Impact of Aortic Root Anatomy and Geometry on Paravalvular Leak in Transcatheter Aortic Valve Replacement With Extremely Large Annuli Using the Edwards SAPIEN 3 Valve

Gilbert H L Tang; Syed Zaid; Isaac George; Omar K Khalique; Yigal Abramowitz; Yoshio Maeno; Raj R Makkar; Hasan Jilaihawi; Norihiko Kamioka; Vinod H Thourani; Vasilis Babaliaros; John G Webb; Nay M Htun; Adrian Attinger-Toller; Hasan Ahmad; Ryan Kaple; Kapil Sharma; Joseph A Kozina; Tsuyoshi Kaneko; Pinak Shah; Sameer A Hirji; Nimesh D Desai; Saif Anwaruddin; Dinesh Jagasia; Howard C Herrmann; Sukhdeep S Basra; Molly A Szerlip; Michael J Mack; Moses Mathur; Christina W Tan; Creighton W Don; Rahul Sharma; Sameer Gafoor; Ming Zhang; Samir R Kapadia; Stephanie L Mick; Amar Krishnaswamy; Nicholas Amoroso; Arash Salemi; S Chiu Wong; Annapoorna S Kini; Josep Rodés-Cabau; Martin B Leon; Susheel K Kodali

doi:10.1016/j.jcin.2018.03.034

Impact of Aortic Root Anatomy and Geometry on Paravalvular Leak in Transcatheter Aortic Valve Replacement With Extremely Large Annuli Using the Edwards SAPIEN 3 Valve

JACC Cardiovasc Interv. 2018 Jul 23;11(14):1377-1387. doi: 10.1016/j.jcin.2018.03.034. Epub 2018 Jun 27.

Authors

Gilbert H L Tang¹, Syed Zaid², Isaac George³, Omar K Khalique³, Yigal Abramowitz⁴, Yoshio Maeno⁴, Raj R Makkar⁴, Hasan Jilaihawi⁵, Norihiko Kamioka⁶, Vinod H Thourani⁷, Vasilis Babaliaros⁶, John G Webb⁸, Nay M Htun⁸, Adrian Attinger-Toller⁸, Hasan Ahmad², Ryan Kaple², Kapil Sharma⁹, Joseph A Kozina⁹, Tsuyoshi Kaneko¹⁰, Pinak Shah¹⁰, Sameer A Hirji¹⁰, Nimesh D Desai¹¹, Saif Anwaruddin¹¹, Dinesh Jagasia¹¹, Howard C Herrmann¹¹, Sukhdeep S Basra¹², Molly A Szerlip¹², Michael J Mack¹², Moses Mathur¹³, Christina W Tan¹³, Creighton W Don¹³, Rahul Sharma¹⁴, Sameer Gafoor¹⁴, Ming Zhang¹⁴, Samir R Kapadia¹⁵, Stephanie L Mick¹⁵, Amar Krishnaswamy¹⁵, Nicholas Amoroso⁵, Arash Salemi¹⁶, S Chiu Wong¹⁶, Annapoorna S Kini¹⁷, Josep Rodés-Cabau¹⁸, Martin B Leon³, Susheel K Kodali³

Affiliations

¹ Mount Sinai Medical Center, New York, New York. Electronic address: gilbert.tang@mountsinai.org.
² Westchester Medical Center, Valhalla, New York.
³ Columbia University Medical Center, New York, New York.
⁴ Cedars-Sinai Medical Center, Los Angeles, California.
⁵ New York University Langone Medical Center, New York, New York.
⁶ Emory University School of Medicine, Atlanta, Georgia.
⁷ Medstar Washington Hospital Center, Washington, District of Columbia.
⁸ St. Paul's Hospital, Vancouver, British Columbia, Canada.
⁹ Mercy General Hospital, Sacramento, California.
¹⁰ Brigham and Women's Hospital, Boston, Massachusetts.
¹¹ Hospitals of the University of Pennsylvania System, Philadelphia, Pennsylvania.
¹² Baylor, Scott and White Health System, Plano, Texas.
¹³ University of Washington Medical Center, Seattle, Washington.
¹⁴ Swedish Medical Center, Seattle, Washington.
¹⁵ Cleveland Clinic, Cleveland, Ohio.
¹⁶ Weill Cornell Medical Center, New York, New York.
¹⁷ Mount Sinai Medical Center, New York, New York.
¹⁸ Laval Heart and Lung Institute, Laval, Quebec, Canada.

PMID: 29960755
DOI: 10.1016/j.jcin.2018.03.034

Abstract

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.

Keywords: TAVR; aortic stenosis; heart valve; paravalvular leak.

Publication types

Multicenter Study
Research Support, Non-U.S. Gov't

MeSH terms

Aged
Aged, 80 and over
Aortic Valve / diagnostic imaging
Aortic Valve / physiopathology
Aortic Valve / surgery*
Aortic Valve Insufficiency / diagnostic imaging
Aortic Valve Insufficiency / etiology*
Aortic Valve Insufficiency / physiopathology
Aortic Valve Stenosis / diagnostic imaging
Aortic Valve Stenosis / physiopathology
Aortic Valve Stenosis / surgery*
Female
Heart Valve Prosthesis*
Humans
Male
Prosthesis Design
Registries
Retrospective Studies
Risk Factors
Time Factors
Transcatheter Aortic Valve Replacement / adverse effects*
Transcatheter Aortic Valve Replacement / instrumentation*
Treatment Outcome
United States