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One-year outcomes associated with a novel stented bovine pericardial aortic bioprosthesis.

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Citation: Journal of Thoracic & Cardiovascular Surgery. 2018 Apr 18PMID: 29778342Institution: MedStar Heart & Vascular InstituteForm of publication: Journal ArticleMedline article type(s): Journal ArticleSubject headings: IN PROCESS -- NOT YET INDEXEDYear: 2018 Local holdings: Available online from MWHC library: 1994 - present, Available in print through MWHC library: 1999 - 2006ISSN:

0022-5223

Name of journal: The Journal of thoracic and cardiovascular surgeryAbstract: 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.Copyright (c) 2018. Published by Elsevier Inc.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.OBJECTIVES: The study objectives were to evaluate the safety, effectiveness, and hemodynamic performance of a new stented bovine pericardial aortic valve.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).All authors: Asch FM, Bapat V, Dagenais F, Kappetein AP, Klautz RJM, Labrousse L, Lange R, Moront M, Patel HJ, PERIGON Investigators, Rao V, Reardon MJ, Sabik JF 3rd, Weissman NJ, Zeng CFiscal year: FY2018Digital Object Identifier:

https://dx.doi.org/10.1016/j.jtcvs.2018.03.171

Date added to catalog: 2018-06-19

Holdings ( 1 )
Title notes ( 7 )

Holdings
Item type	Current library	Collection	Call number	Status	Date due	Barcode
Journal Article	MedStar Authors Catalog	Article	29778342	Available		29778342

Available online from MWHC library: 1994 - present, Available in print through MWHC library: 1999 - 2006

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.

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.

OBJECTIVES: The study objectives were to evaluate the safety, effectiveness, and hemodynamic performance of a new stented bovine pericardial aortic valve.

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).

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