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DOI: 10.1055/s-0031-1297393
Transapical aortic valve implantation for high risk patients with severe aortic stenosis: 3 months results of a multicenter study using the JenaValve second generation transcatheter aortic valve implantation system
Objectives: Transcatheter aortic valve implantation (TAVI) has shown promising results in patients with severe aortic stenosis at high risk for surgery. Safety and efficacy of transapical aortic valve implantation using the JenaValveTM, a second generation TAVI device featuring a tested porcine root valve mounted on a nitinol stent with feeler guided positioning and clip fixation on the diseased leaflets was evaluated.
Methods: This multicenter, prospective, single arm study conducted at 7 German sites enrolled 73 patients (mean age 83.1±3.9, EuroSCORE 28.3±6.8%) of whom 67 patients underwent TAVI with 23mm (N=21), 25mm (N=31) and 27mm (N=15) valves. Clinical and echocardiographic evaluation was performed at baseline, post-procedure, discharge, 30 days, 3, 6, and 12 months. Primary endpoint was all cause mortality at 30 days. Secondary endpoints were procedural success, major adverse cerebrovascular and cardiac events, and echocardiographic performance.
Results: TAVI with the JenaValveTM device was successful in 60 patients (procedural success rate 89.6%). Overall mortality at 30 days was 7.6%. Conversion to surgery was necessary in 4 patients (6%), 2 patients underwent valve-in-valve implantations (3%), one patient was converted to TAVI using a balloon-expandable valve (2.4%). Perioperative stroke occurred in two cases (3%). Pacemakers were implanted in 8 patients (11.9%). No coronary ostium obstructions were seen. TAVI resulted in favourable reduction of mean transvalvular gradients (40.0±16.1mmHg vs. 10.0±7.3mmHg, p<0.0001) and increase in valve opening area (0.7±0.2cm2 vs. 1.7±0.6cm2, p<0.0001). None of the successful implanted patients had severe post procedural aortic regurgitation (> grade 2). Three months results will be presented at the conference.
Conclusions: Transapical JenaValveTM implantation was safe and effective in treatment of severe aortic stenosis in elderly patients at high risk for surgery. Active clip fixation on the native leaflets and feeler guided anatomically correct positioning led to good functionality and prevented coronary impairment. Implantation without the need of rapid pacing prevents hemodynamic compromise during valve implantation.