TTVR with Evoque system linked to positive real-world outcomes after 30 days
Transcatheter tricuspid valve replacement (TTVR) with the Evoque system from Edwards Lifesciences is associated with positive real-world outcomes, according to new data published in JACC: Cardiovascular Interventions.[1]
The Evoque system received CE mark approval in 2023. In 2024, it was the first TTVR device to gain full U.S. Food and Drug Administration (FDA) approval. By early 2025, the U.S. Centers for Medicare and Medicaid Services was finalizing its decision to cover TTVR in patients with symptomatic tricuspid regurgitation (TR) on a national level.
This new analysis delivers an early look at patients receiving the Evoque system in a real-world setting as opposed to a clinical trial. Researchers tracked data from 176 patients who received the device from October 2023 to February 2025 in Europe. While 72% of patients were women, the mean age was 77.8 years old and median follow-up time was 30 days.
Overall, the intraprocedural success rate was 97.2% and the mean procedure length was 102 minutes. The 52-mm device was the most commonly implanted, followed by the 48-mm device. The in-hospital mortality rate was 3.4%, and device-related complications were rare.
After 30 days, the mortality rate was 5.1%. Severe or greater TR was reduced to mild or none in 98.4% of patients 30 days after treatment. The percentage of patients presenting with New York Heart Association functional class I or II symptoms, meanwhile, improved from 20.2% at baseline to 79.7% after 30 days.
The Evoque TTVR system from Edwards Lifesciences. Image taken during TCT 2024.
The study’s authors also identified signs of “significant weight loss” and improved hepatorenal function.
“Commercial use of the Evoque system is safe and effective,” wrote first author Domenico Angellotti, MD, a cardiologist with Bern University Hospital in Switzerland, and colleagues. “TR elimination following TTVR is associated with significant symptom and end-organ functional improvements, in particular when TR was massive or torrential.”
One key take away from these real-world data was the fact that right ventricular (RV) dysfunction was linked to worse patient outcomes. Patients who presented with moderate or severe RV dysfunction faced an increased risk of in-hospital mortality, 30-day mortality and 30-day clinical failure. Heart failure hospitalizations, meanwhile, were not significantly more likely for these patients.
The authors also noted that permanent pacemaker implantation was required in 18.9% of patients, with the risk of that outcome increasing when patients presented with conduction disturbances prior to treatment.
“Future research should focus on refining patient selection, especially regarding RV dysfunction, and optimizing strategies to reduce conduction disturbances after the procedure,” the authors concluded.
Read the full analysis here.
Michael has more than 19 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.