Selected Aortic Valve Procedures

Number: 0407

Table Of Contents

Policy
Applicable CPT / HCPCS / ICD-10 Codes
Background
References

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Policy

Scope of Policy

This Clinical Policy Bulletin addresses selected aortic valve procedures, including the following: 

• • Ross Pulmonary Autograft
  • Aortic valve-sparing procedures
  • Personalized External Aortic Root Support (PEARS).

1. Medical Necessity

   Aetna considers the following interventions medically necessary:

   1. The Ross pulmonary autograft procedure for members undergoing aortic valve replacement secondary to either congenital anomalies or aortic valve disease, such as:

      1. Aortic incompetence (including endocarditis, rheumatism of the heart); or
      2. Aortic stenosis; or
      3. Aortic stenosis; or
      4. Congenital lesions;

      For contraindications to this procedure, see Appendix.

   2. The minimally invasive approach to the aortic valve as an acceptable alternative to the conventional approach to aortic valve replacement;
   3. Aortic valve-sparing re-implantation for the treatment of secondary aortic regurgitation due to aortic root dilatation as occurs in Marfan syndrome as well as for the treatment of type A acute aortic dissections (i.e., dissection of the ascending and descending aorta); or
   4. Aortic valve-sparing procedures for the treatment of aortic root ectasia, and dissection and aneurysms of the ascending aorta.

2. Experimental, Investigational, or Unproven

   The following interventions are considered experimental, investigational, or unproven because the effectiveness and/or safety of these approaches has not been established:

   1. The Ross pulmonary autograft for all other indications (e.g., middle-aged or older adults when suitable alternatives to autograft replacement of the aortic valve are available with comparable results and without the need for replacement of the right ventricular outflow tract, and individuals with bicuspid valves and aortic regurgitation or aortic dilation if other alternatives are available) for indications other than the ones listed above;
   2. Aortic valve-sparing re-implantation for all other indications other than the ones listed above;
   3. The decellularized Matrix P bioprosthesis for pulmonary valve replacement for Ross procedures;
   4. The Florida Sleeve valve-sparing procedure for the treatment of aortic root ectasia and aneurysm;
   5. The Personalized External Aortic Root Support (PEARS) procedure.

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Table:

CPT Codes / HCPCS Codes / ICD-10 Codes

Code	Code Description
CPT codes covered if selection criteria are met:
33390 - 33391	Valvuloplasty, aortic valve, open, with cardiopulmonary bypass
33413	Replacement, aortic valve; by translocation of autologous pulmonary valve with allograft replacement of pulmonary valve (Ross procedure)
33440	Replacement, aortic valve; by translocation of autologous pulmonary valve and transventricular aortic annulus enlargement of the left ventricular outflow tract with valved conduit replacement of pulmonary valve (Ross- Konno procedure)
CPT codes not covered for indications listed in the CPB:
Florida Sleeve valve-sparing procedure, Personalized External Aortic Root Support (PEARS)- - no specific code:
HCPCS codes not covered for indications listed in the CPB:
Decellularized Matrix P bioprosthesis - no specific code:
ICD-10 codes covered if selection criteria are met:
I06.0	Rheumatic aortic stenosis
I06.1	Rheumatic aortic insufficiency
I35.0 - I35.9	Nonrheumatic aortic valve disorders [not covered for individuals with bicuspid valves and aortic regurgitation or aortic dilation if other alternatives are available]
I71.00 - I71.9	Aortic aneurysm and dissection
I77.810 - I77.819	Aortic ectasia [aortic dilation]
Q23.0	Congenital stenosis of aortic valve
Q23.1	Congenital insufficiency of aortic valve
Q25.21 - Q25.49, Q25.8 - Q25.9	Other congenital malformations of aorta

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Background

Surgical management of aortic valve disease includes established valve replacement approaches as well as selected valve-preserving and aortic root–stabilizing procedures used in defined clinical scenarios. Aortic valve replacement (AVR) remains the standard intervention and comprises three primary options — prosthetic valve replacement (mechanical or bioprosthetic), aortic homograft implantation, and the pulmonary autograft (Ross) procedure. In addition, several reconstructive strategies have been developed to address aortic valve dysfunction associated with aortic root or annular pathology while preserving native valve tissue. These include aortic valve–sparing root procedures (such as reimplantation techniques), external aortic root support approaches including personalized external aortic root support (PEARS), and hybrid stabilization methods such as the Florida Sleeve procedure. These techniques are distinct from conventional AVR in operative complexity, long‑term surveillance requirements, and evidence base.

Aortic Valve-Sparing Procedures, Including Reimplantation

Aortic valve-sparing reimplantation is a valve-sparing technique employed for patients with aortic regurgitation secondary to aortic root dilatation, in which valvular insufficiency is due to the outward displacement of the valve commissures. This technique, which is different from aortic valve repair, has the advantages of not requiring anticoagulation and avoiding other problems and complications associated with mechanical prosthetic valves. Although primarily used for secondary aortic regurgitation due to root dilatation, as occurs in Marfan syndrome, guidelines from the European Society of Cardiology (Erbel et al., 2001) state that aortic valve-sparing re-implantation may also be indicated for patients with type A acute aortic dissections (i.e., dissection of the ascending and descending aorta).

Guidelines from the European Society of Cardiology (Erbel et al., 2014) state that In most cases of aortic insufficiency associated with acute Type A dissection, the aortic valve is essentially normal and can be preserved by applying an aortic valve-sparing repair of the aortic root. In cases of aneurysms of the ascending aorta, where total replacement is indicated, the choice between a valve-sparing intervention and a composite graft with a valve prosthesis depends on the analysis of aortic valve function and anatomy, the size and site of TAA, life expectancy, desired anticoagulation status, and the experience of the surgical team.

Similarly, guidelines from the American College of Cardiology (Hiratzka et al., 2010) state that extensive dissection of the aortic root should be treated with aortic root replacement with a composite graft or with a valve sparing root replacement.

Stephens et al. (2014) examined whether recurrent or residual mild aortic regurgitation, which occurs after valve-sparing aortic root replacement, progresses over time. Between 2003 and 2008, a total of 154 patients underwent Tirone David-V valve-sparing aortic root replacement; 96 patients (62%) had both 1-year (median of 12 ± 4 months) and mid-term (62 ± 22 months) transthoracic echocardiograms available for analysis. The average age of patients was 38 ± 13 years, 71% were male, 31% had a bicuspid aortic valve, 41% had Marfan syndrome, and 51% underwent aortic valve repair, predominantly cusp free margin shortening. A total of 41 patients (43%) had mild aortic regurgitation on the 1-year echocardiogram. In 85% of patients (n = 35), mild aortic regurgitation remained stable on the most recent echocardiogram (median of 57 ± 20 months); progression to moderate aortic regurgitation occurred in 5 patients (12%) at a median of 28 ± 18 months and remained stable thereafter; severe aortic regurgitation developed in 1 patient, eventually requiring reoperation. Five patients (5%) had moderate aortic regurgitation at 1 year, which did not progress subsequently. Two patients (2%) had more than moderate aortic regurgitation at 1 year, and both ultimately required reoperation. The authors concluded that although mild aortic regurgitation occurs frequently after valve-sparing aortic root replacement, it is unlikely to progress over the next 5 years and should not be interpreted as a failure of the valve-preservation concept. Furthermore, these investigators suggested that mild aortic regurgitation should not be considered non-structural valve dysfunction, as the 2008 valve reporting guidelines would indicate. The authors noted that 10- to 15-year follow-up is needed to learn the long-term clinical consequences of mild aortic regurgitation early after valve-sparing aortic root replacement.

