麻豆传媒

PARIS -- A repurposed MitraClip is an attractive device to treat tricuspid regurgitation, according to early-stage research presented here at the EuroPCR meeting.

The effectiveness of TriClip placement was shown at 30 days, when 86.6% of the 85 patients with symptomatic moderate-or-greater tricuspid regurgitation in the TRILUMINATE study had it reduced by at least one grade.

Severe-or-worse tricuspid regurgitation went down from 94% of patients at baseline to 43% at 30 days, reported Georg Nickenig, MD, PhD, of the University of Bonn in Germany. Moreover, zero deaths and strokes were observed at 30 days.

"The TRILUMINATE study found edge-to-edge repair with the TriClip device to be a promising treatment option for patients with symptomatic severe TR [tricuspid regurgitation]," Nickenig concluded, adding that the findings justify a randomized trial to test this therapy.

"In 2019, we are still limited in our treatment options for the 'forgotten valve.' Presented here, patients with significant tricuspid regurgitation treated with a novel clip design had reassuring results," commented Danny Dvir, MD, of the University of Washington Medical Center in Seattle.

But the fact that almost half of patients still had severe-or-worse regurgitation after the procedure means that it's "not perfectly effective," much like other transcatheter therapies, Dvir told 麻豆传媒. Additionally, single leaflet detachment occurred in five cases, which is "more common than I would have liked," he said.

Nickenig highlighted several echocardiographic improvements observed over the short-term:

• Effective regurgitant orifice area down from 0.68 to 0.43 cm² (P<0.0001)

• Regurgitant volume down from 54.9 to 36.3 mL/beat (P<0.0001)

• Vena contracta width down from 1.73 to 0.99 cm (P<0.0001)

Moreover, after the TriClip procedure, more patients reached the New York Heart Association functional classes I and II (80.5%, up from 25.6%), and scores on the Kansas City Cardiomyopathy Questionnaire were about 14 points better.

In this prospective study, the average age was 77.8 years and two-thirds were women. Exclusion criteria included indications for left-sided or pulmonary valve correction, severe hypertension or pulmonary artery pressure, and severely reduced left ventricular ejection fraction (20% or below).

"In this cohort of 85 patients it was important to see that the procedure is safe. Although this was a high-risk cohort, close to an average age of 80 years, with almost half the patients with renal failure, there was no sign for an alarming safety problem," Dvir noted.

One in five patients received one clip, and nearly half of the cohort, two clips.

For a novel treatment option, the 75-minute device time could be considered "acceptable," according to Nickenig.

The TriClip studied in TRILUMINATE was essentially the same device as the MitraClip -- but not the longer XTR version that would have been even more favorable for the tricuspid valve, the study presenter said at a press conference.

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