A European Multicenter Study of 616 Patients Receiving the Freedom Solo Stentless Bioprosthesis.

Autor:	Thalmann M; Krankenhaus Hietzing, Wien, Austria. Electronic address: thalmann99@hotmail.com., Grubitzsch H; Charité-Universitätsmedizin Berlin, Berlin, Germany., Matschke K; Herzzentrum Dresden, Dresden, Germany., Glauber M; Ospedale Pasquinucci Massa, Carrara, Italy., Tan E; Catharina Hospital, Eindhoven, The Netherlands., Francois K; University Hospital Gent, Gent, Belgium., Amorim MJ; Hospital S. João, Porto, Portugal., Hensens AG; MST-Thoraxcentrum, Enschede, The Netherlands., Cesari F; Ospedale Ca Foncello, Treviso, Italy., Feyrer R; Klinik für Herzchirurgie, Erlangen, Germany., Diegeler A; Herz-und Gefäss-Klinik GmbH, Bad Neustadt, Germany., Veit F; Krankenhaus Hietzing, Wien, Austria., Repossini A; Cardiac Surgery, University of Brescia, Spedali Civili, Brescia, Italy.
Jazyk:	angličtina
Zdroj:	The Annals of thoracic surgery [Ann Thorac Surg] 2016 Jan; Vol. 101 (1), pp. 100-8. Date of Electronic Publication: 2015 Oct 09.
DOI:	10.1016/j.athoracsur.2015.06.096
Abstrakt:	Background: The purpose of this study was to evaluate the safety and performance of the Freedom Solo valve in aortic valve replacement by clinical and hemodynamic outcomes. Methods: Six hundred sixteen patients underwent aortic valve replacement in 18 European centers; mean age was 74.5 ± 5.9 years, 54.1% of the patients were male, and concomitant procedures were performed in 43.2% of the patients. The majority (69%) of the implanted sizes were 23 mm and 25 mm. Results: At 1 year, overall survival was 94.0%, whereas freedom from valve-related death was 98.6%. There were 9 (1.5%) early (≤ 30 days) and 27 (4.4%) late (>30 days) deaths. Early and late valve-related mortality was 0.3% (n = 2) and 1.1% (n = 7), respectively. Freedom from explant was 97.6%; 10 valves were explanted for endocarditis and 4 for paravalvular leak. There were 10 (1.6%) early and 5 (0.8%) late strokes. Atrioventricular block requiring pacemaker implant occurred in 8 (1.3%) and 1 (0.2%) patients in the early and late postoperative period, respectively. Thrombocytopenia was seen in 27 cases (4.4%) in the early postoperative period. Preoperatively, 93.8% of patients were in New York Heart Association functional classes II through IV, whereas at 1 year 96.9% of patients were in New York Heart Association functional classes I and II. At 1-year follow-up, mean and peak pressure gradients were 7.2 and 14.6 mm Hg, respectively. Indexed left ventricular mass decreased by 12% from 138 g/m(2) at discharge to 122 g/m(2) at 1 year. Conclusions: At 1-year follow-up after Freedom Solo implantation, we found acceptable clinical results with low mortality and morbidity and good hemodynamic performance, confirming safety and effectiveness in this multicenter experience. (Copyright © 2016 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)
Databáze:	MEDLINE
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