Years of effort are invested in research to advance care for patients and the results are shared with the world through international conferences and top-tier medical journals.
The 2023 American College of Cardiology’s Annual Scientific Session is one example of this journey where the Minneapolis Heart Institute Foundation team was proud to stand on the podium of one of the biggest stages in cardiology research to share primary outcomes from the TRILUMINATE Pivotal Trial of the TriClip™ (manufactured by Abbott). The new, investigational technology is a catheter-based, non-surgical treatment currently being studied as an option for tricuspid regurgitation (leaky tricuspid heart valve). The data from this study will be part of what the manufacturer uses to seek regulatory approval from the U.S. Food and Drug Administration.
Paul Sorajja, MD, Roger L. and Lynn C. Headrick Family Chair for the MHIF Valve Science Center and national principal investigator for the TRILUMINATE Pivotal trial, presented the late-breaking, clinical trial data at ACC.
Dr. Sorajja is also lead author of the manuscript, “Transcatheter Repair for Patients with Tricuspid Regurgitation,” simultaneously published online in the New England Journal of Medicine.
This research journey began years ago when MHIF had the opportunity to be the first to provide this technology to a patient (first-in-human procedure) in 2017. Dr. Sorajja and the team at the MHIF Valve Science Center are proud to be part of contributing to this research starting with the early feasibility study. MHIF was also first-in-the-world to enroll a patient in the TRILUMINATE Pivotal trial in September 2019. The team carried that commitment to innovation as a top enroller (enrolling the first and largest number of patients) of all 75 clinical sites participating in this research trial in the United States, Canada and Europe.
We celebrate this important spotlight on behalf of all the patients living with the debilitating effects of heart valve disease, sharing highlights of some of the articles that were published following ACC2023:
New York Times, March 4, 2023:
New Treatment Could Help Fix the Heart’s ‘Forgotten Valve’
Patients with leaking tricuspid valves in a research trial saw improvements with a procedure that does not require a risky open-heart surgery.
For the first time, patients with damaged tricuspid valves in their hearts might have a safe treatment that actually helps.
“Patients get more and more miserable,” said Dr. Paul Sorajja, chairman of the valve science center at the Minneapolis Heart Institute Foundation and co-principal investigator for the Abbott study.
Patients who got the clip said their disabling symptoms receded and they could enjoy life again.
“I felt better immediately,” said Adelaide Effertz, 86, who lives on a farm in Pine City, Minn., and was one of the first patients treated in the study. “It’s just wonderful.”
She says she no longer has the intense and unrelenting fatigue that forced her to nap a couple of times each afternoon.
TCTMD – March 4, 2023
TRILUMINATE Pivotal: TEER with the TriClip Benefits Patients with Severe TR
The results affirm reductions in TR severity and gains in quality of life compared with medical therapy.
NEW ORLEANS, LA—Transcatheter edge-to-edge repair (TEER) using the TriClip system (Abbott) is safe and effective in patients with symptomatic severe tricuspid regurgitation (TR), the randomized TRILUMINATE Pivotal trial shows.
After 1 year, a primary composite outcome consisting of all-cause death or tricuspid valve surgery; hospitalization for heart failure; and improvement in quality of life (QoL) according to the Kansas City Cardiomyopathy Questionnaire (KCCQ) favored TEER over medical therapy alone (win ratio 1.48; 95% CI 1.06-2.13), a finding driven by the QoL improvements.
The intervention reduced the severity of regurgitation—without fully abolishing it—and was also very safe, with a low rate of major adverse events around the time of the procedure, Paul Sorajja, MD (Allina Health Minneapolis Heart Institute at Abbott Northwestern Hospital, MN), reported here at the American College of Cardiology/World Congress of Cardiology (ACC/WCC) 2023 meeting.
“We feel these results are very meaningful for a highly symptomatic population whose quality of life is impacted by TR,” Sorajja said. “And with the excellent benefit-to-risk profile of the system, we feel that a historically untreated population will now have a treatment option to improve their quality of life.”
Cardiovascular Business – March 13, 2023
TRILUMINATE trial may pave the way for FDA clearance for tricuspid valve clip device
Paul Sorajja, MD, director, Center for Valve and Structural Heart Disease, Minneapolis Heart Institute, Abbott Northwestern Hospital, was the principal investigator for the late-breaking TRILUMINATE pivotal trial at the American College of Cardiology (ACC) 2023 meeting and explains details of this landmark trial.