Clinical Trial Offers Patient an Innovative Solution for Faulty Tricuspid Valve

The TRISCEND Pivotal Trial at Brigham and Women's

The Brigham is one of the select sites in the TRISCEND Pivotal Trial for treating tricuspid regurgitation. This trial is studying the safety and effectiveness of a new transcatheter heart valve designed to replace the heart's tricuspid valve. During a minimally invasive heart surgery, a catheter (thin tube) is placed through a vein in the leg to reach the heart, where the new heart valve is deployed inside of the old valve.

While transcatheter procedures like these are commonly used for treating diseased aortic and mitral valves, this trial is the first to use this approach for tricuspid valves. 

"Tricuspid regurgitation has been ignored for a long time, partly because patients may have the condition for some time without showing major symptoms," Dr. Shah explained. "In the past, the only option was open-heart surgical valve replacement. For many of these patients, that approach would be very risky and entail a long recovery." 

Dr. Shah and other Brigham interventional cardiologists have contributed to many clinical trials exploring new transcatheter valve technologies. In fact, he and his colleagues were involved in early feasibility trials of the same device later used to treat John in a larger-scale pivotal trial.

"We've shown that we can successfully manage tricuspid regurgitation and other heart valve conditions with these catheter-based approaches," Dr. Shah said. "With this particular procedure, we've seen very good results, minimal complications, and a short recovery time. Some patients can go home the next day." 

A swift recovery from minimally invasive valve surgery

Dr. Shah performed John's procedure at the Brigham. The procedure lasted about three hours, and there were no complications. "My wife, Joanne, was appreciative that the surgical team gave her the 'halftime report' while she waited on pins and needles," John said. 

The next morning, John was able to go home. Aside from some soreness in his groin, where the surgical catheter had been inserted, and grogginess from the anesthesia, he felt fine. 

At first, John didn't notice an immediate difference, since his tricuspid regurgitation hadn't caused severe symptoms. But as he resumed biking and other activities, he started to feel subtle improvements in his energy and stamina. 

"Joanne and I spend half our time in Florida. Our place is on the fifth floor of the building," John said. "I try to use the stairs to get some exercise. Last year, I had to take a break on the fourth floor. Now I can make it all the way up without resting." 

As part of the trial, John underwent clinical and echocardiogram follow-up at 30 days and six months after the procedure. Follow-up tests showed the procedure was a success, Dr. Nohria noted. 

"His last echocardiogram revealed much less leakage in the repaired valve," she said. "The pressure in his lungs also has gone down, and his kidney function hasn't gotten any worse. He will continue to be followed for five years within the trial."

John praises the quality of care he has received at the Brigham, highlighting the expertise and kindness of Drs. Nohria and Shah, along with Sinead Coyle, a lead research assistant who helped him navigate scheduling and other logistics during the TRISCEND trial. 

Looking ahead, Dr. Nohria will see John every six months to manage his medications and monitor his new valve. The follow-up data will be shared with the clinical trial team to help advance the technology and benefit care for future patients. 

"It's always a pleasure to do something positive for any patient but particularly for a patient like John, who has such a zest for life," Dr. Nohria said. "Helping someone like him to have a better quality of life is truly a gratifying experience."