Author + information
- Received July 1, 2019
- Revision received August 22, 2019
- Accepted August 29, 2019
- Published online January 20, 2020.
- Aditya Sengupta, MDa,∗,
- Syed Zaid, MDb,∗,
- Norihiko Kamioka, MDc,
- Juan Terre, MDd,
- Masaki Miyasaka, MDe,
- Sameer A. Hirji, MD, MPHf,
- Mark Hensey, MDg,
- Nadim Geloo, MDh,
- George Petrossian, MDi,
- Newell Robinson, MDi,
- Eric Sarin, MDh,
- Liam Ryan, MDj,
- Sung-Han Yoon, MDe,
- Christina W. Tan, MDk,
- Omar K. Khalique, MDl,
- Susheel K. Kodali, MDl,
- Tsuyoshi Kaneko, MDf,
- Pinak B. Shah, MDf,
- S. Chiu Wong, MDm,
- Arash Salemi, MDn,
- Kapil Sharma, MDo,
- Joseph A. Kozina, MDo,
- Molly A. Szerlip, MDp,
- Creighton W. Don, MDk,
- Sameer Gafoor, MDq,
- Ming Zhang, MDq,
- Zachary Newhart, MDq,
- Samir R. Kapadia, MDr,
- Stephanie L. Mick, MDm,
- Amar Krishnaswamy, MDr,
- Annapoorna Kini, MDa,
- Hasan Ahmad, MDb,
- Steven L. Lansman, MD, PhDb,
- Michael J. Mack, MDn,
- John G. Webb, MDg,
- Vasilis Babaliaros, MDc,
- Vinod H. Thourani, MDs,
- Raj R. Makkar, MDe,
- Martin B. Leon, MDl,
- Isaac George, MDl and
- Gilbert H.L. Tang, MD, MSc, MBAa,∗ (, )@GilbertTangMD
- aMount Sinai Medical Center, New York, New York
- bWestchester Medical Center, Valhalla, New York
- cEmory University, Atlanta, Georgia
- dMontefiore Medical Center, Bronx, New York
- eCedars-Sinai Medical Center, Los Angeles, California
- fBrigham and Women’s Hospital, Boston, Massachusetts
- gSt. Paul’s Hospital, Vancouver, British Columbia, Canada
- hVirginia Heart, Falls Church, Virginia
- iSt. Francis Hospital, Manhasset, New York
- jInova Medical Group, Falls Church, Virginia
- kUniversity of Washington, Seattle, Washington
- lColumbia University Medical Center, New York, New York
- mWeill Cornell Medical Center, New York, New York
- nRobert Wood Johnson-Barnabas Health System, New Brunswick, New Jersey
- oMercy General Hospital, Sacramento, California
- pBaylor Scott & White Health System, Plano, Texas
- qSwedish Medical Center, Seattle, Washington
- rCleveland Clinic, Cleveland, Ohio
- sMarcus Heart Valve Center, Piedmont Atlanta Hospital, Atlanta, Georgia
- ↵∗Address for correspondence:
Dr. Gilbert H.L. Tang, Mount Sinai Medical Center, Department of Cardiovascular Surgery, 1190 Fifth Avenue, GP2W, Box 1028, New York, New York 10029.
Objectives The aim of this study was to report the 1-year results of transcatheter aortic valve replacement (TAVR) with the Edwards SAPIEN 3 (S3) valve in extremely large annuli.
Background Favorable 30-day outcomes of S3 TAVR in annuli >683 mm2 have previously been reported. Pacemaker implantation rates were acceptable, and a larger left ventricular outflow tract and more eccentric annular anatomy were associated with increasing paravalvular leak.
Methods From December 2013 to December 2018, 105 patients across 15 centers with mean area 721.3 ± 36.1 mm2 (range 683.5 to 852.0 mm2) underwent TAVR using an S3 device. Clinical, anatomic, and procedural characteristics were analyzed. One-year survival and echocardiographic follow-up were reached in 94.3% and 82.1% of patients, respectively. Valve Academic Research Consortium-2 30-day and 1-year outcomes were reported.
Results The mean age was 76.9 ± 10.4 years, and Society of Thoracic Surgeons predicted risk score averaged 5.2 ± 3.4%. One-year overall mortality and stroke rates were 18.2% and 2.4%, respectively. Quality-of-life index improved from baseline to 30 days and at 1 year (p < 0.001 for both). Mild paravalvular aortic regurgitation occurred in 21.7% of patients, while moderate or greater paravalvular aortic regurgitation occurred in 4.3%. Mild and moderate or severe transvalvular aortic regurgitation occurred in 11.6% and 0%, respectively. Valve gradients remained stable at 1 year.
Conclusions S3 TAVR in annular areas >683 mm2 is feasible, with favorable mid-term outcomes.
↵∗ Drs. Sengupta and Zaid contributed equally to this work.
Dr. Khalique has served on the Speakers Bureau for Edwards Lifesciences and Boston Scientific; and has served as a reader for a core laboratory that has contracts with Edwards Lifesciences. Dr. Makkar has received grants from Edwards Lifesciences and St. Jude Medical; is a consultant for Abbott Vascular, Cordis, and Medtronic; and holds equity in Entourage Medical. Dr. Thourani is a member of the PARTNER Trial Steering Committee; and is a consultant for Edwards Lifesciences, Sorin Medical, St. Jude Medical, and Direct Flow Medical. Dr. Babaliaros has received grant and research support from Medtronic, Abbott Vascular, and Edwards Lifesciences; and is a consultant for Abbott Vascular and Edwards Lifesciences. Dr. Webb has served as a consultant for Edwards Lifesciences. Dr. Kaneko has served as a proctor and an educator for Edwards Lifesciences. Dr. Shah is a proctor and an educator for Edwards Lifesciences; and is an educator for St. Jude Medical. Dr. Szerlip has served as a speaker and proctor for Edwards Lifesciences; has served as a consultant and speaker for Medtronic; and has served as a speaker for Abbott Vascular. Dr. Mack is an uncompensated co–principal investigator of the COAPT trial (Abbott Vascular); and serves on the Apollo Trial Executive Committee (Medtronic). Dr. Don is an investigator for Edwards Lifesciences; and is a consultant for Medtronic. Dr. Gafoor is a consultant for Medtronic, Boston Scientific, and Abbott Vascular. Dr. Zhang has served as proctor for Edwards Lifesciences; has served as a site principal investigator for the REPRISE trial (Boston Scientific); and has served as a site subinvestigator for the REFLECT trial (Keystone Heart) and the TAVR low risk trial (Medtronic). Dr. Kapadia is an unpaid coprincipal investigator of the SENTINEL trial, sponsored by Claret Medical. Dr. Salemi is a physician proctor for Edwards Lifesciences and Medtronic. Dr. Wong has served on the medical advisory board for Medtronic Vascular. Dr. Leon has served as a nonpaid member of the scientific advisory board of Edwards Lifesciences; and has served as a consultant for Abbott Vascular and Boston Scientific. Dr. Kodali is on the steering committee for Edwards Lifesciences; is a consultant for Medtronic and Claret Medical; and is on the scientific advisory board for Thubrikar Aortic Valve. Dr. George is a consultant for Edwards Lifesciences and Medtronic. Dr. Tang is a physician proctor for Edwards Lifesciences and Medtronic. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received July 1, 2019.
- Revision received August 22, 2019.
- Accepted August 29, 2019.
- 2020 American College of Cardiology Foundation
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