Oral anticoagulation after atrial fibrillation catheter ablation: benefits and risks.

BACKGROUND AND AIMS: Few recent large-scale studies have evaluated the risks and benefits of continuing oral anticoagulant (OAC) therapy after catheter ablation (CA) for atrial fibrillation (AF). This study evaluated the status of continuation of OAC therapy and the association between continuation of OAC therapy and thromboembolic and bleeding events according to the CHADS2 score. METHODS: This retrospective study included data from the Japanese nationwide administrative claims database of patients who underwent CA for AF between April 2014 and March 2021. Patients without AF recurrence assessed by administrative data of the treatment modalities were divided into two groups according to continuation of OAC therapy 6 months after the index CA. The primary outcomes were thromboembolism and major bleeding after a landmark period of 6 months. After inverse probability of treatment weighting analysis, the association between OAC continuation and outcomes was determined according to the CHADS2 score. RESULTS: Among 231 374 patients included, 69.7%, 21.6%, and 8.7% had CHADS2 scores of ≤1, 2, and ≥3, respectively. Of these, 71% continued OAC therapy at 6 months. The OAC continuation rate was higher in the high CHADS2 score group than that in the low CHADS2 score group. Among all patients, 2451 patients (0.55 per 100 person-years) had thromboembolism and 2367 (0.53 per 100 person-years) had major bleeding. In the CHADS2 score ≤1 group, the hazard ratio of the continued OAC group was 0.86 [95% confidence interval (CI): 0.74-1.01, P = .06] for thromboembolism and was 1.51 (95% CI: 1.27-1.80, P < .001) for major bleeding. In the CHADS2 score ≥3 group, the hazard ratio of the continued OAC group was 0.61 (95% CI: 0.46-0.82, P = .001) for thromboembolism and was 1.05 (95% CI: 0.71-1.56, P = 0.81) for major bleeding. CONCLUSIONS: This observational study suggests that the benefits and risks of continuing OAC therapy after CA for AF differ based on the patient's CHADS2 score. The risk of major bleeding due to OAC continuation seems to outweigh the risk reduction of thromboembolism in patients with lower thromboembolic risk.

Structural characteristics of patients with superior vena cava foci initiating atrial fibrillation: Analysis with electrocardiogram-triggered computed tomography.

INTRODUCTION: The superior vena cava (SVC) is the most common source of non-pulmonary vein foci in atrial fibrillation (AF); therefore, predicting the existence of non-pulmonary vein foci before the catheter ablation procedure helps construct a proper ablation strategy in preparation for SVC isolation. This study aimed to clarify the structural characteristics of patients with SVC foci initiating AF. METHODS: We enrolled 331 consecutive patients with AF who underwent cardiac computed tomography imaging before radiofrequency catheter ablation treatment, and they were divided into SVC (+) and (-) groups based on the presence or absence of SVC foci initiating AF. RESULTS: The SVC (+) group (n = 27) exhibited SVC crescent signs-defined as a curve-shaped SVC with two narrow pointed ends-more frequently (37% vs. 9%, p < .001), and larger right atrial volume (95.6 ± 20.8 vs. 80.5 ± 26.1 mL, p = .004) than the SVC (-) group (n = 304). Multivariate logistic regression analysis revealed that the SVC crescent sign (odds ratio, 8.88; 95% confidence interval [CI], 3.21-24.60) and right atrial volume (odds ratio, 1.03; 95% CI, 1.01-1.04) were independent predictors of SVC foci. CONCLUSION: Patients with SVC foci exhibited more frequent SVC crescent signs and larger right atrial volumes, and these characteristics may help clinicians choose the appropriate ablation technology.

Transvenous lead extraction versus surgical lead extraction or conservative treatment for cardiac implantable electronic device infections: Propensity score-weighted analyses of a nationwide claim-based database.

