Transcatheter tricuspid valve replacement (TTVR) appears to be a reliable and safe option for older patients with severe tricuspid regurgitation, according to a study that examined the real-world outcomes of the procedure.

The study, published in JAMA, linked TTVR to near-complete elimination of tricuspid regurgitation. Results also demonstrated its effectiveness and safety in this patient population as well as improved quality of life in those with comorbidities outside of a clinical trial.

Severe tricuspid regurgitation, common in older adults, is associated with worsening heart failure and hospitalization and has historically been undertreated because many patients are poor candidates for surgery, said corresponding author of the study Raj R. Makkar, MD, vice president of Cardiovascular Innovation and Intervention at Cedars-Sinai and the Karsh Distinguished Chair in Interventional Cardiology in the Smidt Heart Institute in Los Angeles.

Although the TTVR system showed beneficial outcomes in the TRISCEND II trial and entered real-world US practice in 2024, data were still limited on how it would perform outside of a clinical trial, Makkar said. He and his colleagues sought to understand whether the procedure’s effectiveness and safety would remain strong in routine care, particularly in an older, more medically complex population and in patients with preexisting cardiac implantable electronic devices.

The researchers hoped the benefits observed in the pivotal trial, especially marked reduction in tricuspid regurgitation and improvement in symptoms and quality of life would translate into everyday practice with acceptable safety levels, he said.

Makkar and colleagues led a retrospective cohort study of all US patients in the Society of Thoracic Surgeons/ American College of Cardiology Transcatheter Valve Therapy Registry who underwent TTVR from February 2024 through March 2025.

Near-Complete Elimination of Tricuspid Regurgitation

Of 1034 attempted procedures at 82 centers (mean age, 77.1 years), 98.4% of patients experienced a successful valve implantation. Mild or less tricuspid regurgitation was seen in 98.4% of patients post-procedure and in 97.7% of patients at the 30-day mark.

Makkar said the results suggest severe symptomatic tricuspid regurgitation in older adults should not be viewed as an untreatable condition or simply a consequence of aging. He added that in this national real-world experience, the procedure was associated with near-complete elimination of tricuspid regurgitation in most patients, “along with meaningful improvements in symptoms and health status, even in an older and highly-comorbid population.”

Equally important, adverse event rates at 30 days were relatively low given this population’s risk profile, according to Grant Reed, MD, MSc, Basler Family Endowed Chair in Interventional Cardiology and program director of Interventional Cardiology Fellowship at Cleveland Clinic, Cleveland.

All-cause mortality, he noted, was around 3.1%, stroke 0.2%, and major bleeding 7.9%. About 15.9% of pacemaker-naive patients required a new pacemaker. “Interestingly, pacemaker implantation was substantially lower in this real-world analysis compared with TRISCEND II,” said Reed, who was not involved in the study. “This suggests that improved patient selection, technique, and postprocedure management in real-world practice are already mitigating some risks,” he said.

For older patients with tricuspid regurgitation, valve replacement offers more options than in the past, said Rani K. Hasan, MD, MHS, an interventional cardiologist at Johns Hopkins Medicine in Baltimore. Hasan was not part of the study.

“Other than medication, open heart surgery was once the only option and many patients were not candidates for this,” Hasan said. Many who took medications did not do well in the long run because they do not fix the underlying problem, he added.

Treat Early, More Aggressively

Hasan noted that cardiologists should be treating tricuspid regurgitation earlier and more aggressively. “We need to determine the right timing,” he said, adding that surgeons and interventional cardiologists often see patients later in the disease course, which delays treatment.

Although the study provided encouraging 30-day results, extended follow-up should be explored, Reed said. “We need data at 1-2 years and beyond to confirm that the early improvements in tricuspid regurgitation and quality of life translate into sustained reductions in heart failure hospitalizations and mortality,” he said.

“Recently presented 2-year results from the TRISCEND II trial suggest a potential mortality benefit with TTVR compared with medical therapy, which is an exciting possibility that warrants confirmation in larger cohorts,” Reed said.

Reed added that head-to-head studies of valve replacement vs transcatheter edge-to-edge repair in specific patient subgroups would be valuable. “These comparative trials or registries will help refine patient selection and guide cardiologists in choosing the optimal therapy for each patient,” he said.

Makkar reported receiving grants from JenaValve, Edwards Lifesciences, Boston Scientific, Medtronic, and Abbott during the conduct of the study and equity from iCardio.ai outside the submitted work. Reed reported receiving consulting and/or medical advisory board honoraria for Abbott Laboratories, Boston Scientific, and Edwards Lifesciences. Hasan reported consulting for Medtronic, having equity in Health Repair Technologies, and receiving research grants from Medtronic and Edwards Lifesciences, and Cardiac Dimensions.