title: 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).
abstract: OBJECTIVE
  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(2) to 13.5 ± 7.1 mm(2) 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(2) to 68.5 ± 21.4 ml/m(2), and LV end-diastolic volume index 118.7 ± 28.6 ml/m(2) to 103.9 ± 21.2 ml/m(2). 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).
authors.affiliation: Division of Cardiovascular Medicine, University of California, Davis Medical Center, Sacramento, California. Electronic address: jhrogers@ucdavis.edu.
authors.forename: Jason H
authors.initials: JH
authors.lastname: Rogers
authors.affiliation: Guy's and St Thomas' Hospital, London, United Kingdom.
authors.forename: Martyn
authors.initials: M
authors.lastname: Thomas
authors.affiliation: Générale de Santé, Institut Cardiovasculaire Paris Sud, Massy, France.
authors.forename: Marie-Claude
authors.initials: MC
authors.lastname: Morice
authors.affiliation: Latvian Centre of Cardiology, Pauls Stradins Clinical University Hospital, Riga, Latvia.
authors.forename: Inga
authors.initials: I
authors.lastname: Narbute
authors.affiliation: Latvian Centre of Cardiology, Pauls Stradins Clinical University Hospital, Riga, Latvia.
authors.forename: Milana
authors.initials: M
authors.lastname: Zabunova
authors.affiliation: Générale de Santé, Institut Cardiovasculaire Paris Sud, Massy, France.
authors.forename: Thomas
authors.initials: T
authors.lastname: Hovasse
authors.affiliation: Cardiology Department, Centre Hospitalier Prive, Claude Galien, Quincy Sous-Senart, France.
authors.forename: Mathieu
authors.initials: M
authors.lastname: Poupineau
authors.affiliation: Latvian Centre of Cardiology, Pauls Stradins Clinical University Hospital, Riga, Latvia.
authors.forename: Ainars
authors.initials: A
authors.lastname: Rudzitis
authors.affiliation: Latvian Centre of Cardiology, Pauls Stradins Clinical University Hospital, Riga, Latvia.
authors.forename: Ginta
authors.initials: G
authors.lastname: Kamzola
authors.affiliation: Latvian Centre of Cardiology, Pauls Stradins Clinical University Hospital, Riga, Latvia.
authors.forename: Ligita
authors.initials: L
authors.lastname: Zvaigzne
authors.affiliation: MVRx Inc., Belmont, California.
authors.forename: Samantha
authors.initials: S
authors.lastname: Greene
authors.affiliation: Latvian Centre of Cardiology, Pauls Stradins Clinical University Hospital, Riga, Latvia.
authors.forename: Andrejs
authors.initials: A
authors.lastname: Erglis
mesh_terms: D000368:Aged; D006328:Cardiac Catheterization / Q000009:adverse effects / Q000295:instrumentation*; D018618:Echocardiography, Doppler, Color; D004867:Equipment Design; D005260:Female; D006333:Heart Failure / Q000175:diagnosis / Q000503:physiopathology / Q000628:therapy*; D006439:Hemodynamics; D006801:Humans; D007844:Latvia; D008297:Male; D008875:Middle Aged; D008943:Mitral Valve / Q000000981:diagnostic imaging / Q000503:physiopathology*; D008944:Mitral Valve Insufficiency / Q000175:diagnosis / Q000503:physiopathology / Q000628:therapy*; D011446:Prospective Studies; D020127:Recovery of Function; D013318:Stroke Volume; D013536:Suture Techniques / Q000009:adverse effects / Q000295:instrumentation*; D013997:Time Factors; D016896:Treatment Outcome; D016277:Ventricular Function, Left
keywords: coronary sinus; functional mitral regurgitation; heart failure; mitral annulus; transcatheter mitral valve repair