MedStar Authors catalog › Details for: Prospective US investigational device exemption trial of a sutureless aortic bioprosthesis: One-year outcomes.
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Prospective US investigational device exemption trial of a sutureless aortic bioprosthesis: One-year outcomes.

by Weissman, Neil J.
Citation: Journal of Thoracic & Cardiovascular Surgery. 2018 Oct 23.Journal: The Journal of thoracic and cardiovascular surgery.Published: ; 2018ISSN: 0022-5223.Full author list: Suri RM; Javadikasgari H; Heimansohn DA; Weissman NJ; Ailawadi G; Ad N; Aldea GS; Thourani VH; Szeto WY; Michler RE; Michelena HI; Dabir R; Fontana GP; Kessler WF; Moront MG; Brunsting LA 3rd; Griffith BP; Montoya A; Subramanian S; Mostovych MA; Roselli EE.UI/PMID: 30553598.Subject(s): IN PROCESS -- NOT YET INDEXEDInstitution(s): MedStar Heart & Vascular InstituteActivity type: Journal Article.Medline article type(s): Journal ArticleDigital Object Identifier: (Click here) Abbreviated citation: J Thorac Cardiovasc Surg. 2018 Oct 23.Local Holdings: Available online from MWHC library: 1994 - present, Available in print through MWHC library: 1999 - 2006.Abstract: OBJECTIVES: We performed a prospective, single-arm clinical trial approved under a Food and Drug Administration Investigational Device Exemption to assess safety and efficacy of Perceval, a sutureless bovine pericardial aortic valve representing the initial US experience.Abstract: METHODS: From June 2013 to January 2015, 300 patients (mean age 76.7 +/- 7.7 years, 54.3% men, 37.3% >=80 years, median Society of Thoracic Surgeons Predicted Risk of Mortality 2.8%), underwent Perceval valve implantation at 18 centers across the United States. Twenty patients (6.7%) had a bicuspid aortic valve and 5 (1.7%) patients had previous aortic valve replacement. A minimally invasive approach was used in 80 (26.7%) and concomitant procedures were performed in 113 (37.8%) patients.Abstract: RESULTS: Two hundred eighty-nine patients (96.3%) were successfully implanted. Operative mortality (<=30 days) was 1.3% (n = 4) (observed to expected ratio of 0.40). One-year results included all-cause mortality in 5.2% (n = 15), stroke in 1% (n = 3), and endocarditis in 1.7% (n = 5). New permanent periprocedural pacemaker rate was 10.7% (n = 30/281); 2.5% (n = 7/281) resulted from third-degree atrioventricular block. One-year valve-related reoperation was 2.1% (n = 6). At 1-year follow-up, 98% of patients were in New York Heart Association class I/II, left ventricular mass index decreased from 103.5 +/- 30.1 g/m<sup>2</sup> at discharge to 95.8 +/- 27.1 g/m<sup>2</sup> (P = .001), and 3 (1.3%) moderate paravalvular leaks were identified. Health-related quality of life score increased from 62.7 +/- 21.8 before surgery to 85.5 +/- 17.8 at 1 year (P < .001).Abstract: CONCLUSIONS: These results confirm the safety and effectiveness of the Perceval sutureless aortic valve replacement in study patients with lower mortality than expected from a risk prediction model. Persistent hemodynamic benefit and improvement in quality of life at 1 year support the importance of this device in the management of aortic valve disease.Abstract: Copyright (c) 2018 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.

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