1 Year Results after Minimal Access AVR with the EDWARDS INTUITY Valve System

Objectives: The EDWARDS INTUITY TM valve system combines the proven long-term safety and efficacy of the Carpentier-Edwards PERIMOUNT TM platform with anchoring techniques from transcatheter valves. 75 implants were performed in our institution between March 2012 and September 2014 using a minimal access technique. This paper presents short term and 12 months results. The 12 months follow up was performed for 59 patients so far Patients and methods: The mean age was 76,5 (± 6,2) years. A mean logistic Euroscore I of 9,3% ± 1,8% and a mean logistic Euroscore II of 3,9% ± 1,2% was found and 39% ( n = 21) were female. Echocardiographic assessment of the valve performance was performed after 6 months and 12 months Preoperatively, 59 patients (79%) were in NYHA class III or IV. Single AVR was performed using a partial upper sternotomy in all cases. A peak gradient of 72,2 (± 22,3) mmHg and a mean gradient of 44,7 (± 15,9) were measured preoperatively. A mean effective orifice area of 0,8 cm 2 (± 0,3) could be found. The mean ejection fraction was 58,5% (± 15,0). Results: The mean implantation time amounted 9 (± 3) minutes. The mean cross clamp time was 29 ± 16 minutes. An average bypass time of 60 (± 12) minutes was seen. 30-day mortality rate was 2,6% ( n = 2). The peak and mean postoperative transprosthetic gradients were determined to be 21.7 (± 7,6) mmHg and 11.8 (± 3,6) mmHg, respectively. A mean efective orifice area of 1,8 cm 2 (± 0,3) was measured. One case (1,3%) of severe aortic regurgitation due to paravalvuler leakage occurred which was mainly caused by missizing. No further cases of aortic insufficiency were seen. 2 pacemakers (2,6%) had to be implanted within a 30 day period Mortality after 12 months was 5,1% (3/59). No stroke occurred. The specific causes of late deaths were reported to be urogenital infection with consecutive septicemia ( n = 1) and heart failure ( n = 2) After 12 months the mean transprosthetic gradients were 19,2 (± 6,6) mmHg and 10,1 (± 2,3) mmHg, respectively. The mean EOA of 1,8 (± 0,3) remained unchanged. No aortic insufficiency occurred and no pacemakers had to be implanted in the follow up period. Conclusion: Short term and 12 months results show good hemodynamic performance and low complication rates. Nevertheless further follow up investigation is necessary for durability and safety issues.