In a retrospective study, Gamba and colleagues (2015) evaluated their experience using a simplified aortic valve sleeve procedure to treat aortic root ectasia and aneurysms with or without aortic regurgitation. In experienced hands, two aortic valve-sparing procedures, namely, Yacoub and David, have yielded excellent long-term results in the treatment of aortic root aneurysms, with or without aortic regurgitation. However, these techniques are demanding and not widely used. Recently, a new and simplified valve-sparing technique, named the "sleeve procedure," has been proposed and has yielded encouraging early results. A total of 90 consecutive patients with aortic root aneurysms underwent sleeve procedures from October 2006 to October 2012. Follow-up data (clinical 100% complete and echocardiographic 93% complete) were acquired from the authors’ outpatient clinic or from the referring cardiologist. The mean age of the patients was 61.5 ± 12.5 years, 79% were male, 16 (18%) had a bicuspid valve, 3 had Marfan syndrome, and 2 had aortic dissection. Over a mean clinical follow-up of 34 ± 19 months, 2 patients died from non-cardiac causes, and 1 was reoperated on for the recurrence of aortic regurgitation. On follow-up echocardiography after a mean of 18 ± 9 months, aortic regurgitation was absent/negligible, mild, or moderate in 62%, 37%, and 1% of patients, respectively, and the diameters of the annulus, Valsalva sinuses, and sino-tubular junction were 27.3 ± 2.2, 37.0 ± 3.4, and 30.6 ± 3.1 mm, respectively. The authors concluded that these encouraging early and medium-term results suggested that the sleeve procedure is a safe and effective aortic valve-sparing technique for the treatment of aortic root ectasia and aneurysm. However, they stated that longer follow-up is needed in order to draw definitive conclusions.

Bavaria and colleagues (2015) noted that valve-sparing root reimplantation (VSRR) in tricuspid aortic valve (TAV) patients is well-established, but in bicuspid aortic valve (BAV) patients, it has been less widely adopted. These investigators examined whether valve type affects mid-term outcomes with VSRR. They performed a retrospective review of 186 patients who underwent an aortic valve-sparing root reimplantation operation between 2004 and 2013. Of these, 129 patients underwent elective VSRR with the David V technique. Outcomes were compared in this cohort by valve type: TAV (n = 89) versus BAV (n = 40). Demographics were similar in the two groups – BAV patients had a higher degree of aortic insufficiency (AI) at presentation (p < 0.05) and an enlarged pre-operative annulus (30 ± 4 versus 28 ± 6 mm, p = 0.06). All BAV patients required primary leaflet repair (6% in the TAV group; p < 0.01). Post-operative mortality (0), stroke (0% versus 1%), and pacemaker requirement (0% versus 5%) were similar. Post-operative freedom from AI grade greater than or equal to 2+ was 100% in the entire cohort, and transvalvular gradients were similar. At follow-up, a 1-year echocardiogram (ECG) showed higher peak and mean transvalvular gradients in the BAV group (p < 0.01). One patient in the TAV group died from an unknown cause. The 5-year actuarial freedom from aortic valve reoperation was 100% versus 97% ± 3% (p = 0.6); 3 patients in the entire cohort had AI grade greater than 2+ on follow-up (n = 1 in the BAV group; n = 2 in the TAV group). The authors concluded that even though BAV patients presented with a higher AI grade and required concomitant primary valve repair, the VSRR David V technique offered excellent mid-term outcomes with both the BAV and TAV valve types.

Malvindi and associates (2015) stated that aortic valve-sparing operation has been progressively performed for the treatment of aortic root aneurysm. Nowadays, this procedure has been proposed even in the presence of a BAV, severe aortic regurgitation, or in primary aortic dissection repair. These investigators presented their 10-year experience focusing on mid-term ECG follow-up. Between June 2002 and February 2012, a total of 139 patients (mean age of 61 ± 12 years) underwent aortic valve-sparing operation with valve reimplantation; 27 patients (19%) had BAV; in 18 cases (13%), cusp motion or anatomical abnormalities contributed to aortic regurgitation and required adjunct cusp repair. A Gelweave Valsalva graft was implanted in all the patients. The mortality pre-discharge was 0.7% (1 patient). The cumulative 1-year, 5-year, and 8-year survival rates were 99%, 93%, and 87%, respectively. Post-operative aortic regurgitation greater than mild degree (greater than 2+/4+) was the only significant risk factor for redo aortic valve surgery; freedom from reoperation due to aortic valve regurgitation was 96% at 1 year, 90% at 5 years, and 86% at 8 years. When comparing freedom from reoperation in patients with BAV versus TAV, no differences were found (p = 0.31), and the rate of aortic valve reoperation was significantly higher (p < 0.001) in patients who received leaflet repair. The authors concluded that the durability of valve reimplantation was found to be excellent in patients with TAV and normal or nearly normal cusps. Cusp prolapse and complications after cusp repair turned out to be the main causes of early failure.

Sa et al. (2024) stated that the long-term outcomes of valve-sparing aortic root replacement (VSARR) with re-implantation versus remodeling in patients undergoing aortic root surgery remain a controversial subject. This study was a pooled meta-analysis of Kaplan-Meier-derived data from comparative studies published by December 31, 2022. A total of 15 studies met the eligibility criteria, comprising 3,044 patients (1,991 in the re-implantation group and 2,018 in the remodeling group). Patients who underwent VSARR with remodeling had a higher risk of all-cause death (HR, 1.54; 95% CI: 1.16 to 2.03; p = 0.002, log-rank test p < 0.001). Landmark analysis (with 4 years as the landmark time point) showed that survival was lower in patients who underwent VSARR with remodeling (HR, 2.15; 95% CI: 1.43 to 3.24; p < 0.001) in the first 4 years. Beyond the 4-year time point, no difference in survival was observed (HR, 1.04; 95% CI: 0.72 to 1.50; p = 0.822). The risk for the need for aortic valve and/or root re-intervention was higher in patients undergoing VSARR with remodeling (HR, 1.49; 95% CI: 1.07 to 2.07; p = 0.019, log-rank test p < 0.001). These researchers did not find statistically significant coefficients for the covariates of age, female sex, connective tissue disorders, bicuspid aortic valve, aortic dissection, coronary bypass surgery, total arch replacement, or annular stabilization, which meant that these covariates did not modulate the effects observed in these pooled analyses. The authors concluded that VSARR with re-implantation was associated with better overall survival (OS) and a lower risk of the need for re-intervention over time compared with VSARR with remodeling. Regarding OS, these investigators observed a time-varying effect that favored the re-implantation technique up to 4 years of follow-up, but not beyond this time point.

