https://doi.org/10.1007/s00392-024-02526-y
1Universitätsklinikum Schleswig-Holstein Innere Medizin III mit den Schwerpunkten Kardiologie und internistische Intensivmedizin Kiel, Deutschland; 2Universitätsklinikum Schleswig-Holstein Innere Medizin III mit den Schwerpunkten Kardiologie, Angiologie und internistische Intensivmedizin Kiel, Deutschland
Background: Mitral Transcatheter Edge-to-Edge Repair (M-TEER) is a minimal invasive procedure for the treatment of patients with mitral regurgitation (MR) and has emerged as an essential tool for patients with MR who are at high risk for surgery. Currently, the PASCAL™ and the MitraClip™ systems are the two CE marked devices used for M-TEER. However, apart from one RCT (CLASP IID) there is only little data on head-to-head comparisons between these two systems. 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 M-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: N=148 patients underwent M-TEER, of these N=81 (55%) were treated with MitraClip™, while N=67 (45%) received treatment with the PASCAL™ system. In the MitraClip™ cohort, 68% (54/79) were females. In the PASCAL™ cohort 46% (31/67) were females. There was no significant difference in age, MR 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 (MitraClip™: 1,3% vs PASCAL™: 0%, p=>0.9). Procedural time was sig. shorter in the MitraClip™group (32.27±27.67 min vs 47.02±28.76, p=0.073). Technical success was numerically better in the PASCAL™ group (93% vs 87%, p=0.3), while MR reduction at the end of the procedure was equal in both groups (MR ≤ grade 2: 94% vs 94%, p=0.7).
Conclusion: Regarding a combined clinical event both systems performed equally well. Numerical differences were found only for duration of procedure and technical success 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.