New Minimally Invasive Procedure Can Fix Your Heart’s Tricuspid Valve

There weren’t always good solutions for repairing a faulty tricuspid valve, the valve on the right side of the heart that allows blood to flow from the top chamber to the bottom one. In fact, for many years, a lack of safe and effective treatments contributed to the tricuspid’s nickname: “the forgotten valve.”

For the 1.6 million people in the United States who have tricuspid valve regurgitation, a condition in which a faulty tricuspid valve causes blood to leak backwards (or backflow), medication has difficult side effects, including serious kidney problems. And while open heart surgery can effectively repair the condition, it’s risky for many patients who are older, have tricuspid-related issues such as liver disease, and may have other medical conditions that are more common with age. But without treatment, they experience a poor quality of life, with symptoms such as irregular heart rhythms, fatigue, swelling in the legs, shortness of breath, and, in severe cases, heart failure.

That’s finally changing, with the introduction of new solutions, such as the TriClip G4™, a clip that reduces leaking across this valve. The clip was approved by the Food and Drug Administration (FDA) in April 2024.

“The good news is that we have more options now that don’t involve open heart surgery,” says Amit N. Vora, MD, MPH, a Yale Medicine interventional cardiologist who performs complex catheter-based repairs. Dr. Vora and John K. Forrest, MD, director of Yale Medicine's Interventional Cardiology and Structural Heart Disease programs, contributed to the multisite clinical trial on which the FDA approval was based. The interventional cardiologists began treating patients with the new clip in November 2024, using a procedure called percutaneous tricuspid transcatheter edge-to-edge repair (TEER).

Below, Dr. Vora answered questions about the TriClip and how it can treat a leaky tricuspid valve.

The heart has four chambers—the top two are the right and left atria, and the bottom two are the right and left ventricles. On each side, a valve allows the blood to flow from the top to the bottom—the tricuspid valve is on the right; the mitral valve is on the left. These valves have leaflets (like flaps) that open to let the blood flow through and close to keep it from flowing backward.

“When people have tricuspid regurgitation, however, the valve’s leaflets don’t close as they should,” Dr. Vora explains.

The condition, which can get worse over time depending on its cause, is primarily diagnosed using an echocardiogram, which uses ultrasound waves to produce detailed images of the heart, allowing doctors to assess the movement of the tricuspid valve and the extent of blood backflow. Additional tests, such as an electrocardiogram (ECG) to evaluate heart rhythm and a chest X-ray to observe heart size, can provide additional information. In some cases, a cardiac CT scan or heart catheterization procedure may be used for a more comprehensive assessment.

“Not everyone who has tricuspid regurgitation will need treatment,” says Dr. Vora, adding that many people with mild tricuspid regurgitation don’t have symptoms. “The clip is a therapy geared more toward people who are having symptoms and a more severe form of the disease, in which a substantial amount of blood leaks backward, leading to heart enlargement and failure.”

It may also be an option for those with a moderate-to-severe form of the condition who cannot tolerate the side effects of medication or who are too sick for open heart surgery.

The TriClip G4, by Abbott, is identical to the company’s MitraClip™, which was introduced several years ago to correct regurgitation, or “backward leaking,” in the mitral valve. The TriClip has arms that open and close. When it is attached to the valve leaflets in a catheter-based procedure, “it allows us to bring the leaflets of the valve together, and, by doing so, reduce the amount of leaking,” he says.

A study called TRILUMINATE, published in The New England Journal of Medicine in March 2023, assessed the safety and efficacy of this procedure in patients with severe tricuspid regurgitation treated at 65 medical centers, including Yale. The study compared participants treated with medication to those given the clip and found the TEER procedure had a significant advantage—in 87% of patients who underwent the procedure, it lowered their severe regurgitation diagnosis to mild or moderate. “The main thing the study demonstrated for the tricuspid valve is that the procedure can reduce the amount of tricuspid regurgitation significantly,” Dr. Vora says.

The study also found TEER to be safe; 98.3% of the patients who underwent the procedure were free from major adverse events at 30 days. The main risks are bleeding, damage to structures surrounding the valve, and a small risk of stroke and death. There is also a small risk that the clip can detach from one or both of the leaflets, which, in extreme situations, may lead to open heart surgery.

