Background: Empagliflozin reduces the risk of hospitalization for heart failure in patients with type 2 diabetes and cardiovascular disease. We sought to elucidate the effect of empagliflozin as an add-on therapy on decongestion and renal function in patients with type 2 diabetes admitted for acute decompensated heart failure. Methods: The study was terminated early due to COVID-19 pandemic. We enrolled 59 consecutive patients with type 2 diabetes admitted for acute decompensated heart failure. Patients were randomly assigned to receive either empagliflozin add-on (n=30) or conventional glucose-lowering therapy (n=29). We performed laboratory tests at baseline and 1, 2, 3, and 7 days after randomization. Percent change in plasma volume between admission and subsequent time points was calculated using the Strauss formula. Results: There were no significant baseline differences in left ventricular ejection fraction and serum NT-proBNP (N-terminal pro-B-type natriuretic peptide), hematocrit, or serum creatinine levels between the 2 groups. Seven days after randomization, NT-proBNP level was significantly lower in the empagliflozin group than in the conventional group ( P =0.040), and hemoconcentration (≥3% absolute increase in hematocrit) was more frequently observed in the empagliflozin group than in the conventional group ( P =0.020). The decrease in percent change in plasma volume between baseline and subsequent time points was significantly larger in the empagliflozin group than in the conventional group 7 days after randomization ( P =0.017). The incidence of worsening renal function (an increase in serum creatinine ≥0.3 mg/dL) did not significantly differ between the 2 groups. Conclusions: In this exploratory analysis, empagliflozin achieved effective decongestion without an increased risk of worsening renal function as an add-on therapy in patients with type 2 diabetes with acute decompensated heart failure. Registration: URL: https://www.umin.ac.jp/ctr/index.htm ; Unique identifier: UMIN000026315.

Low-voltage areas (LVAs) in the left atrium may promote atrial fibrillation (AF), but the efficacy of LVA ablation for preventing arrhythmia has not been determined. In the present study, we carried out a multicenter, randomized controlled trial (SUPPRESS-AF) to investigate the efficacy of LVA ablation in patients with persistent AF who had left atrial LVAs. Patients with persistent AF and left atrial LVAs that covered ≥5 cm² of the left atrial surface on a voltage map after pulmonary vein isolation (PVI) were randomized to undergo LVA ablation (PVI + LVA-ABL group) or not (PVI-alone group) in a 1:1 fashion. Recurrence of AF or atrial tachycardia (AT) was monitored using 24-h Holter electrocardiography (ECG) and twice-daily portable ECG recordings. The primary endpoint was freedom from AF or AT recurrence without antiarrhythmic drug use during 1 year of follow-up. Of 1,347 patients (1,003 males and 344 females) who underwent initial ablation for AF, patients with left atrial LVAs were assigned to the PVI + LVA-ABL (n = 170) or the PVI-alone group (n = 171). Although the PVI + LVA-ABL group demonstrated a numerically higher rate of freedom from AF or AT recurrence compared with the PVI-alone group (61% (95% confidence interval (CI) = 53–68%) versus 50% (95% CI = 42–57%)), this difference did not reach statistical significance (P for log(rank) test = 0.127). There was no difference in the procedure-related serious adverse events between the two groups (1.7% versus 1.8%, P < 0.0001). In conclusion, LVA ablation in addition to PVI did not significantly reduce 1-year AF or AT recurrence in patients with persistent AF with left atrial LVAs. Future studies are needed to identify patients who may receive greater benefit from LVA ablation.

Background: Stent thrombosis (ST) remains a significant medical issue. In particular, longer‐term mortality and clinical predictors after ST occurrence have yet to be elucidated. Methods and Results: This was a multicenter, retrospective, observational study. A total of 187 definite ST cases from January 2008 to December 2017 were enrolled, and the long‐term clinical outcomes were investigated. The primary outcome measure was the cumulative mortality after ST occurrence. In addition, independent predictors of mortality were assessed. Among the stent types causing ST, bare‐metal stent, first‐generation drug‐eluting stent, second‐generation drug‐eluting stent, and third‐generation drug‐eluting stent comprised 31.0%, 19.3%, 36.9%, and 6.4% of cases, respectively. Median duration from stent implantation to ST was 680.5 (interquartile range, 33.8–2450.5) days. Cumulative mortality was 14.6%, 17.4%, 21.2%, 24.4%, and 33.8% at 1, 2, 3, 5 and 10 years, respectively. The cumulative mortality did not significantly differ by type of stent, and mortality of late ST was higher than that of early ST and very late ST; however, it did not reach statistical significance after the multivariate analysis. Independent predictors of mortality were hemodialysis (hazard ratio [HR], 7.80; 95% CI, 3.07–19.81; P <0.001), culprit lesions in the left main trunk (HR, 8.14; 95% CI, 1.71–38.75; P =0.008), culprit lesions in the left coronary artery (HR, 2.77; 95% CI, 1.10–6.96; P =0.030), and peak creatine kinase (HR, 1.017; 95% CI, 1.011–1.022; P <0.001). Conclusions: The 10‐year cumulative mortality after ST reached 33.8%. Close follow‐up is thus mandatory for patients with ST, especially with hemodialysis, culprit lesions in the left main trunk and left coronary artery, and high peak creatine kinase.

