Long-Term Clinical Outcomes of the Carpentier-Edwards Perimount Pericardial Bioprosthesis in Chinese Patients with Single or Multiple Valve Replacement in Aortic, Mitral, or Tricuspid Positions

Abstract

Objectives: To report the safety and efficacy results of a 9- to 15-year follow-up investigation among patients who had received Carpentier-Edwards Perimount (CE-P) bovine pericardial bioprostheses (Edwards Lifesciences, Irvine, CA, USA) for valve replacement.

Methods: This retrospective study investigated freedom from structural valve deterioration (SVD) as well as survival and reoperation among different age and etiology groups in patients who were implanted with a CE-P bioprosthesis at Guangdong General Hospital between 2001 and 2007. Kaplan-Meier survival analysis and multivariate Cox proportional hazards regression were performed.

Results: The mean age of the patients (N = 225) was only 61.2 ± 11.5 years at valve replacement. More than half of the patients (55.1%) had rheumatic heart disease. The survival rates were 86.46, 81.58, and 74.42% at 5 years, 64.39, 66.19, and 55.85% at 10 years, and 48.37, 57.33, and 46.54% at 15 years for the groups with mitral valve replacement (MVR), aortic valve replacement (AVR), and double valve replacement (DVR), respectively. The median time to freedom from SVD was 12.5, 13.2, and 11.2 years, respectively, for patients with MVR, AVR, and DVR. A higher age at valve replacement was a significant risk factor for SVD in all patients (p < 0.01).

Conclusions: Good long-term clinical results of CE-P valves have been demonstrated in Chinese patients >60 years.

Keywords: Bioprosthesis; Rheumatic heart disease; Structural valve deterioration.