"Transcatheter Mitral-Valve Repair in Heart Failure Patients with Mitral Regurgitation".The New England Journal of Medicine. 2018. DOI: 10.1056/NEJMoa1806640.
Links to original sources: Wiki Journal Post Full Journal Article
Does transcatheter mitral-valve repair improve clinical outcomes in patients with heart failure and moderate-to-severe or severe secondary mitral regurgitation who remain symptomatic despite maximal doses of guideline-directed medical therapy?
Transcatheter mitral-valve repair plus medical therapy was superior to medical therapy alone in reducing hospitalizations for heart failure and all-cause mortality within 24 months in patients with heart failure and significant secondary mitral regurgitation.
Patients with heart failure and secondary mitral regurgitation who remain symptomatic despite medical therapy have few treatment options and a poor prognosis. Transcatheter mitral-valve repair may reduce heart failure symptoms and potentially improve survival for these patients.
No guidelines were specified within the study. The treatment modalities were chosen according to standard medical guidelines for heart failure therapy.
Multicenter, randomized, controlled, parallel-group, open-label trial.
Enrolled 614 patients at 78 centers in the United States and Canada with heart failure and secondary mitral regurgitation.
Inclusion Criteria - Left ventricular ejection fraction of 20 to 50% - Moderate-to-severe or severe secondary mitral regurgitation - Symptomatic (NYHA class II, III, or IVa) despite maximal doses of guideline-directed medical therapy
Exclusion Criteria The specific exclusion criteria were not disclosed in the summary.
Baseline Characteristics - Mean age: 72.2 ± 11.2 years - 36.0% women - 36.5% received cardiac resynchronization therapy - Mitral regurgitation grade 3+ in 52.2% and 4+ in 47.8% - Mean STS score: 8.2 ± 5.9%
Patients were randomized to receive either transcatheter mitral-valve repair plus medical therapy (device group) or medical therapy alone (control group).
Primary Effectiveness - Hospitalizations for heart failure within 24 months
Primary Safety - Freedom from device-related complications at 12 months
- All-cause mortality within 24 months - Quality of life and functional capacity within 24 months
The trial was open-label, with potential for bias in intervention awareness. Longer median follow-up in the device group, possibly due to lower mortality. By chance, a higher use of agents affecting the renin–angiotensin axis was noted in the device group at baseline.
Funded by Abbott.
Full text available at nejm.org and ClinicalTrials.gov number, NCT01626079.