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Abstract Background A wearable cardioverter defibrillator (WCD) is indicated for a limited period in patients at high risk of sudden cardiac death (SCD). Nonischemic heart failure (HF) is common among Japanese patients with HF. The aim of this study was to evaluate the incidence of fatal arrhythmias during WCD use and the clinical outcomes after WCD withdrawal in Japanese patients with HF. Methods We retrospectively studied 105 hospitalized HF patients who were discharged with a WCD. The main outcome was SCD/ventricular arrhythmias during WCD use and the other outcomes were implantation of an implantable cardioverter‐defibrillator (ICD), SCD/ventricular arrhythmias after WCD withdrawal, and changes in left ventricular ejection fraction (LVEF). Results Eighty‐seven (83%) patients received a WCD for primary prevention of SCD, of whom 60 (69%) were new‐onset HF patients with an LVEF ≤35%. The median daily wear time was 22.1 h. Two patients experienced sustained ventricular tachycardia and one patient experienced atrioventricular block with asystole while on WCD. After WCD withdrawal, 81 (77%) patients decided not to receive ICD implantation. The percentage of patients with an LVEF ≥35% increased from 20% at baseline to 70% at 1 year after discharge. During the median follow‐up of 50 months, 78 (96%) of the 81 patients who did not have an ICD were free of SCD/ventricular arrhythmias. Conclusions The use of a WCD is useful for determining the appropriate indication for ICD implantation in Japanese patients with new‐onset HF, a low LVEF, and a risk of SCD.

Abstract Background Various surgical procedures have employed microporous polysaccharide hemosphere (MPH) hemostatic agents. However, data regarding their effectiveness in preventing pocket hematomas (PHs) during the implantation of cardiac implantable electronic devices (CIED) among the Asian population are limited. Therefore, this study aimed to investigate the potential benefits of using MPH hemostatic agents during CIED implantations as a preventive measure against post‐procedural PHs. Methods We conducted a retrospective, single‐center, observational study involving 255 consecutive Japanese patients who underwent CIED implantation between November 2017 and April 2021. We compared PH occurrences within 28 days after CIED implantation between patients who received MPH hemostatic agents (n = 145) and those who did not (n = 110). Results PH development was observed in nine (6.2%) patients who received MPH hemostatic agents and in 13 (11.8%) patients without MPH hemostatic (p = .111). Kaplan–Meier analysis of PH development revealed no significant difference between the two groups (log‐rank p = .102). However, utilizing MPH hemostatic agents among patients taking antithrombotic drugs, including antiplatelet medications, direct oral anticoagulants, and warfarin, significantly reduced PH incidence (log‐rank p = .03). The multivariate Cox proportional hazards model demonstrated that MPH hemostatic agent utilization independently correlated with a decreased PH risk (hazard ratio 0.22, 95% confidence interval 0.08–0.63, p = .004). Conclusions The findings of this study suggest that the incorporation of MPH hemostatic agents into standard practice may benefit to mitigate PH risk during CIED implantations in patients on antithrombotic therapy. This simple and practical measure may be valuable, especially in high‐risk patients, such as those taking antithrombotic medications.

Abstract Background Sodium-glucose cotransporter 2 (SGLT2) inhibitors reduce the risk of hospitalization for heart failure and cardiovascular death with type 2 diabetes; however, their effect on arrhythmias is unclear. The purpose of this study was to investigate the effects of empagliflozin on ventricular arrhythmias in patients with type 2 diabetes. Methods A total of 150 patients with type 2 diabetes who were treated with an implantable cardioverter-defibrillator or cardiac resynchronization therapy defibrillator (ICD/CRT-D) were randomized to once-daily empagliflozin or placebo for 24 weeks. The primary endpoint was the change in the number of ventricular arrhythmias from the 24 weeks before to the 24 weeks during treatment. Secondary endpoints included the change in the number of appropriate device discharges and other values. Results In the empagliflozin group, the number of ventricular arrhythmias recorded by ICD/CRT-D decreased by 1.69 during treatment compared to before treatment, while in the placebo group, the number increased by 1.79. The coefficient for the between-group difference was − 1.07 (95% confidence interval [CI] − 1.29 to − 0.86; P

