Search

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. From January 2022, the data registration system was changed from Research Electronic Data Capture (REDCap) system to Fountayn system. The purpose of this registry was 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 2022, we have collected a total of 90,042 procedures (mean age of 66.7 years and 65.9% male) from 614 participant hospitals. Detailed data were shown in Figures and Tables.

Abstract Background Predicting the origin of premature ventricular contraction (PVC) from the preoperative electrocardiogram (ECG) is important for catheter ablation therapies. We propose an explainable method that localizes PVC origin based on the semantic segmentation result of a 12‐lead ECG using a deep neural network, considering suitable diagnosis support for clinical application. Methods The deep learning‐based semantic segmentation model was trained using 265 12‐lead ECG recordings from 84 patients with frequent PVCs. The model classified each ECG sampling time into four categories: background (BG), sinus rhythm (SR), PVC originating from the left ventricular outflow tract (PVC‐L), and PVC originating from the right ventricular outflow tract (PVC‐R). Based on the ECG segmentation results, a rule‐based algorithm classified ECG recordings into three categories: PVC‐L, PVC‐R, as well as Neutral, which is a group for the recordings requiring the physician's careful assessment before separating them into PVC‐L and PVC‐R. The proposed method was evaluated with a public dataset which was used in previous research. Results The evaluation of the proposed method achieved neutral rate, accuracy, sensitivity, specificity, F1‐score, and area under the curve of 0.098, 0.932, 0.963, 0.882, 0.945, and 0.852 on a private dataset, and 0.284, 0.916, 0.912, 0.930, 0.943, and 0.848 on a public dataset, respectively. These quantitative results indicated that the proposed method outperformed almost all previous studies, although a significant number of recordings resulted in requiring the physician's assessment. Conclusions The feasibility of explainable localization of premature ventricular contraction was demonstrated using deep learning‐based semantic segmentation of 12‐lead ECG. Clinical trial registration: M26‐148‐8.

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 The number of patients with atrial fibrillation is increasing, and frailty prevalence increases with age, posing challenges for physicians in prescribing anticoagulants to such patients because of possible harm. The effects of frailty on anticoagulant therapy in older Japanese patients with nonvalvular atrial fibrillation (NVAF) are unclear. Herein, we prescribed rivaroxaban to Japanese patients with NVAF and monitored for a mean of 2.0 years. The primary endpoint was stroke or systemic embolism. The secondary endpoints were all-cause or cardiovascular death, composite endpoint, and major or non-major bleeding. Frailty was assessed using the Japanese long-term care insurance system. A multiple imputation technique was used for missing data. The propensity score (PS) was obtained to estimate the treatment effect of frailty and was used to create two PS-matched groups. Overall, 5717 older patients had NVAF (mean age: 73.9 years), 485 (8.5%) were classified as frail. After PS matching, background characteristics were well-balanced between the groups. Rivaroxaban dosages were 10 and 15 mg/day for approximately 80% and the remaining patients, respectively. Frailty was not associated with the primary endpoint or secondary endpoints. In conclusion, frailty does not affect the effectiveness or safety of rivaroxaban anticoagulant therapy in older Japanese patients with NVAF. Trial registration: UMIN000019135, NCT02633982.

Background We aimed to quantify the incidence of atrial fibrillation (AF) in patients with cryptogenic stroke globally, as well as separately in patients in and outside of Japan, using an implantable loop recorder from a prospective, observational, Reveal LINQ Registry. Methods and Results Patients developing cryptogenic stroke and monitored by implantable loop recorder for searching AF were studied. The primary end point was incidence of AF within 36 months after insertion. Secondary end points were recurrent ischemic stroke/transient ischemic attack and AF‐related treatment strategies. A total of 271 patients (61.6±14.3 years, 170 men, 60 from Japan) were enrolled from 12 countries. AF was detected in 28.2% at 36 months. The median time from enrollment to AF detection was 7.9 months. During the first 12 months, the AF detection rate slope was relatively steeper in the Japanese subgroup versus non‐Japanese patients. However, by 3 years, the cumulative incidence of AF detection did not differ between groups. Age was the only variable associated with AF detection (hazard ratio, 1.05 [95% CI, 1.02–1.07] per year), trending higher in older age groups. Of the 271 patients, 11 (4.1%) developed recurrent ischemic stroke/transient ischemic attack; AF was detected by implantable loop recorder in only 1 of these patients. Patients with detected AF were more commonly taking oral anticoagulation than those without AF at the last follow‐up (64.7% versus 25.3%, P

