Durability Data for Bioprosthetic Surgical Aortic Valve

Abstract

IMPORTANCEAlthough several studies have reported data on surgical aortic valve durability, variability in study methodologies and definitions as well as inadequate follow-up make the interpretation of data from these studies difficult to interpret.OBJECTIVE To review available data on structural valve deterioration (SVD) of surgical bioprosthetic aortic valves by examining the published literature as well as data reported to the US Food and Drug Administration (FDA).EVIDENCE REVIEW A systematic review using Preferred Reporting Items for Systematic Review and Meta-Analysis reporting guidelines to obtain all available data from preexisting literature on the actuarial freedom from SVD and outcomes of SVD. Data were collected from database inception to November 2016. Additionally, data reported to the FDA were obtained. FINDINGS In total, 167 studies and 12 FDA reports including 101 650 patients and 17 different valve types were analyzed. There were 11 different definitions of SVD used in the studies. Core laboratory data were available for 11 studies. Mean follow-up ranged from less than 1 year to 14 years. Kaplan-Meier estimates were reported for up to 30 years of follow-up, with 0% to 37% of patients remaining at risk at maximum follow-up. Food and Drug Administration-reported data are similarly variable in duration (mean follow-up range, 1.2 to 7 years) and completeness of follow-up, with final follow-up of 0.1% to 95%. CONCLUSIONS AND RELEVANCEThere is considerable variability in reporting SVD of surgical aortic valves, with different definitions and inadequate long-term systematically collected core laboratory data. Rigorously collected long-term data with standardized definitions for surgical valves are needed to provide a benchmark for the durability of rapidly evolving transcatheter valves.

Mid-term outcomes of Sapien 3 versus Perimount Magna Ease for treatment of severe aortic stenosis

“…The question of valve durability is becoming more relevant as TAVR is adopted for lower-risk patients. Several studies showed reasonable durability of surgical bioprosthesis up to 15-20 years after SAVR [17], but variable definitions used for structural valve deterioration in surgical prostheses makes benchmarking for transcatheter valves difficult [26]. The incidence of structural valve deterioration cannot be estimated in our study since a comprehensive echocardiographic followup data was not available and solely reintervention rate inevitably leads to a major underestimation of its true incidence.…”

Essential Information on Surgical Heart Valve Characteristics for Optimal Valve Prosthesis Selection: Expert Consensus Document From the European Association for Cardio-Thoracic Surgery (EACTS)–The Society of Thoracic Surgeons (STS)–American Association for Thoracic Surgery (AATS) Valve Labelling Task Force

“…Besides the information provided on the Valve Chart, individual patient characteristics, comorbidities, life expectancy and preference, local resources and expertise and predicted in vivo prosthesis durability and thrombogenicity should be considered when selecting an SHV for implantation. Due to the suboptimal quality and quantity of the currently available data on in vivo SHV durability and thrombogenicity and considering the significant heterogeneity of the definitions used to describe these important clinical end points [28][29][30], data regarding SHV durability and thrombogenicity are not provided on the Valve Charts.…”

Fifty years of the pericardial valve: Long‐term results in the aortic position

“…Dvir et al attempted to standardise the reporting of SVD but definitions remain heterogenous in the literature with the need for repeat valve replacement, echocardiographic findings, increase in valve gradients, or findings at autopsy all being reported. 31,32 The methods of reporting SVD also differ with the majority of studies reporting actuarial rates of SVD whilst others report actual rates. The actuarial rate of SVD is the rate assuming that all patients survived to be able to experience valve degeneration whilst the actual rate is the percentage of patients whose valve will actually fail before they die.…”

“…It is hard to make direct comparisons between different pericardial heart valves in terms of their freedom from SVD. Dvir et al attempted to standardise the reporting of SVD but definitions remain heterogenous in the literature with the need for repeat valve replacement, echocardiographic findings, increase in valve gradients, or findings at autopsy all being reported 31,32 . The methods of reporting SVD also differ with the majority of studies reporting actuarial rates of SVD whilst others report actual rates.…”