Abstract Background Despite the positive impact of implantable cardioverter defibrillators (ICDs) and wearable cardioverter defibrillators (WCDs) on prognosis, their implantation is often withheld especially in Japanese heart failure patients with reduced left ventricular ejection fraction (HFrEF) who have not experienced ventricular tachycardia (VT) or ventricular fibrillation (VF) for uncertain reasons. Recent advancements in heart failure (HF) medications have significantly improved the prognosis for HFrEF. Given this context, a critical reassessment of the treatment and prognosis of ICDs and WCDs is essential, as it has the potential to reshape awareness and treatment strategies for these patients. Methods We are initiating a prospective multicenter observational study for HFrEF patients eligible for ICD in primary and secondary prevention, and WCD, regardless of device use, including all consenting patients. Study subjects are to be enrolled from 31 participant hospitals located throughout Japan from April 1, 2023, to December 31, 2024, and each will be followed up for 1 year or more. The planned sample size is 651 cases. The primary endpoint is the rate of cardiac implantable electronic device implementation. Other endpoints include the incidence of VT/VF and sudden death, all‐cause mortality, and HF hospitalization, other events. We will collect clinical background information plus each patient's symptoms, Clinical Frailty Scale score, laboratory test results, echocardiographic and electrocardiographic parameters, and serial changes will also be secondary endpoints. Results Not applicable. Conclusion This study offers invaluable insights into understanding the role of ICD/WCD in Japanese HF patients in the new era of HF medication.

Abstract Cardiac physiologic pacing (CPP), encompassing cardiac resynchronization therapy (CRT) and conduction system pacing (CSP), has emerged as a pacing therapy strategy that may mitigate or prevent the development of heart failure (HF) in patients with ventricular dyssynchrony or pacing‐induced cardiomyopathy. This clinical practice guideline is intended to provide guidance on indications for CRT for HF therapy and CPP in patients with pacemaker indications or HF, patient selection, pre‐procedure evaluation and preparation, implant procedure management, follow‐up evaluation and optimization of CPP response, and use in pediatric populations. Gaps in knowledge, pointing to new directions for future research, are also identified.

Abstract Background The long‐term relationship between fracture‐prone implantable cardioverter‐defibrillator (ICD) leads and poor prognosis remains unclear in Japanese patients. Methods We conducted a retrospective review of the records of 445 patients who underwent implantation of advisory/Linox leads (Sprint Fidelis, 118; Riata, nine; Isoline, 10; Linox S/SD, 45) and non‐advisory leads (Endotak Reliance, 33; Durata, 199; Sprint non‐Fidelis, 31) between January 2005 and June 2012 at our hospital. The primary outcomes were all‐cause mortality and ICD lead failure. The secondary outcomes were cardiovascular mortality, heart failure (HF) hospitalization, and the composite outcome of cardiovascular mortality and HF hospitalization. Results During the follow‐up period (median, 8.6 [4.1–12.0] years), there were 152 deaths: 61 (34%) in patients with advisory/Linox leads and 91 (35%) in those with non‐advisory leads. There were 32 ICD lead failures: 27 (15%) in patients with advisory/Linox leads and five (2%) in those with non‐advisory leads. Multivariate analysis for ICD lead failure demonstrated that the advisory/Linox leads had a 6.65‐fold significantly greater risk of ICD lead failure than non‐advisory leads. Congenital heart disease (hazard ratio 2.51; 95% confidence interval 1.08–5.83; p = .03) could also independently predict ICD lead failure. Multivariate analysis for all‐cause mortality demonstrated no significant association between advisory/Linox leads and all‐cause mortality. Conclusions Patients who have implanted fracture‐prone ICD leads should be carefully followed up for ICD lead failure. However, these patients have a long‐term survival rate comparable with that of patients with non‐advisory ICD leads in Japanese patients.

