Mitral valve transcatheter edge-to-edge repair (TEER) using either the MitraClip or PASCAL device was safe, and both devices offered similar technical success and comparable short- and long-term outcomes, according to a new study. Findings from the study published Monday online ahead of the Dec 26 issue of the Journal of the American College of Cardiology provides some much-needed evidence of both devices’ effectiveness in treating mitral regurgitation (MR) given the paucity of comparative data. “In our analysis, optimal MR results were consistent and comparable with both TEER systems in the overall cohort after 1 year (78.0% with [MitraClip] vs 82.3% with PASCAL),” stated the retrospective multicenter study. “Although optimal MR results were more frequently achieved with the PASCAL system, device choice did not reach statistical significance as an independent predictor of an optimal result after [mitral valve] TEER in multivariate regression analysis.” Study details The researchers initially identified 412 patients (216 MitraClip, 196 PASCAL) for the study, with 184 patients (92 in each treatment group) remaining after propensity-score matching. Patients were exclusively treated with the third (NTR and XTR) and fourth (NT, NTW, XT, and XTW) device generations of Abbott’s MitraClip system. With respect to Edwards Lifesciences’ PASCAL device, both generations (P10 and Ace) were used within the course of the investigation. The study’s primary endpoint was residual MR at discharge, with secondary endpoints being degree of technical success, extent of MR reduction from preprocedure to discharge, and 30-day mortality. Long-term clinical and echocardiographic follow-up, including all-cause mortality and residual MR at 1 year, were also reported. The study, which to date represents the largest short- and long-term multicenter comparison of the MitraClip and the PASCAL TEER systems, found optimal residual MR ≤1 was achieved in 72.6% of patients receiving MitraClip compared with 79.1% of patients receiving PASCAL (P = 0.13) in the total cohort. This was despite greater effective regurgitation orifice area (EROA) in the PASCAL group, resulting in MR reduction by ≥2 grades in 85.7% of the MitraClip group compared with 87.7% of the PASCAL group (P = 0.19). Comparable technical success rates Further findings revealed that both devices offered excellent performance in the overall cohort, with comparable technical success rates (MitraClip 97.2% and PASCAL 97.4%; P = 0.87). Also noted was the similarly low 30-day mortality rate for both devices in the overall cohort (2.4% in the MitraClip group and 1.6% in the PASCAL group (P = 0.55). The research team also found that after propensity score matching for differences between the MC and PASCAL groups, the TEER systems achieved optimal residual MR ≤1 at discharge in 69.6% compared with 77.1% of patients (P = 0.24). “MR reduction by ≥2 grades were achieved in 83.7% in the [MitraClip] group compared with 92.4% in the PASCAL group (P = 0.13), and both devices showed high technical success rates (97.8%; P > 0.99),” said the research team, led by Leonhard Schneider, MD, from the University Hospital of Ulm in Germany. Further findings, which compared patients with functional mitral regurgitation (FMR) with those with degenerative mitral regurgitation (DMR) or mixed-etiology MR treated with the MitraClip or PASCAL system showed consistent results in the overall and propensity-score-matched cohorts. Long-term residual MR outcomes Finally, 1-year outcomes regarding residual MR were comparable, with MR ≤1 in 78.0% of patients with MitraClip and 82.3% with PASCAL (P = 0.70) in the propensity-score-matched cohort and in 79.5% with MitraClip and 78.7% with PASCAL in the overall cohort (P = 0.92). Likewise, 1-year all-cause mortality was comparable in the propensity-score-matched cohort, with 14.1% in the MitraClip group and 6.5% in the PASCAL group (P = 0.14). However, differences in 1-year all-cause mortality were apparent in the unmatched overall cohort, with 15.7% in the MC group and 8.7% in the PASCAL group (P = 0.036). “Results were consistent between the MC and PASCAL in patients with FMR and those with DMR or mixed-etiology MR in the overall and propensity score–matched cohorts,” the study stated. “Overall, both devices offered excellent performance resulting in comparable technical success rates, with a slight tendency toward more optimal short- and long-term MR results using PASCAL and a strong safety profile with a tendency toward fewer leaflet detachments with the [MitraClip].” ‘Timely and well-performed’ study In an accompanying editorial, Ahmed El Shaer, MD, from the University of Wisconsin Hospital, Madison, and Mohamad Alkhouli, MD, from the Mayo Clinic, Rochester, Minnesota, described the study as “timely and well-performed.” “The strengths of the study are the inclusion of patients with various MR etiologies and the relatively large sample size,” they said. The editorialists also noted an absence of data addressing difficult valve features (MR jet[s] number and location, leaflet length, coaptation gap, annular/leaflet calcifications), which precluded an efficacy comparison between the two devices based on anatomical factors. “Further investigations are needed to guide our device selection for various MR phenotypes, especially considering the expected approval of transcatheter mitral valve replacement devices in the foreseen future,” they wrote. Sources: Schneider L, Markovic S, Mueller K, et al. Mitral valve transcatheter edge-to-edge repair using MitraClip or PASCAL: a multicenter propensity score-matched comparison. JACC Cardiovasc Interv. 2022;15:2554–2567. El Shaer A, Alkhouli M. The Expanding Landscape of Transcatheter Mitral Valve Therapies. JACC Cardiovasc Interv. 2022;15:2568–2570. Image Credit: iushakovsky – stock.adobe.com