TY  - BOOK
AU  - Asch, Federico M
AU  - Weissman, Neil J
TI  - Thirty-day VARC-2 and performance data of a new self-expanding transcatheter aortic heart valve
SN  - 1774-024X
PY  - 2015///
KW  - *Aortic Valve
KW  - *Aortic Valve Stenosis/th [Therapy]
KW  - *Cardiac Catheterization/is [Instrumentation]
KW  - *Heart Valve Prosthesis
KW  - *Heart Valve Prosthesis Implantation/is [Instrumentation]
KW  - Aged
KW  - Aged, 80 and over
KW  - Aortic Valve Stenosis/di [Diagnosis]
KW  - Aortic Valve Stenosis/pp [Physiopathology]
KW  - Aortic Valve/pp [Physiopathology]
KW  - Aortic Valve/ra [Radiography]
KW  - Cardiac Catheterization/mt [Methods]
KW  - Coronary Angiography
KW  - Feasibility Studies
KW  - Female
KW  - Germany
KW  - Heart Valve Prosthesis Implantation/mt [Methods]
KW  - Humans
KW  - Male
KW  - Prospective Studies
KW  - Prosthesis Design
KW  - Severity of Illness Index
KW  - Time Factors
KW  - Treatment Outcome
KW  - MedStar Heart & Vascular Institute
KW  - Clinical Trial
KW  - Journal Article
KW  - Video-Audio Media
N2  - AIMS: Transcatheter aortic valve therapy has become an established procedure for patients at high risk for surgical valve replacement. The BIOVALVE-I study aims to assess the safety and performance of a novel self-expanding transcatheter heart valve; CONCLUSIONS: In this first-in-human study, the feasibility of implantation of the BIOVALVE system and its re-sheathing functionality was demonstrated, and short-term safety data were encouraging. Larger studies are required to confirm the performance of the device; METHODS AND RESULTS: In this prospective, single-centre, first-in-human study, 13 patients with severe aortic stenosis suitable for transfemoral transcatheter aortic valve implantation were enrolled. Mean logistic EuroSCORE was 14.4+/-3.7% and mean STS PROM score was 4.3+/-1.6%. The primary endpoint, 30-day early safety composite per VARC-2, was observed in two patients (15.4%, one life-threatening bleeding and one valve-in-valve procedure). The implant was aborted in two patients due to unsuitable aortic anatomy. Overall, device success was obtained in nine patients (69.2%, two aborted implants, one valve-in-valve procedure and one patient with moderate aortic regurgitation). As determined by an independent core laboratory, all but one patient had less than moderate total aortic regurgitation at 30-day follow-up, mean aortic gradient was 6.7+/-2.3 mmHg and effective orifice area 1.8+/-0.3 cm. Pacemakers were implanted in three patients (23.1%), and no death, stroke, myocardial infarction or acute kidney failure was observed
UR  - http://dx.doi.org/10.4244/EIJY15M05_05
ER  -