Author + information
- Stephen G. Worthley1,
- Andrejs Erglis2,
- Simon Redwood3,
- David Hildick-Smith4,
- Tony Rafter5 and
- Alan Whelan6
- 1Genesis Healthcare, Sydney, Victoria, Australia
- 2P. Stradins Clinical University Hospital, Riga, Latvia
- 3St Thomas' Hospital, London, United Kingdom
- 4Royal Sussex County Hospital, Brighton, United Kingdom
- 5The Wesley Hospital, Brisbane, Queensland, Australia
- 6Mount Hospital, Perth, Western Australia, Australia
The ARTO™ System (MVRx, San Mateo, CA) is a Transcatheter Annular Repair Therapy (TART) that modifies the mitral annulus to improve leaflet coaptation in patients with functional mitral regurgitation and systolic heart failure. The MAVERIC trial was designed to evaluate the safety and performance of the ARTO™ System in these patients.
MAVERIC is a prospective, single arm study conducted in 8 sites in 4 countries and has enrolled 45 patients. Key inclusion criteria are symptomatic systolic HF with NYHA Class II-IV and FMR grade ≥ 2+.Exclusion criteria consist of clinical variables that preclude feasibility of the ARTO procedure and significant structural abnormality of the valve. Primary outcomes are the major adverse event rate at 30 days post-procedure, MR grade change from baseline to 30 days and procedural device success. Additional planned clinical/echo follow-up is at 180 days and yearly for 3 years. Clinical outcomes are CEC adjudicated and all echo parameters are analyzed by an echo core lab. 30 day data on 45 patients was presented at EuroPCR 2017. This presentation will report the 6 month follow-up on these patients.
At baseline, mean age of the patients is 70 +12, 60% are male, LVEF 40 +9, prior PCI 33%, prior MI 38%, atrial fibrillation 44% and COPD 21%. Results to date: 30 day outcomes on 45 patients include 0 deaths, 0 myocardial infarctions and 0 strokes and 100% device technical success including no incidence of LCX compression. There were 2 major adverse events in the first 30 days: a pericardial effusion which was surgically drained without recurrence and one acute kidney injury post-procedure which has resolved without sequalae. From baseline to 30 days, there were meaningful improvements in MR, LV volumes and functional measures. 71% of patients had MR grade 3+/4+ at baseline and at 30 days 86% were Grade 0 to 2+ (p<0.0001). Regurgitant volume decreased from 43.1 ± 12.1 to 23.6 ± 9.7ml. (p<0.0001). NYHA functional class status improved from 71% in Grade III/IV at baseline to 73% in Class I and II at 30 days. Currently, all of these measures are stable or improved out to 3 years.
The MAVERIC trial establishes the safety and efficacy of the ARTO system in the treatment of FMR associated with systolic HF. Key highlights of the study include a very low rate of adverse events accompanied by structural improvements in cardiac function and clinical status.
STRUCTURAL: Valvular Disease: Mitral