Prospective US investigational device exemption trial of a sutureless aortic bioprosthesis: One-year outcomes.

MedStar author(s):
Citation: Journal of Thoracic & Cardiovascular Surgery. 157(5):1773-1782.e3, 2019 May.PMID: 30553598Institution: MedStar Heart & Vascular InstituteForm of publication: Journal ArticleMedline article type(s): Journal ArticleSubject headings: *Aortic Valve/ab [Abnormalities] | *Bioprosthesis | *Heart Valve Diseases/su [Surgery] | *Heart Valve Prosthesis | *Heart Valve Prosthesis Implantation/is [Instrumentation] | *Sutureless Surgical Procedures/is [Instrumentation] | Aged | Aged, 80 and over | Aortic Valve/dg [Diagnostic Imaging] | Aortic Valve/pp [Physiopathology] | Aortic Valve/su [Surgery] | Female | Heart Valve Diseases/dg [Diagnostic Imaging] | Heart Valve Diseases/mo [Mortality] | Heart Valve Diseases/pp [Physiopathology] | Heart Valve Prosthesis Implantation/ae [Adverse Effects] | Heart Valve Prosthesis Implantation/mo [Mortality] | Hemodynamics | Humans | Male | Postoperative Complications/mo [Mortality] | Prospective Studies | Prosthesis Design | Recovery of Function | Risk Factors | Sutureless Surgical Procedures/ae [Adverse Effects] | Sutureless Surgical Procedures/mo [Mortality] | Time Factors | Treatment Outcome | United StatesYear: 2019Local 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: 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.Copyright (c) 2018 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.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.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.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).All authors: Ad N, Ailawadi G, Aldea GS, Brunsting LA 3rd, Dabir R, Fontana GP, Griffith BP, Heimansohn DA, Javadikasgari H, Kessler WF, Michelena HI, Michler RE, Montoya A, Moront MG, Mostovych MA, Roselli EE, Subramanian S, Suri RM, Szeto WY, Thourani VH, Weissman NJFiscal year: FY2019Digital Object Identifier: Date added to catalog: 2019-01-08
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Item type Current library Collection Call number Status Date due Barcode
Journal Article MedStar Authors Catalog Article 30553598 Available 30553598

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

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.

Copyright (c) 2018 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.

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.

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.

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).

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