Author + information
- Received April 19, 2017
- Revision received June 20, 2017
- Accepted July 19, 2017
- Published online October 16, 2017.
- Paul Sorajja, MDa,∗ (, )
- Susheel Kodali, MDb,
- Michael J. Reardon, MDc,
- Wilson Y. Szeto, MDd,
- Stanley J. Chetcuti, MDe,
- James Hermiller Jr., MDf,
- Sharla Chenoweth, MSg,
- David H. Adams, MDh and
- Jeffrey J. Popma, MDi
- aValve Science Center, Minneapolis Heart Institute Foundation, Minneapolis, Minnesota
- bColumbia University Medical Center, New York, New York
- cHouston Methodist DeBakey Heart and Vascular Center, Houston, Texas
- dUniversity of Pennsylvania, Philadelphia, Pennsylvania
- eUniversity of Michigan, Ann Arbor, Michigan
- fSt. Vincent’s Heart Center of Indiana, Indianapolis, Indiana
- gMedtronic, Minneapolis, Minnesota
- hMount Sinai Medical Center, New York, New York
- iBeth Israel Deaconess Medical Center, Boston, Massachusetts
- ↵∗Address for correspondence:
Dr. Paul Sorajja, Valve Science Center, Minneapolis Heart Institute Foundation, Abbott Northwestern Hospital, 920 East 28th Street, Minneapolis, Minnesota 55407.
Objectives The authors sought to compare the outcomes of commercial transcatheter aortic valve replacement (TAVR) with the repositionable Evolut R platform to those observed with the CoreValve device in the Society of Thoracic Surgeons (STS)/American College of Cardiology (ACC) Transcatheter Valve Therapy (TVT) Registry.
Background TAVR continues to evolve, with rapid adoption of iterative changes for commercial practice. Insight into the outcomes of this adoption is needed.
Methods Patients in the TVT Registry who had TAVR using a 23-, 26-, or 29-mm self-expanding prosthesis were enrolled. Site-reported events for procedural, in-hospital, and 30-day outcomes were examined.
Results Between January 2014 and April 2016, 9,616 patients underwent TAVR with a self-expanding prosthesis with data entered in the TVT Registry. Compared with patients treated with CoreValve TAVR, those who received Evolut R TAVR had a lower STS-PROM score (8.0 ± 5.4% vs. 8.7 ± 5.3%; p < 0.001), more iliofemoral access (91.6% vs. 89.2%; p < 0.001), and more frequently had conscious sedation (27.4% vs. 12.7%; p < 0.001). With Evolut R TAVR, there was less need for a second prosthesis (2.2% vs. 4.5%; p < 0.001), less device migration (0.2% vs. 0.6%; p = 0.01), a lower incidence of moderate/severe paravalvular regurgitation (post-procedure, 4.4% vs. 6.2%; p < 0.001), and shorter median hospital stay (4.0 vs. 5.0 days; p < 0.001). Patients treated with Evolut R TAVR had greater device success (96.3% vs. 94.9%; p = 0.001). At 30 days, Evolut R patients had both lower mortality (3.7% vs. 5.3%; p < 0.001) and less need for a pacemaker (18.3% vs. 20.1%; p = 0.03).
Conclusions Commercial adoption of the Evolut R platform is associated with significant improvements in acute outcomes for patients undergoing TAVR for aortic stenosis.
STS/ACC TVT Registry is an initiative of The Society of Thoracic Surgeons and the American College of Cardiology. This research was supported by the American College of Cardiology's National Cardiovascular Data Registry (NCDR). The views expressed in this manuscript represent those of the author(s), and do not necessarily represent the official views of the NCDR or its associated professional societies identified at CVQuality.ACC.org/NCDR. Dr. Sorajja has received consulting fees from Abbott Vascular, Medtronic, and Lake Region; speaking fees from Boston Scientific; and has served on advisory boards for Abbott Vascular and Boston Scientific. Dr. Kodali has received research support from Medtronic, Edwards Lifesciences, Boston Scientific, and Abbott Vascular; is a consultant for Claret Medical and Medtronic; has served on the steering committees of the PARTNER III trial for Edwards Lifesciences and the REPRISE IV trial for Boston Scientific; has served on scientific advisory boards for Boston Scientific, Claret Medical, Thubrikar Aortic Valve, Inc., and Dura Biotech; and has equity in Thubrikar Aortic Valve, Inc. and Dura Biotech. Dr. Reardon has received fees from Medtronic for providing educational services; and has served on an advisory board for Medtronic. Dr. Szeto is an investigator for Medtronic and Edwards Lifesciences; and a member of the Medtronic surgical advisory board. Dr. Chetcuti has received research grants from Abbott Vascular, Medtronic, Edwards Lifesciences, and Gore; has been a consultant/proctor for Medtronic; and has received personal fees from Medtronic. Dr. Hermiller has received fees for educational services from Medtronic; and has been a consultant for Edwards Lifesciences and Medtronic. Ms. Chenoweth is an employee and shareholder of Medtronic. Dr Adams has received grant support from Medtronic and royalty agreements through Mount Sinai School of Medicine with Medtronic and Edwards Lifesciences. Dr. Popma has received grant support to his institution from Medtronic, Abbott Vascular, and Boston Scientific; has served on a medical advisory board for Boston Scientific; and has received personal fees from Direct Flow and Boston Scientific.
- Received April 19, 2017.
- Revision received June 20, 2017.
- Accepted July 19, 2017.
- 2017 American College of Cardiology Foundation