Original article
Adult cardiac
Long-Term Durability of Bioprosthetic Aortic Valves: Implications From 12,569 Implants

Presented at the Fiftieth Annual Meeting of The Society of Thoracic Surgeons, Orlando, FL, Jan 27–29, 2014.
https://doi.org/10.1016/j.athoracsur.2014.10.070Get rights and content

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.

Section snippets

Patients

From June 1982 to January 2011, 12,569 patients underwent AVR using PERIMOUNT bioprosthesis models 2700PM (n = 310) or 2700 (n = 12,259) at the Cleveland Clinic. In 3,319 patients (26%), AVR with this prosthesis was an isolated procedure; in 9,250 (74%), it was combined with concomitant procedures, such as coronary artery bypass grafting (48%), thoracic aortic surgery (21%), and mitral valve surgery (20%; Table 1). In 11,741 patients (93%), the native aortic valve was replaced, and this was

Overall Risk of Prosthesis Explantation

A total of 354 prostheses were explanted during follow-up, 41% related to endocarditis and 44% related to SVD. Diverse causes made up the remaining 14%, with less than 1% attributable to valve thrombosis.

Instantaneous risk of explantation for any cause was characterized by an early decreasing phase of risk followed by a late rising phase (Fig 1A). This overall temporal pattern of risk resulted from different cause-specific time-varying risks of reoperation for endocarditis versus SVD (Fig 1B).

Principal Findings

Aortic valve replacement with the PERIMOUNT bioprosthesis is associated with long-lasting durability. In older patients, explantation for SVD is rare and unlikely to be affected by valve size or implant technique. Structural valve deterioration is more common in younger patients; however, durability in those younger than 60 years is good, with 55% freedom from explant for SVD at 20 years. In younger patients, severe prosthesis–patient mismatch was associated with increased risk of explant for

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