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J Thorac Cardiovasc Surg. 2014 Dec;148(6):2869-76.e1-7. doi: 10.1016/j.jtcvs.2014.07.020. Epub 2014 Jul 30.

Self-expanding transcatheter aortic valve replacement using alternative access sites in symptomatic patients with severe aortic stenosis deemed extreme risk of surgery.

Author information

1
Houston-Methodist-Debakey Heart and Vascular Center, Houston, Tex. Electronic address: mreardon@houstonmethodist.org.
2
Mount Sinai Medical Center, New York, NY.
3
Texas Heart Institute, St Luke's Medical Center, Houston, Tex.
4
University of Michigan Medical Center, Ann Arbor, Mich.
5
Houston-Methodist-Debakey Heart and Vascular Center, Houston, Tex.
6
Riverside Methodist Hospital, Columbus, Ohio.
7
St Vincent's Medical Center, Indianapolis, Ind.
8
Duke University Medical Center, Durham, NC.
9
Beth Israel Deaconess Medical Center, Boston, Mass.
10
University of Kansas Hospital, Kansas City, Kan.
11
Spectrum Health Hospitals, Grand Rapids, Mich.
12
St Francis Hospital, Roslyn, NY.
13
Pinnacle Health, Harrisburg, Pa.
14
University of Pittsburgh Medical Center, Pittsburgh, Pa.
15
Johns Hopkins University Hospital, Baltimore, Md.
16
Medtronic, Inc, Minneapolis, Minn.

Abstract

OBJECTIVES:

The CoreValve Extreme Risk US Pivotal Trial enrolled patients with symptomatic severe aortic stenosis deemed unsuitable for surgical aortic valve replacement. Implants were attempted using transfemoral access (n = 489) or an alternative access (n = 150). In present analysis, we sought to examine the safety and efficacy of CoreValve transcatheter aortic valve replacement using alternative access.

METHODS:

The present study included 150 patients with prohibitive iliofemoral anatomy who were treated with the CoreValve transcatheter heart valve delivered by way of the subclavian artery (n = 70) or a direct aortic approach (n = 80). The echocardiograms were read by an independent core laboratory. The primary endpoint was all-cause mortality or major stroke at 12 months.

RESULTS:

The preoperative aortic valve area was 0.72 ± 0.27 cm(2) and mean aortic valve gradient was 49.5 ± 17.0 mm Hg. After the transcatheter aortic valve replacement, the effective aortic valve area was 1.82 ± 0.64 cm(2) at 1 month and 1.85 ± 0.51 cm(2) at 12 months. The mean aortic valve gradient was 9.7 ± 5.8 mm Hg at 30 days and 9.5 ± 5.7 mm Hg at 12 months. The death or major stroke rate was 15.3% at 30 days and 39.4% at 12 months. The individual rate of all-cause mortality and major stroke was 11.3% and 7.5% at 30 days and 36.0% and 9.1% at 12 months.

CONCLUSIONS:

These data demonstrate that the CoreValve transcatheter heart valve delivered by an alternative access provides a suitable alternative for treatment of extreme risk patients with symptomatic severe aortic stenosis, who have prohibitive iliofemoral anatomy and no surgical options.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT01240902.

Comment in

PMID:
25152474
DOI:
10.1016/j.jtcvs.2014.07.020
[Indexed for MEDLINE]
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