The PASCAL P10 system for mitral valve transcatheter edge-to-edge repair has undergone iterations, including introduction of the narrower Ace implant and the Precision delivery system. The study sought to evaluate outcomes and the impact of PASCAL mitral valve transcatheter edge-to-edge repair device iterations. The REPAIR (REgistry of PAscal for mltral Regurgitation) study is an investigator-initiated, multicenter registry including consecutive patients with mitral regurgitation (MR) treated from 2019 to 2024. Patients were stratified by device iteration: P10_only, P10/Ace_Gen1 (introduction of Ace), and P10/Ace_Prec (introduction of Precision). The primary endpoint was MR ≤1+ at discharge; secondary endpoints included technical success and MR durability (discharge vs 30 days, 1 year, and 2 years). A total of 2,165 patients (mean age 78 ± 10 years, 44% female, 85% in NYHA functional class ≥III, EuroSCORE II [European System for Cardiac Operative Risk Evaluation II] 4.9% [Q1-Q3: 3.0% to 8.1%]) were included: 660 P10_only, 945 P10/Ace_Gen1, and 560 P10/Ace_Prec. Median follow-up was 510 days (Q1-Q3: 369-874 days). Primary (47% [n = 1,019 of 2,142]) and secondary (52% [n = 1,123 of 2,142]) MR etiology did not change across device iterations (P = 0.547). Technical success was achieved in 97.0% (n = 2,099 of 2,165) with similar rates across device iterations (P = 0.290). MR ≤1+ was achieved in 72% (n = 1,397 of 2,085), improving with device iterations (P10_only: 66% [n = 422 of 638], P10/Ace_Gen1: 73% [n = 661 of 906], P10/Ace_Prec: 77% [n = 414 of 541]; P < 0.001). MR grades of ≤1+ and ≤2+ slightly worsened at 30 days, 1 year, and 2 years, primarily in patients with primary MR, with no differences across iterations. Device iterations of the PASCAL system resulted in increasing rates of achieving MR reduction to ≤1+ at discharge, with stable and high technical success rates. A slight deterioration of the initial result warrants further investigation.

Secondary mitral regurgitation (SMR) has 2 phenotypes: atrial (aSMR) and ventricular (vSMR). The role of mitral valve transcatheter edge-to-edge repair (M-TEER) in aSMR remains less defined, with limited evidence on the PASCAL implant (Edwards Lifesciences). The authors sought to evaluate and compare outcomes of SMR phenotypes undergoing M-TEER. REPAIR (REgistry of PAscal for mItral Regurgitation) is an investigator-initiated, multicenter registry of patients undergoing M-TEER. aSMR was defined by left atrial dilation with preserved left ventricular size and ejection fraction. Outcomes included MR ≤1+ at discharge, technical success, NYHA functional class improvement, and 1-year survival. Among 915 patients (166 [18%] aSMR, 749 [82%] vSMR), the median follow-up was 491 days (Q1-Q3: 360-833 days). MR ≤1+ was achieved in 77.2% vs 71.4% (P = 0.162), with technical success in 97.0% vs 98.3% (P = 0.446). NYHA functional class improved in both phenotypes (P < 0.001), with 61.2% vs 61.3% in functional class ≤II at follow-up (P > 0.999). One-year survival was 88.4% (95% CI: 82.8%-94.4%) vs 86.0% (95% CI: 83.1%-89.0%; P = 0.346). In aSMR patients, 1-year survival was significantly lower in patients with baseline tricuspid regurgitation (TR) grade ≥moderate compared with those with <moderate TR (84.3% [95% CI: 77.0%-92.3%] vs 100.0% [95% CI: 100.0%-100.0%]; P = 0.041). In vSMR patients, survival was similar between ≥moderate and <moderate baseline TR (83.9% [95% CI: 79.8%-88.2%] vs 89.3% [95% CI: 85.0%-93.8%]; P = 0.051). M-TEER effectively reduces MR to ≤1+ and improves symptoms in both aSMR and vSMR. Particularly in aSMR, ≥moderate baseline TR is linked to worse outcomes, warranting consideration as an additional treatment target.

