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Background/Objectives: Previous trials reported comparable results with PASCAL and earlier MitraClip generations. Limited comparative data exist for more contemporary MitraClip generations, particularly the large MitraClip XT(R/W). We aimed to evaluate acute and 30-day outcomes in patients undergoing mitral valve transcatheter edge-to-edge repair (M-TEER) with one of the large devices, either PASCAL P10 or MitraClip XT(R/W) (3rd/4th generation). Methods: A total of 309 PASCAL-treated patients were matched by propensity score to 253 MitraClip-treated patients, resulting in 200 adequately balanced pairs. Procedural, clinical, and echocardiographic outcomes were collected for up to 30 days, including subgroup analysis for mitral regurgitation (MR) etiologies. Results: PASCAL and MitraClip patients were comparable regarding age (80 vs. 79 years), sex (female: 45.5% vs. 50.5%), and MR etiology (degenerative MR: n = 94, functional MR [FMR]: n = 96, mixed MR: n = 10 in each group). Technical success rates were comparable (96.5% vs. 96.0%; p > 0.999). At discharge, the mean gradient was higher (3.3 mmHg vs. 3.0 mmHg; p = 0.038), and the residual mitral valve orifice area was smaller in MitraClip patients (3.0 cm2 vs. 2.3 cm2; p < 0.001). At discharge, the reduction to MR ≤ 2+ was comparable (92.4% vs. 87.8%; p = 0.132). However, reduction to MR ≤ 1+ was more frequently observed in PASCAL patients (67.7% vs. 56.6%; p = 0.029), driven by the FMR subgroup (74.0% vs. 60.0%; p = 0.046). No difference was observed in 30-day mortality (p = 0.204) or reduction in NYHA-FC to ≤II (p > 0.999). Conclusions: Both M-TEER devices exhibited high and comparable rates of technical success and MR reduction to ≤2+. PASCAL may be advantageous in achieving MR reduction to ≤1+ in patients with FMR.

BACKGROUND: Several repair strategies emerged as possible treatment for severe mitral regurgitation (MR). A systematic review and meta-analysis was performed to compare the different percutaneous mitral valve repair approaches.
METHODS: PubMed and Scopus electronic databases were scanned for eligible studies until December 11th, 2023. Clinical efficacy endpoints were all-cause mortality, major adverse cardiovascular events, and post-procedural NYHA functional class <3; the echocardiographic efficacy endpoint was a post-intervention residual MR less than moderate. Safety endpoints and procedural outcome measures were also assessed.
RESULTS: Eleven studies were included: 8 [N = 1662 patients, mean follow-up (FUP) 294 days] compared MitraClip® vs Pascal® device, 2 (N = 195 patients) MitraClip® vs Carillon® and 1 study (N = 186 patients) evaluated MitraClip® against Cardioband®. The Pascal®-treated group had lower MR degree compared to the MitraClip®-treated group, without difference in post-intervention mean trans-mitral gradient and in clinical and safety endpoints. A longer procedure time was observed in the Pascal® group, albeit with a lower average number of implanted devices per procedure. The two studies comparing MitraClip® and Carillon® were inconsistent in terms of both efficacy and safety outcomes, while the study evaluating MitraClip® vs Cardioband® showed that the latter might confer a significant clinical benefit, with a similar reduction in MR.
CONCLUSIONS: Pascal® is as safe and clinically effective as MitraClip® in treating patients with MR, with an apparent greater reduction in the magnitude of residual valve insufficiency over the long term. Data on Cardioband® and Carillon® are not robust enough to draw conclusions from the use of such devices.

