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December 5, 2018

Durability Data for Bioprosthetic Surgical Aortic ValveA Systematic Review

Author Affiliations
  • 1Department of Cardiovascular Medicine, Heart and Vascular Institute, Cleveland Clinic, Cleveland, Ohio
  • 2Department of Cardiovascular Surgery, Mayo Clinic, Rochester, Minnesota
  • 3Department of Cardiothoracic Surgery, Heart and Vascular Institute, Cleveland Clinic, Cleveland, Ohio
JAMA Cardiol. Published online December 5, 2018. doi:10.1001/jamacardio.2018.4045
Key Points

Question  What is the durability of surgical bioprosthetic aortic valves?

Findings  In this systematic review with 167 studies and 12 US Food and Drug Administration reports, a considerable variability in reporting of structural valve deterioration with different definitions and follow-up as well as inadequate long-term systematically collected core laboratory data were noted.

Meaning  Available data on surgical aortic valves do not provide a reliable benchmark for structural valve deterioration over long-term follow-up; there is a great need to standardize study methodologies, definitions of outcomes, and reporting of long-term systematic core laboratory analysis.


Importance  Although 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 Relevance  There 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.