INTRODUCTION: Infection is one of the most important complications associated with cardiac implantable electronic device (CIED) therapy. The number of reports comparing the outcomes of transvenous lead extraction (TLE), surgical lead extraction, and conservative treatment for CIED infections using a real-world database is limited. This study investigated the association between the treatment strategies for CIED infections and their outcomes. METHODS: We performed a retrospective analysis of 3605 patients with CIED infections admitted to 681 hospitals using a nationwide claim-based database collected between April 2012 and March 2018. RESULTS: We divided the 3605 patients into TLE (n = 938 [26%]), surgical lead extraction (n = 182 [5.0%]), and conservative treatment (n = 2485 [69%]) groups. TLE was performed more frequently in younger patients and at larger hospitals (p for trend < .001 for both). The rate of TLE increased during the study period, whereas that of surgical lead extraction decreased (p for trend < .001 for both). TLE was associated with lower in-hospital mortality (vs. surgical lead extraction: odds ratio [OR], 0.20; 95% CI, 0.06-0.70; vs. conservative treatment: OR, 0.45; 95% CI: 0.22-0.94) and lower 30-day readmission rates (vs. surgical lead extraction: OR, 0.18; 95% CI: 0.06-0.56; vs. conservative treatment: OR, 0.06; 95% CI, 0.03-0.13) in propensity score-weighted analyses. CONCLUSIONS: Only 26% of patients hospitalized for CIED infections received TLE. TLE was associated with significantly lower in-hospital mortality and 30-day recurrence rates than surgical lead extraction and conservative treatment, suggesting that TLE should be more widely recommended as a first-line treatment for CIED infections.

Current status of real-world big data research in the cardiovascular field in Japan.

Real-world data (RWD) are observational data obtained by collecting, structuring, and accumulating patient information among the medical big data. RWD are derived from a variety of patient medical care and health information outside of conventional research data, and include electronic health records, claims data, registry data of disease, drug and device, health check-up data, and more recently, patient information data from wearable devices. They are currently being utilized in various forms for optimal medical care and real-world evidence (RWE) is constructed through a process of hypothesis generation and verification based on the RWD research. Together with classic clinical research and pragmatic trials, RWE shapes the learning healthcare system and contributes to the improvement of medical care. In the cardiovascular medical care of the current super-aged society, the need for a variety of RWE and the research is increasing, since the guidelines established over time and the medical care based on it cannot necessarily be the best in accordance with the current medical situation. In this review, we focus on the RWD and RWE studies in the cardiovascular medical field and outlines their current status in Japan. Furthermore, we discuss the potential for extending the studies and issues related to the use of medical big data and RWD.

Impact of Low Body Mass Index on Cardiac Tamponade During Catheter Ablation for Atrial Fibrillation.

BACKGROUND: Cardiac tamponade is a potentially fatal complication of catheter ablation for atrial fibrillation (AF). OBJECTIVES: This study aimed to evaluate the impact of body mass index (BMI) on cardiac tamponade during AF ablation. METHODS: Patients who underwent catheter ablation for AF between April 1, 2016 and March 31, 2018 were analyzed using a Japanese nationwide claims database. Mixed-effects multivariable Poisson regression analysis was performed to investigate the association between BMI and cardiac tamponade. RESULTS: A total of 59,789 hospitalizations (age 65.6 ± 10.4 years, 29% women) with catheter ablation for AF were analyzed. Cardiac tamponade occurred in 647 patients (1.1%). Multivariable analysis revealed that being underweight (BMI <18.5 kg/m2) was associated with an increased risk of cardiac tamponade (relative risk [RR]: 1.42; 95% CI: 1.03-1.95) when compared with having a normal weight (BMI ≥18.5 and <25 kg/m2). Other characteristics that were associated with an increased risk of cardiac tamponade were age ≥75 years, female sex, and a history of heart failure, hypertension, diabetes, and dialysis treatment. CONCLUSIONS: In this analysis of a large nationwide database of patients with AF who underwent ablation, being underweight was independently associated with an increased risk of cardiac tamponade during AF ablation. Clinicians should consider the higher risk of cardiac tamponade in the underweight population and take appropriate measures to reduce this risk.

The Japanese Catheter Ablation Registry (J-AB): Annual report in 2021.

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.

Differences in patient characteristics, clinical practice and outcomes of cardiac implantable electric device therapy between Japan and the USA: a cross-sectional study using data from nationally representative administrative databases.

