Transcatheter Edge-to-Edge Repair for Reduction of TR
What is the safety and effectiveness of TriClip, a minimally invasive transcatheter tricuspid valve repair system, for reducing tricuspid regurgitation (TR)?
The investigators conducted a prospective, multicenter, single-arm study, the TRILUMINATE trial, in 21 sites in Europe and the United States. Patients with moderate or greater TR, New York Heart Association class II or higher heart failure, and who were adequately treated per applicable standards were eligible for enrollment. Patients were excluded if they had systolic pulmonary artery pressure of >60 mm Hg, a previous tricuspid valve procedure, or a cardiovascular implantable electronic device that would inhibit TriClip placement. Participants were treated using a clip-based edge-to-edge repair technique with the TriClip tricuspid valve repair system. TR was graded using a five-class grading scheme (mild, moderate, severe, massive, and torrential) that expanded on the standard American Society of Echocardiography grading scheme. The primary efficacy endpoint was TR reduction by at least one grade at 30 days post-procedure; the success rate was tested against a prespecified performance goal of 35% using the exact binomial test at a one-sided 2.5% significance level. The primary safety endpoint was a composite of major adverse events at 6 months, with a performance goal of 39%. Patients were excluded from the primary safety analysis if they did not reach 6-month follow-up and did not have a major adverse event during previous follow-ups.
Between August 1, 2017, and November 29, 2018, 85 patients (mean age 77.8 years [SD 7.9]; 56 [66%] women) were enrolled and underwent successful TriClip implantation. TR severity was reduced by at least one grade at 30 days in 71 (86%) of 83 patients who had available echocardiogram data and imaging. The one-sided lower 97.5% confidence limit was 76%, which was greater than the prespecified performance goal of 35% (p < 0.0001). One patient withdrew before 6-month follow-up without having had a major adverse event and was excluded from analysis of the primary safety endpoint. At 6 months, 3 (4%) of 84 patients experienced a major adverse event, which was less than the prespecified performance goal of 39% (p < 0.0001). Single leaflet attachment occurred in 5 (7%) of 72 patients. No periprocedural deaths, conversions to surgery, device embolizations, myocardial infarctions, or strokes occurred. At 6 months, all-cause mortality had occurred in 4 (5%) of 84 patients.
The authors concluded that the TriClip system appears to be safe and effective at reducing TR by at least one grade.
This prospective, multicenter, single-arm study reports that edge-to-edge tricuspid leaflet treatment with the TriClip is feasible and safe. Furthermore, the TriClip effectively reduced TR, which was associated with significant right heart remodeling, improved right ventricular function, and clinical and functional improvement. Since this is not a randomized controlled study, it does not provide clear evidence that reduction of TR is associated with reduced morbidity and mortality. Additional prospective randomized studies comparing TriClip with optical medical therapy and/or surgery is indicated to assess safety and efficacy.
Clinical Topics: Cardiac Surgery, Geriatric Cardiology, Heart Failure and Cardiomyopathies, Invasive Cardiovascular Angiography and Intervention, Noninvasive Imaging, Prevention, Valvular Heart Disease, Cardiac Surgery and Arrhythmias, Cardiac Surgery and Heart Failure, Cardiac Surgery and VHD, Acute Heart Failure, Interventions and Imaging, Interventions and Structural Heart Disease, Echocardiography/Ultrasound
Keywords: Cardiac Surgical Procedures, Cardiology Interventions, Diagnostic Imaging, Echocardiography, Geriatrics, Heart Failure, Heart Valve Diseases, Secondary Prevention, Tricuspid Valve Insufficiency, Ventricular Function, Right
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