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Eur Heart J. 2016 Jul 21;37(28):2252-62. doi: 10.1093/eurheartj/ehw112. Epub 2016 Mar 31.

Early clinical and echocardiographic outcomes after SAPIEN 3 transcatheter aortic valve replacement in inoperable, high-risk and intermediate-risk patients with aortic stenosis.

Author information

1
Columbia University Medical Center, New York-Presbyterian Hospital, 177 Fort Washington Avenue, Room 501, New York, NY 10032, USA skodali@columbia.edu.
2
Emory University School of Medicine, Atlanta, GA, USA.
3
Columbia University Medical Center, New York-Presbyterian Hospital, 177 Fort Washington Avenue, Room 501, New York, NY 10032, USA.
4
Northwestern University, Chicago, IL, USA.
5
University of Virginia, Charlottesville, VA, USA.
6
Mayo Clinic, Rochester, MN, USA.
7
NYU Langone Medical Center, New York, NY, USA.
8
NorthShore University HealthSystem, Evanston, IL, USA.
9
Central Maine Heart and Vascular Institute, Lewiston, ME, USA Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.
10
Cleveland Clinic, Cleveland, OH, USA.
11
The Christ Hospital, Cincinnati, OH, USA.
12
University of Pennsylvania, Philadelphia, PA, USA.
13
Laval University, Quebec, QC, Canada.
14
Medstar Health Research Institute and Georgetown University, Washington, DC, USA.
15
St Paul's Hospital, Vancouver, BC, Canada.
16
Intermountain Medical Center, Salt Lake City, UT, USA.
17
Cedars-Sinai Medical Center, Los Angeles, CA, USA.
18
Cardiovascular Research Foundation, New York, NY, USA.
19
Baylor Scott and White Healthcare, Plano, TX, USA.

Abstract

AIMS:

Based on randomized trials using first-generation devices, transcatheter aortic valve replacement (TAVR) is well established in the treatment of high-risk (HR) patients with severe aortic stenosis (AS). To date, there is a paucity of adjudicated, prospective data evaluating outcomes with newer generation devices and in lower risk patients. We report early outcomes of a large, multicentre registry of inoperable, HR, and intermediate-risk (IR) patients undergoing treatment with the next-generation SAPIEN 3 transcatheter heart valve (THV).

METHODS AND RESULTS:

Patients with severe, symptomatic AS (583 high surgical risk or inoperable and 1078 IR) were enrolled in a multicentre, non-randomized registry at 57 sites in the USA and Canada. All patients received TAVR with the SAPIEN 3 system via transfemoral (n = 1443, 86.9%) and transapical or transaortic (n = 218, 13.1%) access routes. The rate of 30-day all-cause mortality was 2.2% in HR/inoperable patients [mean Society of Thoracic Surgeons (STS) score 8.7%] and 1.1% in IR patients (mean STS score 5.3%); cardiovascular mortality was 1.4 and 0.9%, respectively. In HR/inoperable patients, the 30-day rate of major/disabling stroke was 0.9%, major bleeding 14.0%, major vascular complications 5.1%, and requirement for permanent pacemaker 13.3%. In IR patients, the 30-day rate of major/disabling stroke was 1.0%, major bleeding 10.6%, major vascular complications 6.1%, and requirement for permanent pacemaker 10.1%. Mean overall Kansas City Cardiomyopathy Questionnaire score increased from 47.8 to 67.8 (HR/inoperable, P < 0.0001) and 54.7 to 74.0 (IR, P < 0.0001). Overall, paravalvular regurgitation at 30 days was none/trace in 55.9% of patients, mild in 40.7%, moderate in 3.4%, and severe in 0.0%. Mean gradients among patients with paired baseline and 30-day or discharge echocardiograms decreased from 45.8 mmHg at baseline to 11.4 mmHg at 30 days, while aortic valve area increased from 0.69 to 1.67 cm(2).

CONCLUSIONS:

The SAPIEN 3 THV system was associated with low rates of 30-day mortality and major/disabling stroke as well as low rates of moderate or severe paravalvular regurgitation.

TRIAL REGISTRATION:

ClinicalTrials.gov #NCT01314313.

KEYWORDS:

TAVI; TAVR; Transcatheter aortic valve replacement

PMID:
27190101
PMCID:
PMC6392433
DOI:
10.1093/eurheartj/ehw112
[Indexed for MEDLINE]
Free PMC Article

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