Short term results after minimal access AVR using the EDWARDS INTUITY Valve system
Markus Schloemicher, Peter Lukas Haldenwang, Baerbel Buchwald, Matthias Bechtel, Vadim Moustafine, Justus Thomas Strauch.
Ruhr-University Hospital Bergmannsheil, Bochum, Germany.
OBJECTIVE: The EDWARDS INTUITYTM valve system combines the proven long-term safety and efficacy of the Carpentier-Edwards PERIMOUNTTM 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.
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.
CONCLUSIONS: 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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