The Ross Pulmonary Autograft Procedure

The Ross pulmonary autograft procedure is a surgical technique for aortic valve replacement in which the patient’s native pulmonary valve is transplanted into the aortic position, and the right ventricular outflow tract is reconstructed with a homograft or conduit. The theoretical advantages of the Ross procedure include excellent hemodynamic performance, resistance to thrombosis without lifelong anticoagulation, and the potential for growth and adaptive remodeling in younger patients.

Ross pulmonary autograft refers to essentially a double valve replacement in which the native pulmonic valve is substituted for the diseased aortic valve, while a homograft prosthetic valve replaces the pulmonic valve. This procedure was first devised in 1967 and sought to provide a permanent aortic valve substitution that would not degenerate like a homograft valve and would not require chronic anticoagulation therapy like a prosthetic valve. The risk-benefit ratio involves a balance between a more complicated surgical procedure (essentially a double valve replacement) and a potentially more durable and physiologic aortic valve replacement. Furthermore, it is thought that the autografted pulmonary valve will grow with the young patient, thus obviating the need for reoperation. Studies have also shown that the Ross procedure resulted in significant improvement in left ventricular wall thickness and outflow tract velocity, which were not observed in allograft aortic valve replacements in children. For these reasons, the Ross procedure is considered most appropriate for young adults. Candidates for this procedure should be adequately counseled on the various valve replacement alternatives.

In a systematic review and meta-analysis, Takkenberg et al. (2009) stated that the Ross procedure provides satisfactory results for both children and young adults (less than or equal to 50 years of age). Furthermore, David (2009) noted that young adults with aortic stenosis and a normal-sized aortic root are the best candidates for the Ross procedure.

The Society of Thoracic Surgeons’ “Aortic valve and ascending aorta guidelines for management and quality measures” (Svensson et al., 2013) stated that

• The Ross procedure is not recommended for middle-aged or older adults when suitable alternatives to autograft replacement of the aortic valve are available with comparable results and without the need for replacement of the right ventricular outflow tract (RVOT), as the latter adds the additional risk of pulmonary valve dysfunction and subsequent replacement. (Level of evidence C)
• The Ross procedure is not recommended for patients with bicuspid valves and aortic regurgitation or aortic dilation if other alternatives are available. (Level of evidence C).

The Ross Procedure for Middle-Aged or Older Adults

In a retrospective, single-center study, Guerreiro and colleagues (2019) examined the long-term clinical and echocardiographic outcomes of the Ross procedure. This study analyzed the findings of 56 adult patients who underwent the Ross procedure. Mean age at surgery was 44 ± 12 years (range of 16 to 65 years), and 55% were male. Clinical endpoints included overall mortality and the need for valve reoperation due to graft failure. The echocardiographic endpoint was the presence of any graft deterioration. Median clinical follow-up was 20 years (1,120 patient-years). Indications for surgery were dominant aortic stenosis in 50% and isolated aortic regurgitation in 21%. Concomitant mitral valve repair was performed in 21%, and a sub-coronary technique was most commonly used (86%). Overall long-term survival was 91%, 80%, and 77% at 15, 20, and 24 years, respectively. The survival rate was similar to the age- and gender-matched general population (p = 0.44). During the follow-up period, freedom from graft reoperation was 80%; 11 patients (31%) developed moderate AV regurgitation, 3 (8.6%) developed moderate pulmonary regurgitation, and 1 (2.9%) presented with moderate pulmonary stenosis. The authors concluded that the Ross procedure, mostly using a sub-coronary approach, proved to have good clinical and hemodynamic results, with low reoperation rates in long-term follow-up. Moderate autograft regurgitation was a frequent finding but had no significant clinical impact.

Oeser and co-workers (2019) examined the long-term durability and function of pulmonary homografts used for RVOT reconstruction in the Ross procedure at a single center with 25 years of experience. The study included 274 patients (212 male patients and 62 female patients; age of 3 to 59 years) who underwent the Ross procedure between 1991 and 2014. Homograft-related complications and reinterventions were evaluated. Homograft hemodynamic function was determined using trans-thoracic echocardiography (TTE) undertaken by a single cardiologist. The all-cause 30-day mortality was 1.1% (3 patients), and there were 17 late deaths; 1 death was associated with a homograft-related complication. During the observation period (median of 13.3 years; 3,327.5 cumulative patient-years), 21 patients (7.7%) underwent at least 1 RVOT reintervention. Freedom from homograft reintervention was 95.6%, 90.4%, and 87.5% at 10, 15, and 20 years, respectively. Pediatric patients had a significantly lower rate of freedom from reintervention (log-rank p < 0.001). Remarkably, all patients who underwent reintervention were male (log-rank p = 0.009). Female patients received homografts with a significantly higher (p < 0.001) indexed diameter than male patients, which might be causally related to the absence of reinterventions in women. The linearized rate of homograft endocarditis was 0.2% per patient-year. At the latest echocardiography (median follow-up time of 14.7 years; 164 patients), the peak trans-homograft pressure gradient was less than 40 mmHg in 150 patients (91.5%), and homograft incompetence was none or trivial in 111 patients (67.7%), mild in 49 patients (29.9%), and moderate in 3 patients (1.8%). In 1 patient (0.6%), it was not possible to determine the degree of incompetence. Younger patient age (p < 0.001), a smaller homograft diameter (p = 0.014), and an increase in body surface area (BSA) during the follow-up time (p = 0.006) were significantly correlated with a higher peak trans-homograft pressure gradient. Men had a significantly higher peak trans-homograft pressure gradient than women (p = 0.018). The authors concluded that pulmonary homograft provided very satisfying long-term results after the Ross procedure; differences in long-term performance are related to under-sizing and young age.

Chauvette et al. (2020) examined the safety and late outcomes of the Ross procedure for the treatment of active infective endocarditis (IE). From 2000 to 2019, a total of 31 consecutive patients underwent a Ross procedure to treat active IE (mean age of 43 ± 12 years, 84% male). All patients were followed up prospectively; 4 patients (13%) were intravenous (IV) drug users, and 6 patients (19%) had prosthetic IE. The most common infective organism was Streptococcus (58%). Median follow-up was 3.5 (0.9 to 4.5) years and 100% complete. There were no in-hospital deaths; 1 patient suffered a post-operative stroke (3%), and 1 patient (3%) required reintervention for bleeding; 3 patients had a new occurrence of endocarditis: 2 patients were limited to the pulmonary homograft and were successfully managed with IV antibiotics, whereas 1 IV drug user patient developed concomitant autograft and homograft endocarditis. Overall, the cumulative incidence of IE recurrence was 13 ± 8% at 8 years. The cumulative incidence for autograft endocarditis was 5 ± 4% at 8 years; 2 patients (6%) died during follow-up, both from drug overdoses. At 8 years, actuarial survival was 88 ± 8%. The authors concluded that in selected patients with IE, the Ross procedure was a safe and reasonable alternative with good mid-term outcomes.