Abstract Background Reports of long‐term outcomes after atrial fibrillation (AF) ablation for tachycardia‐bradycardia syndrome (TBS) are limited. This study aimed to investigate the impact of radiofrequency catheter ablation (RFCA) on clinical outcomes in patients with TBS. Methods Among 1669 patients who underwent AF ablation between January 2010 and April 2020, we retrospectively enrolled 53 patients (62.3% males; age, 67.1 ± 7.0 years) who had been diagnosed with TBS before RFCA for paroxysmal AF (TBS group). After 1:2 propensity score‐matching based on age, gender, AF type, and left atrial dimension, 106 patients were assigned to the control group (non‐TBS group). The atrial tachyarrhythmia (ATA) recurrence rate and rate of avoidance of permanent pacemaker implantation (PMI) were examined. Results During a median follow‐up period of 37.7 months, the ATA recurrence rate after a single ablation procedure was significantly higher in the TBS group than in the non‐TBS group (51.0% vs. 38.5%; log‐rank p = .008); however, the ATA recurrence rate after the final ablation procedure did not significantly differ between groups. In the TBS group, the rate of PMI avoidance after AF ablation was 92.5%. A Cox‐regression multivariate analysis revealed that the presence of non‐pulmonary vein/superior vena cava premature atrial contractions (odds ratio, 3.38; 95% confidence interval, 1.49–7.66; p = .004) was an independent predictor of ATA recurrence in the TBS group. Conclusions Patients with TBS had higher ATA recurrence rates after the first ablation procedure compared to those without TBS. However, ATA recurrence after AF ablation did not necessarily result in PMI for TBS patients.

Abstract Background Appropriate shock therapy is associated with subsequent all-cause death in heart failure (HF) patients who receive an implantable cardioverter defibrillator (ICD) for the primary prevention of sudden cardiac death. To evaluate the impact of signal-averaged electrocardiography (SAECG) findings on appropriate shocks in prophylactic ICD patients with nonischemic systolic HF. Methods We studied 86 patients with nonischemic HF and a left ventricular ejection fraction ≤ 35% who underwent new ICD implantation for the primary prevention of sudden cardiac death. We excluded patients who had a previously implanted permanent pacemaker and patients who received cardiac resynchronization therapy with an ICD. SAECG was performed before implantation. Abnormal SAECG findings were defined if 2 of the following 3 conditions were identified: filtered QRS duration (fQRS) ≥ 114 ms, root-mean-square voltage during the last 40 ms of the fQRS (RMS 40) 38 ms; additionally, patients with a QRS complex ≥ 120 ms who met both the RMS 40 and LAS 40 criteria were also considered to have abnormal SAECG findings. The primary outcome was the first occurrence of appropriate shock after implantation of the ICD. The secondary outcomes were the first occurrence of inappropriate shock and all-cause mortality. Results Forty-two patients met the criteria for abnormal SAECG findings (49%). During a median follow-up period of 61 months, 17 patients (20%) died, 24 (28%) received appropriate shock therapy, and 19 (22%) received inappropriate shock therapy. There was a significantly higher incidence of appropriate shocks in patients with abnormal SAECG findings than in those with normal SAECG findings (log-rank test, p = 0.025). Multivariate analysis revealed that abnormal SAECG findings were independently associated with the occurrence of appropriate shock (hazard ratio 2.67, 95% confidential interval 1.14–6.26). However, abnormal SAECG findings were not related to inappropriate shock. There was no difference in the incidence of all-cause death between patients with abnormal and normal SAECG findings. Conclusions Our results suggest that abnormal SAECG findings are associated with a high probability of appropriate shocks in prophylactic ICD patients with nonischemic systolic HF.

Abstract The Japanese Heart Rhythm Society established a nationwide, mandatory, multi‐center, prospective, observational registry of transvenous lead extraction (TLE) named the Japanese lead extraction registry (J‐LEX) in 2018. We have published the first annual report of J‐LEX with 661 cases from 42 hospitals. The second annual report of J‐LEX in 2020 enrolled increased numbers of 785 cases from 75 hospitals. TLE procedure was attempted on patients with an average age of 71.7 years old, male in 72.5% in the hybrid operating room in 57.9%, and in standard OR with a C‐arm fluoroscope in 18.7%. The indication of TLE was an infection in 62.8% and the guideline classification was class‐I in 67.4% and class‐IIa in 23.8%. The average implantation duration of target leads was 7.9 years. Complete removal was achieved in 96.6% of the target leads and clinical success in 98.1% of the patients. Perioperative complications were observed in 7.1% of the patients. One patient died during a TLE operation and the other three patients died in‐hospital (cardiac death in one patient and non‐cardiac in two patients). Although the annual J‐LEX report in 2020 demonstrated an increased number of TLE procedures despite the first pandemic year of coronavirus disease‐2019 (COVID‐19), perioperative complications increased a little in comparison with J‐LEX 2019.

