TPVR Offers Lower-risk Option for Pulmonary Regurgitation

Massachusetts General Hospital is among a select group of institutions offering new minimally invasive options for adult and pediatric patients with severe pulmonary regurgitation. Two novel valve systems allow certain patients to avoid or delay open-heart surgery to repair the pulmonary valve.

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"Over time, progressive pulmonary regurgitation leads to right ventricular volume overload and dilation, systolic and diastolic dysfunction, risk of heart failure and arrhythmia, and significant morbidity and increased mortality risk," says Ada Stefanescu Schmidt, MDCM, MSc, FACC, an interventional cardiologist in the Corrigan Minehan Heart Center who was instrumental in bringing the technology to Mass General along with her colleagues Ignacio Inglessis-Azuaje, MD, and Rahul Sakhuja, MD, from Interventional Cardiology, and Doreen DeFaria Yeh, MD, and Chris Learn, MD, from the Adult Congenital Heart Disease Program. "Some of these patients are high-risk for open heart surgery, and a minimally invasive transcatheter procedure was preferred. But many patients have right ventricular outflow tracts and pulmonary arteries that are too large to accommodate the previously available transcatheter valves. Now, many patients for whom we used to think we had no good treatment options, are candidates for this new procedure."

The Alterra Prestent System and Harmony™ Transcatheter Pulmonary Valve System improve blood flow to the lungs without open-heart surgery. Mass General has performed seven self-expanding transcatheter pulmonary valve replacement (TPVR) procedures so far, with excellent outcomes. The team is screening many more potential candidates.

Advances in Pulmonary Regurgitation Treatment

Pulmonary regurgitation occurs when the pulmonary valve doesn't close completely, permitting blood to leak backward into the heart. It's often related to congenital heart abnormalities such as tetralogy of Fallot or occurs after procedures to repair congenital issues.

Over time, the right ventricle has to pump harder to push the excess blood out, causing various symptoms, including palpitations, dizziness, and shortness of breath. It also can damage the right ventricle and cause right heart failure.

Until recently, the only treatment option for pulmonary regurgitation was open-heart surgery to replace the valve with a biosynthetic or donated human valve, or, for patients with a relatively small pulmonary valve annulus, transcatheter replacement with balloon-expandable valves, such as the Melody or Sapien valves. In 2021, the U.S. Food and Drug Administration approved the Harmony and Alterra valves for TPVR.

Like its open-heart counterpart, TPVR immediately improves symptoms and can help prevent heart failure, says Dr. Stefanescu Schmidt. But it carries a lower risk of complications and involves a faster recovery time. And the new approach also allows more flexibility in planning a lifelong course of treatment for pulmonary regurgitation.

"We think about our patients in terms of their lifelong trajectory, and we know that the interventions we do today will impact the options we have in 10 or 15 years from now and all the interventions over the course of their life," says Dr. Stefanescu Schmidt. "Younger patients might choose to have a transcatheter procedure now, which we hope lasts about 10 years, and then have surgery or another transcatheter procedure. And some patients might prefer to have the surgery now and then do the transcatheter valve later on."

Candidates for Transcatheter Pulmonary Valve Replacement

The two valves and their associated procedures are quite similar, with some minor technical details, Dr. Stefanescu Schmidt explains. The Alterra system is a bit stiffer, which can improve positioning and may be more appropriate in slightly larger tracts. The softer Harmony valve may reduce the risk of injury in some anatomies.

When a patient is referred to Mass General for the procedure, they receive care from a team, including:

• Cardiologists, Dr. Defaria Yeh, Dr. Learn, and Dr. Stefanescu Schmidt, and surgeons, Duke E. Cameron, MD, and Jordan Bloom, MD, MPH, with expertise in heart structure and congenital heart conditions
• Interventional cardiologists who have extensive experience with transcatheter valve placement for other conditions, such as aortic valve disease, as well as congenital heart disease
• A cardiologist who has been treating the patient over time
• Radiologists who specialize in cardiac imaging and anesthesiologists who specialize in heart procedures
• Consultation with national experts in transcatheter pulmonary valves (TPVs)
• Heartfelt Dreams Foundation, which can help patients travel to Boston for the procedure

Dr. Stefanescu Schmidt and her team work together to determine the best option for each patient. Each person is screened with high-resolution coronary computed tomography angiography (CCTA), under a protocol specifically established by the expert cardiac radiology team under the leadership of Brian B. Ghoshhajra, MD. The test takes precise measurements and performs 3D modeling to see whether the valve will fit well. Sometimes the screening process can be conducted virtually, with the local cardiologist sending CCTA results to Mass General for review.

Mass General began screening about 40 patients between March and September 2022, Dr. Stefanescu Schmidt says. Fourteen patients so far have been deemed good candidates, and only one has been declined due to high-risk anatomy. The others are still in the screening process.

Outcomes After TPVR

Outcomes for the TPVR procedures completed at Mass General have been excellent, Dr. Stefanescu Schmidt reports. The patients, ranging in age from 40 to 75 years, have experienced:

• Immediate improvement or resolution of symptoms
• Increased exercise capacity
• Less need for diuretics
• Recovery from the procedure within a few days
• Resolution of heart failure

"One of our early patients was a gentleman in his 70s who lives in upstate New York and had heart surgery when he was 40 years old. He was feeling well and was lost to follow-up for many years, but he started becoming more symptomatic. In his retirement, he enjoyed trapping and going for long hikes in the woods. But he couldn't do that because he was very short of breath," Dr. Stefanescu Schmidt says. "He had been told that the only option would be a relatively high-risk surgery. But he was referred to us, and we discussed this lower-risk procedure. He made the trip down to Boston for a few days, and he was able to undergo this procedure and did exceedingly well. Within a week, he was getting ready to go back on his ATV and go out in the woods and check his traps."

She recalls another patient, a Jehovah's Witness in his 40s who had impaired heart and kidney function. Because of the religion's restrictions on the use of blood products and his risk factors, other practitioners told him there were no options. "He was able to undergo this procedure at Mass General and did very well. A few days beforehand, he attended his son's grade-school graduation, then a couple of days later, he was back with his family. It was a really lovely outcome," Dr. Stefanescu Schmidt says.

The Mass General team usually follows up with patients at one month and then one year after the procedure, and as needed after that. They work closely with the local cardiology teams, also with the option of seeing patients via telehealth.

Changing the Future of Pulmonary Regurgitation Care

Dr. Stefanescu Schmidt is working to make more cardiologists and patients aware of this new option. Among her strategies is participating in a research initiative and databases to track outcomes, such as the American College of Cardiology's IMPACT Registry and the multi-institutional SERVE (Self-Expanding RVOT Valve Evidence) Registry. She hopes this will eventually lead to revised international guidelines that include TPV placement earlier in the treatment trajectory.

"These patients traditionally thought they had no low-risk solution—that the only solution might be surgery. We've actually seen patients who are scared of coming back to care; they're scared of reporting their symptoms because they think that will mean they need an operation," she says. "We want people to know that we can now offer patients a new, lower-risk option."

Dr. Stefanescu Schmidt and colleagues recently published additional background information on percutaneous pulmonary valve therapeutics on the American College of Cardiology website.

Learn more about the Adult Congenital Heart Disease Program

Refer a patient to the Corrigan Minehan Heart Center