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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.

Abstract Background Patients with heart failure (HF) and low left ventricular ejection fraction (LVEF) are at high risk of sudden cardiac death (SCD). Optimal HF treatment can improve LVEF and reduce the risk of SCD. The aim of this study was to evaluate the incidence and predictors of SCD in Japanese patients with new‐onset systolic HF and to investigate factors that affect LVEF improvement. Methods We retrospectively studied 174 consecutive hospitalized patients with new‐onset HF and LVEF ≤35% (median age, 66 years; men, 71%). The primary outcome was a composite of SCD, sustained ventricular arrhythmias, and appropriate implantable cardioverter‐defibrillator therapy. Results The cumulative rates of meeting of the primary outcome at 3, 12, and 36 months after discharge were 3.9%, 8.1%, and 10.5%, respectively. Atrial fibrillation was a significant predictor of the primary outcome within 12 months after discharge (odds ratio, 5.87; 95% confidence interval [CI], 1.60–21.57). Among 104 patients who completed follow‐up echocardiography within 12 months after discharge, changes in LVEF were inversely associated with SCD (odds ratio/1% increase, 0.78; 95% CI, 0.65–0.93). A QRS duration 35% (odds ratio, 3.69; 95% CI, 1.15–11.77; odds ratio, 3.19; 95% CI, 1.33–7.69, respectively). Conclusions Our results showed a high incidence of meeting of the primary outcome within 12 months after discharge in hospitalized patients with new‐onset systolic HF. An improved LVEF may reduce the risk of late SCD.

Abstract Background Acute pulmonary vein reconnection (PVR) is associated with long procedure times and large radiofrequency (RF) energy delivery during pulmonary vein isolation (PVI). Although the efficacy of high‐power PVI (HP‐PVI) has been recently established, the determinants of acute PVR following HP‐PVI remain unclear. Methods We evaluated data on 62 patients with paroxysmal atrial fibrillation undergoing unipolar signal modification (USM)‐guided HP‐PVI. A 50‐W RF wave was applied for 3‐5 seconds after USM. In the segments adjacent to the esophagus (SAEs), the RF time was limited to 5 seconds. Each circle was subdivided into six regions (segments), and the possible predictors of acute PVR, including minimum contact force (CFmin), minimum force‐time integral (FTImin), minimum ablation index (AImin), minimum impedance drop (Imp‐min), and maximum inter‐lesion distance (ILDmax), were assessed in each segment. Results We investigated 1162 ablations in 744 segments (including 124 SAEs). Acute PVR was observed in 21 (17%) SAEs and 43 (7%) other segments (P = .001). The acute PVR segments were characterized by significantly lower CFmin, FTImin, AImin, and Imp‐min values in the segments other than the SAEs and larger ILDmax values in the SAEs. Furthermore, lower Imp‐min and larger ILDmax values independently predicted acute PVR in the segments other than the SAEs and SAEs (odds ratios 0.90 and 1.39 respectively). Acute PVR was not significantly associated with late atrial fibrillation recurrence. Conclusions Avoiding PVR remains a challenge in HP‐PVI cases, but it might be resolved by setting the optimal target impedance drop and lesion distance values.

