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Edwards Intuity Sutureless valve system: the bioprosthesis of the future?
Vlad Gariboldi, Sr., Alexis Theron, Dominique Grisoli, Laetitia Nee, Pierre Morera, Séverine Leroux, Frédéric Collart.
Hôpital adultes de la timone, Marseille, France.

Objective: The Edwards Intuity prosthesis is a sutureless rapid deployment pericardial bioprosthesis design for faster procedures, requiring only three sutures in conjunction with expanded frame for secure annular placement, reducing procedural steps and time. We analyze the results of the first 54 patients implanted in our institution. Methods: From July 2012 to December 2013, 54 patients received an Intuity bioprosthesis. Data were collected prospectively. All patients had pre- and postoperative transthoracic (at one month follow-up). Results: There were 40 male with a mean age of 78.1 ± 8 years (50 to 88 years). One patient had a previous aortic valve replacement with a Freestyle prosthesis. Mean Euroscore 2 was 4.1 ± 3.2% (0.81% to 9.5%). Mean corporeal surface was 1.84 m2. NYHA class was II in 27 patients and III in 25 patients. Mean serum level of creatinin was 84 ± 18 μmol/l (67 to 127 μmol/l). Five patients had permanent atrial fibrillation. All except one natives aortic valves were tricuspid. Procedures were performed by full sternotomy. Mean cardiopulmonary bypass time was 64 ± 23 min (45 to 109 min). Mean aortic cross-clamping time was 46 ± 20 min (32 to 87 min). The diameters of the prosthesis implanted were 19 in 13 patients, 21 in 18 patients, 23 in 11 patients, 25 in 3 patients and 27 in 1 patient. The delivery of the device was successful in 100% patients. Associated procedures consisted in coronary artery bypass in 18 patients (33%). One patient died. Mean duration of ICU stay was 3.4 ± 2.1 days. Mean duration on in-hospital stay was 11 ± 2.9 days. Significant improvements in transthoracic echocardiography parameters were observed between preoperative versus postoperative mean ± SD measurements of: Vmax (4.8±0.8 m/sec versus 2.2±0.5 m/sec, respectively; p<0.001); aortic valve area (0.7±0.2 cm² versus 1.8±0.5 cm², respectively; p<0.001); aortic valve area index (0.4±0.1 cm²/m² versus 1.0±0.3 cm²/m², respectively; p<0.001); mean transaortic gradient (58±21 mmHg versus 12±4 mmHg, respectively; p<0.001). Conclusions: Edwards's Intuity bioprosthesis provides excellent early clinical and echocardiographic results. This device should enhance minimal invasive aortic valve replacement. Midterm results should be evaluated.

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