Background: Limited data are available about clinical outcomes and residual mitral regurgitation (MR) after transcatheter edge‐to‐edge repair in the large Asian‐Pacific cohort. Methods and Results: From the Optimized Catheter Valvular Intervention (OCEAN‐Mitral) registry, a total of 2150 patients (primary cause of 34.6%) undergoing transcatheter edge‐to‐edge repair were analyzed and classified into 3 groups according to the residual MR severity at discharge: MR 0+/1+, 2+, and 3+/4+. The mortality and heart failure hospitalization rates at 1 year were 12.3% and 15.0%, respectively. Both MR and symptomatic improvement were sustained at 1 year with MR ≤2+ in 94.1% of patients and New York Heart Association functional class I/II in 95.0% of patients. Compared with residual MR 0+/1+ (20.4%) at discharge, both residual MR 2+ (30.2%; P < 0.001) and 3+/4+ (32.4%; P = 0.007) were associated with the higher incidence of death or heart failure hospitalization (adjusted hazard ratio [HR], 1.59; P < 0.001, and adjusted HR, 1.73; P = 0.008). New York Heart Association class III/IV at 1 year was more common in the MR 3+/4+ group (20.0%) than in the MR 0+/1+ (4.6%; P < 0.001) and MR 2+ (6.4%; P < 0.001) groups, and the proportion of New York Heart Association class I is significantly higher in the MR 1+ group (57.8%) than in the MR 2+ group (48.3%; P = 0.02). Conclusions: The OCEAN‐Mitral registry demonstrated favorable clinical outcomes and sustained MR reduction at 1 year in patients undergoing transcatheter edge‐to‐edge repair. Both residual MR 2+ and 3+/4+ after transcatheter edge‐to‐edge repair at discharge were associated with worse clinical outcomes compared with residual MR 0+/1+. Registration Information: https://upload.umin.ac.jp . Identifier: UMIN000023653.

Transcatheter edge-to-edge repair (TEER) is a less invasive treatment for patients with mitral regurgitation (MR). Limited safety and efficacy data of TEER with MitraClip, including the fourth-generation (G4) system, in a large cohort, are available. This study aimed to summarize the initial experience of the TEER system in patients with MR from a large registry in Japan. The OCEAN (Optimized CathEter vAlvular iNtervention)-Mitral Registry is an ongoing, prospective, investigator-initiated, multicenter, observational registry for patients with primary and secondary MR undergoing transcatheter mitral valve therapies. A total of 21 centers participated in the registry. Patients undergoing TEER were enrolled, and their characteristics, procedural details, and clinical outcomes were recorded. In total, 2,150 patients including 1,605 patients (75.0%) with secondary MR, were enrolled between April 2018 and June 2021. The median age was 80 years, and 43.7% were women. The median device and fluoroscopy times were 60 and 26 minutes, respectively. Those with the G4 system (618/2,150 [28.7%]) were significantly shorter than those with the second generation (G2) system (1,532/2,150 [71.3%]). Overall, 94.6% met acute procedural success without significant differences between the 2 systems (G2 94.7% vs G4 94.6%; P = 0.961). The OCEAN-Mitral registry has demonstrated the short-term outcomes of TEER systems, including the G4 system, in symptomatic patients with primary and secondary MR. The acute procedural success rate in the G2 system was excellent, and that in the G4 system was expected to improve with the multidisciplinary heart valve team approach. (Japanese Registry study of valvular heart diseases treatment and prognosis; UMIN000023653)

Mitral annular calcification (MAC) has been associated with mitral valve (MV) disease and cardiovascular events in patients undergoing transcatheter aortic valve implantation (TAVI). We aimed to investigate the incidence and impact of mitral calcium volume (MCV) quantified by multidetector computed tomography (MDCT) on MV function and clinical outcomes after TAVI. Consecutive patients with exploitable echocardiography and MDCT performed during TAVI screening were enrolled in this retrospective analysis. Mitral calcium was assessed visually and measured using a semi-automatic tool developed for the aortic valve in an off-label fashion. MCV >0 mm3 was found in 65% of the 875 included patients. Patients with calcification were older (82 ± 6 versus 81 ± 7; P = 0.002) and had high prevalence of renal dysfunction (69% versus 61%; P = 0.017) and mitral stenosis (25% versus 4%, P < 0.001). MCV correlated well with visual MAC severity (r = 0.94; P < 0.001), but showed a greater predictive value for mitral stenosis (AUC = 0.804 vs. 0.780, P = 0.012) , while it was not a predictor of mitral regurgitation (AUC = 0.514). Correlations were found between MCV and echocardiographic parameters including MV area, mean transmitral gradient, and pressure half-time (P < 0.001 for all). MCV did not impact on cardiovascular mortality or new permanent pacemaker implantation after TAVI. Calcification of the mitral apparatus is common in TAVI candidates and results in mitral stenosis in 25% of the patients. Increasing MCV predicts mitral stenosis, but had no impact on clinical outcomes following TAVI. NCT01368250.

