Heart valve disease

Heart valve disease means that at least one of the heart's four valves is not working properly. A valve can leak backward (regurgitation), can be too narrow (stenosis), or can lack an opening (atresia). Some people are born with a valve problem. In others it develops with age or after an infection. NHLBI says most valve conditions are treatable, with medicine, a repair or a replacement.

Also called Heart valve diseases · Valvular heart disease

Condition
In this atlas

Overview

Technical summary

Parent record for the valve conditions in this atlas: aortic stenosis, mitral regurgitation and rheumatic heart disease. NHLBI names three types of heart valve disease (regurgitation, stenosis and atresia). MeSH D006349 (Heart Valve Diseases) is the matching heading. The atlas has no separate tricuspid regurgitation record, so the TriClip and TRILUMINATE records file their link under this one. Replacement and repair covered here: transcatheter aortic valve replacement, surgical aortic valve replacement and transcatheter edge-to-edge repair.

Recognition

NHLBI says a doctor may ask about symptoms, listen to the heart or order imaging tests, and that a person can have a valve problem without symptoms.

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: TriClip (Evaluated for, seen from the other side)
Applies to Adult
- Patients 18 years or older (registry minimum age) with symptomatic severe tricuspid regurgitation, 350 of whom were randomized 1:1 at 65 centers in the United States, Canada and Europe (175 to each group). The abstract gives a mean age of 78 years, with 54.9% women. The registry record also covers a single-arm cohort and a continued access study. The detailed inclusion and exclusion criteria are in the registry record and were not extracted.
- 65 centers in the United States, Canada and Europe (abstract)
- United States, Canada and Europe
- Registry minimum age 18 years; mean age 78 years (abstract)
Follow-up The primary end point was at 12 months (abstract). The registry gives the primary completion as 2022-11-18 and an estimated study completion of 2029-04.
In TRILUMINATE Pivotal, 350 patients with symptomatic severe tricuspid regurgitation were randomized 1:1 at 65 centers to transcatheter edge-to-edge repair (the TriClip device) plus medical therapy or to medical therapy alone (175 patients in each group). The primary end point was a hierarchical composite of death from any cause or tricuspid-valve surgery, hospitalization for heart failure, and an improvement of at least 15 points on the Kansas City Cardiomyopathy Questionnaire (a quality-of-life score) at 1 year. The result favored repair (win ratio 1.48, 95% confidence interval 1.06 to 2.13, P = 0.02). The incidence of death or tricuspid-valve surgery and the rate of hospitalization for heart failure did not appear to differ between the groups. The quality-of-life score changed by 12.3 points with repair and 0.6 points in the control group. At 30 days, 87.0% of the repair group and 4.8% of the control group had tricuspid regurgitation of no greater than moderate severity. 98.3% of the patients who had the procedure were free from major adverse events at 30 days.
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 records masking of the outcomes assessor only. The abstract reports no apparent difference in death or tricuspid-valve surgery, or in hospitalization for heart failure, so the benefit shown is in the combined score, in quality of life and in the severity of the regurgitation. The abstract does not say how much each component contributed to the win ratio. The FDA indication is for quality of life and function, not for survival or hospitalization. The result is at 1 year. Only the abstract was read.

Record details

Record id: cardio:heart-valve-disease
Content hash: 0928b1e8f52d28a7125ad856cf5900b7a3fe898c39450cf975d67ca8122891e3