麻豆传媒

Transcatheter tricuspid valve repair with the PASCAL system appeared safe, with preliminary promise in reducing regurgitation and symptoms, the early feasibility CLASP TR trial showed.

Major adverse events -- cardiovascular death, myocardial infarction, stroke, new need for dialysis, device-related reintervention, severe bleeding, or major access site or vascular complications requiring intervention -- occurred in six of the 65 treated patients (9.2%) at 30 days and in 11 (16.9%) evaluable patients at 1 year.

All 36 patients with echocardiography available at 1 year improved by at least one grade of tricuspid regurgitation, 75% improved by at least two grades, and 86% achieved moderate or less regurgitation, reported Adam Greenbaum, MD, of Emory University Hospital in Atlanta, at the American College of Cardiology meeting in Washington, D.C.

Regarding the relatively low 1-year follow-up rate, "there's no doubt that conducting a trial in the pandemic time frame was difficult to get patients back for follow-up," Greenbaum told attendees.

However, he pointed to the findings as evidence of durable effect. "We weren't losing any ground as some people thought might occur," he added.

"This is a very exciting early feasibility study," said discussant Megan Coylewright, MD, MPH, director of the Structural Heart Program at Erlanger Health System in Chattanooga, Tennessee. "Before this, we just gave [these patients] diuretics, and it led to hospitalizations and early death. We didn't offer surgery; they're too high risk. We only did about 5,000 isolated tricuspid valve surgeries over a 10-year period. ... So it is so important to have new choices for patients."

In the single-arm multicenter trial of 65 patients with severe tricuspid regurgitation, the mortality rate was "incredibly low" (12% at 1 year) and the improvement in quality of life was "impressive," said Coylewright at a press conference for the late-breaking clinical trial session.

Kansas City Cardiomyopathy Questionnaire scores rose 18 points on average from baseline to 1 year (P<0.001), with 79% of the cohort free from heart failure hospitalization at that point. The trial also showed significant 1-year improvements in New York Heart Association class and 6-minute walk distance.

Success at implanting the device, which has two clasps for independent leaflet capture and adjustment, paddles to reduce leaflet stress, and a central spacer that fills the regurgitant gap, was 91%. There were no late device detachments.

The impact on tricuspid regurgitation and remodeling is "always going to be more with a replacement strategy," Greenbaum noted, "but what we don't know is which is better for which subtype."

There's also the TriClip device being developed for transcatheter tricuspid valve repair, but having options would be useful, Coylewright said.

"Some who might not be a candidate for repair might be for replacement, and vice versa," she said. "I'm hopeful that we'll see benefit in the larger pivotal trials and be able to have that available. There will still be patients that are not candidates for those therapies that need access to transcatheter valves."

The comparing the PASCAL system against optimal medical therapy is enrolling and expected to read out primary results later this year.

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