Safety, efficacy, and hemodynamic performance of a stented bovine pericardial aortic valve bioprosthesis: Two-year analysis.
J Thorac Cardiovasc Surg
; 160(2): 371-381.e4, 2020 Aug.
Article
em En
| MEDLINE
| ID: mdl-31590957
ABSTRACT
OBJECTIVES:
The study objectives were to evaluate the safety, efficacy, and hemodynamic performance of a novel stented bovine pericardial aortic valve bioprosthesis 2 years after implantation.METHODS:
The PERIcardial SurGical AOrtic Valve ReplacemeNT Pivotal Trial enrolled patients with symptomatic moderate/severe aortic stenosis or regurgitation at centers in Canada, Europe, and the United States. We report the outcomes and hemodynamic performance in patients with up to 2 years of follow-up.RESULTS:
A total of 1273 patients were enrolled, and 1110 underwent implantation. Among patients undergoing implantation, the mean age was 70.2 ± 8.9 years; 833 (75.0%) were male. Risk of mortality (Society of Thoracic Surgeons) was 2.0% ± 1.4%. At the time of analysis, 604 patients had completed the 2-year follow-up visit. Linearized late event rates were as follows all death, 2.68%; valve-related death, 0.42%; valve thrombosis, 0.05%; endocarditis, 0.94%; thromboembolism, 1.68%; all hemorrhage, 2.94%; major hemorrhage, 1.99%; all paravalvular leak, 0.26%; and major paravalvular leak, 0.05% per patient-year. Mean 2-year aortic gradient and effective orifice area were 13.4 ± 5.0 mm Hg and 1.5 ± 0.37 cm2, respectively. Moderate and severe prosthesis-patient mismatch were observed in 43.5% and 34.8% of patients at 2 years, respectively. Improvement in New York Heart Association class compared with baseline was observed in 73.0% with moderate mismatch and 74.1% with severe mismatch.CONCLUSIONS:
The Avalus (Medtronic, Minneapolis, Minn) bovine pericardial valve demonstrates good clinical and safety outcomes at 2 years. Hemodynamic performance shows mean gradients comparable to currently available bovine pericardial aortic valves. There was no clinical impact of moderate to severe mismatch at 2 years. Further follow-up is required to evaluate midterm to long-term clinical outcome.Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Valva Aórtica
/
Insuficiência da Valva Aórtica
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Estenose da Valva Aórtica
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Pericárdio
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Bioprótese
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Próteses Valvulares Cardíacas
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Stents
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Implante de Prótese de Valva Cardíaca
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Hemodinâmica
Tipo de estudo:
Clinical_trials
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Etiology_studies
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Observational_studies
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Risk_factors_studies
Limite:
Aged
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Animals
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Female
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Humans
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Male
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Middle aged
País/Região como assunto:
America do norte
/
Europa
Idioma:
En
Ano de publicação:
2020
Tipo de documento:
Article