Thirty-day VARC-2 and performance data of a new self-expanding transcatheter aortic heart valve.
Citation: Eurointervention. 11(7):785-92, 2015 Nov.PMID: 25983028Institution: MedStar Heart & Vascular InstituteForm of publication: Journal ArticleMedline article type(s): Clinical Trial | Journal Article | Video-Audio MediaSubject headings: *Aortic Valve | *Aortic Valve Stenosis/th [Therapy] | *Cardiac Catheterization/is [Instrumentation] | *Heart Valve Prosthesis | *Heart Valve Prosthesis Implantation/is [Instrumentation] | Aged | Aged, 80 and over | Aortic Valve Stenosis/di [Diagnosis] | Aortic Valve Stenosis/pp [Physiopathology] | Aortic Valve/pp [Physiopathology] | Aortic Valve/ra [Radiography] | Cardiac Catheterization/mt [Methods] | Coronary Angiography | Feasibility Studies | Female | Germany | Heart Valve Prosthesis Implantation/mt [Methods] | Humans | Male | Prospective Studies | Prosthesis Design | Severity of Illness Index | Time Factors | Treatment OutcomeYear: 2015ISSN:- 1774-024X
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Journal Article | MedStar Authors Catalog | Article | 25983028 | Available | 25983028 |
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.
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