Patients with severe heart valve disease who underwent nonsurgical tricuspid valve replacement showed significant improvements in overall cardiovascular health status and quality of life within 30 days post-procedure, according to a recent study published in JAMA.  

The findings underscore the effectiveness and safety of the procedure for patients with the condition, severe symptomatic tricuspid regurgitation, said Charles Davidson, MD, ‘85 GME, Professor of Medicine in the Division of Cardiology and Executive Vice chair for Clinical Affairs in the Department of Medicine, who was a principal investigator of the Northwestern Medicine clinical site and senior author of the study.  

“What this shows us is that there’s scalability to this treatment to a broad population showing that we can achieve mild or less tricuspid regurgitation in virtually all patients, and that this significantly improves patients’ quality of life by all objective and subjective metrics,” Davidson said. “We demonstrated that we have a technology that can be applied to a larger population beyond those studied in the clinical trials.”  

Tricuspid regurgitation — in which the heart’s tricuspid valve does not close properly, causing blood to leak backwards from the right ventricle into the right atrium — is the most common valvular heart disease in adults 65 years and older. Previously this was underrecognized and undertreated when relying on medical therapy that is often ineffective in preventing disease progression disease and worsening symptoms.  

Nonsurgical transcatheter tricuspid valve replacement was approved by the U.S. Food and Drug Administration in February 2024 as an alternative treatment option for tricuspid regurgitation. The FDA’s approval was the result of a previous clinical trial, of which Davidson was also a co-author, that found that the procedure significantly improved outcomes in patients with tricuspid regurgitation compared to clinical surveillance that included standard care alone.  

In the current study, Davidson and his team evaluated 30-day outcomes, tricuspid regurgitation reduction and changes in health status in more than 1,000 patients with severe tricuspid regurgitation who underwent transcatheter tricuspid valve replacement at 82 medical centers across the U.S. from February 2024 through March 2025.  

The events tracked by the study included all-cause death, stroke, bleeding, new cardiac implantable electronic device (CIED) implantation and heart failure hospitalizations. 

The investigators found that the valve was successfully implanted in 98.4 percent of patients, and residual mild or less tricuspid regurgitation was achieved in 97.7 percent of patients at 30 days.  

Additionally, at 30 days they found that all-cause mortality was 3.1 percent; stroke was 0.2 percent; bleeding was 7.9 percent; and the need for a new CIED among patients without a preexisting device was 15.9 percent.  

“This is a validation that the technology is as effective of what was reported in the previous pivotal trial, and in some cases may actually be better than what observed because of moving beyond the early learning curve and the better standardized education at new centers,” Davidson said. 

The study is the first-of-its-kind to report safety and effectiveness of transcatheter tricuspid valve replacement in a commercial clinical setting. Davidson also highlighted the need for a standardized design framework for future clinical trials to determine the durability of the device in patients and how outcomes compare to surgery in patients over time.  

“Valve replacements are not meant to last forever, so durability is an important unanswered question that we’ll need to continue to study. I think this does create an opportunity for additional transcatheter replacement devices in the tricuspid space. We know that this can completely eliminate tricuspid regurgitation, patients feel better, but there are populations that we cannot address and how do we manage them,” Davidson said.  

This study was funded by Edwards Lifesciences.