Transcatheter tricuspid valve implantation for symptomatic severe tricuspid regurgitation

Tricuspid regurgitation is when blood flows backwards through the tricuspid valve because it does not close properly during systole (when the heart contracts). It can be caused by a problem with the valve itself, but more commonly is a result of an underlying cardiac problem that has caused the heart to become dilated. This stretches the annulus that supports the valve leaflets so they do not meet and regurgitation of blood happens. Mild tricuspid regurgitation does not usually cause symptoms. Severe regurgitation may cause fatigue, weakness, active pulsing in the neck veins, liver enlargement, ascites, peripheral oedema and renal impairment. Medicines may not effectively control the symptoms. Pulmonary hypertension may develop.

Treatment options for symptomatic severe tricuspid regurgitation include medicines to reduce pulmonary artery pressure or pulmonary vascular resistance. Open-heart surgery to repair or replace the tricuspid valve may also be an option. But surgery on the tricuspid valve only is rarely done because it is associated with high morbidity and mortality. It is more commonly done at the same time as surgery on the valves in the left side of the heart (mitral and aortic). There are also transcatheter techniques for repairing the tricuspid valve, including leaflet repair and annuloplasty.

Symptomatic severe tricuspid regurgitation can be debilitating and lead to poor quality of life. Medication does not address the underlying cause and open-heart surgery is often prohibitively high risk. Transcatheter tricuspid valve repair techniques may not be suitable for some people. Transcatheter tricuspid valve implantation may provide a treatment option for people with severe tricuspid regurgitation who have symptoms despite optimal medical therapy, when open-heart surgery or other transcatheter techniques are unsuitable.

NICE did a rapid review of the published literature on the efficacy and safety of this procedure. This comprised a comprehensive literature search and detailed review of the evidence from 12 sources, which was discussed by the committee. The evidence included 1 randomised controlled trial (reported in 2 publications), 1 systematic review and meta-analysis, 2 prospective single-arm studies, 1 retrospective cohort study, 1 registry study, 3 non-randomised comparative studies and 2 case reports. It is presented in the summary of key evidence section in the interventional procedures overview. Other relevant literature is in the appendix of the overview.

The professional experts and the committee considered the key efficacy outcomes to be:

• reduced tricuspid regurgitation

• reduced signs and symptoms of right-sided heart failure

• improved quality of life, reduced hospital admissions related to heart failure

• improved survival.

The professional experts and the committee considered the key safety outcomes to be:

• mortality

• bleeding

• paravalvular leak

• need for permanent pacemaker implantation.

Patient commentary was sought but none was received.

Most people need anticoagulation after the procedure and regimens for this are being developed.

People who do not already have a pacemaker may need one after this procedure. Pacemaker implantation may be more complex because of the need to avoid having leads going through the implanted valve. It may be necessary to use a leadless pacemaker.

When the tricuspid valve has been made competent after severe regurgitation, there is a small risk of making heart failure worse if the right heart's function was substantially impaired before the procedure.

The implanted valves may be made from animal tissue. .

Tricuspid regurgitation has a higher prevalence and faster progression in women than men. Women often present with more severe tricuspid regurgitation, when open-heart surgery is often unsuitable. So this procedure could particularly benefit women, helping to address inequality of care.

Some people may not want to have a valve containing animal tissue because of their religious or cultural beliefs.