title: Thirty-day VARC-2 and performance data of a new self-expanding transcatheter aortic heart valve.
abstract: OBJECTIVE
  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.
  
  
  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.
  
  
  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.
authors.affiliation: Department of Cardiovascular Surgery, University Heart Center Hamburg, Hamburg, Germany.
authors.forename: Hendrik
authors.initials: H
authors.lastname: Treede
authors.forename: Edith
authors.initials: E
authors.lastname: Lubos
authors.forename: Lenard
authors.initials: L
authors.lastname: Conradi
authors.forename: Florian
authors.initials: F
authors.lastname: Deuschl
authors.forename: Federico M
authors.initials: FM
authors.lastname: Asch
authors.forename: Neil J
authors.initials: NJ
authors.lastname: Weissman
authors.forename: Niklas
authors.initials: N
authors.lastname: Schofer
authors.forename: Johannes
authors.initials: J
authors.lastname: Schirmer
authors.forename: Dietmar
authors.initials: D
authors.lastname: Koschyk
authors.forename: Stefan
authors.initials: S
authors.lastname: Blankenberg
authors.forename: Hermann
authors.initials: H
authors.lastname: Reichenspurner
authors.forename: Ulrich
authors.initials: U
authors.lastname: Schaefer
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001021:Aortic Valve / Q000000981:diagnostic imaging / Q000503:physiopathology; D001024:Aortic Valve Stenosis / Q000175:diagnosis / Q000503:physiopathology / Q000628:therapy*; D006328:Cardiac Catheterization / Q000295:instrumentation* / Q000379:methods; D017023:Coronary Angiography; D005240:Feasibility Studies; D005260:Female; D005858:Germany; D006350:Heart Valve Prosthesis; D019918:Heart Valve Prosthesis Implantation / Q000295:instrumentation* / Q000379:methods; D006801:Humans; D008297:Male; D011446:Prospective Studies; D011474:Prosthesis Design; D012720:Severity of Illness Index; D013997:Time Factors; D016896:Treatment Outcome