BACKGROUND: Mitral transcatheter edge-to-edge repair (M-TEER) is a guideline-recommended treatment option for patients with severe symptomatic mitral regurgitation (MR). Outcomes with the PASCAL system in a post-market setting have not been established.
OBJECTIVE: The authors report 30-day and 1-year outcomes from the MiCLASP (Transcatheter Repair of Mitral Regurgitation with Edwards PASCAL Transcatheter Valve Repair System) European post-market clinical follow-up study.
METHODS: Patients with symptomatic, clinically significant MR were prospectively enrolled. The primary safety endpoint was clinical events committee-adjudicated 30-day composite major adverse event rate and the primary effectiveness endpoint was echocardiographic core laboratory-assessed MR severity at discharge compared with baseline. Clinical, echocardiographic, functional, and quality-of-life outcomes were assessed at 1 year.
RESULTS: A total of 544 patients were enrolled (59% functional MR, 30% degenerative MR). The 30-day composite major adverse event rate was 6.8%. MR reduction was significant from baseline to discharge and sustained at 1 year with 98% of patients achieving MR ≤2+ and 82.6% MR ≤1+ (all P < 0.001 vs baseline). One-year Kaplan-Meier estimate for survival was 87.3%, and freedom from heart failure hospitalization was 84.3%. Significant functional and quality-of-life improvements were observed at 1 year, including 71.6% in NYHA functional class I/II, 14.4-point increase in Kansas City Cardiomyopathy Questionnaire score, and 24.2-m improvement in 6-minute walk distance (all P < 0.001 vs baseline).
CONCLUSIONS: One-year outcomes of this large cohort from the MiCLASP study demonstrate continued safety and effectiveness of M-TEER with the PASCAL system in a post-market setting. Results demonstrate high survival and freedom from heart failure hospitalization, significant and sustained MR reduction, and improvements in symptoms, functional capacity, and quality of life.

Both the MitraClip and PASCAL systems offer transcatheter edge-to-edge repair (TEER) solutions for mitral regurgitation. Evidence indicates a lower technical success rate for TEER in complex degenerative mitral regurgitation (DMR) cases. We conducted a retrospective analysis of patients who underwent transcatheter edge-to-edge therapy for primary mitral regurgitation with advanced anatomy, defined as mitral regurgitation effective regurgitant orifice area (MR-EROA) ≥0.40 cm2 or large flail gap (≥5 mm) or width (≥7 mm) or Barlow\'s disease, that completed follow-up after 1 year. Our criteria were met by 27 patients treated with PASCAL and 18 with MitraClip. All patients exhibited a significant, equivalent short-term reduction in MR-EROA, mitral regurgitation vena contracta diameter (MR-VCD), regurgitant volume, and clinical status. At 1 year follow-up, reductions in MR-VCD, regurgitant volume, and MR-EROA remained significant for both groups without significant differences between groups. MR-Grade ≤ 1+ was achieved in 18 (66.7%) and 10 (55.6%) patients, respectively. At follow-up, no difference in hospitalization for cardiac decompensation was observed. Overall death was similar in both groups. Our study suggests that both the PASCAL and MitraClip systems significantly reduce mitral regurgitation even in advanced degenerative diseases. Within our limited data, we found no evidence of inferior performance of the PASCAL system.

BACKGROUND: Transcatheter edge-to-edge repair (TEER) has become an established treatment for primary and secondary mitral regurgitation (PMR and SMR). The objective of this study was to compare the accuracy of different risk scores for predicting 1-year mortality and the composite endpoint of 1-year mortality and/or heart failure (HF) hospitalization after TEER.
METHODS: We analyzed data from 206 patients treated for MR at a tertiary European center between 2011 and 2023 and compared the accuracy of different mitral and surgical risk scores: EuroSCORE II, GRASP, MITRALITY, MitraScore, TAPSE/PASP-MitraScore, and STS for predicting 1-year mortality and the composite of 1-year mortality and/or HF hospitalization in PMR and SMR. A subanalysis of SMR-only patients with the addition of COAPT Risk Score and baseline N-Terminal pro-Brain Natriuretic Peptide (NT-proBNP) list was also performed.
RESULTS: MITRALITY had the best discriminative ability for 1-year mortality and the composite endpoint of 1-year mortality and/or HF hospitalization, with an area under the curve (AUC) of 0.74 and 0.74, respectively, in a composed group of PMR and SMR. In a SMR-only population, MITRALITY also presented the best AUC for 1-year mortality and the composite endpoint of 1-year mortality and/or HF hospitalization, with values of 0.72 and 0.72, respectively.
CONCLUSIONS: MITRALITY was the best mitral TEER risk model for both 1-year mortality and the composite endpoint of 1-year mortality and/or HF hospitalization in a population of PMR and SMR patients, as well as in SMR patients only. Surgical risk scores, MitraScore, TAPSE/PASP-MitraScore and NT-proBNP alone showed poor predictive values.

