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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

Date

07/02/2018

Pubmed ID

29960755

DOI

10.1016/j.jcin.2018.03.034

Scopus ID

2-s2.0-85048991285 (requires institutional sign-in at Scopus site)   40 Citations

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.

Author List

Tang GHL, Zaid S, George I, Khalique OK, Abramowitz Y, Maeno Y, Makkar RR, Jilaihawi H, Kamioka N, Thourani VH, Babaliaros V, Webb JG, Htun NM, Attinger-Toller A, Ahmad H, Kaple R, Sharma K, Kozina JA, Kaneko T, Shah P, Hirji SA, Desai ND, Anwaruddin S, Jagasia D, Herrmann HC, Basra SS, Szerlip MA, Mack MJ, Mathur M, Tan CW, Don CW, Sharma R, Gafoor S, Zhang M, Kapadia SR, Mick SL, Krishnaswamy A, Amoroso N, Salemi A, Wong SC, Kini AS, Rodés-Cabau J, Leon MB, Kodali SK

Author

Saif Anwaruddin MD Associate Professor in the Medicine department at Medical College of Wisconsin




MESH terms used to index this publication - Major topics in bold

Aged
Aged, 80 and over
Aortic Valve
Aortic Valve Insufficiency
Aortic Valve Stenosis
Female
Heart Valve Prosthesis
Humans
Male
Prosthesis Design
Registries
Retrospective Studies
Risk Factors
Time Factors
Transcatheter Aortic Valve Replacement
Treatment Outcome
United States