Singh and colleagues (2022) noted that the Ross procedure is rarely considered in older patients. These researchers compared the perioperative and long-term outcomes of patients greater than 50 years of age with younger patients after the Ross procedure. Between 1992 and 2018, a total of 455 patients underwent the Ross procedure utilizing the inclusion technique. Patients with redo surgery, non-aortic procedures, and unsupported root replacement were excluded. The remaining patients were matched for native valve morphology, valve lesion, and annular manipulation, yielding 96 matched pairs. Preoperative and operative characteristics, perioperative outcomes, survival rates, valve-related adverse events (AEs), and valve hemodynamics were evaluated. There was no in-hospital mortality. The median follow-up was 11 years for both cohorts. Overall survival at 15 years was similar: 99% (95% CI: 89.8% to 99.8%) for patients greater than 50 years of age and 98% (95% CI: 89.3% to 99.7%) for younger patients. Patients over 50 years had a notable freedom from Ross-related reintervention at 15 years: 94% (95% CI: 84.8% to 97.7%) versus 90% (95% CI: 80.2% to 95.6%) in younger patients. The mixed model analysis revealed that being 50 years and older was not significantly associated with a higher autograft gradient or regurgitation. Interestingly, being 50 years and older correlated with decreased allograft regurgitation and stenosis. The authors concluded that older patients undergoing the Ross procedure had comparable outcomes to younger patients. Patients 50 years of age and over, who are high functioning with minimal comorbidities, should be considered for the Ross procedure.

In a retrospective, international cohort, multi-center study, Romeo and associates (2021) examined the long-term clinical and echocardiographic outcomes in young and middle-aged patients undergoing the Ross procedure. This trial had a median follow-up period of 9.2 years and was carried out in 5 experienced centers regularly performing the Ross procedure. Consecutive patients aged 18 to 65 years were included by each center between 1991 and 2018. Main outcomes and measures included survival and autograft-related and homograft-related reintervention. Serial echocardiographic measurements of valve function were analyzed using mixed-effects modeling. During the study period, a total of 1,431 patients (74.3% men; n = 1,063) were operated on at a median age of 48.5 years (mean [SD], 47.7 [9.5]; range of 18.1 to 65 years; inter-quartile range [IQR], 42.7 to 54.0 years). Implantation techniques were root inclusion in 355 (24.9%), root replacement in 485 (34.0%), and sub-coronary implantation in 587 (41.1%). Right ventricular outflow tract reconstruction was carried out with homograft in 98.6% (n = 1,189) and bioprosthesis in 1.4% (n = 17); 10 patients (0.7%) died before discharge. Median follow-up was 9.2 years (13,015 total patient-years). Survival after 10 and 15 years was 95.1% (95% CI: 93.8% to 96.5%) and 88.5% (95% CI: 85.9% to 91.1%), respectively. Freedom from autograft and homograft reintervention after 15 years was 92.0% and 97.2%, respectively. Late events included autograft endocarditis in 14 patients (0.11% per patient-year), homograft endocarditis in 11 patients (0.08% per patient-year), and stroke in 37 patients (0.3% per patient-year). The authors concluded that given its excellent short-term and long-term outcomes in young and middle-aged adults in this study, the Ross procedure should be considered in young and middle-aged adults who require aortic valve replacement. Patients should be referred to an experienced center with a program dedicated to the Ross procedure.

Shimamura et al. (2023) noted that the optimal aortic valve substitute for non-elderly adults remains controversial. Recently, considerable data on the Ross procedure have accumulated. These investigators analyzed long-term outcomes following the Ross procedure from the current literature using a meta-analysis of time-to-event outcomes. They carried out a literature search with Medline, Embase, Cochrane Library, Web of Science, and Google Scholar through June 2022; studies reporting clinical outcomes of the Ross procedure beyond 20 years were included for analysis. The outcomes of interest were late survival and freedom from surgical or percutaneous reintervention of the autograft or RVOT. A total of 6 studies, including 4,910 patients (3,601 males), were identified and analyzed. The survival rate at 5, 10, 15, and 20 years was 99.9% ± 0.1%, 97.6% ± 0.5%, 94.3% ± 0.9%, and 87.4% ± 1.9%. Freedom from autograft reintervention at 5, 10, 15, and 20 years was 97.7% ± 0.5%, 95.3% ± 0.7%, 91.4% ± 1.2%, and 84.8% ± 2.5%. Freedom from RVOT reintervention was 99.0% ± 0.3%, 99.0% ± 0.3%, 97.5% ± 0.7%, and 93.3% ± 1.8%. Freedom from any valve reintervention (either autograft or RVOT) at 5, 10, 15, and 20 years was 95.8% ± 0.6%, 92.6% ± 0.9%, 88.5% ± 1.2%, and 80.8% ± 2.5%. The authors concluded that this meta-analysis showed that the Ross procedure was confirmed to provide excellent survival despite the need for reintervention of the autograft or RVOT in about 20% of patients at 20 years.

Perri and Galletti (2023) stated that the ideal aortic valve substitute for young and middle-aged adults with aortic valve disease is still debated. The Ross procedure (pulmonary autograft replacement) is the only operation that allows replacement of the diseased aortic valve with a living substitute. Over the years, the use of the Ross pulmonary autograft procedure has declined due to concerns over increased intraoperative risk and, in particular, potential long-term failure of the operation. However, several recent studies have demonstrated that, after an appropriate learning curve and in specialized centers, the Ross procedure can be carried out safely in appropriately selected patients. Moreover, comparative studies suggested that the Ross procedure is associated with better long-term outcomes compared to conventional aortic valve replacement in young and middle-aged adults.