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 (

Abstract Background Conventional risk factors for sudden cardiac death (SCD) justify primary prevention through implantable cardioverter-defibrillator (ICD) implantation in hypertrophic cardiomyopathy (HCM) patients. However, the positive predictive values for these conventional SCD risk factors are low. Left ventricular outflow tract obstruction (LVOTO) and midventricular obstruction (MVO) are potential risk modifiers for SCD. The aims of this study were to evaluate whether an elevated intraventricular pressure gradient (IVPG), including LVOTO or MVO, is a potential risk modifier for SCD and ventricular arrhythmias requiring ICD interventions in addition to the conventional risk factors among HCM patients receiving ICDs for primary prevention. Methods We retrospectively studied 60 HCM patients who received ICDs for primary prevention. An elevated IVPG was defined as a peak instantaneous gradient ≥ 30 mmHg at rest, as detected by continuous-wave Doppler echocardiography. The main outcome was a composite of SCD and appropriate ICD interventions, which were defined as an antitachycardia pacing or shock therapy for ventricular tachycardia or fibrillation. The Cox proportional hazards model was used to assess the relationships between risk factors and the occurrence of SCD and appropriate ICD interventions. Results Thirty patients met the criteria of elevated IVPG (50%). During the median follow-up period of 66 months, 2 patients experienced SCD, and 10 patients received appropriate ICD interventions. Kaplan–Meier curves showed that the incidence of the main outcome was higher in patients with an IVPG ≥ 30 mmHg than in those without an IVPG ≥ 30 mmHg (log-rank P = 0.03). There were no differences in the main outcome between patients with LVOTO and patients with MVO. The combination of nonsustained ventricular tachycardia (NSVT) and IVPG ≥ 30 mmHg was found to significantly increase the risk of the main outcome (HR 6.31, 95% CI 1.36–29.25, P = 0.02). Five patients experienced ICD implant-related complications. Conclusions Our findings showed that a baseline IVPG ≥ 30 mmHg was associated with an increased risk of experiencing SCD or appropriate ICD interventions among HCM patients who received ICDs for primary prevention. Combined with NSVT, which is a conventional risk factor, a baseline IVPG ≥ 30 mmHg may be a potential modifier of SCD risk in HCM patients.

Abstract Background To analyze the type of ablation procedure, acute outcomes, and complications related to catheter ablation in Japan during the year of 2018. Method The Japanese Catheter Ablation (J‐AB) registry 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 procedural outcome and complications during hospitalizations were collected. Result A total of 55 525 procedures (mean age of 64.5 years and 66.5% male) from 369 hospitals were collected. The total number of target arrhythmias was 61 610 including atrial fibrillation (AF, 65.6%), atrial flutter (AFL) or atrial tachycardia (16.7%), atrioventricular nodal reentrant tachycardia (7.4%), atrioventricular reentrant tachycardia (3.5%), premature ventricular contractions (4.1%), and ventricular tachycardia (VT, 2.0%). Over a 90% acute success rate was observed among all arrhythmias except for VT due to structural heart disease, and notably, an over 99% success rate was achieved for pulmonary vein isolation of AF and inferior vena cava‐tricuspid valve isthmus block for isthmus‐dependent AFL. Acute complications during hospitalization were observed in 1558 patients (2.8%), including major bleeding (Bleeding Academic Research Consortium: BARC criteria ≥2) in 1.1%, cerebral or systemic embolisms in 0.2%, and death in 0.1%. Acute complications were more often observed with AF ablation (P

Abstract Background In pulmonary vein isolation, the regional differences in the ablation index (AI) and interlesion distance (ILD) remain unclear. This study aimed to evaluate the association between the AI, ILD, and other relevant indices with pulmonary vein reconnections (PVRs) during the surgical intervention with a focus on the heterogeneous regional variability through a retrospective analysis. Methods We divided the wide area circumferential ablation (WACA) region into 12 segments in 32 consecutive patients, which resulted in a 384 segment analysis to evaluate the association of the minimum AI (AI min) and maximum ILD (ILD max) with acute PVRs, which were defined as spontaneous PVRs or dormant conduction after adenosine triphosphate administration. Results Acute PVRs were observed in 48 (13%) segments and 40 (63%) WACA regions. The AI min was significantly lower and ILD max greater in segments with PVRs than in those without (372 vs 403 au and 6.5 vs 5.7 mm, respectively). PVRs were more frequent in the left posterior segments, adjacent to the esophagus, than in other segments (23% vs 10%, respectively). Notably, ILD max was significantly greater in the left posterior segments with acute PVRs with AI min

Abstract Background Transvenous lead extractions (TLEs) in Japan have grown to become the standard therapy since the approval of the laser extraction system in 2008. However, little is known about the current indications, methods, success rate, and acute complications in the real‐world setting. Methods The Japanese Lead EXtraction (J‐LEX) registry is a nationwide, multicenter, observational registry, performed by the Japanese Heart Rhythm Society (JHRS) in collaboration with the National Cerebral and Cardiovascular Center. This study is a nationwide registry ordered by the JHRS and its data are collected prospectively using the Research Electronic Data Capture (REDCap) system. The acute success rate at discharge and complications associated with TLEs will be collected in all cases. Based on the provided information, the annual incidence and predictive factors for the outcomes will be investigated by the Event Assessment Committee (EAC). This registry started in July 2018 and the number of participating medical institutions will be more than 50 hospitals and the target number of procedures will be 500‐1000 per year. We will also compare the results with other registries in foreign countries. Result The results of this study are currently under investigation. Conclusion The J‐LEX registry will provide real‐world data regarding the results and complications of TLEs for the various types of indications, methods, and performing hospitals in Japan.

