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

Stephen Worthley
Stephen Worthley1,2, MBBS; Simon Redwood3, MD; David Hildick-Smith4, MD; Tony Rafter5, MBBS; Alan Whelan6, MBBS; Federico De Marco7, MD; Mark Horrigan8, MBBS; Sinny Delacroix1,2, MD; John Gregson9, PhD; Andrejs Erglis10, MD
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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clinical researchmitral regurgitationmitral valve repairspecific closure device/technique
Coronary interventionsInterventions for valvular diseaseOther coronary interventionsMitral valve replacement and repair
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