2. St Thomas’ Hospital, London, United Kingdom
3. Brighton and Sussex NHS Trust, Brighton, United Kingdom
4. HeartCare Partners, Brisbane, Qld, Australia
5. HeartCare WA, Perth, WA, Australia
6. IRCCS Policlinico San Donato, Milan, IT
7. Austin Health, HeartCare Victoria, Melbourne, Vic, Australia
8. St. Andrew's Hospital, Adelaide, SA, Australia; GenesisCare, The Mill, 41-43 Bourke Road, Alexandria, NSW, Australia, Australia
9. London School of Hygiene and Tropical Medicine, London, UK
10. Latvian Centre of Cardiology, Pauls Stradins Clinical University Hospital, Riga, Latvia
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Methods and Results MAVERIC is a multicenter, prospective, non-randomized pre-commercial study. Eligible patients were on guideline-recommended therapy for NYHA class II-IV systolic heart failure and had an FMR grade≥2+.
ARTO™ system was implanted in forty-five (100%) patients. Primary safety composite endpoint (death, stroke, myocardial infarction, device related surgery, cardiac tamponade, renal failure) at 30-days and one-year was 4.4% [95%CI 1.5-16.6] and 17.8% [95%CI 9.3-32.4]. Periprocedural complications occurred in seven patients (15.5% [95%CI 6.5-29.5]) and five patients (11.1% [95%CI 4.9-24.0]) died during one-year follow-up. Paired results for 36 patients demonstrated 24 (66.7%) had Grade 3+/4+ mitral regurgitation at baseline however, only 5 (13.9%) and 3 (8.3%) patients remained at Grade 3+/4+ 30-days and one-year post-procedure (p<0.0001). Echocardiographic parameters such as antero-posterior annulus diameter decreased from 41.4mm (baseline) to 36.0 and 35.3mm at 30-days and one-year respectively
(p<0.0001). Twenty-five patients (69.4%) had baseline NYHA Class III/IV symptoms decreasing significantly to 9 (25.0%) at 30-days and 8 (22.2%) at one-year post-procedure (p<0.0001).
Conclusion The ARTO™ transcatheter mitral valve repair system is both safe and effective in decreasing FMR up to one-year post-procedure.
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