UNASSIGNED: Over the last two decades, mitral transcatheter edge-to-edge repair (M-TEER) has become a safe and effective therapy for severe mitral regurgitation in patients deemed at high surgical risk.
UNASSIGNED: This review aims to encompass the most relevant and updated evidence in the field of M-TEER from its inception, focusing on clinical and anatomical features for proper patient and device selection.
UNASSIGNED: Growing operator experience and device iterations have resulted in improved clinical outcomes and an expansion of the therapy to patients with complex anatomies and clinical scenarios. Future investigations are warranted to determine the best management options and the most suitable device for every patient with MR.

BACKGROUND: We previously reported procedural and 30-day outcomes of a German early multicenter experience with the PASCAL system for severe mitral regurgitation (MR). This study reports 1-year outcomes of mitral valve transcatheter edge-to-edge repair with the PASCAL system according to MR etiology in a large all-comer cohort.
RESULTS: Clinical and echocardiographic outcomes up to 1-year were investigated according to MR etiology (degenerative [DMR], functional [FMR], or mixed [MMR]) in the first 282 patients with symptomatic MR 3+/4+ treated with the PASCAL implant at 9 centers in 2019. A total of 282 patients were included (33% DMR, 50% FMR, 17% MMR). At discharge, MR reduction to ≤1+/2+ was achieved in 58%/87% of DMR, in 75%/97% of FMR, and in 78%/98% of patients with MMR (P=0.004). MR reduction to ≤1+/2+ was sustained at 30 days (50%/83% DMR, 67%/97% FMR, 74%/100% MMR) and at 1 year (53%/78% DMR, 75%/97% FMR, 67%/91% MMR) with significant differences between etiologies. DMR patients with residual MR 3+/4+ at 1-year had at least complex valve morphology in 91.7%. Valve-related reintervention was performed in 7.4% DMR, 0.7% FMR, and 0.0% MMR (P=0.010). At 1-year, New York Heart Association Functional Class was significantly improved irrespective of MR etiology (P<0.001).
CONCLUSIONS: In this large all-comer cohort, mitral valve transcatheter edge-to-edge repair with the PASCAL system was associated with an acute and sustained MR reduction at 1-year in all causes. However, in patients with DMR, MR reduction was less pronounced, reflecting the high incidence of complex or very complex anatomies being referred for mitral valve transcatheter edge-to-edge repair.

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BACKGROUND: mitral regurgitation (mr) is the most common valvular heart disease (vhd) in the elderly and tends to be more prevalent in women. while relevant sex differences in outcomes are evident in surgically treated collectives, there are very limited and conflicting sex-specific data for the growing cohort of patients undergoing transcatheter edge-to-edge repair (teer).
OBJECTIVE: to investigate whether sex impacts procedural safety and efficacy, and in-hospital- and long-term outcomes, after teer for mr.
METHODS: in a multicenter observational cohort study, patients who underwent teer were stratified by sex and relevant outcome measures, and analyzed using multivariable cox regression and propensity score matching (psm).
RESULTS: a total of 821 patients were analyzed, of whom 37.4% (307/821) were female. compared to male patients, females were significantly older (77 ± 8.5 vs. 80.4 ± 6.7 years, p = 0.03), and had less coronary artery disease (cad, 67.7% vs. 53.1%, p < 0.0001) and a higher proportion of preserved left ventricular function (lvef > 50%, 32.5% vs. 50.5%, p > 0.0001). safety and efficacy of the teer procedure and in-hospital mortality did not differ between the sexes. after psm, women showed significantly better survival 3 years after teer compared to men (60.7% vs. 54.2%, p = 0.04) and a lower risk of all-cause death according to multiple cox regression (hr 0.8, 95% ci 0.6-0.9, p = 0.02). after sex-specific stratification for concomitant atrial fibrillation (af), the most common comorbidity in the present collective, women with af experience significantly worse adjusted survival compared to women without af (53.9% vs. 75.1%, p = 0.042) three years after teer and lose the survival advantage over men.
CONCLUSIONS: female patients are older and less comorbid than males undergoing TEER. The TEER procedure is equally safe and effective in both sexes. While in-hospital mortality did not differ, female patients experienced a significantly better adjusted long-term survival compared to male patients. Concomitant AF offsets the prognostic advantage of females over males and, in contrast to males, significantly impairs long-term survival in women undergoing TEER. Further research is warranted to elucidate underlying causes for the observed sex disparities and to develop sex-tailored treatment recommendations.