First clinical experience and 1-year follow-up with the sutureless 3F-Enable aortic valve prosthesis

Aortic valve replacement (AVR) with extracorporeal circulation (ECC) is currently the treatment of choice for symptomatic aortic stenosis. However, patients with multiple high-risk comorbid conditions may benefit from reduced ECC time and thus, reduced myocardial ischemia, by the use of sutureless AVR. We describe the initial experience and 1-year results of our first 3F-Enable AVR implants.

Between 09/05 and 12/05, six patients (age 74+/-1.8 years; three females) with symptomatic aortic stenosis (NYHA III) underwent AVR with an equine pericardial and nitinol-stented sutureless prosthesis. For additional safety up to three stay sutures were placed. Echocardiography was performed preoperatively, intraoperatively, at 6- and 12-month follow-up. Clinical data, adverse events and patient outcome were recorded prospectively.

Prosthesis sizes were 27 mm (n=3), 25 mm (n=1), 23 mm (n=1) and 21 mm (n=1). ECC time was 87+/-32 min; aortic clamp time was 56+/-24 min. Prosthesis deployment time was 148 +/- 173 s. There were no intraoperative deaths or complications. At 12-month follow-up mean pressure gradients (MPG) were 6.8+/-3.5 mmHg and aortic valve area (AVA) was 2.2 +/- 0.5 cm(2). One patient underwent successful redo AVR after 8 months due to severe paravalvular leakage (PVL), and one patient died due to lung cancer 10 months after surgery. At 12 months follow-up four out of six patients are alive and asymptotic (NYHA I) with the 3F-Enable aortic valve prosthesis, however, one patient showed mild paravalvular leakage.

These first 1-year follow-up data suggest the feasibility of this new concept of sutureless aortic valve implantation. However, severe aortic insufficiency at 8 months and paravalvular leakage at 1-year follow-up should prompt further procedural and device enhancements.