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EDWARDS INTUITY Valve System: a New Useful Tool for Minimally Invasive Aortic Valve Replacement
Marco Solinas, Francesca Chiaramonti, Pier Andrea Farneti, Federica Marchi, Tommaso Gasbarri, Giacomo Bianchi, Paolo Antonio Del Sarto, Sergio Berti, Mattia Glauber.
Heart Hospital G.Pasquinucci FTGM, Massa, Italy.
OBJECTIVE: The sutureless bioprosthesis are designed to allow faster and easier valve implantation reducing the cardiopulmonary bypass (CPB) and aortic cross-clamp (ACC) times. These characteristics make it especially useful for minimally invasive approaches (MIA). We present our initial experience with a new class of rapid-deployment aortic valves, the EDWARDS INTUITY Valve System (Edwards Lifesciences LLC, Irvine, Calif) implanted in MIA.
METHODS: Between June 2012 and December 2013, 47 patients with symptomatic aortic stenosis underwent aortic valve replacement (AVR) with EDWARDS INTUITY Valve System. Of these 36 patients underwent isolated AVR. In 31 (66% of all patients and 86% of isolate aortic valve disease patients) patients was performed an AVR in MIA: 21(68%) patients received an upper J-type ministernotomy and 10 (32%) patients received a right anterior minithoracotomy. One-month follow-up (phone call) and three months follow-up (echocardiographic evaluation) were completed.
RESULTS: Implantation success was 100% (30/30). In 1 patient it was decided to not implant the sutureless bioprosthesis for evidence of bicuspid aortic valve. Deployment time was 15,3 ± 4,1 minutes. CPB and ACC time were respectively 85,8 ± 17,5 and 52,2 ± 13,8 minutes. These times are significantly lower then observed in our previous experience using sutured bioprosthesis during MIA. Mechanical ventilation time was 5,7 ± 2,4 hours, ICU stay was 1,7 ± 0,5 days and ward stay was 5,7 ± 1,4 days. The transvalvular gradient at discharge was 10,2 ± 4,1 mmHg (mean) and 16,6 ± 6,4 mmHg (peak). A three months follow up the mean transvalvular gradient was 8,3 ± 4,6 mmHg and the peak transvalvular gradient was 13,7 ± 7,2 mmHg. Three months survival was 100%.
CONCLUSIONS: AVR with EDWARDS INTUITY Valve System is feasible and reproducible and it is associated in our experience with excellent results in terms of survival and hemodynamic performance at short term follow up. This bioprosthesis represent a new tool that promise to reduce technical difficulties and operative times during AVR in MIA compared to sutured bioprosthesis. However, experience with a larger number of patients and a longer follow up are necessary to validate these preliminary data.
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