Transcatheter Repair for Patients with Tricuspid Regurgitation.

Paul Sorajja, Brian Whisenant, Nadira Hamid, Hursh Naik, Raj Makkar, Peter Tadros, Matthew J. Price, Gagan Singh, Neil Fam, Saibal Kar, Jonathan G. Schwartz, Shamir Mehta, Richard Bae, Nishant Sekaran, Travis Warner, Moody Makar, George Zorn, Erin M. Spinner, Phillip M. Trusty, Raymond BenzaUlrich Jorde, Patrick McCarthy, Vinod Thourani, Gilbert H.L. Tang, Rebecca T. Hahn, David H. Adams

Research output: Contribution to journalArticlepeer-review

229 Scopus citations

Abstract

Abstract 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.)

Original languageEnglish
Pages (from-to)1833-1842
Number of pages10
JournalNew England Journal of Medicine
Volume388
Issue number20
DOIs
StatePublished - 2023
Externally publishedYes

Keywords

  • Cardiology
  • Cardiology General
  • Heart Failure
  • Valvular Heart Disease

Fingerprint

Dive into the research topics of 'Transcatheter Repair for Patients with Tricuspid Regurgitation.'. Together they form a unique fingerprint.

Cite this