Initial experience with the Edwards Intuity rapid deployment valve

Background: Since March 2012 45 implants of the Edwards Intuity© rapid deployment valve were performed in our institution. This paper presents the first short term clinical and hemodynamic results. Patients and methods: There were 14 (31%) female and 31 (68%) male patients with a mean age of 72,9 (± 15,3) years. Preoperatively, 12 patients (26%) were in NYHA Class II, 26 (58%) in Class III and 7 (16%) in Class IV. Concomitant Bypass Surgery was performed in 4 cases. Single AVR was performed using a partial upper sternotomy in 41 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 cm 2 (± 0,3) and an ejection fraction of 58,5% (± 15,0) could be found. The mean euroscore II was 3,5% (± 1,3). Results: 30-day mortality rate was 2,2% (n = 1). One patient died because of severe postoperative bleeding from the aortotomy. In one procedure intraoperative echo showed severe paravalvular leakage after implantation which led to implantation of a conventional bovine pericardial valve. No neurologic events occured. Neither myocardial infarction. By using Doppler echocardiography, the peak and mean postoperative transprosthetic gradients were determined to be 21.9 (± 7,6) mmHg and 12.1 (± 4,2) mmHg, respectively. The mean gradients of the 19 mm prostheses (n = 2) were 33,5 (± 4,9) mmHg / 18 (± 1,4) mmHg, of the 21 mm prostheses (n = 15) 23,2 (± 8,3) mmHg / 12,2 (± 4,3 mmHg), of the 23 mm prostheses (n = 9) 20,9 (± 5,9 mmHg) / 11,7 (±±± 3,0 mmHg), of the 25 mm Prostheses (n = 14) 20,9 (± 4,9) mmHg / 11,8 (± 3) mmHg, and 15,3 (± 4,2) mmHg / 8,5 (± 3,5) mmHg of the 27 mm Prostheses (n = 5). A mean efective orifice area of 1,8 cm 2 (± 0,3) was determined. Two Patients showed mild (AI I) aortic regurgitation at the time of discharge. No higher grade regurgitation occured. The mean implantation time amounted 8 (± 3 ) minutes. The mean cross clamp time in single avr procedures was 34 ± 15 minutes. An average bypass time of 66 (± 22) minutes was seen. Conclusion: Short term results show excellent hemodynamic results. A satisfying reduction of cross clamp and bypass times could be achieved. We see a clear future domain of this valve in MIS surgery as well as in combined procedures with regard to the reduction of clamping time in conventional valve surgery. Nevertheless future follow up investigation has to be awaited to gain more data concerning durability and safety issues.