Additionally, because the clip is identical to Abbott’s mitral valve clip, “it has a well-demonstrated safety profile,” Dr. Vora says. “It has been used in hundreds of thousands of patients worldwide in the mitral position without trouble.”

The study did not, however, show that the clip can prolong life or prevent hospitalization for heart failure, which he says might be an unrealistic primary goal, considering that many of the patients already have advanced tricuspid disease and often other serious medical issues. “With that in mind, we want to focus on helping these patients maximize their quality of life—and with the clip, there is a significant improvement in that area,” he says.

A tricuspid clip procedure is performed in the hospital under general anesthesia. The interventional cardiologist makes several needle punctures in the groin and inserts a catheter, with the clip attached, through the largest vein, then pushes it toward the tricuspid valve, using X-ray and ultrasound imaging for guidance. The clip has arms that grip the tricuspid leaflets and bring them together, reducing the backflow of blood. Once the clip is in the proper position, it is released from the catheter, which is then removed.

“The majority of patients need two or three clips to effectively reduce the amount of blood leaking from the valve,” Dr. Vora says. “The number of clips needed depends on a patient's specific anatomy.” (The TriClip comes in four sizes, so the surgeon can choose the one best tailored to the patient.)

Once a clip is inserted, it’s difficult to remove, but the expectation is that the clip will stay in place for the rest of the patient’s life, Dr. Vora adds.

Patients go home the same day as the procedure or the next day, and are advised to avoid lifting more than 10 pounds for one week. “Outside of that, we want people to be up, active, and moving,” Dr. Vora says. “Most people are back to doing what they want to do within days or a week or two.”

The condition can arise from issues directly affecting the tricuspid valve or from changes in the heart's structure and function that indirectly impact the valve. Primary causes involve direct valve damage or congenital (present at birth) issues, while secondary causes are usually related to changes in heart dynamics, such as right ventricular enlargement or pulmonary hypertension, which affect the valve's ability to close properly. Treatment for secondary causes may involve addressing the underlying issue, in addition to surgery or medications.

The TriClip can be helpful for patients who are older (the average age in the TRILUMINATE study was 78), have severe tricuspid regurgitation, and are at risk for complications from open heart surgery. “Often, they are patients with right-sided heart failure symptoms,” Dr. Vora says. “They feel short of breath, particularly with activity, and have swelling in their ankles or fullness in their belly.”

Also, many of the patients are older people who have had long-standing mitral valve disease—to the point where the mitral valve regurgitation is affecting the tricuspid valve as well, Dr. Vora says. “The pressure this puts on the mitral valve [on the left side of the heart] transmits through the lungs to the tricuspid valve [on the right side], causing regurgitation there too,” he says. “For that reason, many patients who undergo mitral valve repair have tricuspid valve repair as well.”

Other patients who may benefit from this procedure are those with pacemakers, whose pacemaker lead (an insulated wire that delivers energy from the device to the heart) has impacted the tricuspid valve—sometimes by impinging upon the leaflet, causing regurgitation. Still others have atrial fibrillation, an irregular heart rhythm, that can lead to the enlargement of the top two chambers of the heart, dilating the ring the tricuspid valve sits in, leading to severe tricuspid regurgitation, Dr. Vora says.

Early or mild tricuspid valve regurgitation often doesn’t cause symptoms and requires little or no treatment—and it may never become severe.

But it is one reason why everyone should pay attention to their general heart health, especially as they get older, Dr. Vora says. “Often, a person may feel as though they're not able to be as active as they were even just a year or two ago. They may attribute that to normal aging when that's not necessarily the case.” Getting tired more easily than usual or noticing shortness of breath with activity are also good reasons to consult a primary care provider or cardiologist, he says.

Symptoms of severe tricuspid disease may also include extreme fatigue, a rapid or pounding heartbeat, active pulsing in the neck veins, and decreased urine output. In rare cases, fluid may accumulate in the body, especially in the legs.

“In these situations, especially in someone who has existing valve disease, it may be important to have a conversation with a cardiologist who can then decide whether or not they should be referred to a comprehensive valve clinic for additional evaluation, Dr. Vora says.