Author + information
- Received February 5, 2018
- Revision received March 14, 2018
- Accepted March 26, 2018
- Published online July 16, 2018.
- Gilbert H.L. Tang, MD, MSc, MBAa,∗∗ (, )
- Syed Zaid, MDb,∗,
- Isaac George, MDc,
- Omar K. Khalique, MDc,
- Yigal Abramowitz, MDd,
- Yoshio Maeno, MDd,
- Raj R. Makkar, MDd,
- Hasan Jilaihawi, MDe,
- Norihiko Kamioka, MDf,
- Vinod H. Thourani, MDg,
- Vasilis Babaliaros, MDf,
- John G. Webb, MDh,
- Nay M. Htun, MDh,
- Adrian Attinger-Toller, MDh,
- Hasan Ahmad, MDb,
- Ryan Kaple, MDb,
- Kapil Sharma, MDi,
- Joseph A. Kozina, MDi,
- Tsuyoshi Kaneko, MDj,
- Pinak Shah, MDj,
- Sameer A. Hirji, MDj,
- Nimesh D. Desai, MDk,
- Saif Anwaruddin, MDk,
- Dinesh Jagasia, MDk,
- Howard C. Herrmann, MDk,
- Sukhdeep S. Basra, MDl,
- Molly A. Szerlip, MDl,
- Michael J. Mack, MDl,
- Moses Mathur, MDm,
- Christina W. Tan, MDm,
- Creighton W. Don, MDm,
- Rahul Sharma, MDn,
- Sameer Gafoor, MDn,
- Ming Zhang, MDn,
- Samir R. Kapadia, MDo,
- Stephanie L. Mick, MDo,
- Amar Krishnaswamy, MDo,
- Nicholas Amoroso, MDe,
- Arash Salemi, MDp,
- S. Chiu Wong, MDp,
- Annapoorna S. Kini, MDa,
- Josep Rodés-Cabau, MDq,
- Martin B. Leon, MDc and
- Susheel K. Kodali, MDc
- aMount Sinai Medical Center, New York, New York
- bWestchester Medical Center, Valhalla, New York
- cColumbia University Medical Center, New York, New York
- dCedars-Sinai Medical Center, Los Angeles, California
- eNew York University Langone Medical Center, New York, New York
- fEmory University School of Medicine, Atlanta, Georgia
- gMedstar Washington Hospital Center, Washington, District of Columbia
- hSt. Paul’s Hospital, Vancouver, British Columbia, Canada
- iMercy General Hospital, Sacramento, California
- jBrigham and Women’s Hospital, Boston, Massachusetts
- kHospitals of the University of Pennsylvania System, Philadelphia, Pennsylvania
- lBaylor, Scott and White Health System, Plano, Texas
- mUniversity of Washington Medical Center, Seattle, Washington
- nSwedish Medical Center, Seattle, Washington
- oCleveland Clinic, Cleveland, Ohio
- pWeill Cornell Medical Center, New York, New York
- qLaval Heart and Lung Institute, Laval, Quebec, Canada
- ↵∗Address for correspondence:
Dr. Gilbert H. L. Tang, Mount Sinai Health System, Icahn School of Medicine at Mount Sinai, 1190 Fifth Avenue, GP2W, Box 1028, New York, New York 10029.
Objectives The aim of this study was to determine factors affecting paravalvular leak (PVL) in transcatheter aortic valve replacement (TAVR) with the Edwards SAPIEN 3 (S3) valve in extremely large annuli.
Background The largest recommended annular area for the 29-mm S3 is 683 mm2. However, experience with S3 TAVR in annuli >683 mm2 has not been widely reported.
Methods From December 2013 to July 2017, 74 patients across 16 centers with mean area 721 ± 38 mm2 (range: 684 to 852 mm2) underwent S3 TAVR. The transfemoral approach was used in 95%, and 39% were under conscious sedation. Patient, anatomic, and procedural characteristics were retrospectively analyzed. Valve Academic Research Consortium–2 outcomes were reported.
