Background: Transcatheter edge-to-edge repair (TEER) of the mitral valve has emerged as the standard treatment for patients with mitral regurgitation (MR) with high surgical risk. Even though MitraClip is widely used, the novel PASCAL device system offers distinct technical features. We aim to study the safety and efficacy of the PASCAL repair system in clinically significant MR.
Methods: PubMed, Medline, Cochrane Central Register of Controlled Trials, and EMBASE were searched for articles published from August 2016 until June 2022 to identify studies that investigated the safety and efficacy of PASCAL for patients with degenerative, functional and mixed MR. Primary performance endpoints were technical, device, and procedural successes. Primary safety endpoint was composite 30 day major adverse events (MAE). Secondary endpoints were MR grade at discharge and 30 days, 30 day postprocedural NYHA functional class, left ventricular ejection fraction (LVEF), change in 6-min walk distance (6MWD), 30-day and 12-month all-cause mortality.
Results: We included twelve retrospective and prospective observational studies and one randomized controlled study consisting of 1028 patients with severe, symptomatic MR (NYHA III-IV: 84.0%, MR ≥ 3+: 99.7%) and high surgical risk (mean logistic EuroSCORE of 16.4).Technical success was 95.7%, procedural success was 95.2%, and device success was 86.1% relative to the weighted average. MR grade was ≤2+ in 94.7% of patients at discharge and 94.0% patients at 30-day follow-up. Mean 30-day and 12-month mortality after device implantation were 4.54% and 12.2%.
Conclusion: The PASCAL repair system appears to be a safe and effective therapeutic option to treat severe, symptomatic MR in high surgical risk patients.
Keywords: MitraClip; Mitral regurgitation; PASCAL; Transcatheter edge-to-edge repair.
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