Background: Transcatheter Edge-to-Edge Repair (TEER) has become an increasingly used therapeutic option for patients with Tricuspid Regurgitation (TR) who are at high risk for cardiac surgery. The TriClip™ System (Abbott Medical, IL, USA) was the first device to acquire CE mark in Europe in 2020. With the PASCAL™ system (Edwards lifescience, CA, USA) a competing TEER device was commercialized in Europe later in 2020. Little data is available on head-to-head comparison. With this retrospective study we sought to compare performance and safety of both systems in a single-centre university hospital cohort.
Methods: All consecutive patients who underwent a T-TEER procedure with either one system from January 2022 until February 2024 were enrolled. System use did not follow clinical but organisational aspects in an alternating (pseudorandomized) manner as a priori no specific advantage of either system was perceived. Main composite endpoint was a combination of all-cause mortality, heart-failure hospitalization, re-intervention or cardiac surgery as defined by the MVARC criteria. Further, we compared the postprocedural severity of tricuspid regurgitation and safety of both systems.
Results: A total of 69 patients underwent a T-TEER procedure, n=41 of them were treated with the TriClip™, n=28 with PASCAL™ system. The median age of the cohort was 80.6 years (IQR: 76 - 85), 45% were female. There was no significant difference in age, gender, TR severity, comorbidities and medication between the two groups, nor regarding lab parameters including NT-proBNP. The combined endpoint was reached similarly often in both groups (TriClip™: 5% vs PASCAL™: 0%, p=0.5). Procedural time was significant shorter in the TriClip™ group (62.33±43.42 min vs 78.39±43.51, p=0.073). Technical success was numerically better in the TriClip™ group (88% vs 82%, p=0.7), while TR reduction at the end of the procedure was more pronounced in the TriClip™ group (TR ≤ grade 2: 90% vs 77.7%, p=0.2).
Conclusion: Regarding a combined clinical event both systems performed equally well. Numerical differences were found for technical success and TR reduction that did not translate into clinical endpoint as mean follow-up was short. Further studies are warranted to identify possible pros and cons for the use of either one system in specific clinical scenarios.
