Severe tricuspid regurgitation (TR) is difficult to manage and is associated to high morbimortality.
Surgical repair is complex and not free from complications: its mortality rate ranges from 5 to 20% and depends on series, surgeon and center expertise.
Edge-to-edge repair with clips has become a valid alternative to treat this disease, but most data come from one device designed to treat the mitral valve.
The TRILUMINATE Pivotal is an international, randomized control study of patients with severe symptomatic TR undergoing transcatheter repair with TriClip (Abbott Structural Heart) vs a control group. All patients received complete guideline medical therapy.
Primary end point was a hierarchical composite of all cause death, surgical tricuspid repair, hospitalization for heart failure, and improved quality of life as an increase of at least 15 points in the KCCQ score.
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It included 350 patients, half receiving the device and the rest as part of the control group.
There were no differences between the groups. Mean age was 78 and 55% were women. 60% was in functional class III-IV, 90% had atrial fibrillation, 8% stroke, 18% prior CABG, 15% aortic valve surgery and 20% mitral valve surgery. eGFR was 54 ml/min, BNP was 3.600 pg/ml, and the 6-minute walk test was 250 meters.
90% of patients were on diuretics, 65% on beta-blockers, 38% ACE-I, ARB or ARNI and 9% vessel dilators.
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Ejection fraction was 59%, right end diastolic diameter was 51 mm and tricuspid annulus 44 mm. In addition, right atrial volume was 148 ml and 70% were massive or torrential TR.
Device implantation rate was 98.8%. Two 2.2 clips were used per patient.
Primary end point at 12 months was in favor of the device (win ratio, 1.48; 95% confidence interval, 1.06 to 2.13; P = 0.02). There were no differences in all-cause mortality, tricuspid valve surgery or hospitalization for cardiac failure. Quality of life improved in patients receiving the device. It increased 12.3±1.8 in the Triclip group vs. 0.6±1.8 (p<0.001) in the control group.
The presence of minor to moderate TR was superior in the Triclip group (87% vs. 4.8% p<0.001).
There were no differences in 6-minute walk test outcomes.
Conclusion
Edge-to-edge repair was safe in patients with severe tricuspid failure, reducing severity and was associated to better quality of life.
Dr. Carlos Fava.
Member of the Editorial Board of SOLACI.org.
Original Title: Transcatheter Repair for Patients with Tricuspid Regurgitation. TRILUMINATE Pivotal.
Reference: Paul Sorajja, et al NEJM DOI: 10.1056/NEJMoa2300525.
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