Percutaneous edge-to-edge therapy with PASCAL or MitraClip: a multicenter propensity score matched comparison

Abstract

Abstract Background The MitraClip is the worldwide established transcatheter edge-to-edge repair system with over 100,000 treated patients. The recently approved PASCAL repair system is well adopted in the field of percutaneous mitral regurgitation (MR) treatment with growing acceptance both in mitral and tricuspid valves. The aim of this retrospective multicenter study was to compare the Edwards' PASCAL System with the Abbott MitraClip System in terms of procedural results and short-term outcome. Methods We retrospectively evaluated patient data of three high volume German centers that performed percutaneous edge to edge procedures either with the MitraClip or the PASCAL repair system. Primary endpoint was the amount of MR reduction. Secondary endpoints were residual MR at discharge, technical success, device success and 30-day mortality. Results Between 2018 and 2020 a total of 412 procedures were performed in the three centers. 216 cases were performed with the MitraClip compared to 196 procedures done with the PASCAL repair system. Patients were male in 55.6% of the cases (50.5% in the MitraClip cohort compared to 61.2% in the PASCAL cohort, p=0.028), mean Logistic Euro-Score II was 4.42 (3.58 in the MitraClip and 3.23 in the PASCAL cohort, p=0.038) and reduced LVEF beyond 45% was seen in 42.6% of the cases (49.5% in the MitraClip compared to 35.3% in the PASCAL cohort, p=0.004). Severe MR at baseline was seen in 98.5% in the MitraClip cohort compared to 98.6% in the PASCAL cohort, p=0.909). Mean number of implanted devices was 1.41±0.56 in the MitraClip cohort and 1.37±0.55 in the PASCAL cohort (p=0.401). Procedures were successfully conducted with both edge-to-edge systems (device success rate 93.2% in the MitraClip cohort and 94.0% in the PASCAL cohort, p=0.775), leading to comparably good results (final MR ≤2 in 94.4% with the MitraClip compared to 95.9% with the PASCAL system, p=0.448) and very good results (final MR ≤1 in 72.6% in the MitraClip compared to 79.5% in the PASCAL cohort, p=0.102). After propensity score matching for adjustment of major differences among the two treatment strategies (including age, gender, MR etiology, EROA, Severe MR (III and IV), reduced LVEF and Mitral Valve orifice area) the achieved mean MR reduction remains comparable (2.29±0.82 with the MitraClip compared to 2.46±0.82 with the PASCAL system, p=0.191). In multivariate regression analysis STS Score independently correlates with a very good final result while device choice did not show a significant impact in this cohort. Conclusion In this retrospective multicenter study both the MitraClip and PASCAL system performed excellent with comparable procedural success rates. Achieved final average reduction of MR Grade was 2.29±0.82 with the MitraClip and 2.46±0.82 with the PASCAL system. Funding Acknowledgement Type of funding sources: None.