The Official Journal of EuroPCR and the European Association of Percutaneous Coronary Interventions (EAPCI)

Interventions for valvular disease and heart failure

Transcatheter reshaping of the mitral annulus in patients with functional mitral regurgitation: one-year outcomes of the MAVERIC trial

EuroIntervention 2021;16:1106-1113. DOI: 10.4244/EIJ-D-20-00484

1. St Andrews Hospital, Adelaide, SA, Australia; 2. GenesisCare, Alexandria, NSW, Australia; 3. St Thomas Hospital, London, United Kingdom; 4. Brighton and Sussex NHS Trust, Brighton, United Kingdom; 5. HeartCare Partners, Brisbane, QLD, Australia; 6. HeartCare WA, Perth, WA, Australia; 7. IRCCS Policlinico San Donato, Milan, Italy; 8. Austin Health, HeartCare Victoria, Melbourne, VIC, Australia; 9. London School of Hygiene and Tropical Medicine, London, United Kingdom; 10. Latvian Centre of Cardiology, Pauls Stradins Clinical University Hospital, Riga, Latvia

Aims: The aim of this study was to assess the one-year safety and efficacy of the transcatheter ARTO system in the treatment of functional mitral regurgitation (FMR).

Methods and results: MAVERIC is a multicentre, prospective, non-randomised pre-commercial study. Eligible patients were on guideline-recommended therapy for NYHA Class II-IV systolic heart failure and had an FMR grade ≥2+. The ARTO system was implanted in forty-five (100%) patients. The 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), respectively. 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 that 24 (66.7%) had grade 3+/4+ mitral regurgitation at baseline; however, only five (13.9%) and three (8.3%) patients remained at grade 3+/4+ 30 days and one year post procedure (p<0.0001). Echocardiographic parameters such as anteroposterior annulus diameter decreased from 41.4 mm (baseline) to 36.0 and 35.3 mm 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 nine (25.0%) at 30 days and eight (22.2%) at one year post procedure (p<0.0001).

Conclusions: 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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