Citation: Journal of Thoracic & Cardiovascular Surgery. 2018 Apr 18.Journal: The Journal of thoracic and cardiovascular surgery.Published: 2018ISSN: 0022-5223.Full author list: Sabik JF 3rd; Rao V; Lange R; Kappetein AP; Dagenais F; Labrousse L; Bapat V; Moront M; Weissman NJ; Patel HJ; Reardon MJ; Asch FM; Zeng C; Klautz RJM; PERIGON Investigators.UI/PMID: 29778342.Subject(s): IN PROCESS -- NOT YET INDEXEDInstitution(s): MedStar Heart & Vascular InstituteActivity type: Journal Article.Medline article type(s): Journal ArticleOnline resources: Click here to access onlineDigital Object Identifier: https://dx.doi.org/10.1016/j.jtcvs.2018.03.171 (Click here)Abbreviated citation: J Thorac Cardiovasc Surg. 2018 Apr 18.Local Holdings: Available online from MWHC library: 1994 - present, Available in print through MWHC library: 1999 - 2006.Abstract: OBJECTIVES: The study objectives were to evaluate the safety, effectiveness, and hemodynamic performance of a new stented bovine pericardial aortic valve.Abstract: METHODS: This trial enrolled patients with symptomatic moderate or severe aortic stenosis or chronic, severe aortic regurgitation. We assessed death, valve-related adverse events, functional recovery, and hemodynamic performance at discharge, 3 to 6 months, and 1 year, as required by the US Food and Drug Administration for regulatory approval. The primary analysis compared late linearized rates of valve-related adverse events after implantation with Food and Drug Administration-specified objective performance criteria to determine whether the adverse event rates associated with the valve are within acceptable limits. Adverse events included thromboembolism, thrombosis, all and major hemorrhage, all and major paravalvular leak, and endocarditis.Abstract: RESULTS: The primary analysis included 864 patients who received an implant and 904.1 valve-years of follow-up. A total of 577 patients completed the 1-year evaluation. The primary end point was met for death, thromboembolism, thrombosis, all and major paravalvular leak, and endocarditis, but not for all and major hemorrhage. At 1 year, freedom from all death and from valve-related death was 96.4% and 99.7%, respectively. From baseline to 1 year, New York Heart Association class changed as follows: I, 10.8% to 73.7%; II, 48.9% to 22.6%; III, 38.0% to 3.5%; and IV, 2.3% to 0.2%. Effective orifice area increased from 0.9 +/- 0.5 to 1.5 +/- 0.4 (P < .0001), and mean aortic gradient decreased from 42.7 +/- 16.5 to 12.5 +/- 4.3 (P < .0001).Abstract: CONCLUSIONS: This analysis of a new stented bovine pericardial aortic valve demonstrated low overall mortality and valve-related adverse events, and hemodynamic performance comparable to that of other surgical aortic valves.Abstract: Copyright (c) 2018. Published by Elsevier Inc.