TRI-REPAIR Study Evaluates Edwards' Cardioband System at 6 Months
April 15, 2019—Data from the TRI-REPAIR study evaluating the safety and performance of tricuspid regurgitation (TR) repair with the Cardioband transcatheter tricuspid valve reconstruction system (Edwards Lifesciences) were published by Georg Nickenig, MD, et al in Journal of the American College of Cardiology (JACC; 2019;73:1905–1915).
In JACC, TRI-REPAIR investigators report that in the treatment of moderate to severe functional TR, the Cardioband system resulted in a significant reduction of TR through the decrease of annular dimensions and improvements in heart failure symptoms, quality of life, and exercise capacity at 6 months.
The single-arm, multicenter, prospective trial enrolled 30 patients between October 2016 and July 2017. Patients were diagnosed with moderate to severe, symptomatic TR in the absence of untreated left-heart disease and deemed inoperable because of unacceptable risk for open-heart surgery by the local heart team.
Investigators prospectively collected clinical, functional, and echocardiographic data before and up to 6 months postprocedure. An independent core lab assessed all echocardiographic data, and an independent clinical event committee adjudicated the safety events.
As summarized in JACC, the study patients' mean age was 75 years, 73% were women, and 23% had ischemic heart disease. At baseline, 83% were in New York Heart Association (NYHA) functional class III to IV, and mean left ventricular ejection fraction was 58%.
Technical success was 100%. Through 6 months, three patients died.
The investigators reported that between baseline and 6 months, echocardiography showed the following average reductions:
- Annular septolateral diameter of 9% (42 vs 38 mm; P < .01)
- Proximal isovelocity surface area effective regurgitant orifice area of 50% (0.8 vs 0.4 cm2; P < .01)
- Mean vena contracta width of 28% (1.2 vs 0.9 cm; P < .01)
Clinical assessment showed the following:
- 76% of patients improved by at least one NYHA functional class with 88% in NYHA functional class I or II
- Six-minute walk distance improved by 60 m (P < .01)
- Kansas City Cardiomyopathy Questionnaire score improved by 24 points (P < .01)
From these 6-month findings, the TRI-REPAIR investigators concluded that the Cardioband system performs as intended and appears to be safe in patients with symptomatic and moderate to severe functional TR. Further studies are warranted to validate these initial results, advised the investigators in JACC.