Author + information
- Received May 15, 2019
- Revision received July 3, 2019
- Accepted July 30, 2019
- Published online September 25, 2019.
- Janarthanan Sathananthan, MBChB, MPHa,
- Mark Hensey, MB BCh BAOa,
- Uri Landes, MDa,
- Abdullah Alkhodair, MDa,
- Adeeb Saiduddin, BScb,
- Stephanie Sellers, PhDc,
- Anson Cheung, MDa,
- Sandra Lauck, PhDa,
- Philipp Blanke, MDa,
- Jonathon Leipsic, MDa,
- Jian Ye, MDa,
- David A. Wood, MDa and
- John G. Webb, MDa,∗ ()
- aCentre for Heart Valve Innovation, St. Paul’s Hospital, University of British Columbia, Vancouver, Canada
- bEdwards Lifesciences, Irvine, California
- cCentre for Heart Lung Innovation, Vancouver, Canada
- ↵∗Address for correspondence:
Dr. John G. Webb, St. Paul’s Hospital, Centre for Heart Valve Innovation, 1081 Burrard Street, Vancouver, BC, Canada V6Z 1Y6.
Objectives This study assessed the long-term durability of nominally deployed transcatheter heart valves (THV) to 1 billion cycles (equivalent to 25 years) and non-nominal (overexpansion, underexpansion, and elliptical) THV deployments to 200 million cycles (equivalent to 5 years) with accelerated wear testing.
Background The long-term durability of THVs is currently unknown. As transcatheter aortic valve replacement expands to lower-risk patients, durability will be of increasing importance.
Methods SAPIEN 3 THVs, sized 20, 23, 26, and 29 mm were assessed. Nominally deployed THVs underwent hydrodynamic performance and mechanical durability as assessed with accelerated wear testing to 1 billion cycles. Magna Ease surgical valves were used as comparators. Durability of non-nominal THV deployments was tested to 200 million cycles. Valves were tested to International Standards Organization 5840:2013 standard.
Results THV durability was excellent for both the nominal and non-nominal THV deployments to 1 billion and 200 million cycles, respectively. At 1 billion cycles the regurgitant fraction for the 20-, 23-, 26-, and 29-mm SAPIEN 3 was 0.92 ± 0.47%, 1.29 ± 0.04%, 1.73 ± 0.46%, and 2.47 ± 0.15%, respectively. There was also excellent durability in the comparator Magna Ease valves. The regurgitant fraction of non-nominal overexpanded (20 mm, 4.36 ± 0.53; 23 mm, 7.68 ± 1.39; 26 mm, 6.80 ± 1.17; 29 mm, 9.00 ± 0.37), underexpanded (20 mm, 3.06 ± 0.28; 23 mm, 4.46 ± 0.45; 26 mm, 7.72 ± 0.48; 29 mm, 8.65 ± 2.01), and elliptical (20 mm, 3.30 ± 0.38; 23 mm, 6.13 ± 0.94; 26 mm, 6.77 ± 1.22; 29 mm, 8.72 ± 0.24) THVs were excellent at 200 million cycles.
Conclusions Nominal SAPIEN 3 THVs demonstrated excellent durability, to an equivalent of 25-years wear. THV durability was similar to the comparator surgical valves tested. Non-nominal (overexpansion, underexpansion, and elliptical) THV deployments also had excellent durability to an equivalent of 5-years wear.
Dr. Sathananthan has received speaking fees and is a consultant to Edwards Lifesciences. Dr. Cheung is a consultant to Abbot Vascular, Medtronics, and Neovasc Inc. Dr. Lauck is a consultant to Edwards Lifesciences and Abbott. Dr. Blanke provides CT core laboratory services for Edwards Lifesciences, Medtronic, Neovasc, Guided Delivery Systems, and Abbott, for which no direct compensation is received; and is a consultant to Edwards Lifesciences, Tendyne, Gore, Abbott, Neovasc, and Circle Cardiovascular Imaging. Dr. Leipsic is a consultant to Edwards Lifesciences and provides CT core laboratory services for Edwards Lifesciences, Medtronic, Neovasc, Guided Delivery Systems, and Abbott, for which no direct compensation is received; and has stock options in, is a consultant to, and receives institutional research support from HeartFlow and Circle Cardiovascular Imaging. Dr. Ye is a consultant for Edwards Lifesciences and JC Medical. Dr. Wood is a consultant to, and has received research funding from, Edwards Lifesciences and Abbott. Dr. Webb is a consultant to, and has received research funding from, Edwards Lifesciences, Abbott, and ViVitro Labs. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received May 15, 2019.
- Revision received July 3, 2019.
- Accepted July 30, 2019.
- 2019 American College of Cardiology Foundation
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