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... Show moreOBJECTIVES 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. Show less
OBJECTIVESThis 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... Show moreOBJECTIVESThis 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.METHODSKaplan–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.RESULTSA 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.CONCLUSIONSThe 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. Show less