Background: Recent developments in transcatheter mitral valve repair (M-TEER) have expanded the indication for the procedure beyond conventional criteria to include patients with anatomically complex degenerative mitral regurgitation (DMR), but long-term outcomes are not well known. Aims: To investigate outcomes by specific anatomical criteria in patients with severe DMR and complex valve anatomy enrolled in the prospective MitraUlm registry. Methods: Clinical and echocardiographic 3-year outcomes of 304 patients with DMR and complex mitral valve anatomy, defined according to the CLASP IID registry criteria, were investigated. Outcomes were analysed separately for specific anatomical complexities. Results: 33.5% of patients had ≥ independent significant jets, 12% multisegmental prolapse, 12.3% mitral valve orifice area < 4 cm², 10.9% commissural lesions with wide/multiple jets, and 10.1% large flail. Mitral regurgitation (MR) reduction ≤ 2 was achieved in 93.8% of patients at discharge and in 85.9% at 3-year follow-up. Patients with multisegmental prolapse and commissural lesions with multiple/wide jets had the lowest MR reduction at discharge. Compared to patients treated with MitraClip Generation 1–3, patients treated with MitraClip Generation 4 had significantly better post-procedural MR reduction (MR ≤ 1 in 74.3% vs 50.7%, P < 0.001) and higher 3-year survival rates (80.2% vs 61.6%, Log Rank P = 0.002). Postprocedural MR reduction to MR ≤ 1 was the strongest independent predictor of 3-year survival, whereas the presence of at least two anatomical complexities and elevated post-procedural left atrial pressure predicted 3-year all-cause mortality. Conclusions: In patients with anatomically complex DMR, advances in procedural techniques for M-TEER have allowed successful treatment with sustained MR reduction and improved long-term survival. Graphical

Background: Transcatheter tricuspid edge-to-edge repair (T-TEER) is widely used to treat atrial (AFTR) and ventricular (VFTR) functional tricuspid regurgitation (FTR). Methods: The outcome of 136 patients treated with T-TEER for severe AFTR or VFTR was analyzed using a composite endpoint of all-cause death and rehospitalization for decompensated heart failure. AFTR was defined as TR in the context of left ventricular ejection fraction ≥50%, right ventricular fractional area change (RVFAC) ≥ 35% and sPAP ≤ 50 mmHg. Results: Patients with VFTR (N = 109) and AFTR (N = 27, 19.9%) were both elderly (82.0 {IQR: 74.5–84.5} vs. 82.0 {IQR: 75.0–84.0} years, p = 0.98) and had similar interventional risk according to the EuroScore II (6.1 {4.0–9.8} vs. 4.7 {3.6–9.6} %, p = 0.3). Atrial fibrillation was equally frequent in both groups (89.9 vs. 88.9%, p = 0.88). AFTR patients were significantly more often female (56.0 vs. 77.8%, p = 0.04) and had lower NT-proBNP (3600.0 {1706.0–6302.0} vs. 1988.0 {1034.8–3723.3} pg/mL, p < 0.01). While RVFAC (29.5 ± 8.6 vs. 42.1 ± 4.3%, p < 0.01) and LVEF (48.5 ± 12.3 vs. 58.6 ± 8.0%, p < 0.01) were expectedly lower in patients with VFTR, right atrial dilation (RA volume: 126.7 ± 56.5 vs. 127.6 ± 74.2 mL, p = 0.99) was similar. Successful T-TEER with TR reduction ≥ 2 degrees (96.3 vs. 92.6%, p = 0.34) was observed in both groups, and residual TR ≤ II was equally frequent (94.5 vs. 96.3%, p = 1.0). The incidence of the 1-year composite endpoint was significantly higher (34.3 vs. 12.0%) in patients with VFTR (log-rank p = 0.02). AFTR was inversely associated with the composite endpoint (HR: 0.21, 95% CI: 0.06–0.7, p < 0.01) in multivariate Cox regression. Conclusions: Despite equally effective TR reduction through T-TEER, a better outcome was observed in patients with AFTR.

