BACKGROUND:For patients with atrial fibrillation, the use of oral anticoagulant therapy to prevent stroke is limited by the risk of bleeding. Left atrial appendage closure is considered for patients who are unsuitable candidates for long-term anticoagulation, but its role in patients who are eligible for anticoagulants has not been established. METHODS:In this ongoing, prospective, international, randomized trial involving patients with atrial fibrillation who were suitable candidates for anticoagulation, we randomly assigned patients in a 1:1 ratio to receive either device-based left atrial appendage closure (device group) or non-vitamin K antagonist oral anticoagulant (NOAC) therapy (anticoagulation group). The primary efficacy end point - a composite of death from cardiovascular causes, stroke, or systemic embolism - was tested for noninferiority (noninferiority margin, 4.8 percentage points) after 3 years of follow-up. The primary safety end point, non-procedure-related bleeding, was tested for superiority. RESULTS:Of the 3000 patients who underwent randomization, 1499 were assigned to the device group and 1501 to the anticoagulation group. The mean (±SD) age of the patients was 71.7±7.5 years, 31.9% of the patients were women, and the mean CHA2DS2-VASc score was 3.5±1.3. At 3 years, a primary efficacy end-point event had occurred in 81 patients (Kaplan-Meier estimate, 5.7%) in the device group and in 65 patients (Kaplan-Meier estimate, 4.8%) in the anticoagulation group (difference, 0.9 percentage points; 95% confidence interval [CI], -0.8 to 2.6; P<0.001 for noninferiority). Non-procedure-related bleeding occurred in 154 patients (Kaplan-Meier estimate, 10.9%) in the device group and in 260 patients (Kaplan-Meier estimate, 19.0%) in the anticoagulation group (hazard ratio, 0.55; 95% CI, 0.45 to 0.67; P<0.001 for superiority). CONCLUSIONS:Among patients with atrial fibrillation who were candidates for anticoagulation, device-based left atrial appendage closure was noninferior to NOAC therapy with respect to a composite of death from cardiovascular causes, stroke, or systemic embolism and was superior to NOAC therapy for non-procedure-related bleeding at 3 years. (Funded by Boston Scientific; CHAMPION-AF ClinicalTrials.gov number, NCT04394546.).
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.
BackgroundChildren with a history of Kawasaki disease (KD) and severe coronary involvement are at risk for acute coronary syndrome later in adulthood even in the absence of severe luminal lesions. We therefore investigated whether the coronary vessel walls in such adults are accompanied by potential substrates for acute coronary syndrome using optical coherence tomography (OCT), a high-resolution imaging modality.MethodsOCT was performed in patients who were followed up by serial coronary angiogram (CAG) and cardiac multi-detector computed tomography (MDCT) for ≥ 15 years after the diagnosis of acute KD with coronary artery aneurysms (≥ 6 mm in diameter).ResultsEleven patients (6 males, 55%) with median age 25.3 years (IQR: 22.7-30.3) and median interval 22.6 years (19.9-25.8) after acute KD were recruited. We investigated 51 coronary segments, comprising 43 coronary artery lesions (CALs) (19 regressed aneurysms, 37.2%; 16 persistent aneurysms, 31.4%; and 8 localized stenoses, 15.7%) and 8 normal segments (15.7%). OCT findings revealed fibrocalcific plaque in 20 segments (39.2%), fibroatheroma in 16 (31.4%), superficial signal-rich regions with attenuation in 14 (27.5%), microvessels in 18 (35.3%), luminal thrombi in 13 (25.5%), and ruptured plaque in 4 (7.8%). Qualitatively, all but one normal segment showed no OCT-derived abnormalities, whereas CALs, including regressed aneurysms, exhibited fibrocalcific plaques, fibroatheroma, and microvessels, along with luminal thrombi and ruptured plaques. Quantitatively, CAG-derived advanced lesions (persistent aneurysms and localized stenoses) and MDCT-derived calcified plaques were associated with OCT-detected vessel wall abnormalities.ConclusionsThe present study showed that CALs in adults long after acute KD with severe coronary involvement are associated with OCT-derived vessel wall abnormalities, which are correlated with luminal lesions and MDCT-detected calcified plaques. Although these results do not demonstrate causality and may not be generalizable to milder cases, they warrant further studies to optimize screening and monitoring of adult KD-related coronary sequelae.
BACKGROUND:The interplay between atrial fibrillation (AF) and tricuspid regurgitation (TR) has been recognized. However, it is not simple and has not been fully investigated. OBJECTIVES:The aim of this study was to examine the association among AF, TR, and outcomes in patients undergoing mitral valve transcatheter edge-to-edge repair (M-TEER). METHODS:Patients were divided into 4 groups according to the presence of AF and postprocedural significant TR (moderate or greater): no AF and no TR, no AF with significant TR, AF and no TR, and AF with significant TR. The primary outcome was cardiovascular death or heart failure (HF) hospitalization. Right heart structure and function were also evaluated according to AF and TR status. RESULTS:The numbers of patients in each group were 1,184 (no AF and no TR), 229 (no AF with significant TR), 1,423 (AF and no TR), and 830 (AF with significant TR). AF was associated with a higher prevalence of significant TR at baseline and more frequent TR progression and less common improvement during follow-up. Both AF and TR appeared to be independently associated with right-ventricular remodeling and dysfunction, with distinct patterns observed according to MR and TR pathologies. TR grade moderate or greater after M-TEER was associated with a higher adjusted risk for cardiovascular death or HF hospitalization, especially in patients with AF (Pinteraction = 0.02). CONCLUSIONS:Patients with AF, compared with those without AF, experienced greater incidence and progression and less common improvement of TR after M-TEER. In addition, both AF and TR appeared to be independently associated with worse right ventricular status and an increased risk for HF outcomes.
Transcatheter aortic valve replacement (TAVR) has several alternative access routes when transfemoral access is unsuitable. This study compared perioperative and mid-term outcomes of transaxillary (TAx) TAVR with those of transapical (TA) and direct aortic (DA) approaches. Among 2,185 patients who underwent TAVR at our three centers between April 2015 and April 2024, 198 non-transfemoral cases were retrospectively analyzed. TAx-TAVR was classified as a non-thoracotomy approach, whereas TA/DA-TAVR were classified as thoracotomy approaches. Perioperative and mid-term outcomes were compared between the two groups. Of the 198 patients, 97 underwent the non-thoracotomy approach and 101 underwent thoracotomy (TA, n = 64; DA, n = 37). Most baseline characteristics were comparable, although dialysis-dependent patients were more common in the non-thoracotomy group. Operative time, transfusion requirement, and hospital stay were significantly greater in the thoracotomy group. Access-related complications included four events in the thoracotomy group (aortic injury or apical rupture) and five events in the non-thoracotomy group (aortic dissection or intimal injury). Postoperative ischemic stroke tended to occur more frequently in the non-thoracotomy group, though not significantly. One-year survival was significantly higher in the non-thoracotomy group, whereas mid-term mortality did not differ between groups. TAx-TAVR was associated with lower perioperative invasiveness and superior one-year survival compared with TA/DA-TAVR. However, the trend toward increased postoperative stroke underscores the importance of careful patient selection and thorough preoperative vascular assessment.