Abstract A 45‐year‐old man with paroxysmal atrial fibrillation (PAF) was admitted to our hospital for hot balloon ablation. At admission, atrial tachycardia (AT) was observed. Activation map showed focal atrial tachycardia originating from the posterior wall of the left superior pulmonary vein (LSPV) antrum. We performed hot balloon ablation at the LSPV antrum, terminated AT, and performed pulmonary vein isolation with a hot balloon. The hot balloon was successfully applied for the ablation of the focal atrial tachycardia from the pulmonary vein.

Abstract Background The increase in the use of cardiac implantable electronic devices (CIEDs) has been associated with an increase in CIED‐related infections. Transvenous lead extraction is safe and effective for patients with CIED‐related infections; however, the mortality rate in these patients is high. The prognosis after transvenous lead extraction in Japanese patients, especially those with lead‐related infective endocarditis, has not been evaluated. Then, the purpose of this study is to clarify the prognosis after transvenous lead extraction in Japanese patients with CIED‐related infections at a single Japanese center. Methods A total of 107 patients who underwent transvenous lead extraction were retrospectively reviewed. The patients were divided into a lead‐related infective endocarditis group (n = 32) and a pocket infection group (n = 75). Procedure success rate and prognosis after lead extraction were evaluated between the two groups. Results Procedure success rate was not significantly different between the groups. There were no deaths associated with the procedure or with infection. The survival rate was not significantly different at 1 year or at a median of 816 days (lead‐related infective endocarditis vs pocket infection; 93.7% vs 94.7%, P = 1.000; 78.1% vs 81.3%, P = 0.791) Time to reimplantation and duration of hospital stay and antibiotics therapy were significantly longer for patients with lead‐related infective endocarditis. Conclusion In this study, the prognosis for patients with lead‐related infective endocarditis after transvenous lead extraction was favorable. Thus, extraction should be strongly recommended, even if the general condition of the patient is poor.

Abstract Background Catheter ablation has become a popular interventional treatment for cardiac tachyarrhythmias and the number has been on the rise year by year. However, little is known about its efficacy and safety in the real‐world settings. Method Japanese Catheter Ablation (J‐AB) Registry is a nationwide, multicenter, observational registry, performed by Japanese Heart Rhythm Society (JHRS), collaborated with National Cerebral and Cardiovascular Center. This study is a voluntary nationwide registry and data are collected prospectively using a Research Electronic Data Capture (REDCap) system. Detailed data collection including antiarrhythmic medication is also performed every September. The acute success rate at discharge and the complications associated with ablation procedure will be collected in all cases. Major bleeding events are defined according to Bleeding Academic Research Consortium criteria. Based on the provided information, the annual incidence and predictive factors for outcome will be investigated by the Event Assessment Committee. This registry started in August 2017 and the number of participating medical instructions will be more than 250 hospitals and the target procedure number will be 70 000 per year. We will also compare the results with other registries in foreign countries. Result The results of this study are currently under investigation. Conclusion The J‐AB registry will provide a real‐world data regarding the acute success and complications in Japan, focusing on various types of catheter ablation for cardiac arrhythmias.