Background The optimal surgical timing for asymptomatic or equivocally symptomatic chronic severe aortic regurgitation with preserved left ventricular ejection fraction remains controversial. Methods and Results Two hundred ten consecutive patients (median age 65 years) with asymptomatic or equivocally symptomatic chronic severe aortic regurgitation and left ventricular ejection fraction ≥50% were registered. First, the treatment plans (aortic valve replacement or watchful waiting) after initial diagnosis were investigated. Then, 2 studies were set: Study A (n=144) investigated the prognosis of patients who were managed under the watchful waiting strategy after initial diagnosis; Study B (n=99) investigated the postoperative prognosis in patients who underwent aortic valve replacement at initial diagnosis or after watchful waiting. The primary outcomes were all‐cause death in Study A and postoperative cardiovascular events in Study B. In Study A, 3 died of noncardiovascular causes during a median follow‐up of 3.2 years. In Kaplan–Meier analysis, the survival curve was similar to that of an age‐sex‐matched general population in Japan. In Study B, 9 experienced the primary outcome during a median follow‐up of 5.0 years. In Cox regression analysis, preoperative left ventricular end‐systolic diameter enlargement (hazard ratio, 1.11; P=0.048) and left ventricular end‐systolic diameter >45 mm (hazard ratio, 12.75; P=0.02) were significantly associated with poor postoperative prognosis. In Kaplan–Meier analysis, left ventricular end‐systolic diameter >45 mm predicted a higher risk of the primary outcome (P 45 mm predicted a poor postoperative outcome and may be an optimal cut‐off value for surgical indication.

A 10-year-old female patient experienced syncope while swimming, and electrocardiography revealed polymorphic ventricular tachycardia, leading to a diagnosis of catecholaminergic polymorphic ventricular tachycardia. No pathogenic variant was identified in RYR2. Additional comprehensive genetic testing revealed novel compound heterozygous variants in trans-2,3-enoyl-coenzyme A reductase–like gene, which caused a recessive form of catecholaminergic polymorphic ventricular tachycardia.

A 77-year-old female patient with multiple pacemaker leads experienced hypotension and syncope during right heart catheterization. Imaging studies revealed a stenotic inferior vena cava with superior vena cava obstruction and well-developed retrograde collateral vessels, suggesting that balloon obstruction of the sole venous return site caused low cardiac output leading to syncope.

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 2021, we have collected a total of 89 609 procedures (mean age of 66.1 years and 65.9% male) from 506 participant hospitals. Detailed data are shown in Figures and Tables.

Abstract Introduction Cardiac implantable electronic devices are used in patients with cardiac rhythm disorders. Computed tomography irradiation is not prohibited for patients with cardiac implantable electronic devices, despite adverse events being reported. Hence, appropriate preparation and knowledge are required before computed tomography irradiation can be carried out in these patients. Since there is limited knowledge or literature about the influence of computed tomography irradiation in cases with recent cardiac implantable electronic devices, we aimed to evaluate the adverse events and elucidate the necessary and sufficient safety measures associated with this therapy. Methods and Results We placed cardiac implantable electronic devices on an anthropomorphic phantom model and observed their electrical activity in electrograms, while various protocols of computed tomography irradiation were implemented and adverse events evaluated. Oversensing with pauses of up to 3.2 s was observed in standard computed tomography protocols, but ventricular tachyarrhythmia or other clinically significant events could not be confirmed. Oversensing with pauses of up to 8.0 s was observed and ventricular tachyarrhythmia was detected in the maximum‐dose protocols. However, treatments such as antitachycardia pacing or shock therapy for ventricular tachyarrhythmia were not observed because of their absence. Conclusion Computed tomography irradiation for patients using cardiac implantable electronic devices is highly unlikely to cause clinically significant adverse events with the device settings and computed tomography protocols currently being used. Changing or monitoring the device settings routinely before computed tomography irradiation is not necessarily required for most patients.

