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Minimal Access Rapid valve deployment AVR using the EDWARDS INTUITY Valve system
Markus Schloemicher, Peter Haldenwang, Baerbel Buchwald, Matthias Bechtel, Vadim Moustafine, Justus Thomas Strauch.
Ruhr University Hospital Bergmannsheil, Bochum, Germany.

Objectives: The EDWARDS INTUITY valve system combines the proven long-term safety and efficacy of the Carpentier-Edwards PERIMOUNT platform with recent innovations from transcatheter valve programmes. Since March 2012 54 implants were performed in our institution. This paper presents the first short term and 6 months clinical and hemodynamic results. Patients and methods: The mean age was 75,5 (± 6,2) years. A Euroscore II of 3,5% ± 1,3% was found and 39 % (n= 21) were female. A clinical follow up for echocardiographic assessment of the valve performance was performed after 6 months. Preoperatively, 41 patients (76%) were in NYHA class III or IV. Single AVR was performed using a partial upper sternotomy in all cases. A peak gradient of 69,5 (±23,7) mmHg and a mean gradient of 46,7 (±17,9) were measured preoperatively. A mean effective orifice area of 0,8 cm2 (±0,3) and an ejection fraction of 58,5% (±15,0) could be found. Results: 30-day mortality rate was 1,9 % (n=1). One patient died because of severe postoperative bleeding from aortotomy. In one procedure intraoperative severe paravalvular leakage led to implantation of a conventional bovine pericardial valve. The peak and mean postoperative transprosthetic gradients were determined to be 21.9 (± 7,6) mmHg and 12.1 (± 4,2) mmHg, respectively. A mean efective orifice area of 1,8 cm2 (± 0,3) was determined. No higher grade regurgitation (AI > +1) occured. Late mortality rate was 5,7 % (3/53). The specific causes of late deaths were reported to be urogenital infection with consecutive septicemia (n=1) and heart failure (n=2) After 6 months the mean transprosthetic gradients were 19,0 (± 6,3) mmHg and 10,0 (± 2,7) mmHg, respectively. The mean EOA of 1,8 (± 0,3) remained unchanged . The mean implantation time amounted 9 (± 3 )minutes. The mean cross clamp time was 29 ± 17 minutes. An average bypass time of 62 (± 16) minutes was seen. Conclusion: Short term results show excellent hemodynamic results. A satisfying reduction of cross clamp and bypass times could be achieved. Nevertheless future follow up investigation has to be awaited to gain more data concerning durability and safety issues


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