A Sham-Controlled Randomized Trial of Transcatheter Indirect Mitral Annuloplasty in Heart Failure Patients With Functional Mitral Regurgitation - REDUCE-FMR
Contribution To Literature:
The REDUCE-FMR trial showed that among patients with HF with dilated LVs and moderate to severe secondary MR, transcatheter mitral annuloplasty with the Carillon device significantly reduced the degree of MR at 1 year compared with sham controls.
The goal of the trial was to assess the safety and efficacy of transcatheter mitral annuloplasty in reducing regurgitant volumes among symptomatic heart failure (HF) patients with dilated left ventricles (LVs) and secondary mitral regurgitation (MR).
Patients with HF and moderate to severe MR were randomized in a 2:1 fashion to transcatheter mitral annuloplasty with the Carillon device (n = 87) or a sham procedure (n = 33).
- Total screened: 135
- Total number of enrollees: 120
- Duration of follow-up: 1 year
- Dilated ischemic or nonischemic cardiomyopathy
- Functional moderate to severe MR defined as: grade 2+, 3+ or 4+; New York Heart Association (NYHA) class II, III, or IV
- LV ejection fraction (LVEF) ≤50%; 40-50% LVEF must be MR grade 3+/4+ AND NYHA class III/IV
- LV end-diastolic dimension (LVEDD) >55 mm, or LVEDD/body surface area >3.0 cm/m2
- Stable HF medication for ≥3 months
- Hospitalization in past 3 months due to myocardial infarction (MI), coronary artery bypass grafting, or unstable angina
- Hospitalization in past 30 days for coronary angioplasty or stent placement
- Expected to require any cardiac surgery within 1 year
- Presence of coronary artery stent under the coronary sinus/great cardiac vein, in the implant target zone
- Severe mitral annular calcification
- Significant organic mitral valve pathology
The primary effectiveness endpoint, change in regurgitant volume at 1 year, for Carillon vs. sham control, was -7.1 vs. 3.3 ml (p = 0.03).
Secondary outcomes for Carillon vs. sham:
- Death at 1 year: 12.6% vs. 15.2%
- Procedure-related MI at 30 days: 3.5% vs. 3.0%
- Cumulative major adverse event at 1 year: 16.1% vs. 18.2%
- Change in regurgitant volume at 1 year, per protocol (n = 27): -12.5 vs. 1.3 ml, p = 0.06
- Change in LV end-diastolic volume at 1 year: -8.6 vs. 6.5 ml, p = 0.06
The results of this trial indicate that, among patients with HF with dilated LVs and moderate to severe secondary MR, transcatheter mitral annuloplasty with the Carillon device significantly reduced the degree of MR at 1 year compared with sham controls. Among patients with available data, there were also reductions noted in LV volumes. Procedural safety seemed reasonable in this small trial.
Functional MR is a tough condition to treat. This device uses a different approach than the MitraClip for MR reduction. The trial specifically enrolled patients with dilated LVs and used a percutaneous device (Carillon) that is inserted into the coronary sinus and reduces MR much like an annuloplasty band. Results from the ongoing CARILLON FDA pivotal randomized trial are awaited.
Presented by Dr. Horst Sievert at the Transcatheter Cardiovascular Therapeutics meeting (TCT 2018), San Diego, CA, September 23, 2018.
Clinical Topics: Cardiac Surgery, Heart Failure and Cardiomyopathies, Invasive Cardiovascular Angiography and Intervention, Valvular Heart Disease, Aortic Surgery, Cardiac Surgery and Heart Failure, Cardiac Surgery and VHD, Acute Heart Failure, Interventions and Structural Heart Disease, Mitral Regurgitation
Keywords: TCT18, Transcatheter Cardiovascular Therapeutics, Cardiac Surgical Procedures, Cardiomyopathies, Coronary Sinus, Heart Failure, Heart Valve Diseases, Myocardial Infarction, Mitral Valve Annuloplasty, Mitral Valve Insufficiency, Percutaneous Coronary Intervention, Stents, Stroke Volume
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