Six-Month Outcomes of the Tri-Repair Study Assessing the Cardioband Tricuspid Valve Reconstruction System for Patients with Severe Tricuspid Regurgitation

Background: Severe tricuspid regurgitation (TR) is associated with high morbidity and mortality rates with limited treatment options. We report the six-month safety and performance of the Cardioband™ Tricuspid Valve Reconstruction System in the treatment of severe functional TR in 30 patients enrolled in the TRI-REPAIR study. Methods: Between October 2016 and July 2017, 30 patients were enrolled in this single-arm, multicenter, prospective trial. Patients were diagnosed with severe, symptomatic TR in the absence of untreated left-heart disease and deemed inoperable because of unacceptable risk for open-heart surgery by the local heart team. Clinical, functional, and echocardiographic data were prospectively collected before and up to six months post-procedure. An independent core lab assessed all echocardiographic data and an independent Clinical Event Committee adjudicated the safety events. Findings: Mean patient age was 75 years and all patients presented with functional TR. At baseline, 25 (83%) patients were in NYHA Class III-IV and LVEF was 58%. Technical success was 100%. Through six months, three (10%) patients died. Between baseline and 6 months, echocardiography showed average reductions of annular septolateral diameter of 10% (41·9mm vs. 37·9mm; p=0·0014), PISA EROA of 48% (0·78cm2 vs. 0·41cm2, p=0·0004), and mean vena contracta of 28% (1·2cm vs. 0·9cm, p<0·0001). Clinical assessment showed that 19 (76%) of 25 patients improved by at least one NYHA Class with 22 (88%) in NYHA Class I-II (p<0·0001). Six minute walk distance improved by 78m (p=0.0035) and Kansas City Cardiomyopathy Questionnaire score improved by 25 points (p<0·0001). Interpretation: Six-month outcomes show that the Cardioband system performs as intended and appears to be safe in patients with symptomatic and severe functional TR. Significant reduction of TR through decrease of annular dimensions, improvements in heart failure symptoms, quality of life, and exercise capacity were observed. Further studies are warranted to validate these initial promising results. Clinical Trial Number: The study is registered in clinicaltrials.gov (NCT02981953). Funding Statement: Edwards Lifesciences. Declaration of Interests: GN, US, SB, and FD have received speakers’ honoraria as well as travel and grant support from Edwards Lifesciences. EA and RS have received speakers’ honoraria from Edwards Lifesciences. PV and PV are employees of Edwards Lifesciences. Ethics Approval Statement: The TRI-REPAIR study was conducted in conformity with the ethical principles set forth by the Declaration of Helsinki, Good Clinical Practice principles, and in accordance with ISO 14155:2011. The study was approved by local ethics committees and respective health authorities of the participating countries.