Contact: Nicole Napoli, nnapoli@acc.org, 202-669-1465

WASHINGTON (Oct 30, 2024) -

Two FDA approved devices for tricuspid regurgitation are safe, effective and improve quality of life at one-year according to studies published in JACC, the flagship journal of the American College of Cardiology, and simultaneously being presented at the Cardiovascular Research Foundation’s annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium.

The FDA approved two devices this year to treat tricuspid regurgitation. The EVOQUE transcatheter tricuspid valve replacement (TTVR) system was approved in February based on results from the TRISCEND II trial presented at TCT 2023, and the TriClip device for tricuspid transcatheter edge-to-edge repair (T-TEER) was approved in April 2024 based on primary results from TRILUMINATE Pivotal that were presented at the American College of Cardiology’s 2023 Annual Scientific Session.

Tricuspid regurgitation is a type of heart valve disease where the valve between the two right chambers of the heart can’t close tightly enough to prevent blood from flowing back into the heart. With heart valve disease, the heart must work harder and may not be able to pump enough blood out to the rest of the body. As a result, people can experience severe symptoms including shortness of breath, unusual fatigue, dizziness, or extreme swelling throughout the body. Medical interventions provide little relief from symptoms, and surgery is often too dangerous.

The new study results in JACC show sustained symptom relief through one year of follow-up after device therapy.

"The studies further support the longer-term benefit of these devices for the treatment of selected patients with tricuspid regurgitation, demonstrating meaningful and sustained improvements in patients' quality of life,” said Harlan Krumholz, MD, SM, FACC, JACC Editor-in-Chief and the Harold H. Hines Jr Professor of Medicine Yale University School of Medicine. “The key next step will be to identify the individuals who stand to benefit the most and to develop strategies that support patients in making decisions aligned with their personal health goals."

Embargoed until Sunday, Oct. 27 at 1:30 pm ET
TRILUMINATE Pivotal Shows T-TEER Safe, Effective for Symptomatic, Severe TR

Tricuspid transcatheter edge-to-edge repair (T-TEER) is safe and effective for tricuspid regurgitation (TR). TRILUMINATE Pivotal was the first randomized controlled trial to study safety and effectiveness of T-TEER for TR. In this latest study researchers report one-year outcomes of the full randomized cohort of 572 patients, including the original 350 patient cohort and an additional 222 enrolled later, randomized to receive a TriClip device or medical therapy alone. Participants were around 78 years old and predominantly female, with majority having atrial fibrillation and prior heart failure hospitalization. At one year, patients who received T-TEER had lower rates of all-cause mortality or need for tricuspid valve surgery, fewer heart failure hospitalizations, and greater quality of life improvement as measured by Kansas City Cardiomyopathy Questionnaire.

Embargoed until Wed., Oct. 30 at 11 a.m. ET
TRISCEND II Shows Improved QOL at One Year with TTVR and Optimal Medical Therapy

In a quality-of-life substudy of the TRISCEND II trial, researchers found that patients with severe, symptomatic TR treated with TTVR and optimal medical therapy had significant improvement in symptoms, function and quality of life at one year compared to optimal medical therapy alone. The trial randomized 400 patients to receive TTVR with the EVOQUE tricuspid valve replacement system plus optimal medical therapy or optimal medical therapy. Mean age was 79 years old and 75% were women. The Kansas City Cardiomyopathy Questionnaire was used to assess health status. Patients receiving TTVR plus OMT had higher KCCQ scores at each follow-up interval and at one year 64.6% were alive and well with a KCCQ score of greater than or equal to 60 points.

Embargoed until Sun., Oct. 27 at 2:15 p.m. ET
PASTE Registry Shows PASCAL T-TEER System Safe and Effective at One Year in High-Risk TR Patients

According to a study using data from more than 1,059 high-risk patients with multiple comorbidities in a European T-TEER registry, the PASCAL transcatheter valve repair system was successful in treating severe TR in high-risk patients and showed sustained TR reduction and significant clinical improvements at one year. Patients were an average of 79 years old and 53% were female. This European data on T-TEER provides additional data to help inform clinical practice with emerging device therapies.

 

Embargoed until Wed., Oct. 30 at 11 a.m. ET
State of the Art Review on TTVR

The latest research and recent FDA approvals have positioned tricuspid valve treatments as successful, safe and effective interventions that improve quality of life for many very sick patients. In a JACC state-of-the-art review on TTVR, experts provide a comprehensive overview focusing on patient selection, procedural details and follow up care, including the most recent trial data presented during TCT 2024.

“At its core, the story of transcatheter therapies for tricuspid regurgitation is one about patient experience. The focus on quality-of-life gains despite no improvement in clinical endpoints in these patients with several comorbidities, drove FDA approvals for the TriClip and EVOQUE devices,” said Aakriti Gupta, MD, MSc, JACC Executive Associate Editor. “Moving forward, incorporating sham controls in future trials will be crucial to clearly distinguish the placebo effect from the true clinical benefit. And we must continue to expand the possibilities of these therapies, striving not only to alleviate symptoms but also to change the course of the disease—preventing right heart failure, reducing hospitalizations, and optimistically improving survival.”

For embargoed copies of these paper, contact Nicole Napoli, ACC director of media relations, at nnapoli@acc.org.

 

The American College of Cardiology (ACC) is the global leader in transforming cardiovascular care and improving heart health for all. As the preeminent source of professional medical education for the entire cardiovascular care team since 1949, ACC credentials cardiovascular professionals in over 140 countries who meet stringent qualifications and leads in the formation of health policy, standards and guidelines. Through its world-renowned family ofJACCJournals, NCDR registries, ACC Accreditation Services, global network of Member Sections, CardioSmart patient resources and more, the College is committed to ensuring aworld where science, knowledge and innovation optimize patient care and outcomes. Learn more at www.ACC.org or follow @ACCinTouch.

The ACC’s JACC Journals rank among the top cardiovascular journals in the world for scientific impact. The flagship journal, the Journal of the American College of Cardiology (JACC) — and specialty journals consisting of JACC: Advances, JACC: Asia, JACC: Basic to Translational Science, JACC: CardioOncology, JACC: Cardiovascular Imaging, JACC: Cardiovascular Interventions, JACC: Case Reports, JACC: Clinical Electrophysiology and JACC: Heart Failure — pride themselves on publishing the top peer-reviewed research on all aspects of cardiovascular disease. Learn more at JACC.org.

 

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