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Implant and short-term outcome with the JenaValveTM a second generation self-expanding trans-apical TAVI system: Post CE mark single center experience
Devdas T. Inderbitzin1, Florian Rueter1, Raban Jeger2, Christoph Kaiser2, Jens Fassl3, Friedrich S. Eckstein1, Oliver Reuthebuch1.
1Clinic for Cardiac Surgery Basel-Bern, University Hospital Basel, Basel, Switzerland, 2Department of Cardiology, University Hospital Basel, Basel, Switzerland, 3Department of Anesthesiology, University Hospital Basel, Basel, Switzerland.

OBJECTIVE: We present the first Swiss and post CE-mark implant experience and short-term outcome with the JenaValveTM TAVI system.
METHODS: Patients receiving trans-apical TAVI on beating heart using the JenaValveTM System (JenaValve Technology GmbH, Munich, Germany) from November 2011 to August 2012 were evaluated. Baseline characteristics, intra- and postoperative course with clinical/echocardiographic evaluation were analyzed. Perioperative complications were defined to Valve Academic Research Consortium criteria.
RESULTS: 27 patients (30% female, mean age 80.3 ± 5.5 years, mean logistic EuroSCORE 23.3 ± 11.7) presented in median NYHA class III (min. II, max. IV), a mean LVEF of 50.5 ± 13.3% and a severe calcified aortic valve stenosis (mean dP 47.5 ± 16.2 mmHg, mean valve opening area: 0.81 ± 0.21 cm2). Mean operation time was 123.7 ± 23.2 minutes (reducing from 122.8 ± 28.8 to 114.0 ± 17.9 min from first to second half). Implant success rate was 100%, 17 (63%) cases needed intraoperative balloon dilation to correct paravalvular leakage (success rate 70.6%). Used prostheses’ sizes were 23 mm (22.2%), 25 mm (51.8%), 27 mm (26%). In-hospital MACCE: Intra-operative resuscitation with aortic rupture (3.7%), postoperative hemorrhage needing revision or drainage (7.4%), myocardial infarction (3.7%), AV-block needing definitive pacemaker (3.7%), new onset renal failure needing hemodialysis (3.7%), pleural empyema (3.7%) and stroke (3.7%). 30-day-mortality was 11.1% (n=3, cardiac). Except one conversion to open surgery due to aortic rupture, no perioperative directly device related complications occurred. Mean ICU/total stay was 2.2 ± 1.7 / 11.7 ± 7.9 days. Median NYHA class increased to II until discharge (p=0.0001, Wilcoxon signed rank test). Postoperative (day 6.7 ± 4.8) echocardiography revealed residual paravalvular leakage grade 1 in 12 patients (55.5%) and a mean trans-valvular pressure gradient of 11.6 ± 5.6 mmHg with significant reduction by 36.0 ± 17.7 mmHg (p=0.0001, Wilcoxon signed rank test). LVEF did not significantly change (p = 0.769, Wilcoxon signed rank test).
CONCLUSIONS: Trans-apical TAVI with the JenaValveTM was safe with an excellent short-term outcome, a significant reduction of mean pressure gradient, low complication rate and mortality with an overall clinical improvement at discharge. Long-term follow-up has to confirm this favorable tendency.


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