Author + information
- Received June 11, 2019
- Revision received July 30, 2019
- Accepted August 20, 2019
- Published online January 20, 2020.
- John K. Forrest, MDa,∗ (, )
- Ryan K. Kaple, MDa,
- Gilbert H.L. Tang, MD, MSc, MBAb,
- Steven J. Yakubov, MDc,
- Tamim M. Nazif, MDd,
- Mathew R. Williams, MDe,
- Angie Zhang, MSf,
- Jeffrey J. Popma, MDg and
- Michael J. Reardon, MDh
- aDepartment of Internal Medicine (Cardiology), Yale University School of Medicine, New Haven, Connecticut
- bDepartment of Cardiovascular Surgery, Mount Sinai Medical Center, New York, New York
- cDepartment of Cardiology, Riverside Methodist – Ohio Health, Columbus, Ohio
- dDepartment of Cardiology, Columbia University Medical Center, New York, New York
- eDepartment of Cardiothoracic Surgery, New York University-Langone Medical Center, New York, New York
- fDepartment of Statistical Services, Medtronic, Minneapolis, Minnesota
- gDepartment of Cardiology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts
- hDepartment of Cardiovascular Surgery, Houston Methodist DeBakey Heart and Vascular Institute, Houston, Texas
- ↵∗Address for correspondence:
Dr. John K. Forrest, Cardiology Section, Yale University School of Medicine, 789 Howard Avenue, Dana 3, New Haven, Connecticut 06519.
Objectives The aim of this study was to assess the evolution of early outcomes for 3 iterative self-expanding transcatheter aortic valves.
Background Over the past decade there have been rapid advancements in transcatheter aortic valve replacement (TAVR) technologies, including 3 generations of supra-annular self-expanding transcatheter systems.
Methods Data from the Society of Thoracic Surgeons/American College of Cardiology TVT (Transcatheter Valve Therapy) Registry for patients undergoing TAVR with CoreValve, Evolut R, or Evolut PRO valves to treat tricuspid aortic stenosis between January 2014 and September 2017 were obtained. Patient risk and echocardiographic data are site reported. Valves analyzed included 23-, 26-, and 29-mm sizes to fit 18- to 26-mm annular diameters. Propensity score matching was performed using the Evolut PRO group as the common reference.
Results Of 18,874 patients undergoing TAVR at 381 centers, 5,514 patients were implanted with CoreValve, 11,295 with Evolut R, and 2,065 with Evolut PRO valves. At 30 days, there were significantly fewer patients with more than mild aortic regurgitation for the unmatched (7.8% CoreValve, 5.2% Evolut R, and 2.8% Evolut PRO; p < 0.001) and matched populations (8.3% CoreValve, 5.4% Evolut R, and 3.4% Evolut PRO; p = 0.032). The mean aortic valve gradients at 30 days in the matched populations were <8 mm Hg for all 3 valves (7.3 mm Hg CoreValve, 7.5 mm Hg Evolut R, 7.2 mm Hg Evolut PRO).
Conclusions Advancements in transcatheter valve technologies and expanding indications for TAVR have resulted in improved outcomes for patients undergoing TAVR in the United States with self-expanding, supra-annular valves. In particular, the addition of an outer pericardial tissue wrap designed to enhance sealing at the level of the aortic annulus has resulted in very low rates of significant aortic regurgitation while maintaining excellent hemodynamic status.
This research was funded by Medtronic. This research was supported by the American College of Cardiology’s National Cardiovascular Data Registry (NCDR). The views expressed in this paper represent those of the authors and do not necessarily represent the official views of the NCDR or its associated professional societies (identified at http://cvquality.acc.org/ncdr). Dr. Forrest has received grant support, research contracts, consulting fees, honoraria, and speaking fees from Edwards Lifesciences and Medtronic. Dr. Tang is a physician proctor for Edwards Lifesciences and Medtronic. Dr. Yakubov has received institutional research grants from Boston Scientific and Medtronic. Dr. Nazif serves as a consultant for and has received honoraria from Boston Scientific, Edwards Lifesciences, and Medtronic. Dr. Williams serves as a consultant for Edwards Lifesciences and Medtronic; serves as a speaker for Abbott Laboratories; and has received research grants from Medtronic. Ms. Zhang is an employee and shareholder of Medtronic. Dr. Popma has received research grants from Medtronic and Abbott Vascular; and has received research grants and personal fees from Edwards Lifesciences and Boston Scientific. Dr. Reardon serves as an advisor to Medtronic with the consulting fees paid to his institution. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received June 11, 2019.
- Revision received July 30, 2019.
- Accepted August 20, 2019.
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