Aims: Transcatheter aortic valve implantation (TAVI) has traditionally required pre TAVI valvuloplasty. The aim of this study was to evaluate Major Adverse Cardiac and Cerebrovascular Events (MACCE) related to TAVI procedures and mid-term follow-up after direct implantation of Edwards Sapien XTwithout prior balloon valvuloplasty. Methods and results: From January 2011 to May 2013, 108 patients underwent TAVI in our institution. For the purpose of the study only patients with direct implantation of Edwards Sapien XT valve were included. Patients were selected for direct implantation based on the presence of favourable features (central opening of the native valve which was not severely calcified) on transesophageal echocardiography. MACCE was defined according to Academic Research Consortium definition. All data was collected prospectively and a clinical follow-up was performed. A total of 19 patients were included in this study. The mean age was 81,7+/-6,9 years, 64,7% female and mean logistic EuroScore was 18%. Technical success rate was achieved in all patients (valve crossed successfully and expanded adequately). There was a significant reduction of the mean transvalvular gradient from 42.78+/-16 mm Hg to 7.15+/-3.2 mm Hg and similar comparable improments were observable with regard to the effective orifice area from 0.64+/-1.65 cm2 to 2.08+/-0.25 cm2. During the procedure no coronary obstruction or other prosthesis-related adverse events were recorded. There were no any major vascular complications. The Mean follow-up was 114.6 days. During this time there were no any death, stroke, myocardial infarction or kidney failure; the need for pacemaker implantation occurred in 5,2% of patients. Conclusions: Direct implantation of Edwards Sapien XT aortic valve is feasible and safe in selected patients and is followed by good midterm outcome.
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