Transcatheter edge-to-edge repair in symptomatic patients with severe tricuspid regurgitation and prior heart valve surgery.

Background: Tricuspid valve surgery for tricuspid regurgitation (TR) following prior valve surgery carries increased risk. This study evaluated 2-year outcomes of tricuspid transcatheter edge-to-edge repair (T-TEER) in patients with severe TR and prior valve surgery. Methods: TRILUMINATE Pivotal is an international randomized trial comparing T-TEER with the TriClip (device group) to medical therapy (control group) in patients with symptomatic severe TR, with a concurrent single-arm cohort (device) for anatomically complex patients. Echocardiograms were assessed in a core laboratory, and outcomes were adjudicated by an independent clinical events committee. Results: Among the 469 patients in the device group, 113 had prior valve surgery and 356 did not. Baseline characteristics were comparable in the 2 groups: mean age, 77 years versus 79 years; female sex, 64% versus 59%; atrial fibrillation, 87% versus 86%; and heart failure hospitalization (HFH) within 1 year prior to T-TEER, 26% versus 25%. The T-TEER success rate was 99% in both groups, with no in-hospital deaths, a median hospital stay of 1 day, and 97% discharged home. Thirty-day adverse event rates were low and similar: rates of all-cause mortality, stroke, and new pacemaker implantation were all <2%, and the rate of major bleeding was <4%. At 2 years, outcomes remained favorable and comparable: ≤ moderate TR was achieved in 81% versus 80% ( Conclusions: In patients with prior valve surgery, T-TEER was safe and resulted in significant TR reduction and symptom improvement.