Notenboom et al. (2024) noted that the Ross procedure as treatment for adults with aortic valve disease (AVD) has been the subject of renewed interest. In a post-hoc analysis of a randomized clinical trial, these investigators examined the long-term clinical and echocardiographic outcomes following the Ross procedure for the treatment of adults with AVD. This study included adult patients (age of less than 69 years) who underwent a Ross procedure for the treatment of AVD, including those with active endocarditis, rheumatic AVD, decreased ejection fraction (EF), and previous cardiac surgery. The trial, conducted from September 1, 1994, to May 31, 2001, compared homograft root replacement with the Ross procedure at a single center. Data after 2010 were collected retrospectively in November and December 2022. The primary endpoint was long-term survival among patients who underwent the Ross procedure compared with that in the age-, country of origin-, and sex-matched general population. Secondary endpoints were freedom from any reintervention, autograft reintervention, or homograft reintervention, and time-related valve function, autograft diameter, and functional status. This study included 108 adults (92 [85%] male) with a median age of 38 years (range of 19 to 66 years). Median duration of clinical follow-up was 24.1 years (IQR, 22.6 to 26.1 years; 2,488 patient-years), with 98% follow-up completeness. Of these patients, 9 (8%) had active endocarditis, and 45 (42%) underwent reoperations. The main hemodynamic lesion was stenosis in 30 (28%) and regurgitation in 49 (45%). There was 1 perioperative death (0.9%). Twenty-five-year survival was 83.0% (95% CI: 75.5% to 91.2%), representing a relative survival of 99.1% (95% CI: 91.8% to 100%) compared with the general population (83.7%). At 25 years, freedom from any reintervention was 71.1% (95% CI: 61.6% to 82.0%); from autograft reintervention, 80.3% (95% CI: 71.9% to 89.6%); and from homograft reintervention, 86.3% (95% CI: 79.0% to 94.3%). Thirty-day mortality after the first Ross-related reintervention was 0%, and after all Ross-related reinterventions was 3.8% (n = 1); 10-year survival after reoperation was 96.2% (95% CI: 89.0% to 100%). The authors concluded that this study found that the Ross procedure provided excellent survival into the third decade postoperatively that was comparable to that in the general population. Long-term freedom from reintervention showed that the Ross procedure may be a durable substitute into late adulthood, showing a delayed but progressive functional decline.

The Ross Procedure for Neonates, Infants, and Young Patients

In a meta-analysis, Tohme et al. (2022) examined early and late outcomes of the Ross/Ross-Konno procedures in neonates and infants. This meta-analysis was carried out in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement. These investigators used Ovid versions of Medline/PubMed for relevant studies and included those that reported Ross/Ross-Konno operations in neonates and infants and at least one of the pre-determined clinical outcomes; the I² and double arcsine methods assessed the heterogeneity between pooled estimates. These researchers employed a random-effect model to account for heterogeneity with MetaXL. They calculated point estimates of pooled estimates along with their 95% confidence intervals (CIs). A total of 587 neonate and infant patients were included, with a median age of 87.5 days. The follow-up range was from 5 days to 23 years. Early mortality was reported in 25 studies, with pooled estimates of 18.3% (95% CI: 13.6% to 23.5%). Estimates ranged from 0% to 50% with relatively substantial heterogeneity (p = 0.01, I² = 48.6%). Late mortality was reported in 22 studies, with a pooled incidence of 9.7% (95% CI: 5.9% to 14.3%). Estimates ranged from 0% to 53% with relatively substantial heterogeneity (p = 0.01, I² = 46.1%). Autograft reintervention was reported in 18 studies, with a pooled estimate of 19.2% (95% CI: 7.3% to 34.5%). Estimates ranged from 0% to 81.8% with high heterogeneity (p < 0.001, I² = 90.5%). Right ventricle-to-pulmonary artery conduit reintervention was reported in 16 studies, with pooled estimates of 32.0% (95% CI: 20.9% to 44.12%). Estimates ranged from 0% to 92.3% with high heterogeneity (p < 0.001, I² = 75.9%). The authors concluded that these findings suggested that the Ross/Ross-Konno procedure in neonates and infants still carries a significant risk of early and late mortality and autograft/conduit reintervention. The high variability of results among centers confirmed the need for surgical expertise and good patient selection. These researchers stated that prospective, multi-center studies are needed to examine the rate of autograft reintervention and the impact on long-term survival in this specific population.

Varrica et al. (2023) stated that aortic valve replacement early in life may be inevitable. The Ross operation, until the present day, remains the preferred surgical option in pediatrics for irreparable aortic valve disease. Nonetheless, the necessity for reoperation has always been its principal limitation due to aortic valve failure or homograft degeneration. In a retrospective study, these investigators presented their 25 years of experience in the pediatric population. From August 1994 until June 2018, a total of 157 children below 18 years underwent the Ross operation. This review examined the long-term outcomes, as well as the risk factors for reoperation following the Ross procedure. The median age was 10.9 years, of which 7 patients were infants, 79 were children, and 71 were adolescents. The median follow-up time was 14 years. Hospital mortality was 0.6%. Freedom from autograft reoperation for children was 96.7% and 94.1% at 10 years and 20 years, respectively, whereas for adolescents, it was 92.6% and 74.9% at 10 years and 20 years, respectively. For children, freedom from homograft reoperation was 92.5%, 83.5%, and 56.2% at 10, 15, and 20 years, respectively; while for adolescents, it was 96.8%, 91.8%, and 86.7% at 10, 15, and 20 years, respectively. Homograft size (p = 0.008) and childhood (p = 0.05) were risk factors for homograft reoperation. A pulmonary valve diameter of greater than 24 mm (p = 0.044) and adolescence (p = 0.032) were risk factors for autograft reoperation. The authors concluded that their experience demonstrated excellent early and late survival. While children exhibited preferential outcomes concerning autograft reoperation, those who received a smaller homograft had a higher incidence of right-sided reintervention than adolescents. A pulmonary diameter of greater than 24 mm at surgery was an indicator of future autograft failure.

Greenberg et al. (2024) stated that for neonates and infants with aortic valve pathology, the Ross procedure has historically been associated with high rates of morbidity and mortality. Data regarding long-term durability are lacking. The international, multi-institutional Ross Collaborative included six tertiary care centers. Infants who underwent a Ross operation between 1996 and 2016 (allowing a minimum of 5 years of follow-up) were retrospectively identified. Serial echocardiograms were examined to study the evolution in neo-aortic size and function. Primary diagnoses for the 133 patients (n = 30 neonates) included isolated aortic stenosis (14%, n = 19), Shone complex (14%, n = 19), and aortic stenosis plus other conditions (excluding Shone complex; n = 95, 71%), including arch obstruction (n = 55), left ventricular hypoplasia (n = 9), and mitral disease (moderate or greater stenosis or regurgitation, n = 31). At the time of the Ross procedure, the median age was 96 days (IQR, 36 to 186), and the median weight was 4.4 kg (3.6 to 6.5). In-hospital mortality occurred in 13 of 133 patients (10%) (4/30 [13%] neonates). Post-discharge mortality occurred in 10 of 120 patients (8%) at a median of 298 days post-Ross. Post-Ross neo-aortic dilatation occurred, peaking at 4 to 5 standard deviations above normal at 2 to 3 years before returning to near-baseline z-scores at a median follow-up of 11.5 years (IQR, 6.4 to 17.4). Autograft/left ventricular outflow tract (LVOT) re-intervention was required in 5 of 120 patients (4%) at a median of 10.3 years (IQR, 4.1 to 12.8). Freedom from moderate or greater neo-aortic regurgitation was 86% at 15 years. The authors concluded that neonates and infants experienced excellent post-discharge survival and long-term freedom from autograft re-intervention and aortic regurgitation after the Ross procedure. Neo-aortic dilatation normalized in this population in the long term, and increased consideration should be given to the Ross procedure in neonates and infants with aortic valve disease.

