Author + information
- Ulrich Schäfer1,
- Lenard Conradi1,
- Frank Hoelschermann2,
- Hidehiro Kaneko2,
- Lisa Voigtländer1,
- Yvonne Schneeberger1 and
- Christian Butter3
The Allegra Transcatheter Heart Valve (THV) is a novel, supra-annular, self-expanding nitinol valve, made from bovine pericardial tissue that is 18F compatible. Initial acute procedural results of safety, effectiveness and hemodynamic performance are reported and intermediate long-term results including more patients at the time of TCT2017 will be presented.
The study was a conceptual study to investigate the hemodynamic performance of the Allegra THV for treatment of degenerated surgical and transcatheter bioprostheses in two centers in Germany. Follow-up visits’ evaluations encompass the primary endpoint of all-cause mortality, safety endpoints, echocardiographic results, paravalvular leak and functional assessments.
So far, transfemoral THV implantation was conducted in 5 patients with a degenerated bioprosthesis and increased surgical risk (STS Score was 7.1±3.2%, log EuroSCORE 24.9±12.4%) and successfully completed in 4 patients (acute device success, 80%). The mean age was 78±1.4 years, 80% were female, and 100% were in NYHA class III/IV, The implanted valve size was 23 mm in all patients. Echocardiographic hemodynamic performance revealed mean aortic valve area increased from 0.8±0.7 cm2 at baseline to 1.8±0.4 cm2 at conclusion of the procedure (p < 0.01). Mean transaortic gradient decreased from 49.2±28.7 mmHg to 11±4.6 mmHg (p <0.01). Paravalvular aortic regurgitation post-procedure was none in 80%, and severe in 20% (too low implant). In hospital survival was 100%. The freedom from disabling stroke was 100% and new permanent pacemaker was 80% (one patient had an AV-block already before TAVR).
This novel self-expanding transcatheter valve with a supraannular valve function demonstrates to be effective with significant hemodynamic improvements after treatment of degenerated bioprostheses with favorable transvalvular gradients. More patients including intermediate long-term results will be presented at the meeting.
STRUCTURAL: Valvular Disease: Aortic