Background: The All Nippon Atrial Fibrillation In the Elderly Registry provides real-world insights into non-valvular atrial fibrillation (NVAF) in >30,000 elderly Japanese patients (aged ≥75 years), including >2,000 nonagenarians. We aimed to investigate outcomes in these patients by age and oral anticoagulant (OAC) type.

Methods and Results: This prospective, multicenter, observational, cohort, 2-year follow-up study included elderly patients with NVAF who were able to attend hospital visits. The incidences of stroke/systemic embolic events (SEE), major bleeding, intracranial hemorrhage (ICH), cardiovascular death, all-cause death, and major adverse cardiovascular or neurological events (MACNE) were evaluated by age. Incidence rates increased significantly with age. Stroke/SEE, major bleeding, and ICH incidences plateaued in patients aged ≥90 years. Direct OACs (DOACs) yielded a numerically lower event incidence vs. warfarin in all age groups and endpoints, except for major bleeding in patients aged ≥90 years. DOACs (vs. warfarin) were significantly associated with a lower risk of stroke/SEE, major bleeding, and ICH in the ≥80–<85 years group, and reduced cardiovascular and all-cause death in the ≥75–<80 years group. In the ≥90 years subgroup, major bleeding history was a risk factor for all-cause death.

Conclusions: Although DOAC vs. warfarin offers potential benefits for stroke prevention, limitations occurred in reducing major bleeding among those aged ≥90 years, indicating a potential benefit of very-low-dose DOAC for this demographic.

Background: Outcomes in patients with relatively high His-bundle (HB) capture thresholds at implantation are unknown. This study aimed to compare changes in the HB capture threshold and prognosis between patients with a relatively high threshold and those with a low threshold.

Methods and Results: Forty-nine patients who underwent permanent HB pacing (HBP) were divided into two groups: low (<1.25 V at 1.0 ms; n=35) and high (1.25–2.49 V; n=14) baseline HB capture threshold groups. The HB capture threshold was evaluated at implantation, and after 1 week, 1, 3, and 6 months, and every 6 months thereafter. HB capture threshold rise was defined as threshold rise ≥1.0 V at 1.0 ms compared with implantation measures. We compared outcomes between the groups. During a mean follow-up period of 34.6 months, the high-threshold group showed a trend toward a higher incidence of HB capture threshold of ≥2.5 V (50% vs. 14%; P=0.023), HBP abandonment (29% vs. 8.6%; P=0.091), lead revision (21% vs. 2.9%; P=0.065), and clinical events (all-cause death, heart failure hospitalization, and new-onset or progression of atrial fibrillation; 50% vs. 23%; P=0.089) than the low-threshold group. A baseline HB capture threshold of ≥1.25V was an independent predictor of clinical events.

Conclusions: A relatively high HB capture threshold is associated with increased risk of HBP abandonment, lead revision, and poor clinical outcomes.

Background: This study aimed to systematically evaluate voice symptoms during heart failure (HF) treatments and to exploratorily extract HF-related vocal biomarkers.

Methods and Results: This single-center, prospective study longitudinally acquired 839 audio files from 59 patients with acute decompensated HF. Patients’ voices were analyzed along with conventional HF indicators (New York Heart Association [NYHA] class, presence of pulmonary congestion and pleural effusion on chest X-ray, and B-type natriuretic peptide [BNP]) and GOKAN scores based on the assessment of a cardiologist. Machine-learning (ML) models to estimate HF conditions were created using a Light Gradient Boosting Machine. Voice analysis identified 27 acoustic features that correlated with conventional HF indicators and GOKAN scores. When creating ML models based on the acoustic features, there was a significant correlation between actual and ML-derived BNP levels (r=0.49; P<0.001). ML models also identified good diagnostic accuracies in determining HF conditions characterized by NYHA class ≥2, BNP ≥300 pg/mL, presence of pulmonary congestion or pleural effusion on chest X-ray, and decompensated HF (defined as NYHA class ≥2 and BNP levels ≥300 pg/mL; accuracy: 75.1%, 69.1%, 68.7%, 66.4%, and 80.4%, respectively).

Conclusions: The present study successfully extracted HF-related acoustic features that correlated with conventional HF indicators. Although the data are preliminary, ML models based on acoustic features (vocal biomarkers) have the potential to infer various HF conditions, which warrant future studies.

Background: Because the clinical benefit of antiplatelet therapy (APT) for patients with nonsignificant coronary artery disease (CAD) remains poorly understood, we evaluated it in patients after fractional flow reserve (FFR)-guided deferral of revascularization.

Methods and Results: From the J-CONFIRM (Long-Term Outcomes of Japanese Patients with Deferral of Coronary Intervention Based on Fractional Flow Reserve in Multicenter Registry), we investigated 265 patients with deferred lesions who did not require APT for secondary prevention of cardiovascular disease. A 2-year landmark analysis assessed the relationship between APT at 2 years and 5-year major cardiac adverse events (MACE: composite of all-cause death, target vessel-related myocardial infarction, clinically driven target vessel revascularization). Of the 265 patients, 163 (61.5%) received APT. The 5-year MACE did not significantly differ between the APT and non-APT groups after adjustment for baseline clinical characteristics (9.2% vs. 6.9%, inverse probability weighted hazard ratio, 1.40 [95% confidence interval, 0.53–3.69]; P=0.49). There was a marginal interaction between the effect of APT on MACE and FFR values (< or ≥0.84) (P for interaction=0.066).

Conclusions: The 5-year outcomes after FFR-guided deferral of revascularization did not significantly differ between the APT and non-APT groups, suggesting that APT might not be a critical requirement for nonsignificant obstructive CAD patients not requiring APT for secondary prevention of cardiovascular disease.