Liebrich et al. (2024) noted that the standard aortic valve replacement (AVR) operations in young patients are bioprosthetic or mechanical AVR. These investigators presented the long-term results of the Ross operation in young patients. The Ross operation with root replacement was performed between 1995 and 2020. The endpoints were overall survival (OS), re-operation/re-intervention rates on the autograft and homograft/right ventricle-pulmonary artery (RV-PA) conduit, and the occurrence of serious adverse events (AEs). A total of 795 patients (75% male, 25% female; mean age of 43 ± 14 years) underwent the Ross operation with root replacement. The 30-day mortality was 1% (8 patients; 95% CI: 0.48 to 1.9). The follow-up was 96% complete and covered 9,540 patient-years, with a mean follow-up time of 12 ± 7 years. The survival rates at 5, 10, 15, and 20 years were 97% [96% to 98%], 96% [93% to 96%], 92% [89% to 94%], and 86% [83% to 90%]. The rate of autograft survival without re-operation was 94% [92% to 96%] at 10 years and 80% [76% to 85%] at 20 years. The rate of homograft/RV-PA conduit survival without re-operation was 95% [93% to 97%] at 10 years and 85% [81% to 90%] at 20 years. There were 5 cases of hemorrhage, 14 cases of thromboembolic complications or apoplexy, and 19 cases of endocarditis. The authors concluded that the Ross operation with root replacement was associated with high survival rates over 25 years of follow-up. The rates of re-operation and re-intervention, morbidity and mortality, and the rate of endocarditis were low; thus, the Ross operation is an effective surgical option for young patients with aortic valve disease.

Bakhshaliyev et al. (2025) stated that the Ross procedure is the preferred surgical treatment for pediatric aortic valve diseases, and its long-term outcomes have been extensively documented. These investigators presented the results of the Ross and Ross-Konno procedures carried out on pediatric patients in their center. The Ross and Ross-Konno procedures were performed on 20 patients between January 2015 and January 2019. Participants’ mean age was 10.6 years (range of 23 days to 18 years) and mean weight was 37.6 kg (range of 3 to 63 kg) – 13 had aortic valve stenosis, 4 had aortic valve insufficiency, and 3 had mixed disease. The Ross-Konno procedure was used for 4 patients. The mean cardiopulmonary bypass time was 184.68 ± 60.1 minutes, and the mean cross-clamp time was 149 ± 67.8 minutes. One neonatal patient died in the early postoperative phase due to low cardiac output. The mean follow-up time was 60.15 ± 24.45 months. One patient later underwent re-operation due to conduit stenosis, and one patient was being monitored for moderately serious conduit stenosis. Of those who underwent the procedure, 1 had moderate aortic regurgitation, 2 had mild or moderate aortic regurgitation, and others exhibited minimal aortic regurgitation. No patients required intervention for left ventricular outflow tract (LVOT) obstruction, and mortality was not observed in the long term. The authors concluded that the re-intervention rates for autograft and conduit-related cases were low in early and medium-term follow-up, and no significant autograft insufficiency was observed. These investigators stated that Ross or Ross-Konno surgery is preferred for aortic diseases in pediatric patients due to its low mortality and satisfactory long-term results.

The Ross Procedure versus Other Aortic Valve Replacement

Um and colleagues (2018) noted that life expectancy in young adults undergoing mechanical or bioprosthetic aortic valve replacement (AVR) may be reduced by up to 20 years compared to age-matched controls. The Ross procedure is a durable, anticoagulation-sparing alternative. These investigators performed a systematic review and meta-analysis to compare the valve hemodynamics of the Ross procedure versus other AVR. They searched Cochrane CENTRAL, Medline, and Embase from inception to February 2017 for randomized controlled trials (RCTs) and observational studies (n of greater than or equal to 10 Ross). Independently and in duplicate, these researchers performed title and abstract screening, full-text eligibility assessment, and data collection. They evaluated the risk of bias with the Cochrane and CLARITY tools and the quality of evidence with the GRADE framework. The authors identified 2 RCTs and 13 observational studies that met eligibility criteria (n = 1,412). In observational studies, the Ross procedure was associated with a lower mean aortic gradient at discharge (mean difference [MD] -9 mmHg, 95% confidence interval [CI]: -13 to -5, p < 0.0001, I² = 97%) and at the latest follow-up (MD -5 mmHg, 95% CI: -7 to -3, p < 0.0001, I² = 92%). There was no significant difference in the incidence of severe aortic regurgitation at the latest follow-up (relative risk [RR] 1.3, 95% CI: 0.3 to 5.8, p = 0.70, I² = 30%). In RCTs, the Ross procedure was associated with a lower mean gradient at the latest follow-up (MD -15 mmHg, 95% CI: -32 to 2, p = 0.08, I² = 99%). The mean pulmonic gradient for the Ross procedure was 18.0 mmHg (95% CI: 16 to 20, p < 0.0001) at the latest follow-up. The evidence for all outcomes from observational studies was deemed to be of very low quality, while the evidence from RCTs was downgraded for imprecision and moderately serious risk of bias. The authors concluded that compared to conventional AVR, the Ross procedure was associated with better aortic valve hemodynamics. These researchers stated that future studies should evaluate the impact of the Ross procedure on exercise capacity and quality of life (QOL).

In a propensity-matched study, Mazine and colleagues (2022) compared the long-term outcomes of patients undergoing the Ross procedure and those receiving bioprosthetic AVRs. Consecutive patients aged 16 to 60 years who underwent a Ross procedure or surgical bioprosthetic AVR at the Toronto General Hospital between 1990 and 2014 were identified. Propensity score matching was employed to account for differences in baseline characteristics. The primary outcome was all-cause mortality, and secondary outcomes included valve re-intervention, valve deterioration, endocarditis, thromboembolic events, and permanent pacemaker implantation. Propensity score matching yielded 108 pairs of patients. The median age was 41 years (inter-quartile range [IQR]: 34 to 47 years). Baseline characteristics were similar between the matched groups. There was no operative mortality in either group. Mean follow-up was 14.5 ± 7.2 years. All-cause mortality was lower following the Ross procedure (hazard ratio [HR]: 0.35; 95% CI: 0.14 to 0.90; p = 0.028). Using death as a competing risk, the Ross procedure was associated with lower rates of re-intervention (HR: 0.21; 95% CI: 0.10 to 0.41; p < 0.001), valve deterioration (HR: 0.25; 95% CI: 0.14 to 0.45; p < 0.001), thromboembolic events (HR: 0.15; 95% CI: 0.05 to 0.50; p = 0.002), and permanent pacemaker implantation (HR: 0.22; 95% CI: 0.07 to 0.64; p = 0.006). The authors concluded that the Ross procedure was associated with better long-term survival and freedom from adverse valve-related events compared with bioprosthetic AVR. In specialized centers with sufficient expertise, the Ross procedure should be considered the primary option for young and middle-aged adults undergoing AVR.