Background The association between first‐degree atrioventricular block (AVB) and life‐threatening cardiac events in patients with hypertrophic cardiomyopathy (HCM) remains unclear. This study sought to investigate whether presence of first‐degree AVB was associated with HCM‐related death in patients with HCM. Methods and Results We included 414 patients with HCM (mean age, 51±16 years; 64.5% men). The P‐R interval was measured at the time of the initial evaluation and patients were classified into those with and without first‐degree AVB, which was defined as a P‐R interval ≥200 ms. HCM‐related death was defined as a combined end point of sudden death or potentially lethal arrhythmic events, heart failure–related death, and stroke‐related death. First‐degree AVB was noted in 96 patients (23.2%) at time of enrollment. Over a median (interquartile range) follow‐up period of 8.8 (4.9–12.9) years, a total of 56 patients (13.5%) experienced HCM‐related deaths, including 47 (11.4%) with a combined end point of sudden death or potentially lethal arrhythmic events. In a multivariable analysis that included first‐degree AVB and risk factors for life‐threatening events, first‐degree AVB was independently associated with an HCM‐related death (adjusted hazard ratio, 2.41; 95% CI, 1.27–4.58; P=0.007), and this trend also persisted for the combined end point of sudden death or potentially lethal arrhythmic events (adjusted hazard ratio, 2.60; 95% CI, 1.28–5.27; P=0.008). Conclusions In this cohort of patients with HCM, first‐degree AVB may be associated with HCM‐related death, including the combined end point of sudden death or potentially lethal arrhythmic events.

BackgroundThe composite Model for End-Stage Liver Disease Excluding International Normalized Ratio Score (MELD-XI) is a novel tool to evaluate cardio-renal and cardio-hepatic interactions in patients with advanced heart failure (HF). However, its prognostic ability remains unclear in elderly HF patients.Methods and resultsFrom July 2014 to July 2018, patients hospitalized for HF were prospectively recruited at 16 centers. Clinical features, laboratory findings, and echocardiography results were assessed prior to discharge. Cardiovascular (CV) death and HF re-hospitalization were recorded. Of the 676 patients enrolled, 264 (39.1%) experienced CV events throughout a 1-year median follow-up period. Patients with high MELD-XI were predominantly male and had a higher prevalence of NYHA III/IV, history of HF admission, hyperuricemia, ventricular tachycardia, anemia, and ischemic heart disease. In Kaplan-Meyer analysis, patients with higher MELD-XI (≥11) scores showed a worse prognosis than did those with lower (ConclusionsCardio-renal and cardio-hepatic interactions predicted CV events in aged HF patients.

Abstract Background and purpose In expectation of better outcome of catheter ablation of atrial fibrillation (AF), several strategies of extra‐PV (pulmonary vein) substrate modification have been utilized. We assessed whether substrate modification or ablation of extra‐PV source is a predictor of complications. Methods Japanese Heart Rhythm Society requested electrophysiology centers to register the data of patients who underwent AF ablation. Results The data of 10 795 AF ablation cases (age; 63.8 ± 10.6 years) treated during 2011‐2016 were registered. Pericardial effusion (n = 105), massive bleeding (n = 108), stroke (n = 6), atrial‐esophageal fistula (n = 2), and other 114 complications occurred in 323 patients (3.0%). Univariate analysis revealed that age ≧ 65 years, female gender, heart failure, CHA2DS2‐VASc≧3, hemodialysis, deep sedation, and complex fractionated atrial electrogram (CFAE)‐guided ablation ([+] vs [−] = 4.3% vs 2.8%, P = .005) were related with the higher incidence of complications. Redo session, 3‐D imaging system ([+] vs [−]: 4.4% vs 2.9%, P = .017), and periprocedural dabigatran were related with the lower incidence of complications. None of the linear ablation of the left atrium, ganglionated plexi ablation, and superior vena cava ablation affected the incidence of complications. Multiple logistic regression analysis showed that in addition to 3‐D imaging system, age ≧ 65 years, redo session, and deep sedation, CFAE ablation was an independent predictor of the risk of complications (OR 1.78, P = .001). Specifically, implantation of a permanent pacemaker due to emerging sinus node dysfunction was frequent after CFAE ablation (CFAE [+] vs [−] = 4/1047 vs 2/9748, P

Abstract Twiddler syndrome is an uncommon complication that occurs by twisting of the generator and may cause torsion, dislodgement, and injury of the leads. We report a rare case of a twiddler syndrome associated with an abdominal permanent pacemaker. Abdominal twiddler syndrome may possess a unique mechanism, which may not be seen in chest twiddler syndrome.

