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

^a Department of Thoracic and Cardiovascular Surgery, West-German Heart Center Essen, University Hospital Essen, Hufelandstraße 55, 45122 Essen, Germany
^b Department of Cardiology, West-German Heart Center Essen, University Hospital Essen, Essen, Germany
^c Department of Cardiac Surgery, Heart Center Leipzig, University Hospital Leipzig, Leipzig, Germany

Received 16 September 2007; received in revised form 23 December 2007; accepted 29 December 2007.

^_* Corresponding author. Tel.: +49 201 723 84912; fax: +49 201 723 5451. (Email: daniel.wendt{at}uk-essen.de).

Background: 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. Methods: 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. Results: 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 cm². 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. Conclusions: 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.

Key Words: Sutureless • Aortic valve replacement • 3F-Enable