Redo Operations After the Ross Procedure

Shih et al. (2023) noted that the Ross procedure is not commonly performed, owing to the procedural complexity and the risk of autograft and/or homograft reoperation. In a retrospective study, these investigators examined the outcomes of patients undergoing Ross reinterventions at a dedicated Ross center. They reviewed 225 consecutive patients who underwent a Ross procedure between 1994 and 2019. Index and redo operation characteristics and outcomes were compared between patients with and those without redo operations. Multivariate analysis was used to identify independent predictors of Ross-related reinterventions. Survival was estimated with Kaplan-Meier analysis. A total of 66 patients (29.3%) required redo Ross surgery; 41 patients (18.2%) underwent autograft reoperation only, 8 patients (3.6%) had a homograft reintervention, and 17 patients (7.6%) had both autograft and homograft reoperations (12 as a combined procedure and 5 as sequential procedures). The mean time to reintervention was 11 ± 6 years for autograft reoperations and 12 ± 7 years for homograft reoperations. Patients who underwent Ross-related reinterventions were younger (mean of 38 ± 11 years versus 43 ± 11 years; p < 0.01) and had a higher rate of New York Heart Association (NYHA) class III/IV (56% versus 38%; p = 0.02) at the index Ross procedure. Most patients undergoing autograft reintervention had aortic insufficiency and/or aneurysm (98.2%; 57 of 58). The primary reason for homograft reintervention was pulmonary stenosis (92%; 23 of 25). The operative mortality of Ross reintervention was 1.5% (1 of 66). Survival at 15 years was similar in patients who required a redo operation and those who did not (91.2% versus 93.9%; p = 0.23). The authors concluded that Ross reinterventions could be carried out safely and maintained patients at the normal life expectancy restored by the index Ross procedure for up to 15 years at experienced centers.

Bentall-De Bono Composite Aortic Valve-Graft Versus Valve-Sparing Aortic Root Replacement

Formica et al. (2025) stated that for patients with aortic root dilatation and a structurally normal aortic valve (AV) undergoing composite aortic valve-graft (Bentall-De Bono) versus valve-sparing aortic root replacement (VSARR) procedures, there are conflicting data regarding early and long-term benefits. These researchers carried out a study-level meta-analysis to compare the results of both procedures. Three databases were assessed, and both randomized trials and observational studies were considered eligible. Kaplan-Meier curves of long-term survival and re-operation risk were reconstructed and compared using Cox linear regression and incidence rate ratios (IRR) with 95% confidence intervals (CIs). Landmark analysis and time-varying hazard ratios (HRs) were also analyzed. Odds ratios (ORs) were calculated for early mortality, postoperative stroke, and re-exploration for postoperative bleeding. A random effects model was employed, and sensitivity analyses included leave-one-out analysis, meta-regression, and subgroup analysis. A total of 1,456 studies were identified, including 39 observational studies, totaling 14,651 patients (Bentall-De Bono = 9,557 and VSARR = 5,094); 12 studies were adjusted. The mean weighted follow-up was 5.05 ± 3.7 years. VSARR was associated with significantly greater survival (HR = 0.50; 95% CI: 0.45 to 0.57; p < 0.0001) at the 15-year follow-up. The re-operation risk was higher following VSARR (HR = 1.30; 95% CI: 1.03 to 1.63; p = 0.02), although the time-varying HR model and landmark analysis reported an increased risk of re-operation within 5 years after VSARR (HR = 1.57; 95% CI: 1.23 to 2.01; p < 0.001), after which the difference disappeared. Subgroup analysis of studies excluding aortic dissection showed a comparable rate of late re-operation. The authors concluded that VSARR was associated with improved long-term survival compared to Bentall-De Bono. The risk of late re-operation was higher within 5 years following VSARR, after which the two procedures were comparable.

Decellularized Matrix P Bioprosthesis for Pulmonary Valve Replacement for Ross Procedures

Christ and colleagues (2019) noted that since 1967, the Ross procedure has been performed to treat aortic valve disease using homografts for pulmonary valve replacement (PVR). The decellularized Matrix P bioprosthesis was developed to overcome some limitations of homografts. Until now, long-term outcome data have been unavailable. Between 2002 and 2010, the Ross procedures using the Matrix P bioprosthesis were performed in 492 adult patients (mean age of 57.2 ± 10.6 years, range of 21 to 73 years) at the authors’ institution. Patient data were prospectively collected and analyzed (3,617.3 patient-years, mean follow-up of 7.7 ± 4.3 years). Completeness of follow-up at 1, 5, and 10 years was 98.4%, 94.5%, and 91.0%, respectively. Hospital mortality was 3.9% (n = 19). During follow-up, 121 patients died, resulting in a survival rate at 5, 10, and 12.5 years of 82.8 ± 1.7%, 70.4 ± 2.3%, and 62.4 ± 2.9%, respectively. Echocardiography revealed a high incidence of relevant dysfunction of the Matrix P bioprosthesis and subsequent right ventricular failure. Primary reoperation/reintervention was necessary for 150 Matrix P and 48 autografts. Freedom from pulmonary valve reoperation at 5, 10, and 12.5 years was 76.2 ± 2.1%, 58.6 ± 2.9%, and 53.4 ± 3.4%, respectively. The autograft function and the left ventricular function showed similar results as previously reported, with a freedom from autograft reoperation at 5, 10, and 12.5 years of 91.8 ± 1.4%, 86.1 ± 2.0%, and 86.1 ± 2.0%, respectively. The authors concluded that the Matrix P bioprosthesis used for the RVOT reconstruction in the Ross procedure showed unfavorable long-term echocardiographic results, with a high rate of reoperation/reintervention for structural pulmonary valve failure. As a consequence, long-term survival of this patient cohort was impaired. The authors concluded that based on these findings, the use of the Matrix P bioprosthesis for PVR in Ross procedures in adults should not be recommended.

The Florida Sleeve Valve-Sparing Procedure for the Treatment of Aortic Root Ectasia and Aneurysm

Aalaei-Andabili and associates (2019) stated that the Florida (FL) Sleeve procedure was introduced as a simplified approach for valve-sparing correction of functional type I aortic insufficiency (AI) associated with aortic root aneurysms. In this study, these researchers examined the short- and long-term outcomes following the FL Sleeve procedure. From May 2002 to January 2016, a total of 177 patients underwent the FL Sleeve procedure. Left ventricular end-diastolic diameter (LVEDD), left ventricular end-systolic diameter (LVESD), left ventricular ejection fraction (LVEF), and degree of AI (none = 0, minimal = 1, mild = 2, moderate = 3, severe = 4) were evaluated by echocardiography. The mean ± standard deviation of age was 49.41 ± 15.37 years. The survival rate was 98% at 1 year, 97% at 5 years, and 93% at 8 years. Freedom from reoperation was 99% at 1 year and 98% at 2 to 8 years; 3 patients (1.69%) died during hospitalization, and 3 patients (1.69%) developed peri-procedural stroke. Post-operative follow-up echocardiography was available in 140 patients at 30 days and 31 patients at 5 years. AI grade significantly improved from baseline at 30 days (2.18 ± 1.26 versus 1.1 ± 0.93, p < 0.001) and at 5 years (2.0 ± 1.23 versus 1.45 ± 0.88, p = 0.04). Pre-operative mean LVEDD significantly decreased from 52.20 ± 6.73 to 46.87 ± 8.40 (p < 0.001) at 30 days and from 53.22 ± 7.07 to 46.61 ± 10.51 (p = 0.01) at 5 years. The authors concluded that the FL Sleeve procedure was a safe, effective, and durable treatment of aortic root aneurysm and type I AI; long-term survival and freedom from reoperation rates were encouraging.