Background: Pericardial effusion (PE) is one of the most frequent complications from catheter ablation of atrial fibrillation (AF). We assessed the prevalence and predictive factors of PE that require invasive treatment as an early complication of AF ablation. Methods: The Japanese Heart Rhythm Society requested electrophysiology centers to register the relevant data of patients who underwent AF ablation during 6 months from 2011 to 2015. We compared the clinical profiles and the procedures of AF ablation between patients who had ablation-related PE and those who did not. Results: Two-hundred-and-eight institutions reported the data of 8319 AF ablation sessions (age 63.4±10.7 years). A total of 414 complications occurred in 401 patients (4.8%). The incidence of invasively treated critical PE was 1.0% (n=85) of total procedures, while conservatively treated noncritical PE appeared in 95 subjects. When clinical and procedural variables were compared between patients who suffered critical PE and 8140 PE-free patients, deep sedation (p=0.030), impaired left ventricular function (p=0.031), and periprocedural warfarin (p=0.023) significantly increased the incidence of critical PE in univariate analysis. Use of 3-D imaging system (p

Background: To obtain a perspective of the current status of catheter ablation for the cure of atrial fibrillation, the Japanese Heart Rhythm Society conducted a nationwide survey: the Japanese Catheter Ablation Registry of Atrial Fibrillation. In this report, we aimed to evaluate the periprocedural use of direct oral anticoagulants with respect to thromboembolic or bleeding complications. Methods: Using an online questionnaire, the Japanese Heart Rhythm Society requested electrophysiology centers in Japan to register the relevant data of patients who underwent atrial fibrillation ablation over selected five-months from 2011 to 2014. We compared the clinical profiles and the ablation data, including the incidence of pericardial effusion, major bleeding, and ischemic stroke among patients with periprocedural use of warfarin or a direct oral anticoagulant. Results: A total of 204 institutions reported data on 6200 atrial fibrillation ablation sessions. We analyzed data obtained from 4698 subjects (Age 63.2±10.6 yr; 73.9% male, 26.1% female) who were administered warfarin or a direct oral anticoagulant, at least up to the day before atrial fibrillation ablation. Warfarin was administered to 54.7% of patients. Dabigatran, rivaroxaban, and apixaban were used in 21.9%, 12.9%, and 10.6% of patients, respectively. Clinical profiles of apixaban-treated patients were similar to those of warfarin-treated patients; they were different from the clinical profiles of patients treated with dabigatran or rivaroxaban. There were 104 complications in 103 subjects (2.2%). Complications were more frequent in older patients (65.3±8.6 yr vs. 63.1±10.7 yr; P=0.012), patients on chronic hemodialysis (4.9% vs. 1.1%; P=0.001), or those treated with warfarin (66.0% vs. 54.4%; P=0.019). Multiple logistic regression analysis revealed that age (OR, 1.02; 95% CI: 1.00–1.04; P=0.035), chronic hemodialysis (OR, 4.40; CI: 1.68–11.50; P=0.003), and assistance by 3-D mapping system (OR, 0.30; CI: 0.16–0.57; P

Background: Vascular endothelial function has recently been recognized as an independent predictor of cardiovascular events. However, studies investigating its association with atrial fibrillation (AF) are lacking. This study aimed to examine association with AF recurrence and vascular endothelial function as assessed using natural logarithmic transformation of reactive hyperemia peripheral arterial tonometry index (LnRHI). Methods: Ninety-nine consecutive AF patients who underwent catheter ablation (CA) at Shinshu University Hospital between September 2015 and April 2017 were enrolled. LnRHI was measured 48 to 72 h before CA using the EndoPAT system. The primary outcome was AF recurrence beyond 3 months post-ablation. Results: A total of 30 (30.3%) patients experienced AF recurrence after CA over a median follow-up period of 210 days (range: 93–764 days). Female sex and low LnRHI were significantly associated with AF recurrence. In multivariate analysis, LnRHI was an independent predictor of AF recurrence (hazard ratio: 0.087, 95% confidence interval 0.015–0.51, p = 0.007). In comparison in Kaplan-Meier analysis of high LnRHI (LnRHI ≥0.52, n = 52) and low LnRHI (LnRHI ≪0.52, n = 47) groups, AF recurrence rate was significantly higher in the low LnRHI group (log-rank test, p = 0.043). A negative correlation was observed between LnRHI and AF duration, whereby LnRHI was significantly decreased when the duration of AF events exceeded 1 year. Conclusion: Decreased LnRHI was associated with AF recurrence after CA and prolonged AF duration. Keywords: Vascular endothelial function, Natural logarithmic transformation of reactive hyperemia peripheral arterial tonometry index (LnRHI), Atrial fibrillation, Catheter ablation

