Late outcome analysis of the Braile Biomédica® pericardial valve in the aortic position

Rev Bras Cir Cardiovasc. 2014 Jul-Sep;29(3):316-21. doi: 10.5935/1678-9741.20140081.

Abstract

Objective: Aortic valve replacement with Braile bovine pericardial prosthesis has been routinely done at the Heart Institute of the Universidade de São Paulo Medical School since 2006. The objective of this study is to analyze the results of Braile Biomédica® aortic bioprosthesis in patients with aortic valve disease.

Methods: We retrospectively evaluated 196 patients with aortic valve disease submitted to aortic valve replacement with Braile Biomédica® bovine pericardial prosthesis, between 2006 and 2010. Mean age was 59.41±16.34 years and 67.3% were male. Before surgery, 73.4% of patients were in NYHA functional class III or IV.

Results: Hospital mortality was 8.16% (16 patients). Linearized rates of mortality, endocarditis, reintervention, and structural dysfunction were 1.065%, 0.91%, 0.68% and 0.075% patients/year, respectively. Actuarial survival was 90.59±2.56% in 88 months. Freedom from reintervention, endocarditis and structural dysfunction was respectively 91.38±2.79%, 89.84±2.92% and 98.57±0.72% in 88 months.

Conclusion: The Braile Biomédica® pericardial aortic valve prosthesis demonstrated actuarial survival and durability similar to that described in the literature, but further follow up is required to assess the incidence of prosthetic valve endocarditis and structural dysfunction in the future.

Objetivo: A troca valvar aórtica por substitutos biológicos de pericárdio bovino Braile é realizada rotineiramente no Instituto do Coração da Faculdade de Medicina da USP desde 2006. O objetivo deste estudo é analisar os resultados da utilização da prótese aórtica Braile Biomédica® em pacientes com doença valvar aórtica.

Métodos: Foram analisados, retrospectivamente, 196 pacientes portadores de valvopatia aórtica submetidos à troca valvar aórtica por prótese biológica de pericárdio bovino Braile Biomédica® entre 2006 e 2010. A idade média foi de 59,41±16,34 anos e 67,3% eram do sexo masculino. No pré-operatório, 73,4% dos pacientes estavam em classe funcional III ou IV.

Resultados: A mortalidade hospitalar foi 8,16% (16 pacientes). As taxas linearizadas de óbito, endocardite, reoperação e disfunção estrutural foram de 1,065%, 0,91%, 0,68% e 0,075% pacientes/ano, respectivamente. A sobrevida actuarial foi de 90,59±2,56% em 88 meses. A curva livre de reoperação, endocardite e disfunção estrutural foi respectivamente de 91,38±2,79%, 89,84±2,92% e 98,57±0,72% em 88 meses.

Conclusão: O implante da prótese aórtica de pericárdio bovino Braile Biomédica® demonstrou sobrevida e durabilidade compatível com a literatura, porém maior seguimento é necessário para avaliar a incidência de endocardite e disfunção estrutural no futuro.

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Aged, 80 and over
  • Aortic Valve / surgery
  • Bicuspid Aortic Valve Disease
  • Bioprosthesis*
  • Cause of Death
  • Endocarditis / etiology
  • Female
  • Heart Defects, Congenital / mortality
  • Heart Defects, Congenital / surgery*
  • Heart Valve Diseases / mortality
  • Heart Valve Diseases / surgery*
  • Heart Valve Prosthesis Implantation / methods*
  • Heart Valve Prosthesis Implantation / mortality
  • Heart Valve Prosthesis*
  • Hospital Mortality
  • Humans
  • Kaplan-Meier Estimate
  • Male
  • Middle Aged
  • Reoperation
  • Retrospective Studies
  • Time Factors
  • Treatment Outcome
  • Young Adult