Mitral regurgitation

Mitral regurgitation means the valve between the left upper and lower heart chambers does not close tightly, so some blood leaks backward. A US government patient page says the leak is most often due to prolapse, where the valve flaps sag back. In people with heart failure the leak can be due to weakness of the left lower chamber (left ventricular dysfunction); trials call this secondary or functional mitral regurgitation. Medicines, a repair or a replacement can treat it, and a US government treatment page lists a device placed through a catheter among the options for people for whom open-heart surgery is not advised.

Also called Mitral valve insufficiency · Leaky mitral valve · Secondary mitral regurgitation · Functional mitral regurgitation

Condition
In this atlas

Overview

Technical summary

MeSH D008944 is named Mitral Valve Insufficiency. The registry record for COAPT lists the condition as mitral regurgitation, and its abstract describes patients with heart failure and moderate-to-severe or severe secondary mitral regurgitation who stayed symptomatic despite maximal doses of guideline-directed medical therapy. US approvals for the MitraClip device cover degenerative mitral regurgitation at prohibitive surgical risk (2013) and secondary mitral regurgitation (2019). Secondary mitral regurgitation also relates to heart failure, and this record links to the heart failure record for that reason.

Recognition

A US government patient page says a doctor may diagnose a valve problem from symptoms, by listening to the heart or with imaging tests.

Burden

No burden claims are published.

Claims and evidence

No claims are published for this condition yet.

Clinical links

Each link reports what one cited claim says about one population. "Evaluated for" means studied, not shown to work. These links do not show that anything is effective or right for you.

Claim, not a settled fact Evaluated for this: MitraClip (Evaluated for, seen from the other side)
Applies to Adult
- Patients 18 years or older (registry minimum age) with heart failure and moderate-to-severe or severe secondary mitral regurgitation who remained symptomatic despite maximal doses of guideline-directed medical therapy; 614 were randomized (302 to the device group and 312 to the control group). The registry record also covers a continued access study of 162 further patients. The detailed inclusion and exclusion criteria are in the registry record and were not extracted.
- 78 sites in the United States and Canada (abstract)
- United States and Canada
- Registry minimum age 18 years; no maximum age
Follow-up The primary effectiveness end point covers 24 months; the primary safety end point is at 12 months (abstract). The registry gives the primary completion as 2019-03 and an estimated study completion of 2024-07, with a recruitment status of unknown.
In COAPT, 614 patients with heart failure and moderate-to-severe or severe secondary mitral regurgitation who were still symptomatic on maximal medicines were randomized at 78 sites in the United States and Canada to the MitraClip device plus medicines (302 patients) or medicines alone (312 patients). The annualized rate of all hospitalizations for heart failure within 24 months was 35.8% per patient-year with the device and 67.9% per patient-year with medicines alone (hazard ratio 0.53, 95% confidence interval 0.40 to 0.70). The primary safety end point, freedom from device-related complications at 12 months, was 96.6% (lower 95% confidence limit 94.8%), above the prespecified goal of 88.0%.
Limitations. Funded by Abbott; the registry lists Abbott Medical Devices as lead sponsor and FDA lists ABBOTT MEDICAL as applicant for the device. The registry lists no masking. The result applies to the group enrolled: symptomatic heart failure with secondary mitral regurgitation despite maximal medicines. It does not show the same effect in people with primary (degenerative) mitral regurgitation or in people who are not on maximal medicines. Other trials of the same device in similar patients are not covered in this record. The registry shows a recruitment status of unknown with an estimated completion in 2024-07, which is out of date. Only the abstract was read.
Claim, not a settled fact Evaluated for this: MitraClip (Evaluated for, seen from the other side)
Applies to Adult
- Patients 18 years or older (registry minimum age) with heart failure and moderate-to-severe or severe secondary mitral regurgitation who remained symptomatic despite maximal doses of guideline-directed medical therapy; 614 were randomized (302 to the device group and 312 to the control group). The registry record also covers a continued access study of 162 further patients. The detailed inclusion and exclusion criteria are in the registry record and were not extracted.
- 78 sites in the United States and Canada (abstract)
- United States and Canada
- Registry minimum age 18 years; no maximum age
Follow-up The primary effectiveness end point covers 24 months; the primary safety end point is at 12 months (abstract). The registry gives the primary completion as 2019-03 and an estimated study completion of 2024-07, with a recruitment status of unknown.
In COAPT, death from any cause within 24 months occurred in 29.1% of the patients in the MitraClip plus medicines group and in 46.1% of the patients in the medicines alone group (hazard ratio 0.62, 95% confidence interval 0.46 to 0.82).
Limitations. The abstract does not name death from any cause among the end points in its methods; it reports 24-month death as a result. The registry lists all-cause mortality among its secondary outcomes (a count at 12 months, and Kaplan-Meier freedom from all-cause mortality at 24 months). The abstract does not say whether this test was prespecified or adjusted for multiple comparisons, so treat it as a secondary result. The same limits apply as for the heart-failure hospitalization claim: funded by Abbott, no masking in the registry, selected patients with secondary mitral regurgitation on maximal medicines. Only the abstract was read.

Record details

Record id: cardio:mitral-regurgitation
Content hash: c2e3209fb28fed97ea1e842ca448cee9ff00690d543cf97d6aae9fbb3b257baa