期刊
CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS
卷 98, 期 6, 页码 1204-1209出版社
WILEY
DOI: 10.1002/ccd.29833
关键词
Allegra; aortic stenosis; transcatheter aortic valve; TAVR; transcatheter aortic valve replacement; outcomes
The study found that transfemoral implantation of the Allegra transcatheter heart valve (THV) resulted in favorable clinical and echocardiographic outcomes during hospitalization and short-term follow-up in a large patient population from four European centers.
Objectives We aimed to determine the safety and efficacy of the Allegra transcatheter heart valve (THV) for the treatment of severe aortic valve stenosis in a large patient population treated under real-world conditions. Background The Allegra is a novel self-expanding THV with supra-annular bovine leaflets. The valve is available in three different sizes (23, 27, and 31 mm), all are delivered through an 18F sheath. Methods Consecutive patients undergoing TAVR with the Allegra THV were enrolled in a multicenter-registry. Data were collected throughout initial hospital-stay and at 30-day follow-up. Clinical endpoints were defined according to the updated definitions of the Valve-Academic-Research-Consortium. Results This registry included 255 patients (mean age 83 +/- 6 years, 48% women) from four European centers. Median European System for Cardiac Operative Risk Evaluation II score (EuroSCORE II) was 3.3% (IQR 1.9-5.8%). Acute device success was 95.7%. The remaining 11 patients had either moderate paravalvular regurgitation immediately after the procedure (7 patients) or the device could not be optimal positioned requiring implantation of a second THV (4 patients). Major vascular complications and major/life-threatening bleedings occurred in 10 (3.9%) and 12 (4.7%) patients, respectively. At 30 day follow-up, mean effective orifice area was 2.2 +/- 0.5 cm(2), mean gradient was 6.9 +/- 3.8 mmHg, 7 (3.3%) patients had more than mild paravalvular leakage, 3 patients (1.2%) had died, 6 patients (2.4%) had a stroke and 30 (12.8%) patients had required implantation of a new permanent pacemaker. Conclusions Transfemoral implantation of the Allegra THV resulted in favorable clinical and echocardiographic outcomes during hospitalization and short-term follow up.
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