Author + information
- Received February 3, 2020
- Revision received March 20, 2020
- Accepted March 20, 2020
- Published online August 3, 2020.
- John K. Forrest, MDa,∗ (, )@johnkforrest,
- Ryan K. Kaple, MDa,
- Basel Ramlawi, MDb,
- Thomas G. Gleason, MDc,
- Christopher U. Meduri, MD, MPHd,
- Steven J. Yakubov, MDe,
- Hasan Jilaihawi, MDf,
- Fang Liu, MD, MSg and
- Michael J. Reardon, MDh
- aSection of Cardiovascular Medicine, Yale School of Medicine, New Haven, Connecticut
- bDepartment of Cardiothoracic Surgery, Valley Health System, Winchester, Virginia
- cDepartment of Cardiothoracic Surgery, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania
- dDepartment of Interventional Cardiology, Piedmont Heart Institute, Atlanta, Georgia
- eDepartment of Interventional Cardiology, Riverside Methodist-Ohio Health, Columbus, Ohio
- fHeart Valve Center, New York University Langone Health, New York, New York
- gDepartment of Statistics, Medtronic, Minneapolis, Minnesota
- hDepartment of Cardiothoracic Surgery, Houston Methodist DeBakey Heart and Vascular Center, Houston, Texas
- ↵∗Address for correspondence:
Dr. John K. Forrest, Yale School of Medicine, 789 Howard Avenue, Dana 3, Cardiology Section, New Haven, Connecticut 06519.
Objectives This study sought to compare outcomes in patients with bicuspid versus tricuspid anatomy undergoing transcatheter aortic valve replacement (TAVR).
Background TAVR has shown excellent safety and efficacy in patients with tricuspid aortic valve stenosis, but limited data are available on the use of self-expanding valves in patients with bicuspid valves.
Methods The Society of Thoracic Surgeons/American College of Cardiology TVT Registry was used to analyze patients who underwent TAVR with the Evolut R or Evolut PRO valves. Clinical and echocardiographic outcomes were analyzed through 1-year follow-up.
Results Between July 2015 and September 2018 a total of 932 patients with bicuspid aortic valve stenosis underwent elective TAVR with the self-expanding Evolut R or Evolut PRO valve. These patients were compared with a group of 26,154 patients with tricuspid aortic stenosis who underwent TAVR during that same time period. At baseline, patients with bicuspid valves were younger, had fewer cardiac comorbidities, and had lower Society of Thoracic Surgeons Predicted Risk of Mortality scores (5.3 ± 4.2% vs. 6.9 ± 4.8%; p < 0.001). To account for these differences, propensity matching was performed, which resulted in 929 matched pairs. Within these match groups, the rates of all-cause mortality at 30 days (2.6% vs. 1.7%; p = 0.18) and 1 year (10.4% vs. 12.1%; p = 0.63), as well the rate of stroke at 30 days (3.4% vs. 2.7%; p = 0.41) and 1 year (3.9% vs. 4.4%; p = 0.93), were comparable.
Conclusions All-cause mortality, stroke, and valve hemodynamics did not differ at 30 days or 1 year between patient groups. In patients at increased surgical risk, TAVR for bicuspid aortic valve stenosis indicates acceptable safety outcomes with low complications rates.
This work received funding from Medtronic. This research was supported by the American College of Cardiology’s National Cardiovascular Data Registry. The views expressed in this manuscript represent those of the author(s) and do not necessarily represent the official views of the National Cardiovascular Data Registry or its associated professional societies. Dr. Forrest has received grant support or research contracts and consultant, honoraria, or Speakers Bureau fees from Edwards Lifesciences and Medtronic. Dr. Kaple has served as a speaker for Abbott; and received honoraria from Edwards Lifesciences. Dr. Ramlawi has received grant support, personal fees, and nonfinancial support from Medtronic, LivaNova, Boston Scientific, and AtriCure. Dr. Gleason has received institutional grant support from Boston Scientific and Medtronic, but no personal income; and has served on a medical advisory board for Abbott and Cytosorbents Corporation. Dr. Meduri has served on the advisory board for 4Tech, Admedus, Boston Scientific, and Cardiovalve; and has received consulting fees from Medtronic and Boston Scientific. Dr. Yakubov has received institutional research grants from and served on the advisory board for Boston Scientific and Medtronic. Dr. Jilaihawi has served a consultant for Edwards Lifesciences, Boston Scientific, Medtronic, and Venus Medtech; and has received grant or research support from Medtronic and Abbott Vascular. Dr. Liu is an employee and shareholder of Medtronic. Dr. Reardon has received consulting fees paid to his institution from Medtronic.
The authors attest they are in compliance with human studies committees and animal welfare regulations of the authors’ institutions and Food and Drug Administration guidelines, including patient consent where appropriate. For more information, visit the JACC: Cardiovascular Interventions author instructions page.
- Received February 3, 2020.
- Revision received March 20, 2020.
- Accepted March 20, 2020.
- 2020 American College of Cardiology Foundation
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