A staged approach towards interventional aortic valve implantation with a sutureless valve: initial human implants

Abstract

Objective: Percutaneous implantable aortic valves may become an alternative to conventional approaches. The purpose of this study was to assess a new sutureless aortic valve (Perceval Sorin). As a first step, an open approach using cardiopulmonary bypass (CPB) was chosen to evaluate the feasibility of implantation.

Methods: Between April and September 2007, 16 high-risk patients (13 females, aged 81 [76 - 88]) were operated on via a median sternotomy, using CPB and cardioplegia (Euro Score 17 [8 - 73]). All patients had significant aortic valve disease and seven of these patients had concomitant coronary artery disease. This pilot project was initiated with prior approval of the Institutional Review Board. All patients gave informed consent.

Results: One patient died during hospital stay for unknown reasons. Autopsy revealed no valve related pathologies. CPB time was 60 min (41 - 130), cross-clamping time was 36 (22 - 79) min. Intraoperative as well as postoperative echocardiography revealed neither aortic insufficiency nor paravalvular leakage in any of the patients.

Conclusions: The new approach as described here is a technically simple alternative to conventional aortic valve replacement in high-risk patients and offers the potential of less invasive approaches. It appears especially useful in patients with severe calcification of the aortic root. CPB and cross-clamping times were markedly reduced compared with patients who underwent conventional operations.