Background: Cardioprotective drugs have not been previously shown to improve the prognosis in patients with fulminant myocarditis presentation (FMP). We aimed to investigate whether cardioprotective drugs, including angiotensin-converting enzyme inhibitor (ACEI)/angiotensin II receptor blocker (ARB) and β-blocker, administered during hospitalization improved the prognosis in patients with FMP.

Methods and Results: This multicenter cohort study conducted in Japan included 755 patients with clinically diagnosed FMP. Those who died within 14 days of admission were excluded, and 588 patients (median age 53 [37–65] years and 40% female) were evaluated. The primary outcome was the composite of 90-day mortality or heart transplantation. The patients were divided into 4 groups according to whether they were administered ACEI/ARB or β-blocker during hospitalization. Administration of ACEI/ARB without β-blocker improved the overall patient outcomes (log-rank test [vs. ACEI/ARB − and β-blocker −]: ACEI/ARB + and β-blocker −, P<0.001; ACEI/ARB − and β-blocker +, P=0.256). Subsequently, a matched cohort of 146 patient pairs was generated for patients with or without ACEI/ARB administration during hospitalization. The outcome-free survival at 90 days was significantly higher in the ACEI/ARB administration group than in the non-administration group (hazard ratio 0.37; 95% confidence interval 0.19–0.71).

Conclusions: Administration of ACEI or ARB during hospitalization was associated with favorable outcomes in terms of 90-day mortality and heart transplantation events in patients with clinically diagnosed FMP.

Background: One-month dual antiplatelet therapy (DAPT) in high bleeding risk (HBR) patients undergoing percutaneous coronary intervention (PCI) with the Resolute Onyx^TMzotarolimus-eluting stents (ZES) is safe and effective. Asian patients have a unique ischemia/bleeding risk profile. Here, we compare the outcomes between Asian and non-Asian patients after PCI and 1-month DAPT.

Methods and Results: Onyx ONE Clear was a prospective, multicenter study enrolling HBR patients undergoing PCI with the Resolute Onyx ZES (ClinicalTrials.gov identifier NCT03647475). Event-free patients after 1-month DAPT transitioned to single antiplatelet therapy. Clinical outcomes between 1 month and 2 years were compared between patients from Asian and non-Asian countries after 1 : 1 propensity score matching accounting for baseline differences. Patients from Asian countries represented 18% (n=273) of the study group (n=1,507). Non-Asian patients had greater clinical complexity; however, these differences were minimal after matching. There were no significant differences in ischemic outcomes between matched cohorts from 1 month to 2 years, including the primary composite endpoint of cardiac death or myocardial infarction (12% vs. 12%; P>0.99). However, there were significantly fewer Bleeding Academic Research Consortium types 3–5 bleeding events in the Asian vs. non-Asian cohort (4% vs. 9%; P=0.007), despite similar bleeding risk profiles after matching.

Conclusions: After propensity score matching, HBR patients from Asian countries undergoing PCI treated with 1-month DAPT had similar ischemic outcomes but fewer bleeding events between 1 month and 2 years compared with patients from non-Asian countries.

Background: There are few studies evaluating the prognostic prediction method in atrial fibrillation (AF) patients after bioprosthetic valve (BPV) replacement. The R₂-CHA₂DS₂-VASc score is increasingly used for the prediction of cardiovascular (CV) events in patients with AF, device implantation, and acute coronary syndrome. We aimed to evaluate the predictive value of the R₂-CHA₂DS₂-VASc score for future CV events in AF patients after BPV replacement.

Methods and Results: The BPV-AF, an observational, multicenter, prospective registry, enrolled AF patients who underwent BPV replacement. The primary outcome measure was a composite of stroke, systemic embolism, CV events including heart failure requiring hospitalization, and cardiac death. A total of 766 patients was included in the analysis. The mean R₂-CHA₂DS₂-VASc score was 5.7±1.8. Low (scores 0–1), moderate (scores 2–4), and high (scores 5–11) R₂-CHA₂DS₂-VASc score groups consisted of 12 (1.6%), 178 (23.2%), and 576 (75.2%) patients, respectively. The median follow-up period was 491 (interquartile range 393–561) days. Kaplan-Meier analysis showed a higher incidence of the composite CV events in the high R₂-CHA₂DS₂-VASc score group (log rank test; P<0.001). Multivariate Cox proportional hazards regression analysis revealed that the R₂-CHA₂DS₂-VASc score as a continuous variable was an independent predictor of composite CV outcomes (hazard ratio 1.36; 95% confidence interval 1.18–1.55; P<0.001).

Conclusions: The R₂-CHA₂DS₂-VASc score is useful for CV risk stratification in AF patients after BPV replacement.

Background: Cilostazol has reported effectiveness for preventing aspiration pneumonia in patients with ischemic stroke, but whether it is similarly beneficial for patients with chronic limb-threatening ischemia (CLTI) is unclear.

Methods and Results: This retrospective single-center study enrolled 1,368 CLTI patients treated with endovascular therapy (EVT). In the multivariate analysis, predictors for aspiration pneumonia were age (hazard ratio [HR] 1.06 [95% confidence interval (CI) 1.03–1.10]), non-ambulatory status (HR 2.54 [95% CI 1.38–4.65]), the Geriatric Nutritional Risk Index (HR 0.97 [95% CI 0.95–0.99]), and cilostazol (HR 0.37 [95% CI 0.16–0.87]).

Conclusions: Cilostazol administration reduced the risk of aspiration pneumonia in patients with CLTI undergoing EVT.