Heart failure procedure reveals meaningful outcomes when compared to medical therapy

MedTech News: Transcatheter edge-to-edge repair (TEER) using the TriClip system is safe and effective in patients with symptomatic severe tricuspid regurgitation (TR), according to Abbott’s randomised TRILUMINATE trial presented at the American College of Cardiology/World Congress of Cardiology (ACC/WCC) 2023 meeting.

Patients were on stable guideline-directed medical therapy and/or device therapy for heart failure. They were randomised to TEER – roughly half with the first-generation TriClip system and half with the newer TriClip G4 – or medical therapy alone.

After 1 year, a primary composite outcome consisting of all-cause death or tricuspid valve surgery; hospitalisation for heart failure; and improvement in quality of life (QoL) favoured TEER over medical therapy alone.

“These TRILUMINATE Pivotal trial results are promising because there have historically been very few treatment options for tricuspid regurgitation, and patients with this condition are often not eligible for open-heart surgery due to multiple co-morbidities or other factors,” said Dr Paul Sorajja, Director of the Centre for Valve and Structural Heart Disease for the Minneapolis Heart Institute at Abbott Northwestern Hospital.

“We feel these results are very meaningful for a highly symptomatic population whose quality of life is impacted by TR. 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.”

Dr Patrick O’Gara, Brigham and Women’s Hospital, Boston, MA and a past president of the ACC said “It’s not as if you’ve got a therapy here that looks like sacubitril-valsartan or an SGLT2 inhibitor, in which there’s a significant reduction in hard endpoints, for example, but it’s a step in the right direction making heart failure patients feel better.”

Significant reduction in TR to moderate or less (grade < 2) was achieved in 87% of patients with the device at 30 days vs. 4.8% in the control group, with TR reduction sustained and durable at one year (p<0.001). Also, 50% of patients who received the device achieved at least a 15-point improvement in the Kansas City Cardiomyopathy Questionnaire (KCCQ) score at one year vs. 26% in the control group.

The procedure signalled a strong safety profile. At 30 days, only 1.7% of patients who received the device experienced major adverse events, with no urgent surgery or endocarditis. There were no occurrences of device embolisation or device thrombus.

“These TRILUMINATE Pivotal data show TriClip is the first minimally invasive device therapy for the treatment of tricuspid regurgitation to provide durable improvements in TR severity and quality of life that go beyond taking medication to manage symptoms,” said Michael Dale, senior vice president of Abbott’s structural heart business.

“When left unaddressed, TR can be debilitating and life-threatening. By repairing the damage caused by structural heart disease, TriClip G4 and our latest technological innovations are helping people reclaim their lives so they can get back to doing what they love.”

The results represent an incremental advancement which will improve over time with better medical devices, better imaging and better patient selection similar to what has been experienced with Abbott’s MitraClip.

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