Background: Catheter ablation of non-paroxysmal atrial fibrillation (non-PAF) is a therapeutic challenge especially in elderly patients. This study describes the feasibility of a posterior left atrium isolation as a substrate modification in addition to pulmonary vein isolation, the so-called Box isolation, for elderly patients with non-PAF. Methods: Two hundred twenty-nine consecutive patients who underwent Box isolations for drug-refractory non-PAF were divided into two groups according to their age; younger group comprising 175 patients aged

Overlapping characteristics of Brugada syndrome (BrS) and arrhythmogenic right ventricular cardiomyopathy/dysplasia (ARVC/D) have been reported in recent studies, but little is known about the overlapping disease state of BrS and ARVC/D. A 36-year-old man, hospitalized at our institution for syncope, presented with this overlapping disease state. The electrocardiogram showed spontaneous coved-type ST-segment elevation, and ventricular fibrillation was induced by right ventricular outflow tract stimulation in an electrophysiological study. BrS was subsequently diagnosed; additionally, the presence of epsilon-like waves and right ventricular structural abnormalities met with the 2010 revised task force criteria for ARVC/D. After careful investigation for both BrS and ARVC/D, an implantable cardioverter defibrillator was inserted in the patient. This case revealed 2 important clinical findings: (1) BrS and ARVC/D clinical features can coexist in a single patient, and EPS might be useful for determining the phenotype of overlapping disease (e.g., BrS-like or ARVC/D-like). (2) An overlapping disease state of BrS and ARVC/D can change phenotypically during its clinical course. Therefore, careful examination and attentive follow-up are required for patients with BrS or ARVC/D.

Background: The effect of intravenous amiodarone on spatial and transmural dispersion of ventricular repolarization in patients receiving cardiac resynchronization therapy (CRT) remains unclear. Methods: We studied 14 patients with nonischemic heart failure who received CRT with a defibrillator, experienced electrical storm and were treated with intravenous amiodarone. Each patient underwent 12-lead electrocardiography (ECG) and 187-channel repolarization interval-difference mapping electrocardiography (187-ch RIDM-ECG) before and during the intravenous administration of amiodarone infusion. Results: A recurrence of ventricular tachyarrhythmia was observed in 2 patients during the early period of intravenous amiodarone therapy. Intravenous amiodarone increased the corrected QT interval (from 470±52 ms to 508±55 ms, P=0.003), but it significantly decreased the QT dispersion (from 107±35 ms to 49±27 ms, P=0.001), T peak–T end (Tp–e) dispersion (from 86±17 ms to 28±28 ms, P=0.001), and maximum inter-lead difference between corrected Tp–e intervals as measured by using the 187-ch RIDM-ECG (from 83±13 ms to 50±19 ms, P=0.001). Conclusions: Intravenous amiodarone suppressed the electrical storm and decreased the QT and Tp–e dispersions in patients treated by using CRT with a defibrillator.

Background: Catheter ablation has become an established therapy for the treatment of atrial fibrillation (AF). To obtain a perspective on the current status of this therapy in Japan, the Japanese Heart Rhythm Society (JHRS) conducted a nationwide survey, the Japanese Catheter Ablation Registry of Atrial Fibrillation (J-CARAF). In this study, we focused on whether periprocedural use of novel oral anticoagulants (NOACs) was related with excessive thromboembolic or bleeding complications. Methods: Using an online questionnaire, JHRS requested electrophysiology centers in Japan to register the data of patients who underwent AF ablations in September 2011, March 2012, and September 2012. We compared the clinical profiles and ablation data, including the incidence of complications among patients in whom warfarin, a NOAC or neither was used as a periprocedural anticoagulant. Results: A total of 179 centers submitted data relating to 3373 patients (62.2±10.6 years). Paroxysmal atrial fibrillation (PAF) was observed in 64.4% of patients. Warfarin, as a periprocedural oral anticoagulant, was used by 53.6% (1808/3373) of patients. A NOAC was given to 541 subjects (dabigatran: 504 [16.1%], rivaroxaban: 37 [1.1%]). In the remaining 1024 patients (30.4%), no periprocedural oral anticoagulants (OACs) were used. The proportion of PAF in warfarin-treated patients (61.1%) was significantly lower than that in NOAC-treated patients (70.1%, p

Background: The Japanese Heart Rhythm Society (JHRS) conducted a nationwide survey of catheter ablation of atrial fibrillation (AF) in Japan, the Japanese Catheter Ablation Registry of Atrial Fibrillation (J-CARAF). In this report, to offer a perspective on the current status of hybrid AF therapy, we focus on antiarrhythmic drug (AAD) therapy before and after AF ablation. Methods: The JHRS requested electrophysiology centers in Japan to retrospectively register the comprehensive data of each AF ablation session performed in September 2011, March 2012, or September 2012. Results: A total of 179 EP centers submitted data for 3373 sessions. The average patient age was 62.2±10.6 years, and 76.1% (2587) were male. Patients with paroxysmal AF (PAF) consisted of 64.4% of total patients. The average number of AADs used before AF ablation was 1.13±0.96. Among 2173 PAF patients, 454 subjects (20.9%) underwent AF ablation without preceding AAD therapy. At the time of discharge, 40.3% of PAF patients were given one or more AAD, while 63.0% of persistent AF patients and 71.5% of long-standing-persistent AF patients left the hospital with an AAD (p

The incidence of cardiovascular implantable electronic device infection is increasing. We report a case of and successful device removal in a 79-year-old man with implantable cardioverter-defibrillator infection. Right phrenic nerve paralysis was evident on chest radiography. The lead was in front of the anterior scalene muscle, close to the left phrenic nerve. Therefore, extraction carried a risk of bilateral phrenic nerve paralysis. The lead was successfully extracted from the right internal jugular vein by using the snare technique. No complications occurred, and the extraction was successful.

To assess the current status of atrial fibrillation (AF) ablation in Japan, the Japanese Heart Rhythm Society (JHRS) instituted a national registry, the Japanese Catheter Ablation Registry of AF (J-CARAF). Methods: Using an online questionnaire, the JHRS invited electrophysiology centers in Japan to voluntarily and retrospectively register data regarding the AF ablation procedures performed in September, 2011. Results: A total of 128 centers submitted data regarding AF ablation procedures in 932 patients (age 62.1±10.4 years; male 76.8%; paroxysmal AF 65.7%, CHADS2 score 1.0±1.0). The majority received oral anticoagulant therapy during and following the procedure (68.9% and 97.5%, respectively). Pulmonary vein isolation (PVI) was performed in 97.5% of the patients; ipsilateral encircling PVI was the preferred technique (79.7%). Three-dimensional (3D) mapping systems and irrigated-tip catheters were used in 94.8% and 87.7% of the procedures, respectively. Ablation methods other than PVI were performed in 78.8% of all the patients and 73.5% of the patients with paroxysmal AF. Acute complications were reported in 6.2% of the patients, but no early deaths were recorded. Conclusions: Ipsilateral encircling PVI, using 3D mapping and irrigated-tip catheters, is the standard AF ablation method in Japan. However, adjunctive ablations were performed frequently, even in patients with paroxysmal AF.

Risk stratification of lethal arrhythmias is important for the management of ischemic heart disease. Recently, we developed a novel 187-channel signal-averaged vector-projected high-resolution electrocardiograph (187-ch SAVP-ECG) with a Mason–Likar lead system with 10 electrodes. The purpose of this study was to examine the feasibility of a noninvasive evaluation of the spatial distribution of high-frequency late potentials (HFLPs) in patients with myocardial infarction (MI) by using the 187-ch SAVP-ECG. Sixty-four MI patients (7 women and 57 men), between the age of 39 and 84 years (mean 67.7±9.7 years), with positive ventricular late potentials defined by an X, Y, Z-lead ECG were studied. The integrated ventricular 187-ch SAVP-ECG could identify the area of HFLPs that was projected virtually by mathematically calculated 187 electrograms on the body surface in all patients, and differentiate the locations of MI. The 187-ch SAVP-ECG can be a practical and noninvasive examination tool for identifying the location of infarction areas and possible arrhythmogenic substrates with slow conduction properties in patients with MI.