Age and valve size effect on the long-term durability of the Carpentier-Edwards aortic pericardial bioprosthesis

doi:10.1016/S0003-4975(01)02992-7

The Annals of Thoracic Surgery

Volume 72, Issue 3, September 2001, Pages 753-757

https://doi.org/10.1016/S0003-4975(01)02992-7 Get rights and content

Abstract

Background. Bioprosthesis durability decreases with time and younger age. However, the time-scale and determinants of durability of the aortic Carpentier-Edwards stented bovine pericardial prosthesis are incompletely characterized.

Methods. Between September 1981 and January 1984, 267 patients underwent implantation of the pericardial aortic prosthesis at four centers. Mean age at implant was 65 ± 12 years (range 21 to 86 years). Follow-up averaged 12 ± 4.5 years. The primary end point was explant for structural valve dysfunction (SVD), which was analyzed multivariably in the context of death as a competing risk.

Results. Freedom from explant due to SVD was 99%, 94%, and 77% at 5, 10, and 15 years. Risk of SVD increased exponentially with time and younger age (p = 0.0001) at implantation; an increased risk of small valve size was not reliably demonstrated (p = 0.1). Considering the competing risk of death, patients aged 65 years or older had a less than 10% chance of explant for SVD by 15 years.

Conclusions. Durability of this stented pericardial aortic bioprosthesis is excellent and justifies its use in patients aged 65 or older.

Section snippets

Patients

Between September 1981 and January 1984, 267 patients from four investigational centers were implanted with an aortic Carpentier-Edwards stented bovine pericardial prosthesis. This was part of a larger premarketing clinical investigation for the US Food and Drug Administration. Mean age at implant was 65 ± 12 years (range 21 to 86 years). Of these, 64% were men. Preoperatively, 45 (17%) of the patients were in New York Heart Association (NYHA) functional class IV, 115 (43%) in class III, 93

Valve explantation

Thirty-six pericardial valve explants were performed, 30 of which were deemed valve-related. The cause of explant was SVD in 27 patients, generally because of aortic stenosis from prosthesis calcification. Other causes of valve-related explant were prosthetic valve endocarditis in 2 patients, and periprosthetic leakage in 1 patient. Six explants were considered prophylactic during subsequent CABG or mitral valve replacement.

Explant for structural valve dysfunction

At 5, 10, and 15 years, risk-unadjusted freedom from SVD was 99%, 94%,

Comment

Pericardial valves have been used since the early 1970s with excellent hemodynamic results. However, early model pericardial valves demonstrated limited durability because of design characteristics [9] or tissue preparation techniques [10]. The Carpentier-Edwards pericardial bioprosthesis incorporated a novel tissue-mounting technique under the stent to reduce areas of concentrated stress and a tissue treatment shown to reduce calcification in animal studies [11].

The principal finding from this

Acknowledgements

Supported in part by a research grant from Edwards Lifesciences LLC, Irvine, CA. William Anderson, PhD, wrote the SAS-based algorithms for the variance of the nonparametric competing risks estimates used in the figures, based on Andersen and associates [8].

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Over the last two decades there has been a significant shift towards the use of bioprostheses in the context of surgical aortic valve replacement, despite the well-known process of structural valve deterioration (SVD). This process has been extensively evaluated even though with many different definitions and methods, thus, the true long-term durability of surgical bioprostheses is not yet fully elucidated.
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Structural valve deterioration (SVD) remains the major determinant of bioprosthesis durability. The aim of this study was to investigate the SVD incidence, predictors and outcomes in patients aged 50 years and younger after bioprosthetic aortic valve replacement (bAVR).
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The overall survival-rate at 10/15 years and freedom from SVD at 10/12.5 years were 89.6 ± 5.2%/81.5 ± 9.1% and 73.5 ± 8.2%/41.9 ± 18.9%, respectively. SVD occurred at a median time of 8.2 (IQR: 6.0–9.9) years after bAVR. Age was not found as an independent predictor for SVD at the multivariable model, despite a higher rate of SVD in the age group ≤30 years. Freedom from reoperation due to SVD at 10/15 years was 71.3 ± 14.1%/13.6 ± 12.3%. Reoperation was performed at a median time of 10.0 (IQR: 8.9–11.9) years since first bAVR and was associated with a 100% 12-month survival.
In our study, the rate and time of SVD occurrence were comparable to those of other studies' older age groups. Strict echocardiographic monitoring of valve performance is mandatory to set the appropriate timing of eventual reoperation. This attitude can improve outcomes of bAVR in younger patients.
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To report the implant experience and long-term outcomes from a large tertiary care referral center on surgical aortic valve replacement (SAVR) with a contemporary stented pericardial bioprosthesis with anticalcification treatment.
Patients underwent SAVR using the Trifecta valve at a single institution. Endpoints included procedural outcomes, adverse events, prosthesis–patient mismatch (PPM), long-term survival, and valve durability. Follow-up included 30-day, 6-month, and annual assessments. Treatment for structural valve deterioration (SVD) included surgical explant and valve-in-valve (V-in-V) transcatheter aortic valve implantation (TAVI).
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Outcomes from this large single-center cohort at increased surgical risk demonstrate excellent long-term durability of the Trifecta valve for SAVR and feasibility of treating SVD by V-in-V TAVI.
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^☆: Doctor Cosgrove discloses that he has a financial relationship with Edwards Lifesciences, L.L.C.

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Original article: cardiovascularAge and valve size effect on the long-term durability of the Carpentier-Edwards aortic pericardial bioprosthesis☆

Abstract

Section snippets

Patients

Valve explantation

Explant for structural valve dysfunction

Comment

Acknowledgements

Ann Thorac Surg

Ann Thorac Surg

Ann Thorac Surg

J Vasc Surg

Ann Thorac Surg

Ann Thorac Surg

Long-term durability and patient functional status of the Carpentier-Edwards Perimount pericardial bioprosthesis in the aortic position

J Heart Valve Dis

Original article: cardiovascular
Age and valve size effect on the long-term durability of the Carpentier-Edwards aortic pericardial bioprosthesis☆