Long-Term Durability of Bioprosthetic Aortic Valves: Implications From 12,569 Implants

Abstract

Background Increased life expectancy and younger patients’ desire to avoid lifelong anticoagulation requires a better understanding of bioprosthetic valve failure. This study evaluates risk factors associated with explantation for structural valve deterioration (SVD) in a long-term series of Carpentier-Edwards PERIMOUNT aortic valves (AV). Methods From June 1982 to January 2011, 12,569 patients underwent AV replacement with Edwards Lifesciences Carpentier-Edwards PERIMOUNT stented bovine pericardial prostheses, models 2700PM (n = 310) or 2700 (n = 12,259). Mean age was 71 ± 11 years (range, 18 to 98 years). 93% had native AV disease, 48% underwent concomitant coronary artery bypass grafting, and 26% had additional valve surgery. There were 81,706 patient-years of systematic follow-up data available for analysis. Demographics, intraoperative variables, and 27,386 echocardiographic records were used to identify risks for explant for SVD and assess longitudinal changes in transprosthesis gradients using time-varying covariable analyses. Results Three hundred fifty-four explants were performed, with 41% related to endocarditis and 44% to SVD. Actuarial estimates of explant for SVD at 10 and 20 years were 1.9% and 15% overall, respectively, and in patients younger than 60 years, 5.6% and 46%, respectively. Younger age (p < 0.0001), lipid-lowering drugs (p = 0.002), prosthesis–patient mismatch (p = 0.001), and higher postoperative peak and mean AV gradients were associated with explant for SVD (p < 0.0001). The effect of gradient on SVD was greatest in patients younger than 60 years. Conclusions Durability of the Carpentier-Edwards PERIMOUNT aortic valve is excellent even in younger patients. Explant for SVD is related to gradient at implantation, especially in younger patients. Strategies to reduce early postoperative AV gradients, such as root enlargement or more efficient prostheses, should be considered.

Evolution of surgical therapy for Stanford acute type A aortic dissection

“…If the valve cannot be conserved in a durable manner due to abnormal cusp pathology or dissection trauma, it should be replaced. Although bioprosthetic valves have proven to be reasonably durable when used in patients over 65-70 years of age, younger patients undergoing aortic valve replacement (AVR) with a bioprosthesis [either separately or as part of a composite valve graft (CVG) root replacement] face a much higher risk of bioprosthetic structural valve deterioration (SVD) within 15 years, and this markedly tempers enthusiasm for this approach (52)(53)(54). Mechanical prosthetic AVR requires life-long anticoagulation with the attendant risk of bleeding and embolic complications.…”

Standardized definitions of structural deterioration and valve failure in assessing long-term durability of transcatheter and surgical aortic bioprosthetic valves: a consensus statement from the European Association of Percutaneous Cardiovascular Interventions (EAPCI) endorsed by the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS)

“…All cases of SVD were late events and actuarial freedom from SVD at 15 and 20 years was 78.6 ± 2.2% and 48.5 ± 4.6%, respectively. In the Johnstone et al 5 series assessing SVD in 12 569 patients (81 706 patient-years), actuarial estimates of explant for SVD at 10 and 20 years were 1.9% and 15% overall. Porcine bioprostheses (Hancock II) have also demonstrated long-term durability in patients aged 60 years or older 16 while an accelerated pattern of SVD was observed with the Mitroflow prosthesis in approximately one-third of patients.…”

“…5 However, surgical guidelines for event reporting after cardiac valve interventions have not supported this approach since 2008, and stipulate that SVD should also be defined by clinically detectable measures other than the need for reoperation for a failing bioprosthesis (i.e. using echocardiographic criteria).…”

Mechanical versus biological aortic valve replacement strategies

“…dependency in durability with lower rates of SVD when implanted in increased age [3,4]. The conclusion to implant biological valves at a younger age could therefore be contraproductive.…”