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OBJECTIVE: The growing elderly population increases the number of patients with aortic valve stenosis and multiple comorbidities. In this patient population the sutureless and rapid-deployment bioprosthesis can represent a good option in order to reduce surgical risk. We report our experience with a fast-deployment bioprosthesis: the EDWARDS INTUITY Valve System.
METHODS: Between June 2012 and December 2015, 114 patients with symptomatic aortic stenosis were scheduled for aortic valve replacement (AVR) with EDWARDS INTUITY Valve System. Mean age was 74.9±6.6 years and mean logistic EuroSCORE was 8.6±6.5. Eighty-five patients were male (75%). Sixty-eight patients underwent isolated aortic valve replacement. Concomitant procedure were coronary artery bypass graft (n=32), mitral valve procedures (n=6), mitral valve procedure combined with CABG (n=6) and tricuspid anuloplasty (n=2). Three months and one-year follow-up were performed.
RESULTS: Implantation success was 99% (113/114). Prosthesis size were 19 (n=7), 21 (n=23), 23 (n=35), 25 (n=34) e 27 (n=14). In 66 (58% of all patients and 97% of isolated aortic valve disease patients) patients was performed a minimally invasive approach. Deployment time was 13.7 ± 4.5 minutes. CPB and ACC time were respectively 86.9 ± 20.5 minutes and 50.3 ± 15 minutes, for stand-alone procedures. In 2 patient that underwent a ministernotomy approach, was needed a conversion to full sternotomy due to aortic wall tear after weaning from CPB. Median mechanical ventilation time was 6 hours (range: 2-63), Median ICU stay was 1 day (range:1-27) and Median LOS was 5 days (range: 0-14). The mean transvalvular gradient at discharge was 10.3±3.9 mmHg; at three months follow-up was 8.3±4.3 mmHg and at one-year follow-up was 8.9±4.2. A trivial paravalvular leakage in 6 patients and a moderate paravalvular leakage in one patient were accepted at discharge and were stable at follow up. Survival was 98% at discharge, 98% at 3-months follow-up and 97% at one-year follow-up.
CONCLUSIONS: AVR using the EDWARDS INTUITY Valve System in our experience is a feasible and reproducible procedure associated with excellent results in terms of survival and hemodynamic performance. However, experience with a larger number of patients and longer term follow up are necessary to validate these data.