Background: An optimal strategy for left atrial ablation in addition to pulmonary vein isolation (PVI) in patients with persistent atrial fibrillation (AF) has not been determined. Methods and Results: We conducted an extended follow‐up of the multicenter randomized controlled EARNEST‐PVI (Efficacy of Pulmonary Vein Isolation Alone in Patients With Persistent Atrial Fibrillation) trial, which compared 12‐month rhythm outcomes in patients with persistent AF between patients randomized to a PVI‐alone strategy (n=248) or PVI‐plus strategy (n=248; PVI followed by left atrial additional ablation, including linear ablation or ablation targeting areas with complex fractionated electrograms). The present study extended the follow‐up period to 3 years after enrollment. Outcomes were compared not only between randomly allocated groups but also between on‐treatment groups categorized by actually created ablation lesions. Recurrence rate of AF or atrial tachycardia (AT) was lower in the randomly allocated to PVI‐plus group than the PVI‐alone group (29.0% versus 37.5%, P =0.036). On‐treatment analysis revealed that patients with PVI+linear ablation (n=205) demonstrated a lower AF/AT recurrence rate than those with PVI only (26.3% versus 37.8%, P =0.007). In contrast, patients with PVI+complex fractionated electrograms ablation (n=37) had an AF/AT recurrence rate comparable to that of patients with PVI only (40.5% versus 37.8%, P =0.76). At second ablation in 126 patients with AF/AT recurrence, ATs excluding common atrial flutter were more frequent in patients with PVI+linear ablation than in those with PVI only (32.6% versus 5.7%, P <0.0001). Conclusions: Left atrial ablation in addition to PVI was efficacious during 3‐year follow‐up. Linear ablation was superior to other ablation strategies but may increase iatrogenic ATs. Registration: URL: http://www.umin.ac.jp/ctr/index‐j.htm ; Unique identifier: UMIN000019449.

Background: Modification of arrhythmogenic substrates with extensive ablation comprising linear and/or complex fractional atrial electrogram ablation in addition to pulmonary vein isolation (PVI‐plus) can theoretically reduce the recurrence of atrial fibrillation. The DR‐FLASH score (score based on diabetes mellitus, renal dysfunction, persistent form of atrial fibrillation, left atrialdiameter >45 mm, age >65 years, female sex, and hypertension) is reportedly useful for identifying patients with arrhythmogenic substrates. We hypothesized that, in patients with persistent atrial fibrillation, the DR‐FLASH score can be used to classify patients into those who require PVI‐plus and those for whom a PVI‐only strategy is sufficient. Methods and Results: This study is a post hoc subanalysis of the a multicenter, randomized controlled, noninferiority trial investigating efficacy and safety of pulmonary vein isolation alone for recurrence prevention compared with extensive ablation in patients with persistent atrial fibrillation (EARNEST‐PVI trial). This analysis focuses on the relationship between DR‐FLASH score and the efficacy of different ablation strategies. We divided the population into 2 groups based on a DR‐FLASH score of 3 points. A total of 469 patients were analyzed. Among those with a DR‐FLASH score >3 (N=279), the event rate of atrial arrhythmia recurrence was significantly lower in the PVI‐plus arm than in the PVI‐only arm (hazard ratio [HR], 0.45 [95% CI, 0.28–0.72]; P 3 and DR‐FLASH score ≤3 ( P value for interaction=0.020). Conclusions: The DR‐FLASH score is a useful tool for deciding the catheter ablation strategy for patients with persistent atrial fibrillation. Registration: URL: https://clinicaltrials.gov ; Unique identifier: NCT03514693.

Background: Temporal trends in the management of acute coronary syndrome complicated with cardiogenic shock after the revision of guideline recommendations for intra‐aortic balloon pump (IABP) use and the approval of the Impella require further investigation, because their impact remains uncertain. Methods and Results: Using the Japanese Percutaneous Coronary Intervention (J‐PCI) registry database from 2019 to 2021, we identified 12 171 patients undergoing percutaneous coronary intervention for acute coronary syndrome complicated with cardiogenic shock under mechanical circulatory support. The patients were stratified into 3 groups: (1) IABP alone, (2) Impella, and (3) venoarterial extracorporeal membrane oxygenation (VA‐ECMO); the VA‐ECMO group was further stratified into (3a) VA‐ECMO alone, (3b) VA‐ECMO in combination with IABP, and (3c) VA‐ECMO in combination with Impella. The quarterly prevalence and outcomes were reported. The use of IABP alone decreased significantly from 63.5% in the first quarter of 2019 to 58.3% in the fourth quarter of 2021 ( P for trend=0.01). Among 4245 patients requiring VA‐ECMO, the use of VA‐ECMO in combination with IABP decreased significantly from 78.7% to 67.3%, whereas the use of VA‐ECMO in combination with Impella increased significantly from 4.2% to 17.0% ( P for trend <0.001 for both). After adjusting for the confounders, the risk difference in the fourth quarter of 2021 relative to the first quarter of 2019 for in‐hospital mortality was not significant (adjusted odds ratio, 0.84 [95% CI, 0.69–1.01]). Conclusions: Our study revealed substantial changes in the use of different mechanical circulatory support modalities in acute coronary syndrome complicated with cardiogenic shock, but they did not significantly improve the outcomes.