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TRI-REPAIR: Valve reconstruction system reduces tricuspid regurgitation at 1 year
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PHILADELPHIA — The success of a transcatheter tricuspid valve reconstruction system in patients with tricuspid regurgitation was maintained at 1 year, researchers reported at the Heart Failure Society of America Scientific Meeting.
As Healio previously reported, the valve reconstruction system (Cardioband Transcatheter System, Edwards Lifesciences) reduced annular dimensions, leading to a decrease in tricuspid regurgitation, at 6 months.
Allen S. Anderson, MD, professor of medicine at Northwestern University Feinberg School of Medicine and medical director of the Center for Heart Failure and director of Network Development for Northwestern’s Bluhm Cardiovascular Institute, reported 1-year outcomes here.
The researchers enrolled 30 patients with severe symptomatic tricuspid regurgitation (mean age, 75 years; 73% women; 23% with ischemic heart disease; 93% with atrial fibrillation) in the TRI-REPAIR single-arm, multicenter prospective study.
“This device is actually implanted around the annulus of the tricuspid valve, and the mechanism of action is to reduce the size of the annulus in order to reduce tricuspid regurgitation,” Anderson said during a presentation.
At baseline, mean left ventricular ejection fraction was 58%, 63% of patients had edema, 50% had pulmonary hypertension and 83% had NYHA class III or IV HF. Technical success was 100%.
At 1 year, one patient required a reintervention and exited the study, and there were five deaths, two of which occurred in the first 30 days and one of which was related to the device, Anderson said during a presentation.
He said at 1 year, annual septolateral diameter was reduced by a mean of 16% (baseline, 44 mm; 1 year, 37.1 mm; P < .0001) and severity of tricuspid regurgitation decreased (P < .01).
Proximal isovelocity surface area/effective regurgitant orifice area was reduced by 49% (baseline, 0.73 cm3; 1 year, 0.37 cm3; P = .0037) and mean vena contracta was reduced by 30% (baseline, 1.2 cm; 1 year, 0.9 cm; P = .0046), he said.
Most patients (78%) were in NYHA class I or II HF (P = .0003) and 70% were free from edema at 1 year (P = .07), according to the researchers.
In addition, Anderson said, 6-minute walk distance improved by 42 m (P = .0525) and Kansas City Cardiomyopathy Questionnaire Score improved by 19 points (P = .0009).
“In patients with functional tricuspid regurgitation, which is very difficult to treat, the early experience with the Cardioband system suggests that you can get efficient and effective reduction annular size and regurgitant orifice area,” Anderson said during the presentation. “There is a high rate of survival at 1 year, but further studies are warranted, and there is an ongoing trial called CARDIOBAND-TR designed to look at this more closely. Northwestern is participating in the U.S. trial designed to further evaluate the efficacy of this valve therapy.” – by Erik Swain
Reference:
Anderson A, et al. Abstract 026. Presented at: Heart Failure Society of America Scientific Meeting; Sept. 13-16, 2019; Philadelphia.
Disclosure: The study was sponsored by Edwards Lifesciences. Anderson reports he has financial ties with Advanced Health Media, Alnylam, ApotheCom, GE Healthcare, Insyght Interactive, Novartis, Relypsa and Rx Worldwide Meetings.