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JACC Cardiovasc Interv. 2020 Jan 27;13(2):210-216. doi: 10.1016/j.jcin.2019.08.042. Epub 2019 Dec 25.

Mid-Term Outcomes of Transcatheter Aortic Valve Replacement in Extremely Large Annuli With Edwards SAPIEN 3 Valve.

Author information

1
Mount Sinai Medical Center, New York, New York.
2
Westchester Medical Center, Valhalla, New York.
3
Emory University, Atlanta, Georgia.
4
Montefiore Medical Center, Bronx, New York.
5
Cedars-Sinai Medical Center, Los Angeles, California.
6
Brigham and Women's Hospital, Boston, Massachusetts.
7
St. Paul's Hospital, Vancouver, British Columbia, Canada.
8
Virginia Heart, Falls Church, Virginia.
9
St. Francis Hospital, Manhasset, New York.
10
Inova Medical Group, Falls Church, Virginia.
11
University of Washington, Seattle, Washington.
12
Columbia University Medical Center, New York, New York.
13
Weill Cornell Medical Center, New York, New York.
14
Robert Wood Johnson-Barnabas Health System, New Brunswick, New Jersey.
15
Mercy General Hospital, Sacramento, California.
16
Baylor Scott & White Health System, Plano, Texas.
17
Swedish Medical Center, Seattle, Washington.
18
Cleveland Clinic, Cleveland, Ohio.
19
Marcus Heart Valve Center, Piedmont Atlanta Hospital, Atlanta, Georgia.
20
Mount Sinai Medical Center, New York, New York. Electronic address: gilbert.tang@mountsinai.org.

Abstract

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.

KEYWORDS:

TAVR; aortic stenosis; aortic valve; large annuli; paravalvular leak

PMID:
31883715
DOI:
10.1016/j.jcin.2019.08.042

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