The authors stated that this study had several drawbacks. First, this was a retrospective and single-center study. Second, there was no comparison between outcomes of the FL Sleeve procedure and previous aortic valve-sparing (AVS) techniques. Third, there was loss to follow-up of patients’ echocardiography measurements.

Wu and co-workers (2019) devised a simple modification of the FL Sleeve procedure to perform AVS surgery. This technique was simple, quick, effective, and safe. These researchers employed this technique in operations performed on 2 young patients with Marfan syndrome. The initial and short-term results were satisfactory. Moreover, these researchers stated that a larger number of cases and long-term follow-up are needed to prove its durability.

Tasca and colleagues (2020) noted that the Sleeve procedure is one of the options for patients with aortic root diseases and might be suitable for patients with a bicuspid valve. From October 2006 to December 2018, a total of 42 consecutive patients with a bicuspid aortic valve and aortic root ectasia/aneurysm, with or without aortic regurgitation, were surgically treated with the Sleeve procedure. In 20 patients (48%), leaflet surgery was necessary and consisted of raphe mobilization/resection in 17 patients, plication of both leaflets in 2 patients, and a 2-commissures re-suspension in 1 patient. During a mean clinical follow-up time of 4.4 ± 3.1 years, the survival rate was 100%. One patient required a reoperation at 6.1 years post-operatively, with an overall freedom from reoperation of 94 ± 5%. The rest of the patients (41/42) had no more than mild residual aortic valve regurgitation. With a mean follow-up of 4.3 ± 1.7 years, the magnetic resonance imaging (MRI) performed in 26 patients did not show signs of aortic wall herniation through the keyholes or persisting creases of the aortic wall inside the prosthesis. The authors concluded that patients with aortic root disease and a bicuspid aortic valve may be treated with the Sleeve procedure with excellent mid-term results; however, a longer follow-up is needed before drawing any solid conclusions.

Holubec and colleagues (2022) compared short- and longer-term outcomes of David (DV) versus FL Sleeve procedure in patients requiring valve-sparing aortic root replacement. Between January 1996 and December 2020, a total of 285 patients received a DV procedure (median age of 60 years; 26% females) and 57 patients underwent an FL Sleeve procedure (median age of 64 years; 19% females) in the authors’ department. Propensity score matching using patient characteristics led to 58 (DV) versus 57 (FL Sleeve) patients. Endpoints were defined as primary: freedom from aortic valve and/or aortic root-related reoperation and freedom from aortic regurgitation greater than or equal to moderate, and secondary: early and late survival. The 30-day mortality was 2% (DV) and 0% (FL Sleeve) (p = 0.319). There was 1 early stroke in each group (p = 0.990). Follow-up was complete in 99% with only 1 patient (FL Sleeve) lost. The 5- and 10-year freedom from aortic valve and/or aortic root-related reoperation was 98 ± 2% and 96 ± 3% in the DV group and 92 ± 5% and 84 ± 9% in the FL Sleeve group, respectively (p = 0.095). The 5- and 10-year freedom from aortic regurgitation greater than or equal to moderate was 88 ± 5% and 80 ± 8% in the DV group and 92 ± 5% and 78 ± 1% in the FL Sleeve group, respectively (p = 0.782). The 5- and 10-year survival rates were 93 ± 4% and 82 ± 6% (DV) versus 75 ± 7% and 67 ± 10% (FL Sleeve), respectively (p = 0.058). No cases of endocarditis (DV) and 3 cases of endocarditis (FL Sleeve) (p = 0.055) were observed during follow-up. The authors concluded that both DV and FL Sleeve resulted in similar early and longer-term outcomes, with a trend toward slightly better performance and survival in the DV group. These researchers stated that the FL Sleeve procedure might be an alternative approach for patients with higher-risk profiles requiring valve-sparing aortic root replacement.

The Personalized External Aortic Root Support (PEARS) Procedure

Personalized External Aortic Root Support (PEARS) is a surgical technique designed to prevent progressive dilatation of the aortic root while preserving the native aortic valve and aortic wall. The procedure uses a patient-specific, pliable macroporous mesh sleeve (most commonly the ExoVasc® implant) that is manufactured from preoperative CT imaging and placed externally around the ascending aorta and root. Unlike conventional aortic root replacement or valve-sparing root reconstruction, PEARS does not require excision of the aorta and often avoids cardiopulmonary bypass. The intent is to stabilize the aortic root at an earlier stage of disease, maintaining native valve function and avoiding lifelong anticoagulation, particularly in patients with genetically triggered aortopathies such as Marfan syndrome or bicuspid aortic valve–associated aortic root dilatation (Pepper et al., 2024).

Kalil et al. (2025) report on a single-center case series describing the first clinical experience with Personalized External Aortic Root Support (PEARS) in the Americas for the treatment of aortic root aneurysms associated with Marfan syndrome and bicuspid aortic valve disease. The authors evaluated 10 patients (mean age 37.8 years; 80% Marfan syndrome, 20% bicuspid aortic valve) treated between 2022 and 2023 using the ExoVasc® PEARS implant, with cardiopulmonary bypass required in 40% of cases due to concomitant pathology or surgical complexity. No operative mortality or major adverse cardiovascular events (stroke, myocardial infarction, renal failure, or reoperation) occurred, and postoperative complications were limited to two minor events (pericarditis and atrial fibrillation), both managed medically. Aortic valve preservation was achieved in 100% of patients, with improvement or elimination of preoperative aortic regurgitation and stable aortic dimensions documented at 30-day and one-year follow-up. The authors concluded that PEARS is a feasible and safe alternative to conventional aortic root replacement techniques, offering potential advantages such as avoidance of valve replacement and long-term anticoagulation, reduced use of cardiopulmonary bypass, shorter hospitalization, and favorable early clinical outcomes, while emphasizing the need for larger studies and longer-term follow-up to define durability and comparative effectiveness.

As of 2026, the PEARS device has not received U.S. Food and Drug Administration (FDA) clearance or approval and is not commercially available in the United States.

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Appendix

The pulmonary autograft procedure is contraindicated in individuals with the following conditions:

• Extremes of age; or
• Marfan's syndrome; or
• Multiple pathology in which a second valve replacement device is needed; or
• Multi-vessel coronary artery disease; or
• Severely depressed left ventricular function.

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References