Abstract Along with the incremental cases of cardiac implantable electronic devices implantation or upgrade, the lead‐related complications are also in rise year after year. The most common and serious lead‐related complication is infection that needs a transvenous lead extraction (TLE) as the first‐line therapy. TLE is also performed for abandoned leads in case of lead failure or device upgrade, and for lead‐related trouble such as pain, vessel stenosis or occlusion, too many leads, tricuspid valve regurgitation, and difficulty of radiation therapy. This registration has been performed by the Japanese Heart Rhythm Society and started in July 2018. The first reported data of the Japanese Lead Extraction (J‐LEX) from July 2018 to December 2019 were underestimated since the number of patients and hospitals increased gradually because of the approval process of each hospital’s IRB. The TLE procedure was attempted to 1253 leads among 661 patients. Complete removal was achieved in 96.7% of the target leads and the clinical success was obtained in 98.9% of the patients. Perioperative complications were observed in 4.1% of the patients. The annual J‐LEX report reflects a real‐world TLE medicine in Japan and demonstrates that the clinical outcome is similar to former reports from high‐volume centers in North America and European countries.

Introduction Data are lacking on the extent to which patients with non-valvular atrial fibrillation (AF) who are aged ≥80 years benefit from ablation treatment. The question pertains especially to patients’ postablation quality of life (QoL) and long-term clinical outcomes.Methods and analysis We are initiating a prospective, registry-based, multicentre observational study that will include patients aged ≥80 years with non-valvular AF who choose to undergo treatment by catheter ablation and, for comparison, such patients who do not choose to undergo ablation (either according to their physician’s advice or their own preference). Study subjects are to be enrolled from 52 participant hospitals and three clinics located throughout Japan from 1 June 2022 to 31 December 2023, and each will be followed up for 1 year. The planned sample size is 660, comprising 220 ablation group patients and 440 non-ablation group patients. The primary endpoint will be the composite incidence of stroke/transient ischaemic attack (TIA) or systemic embolism (SE), another cardiovascular event, major bleeding and/or death from any cause. Other clinical events such as postablation AF recurrence, a fall or bone fracture will be recorded. We will collect standard clinical background information plus each patient’s Clinical Frailty Scale score, AF-related symptoms, QoL (Five-Level Version of EQ-5D) scores, Mini-Mental State Examination (optional) score and laboratory test results, including measures of nutritional status, on entry into the study and 1 year later, and serial changes in symptoms and QoL will also be secondary endpoints. Propensity score matching will be performed to account for covariates that could affect study results.Ethics and dissemination The study conforms to the Declaration of Helsinki and the Ethical Guidelines for Clinical Studies issued by the Ministry of Health, Labour and Welfare, Japan. Results of the study will be published in one or more peer-reviewed journals.Trial registration number UMIN000047023.

Abstract The Japanese Catheter Ablation (J‐AB) registry, started in August 2017, is a voluntary, nationwide, multicenter, prospective, observational registry, performed by the Japanese Heart Rhythm Society (JHRS) in collaboration with the National Cerebral and Cardiovascular Center using a Research Electronic Data Capture system. The purpose of this registry is to collect the details of target arrhythmias, the ablation procedures, including the type of target arrhythmias, outcomes, and acute complications in the real‐world settings. During the year of 2019, we have collected a total of 80 795 procedures (mean age of 65.2 years and 66.4% male) from 425 participant hospitals. Detailed data are shown in Figures and Tables.

Background: The relationship between pre-ablation left ventricular diastolic dysfunction (LVDD) and prognosis in patients with left ventricular systolic dysfunction (LVSD) undergoing atrial fibrillation (AF) ablation remains unclear. Methods: The prognosis of 173 patients with impaired left ventricular ejection fraction (