Surgical aortic valve replacement with a stented pericardial bioprosthesis: 5-year outcomes

On behalf of the PERIGON Investigators

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9 Scopus citations


OBJECTIVES: This analysis evaluated the safety, durability and haemodynamic performance of a stented bovine pericardial valve through 5 years of follow-up in patients with an indication for surgical aortic valve replacement. METHODS: Kaplan-Meier analysis was used to estimate the incidence of survival and valve-related thromboembolism, major paravalvular leak, endocarditis, structural valve deterioration (SVD) and reintervention. The mean aortic gradient and New York Heart Association (NYHA) functional class were also evaluated. RESULTS: A total of 1118 patients have received the Avalus valve; 564 have completed the 5-year follow-up. The median follow-up was 4.85 years (4810 patient-years total follow-up). At baseline, the mean age was 70.2 ± 9.0 years; 75.1% of patients were male. The Society of Thoracic Surgeons predicted risk of mortality was 2.0 ± 1.4%. Most patients were in NYHA functional class II (46.8%) or III (40.3%). At the 5-year follow-up, the overall Kaplan-Meier survival rate was 88.1% (85.9-90.0%). The Kaplan-Meier event rates were 5.6% (4.3-7.2%) for thromboembolism, 4.4% (3.2-6.0%) for endocarditis, 0.2% (0.0-0.7%) for a major paravalvular leak and 3.2% (2.3-4.6%) for reintervention. There were no cases of SVD. The mean gradient decreased from 42.1 ± 17.1 mmHg at baseline, to 13.1 ± 4.7 mmHg at discharge and remained stable at 12.5 ± 4.6 mmHg at 5 years. More than 95% of patients were in NYHA functional class I/II 5 years after surgery. CONCLUSIONS: The findings of a high survival rate, excellent safety, no SVD and stable haemodynamic performance and functional status through 5 years of follow-up are encouraging. Additional follow-up is needed to assess the long-term durability of this contemporary surgical bioprosthesis.

Original languageEnglish (US)
Article numberezac374
JournalEuropean Journal of Cardio-thoracic Surgery
Issue number3
StatePublished - Aug 3 2022


  • Aortic valve disease
  • Bovine pericardial aortic bioprosthesis
  • Cardiac surgery
  • Surgical aortic valve replacement
  • Bioprosthesis/adverse effects
  • Follow-Up Studies
  • Humans
  • Middle Aged
  • Male
  • Treatment Outcome
  • Thromboembolism/etiology
  • Endocarditis/surgery
  • Prosthesis Design
  • Aortic Valve Insufficiency/surgery
  • Heart Valve Prosthesis/adverse effects
  • Animals
  • Heart Valve Prosthesis Implantation/adverse effects
  • Cattle
  • Aortic Valve Stenosis/surgery
  • Aortic Valve/surgery
  • Female
  • Aged

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine
  • Pulmonary and Respiratory Medicine
  • Surgery


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