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Bioprosthetic Surgical Aortic Valve Durability Data Review
Study Questions:
What data on structural valve deterioration (SVD) exist for surgically implanted bioprosthetic aortic valves?
Methods:
A systematic review using Preferred Reporting Items for Systematic Review and Meta-Analysis reporting guidelines was performed to obtain all available data from existing 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 Food and Drug Administration (FDA) were obtained.
Results:
In total, 167 studies and 12 FDA reports including 101,650 patients and 17 different valve types were analyzed. Eleven different definitions of SVD were used in the studies. Core laboratory data were available for 11 studies. Mean follow-up ranged from <1 year to 14 years. Kaplan-Meier estimates were reported for up to 30 years of follow-up, with 0-37% of patients remaining at risk at maximum follow-up. FDA-reported data are similarly variable in duration (mean follow-up range, 1.2-7 years) and completeness of follow-up, with final follow-up of 0.1-95%.
Conclusions:
There is considerable variability in reporting SVD of surgical aortic valves, with different definitions and inadequate systematically collected, long-term, core laboratory data. The authors concluded that 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.
Perspective:
Essentially all published reports describing bioprosthetic surgical aortic valve durability are observational studies that report findings at various time intervals among various populations, using various definitions of SVD. In an era in which implanted transcatheter aortic valve devices are subjected to fairly rigorous clinical data acquisition, the data-disarray for the surgically implanted devices stands in stark contrast. As the authors note in their conclusions, comparison between transcatheter and surgically implanted devices will have meaning only if the data are similarly standardized.
Clinical Topics: Cardiac Surgery, Invasive Cardiovascular Angiography and Intervention, Noninvasive Imaging, Valvular Heart Disease, Aortic Surgery, Cardiac Surgery and VHD, Interventions and Imaging, Interventions and Structural Heart Disease
Keywords: Aortic Valve, Cardiac Surgical Procedures, Diagnostic Imaging, Heart Valve Diseases, Heart Valve Prosthesis, Transcatheter Aortic Valve Replacement
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