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 or pulmonary hypertension 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.

Treatment options for symptomatic severe tricuspid regurgitation include medicines, such as loop diuretics. 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 and increased risk of mortality. Medicines do 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.

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.

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

Some 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-sided heart function was substantially impaired before the procedure.

The implanted valves considered in the current evidence are made from animal tissue.

There are different types of device and different access routes used for implantation, which may affect safety and efficacy outcomes.

Evidence suggests the procedure may have a greater benefit in people with more severe tricuspid regurgitation but there may also be a higher proportion of adverse outcomes.

The committee acknowledged that there are different aetiologies of tricuspid regurgitation.

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.

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