Clinical experience with the Medtronic “3F” stentless aortic bioprosthesis - ten years follow-up

Objectives: The 3F aortic bioprothesis is an equine pericardial stentless valve for aortic valve replacement. The study aim was to evaluate the hemodynamic performance of the prosthesis and incidence of valve-related complications in up to ten years of follow-up.

Methods: 35 patients received the prosthesis between 2002 and 2003 at our institution. This cohort was prospectively followed. Clinical outcome was assessed by clinical examination or telephone interviews with the primary care physicians. Hemodynamic performance of the valve was evaluated by transthoracic echocardiography (TTE).

Results: Mean follow-up was 122 (116 to 134) months and 86% complete. Ten-year overall survival rate was 77%. Causes of death were unknown (n = 4) or not valve related (n = 4). Freedom from reoperation was 97%. One patient required reoperation due to prosthetic valve endocarditis. Freedom from severe adverse events (SAE) was 89%. SAE included permanent and transient neuroembolic events. 75% of the current survivors (mean age 80,1 ± 5,4; range 71-88 years) received no oral anticoagulation. A total of 166 valve years have been evaluated by TTE. No severe structural or nonstructural valve dysfunction was revealed; mean transvalvular pressure gradients (Pmean) showed no significant increase after ten years. Pmean was 10.9 ± 5.5, 10.7 ± 6.0, 13.4 ± 5.0, and 14.3 ± 12.8 mmHg at one, three, five and ten years after implantation, respectively.

Conclusions: The 3F aortic valve prosthesis continues to demonstrate good hemodynamic results. With minimal SAE, the prosthesis demonstrated excellent durability and long term clinical results.