Treatment of Heart Failure with Associated Functional Mitral Regurgitation Using the ARTO System Initial Results of the First-in-Human MAVERIC Trial (Mitral Valve Repair Clinical Trial)

Jason H Rogers, Martyn Thomas, Marie Claude Morice, Inga Narbute, Milana Zabunova, Thomas Hovasse, Mathieu Poupineau, Ainars Rudzitis, Ginta Kamzola, Ligita Zvaigzne, Samantha Greene, Andrejs Erglis

Research output: Contribution to journalArticlepeer-review

27 Scopus citations

Abstract

Objectives MAVERIC (Mitral Valve Repair Clinical Trial) reports the safety and efficacy of the ARTO system in patients with symptomatic heart failure and functional mitral regurgitation (FMR). Background The ARTO system percutaneously modifies the mitral annulus to improve leaflet coaptation in FMR. Methods The MAVERIC trial is a prospective, nonrandomized first-in-human study. Key inclusion criteria were systolic heart failure New York Heart Association functional classes II to IV, FMR grade ≥2+, left ventricular (LV) ejection fraction 40%, LV end-diastolic diameter >50 mm and;75 mm. Exclusion criteria were clinical variables that precluded feasibility of the ARTO procedure. Primary outcomes were safety (30-day major adverse events) and efficacy (MR reduction, LV volumes, and functional status). Results Eleven patients received the ARTO system, and there were no procedural adverse events. From baseline to 30 days, there were meaningful improvements. Effective regurgitant orifice area decreased from 30.3 ± 11.1 mm<sup>2</sup> to 13.5 ± 7.1 mm<sup>2</sup> and regurgitant volumes from 45.4 ± 15.0 ml to 19.5 ± 10.2 ml. LV end-systolic volume index improved from 77.5 ± 24.3 ml/m<sup>2</sup> to 68.5 ± 21.4 ml/m<sup>2</sup>, and LV end-diastolic volume index 118.7 ± 28.6 ml/m<sup>2</sup> to 103.9 ± 21.2 ml/m<sup>2</sup>. Mitral annular anteroposterior diameter decreased from 45.0 ± 3.3 mm to 38.7 ± 3.0 mm. Functional status was 81.8% New York Heart Association functional class III/IV improving to 54.6% functional class I/II. At 30 days, there were 2 adverse events: 1 pericardial effusion requiring surgical drainage; and 1 asymptomatic device dislodgement. Conclusions The ARTO system is a novel transcatheter device that can be used safely with meaningful efficacy in the treatment of FMR. (Mitral Valve Repair Clinical Trial [MAVERIC]; NCT02302872)

Original languageEnglish (US)
Pages (from-to)1095-1104
Number of pages10
JournalJACC: Cardiovascular Interventions
Volume8
Issue number8
DOIs
StatePublished - Jul 1 2015

Keywords

  • coronary sinus
  • functional mitral regurgitation
  • heart failure
  • mitral annulus
  • transcatheter mitral valve repair

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

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