Results Procedural success was 100%, with 2 deaths, 1 stroke, and 2 major vascular complications at 30 days. Post-dilatation occurred in 32%, with final balloon overfilling (1 to 5 ml extra) in 70% of patients. Implantation depth averaged 22.3 ± 12.4% at the noncoronary cusp and 20.7 ± 9.9% at the left coronary cusp. New left bundle branch block occurred in 17%, and 6.3% required new permanent pacemakers. Thirty-day echocardiography showed mild PVL in 22.3%, 6.9% moderate, and none severe. There was no annular rupture or coronary obstruction. Mild or greater PVL was associated with larger maximum annular and left ventricular outflow tract (LVOT) diameters, larger LVOT area and perimeter, LVOT area greater than annular area, and higher annular eccentricity.
Conclusions TAVR with the 29-mm S3 valve beyond the recommended range by overexpansion is safe, with acceptable PVL and pacemaker rates. Larger LVOTs and more eccentric annuli were associated with more PVL. Longer term follow-up will be needed to determine durability of S3 TAVR in this population.
↵∗ Drs. Tang and Zaid contributed equally to this work.
Dr. Tang is a physician proctor for Edwards Lifesciences and Medtronic. Dr. George is a consultant for Edwards Lifesciences and Medtronic. Dr. Khalique has served on the Speakers Bureau for Edwards Lifesciences and Boston Scientific; and 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. Jilaihawi has served as a consultant for Edwards Lifesciences and Venus Medtech. Dr. Thourani is a member of the PARTNER Trial Steering Committee and a consultant for Edwards Lifesciences, Sorin Medical, St. Jude Medical, and DirectFlow. 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 educator for Edwards Lifesciences. Dr. Shah is a proctor and educator for Edwards Lifesciences; and is an educator for St. Jude Medical. Dr. Desai has been an investigator for Medtronic, Edwards Lifesciences, St. Jude Medical, Gore, and Cook Medical and has received speaking fees from Medtronic, Edwards Lifesciences, St. Jude Medical, and Gore. Dr. Anwaruddin serves as a consultant and speaker for Edwards Lifesciences and Medtronic. Dr. Herrmann has received grants from Edwards Lifesciences, St. Jude Medical, Medtronic, Boston Scientific, Abbott Vascular, Gore, Siemens, Cardiokinetix, and Mitraspan; has received consulting fees and honoraria from Edwards Lifesciences and Siemens; and holds equity in Microinterventional Devices. Dr. Szerlip has served as a speaker and proctor for Edwards Lifesciences; as a consultant and speaker for Medtronic; and as a speaker for Abbott Vascular. Dr. Mack is an uncompensated co–principal investigator of COAPT trial (Abbott Vascular); and serves on the Apollo Trial Executive Committee (Medtronic). Dr. Don is an investigator for Edwards Lifesciences; and a consultant to Medtronic. Dr. R. Sharma currently serves as a site subinvestigator for the Edwards EARLY TAVR trial; and in the past, he has served as a site subinvestigator for the Low Risk TAVR trial (Medtronic) and the REFLECT trial (Keystone Heart). Dr. Gafoor is a consultant for Medtronic, Boston Scientific, and Abbott Vascular. Dr. Zhang has served as proctor for Edwards Lifesciences, as a site principal investigator for the REPRISE trial (Boston Scientific), and as a site subinvestigator for the REFLECT trial (Keystone Heart) and TAVR Low Risk trial (Medtronic). Dr. Kapadia is an unpaid co–principal 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. Rodés-Cabau receives research grant support from Edwards Lifesciences. Dr. Leon has served as a nonpaid member of the scientific advisory board of Edwards Lifesciences; and 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. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received February 5, 2018.
- Revision received March 14, 2018.
- Accepted March 26, 2018.
- 2018 American College of Cardiology Foundation