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<0.001; CRTD, 24% vs 29%, p<0.001). Length of stay after CIED implantation was longer in Japan than in the USA for all device types (conventional pacemaker, 8(7-11) vs 1 (1-3) days, p<0.001; leadless pacemaker, 5 (3-9) vs 2 (1-5) days, p<0.001; ICD, 8 (7-11) vs 1 (1-3) days, p<0.001, CRTP, 9 (7-13) vs 2 (1-4) days, p<0.001; CRTD, 9 (8-14) vs 2 (1-4) days, p<0.001). In-hospital mortality after CIED implantation was similar between Japan and the USA ((OR) (95% CI), conventional pacemaker 0.58 (0.83 to 1.004); ICD 0.77 (0.57 to 1.03); CRTP 0.85 (0.51 to 1.44); CRTD 1.11 (0.81 to 1.51)), except that after leadless pacemaker implantation in Japan was lower than that in the USA (0.32 (0.23 to 0.43)). 30-day readmission rates were lower in Japan than in the USA for all device types (conventional pacemaker 0.55 (0.53 to 0.57); leadless pacemaker 0.50 (0.43 to 0.58); ICD 0.54 (0.49 to 0.58); CRTP 0.51 (0.42 to 0.62); CRTD 0.57 (0.51 to 0.64)). CONCLUSIONS: International variations in patient characteristics, practice and outcomes were observed. In-hospital mortality after CIED implantation was similar between Japan and the USA, except in cases of leadless pacemaker recipients.

Clinical Predictors of Pacing Device Implantation in Implantable Cardiac Monitor Recipients for Unexplained Syncope.

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.

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.

Mortality and 30-Day Readmission Rates After Inpatient Leadless Pacemaker Implantation: Insights From a Nationwide Readmissions Database.

BACKGROUND: This study aimed to provide real-world data on the rates, trends, and predictors of in-hospital complications and 30-day readmission following leadless pacemaker (LP) implantation. METHODS: We analysed leadless and conventional pacemaker implantations with the use of the all-payer, nationally representative Nationwide Readmissions Database from 2017 to 2019. The national trends of in-hospital mortality, in-hospital complications, and 30-day readmission rates after pacemaker implantation were analysed. Mixed-effects multivariable logistic regression analysis was performed to identify factors associated with in-hospital death and 30-day readmission in LP patients. RESULTS: A total of 137,732 admissions (age 78 years, IQR 70-85 years, 5986 LP implantations) were analysed. The in-hospital mortality, overall in-hospital complication, and 30-day readmission rates after LP implantations were 5.0%, 16%, and 16%, respectively. In LP recipients, the national estimate of in-hospital mortality declined from 10.9% in the second quarter of 2017 to 4.3% in the fourth quarter of 2019 (P < 0.001). Furthermore, the national estimate of overall complications declined from 20.6% in the second quarter of 2017 to 13.0% in the fourth quarter of 2019 (P < 0.001). In LP recipients, female sex, history of chronic kidney disease, heart failure, and malnutrition were factors associated with in-hospital death. CONCLUSIONS: Analysis of the nationally representative claims database from the United States showed in-hospital mortality and complication rates (for LP implantation performed during hospitalisation) of 5.0% and 16%, respectively. Although these rates showed a decreasing trend over time, ongoing surveillance is needed for the safety of LP implantation.

The Japanese Catheter Ablation Registry (J-AB): Annual report in 2020.

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.

Current clinical practice of subcutaneous implantable cardioverter-defibrillator: Analysis using the JROAD-DPC database.

BACKGROUND: Current evidence describing the characteristics of subcutaneous implantable cardioverter-defibrillator (S-ICD) therapy, its trend, and perioperative outcomes compared with transvenous implantable cardioverter-defibrillator (TV-ICD) based on a real-world, large-scale database is scarce. OBJECTIVE: The purpose of this study was to identify the characteristics of current S-ICD therapy using a nationwide database. METHODS: A retrospective analysis of ICD implantation was performed using a nationwide database obtained between 2016 and 2020. A total of 8690 patients implanted with ICD (median age 65 [52-72] year; 6902 men; 2021 S-ICD recipients) were analyzed. RESULTS: Younger patients were more prone to have S-ICD (P <.001). A history of ventricular fibrillation (VF) (odds ratio [OR] 2.45; 95% confidence interval [CI] 2.04-2.93), nonsustained ventricular tachycardia (VT) (OR 1.73; 95% CI 1.36-2.21), Brugada syndrome (BrS) (OR 3.14; 95% CI 2.48-4.00), and dialysis treatment (OR 2.02; 95% CI 1.44-2.82) were independent predictors of S-ICD selection on mixed-model logistic analysis. The proportion of S-ICD implantations has been increasing (P <.001), especially in patients with BrS (P <.001) and dialysis (P = .04). The proportion of combined complications after S-ICD implantation was low (1.3%) in the unmatched cohort and was comparable to TV-ICD in the 1:1 propensity-matched cohort of 3354 patients (1.5% vs 2.3%; OR 0.65; 95% CI 0.38-1.10). CONCLUSION: S-ICD was more likely to be implanted in younger patients and those with a history of VF, nonsustained VT, BrS, and dialysis treatment. The proportion of S-ICD implantation increased, especially in patients with BrS. The incidence of in-hospital complications was low in S-ICD recipients.

