Details

Autor(en) / Beteiligte

• Fischlein, Theodor, MD, PhD
• Meuris, Bart, MD, PhD
• Hakim-Meibodi, Kavous, MD
• Misfeld, Martin, MD, PhD
• Carrel, Thierry, MD, PhD
• Zembala, Marian, MD, PhD
• Gaggianesi, Sara, DVM
• Madonna, Francesco, MD
• Laborde, François, MD
• Asch, Federico, MD
• Haverich, Axel, MD, PhD

Titel

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

Ist Teil von

• The Journal of thoracic and cardiovascular surgery, 2016-06, Vol.151 (6), p.1617-1626.e4

Ort / Verlag

United States: Elsevier Inc

Erscheinungsjahr

2016

Quelle

MEDLINE

Beschreibungen/Notizen

• Abstract 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 cm2 ; pressure gradient was 9.2 ± 5.0 mm Hg. Left ventricular mass decreased from 138.5 g/m2 before surgery to 115.3 g/m2 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.