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Published on: October 16, 2021
Transcatheter Repair for Patients with Tricuspid Regurgitation
Paul Sorajja1, Brian Whisenant1, Nadira Hamid1
1From Allina Health Minneapolis Heart Institute at Abbott Northwestern Hospital, Minneapolis (P.S., N.H., R. Bae); Intermountain Medical Center, Murray, UT (B.W., N.S.); St. Joseph's Hospital and Integrated Medical Services, Phoenix, AZ (H.N., T.W.); Cedars-Sinai Medical Center, Los Angeles (R.M., M.M.), Scripps Clinic Green Hospital, La Jolla (M.J.P.), UC Davis Medical Center, Sacramento (G.S.), Los Robles Regional Medical Center, Thousand Oaks (S.K.), and Abbott Structural Heart, Santa Clara (E.M.S., P.M.T.) - all in California; Kansas University Medical Center, Kansas City (P.T., G.Z.); St. Michael's Hospital, Toronto (N.F.), and McMaster University, Hamilton, ON (S.M.) - both in Canada; Carolinas Medical Center, Charlotte, NC (J.G.S.); Ohio State University, Columbus (R. Benza); Montefiore Medical Center, Bronx (U.J.), and Mount Sinai Health System (G.H.L.T., D.H.A.) and New York-Presbyterian Columbia University Medical Center (R.T.H.), New York - all in New York; Northwestern University, Chicago (P.M.); and Marcus Valve Center, Piedmont Heart Institute, Atlanta (V.T.).
Background:
Severe tricuspid regurgitation is a debilitating condition that is associated with substantial morbidity and often with poor quality of life. Decreasing tricuspid regurgitation may reduce symptoms and improve clinical outcomes in patients with this disease.
Methods:
We conducted a prospective randomized trial of percutaneous tricuspid transcatheter edge-to-edge repair (TEER) for severe tricuspid regurgitation. Patients with symptomatic severe tricuspid regurgitation were enrolled at 65 centers in the United States, Canada, and Europe and were randomly assigned in a 1:1 ratio to receive either TEER or medical therapy (control). The primary end point was a hierarchical composite that included death from any cause or tricuspid-valve surgery; hospitalization for heart failure; and an improvement in quality of life as measured with the Kansas City Cardiomyopathy Questionnaire (KCCQ), with an improvement defined as an increase of at least 15 points in the KCCQ score (range, 0 to 100, with higher scores indicating better quality of life) at the 1-year follow-up. The severity of tricuspid regurgitation and safety were also assessed.
Results:
A total of 350 patients were enrolled; 175 were assigned to each group. The mean age of the patients was 78 years, and 54.9% were women. The results for the primary end point favored the TEER group (win ratio, 1.48; 95% confidence interval, 1.06 to 2.13; P = 0.02). The incidence of death or tricuspid-valve surgery and the rate of hospitalization for heart failure did not appear to differ between the groups. The KCCQ quality-of-life score changed by a mean (±SD) of 12.3±1.8 points in the TEER group, as compared with 0.6±1.8 points in the control group (P<0.001). At 30 days, 87.0% of the patients in the TEER group and 4.8% of those in the control group had tricuspid regurgitation of no greater than moderate severity (P<0.001). TEER was found to be safe; 98.3% of the patients who underwent the procedure were free from major adverse events at 30 days.
Conclusions:
Tricuspid TEER was safe for patients with severe tricuspid regurgitation, reduced the severity of tricuspid regurgitation, and was associated with an improvement in quality of life. (Funded by Abbott; TRILUMINATE Pivotal ClinicalTrials.gov number, NCT03904147.).
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