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AORTIC VALVE REPLACEMENT WITH SUTURELESS EDWARDS INTUITY VALVE SYSTEM: EARLY SINGLE CENTER EXPERIENCE.
Francesca Chiaramonti, Marco Solinas, Simone Simeoni, Federica Marchi, Danyar Gilmanov, Giacomo Bianchi, Tommaso Gasbarri, Antonio Miceli, Mattia Glauber.
Heart Hospital G.Pasquinucci FTGM, Massa, Italy.
OBJECTIVE: High-risk patients referred for aortic valve replacement (AVR) may benefit from sutureless technology in order to reduce mortality and morbidity. We describe our initial experience with a new class of rapid-deployment sutureless aortic valves: the EDWARDS INTUITY Valve System (Edwards Lifesciences LLC, Irvine, Calif).
METHODS: Between June and November 2012, 14 patients with symptomatic aortic stenosis underwent AVR with EDWARDS INTUITY Valve System. Mean age was 74,8 ± 6,6 (range: 63 to 83) and mean logistic EuroSCORE was 6,9 ± 3,8. Twelve patients were male (80%). Concomitant procedure were coronary artery bypass graft (n=3), mitral valve replacement (n=1) and tricuspid anuloplasty (n=1).
RESULTS: Implantation was successful in 12/15 (80%). Prosthesis size were 19 (n=1), 21 (n=4), 23 (n=4), 25 (n=1) e 27 (n=1). In 5 (56% of isolated aortic valve replacement) patients was performed a minimally invasive approach with an Upper J-type ministernotomy in the third intercostal space. Deployment time was 14,8 ± 3,5 minutes. CPB and ACC time were respectively 71,5 ± 13,3 and 43, 3 ± 4 minutes for stand-alone procedures. Combinated procedures required 155 ± 71,7 and 103 ± 44,6 minutes, respectively. There were no complications related to the minimally invasive approach. The 3 procedural failure were prosthesis sizing releated in 2 cases and in one case due to a tearing of the aortic wall after CBP weaning. Mean mechanical ventilation time was 8,9 ± 3,5 hours, mean ICU stay was 1,5 ± 0,9 days and mean hospital stay was 6,6 ± 2,2 days. The transvalvular gradient at discharge was 11,3 ± 4,9 mmHg (mean) and 16,6 ± 5,9 mmHg (peak). Trivial paravalvular leakage was observed in 1 patients. One month survival was 100%.
CONCLUSIONS: AVR with EDWARDS INTUITY in high-risk patients is a feasible and efficacious procedure associated with low in-hospital mortality and excellent hemodynamic performance. Upper J-type ministernotomy in the third intercostal space is a safe and reproducible approach. The new sutureless valve system combine the safety and efficacy of the bioprosthesis Carpentier-Edwards Perimount with the simplicity of implantation. However, longer-term follow-up is necessary to confirm these first results.
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