The sutureless aortic valve at 1 year: A large multicenter cohort study

Fischlein, Theodor; Meuris, Bart; Hakim-Meibodi, Kavous; Misfeld, Martin; Carrel, Thierry; Zembala, Marian; Gaggianesi, Sara; Madonna, Francesco; Laborde, François; Asch, Federico; Haverich, Axel; CAVALIER, Trial Investigators (2016). The sutureless aortic valve at 1 year: A large multicenter cohort study. Journal of thoracic and cardiovascular surgery, 151(6), 1617-1626.e4. Mosby 10.1016/j.jtcvs.2015.12.064

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OBJECTIVE Sutureless aortic valve replacement (AVR) offers an alternative to standard AVR in aortic stenosis. This prospective, single-arm study aimed to demonstrate safety and effectiveness of a bovine pericardial sutureless aortic valve at 1 year. METHODS From February 2010 to September 2013, 658 patients (mean age 78.3 ± 5.6 years; 40.0% octogenarian; 64.4% female; mean Society of Thoracic Surgeons score 7.2 ± 7.4) underwent sutureless AVR in 25 European centers. Concomitant cardiac procedures were performed in 29.5% and minimally invasive cardiac surgery in 33.3%. RESULTS One-year site-reported event rates were 8.1% for all-cause mortality, 4.5% for cardiac mortality, 3.0% for stroke, 1.9% for valve-related reoperation, 1.4% for endocarditis, and 0.6% for major paravalvular leak. No valve thrombosis, migration, or structural valve deterioration occurred. New York Heart Association class improved at least 1 level in 77.5% and remained stable (70.4% New York Heart Association class I or II at 1 year). Mean effective orifice area was 1.5 ± 0.4 cm(2); pressure gradient was 9.2 ± 5.0 mm Hg. Left ventricular mass decreased from 138.5 g/m(2) before surgery to 115.3 g/m(2) at 1 year (P < .001). Echocardiographic core laboratory findings confirmed that paravalvular leak was rare and remained stable during follow-up. CONCLUSIONS The Perceval sutureless valve resulted in low 1-year event rates in intermediate-risk patients undergoing AVR. New York Heart Association class improved in more than three-quarters of patients and remained stable. These data support the safety and efficacy to 1 year of the Perceval sutureless valve in this intermediate-risk population.

Item Type:

Journal Article (Original Article)

Division/Institute:

04 Faculty of Medicine > Department of Cardiovascular Disorders (DHGE) > Clinic of Cardiovascular Surgery

UniBE Contributor:

Carrel, Thierry

Subjects:

600 Technology > 610 Medicine & health

ISSN:

0022-5223

Publisher:

Mosby

Language:

English

Submitter:

Daniela Huber

Date Deposited:

30 Jun 2016 13:33

Last Modified:

04 Jul 2016 12:49

Publisher DOI:

10.1016/j.jtcvs.2015.12.064

PubMed ID:

26936009

Uncontrolled Keywords:

aortic valve; aortic valve replacement; bioprosthesis; sutureless

BORIS DOI:

10.7892/boris.81896

URI:

https://boris.unibe.ch/id/eprint/81896

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