Two-Year Outcomes of Transcatheter Edge-to-Edge Repair for Severe Tricuspid Regurgitation: The TRILUMINATE Pivotal Randomized Controlled Trial
- PMID: 40159089
- DOI: 10.1161/CIRCULATIONAHA.125.074536
Two-Year Outcomes of Transcatheter Edge-to-Edge Repair for Severe Tricuspid Regurgitation: The TRILUMINATE Pivotal Randomized Controlled Trial
Abstract
Background: One-year outcomes of TRILUMINATE Pivotal (Trial to Evaluate Cardiovascular Outcomes in Patients Treated With the Tricuspid Valve Repair System Pivotal) found that transcatheter edge-to-edge repair (TEER) for the treatment of severe, symptomatic tricuspid regurgitation improved quality of life compared with medical therapy alone with similar rates of mortality and heart failure hospitalization. However, additional follow-up is necessary to determine the prolonged benefits of tricuspid TEER.
Methods: A total of 572 patients with severe, symptomatic tricuspid regurgitation were randomized to either tricuspid TEER+medical therapy (device group) or medical therapy alone (control). Two-year prespecified end points were recurrent heart failure hospitalization and freedom from all-cause mortality, tricuspid valve surgery, and tricuspid valve intervention after treatment visit, assessed in the intention-to-treat population.
Results: The annualized rate of recurrent heart failure hospitalizations through 2 years was significantly lower with tricuspid TEER compared with control (0.19 event per patient-year versus 0.26 event per patient-year; P=0.02; joint frailty model hazard ratio, 0.72; one-sided upper confidence limit, 0.93; P=0.02). Freedom from all-cause mortality, tricuspid valve surgery, and tricuspid valve intervention through 2 years was significantly higher with tricuspid TEER compared with control (77.6% versus 29.3%; P<0.0001), driven by more tricuspid valve intervention in control patients who crossed over to device treatment (3.8% versus 61.5%). Rates of all-cause mortality (17.9% versus 17.1%) and tricuspid valve surgery (2.3% versus 4.3%) were similar between groups. Moderate or less tricuspid regurgitation was present in 84% at 2 years in the device group.
Conclusions: At the 2-year follow-up, tricuspid TEER appeared safe, significantly reduced tricuspid regurgitation severity, and decreased rates of heart failure hospitalization compared with medical therapy alone.
Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03904147.
Keywords: hospitalization; tricuspid valve insufficiency.
Conflict of interest statement
Dr Kar receives consulting fees from Abbott, Boston Scientific, InterShunt, Medtronic, Peija, V wave, W.L. Gore & Associates, and Medtronic, is an investigator and steering committee member for TRILUMINATE Pivotal (Abbott), and is coprincipal investigator for EXPAND (Abbott) and coprincipal investigator for REPAIR MR (Abbott). Dr Makkar has received grants and institutional support from Abbott, Boston Scientific, Edwards Lifesciences, and Medtronic; consulting fees from Cordis Corp and Medtronic; and unpaid trial activities from Abbott, Boston Scientific, and Edwards Lifesciences. Dr Whisenant has received consulting fees from Abbott and Edwards Lifesciences. Dr Hamid has received consulting fees from 4C Medical Technologies, Inc, Alleviant Medical, Inc., AMX, Anteris Technologies Corp, Edwards Lifesciences, Philips, Valcare Med Ltd, Vdyne, and W.L. Gore & Associates, Inc. Dr Naik has received consulting fees from Abbott, Boston Scientific, and Edwards Lifesciences. Dr Tadros has received consulting fees from Abbott and Edwards Lifesciences. Dr Price has received consulting fees and honoraria from Abbott, Alleviant, Boston Scientific, Biosense Webster, InnovHeart, Medtronic, Philips Medical, W.L. Gore & Associates, and Shockwave Medical. Dr Singh has served as a consultant and/or on the advisory board for Abbott Structural Heart, Boston Scientific, Siemens Healthcare, and Phillips. Dr Schwartz receives consulting fees from Abbott, Medtronic, Edwards Lifesciences, Boston Scientific, Cordis Corp, Philips, Siemens, and W.L. Gore & Associates; receives research support from Abbott, Edwards Lifesciences, Boston Scientific, and W.L. Gore & Associates; and serves on advisory boards for Medtronic, Edwards Lifesciences, Boston Scientific, and Siemens. Dr Alli receives speaker honoraria and serves on advisory boards for Boston, Abbott, and Edwards LifeSciences. Dr Horr receives consulting fees from Abbott, Edwards Lifesciences, and Boston Scientific. Dr Seshiah is a physician protocol for Abbott. Dr Batchelor serves as a consultant with Abbott, Medtronic, Edwards, and Boston Scientific. Dr Jones receives consulting fees from Abbott, Medtronic Boston Scientific, and Ancora Heart; receives speaker honoraria from Abbott; and is a proctor for Abbott and W.L. Gore & Associates. Dr Ahmed receives consulting fees and speaker honoraria from Medtronic and Abbott. Dr Benza receives consulting fees from Abbott and Bayer HealthCare Pharmaceuticals Inc and is an end-point review committee member for United Therapeutics. Dr Jorde receives consulting fees from Abbott and Edwards Lifesciences. Dr Thourani has received research grants from and is an advisor for Edwards Lifesciences. Dr Ghobrial has received speaker honoraria and served as a physician proctor for Abbott. Dr Tang has received speaker honoraria and served as a physician proctor, consultant, advisory board member, TAVR publications committee member, RESTORE study steering committee member, APOLLO trial screening committee member, and IMPACT MR steering committee member for Medtronic; has received speaker honoraria and served as a physician proctor, consultant, advisory board member, and TRILUMINATE trial anatomic eligibility and publications committee member for Abbott Structural Heart; has served as an advisory board member for Boston Scientific and JenaValve, a consultant and physician screening committee member for Shockwave Medical, a consultant for NeoChord, Peija Medical, and Shenqi Medical Technology; and has received speaker honoraria from Siemens Healthineers. Drs Trusty and Huang are salaried employees of Abbott. Dr Hahn reports speaker fees from Abbott Structural, Baylis Medical, Edwards Lifesciences, and Philips Healthcare; she has institutional consulting contracts for which she receives no direct compensation with Abbott Structural, Anteris, Boston Scientific, Edwards Lifesciences, Medtronic, Novartis, and Philips Healthcare; and she is chief scientific officer for the Echocardiography Core Laboratory at the Cardiovascular Research Foundation for multiple industry-sponsored valve trials, for which she receives no direct industry compensation. Dr Adams is coprincipal investigator for TRILUMINATE Pivotal trial and receives royalties from Edward Lifesciences and Medtronic. Dr Sorajja is coprincipal investigator for TRILUMINATE Pivotal trial; serves on the advisory board for Anteris and VDyne; and has received consulting fees from Boston Scientific, Edwards Lifesciences, Evolution Medical, Medtronic, Shifamed, TriFlo, and W.L. Gore & Associates, Inc. The other authors report no conflicts.
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