Two devices approved by the U.S. Food and Drug Administration (FDA) this year for tricuspid regurgitation (TR) are safe, effective and improve quality of life (QOL) at one year, according to studies published in JACC and simultaneously being presented at TCT 2024.

The EVOQUE transcatheter tricuspid valve replacement (TTVR) system was approved in February 2024 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 ACC.23. 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 JACC Editor-in-Chief Harlan M. Krumholz, MD, SM, FACC. "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."

Highlights from the key trials include:

TRILUMINATE Pivotal Shows T-TEER Safe, Effective For Symptomatic, Severe 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 optimal medical therapy (OMT) alone. Participants were around 78 years old and predominantly women, with the 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 QOL improvement as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ). Read the full article.

TRISCEND II Shows Improved Clinical Benefits, QOL at One Year With TTVR and OMT
TTVR and optimal medical therapy (OMT) was superior to medical therapy alone in terms of a hierarchical composite of safety and effectiveness at one year and led to sustained reductions in tricuspid regurgitation to ≤ mild in nearly all patients, based on findings from the TRISCEND II trial, which were simultaneously published in NEJM. A related quality-of-life substudy published in JACC, also showed significant improvement in symptoms, function and quality of life at one year with TTVR plus OMT compared to optimal medical therapy alone

The trial randomized 400 patients with severe, symptomatic tricuspid regurgitation to receive TTVR with the EVOQUE tricuspid valve replacement system plus OMT or OMT. Mean age was 79 years old and 75% were women. The KCCQ was used to assess health status.

TTVR plus OMT significantly reduced tricuspid regurgitation grade compared OMT alone and had superior clinical benefits (win ratio of 2.02) in terms of all-cause mortality, tricuspid valve intervention, annualized rate of heart failure hospitalization, etc. Patients treated with TTVR plus OMT also 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.

In a related JACC editorial comment, Aakriti Gupta, MD MSc; FACC, Celina M. Yong, MD, FACC; and Rasha Al-Lamee, MD, PhD, write that the rise of transcatheter therapies for TR represents a "profound shift" in treatment "beyond quantity of life to quality of life." However, they caution that "as we celebrate these advances … we must confront the limitations of our current understanding. The goal posts for success may vary. For some patients, symptom relief and improved daily function are the most important goals. For others, particularly those with advanced disease, we must aim higher–preventing right heart failure, reducing hospitalizations, and, ideally, improving survival. Whether this is ultimately achievable remains unknown."

PASTE Registry Shows PASCAL T-TEER System Safe, 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 women. This European data on T-TEER provides additional data to help inform clinical practice with emerging device therapies. Access the paper. In a related JACC editorial comment, Rebecca T. Hahn, MD, FACC, notes that "despite inherent limitations of registries, the PASTE Registry improves our understanding of T-TEER using the PASCAL system." Based on the findings, she stresses the need for patients to "be referred earlier to centers of excellence where quantitation of TR severity and assessment of associated right heart maladaptive remodeling may be comprehensively assessed and shared decision-making about appropriate medical, surgical or transcatheter interventions can be performed."

"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, FACC, executive associate editor of JACC. "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."

Expanding possibilities will also require a focus on health policy. "These new therapeutic advances are a welcome development given the prevalence of valvular heart disease and the associated morbidity and mortality for affected patients," write Kushal T. Kadakia, MSc, and Sanket S. Dhruva, MD, MPH, FACC, in a JACC editorial comment. "However, as is often the case for medical innovation, evolution in care paradigms must be paired with consideration for concomitant changes in health policies."