Limited data are available describing left atrial appendage closure (LAAC) and age-related outcomes in Asians. This study summarizes the initial experience with LAAC in Japan and determines age-related clinical outcomes in patients with nonvalvular atrial fibrillation undergoing percutaneous LAAC. In an ongoing, prospective, investigator-initiated, multicenter, observational registry of patients undergoing LAAC in Japan, we analyzed short-term clinical outcomes in patients with nonvalvular atrial fibrillation who underwent LAAC. Patients were classified into younger, middle-aged, and elderly groups (≤70, 70 to 80, and >80 years of age, respectively) to determine age-related outcomes. Patients (n = 548; mean age, 76.4 ± 8.1 years; male, 70.3%) who underwent LAAC at 19 Japanese centers between September 2019 and June 2021 were enrolled in the study, including 104, 271, and 173 patients in the younger, middle-aged, and elderly groups, respectively. Participants had a high-risk of bleeding and thromboembolism with a mean CHADS₂ score of 3.1 ± 1.3, a mean CHA₂DS₂-VASc score of 4.7 ± 1.5, and a mean HAS-BLED score of 3.2 ± 1.0. Device success rates were 96.5% and anticoagulants discontinuation at the 45-day follow-up was achieved in 89.9%. In-hospital outcomes were not significantly different, but major bleeding events during the 45-day follow-up were significantly higher in the elderly group compared to the other groups (younger vs middle-aged vs elderly, 1.0% vs 3.7% vs 6.9%, respectively; P = 0.047) despite the same postoperative drug regimens. The initial Japanese experience with LAAC demonstrated safety and efficacy; however, perioperative bleeding events were more common in the elderly and postoperative drug regimens must be tailored (OCEAN-LAAC [Optimized Catheter Valvular Intervention–Left Atrial Appendage Closure] registry; UMIN000038498)

Background and Aims: The association between periprocedural change in tricuspid regurgitation (TR) and outcomes in patients undergoing mitral transcatheter edge-to-edge repair (M-TEER) is unclear. This study aimed to examine the prognostic value of TR before and after M-TEER. Methods: Patients in the OCEAN-Mitral registry were divided into four groups according to baseline and post-procedure echocardiographic assessments: no TR/no TR (no TR), no TR/significant TR (new-onset TR), significant TR/no TR (normalized TR), and significant TR/significant TR (residual TR) (all represents before/after M-TEER). Tricuspid regurgitation ≥ moderate was defined as significant. The primary outcome was cardiovascular death or heart failure hospitalization. Tricuspid regurgitation pressure gradient was also evaluated. Results: The numbers of patients in each group were 2103 (no TR), 201 (new-onset TR), 504 (normalized TR), and 858 (residual TR). Baseline assessment for TR and TR pressure gradient was not associated with outcomes after M-TEER. In contrast, patients with new-onset TR had the highest adjusted risk for the primary outcome, followed by those with residual TR [compared with no TR as a reference, hazard ratio 1.83 (95% confidence interval: 1.39–2.40) for new-onset TR, 1.45 (1.23–1.72) for residual TR, and 0.82 (0.65–1.04) for normalized TR]. Similarly, from baseline to post-procedure, TR pressure gradient changes were associated with subsequent outcomes after M-TEER. New-onset and residual TR incidence was commonly associated with dilated tricuspid annulus diameter and atrial fibrillation. Conclusions: Post-procedural TR, but not baseline TR, was associated with outcomes after M-TEER. Careful TR assessment after the procedure would provide an optimal management for concomitant significant TR in patients undergoing M-TEER.

Background and Aims: Atrial functional mitral regurgitation (AFMR) commonly affects elderly and frail individuals. The prognostic impact of transcatheter edge-to-edge repair (TEER) for AFMR has not been investigated. Methods: Patients with AFMR who underwent TEER were selected from the OCEAN-Mitral registry, and medically managed controls were selected from the REVEAL-AFMR registry, using an identical AFMR definition. The primary endpoint was a composite of all-cause mortality and heart failure hospitalization. The secondary endpoint was all-cause mortality. Results: A total of 1081 patients (mean age 80.1 ± 8.2 years, 60.5% female) with moderate or severe AFMR were included, of whom 441 underwent TEER and 640 remained on medical treatment. Overlap weighting based on the propensity score yielded well-balanced characteristics (n = 441 vs 640; all standardized mean differences <0.01), where TEER was associated with a lower incidence of the primary (hazard ratio [HR] 0.65, 95% confidence interval [CI] 0.43–0.99, P = .044) and secondary endpoints (HR 0.58, 95% CI 0.35–0.99, P = .044). In an exploratory subgroup analysis, favourable outcomes might be pronounced in patients with ≤mild residual AFMR after TEER, while event rates in those with ≥ moderate residual AFMR were comparable with the medication group. As sensitivity analyses, inverse probability of treatment weighting (n = 158 vs 173), propensity score matching (n = 104 vs 104), and multivariable Cox regression (n = 441 vs. 640) all confirmed favourable associations of TEER with both endpoints. Conclusions: In real-world data, TEER for patients with moderate or severe AFMR were associated with a lower incidence of adverse events compared with medical treatment.