Two-Year Outcomes for Tricuspid Repair With a Transcatheter Edge-to-Edge Valve Repair From the Transatlantic TRILUMINATE Trial
Authors: von Bardeleben Ralph Stephan , Lurz Philipp , Sorajja Paul , Ruf Tobias , Hausleiter Jörg , Sitges Marta , Da Rocha e Silva Jaqueline , Näbauer Michael , Weber Marcel , Tang Gilbert H.L. , Heitkemper Megan , Ying Shih-Wa , Trochu Jean-Noel , Kar Saibal , Hahn Rebecca T. , Nickenig Georg , Nickenig Georg , von Bardeleben Ralph Stephan , Geyer Martin , Wenaweser Peter , Biaggi Patric , Kapos Ioannis , Alsidawi Said , Lurz Philipp , Arzamendi Dabit , Ander Regueiro , Sabate Manuel , Lala-Trindade Anuradha , Adams David , Swain Julie , Orban Mathias , Hausleiter Jörg , Alfieri Ottavio , Agricola Eustachio , Montorfano Matteo , Sinning Jan-Malte , Tamm Alexander , Hoffmann Steffen , Kowalski Marek , Garatti Andrea , Pecoraro Alessandra , Motta Gessica , Tusa Maurizio , Zuber Michel , Windecker Stephan , Samara Michael , Mudy Karol , Parikh Sachin , Dee Wang Dee , Piriou Nicolas , Rommel Karl-Philipp , Binner Christian , Jimenez Gustavo , Freixa Xavier , Serra Antonio , Lim David , Lerakis Stamatios , Buzzatti Nicola , Baragagna Marta , Tiburtius Claudia , Grasso Carmelo , De Marco Federico , Maisano Francesco , Taramasso Maurizio , Bae Richard , Frisoli Tiberio , Guerin Patrice , Hartung Philipp , Mitter Sumeet , Moss Noah , Stocker Thomas , Ancona Francesco , Agricola Eustachio , Capogrosso Cristina 
Published: August 2023

BACKGROUND:
Tricuspid regurgitation (TR) is a common and progressive valve disease with significant mortality and hospitalization burden. Tricuspid transcatheter edge-to-edge repair provides a treatment option for high-risk patients with primary and secondary TR.

METHODS:
The TRILUMINATE trial ([Trial to Evaluate Treatment With Abbott Transcatheter Clip Repair System in Patients With Moderate or Greater Tricuspid Regurgitation]; n=85) is an international, prospective, single-arm, multicenter study to investigate the safety and performance of tricuspid transcatheter edge-to-edge repair with the TriClip implant in patients with symptomatic moderate or greater TR. Echocardiographic assessment was performed at a core laboratory. Outcomes included safety and clinical effectiveness and echocardiographic assessment of TR.

RESULTS:

At 2 years, TR was reduced to moderate or less in 60% of subjects, and reduction of at least 1 grade was achieved in 85.4% of subjects. TR reduction was sustained in 75% of the patients. While most metrics suggest the majority of favorable remodeling occurred within the first 30 days post-procedure, both right ventricular end diastolic diameter and tricuspid annular plane systolic excursion show signals of continued favorable remodeling through 2 years. Substantial improvements in 6-minute walking distance, New York Heart Association functional class, and Kansas City Cardiomyopathy Questionnaire score were sustained from 30 days to 2 years. Even with low rates of cardiovascular mortality (15.3%) and all-cause mortality (18.7%) noted at 2 years, all-cause hospitalization rate decreased from 1.30 events per patient-year 1 year before device implantation to 0.66 events per patient-year 2 years after the TriClip procedure, representing a reduction of 49% (
P
<0.0001).

CONCLUSIONS:
Tricuspid transcatheter edge-to-edge repair using the TriClip implant was found to be safe and effective, with sustained benefits at 2 years in subjects with symptomatic moderate or greater TR. Repair efficacy was durable at 2 years in 75% of the patients.

REGISTRATION:

URL:
https://www.clinicaltrials.gov
; Unique identifier: NCT03227757.