Author + information
- Received December 9, 2014
- Revision received March 25, 2015
- Accepted April 9, 2015
- Published online July 1, 2015.
- Jason H. Rogers, MD∗∗ (, )
- Martyn Thomas, MD†,
- Marie-Claude Morice, MD‡,
- Inga Narbute, MD§,
- Milana Zabunova, MD§,
- Thomas Hovasse, MD‡,
- Mathieu Poupineau, MD‖,
- Ainars Rudzitis, MD§,
- Ginta Kamzola, MD§,
- Ligita Zvaigzne, MD§,
- Samantha Greene, BA¶ and
- Andrejs Erglis, MD§
- ∗Division of Cardiovascular Medicine, University of California, Davis Medical Center, Sacramento, California
- †Guy’s and St Thomas’ Hospital, London, United Kingdom
- ‡Générale de Santé, Institut Cardiovasculaire Paris Sud, Massy, France
- §Latvian Centre of Cardiology, Pauls Stradins Clinical University Hospital, Riga, Latvia
- ‖Cardiology Department, Centre Hospitalier Prive, Claude Galien, Quincy Sous-Senart, France
- ¶MVRx Inc., Belmont, California
- ↵∗Reprint requests and correspondence:
Dr. Jason H. Rogers, Division of Cardiovascular Medicine, University of California, Davis Medical Center, 4860 Y Street, Suite 2820, Sacramento, California 95817.
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 mm2 to 13.5 ± 7.1 mm2 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/m2 to 68.5 ± 21.4 ml/m2, and LV end-diastolic volume index 118.7 ± 28.6 ml/m2 to 103.9 ± 21.2 ml/m2. 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)
- coronary sinus
- functional mitral regurgitation
- heart failure
- mitral annulus
- transcatheter mitral valve repair
Dr. Rogers is a consultant to MVRx, Inc. Ms. Greene is consultant for MVRx, Inc. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received December 9, 2014.
- Revision received March 25, 2015.
- Accepted April 9, 2015.
- 2015 American College of Cardiology Foundation