Abstract Background Effective diagnostic biomarkers for aortic aneurysm (AA) that are detectable in blood tests are required because early detection and rupture risk assessment of AA can provide insights into medical therapy and preventive treatments. However, known biomarkers for AA lack specificity and reliability for clinical diagnosis. Methods We performed proteome analysis of serum samples from patients with atherosclerotic thoracic AA (TAA) and healthy control (HC) subjects to identify diagnostic biomarkers for AA. Serum samples were separated into low-density lipoprotein, high-density lipoprotein, and protein fractions, and the major proteins were depleted. From the proteins identified in the three fractions, we narrowed down biomarker candidates to proteins uniformly altered in all fractions between patients with TAA and HC subjects and evaluated their capability to discriminate patients with TAA and those with abdominal AA (AAA) from HC subjects using receiver operating characteristic (ROC) analysis. For the clinical validation, serum concentrations of biomarker candidates were measured in patients with TAA and AAA registered in the biobank of the same institute, and their capability for the diagnosis was evaluated. Results Profilin 1 (PFN1) and complement factor D (CFD) showed the most contrasting profiles in all three fractions between patients with TAA and HC subjects and were selected as biomarker candidates. The PFN1 concentration decreased, whereas the CFD concentration increased in the sera of patients with TAA and AAA when compared with those of HC subjects. The ROC analysis showed that these proteins could discriminate patients with TAA and AAA from HC subjects. In the validation study, these candidates showed significant concentration differences between patients with TAA or AAA and controls. PFN1 and CFD showed sufficient area under the curve (AUC) in the ROC analysis, and their combination further increased the AUC. The serum concentrations of PFN1 and CFD also showed significant differences between patients with aortic dissection and controls in the validation study. Conclusion PFN1 and CFD are potential diagnostic biomarkers for TAA and AAA and measurable in blood samples; their diagnostic performance can be augmented by their combination. These biomarkers may facilitate the development of diagnostic systems to identify patients with AA.

Abstract Background Recent studies have reported atrial involvement and coexistence of aortic stenosis in transthyretin (ATTR) cardiac amyloidosis (CA). However, pathological reports of extraventricular ATTR amyloid deposits in atrial structures or heart valves are limited, and the clinical implications of ATTR amyloid deposits outside the ventricles are not fully elucidated. Case presentation We report 3 cases of extraventricular ATTR amyloid deposits confirmed in surgically resected aortic valves and left atrial structures, all of which were unlikely to have significant ATTR amyloidosis infiltrating the ventricles as determined by multimodality evaluation including 99mtechnetium-pyrophosphate scintigraphy, cardiac magnetic resonance, endomyocardial biopsy and their mid-term clinical course up to 5 years. These findings suggested that these were extraventricular ATTR amyloid deposits localized in the aortic valve and the left atrium. Conclusions While long-term observation is required to fully clarify whether these extraventricular ATTR amyloid deposits are truly localized outside the ventricles or are early stages of ATTR-CA infiltrating the ventricles, our 3 cases with multimodality evaluations and mid-term follow up suggest the existence of extraventricular ATTR amyloid deposits localized in the aortic valve and left atrial structures.

