Long-term follow-up after aortic valve replacement with Edwards Prima Plus stentless bioprostheses in patients younger than 60 years of age.

OBJECTIVES: The Edwards Prima Plus was one of the first stentless aortic valve bioprostheses, with larger orifice areas and improved hemodynamics compared to stented bioprostheses. The aim of the present single-center retrospective study was to assess the long-term results of the Edwards Prima Plus in patients 60 years old or younger.

METHODS: From 1993 to 2001, 120 patients (99 men and 21 women) aged 60 years or younger underwent implantation of the Edwards Prima Plus. The indications were stenosis and/or insufficiency. Associated procedures were performed in 38 patients (31.7%). Of the patients, 39% had impaired left ventricular function. Follow-up data were acquired by telephone interview. Time-to event analyses were performed using the Kaplan-Meier method. Variables affecting survival and freedom from reoperation were evaluated using Cox regression analysis. The mean patient age at surgery was 53.1 ± 8.0 years. The follow-up data were 88.8% complete at a mean of 8.5 ± 4.5 years. The total follow-up was 1022.7 patient-years.

RESULTS: At 10 and 15 years, the overall actuarial survival rate was 71.8% ± 4.4% and 48.8% ± 9.6%, respectively. Survival was significantly lower for patients with older age, aortic insufficiency as the surgical indication, and small prosthesis size (≤25 mm vs ≥27 mm). Reoperation was performed in 20 patients (16.7%), with a hospital mortality of 5%. At 10 and 14 years, the overall freedom from reoperation rate was 85.6% ± 3.7% and 65.2% ± 8.6%, respectively. Freedom from reoperation was significantly lower in patients with a small prosthesis size (≤25 mm) and insufficiency as the indication for surgery.

CONCLUSIONS: In patients aged 60 years or younger, an Edwards Prima Plus can provide reliable long-term results with acceptable freedom-from-reoperation rates.