BACKGROUND: Residual mitral regurgitation (rMR) ≤1+ has been associated with improved 1-year outcomes after mitral valve transcatheter edge-to-edge repair, regardless of the mean mitral pressure gradient (MPG). Prior evidence is limited to 30-day echocardiographic follow-up and patients treated with the MitraClip (Abbott Structural Heart). Whether rMR and MPG assessed at discharge are associated with outcomes after PASCAL mitral valve transcatheter edge-to-edge repair (Edwards Lifesciences) remains unknown. METHODS: REPAIR (Registry of Pascal for Mitral Regurgitation) is an investigator-initiated, multicenter registry including all consecutive patients treated with PASCAL mitral valve transcatheter edge-to-edge repair. Based on discharge echocardiography, patients were stratified into 4 groups: optimal (rMR ≤1+, MPG <5 mm Hg), MPG-suboptimal (rMR ≤1+, MPG ≥5 mm Hg), rMR-suboptimal (rMR ≥2+, MPG <5 mm Hg), and dual-suboptimal (rMR ≥2+, MPG ≥5 mm Hg). The primary end point was 1-year mortality. RESULTS: Among 2172 patients (median follow-up, 463 days [Q1–Q3, 357–815]), 59.4% were classified as optimal, 12.2% MPG-suboptimal, 21.3% rMR-suboptimal, and 7.0% dual-suboptimal. One-year mortality differed significantly across groups ( P <0.001), with the lowest rate in the optimal (8.7% [95% CI, 6.8%–10.5%]) and highest in the dual-suboptimal group (20.1% [95% CI, 12.0%–27.4%]; P _Bonferroni <0.001). rMR ≤1+ was associated with lower 1-year mortality (hazard ratio, 0.54 [95% CI, 0.37–0.74]; P <0.001) and remained significant, independent of dichotomized (MPG, 0.450). CONCLUSIONS: Discharge rMR ≤1+ is independently associated with lower 1-year mortality after PASCAL mitral valve transcatheter edge-to-edge repair. Although MPG was not independently associated, modestly elevated gradients may be acceptable when rMR ≤1+ is achieved, but should still warrant clinical attention. REGISTRATION: URL: https://www.drks.de ; Unique identifier: DRKS00033959.

Background: Diabetes mellitus worsens outcomes in patients suffering from heart disease undergoing cardiac procedures. Objectives: To investigate the impact of diabetes in patients undergoing mitral transcatheter edge-to-edge repair (M-TEER). Methods: 1118 patients treated with M-TEER for functional (FMR) and degenerative (DMR) mitral regurgitation (MR) between 2010 and 2021 were analyzed using the combined endpoint of death/rehospitalization for heart failure (HFH). Results: Among diabetics (N = 306; 27.4%), comorbidities such as coronary artery disease (75.2% vs. 62.7%; p < 0.001) and progressed (stage III/IV) chronic kidney disease (79.5% vs. 72.6%; p = 0.018) were more frequent. The rate of FMR was higher in diabetics (71.9% vs. 64.5%; p < 0.001). The combined endpoint occurred more frequently in diabetics (40.2% vs. 35.6%; log-rank = 0.035). While no difference was observed in FMR patients (36.8% vs. 37.6%; log-rank p = 0.710), rates of the combined endpoint differed significantly between diabetics and non-diabetics in DMR patients (48.8% vs. 31.9%; log-rank p = 0.001) only. However, diabetes did neither predict the combined endpoint in the overall (OR: 0.97; 95% CI 0.65–1.45; p = 0.890) nor in the DMR cohort (OR: 0.73; 95% CI 0.35–1.51; p = 0.389). Among diabetics treated with M-TEER, troponin (OR: 2.32; 95% CI 1.3–3.7; p = 0.002) and estimated glomerular filtration rate (OR: 0.52; 95% CI 0.3–0.88; p = 0.018) independently predicted the combined endpoint. Conclusions: Diabetes is associated with adverse outcomes after M-TEER, particularly in DMR patients. However, diabetes does not predict the combined endpoint. In diabetics undergoing M-TEER, biochemical markers associated with organ function and damage independently predict the combined endpoint of death and rehospitalization.