Objectives: A single-center observational study was initialized to evaluate the feasibility of rapid deployment aortic valve replacement using the Edwards Intuity valve system (Edwards Lifesciences Corp, Irvine, Calif) in a minimally invasive setting. A total of 60 implantations have been performed at the Ruhr University Hospital Bergmannsheil using a minimal access technique. We present the first short-term and 12-month clinical and hemodynamic results.
Methods: Aortic valve replacement using a partial sternotomy was performed in all patients. Patients' mean age was 75.5 (±6.2) years. The mean logistic European System for Cardiac Operative Risk Evaluation was 8.4 ± 4.2, and 39% (n = 23) of patients were female. A clinical follow-up for echocardiographic assessment was performed after 12 months.
Results: The 30-day mortality rate was 1.7% (n = 1). The mean postoperative transprosthetic gradient was 11.7 (±4.3) mm Hg. The mean effective orifice area was 1.8 (±0.3) cm(2). One case of higher-grade regurgitation (aortic insufficiency >+1) occurred. The late mortality rate was 5.1% (3/59). After 12 months, the mean transprosthetic gradient was 10.3 (±3.8) mm Hg. The mean effective orifice area of 1.8 (±0.3) cm(2) remained unchanged. The mean implantation time was 9 (±3) minutes. The mean crossclamp time was 26 (±7) minutes. The average bypass time was 56 (±16) minutes.
Conclusions: Reproducible short crossclamp and bypass times were achieved in a minimally invasive setting. The valve shows good hemodynamic performance comparable to other sutureless or rapid deployment valves. Nevertheless, future follow-up investigation has to be awaited to gain more data concerning durability and safety issues.
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