Journal
JACC-CARDIOVASCULAR INTERVENTIONS
Volume 11, Issue 14, Pages 1377-1387Publisher
ELSEVIER SCIENCE INC
DOI: 10.1016/j.jcin.2018.03.034
Keywords
aortic stenosis; heart valve; paravalvular leak; TAVR
Categories
Funding
- Edwards Lifesciences
- St. Jude Medical
- Medtronic
- Abbott Vascular
- Gore
- Boston Scientific
- Siemens
- Cardiokinetix
- Mitraspan
- Claret Medical
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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 mm(2). However, experience with S3 TAVR in annuli >683 mm(2) has not been widely reported. METHODS From December 2013 to July 2017, 74 patients across 16 centers with mean area 721 +/- 38 mm(2) (range: 684 to 852 mm(2)) 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. (c) 2018 by the American College of Cardiology Foundation.
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