Background: Although the dynamic changes of atrial natriuretic peptide (ANP) expressions in a failing heart are well-documented, the clinical implications of detailed measurements of each ANP molecular form processed from proANP remain unclear. Methods: Patients screening was conducted on patients who were eligible for cardiac resynchronization therapy (CRT) between 2014 and 2019 in our institution. Blood samples and echocardiographic parameters were collected on the day before and six months after implantation. Total ANP, proANP, and N-terminal fragment of proANP (NT-proANP) were examined as predictive biomarkers for cardiac death, left ventricular assist device implantation, and heart failure hospitalization following CRT implantation. Results: A total of 86 subjects (mean age 70 years, 64 males) who underwent successful CRT implantation were enrolled. Plasma levels of total ANP, proANP, and NT-proANP were not normally distributed [25.8 pM (interquartile range: 11.1–53.1), 2.2 pM (1.0–5.4), and 4.1 nM (2.4–7.1), respectively]. Over a median follow-up of 2.7 years, 31 patients (2 deaths and 29 heart failure hospitalizations) reached the endpoints. Among the different ANP forms, only NT-proANP emerged as an independent predictor of the composite outcome (adjusted odds ratio of 2.542 in those with levels above vs. below the median, 95 % confidence interval 1.151–5.615, p = 0.021). NT-proANP levels were associated with left atrial volume and left diastolic functional parameters and decreased in response to echocardiographic improvements at six months post-implantation (16 ± 44 % decrease in responders vs 18 ± 60 % increase in non-responders, p = 0.005). Conclusion: Pre-implantation NT-proANP levels could serve as a predictive factor for clinical outcomes in recipients of CRT.

Background: Implantable cardiac monitors (ICMs) help investigate the cause of unexplained syncope, but the probability and predictors of needing a pacing device thereafter remain unclear. Methods: We retrospectively analyzed the data of patients who received ICM insertion for unexplained syncope with suspected arrhythmic etiology. The data were obtained from a nationwide database obtained between April 1, 2012 and March 31, 2020. Multivariable mixed-effects survival analysis was performed to identify predictors of pacing device implantation (PDI), and a risk score model was developed accordingly. Results: In total, 2905 patients (age: 72 years [range: 60-78]) implanted with ICMs to investigate the cause of syncope were analyzed. During the median follow-up period of 128 days (range: 68–209) days, 473 patients (16%) underwent PDI. Older age, history of atrial fibrillation, bundle branch block (BBB), and diabetes were independent predictors of PDI in multivariable analysis. A risk score model was developed with scores ranging from 0 to 32 points. When patients with the lowest quartile score (0–13 points) were used as a reference, those with higher quartiles had a higher risk of PDI (second quartile: 14–15 points, hazard ratio [HR]: 3.86, 95% confidence interval [CI]: 2.62–5.68; third quartile: 16–18 points, HR: 4.67, 95% CI: 3.14–6.94; fourth quartile: 19–32 points, HR: 6.59, 95% CI: 4.47–9.71). Conclusions: The 4 identified predictors are easily assessed during the initial evaluation of patients with syncope. They may help identify patients with a higher risk of requiring permanent PDI. Résumé: Contexte: Les moniteurs cardiaques implantables (MCI) aident à déterminer la cause d’une syncope inexpliquée, mais la probabilité et les facteurs prédictifs du besoin d’un dispositif de stimulation cardiaque par la suite demeurent incertains. Méthodologie: Nous avons analysé de façon rétrospective les données de patients s’étant fait implanter un MCI après une syncope inexpliquée et chez lesquels une étiologie d’arythmie était soupçonnée. Les données proviennent d’une base de données nationale et s’étendent du 1er avril 2012 au 31 mars 2020. Une analyse de survie multivariable à effets mixtes a été effectuée pour cibler les facteurs prédictifs de l’implantation d’un dispositif de stimulation cardiaque (IDSC), et un modèle de score de risque a été conçu en conséquence. Résultats: Au total, les cas de 2905 patients (âge : 72 ans [écart interquartile (ÉI) : 60-78]) ayant reçu un MCI pour déterminer la cause de la syncope ont été analysés. Durant la période de suivi médiane de 128 jours (ÉI : 68-209), 473 patients (16 %) ont subi une IDSC. L’âge avancé, les antécédents de fibrillation auriculaire, le bloc de branche et le diabète étaient des facteurs prédictifs indépendants de l’IDSC dans l’analyse multivariable. Un modèle de score de risque a été conçu, les scores allant de 0 à 32 points. Lorsque les patients ayant un score dans le quartile inférieur (0 à 13 points) étaient utilisés à titre de référence, ceux ayant un score dans les quartiles supérieurs avaient un risque plus élevé d’IDSC (deuxième quartile : 14-15 points, rapport des risques instantanés [RRI] : 3,86, intervalle de confiance [IC] à 95 % de 2,62 à 5,68; troisième quartile : 16-18 points, RRI : 4,67, IC à 95 % de 3,14 à 6,94; quatrième quartile : 19-32 points, RRI : 6,59, IC à 95 % de 4,47 à 9,71). Conclusions: Les quatre facteurs prédictifs ciblés sont faciles à évaluer durant l’évaluation initiale des patients ayant subi une syncope. Ils peuvent aider à repérer les patients présentant un risque plus élevé d’avoir besoin d’un dispositif de stimulation cardiaque permanent.

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 real‐world settings. During the year 2020, we have collected a total of 84 591 procedures (mean age of 65.8 years and 66.6% male) from 466 participant hospitals. Detailed data were shown in Figures and Tables.

Abstract In asymptomatic patients with mitral regurgitation (MR), data of exercise-induced pulmonary hypertension (EIPH) are limited, and feasibility of evaluating EIPH is not high. We aimed to investigate prognostic impact of EIPH and its substitute parameters. Exercise stress echocardiography (ESE) were performed in 123 consecutive patients with moderate to severe degenerative MR. The endpoint was a composite of death, hospitalization for heart failure, and worsening of symptoms. EIPH [tricuspid regurgitation peak gradient (TRPG) at peak workload ≥ 50 mmHg] was shown in 57 patients (46%). TRPG at low workload was independently associated with TRPG at peak workload (β = 0.67, p

Abstract Aims The aim of the Mid‐Q Response study is to test the hypothesis that adaptive preferential left ventricular‐only pacing with the AdaptivCRT algorithm has superior clinical outcomes compared to conventional cardiac resynchronization therapy (CRT) in heart failure (HF) patients with moderately wide QRS duration (≥120 ms and

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 Aims The HINODE study aimed to analyse rates of mortality, appropriately treated ventricular arrhythmias (VA), and heart failure in Japanese patients and compared with those in Western patients. Methods and results After treatment decisions following contemporary practice in Japan, patients were prospectively enrolled into four cohorts: (i) internal cardioverter‐defibrillator (ICD), (ii) cardiac resynchronization therapy (CRT) defibrillator (CRT‐D), (iii) standard medical therapy (‘non‐device’: ND), or (iv) pacing (indicated for CRT; received pacemaker or CRT pacing). Cohorts 1–3 required a left ventricular ejection fraction ≤35%, a history of heart failure, and a need for primary prevention of sudden cardiac death based on two to five previously identified risk factors. Endpoint outcomes were adjudicated by the independent committees. ICD and CRT‐D cohorts, considered as high‐voltage (HV) cohorts, were pooled for Kaplan–Meier analysis and propensity‐matched to Multicenter Automatic Defibrillator Implantation Trial‐Reduce Inappropriate Therapy (MADIT‐RIT) arm B and C patients. The study enrolled 354 patients followed for 19.6 ± 6.5 months, with a minimum of 12 months. Propensity‐matched HV cohorts showed comparable VA (P = 0.61) and mortality rates (P = 0.29) for HINODE and MADIT‐RIT. The ND cohort presented a high crossover rate to ICD therapy (6.1%, n = 7/115), and the CRT‐D cohort showed elevated mortality rates. The pacing cohort revealed that patients implanted with pacemakers had higher mortality (26.0%) than those with CRT‐Pacing (8.4%, P = 0.05). Conclusions The mortality and VA event rates of landmark trials are applicable to patients with primary prevention in Japan. Patients who did not receive guideline‐indicated CRT devices had poor outcomes.

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.

Background: Few large-scale, real-world studies have compared the efficacy and safety of non-antivitamin K anticoagulants (NOACs) with that of warfarin in catheter ablation (CA) for atrial fibrillation (AF). Methods: This retrospective, cross-sectional study used a nationwide administrative claims database, to compare complication-incidence rates following CA for AF between NOAC-treated patients and warfarin-treated matched cohorts in the real-world. Among the 32,797,540 records between June 2011 and August 2020 from 426 hospitals, 41,347 patients (38,065 on NOACs and 3,282 on Warfarin) were considered eligible. After performing propensity matching, 6,564 patients (3,282 per group) were analyzed. Results: The overall complication incidence was significantly lower in the NOACs group than in the warfarin group (2.3 % vs. 4.0 %; P

Objectives To identify differences in patient characteristics, clinical practice and outcomes of cardiac implantable electronic device (CIED) therapy between Japan and the USA.Design A cross-sectional study.Setting Nationally representative administrative databases from Japan and the USA containing hospitalisations with first-time implantations of pacemakers, implantable cardioverter-defibrillators (ICD) and cardiac-resynchronisation therapy with or without defibrillators (CRTP/CRTD).Participants Patients hospitalised with first-time implantations of CIEDs.Outcome measures In-hospital mortality, in-hospital complication and 30-day readmission rates.Results Overall, 107 339 (median age 78 (71–84), 48 415 women) and 295 584 (age 76 (67–83), 127 349 women) records with CIED implantations were included from Japan and the USA, respectively. Proportion of women in defibrillator recipients was lower in Japan than in the USA (ICD, 21% vs 28%, p

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 Despite distinct pathophysiology, arrhythmogenic right ventricular cardiomyopathy (ARVC) and Brugada syndrome (BrS) exhibit overlapping phenotypes. We investigated the prevalence and characteristics of the Brugada electrocardiogram (ECG) pattern in ARVC patients. Methods A total of 114 ARVC patients fulfilling the revised Task Force Criteria were enrolled. The Brugada ECG pattern was evaluated according to the consensus report on right precordial leads, and 1141 ECGs (median, 1; interquartile range, 1‐16 ECGs/patient) were analyzed. Results Five patients (4%) showed a Brugada ECG pattern, which disappeared in four patients with ECGs recorded more than 2 years afterward. ARVC patients with the Brugada ECG pattern had a longer PQ interval (220 ± 62 ms vs 180 ± 35 ms, P = .02) and longer QRS duration (138 ± 25 ms vs 102 ± 23 ms, P

Abstract Background Higher baseline uric acid (UA) was significantly associated with higher atrial fibrillation (AF) incidence in Japanese women. However, no prospective study is evident in the association between UA and incident AF in Japanese urban residents. Methods A total of 6863 participants (aged 30‐79 years; 47% men) without prior AF were followed for 13.9 years on average in the Suita Study. According to the UA categories, cox proportional hazards regression models were used to estimating the Hazard Ratios (HRs) and 95% confidence intervals (CIs) for incident AF. Results During 95178 person‐years of follow‐up, we observed 311 cases of incident AF (204 cases in men and 107 cases in women). Compared to the subjects with UA of 4.0‐4.9 mg/dL, multivariable‐adjusted HR (95% CIs) of incident AF was 1.50 (1.01‐2.25) (P = .047) for the subjects with UA ≥7.0 mg/dL. Conclusion High UA was associated with an increased risk for incident AF in the Japanese population.

Abstract Aims The number of patients with both chronic obstructive pulmonary disease (COPD) and heart failure (HF) is increasing in Asia, and these conditions often coexist. We previously revealed a tendency of beta‐blocker underuse among patients with HF with reduced ejection fraction (HFrEF) and COPD in Asian countries other than Japan. Here, we evaluated the impact of cardio‐selective beta‐blocker use on the long‐term outcomes of patients with HF and COPD. Methods and results Among the 5232 patients with HFrEF (left ventricular ejection fraction of

Abstract Various forms of supraventricular tachycardia (SVT) occur in patients with severe pulmonary hypertension (PH). Despite the high efficacy of radiofrequency catheter ablation (RFCA) for SVT, insufficient data exist regarding patients with PH. Thirty SVTs in 23 PH patients (age 47 [35–60] years; mean pulmonary artery pressure 44 [32–50] mmHg) were analyzed. Procedural success rate, short- and long-term clinical outcomes, were evaluated during a median follow-up of 5.1 years. Single-procedure success rate was 83%; 94% (17/18) in typical atrial flutter, 73% (8/11) in atrial tachycardia (AT), and 100% (1/1) in atrioventricular nodal reentrant tachycardia. Antiarrhythmic drugs, serum brain natriuretic peptide levels and number of hospitalizations significantly decreased after RFCA than that before (p = 0.002, 0.04, and 0.002, respectively). Four patients had several procedures. After last RFCA, 12 patients had SVT and 8 patients died. Kaplan–Meier curves showed that patients with SVT after the last RFCA had a lower survival rate compared to those without (p = 0.0297). Multivariate analysis identified any SVT after the last RFCA as significant risk factor of mortality (hazard ratio: 9.31; p = 0.016). RFCA for SVT in patients with PH is feasible and effective in the short-term, but SVT is common during long-term follow-up and associated with lower survival.

Abstract Cardiac accessory pathways (APs) in Wolff–Parkinson–White (WPW) syndrome are conventionally diagnosed with decision tree algorithms; however, there are problems with clinical usage. We assessed the efficacy of the artificial intelligence model using electrocardiography (ECG) and chest X-rays to identify the location of APs. We retrospectively used ECG and chest X-rays to analyse 206 patients with WPW syndrome. Each AP location was defined by an electrophysiological study and divided into four classifications. We developed a deep learning model to classify AP locations and compared the accuracy with that of conventional algorithms. Moreover, 1519 chest X-ray samples from other datasets were used for prior learning, and the combined chest X-ray image and ECG data were put into the previous model to evaluate whether the accuracy improved. The convolutional neural network (CNN) model using ECG data was significantly more accurate than the conventional tree algorithm. In the multimodal model, which implemented input from the combined ECG and chest X-ray data, the accuracy was significantly improved. Deep learning with a combination of ECG and chest X-ray data could effectively identify the AP location, which may be a novel deep learning model for a multimodal model.

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 Aims Response to cardiac resynchronization therapy (CRT) is known to be associated with a number of clinical characteristics, including QRS duration and morphology, gender, height, and the aetiology of heart failure (HF). We assessed the relation of gender and baseline characteristics with QRS duration and Kansas City Cardiomyopathy Questionnaire. Methods and results AdaptResponse is a global randomized trial. The trial enrolled CRT‐indicated patients with New York Heart Association classes II–IV HF, left bundle branch block (QRS ≥ 140 ms in men, ≥130 ms in women), and baseline PR interval ≤200 ms. In total, 3620 patients were randomized, including 1569 women (43.3%) approaching the actual proportion of women in the HF population. Women were older and more often New York Heart Association class III or IV than men (55.6% vs. 48.7%), had less frequent ischaemic cardiomyopathy (21.2% vs. 39.5%), and had a 5.1 ms shorter QRS duration than men. Women were more often depressed (18.5% vs. 9.7%), had a significantly lower Kansas City Cardiomyopathy Questionnaire score, and had differences in medication prescriptions. Conclusions AdaptResponse is the largest randomized CRT trial and enrolled more women than any other landmark CRT trial. Women differed from men with regard to baseline characteristics and quality of life. Whether these differences translate into clinical outcome differences will be examined further in the AdaptResponse trial.

