MAVERIC: Transcatheter mitral valve repair system confers 6-month benefit
Transcatheter annular reduction therapy for treatment of functional mitral regurgitation was safe and effective at 6 months, according to data presented at TCT 2017.
“[Functional mitral regurgitation] is a burden that is at least four times that of primary mitral incompetence and we know that in terms of prognosis, it has a very poor outlook in patients with HF and [left ventricular] dysfunction and that over half of [the patients] passed away at 3 years,” Stephen G. Worthley, MBBS, PhD, from The University of Adelaide, Australia, said in a press conference.
According to the presentation, current therapies including guideline-directed medical therapy and mitral valve surgery may not adequately treat functional mitral regurgitation. Worthley said that according to the Duke Database, only 11% of patients with isolated functional mitral regurgitation are offered surgery, which drops to 6% when considering only those with LV ejection fraction 20% to 30%.
Worthley and colleagues conducted a multicenter, single-arm study testing the safety and efficacy of the transcatheter annular reduction therapy system (ARTO, MVRx Inc.) for mitral valve repair.
The study included 45 patients (mean age, 70 years; 60% men) who had a mitral regurgitation grade of 2 or more, were NYHA class II to IV, and received optimized medical therapy.
Before the study was conducted, patients had a mandated heart team review to decide their surgical risk.
The primary safety outcome was major adverse events at 30 days. The primary efficacy outcome was mitral regurgitation grade at 30 days.
Secondary outcome measures were NYHA class, HF hospitalization and device success measures.
The technical success rate of the device was 100%.
At 6 months, major adverse events, defined as death, stroke MI, mitral operation/intervention, cardiac tamponade and renal failure, occurred in 16% of patients.
“There have been 3 deaths between that 30-day and 6-month period,” Worthley said. “All of them are CV deaths, although none of them have been adjudicated independently as procedure- or device-related.”
At baseline, all patients had a mitral regurgitation grade of 2 or more, but at 6 months, 18.4% had a grade of 0 or trace and 39.5% had a grade of 1 (P < .0001), according to the researchers.
NYHA class improved in the cohort at 6 months. At baseline, 29.3% were class II, 63.4% were class III and 7.3% were class IV, while at 6 months, 17.1% were class I, 61% were class II and 22% were class III (P < .0001), Worthley said.
According to Worthley, further research through randomized controlled trials is needed to understand the true efficacy of the treatment strategy.
“As we’ve seen from the mitral options, there’s valve replacement, chordal and annular reduction therapies, but for many patients, no one of these treatments is the panacea and I think there is a growing interest in the concept that we could be pairing some of these technologies in the future.” – by Dave Quaile
Worthley, SG, et al. First Report Investigations 3. Presented at: TCT Scientific Symposium; Oct. 29-Nov. 2, 2017; Denver.
Disclosure: The study was funded by MVRx, Inc. Worthley reports he receives consultant fees and honoraria from Abbott and Medtronic.