T2-weighted short-tau-inversion-recovery imaging reflects disease activity of cardiac sarcoidosis.

OBJECTIVE: We investigated the diagnostic performance of semi-quantitative hyperintensity on T2-weighted short-tau-inversion-recovery black-blood (T2W-STIR-BB) images in identifying active cardiac sarcoidosis (CS) in patients, and compared it with that of 18F-fluoro-2-deoxyglucose positron emission tomography (FDG-PET). METHODS: This retrospective study included 40 steroid-naive patients (age 63.1±12.9 years, 20 men) diagnosed with CS who underwent both cardiac MRI and FDG-PET imaging. Active CS cases were defined as satisfying at least one of the following criteria for conventional indices: exacerbation of ventricular arrhythmia, newly identified advanced atrioventricular block, greater than 5% decrease in left ventricular ejection fraction on echocardiography, positive finding on gallium-scintigraphy or elevated levels of sarcoidosis-related serum biomarkers. T2W-STIR-BB images were semi-quantitatively analysed using a myocardium-to-spleen ratio (MSR). The diagnostic performance of T2W-STIR-BB and FDG-PET imaging for detecting active CS was investigated. RESULTS: Thirty-three patients satisfied at least one criterion and were considered as having active CS. Thirty patients (75%) tested positive with T2W-STIR-BB imaging, and 25 patients (63%) tested positive with FDG-PET. The sensitivity, specificity, accuracy, and positive and negative predictive values for identifying active CS by semi-quantitative MSR on T2W-STIR-BB images were 79%, 43%, 73%, 87% and 30%, respectively. These results were statistically comparable to those of FDG-PET (70%, 71%, 70%, 92% and 33%, respectively). CONCLUSIONS: When using conventional diagnostic indices for active CS as the gold standard, T2W-STIR-BB imaging demonstrated comparable diagnostic performance to that of FDG-PET. The semi-quantitative analysis of high signal intensity on T2W-STIR-BB images using MSR was useful for detection of active CS.

Coughing as a potentially effective induction method of atrial tachycardia: a case report.

BACKGROUND: Cough-induced atrial tachycardia (AT) is extremely rare and its electrical origin remains largely unknown. Atrial tachycardias triggered by pharyngeal stimulation, such as swallowing or speech, appears to be more common and the majority of them originate from the superior vena cava or right superior pulmonary vein (PV). Only one case of swallow-triggered AT with right inferior pulmonary vein (RIPV) origin has been reported to date. CASE SUMMARY: We present a case of a 41-year-old man with recurring episodes of AT in the daytime. He underwent electrophysiology study without sedation. Atrial tachycardia was not observed when the patient entered the examination room and could not be induced with conventional induction procedures. By having the patient cough periodically on purpose, transient AT with P-wave morphology similar to the clinical AT was consistently induced. Activation mapping of the AT revealed a centrifugal pattern with the earliest activity localized inside the RIPV. After successful radiofrequency isolation of the right PV, AT was no longer inducible. DISCUSSION: In the rare case of cough-induced AT originating from the RIPV, the proximity of the inferior right ganglionated plexi (GP) suggests the role of GP in triggering tachycardia. This is the first report that demonstrates voluntary cough was used to induce AT. In such cases that induction of AT is difficult using conventional methods, having the patient cough may be an effective induction method that is easy to attempt.