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 Background Catheter ablation of atrial fibrillation (AF) is increasingly performed worldwide in patients with heart failure (HF). However, it has been recently emphasized that AF ablation in patients with HF is associated with increased risks of procedure‐related complications and mortality. There are little data about the differences in the efficacy and safety between cryoballoon (CB) and radiofrequency (RF) ablation of AF in patients with HF. Methods The CRABL‐HF study is designed as a prospective, multicenter, open‐label, controlled, and randomized clinical trial comparing the efficacy and safety of AF ablation between CB and RF ablation in patients with HF (LVEF ≤40%) (UMIN Clinical Trials Registry UMIN000032433). The CRABL‐HF study will consist of 110 patients at multicenter in Japan. The patients will be registered and randomly assigned to either the CB ablation or RF ablation group with a 1:1 allocation. The primary endpoint of this study is the occurrence of atrial tachyarrhythmias (ATs) at 1 year with a blanking period of 90 days after ablation. Key secondary endpoints are the success rate of the pulmonary vein isolation, total procedural time, left atrial dwelling time, total fluoroscopy time, radiation exposure, complication rate, composite of all‐cause mortality or HF hospitalizations, cardiovascular events, change in left ventricular ejection fraction, and change in quality of life. Results The results of this study are currently under investigation. Conclusion The CRABL‐HF study is being conducted to compare the efficacy and safety of catheter ablation of AF between CB and RF ablation in patients with HF.

Abstract Background Periprocedural myocardial injury (pMI) is a common complication of elective percutaneous coronary intervention (PCI) that reduces some of the beneficial effects of coronary revascularization and impacts the risk of cardiovascular events. We developed a 3-dimensional volumetric cardiovascular magnetic resonance (CMR) method to evaluate coronary high intensity plaques and investigated their association with pMI after elective PCI. Methods Between October 2012 and October 2016, 141 patients with stable coronary artery disease underwent T1-weighted CMR imaging before PCI. A conventional 2-dimensional CMR plaque-to-myocardial signal intensity ratio (2D-PMR) and the newly developed 3-dimensional integral of PMR (3Di-PMR) were measured. 3Di-PMR was determined as the sum of PMRs above a threshold of > 1.0 for voxels in a target plaque. pMI was defined as high-sensitivity cardiac troponin T > 0.07 ng/mL. Results pMI following PCI was observed in 46 patients (33%). 3Di-PMR was significantly higher in patients with pMI than those without pMI. The optimal 3Di-PMR cutoff value for predicting pMI was 51 PMR*mm3 and the area under the receiver operating characteristic curve (0.753) was significantly greater than that for 2D-PMR (0.683, P = 0.015). 3Di-PMR was positively correlated with lipid volume (r = 0.449, P

A 48-year-old man who was diagnosed with arrhythmogenic right ventricular cardiomyopathy (ARVC) due to a plakophilin 2 gene mutation developed acute both-sided heart failure with rapid atrial fibrillation and was hospitalized. After admission, sustained ventricular tachycardia, which was refractory to antiarrhythmic agents, occurred repeatedly, and required electrical cardioversion. He was diagnosed with thyroid storm due to Graves’ disease, and treatment for hyperthyroidism was initiated. After the treatment, lethal arrhythmia did not reoccur, and biventricular heart failure ameliorated. To our best knowledge, this is the first report in English of a patient with ARVC showing refractory arrhythmia induced by thyroid storm due to Graves’ disease.

Background Aging is one of the major concerns and determinants of the indications for catheter ablation (CA) for atrial fibrillation. This study aimed to assess the safety of CA in older patients with atrial fibrillation undergoing CA. Methods and Results The JROAD‐DPC (Japanese Registry of All Cardiac and Vascular Diseases‐Diagnosis Procedure Combination) is a nationwide claims database using data from the Japanese Diagnosis Procedure Combination/Per Diem Payment System. Among 6 632 484 records found between April 2012 and March 2018 from 1058 hospitals, 135 299 patients with atrial fibrillation (aged 65±10 years, 38 952 women) who underwent CA in 456 hospitals were studied and divided into the following age groups: