter. In this type I endoleak cohort, 16 (38.1 %) patients had proximal necks less than 10 mm long, and 5 (11.9 %) patients had proximal neck angulation greater than 60°; 22 additional devices (8 stents, 14 cuffs) had been placed in the initial attempts to resolve the endoleaks. After fibrin glue injection, 41 (97.6 %) of the 42 endoleaks were resolved using a mean 15 ± 10 ml of glue. Intra-sac pressure decreased significantly in successfully treated cases. The patient who failed embolotherapy was converted to open surgery (2.4 %); he died 2 months later from multi-organ failure. Two (4.8 %) patients died in the peri-operative period from myocardial infarction. One (2.4 %) patient developed right lower extremity ischemia unrelated to the fibrin glue treatment. There were no allergic reactions. Over a median follow-up of 39.9 months (range of 10 to 88), 3 (7.1 %) patients died (1 aneurysm-related). Cumulative survival was 90.5 % at 1 year, 87.0 % at 3 years, and 82.6 % at 5 years. The mean maximal aneurysm diameter fell from the baseline 59.5 ± 14.7 mm to 49.0 ± 11.6 mm (p < 0.001). Of the 4 patients with increased aneurysm diameter during follow-up, 1 was converted, 2 are being observed due to advanced age, and 1 died of renal failure. No recurrent type I endoleak or glue-related complications were observed in follow-up. The authors concluded that fibrin glue sac embolization to eliminate type I endoleak after EVAR yielded excellent results in their experience, effectively and durably resolving the leaks. Balloon occlusion of the proximal aorta must be done during glue injection to block proximal flow and facilitate formation of a structured fibrin clot.
Sidloff et al (2013) assessed the risk of rupture, and determined the benefits of intervention for the treatment of type II endoleak after EVAR. This systematic review was done according to PRISMA guidelines. Outcome data included incidence, spontaneous resolution, sac expansion, interventions, clinical success, and complications including conversion to open repair, and rupture. A total of 32 non-randomized retrospective studies were included, totaling 21,744 patients who underwent EVAR. There were 1,515 type II endoleaks and 393 interventions. Type II endoleak was seen in 10.2 % of patients after EVAR; 35.4 % resolved spontaneously. Fourteen patients (0.9 %) with isolated type II endoleak had ruptured abdominal aortic aneurysm; 6 of these did not have known aneurysm sac expansion. Of 393 interventions for type II endoleak, 28.5 % were unsuccessful. Translumbar embolization had a higher clinical success rate than transarterial embolization (81 versus 62.5 % respectively; p = 0.024) and fewer recurrent endoleaks were reported (19 versus 35.8 %; p = 0·036). Transarterial embolization also had a higher rate of complications (9.2 % versus none; p = 0.043). The authors concluded that aortic aneurysm rupture after EVAR secondary to an isolated type II endoleak is rare (less than 1 %), but over 1/3 occur in the absence of sac expansion. Translumbar embolization had a higher success rate with a lower risk of complications.
Khaja et al (2014) reported their experience with the use of an ethylene vinyl alcohol copolymer (Onyx) in an off-label fashion for the treatment of type II endoleak after endovascular repair of the thoracic (TEVAR) and abdominal (EVAR) aorta. A retrospective review of patients with type I and/or II endoleak treated with Onyx was performed. Data regarding the technical, clinical, and imaging outcomes were collected. Technical success was defined as decreased or eliminated endoleak on the first imaging follow-up. Clinical success was defined as unchanged or decreased aneurysm sac size on subsequent follow-up. A total of 18 patients (15 males, 3 females) with a mean age of 79 years (range of 69 to 92) met inclusion criteria (16 abdominal aortic aneurysm, 2 thoracic aortic aneurysm). Sixteen patients had type II endoleak, and 2 had complex type II endoleak with a type I component. The interval between endograft placement and treatment was a mean of 30 months. Direct sac treatment approach was used in 13 patients; transarterial approach was used in 3 patients. Seven patients required the use of coils, N-butyl cyanoacrylate glue, or Amplatzer vascular plugs. The average volume of Onyx used per treatment was 5.6 ml (range of 2.5 to 13). Duration of imaging follow-up was 0.75 to 72.5 months (mean of 32.8). Sixteen of 18 (88.9 %) patients had initial technical and clinical success; 2 of 18 patients (11.1 %) were initial technical failures, and 1 remained a failure despite a second treatment and attempted surgical ligation. Eight of 18 (44.4 %) of patients eventually required a second intervention, 5 (27.8 %) of them due to delayed clinical failure. Complications included 1 psoas hematoma, 1 transient L2 nerve paresis, and 1 intraperitoneal Onyx leak; all of these were without clinical sequelae. The authors concluded that Onyx with or without coil/glue/Amplatzer plug embolization is safe and useful in the treatment of type II endoleak after TEVAR and EVAR. However, long-term clinical and imaging follow-up is needed for early detection and management of recurrence of the primary endoleak or the development of new, secondary endoleaks or enlargement of the aneurysm sac.
Eberhardt et al (2014) reported a single-center experience with transcatheter embolization of type I endoleaks using the liquid embolic agent Onyx. A total of 8 patients (4 men; mean age of 74.8 years, range of 63 to 86) with 10 type I endoleaks (6 abdominal and 4 thoracic) diagnosed 2 days to 9 years after endovascular repair were treated with Onyx embolization because cuff extension was precluded by an insufficient landing zone in 6 cases and an unsuitable aortic diameter in 2. Endoleaks were accessed with a 4-F diagnostic catheter and a coaxially introduced dimethylsulfoxide-compatible microcatheter. Onyx-34 was predominantly applied due to its high viscosity; patent side branches were coil embolized prior to Onyx delivery in 3 cases. Technical success of the procedure was achieved in all cases. The mean volume of Onyx used for abdominal endoleaks was 11.8 ml (range of 3.0 to 25.5) and 19.4 ml (range 4.5 to 31.5) for thoracic endoleaks. The average duration of the procedure was 76.7 minutes (range of 34.5 to 110.6), and the average radiation dose area product was 18.8 cGy*cm (2) (range of 10.6 to 55.8). Re-perfusion of the endoleak was detected in 1 case 2 days after the procedure. A second case showed an occluded endoleak but a small trace of contrast between the aortic wall and the stent-graft. Non-target embolization was not found in any case. Mean follow-up was 13.2 months (range of 8 to 24). The mean reduction in diameters for thoracic aneurysms after 6 and 12 months was 0.4 and 0.9 cm, respectively, and 0.6 and 1.2 cm, respectively, for abdominal aneurysms. The authors concluded that transcatheter embolization of type I endoleaks using Onyx is a simple, safe, and sustainable treatment option with a high primary success rate for cases in which stent-graft extension is not possible. Moreover, they stated that the benefit of additional coil embolization remains uncertain.
Ishibashi et al (2014) evaluated the late events and mid-term results after EVAR. Between December 2006 and May 2012, a total of 175 abdominal aortic aneurysms were treated by EVAR. Aneurysm-related events were analyzed. The complications that occurred during the EVAR procedure were renal artery occlusion in 2 patients, access artery injury in 2, delivery failure in 1, retrograde aortic dissection in 1, and death from hepatic failure in 1 patient. Five adverse endoleaks (4 type I, 1 type III) remained at discharge, and the technical success rate was 97 %. On follow-up, limb occlusion had occurred in 5 patients. Unilateral renal atrophy was found in 3 patients, but none of the patients required new hemodialysis. Sac enlargement (greater than or equal to 5 mm) developed in 10 patients. Their culprit endoleaks were type Ia in 1, II in 8, and V in 1 patient. Transarterial embolization was performed for 3 out of the eight type II endoleaks. The rate of freedom from secondary re-intervention was 93 % at 3 and 5 years, respectively. The survival and freedom from aneurysm-related events rates were 74 % at 3 years and 47 % at 5 years. The authors concluded the mid-term results of EVAR were excellent with a low rate of aneurysm-related deaths, although there were relatively high aneurysm-related event rates. Sac re-enlargement from type II endoleaks was the most common major issue at the mid-term follow-up.
An UpToDate review on “Complications of endovascular abdominal aortic repair” (Chaer, 2015) states that “Endoleak is defined as persistent flow of blood into the aneurysm sac after device placement and indicates a failure to completely exclude the aneurysm. Five types of endoleak are described and are discussed below. Endoleak is associated with a continued risk for aneurysm expansion or rupture. The most common types of endoleak (I and II) are usually managed successfully with the placement of additional stents or embolization techniques, but sometimes surgery is needed …. For distal type I endoleaks that persist after balloon angioplasty of the distal attachment site, iliac limb extensions are used. If the iliac limb has been undersized, a flared iliac extension limb can be placed to exclude the endoleak. If the distal common iliac artery does not have an adequate length to provide a proper seal, coil embolization of the origin of the hypogastric artery and placement of a limb extension into the external iliac artery may be needed …. The approach to the repair of type II endoleaks is most commonly endovascular, consisting of transarterial embolization of the feeding vessels or translumbar embolization of the aneurysm sac. In the systematic review, there were 393 interventions for 1515 type II endoleaks, of which 71.5 percent were technically successful. Among studies that reported outcomes of intervention, translumbar embolization (n = 57) had a higher initial success rate (81 versus 63 per cent) and fewer recurrent endoleaks (19 versus 36 percent) compared with transarterial embolization (n = 120)”.
Coil Embolization and Occlusion of the Hypogastric Veins for the Prevention or Treatment of Deep Vein Thrombosis:
UpToDate reviews on “Primary (spontaneous) upper extremity deep vein thrombosis” (Goshima, 2015) and “Approach to the diagnosis and therapy of lower extremity deep vein thrombosis” (Bauer, 2015) do not mention coil embolization as a therapeutic option.
In addition to UpToDate, American College of Chest Physicians’ guidelines have no recommendations for coil embolization and occlusion of the hypogastric veins for the prevention or treatment of DVT. http://journal.publications.chestnet.org/issue.aspx?journalid=99&issueid=23443&direction=P.
|CPT Codes / HCPCS Codes / ICD-10 Codes|
|Information in the [brackets] below has been added for clarification purposes.  Codes requiring a 7th character are represented by "+":|
|ICD-10 codes will become effective as of October 1, 2015:|
|CPT codes covered if selection criteria are met :|
|37241||Vascular embolization or occlusion, inclusive of all radiological supervision and interpretation, intraprocedural roadmapping, and imaging guidance necessary to complete the intervention; venous, other than hemorrhage (eg, congenital or acquired venous malformations, venous and capillary hemangiomas, varices, varicoceles)|
|37242||arterial, other than hemorrhage or tumor (eg, congenital or acquired arterial malformations, arteriovenous malformations, arteriovenous fistulas, aneurysms, pseudoaneurysms)|
|37243||for tumors, organ ischemia, or infarction|
|37244||for arterial or venous hemorrhage or lymphatic extravasation|
|61624||Transcatheter permanent occlusion or embolization (eg, for tumor destruction, to achieve hemostasis, to occlude a vascular malformation), percutaneous, any method; central nervous system (intracranial, spinal cord)|
|61626||Transcatheter permanent occlusion or embolization (eg, for tumor destruction, to achieve hemostasis, to occlude a vascular malformation), percutaneous, any method; non-central nervous system, head or neck (extracranial, brachiocephalic branch)|
|75894||Transcatheter therapy, embolization, any method, radiological supervision and interpretation|
|ICD-10 codes covered if selection criteria are met:|
|C22.0||Liver cell carcinoma [hepatocellular carcinoma]|
|C64.1 - C64.9||Malignant neoplasm of kidney, except pelvis [renal cell carcinoma]|
|I72.8||Aneurysm of other specified arteries [splenic artery]|
|Q27.9||Congenital malformation of peripheral vascular system, unspecified|
|R04.0||Epistaxis [intractable or recurrent severe posterior]|
Splenic Artery Aneurysm
Extracranial Embolization for AV Malformations or Fistulae
Renal Artery Embolization
Coil Embolization for the Treatment of Arterio-Venous Malformations (AVMs)/Aneurysm:
Vascular Embolization for the Treatment of Endovascular Leak:
Coil Embolization and Occlusion of the Hypogastric Veins for the Prevention or Treatment of Deep Vein Thrombosis: