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DOI: 10.1055/s-0034-1367226
Sutureless aortic valves - a word of cautione single-centre experience with the Medtronic 3f Enable™ Prosthesis
Introduction: Recent data suggest that aortic valve replacement (AVR) using the sutureless self-expanding Medtronic Enable™ bioprosthesis is safe and feasible with excellent hemodynamics and a short implantation time. After experiencing 5 cases of severe paravalvular leakage/valve dislocation we critically reviewed all patients who had undergone AVR with the Medtronic Enable™ valve at our institution.
Patients and methods: Between 10/2011 and 4/2013 48 patients (age 76 ± 3.5 years), 25 male, received a Medtronic Enable™ aortic valve via complete (n = 36) or partial (n = = 4) sternotomy or right parasternal thoracotomy (n = 8). Intra- /perioperative and follow-up data were collected with respect to survival, paravalvular leakage and valve dislocation leading to re-operation, atrioventricular block (AVB) with pacemaker implantation and neurologic events. Maximum and mean pressure gradients (pmax/pmean) from postoperative echocardiography were obtained. Mean follow up time was 383 ± 114 (range 116-653) days.
Results: 13 operations were combined procedures. Cardiopulmonary bypass time for isolated AVR averaged 96 ± 27 min., aortic crossclamp time 64 ± 22 min. In-hospital mortality was 8.3% (4/48);overall mortality during follow-up was 12.5% (6/48). Overall Redo-AVR rate was 12.5% (6/48 patients). Severe paravalvular leakage/valve dislocation was observed in 5/48 patients (10.4%);one patient needed immediate revision, because of prosthesis dislocation and occurrence of severe mitral insufficiency, 4 patients underwent redo AVR within 1 week to 14 months. Prosthetic valve endocarditis occured in 1/48 patients (2.1%) after 10 months. Two of those 6 Redo-AVR patients died. Pacemaker implantation was necessary in 14.6% (7/48 patients); serious neurologic events were observed in 4/48 patients (8.3%). Postoperative pmax /pmean was 20.5+/-8.7 mmHg and 8.8+/-5 mmHg, respectively; mild paravalvular leakage was documented in 6/48 patients (12.5%).
Conclusions: Our series of 48 patients undergoing AVR with the Medtronic Enable™ bioprosthesis showed longer than expected cardiopulmonary bypass- and aortic crossclamp times. Due to the high overall redo-AVR rates for leakage/dislocation as well as the high incidence of AVB and neurologic events we could not prove superiority to the conventional procedure for AVR.