"Transcatheter Mitral-Valve Repair in Heart Failure Patients with Mitral Regurgitation".The New England Journal of Medicine. 2018. DOI: 10.1056/NEJMoa1806640.

Clinical Question

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?

Bottom Line

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.

Major Points

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.

Guidelines

No guidelines were specified within the study. The treatment modalities were chosen according to standard medical guidelines for heart failure therapy.

Design

Multicenter, randomized, controlled, parallel-group, open-label trial.

Population

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%

Interventions

Patients were randomized to receive either transcatheter mitral-valve repair plus medical therapy (device group) or medical therapy alone (control group).

Outcomes

Primary Effectiveness
- Hospitalizations for heart failure within 24 months

Primary Safety
- Freedom from device-related complications at 12 months

Secondary Outcomes
- All-cause mortality within 24 months
- Quality of life and functional capacity within 24 months

Criticisms

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.

Funding

Funded by Abbott.

Further Reading

Full text available at nejm.org and ClinicalTrials.gov number, NCT01626079.