Multicenter prospective observational study to clarify the current status and clinical outcome in Japanese patients who have an indication for implantable cardioverter defibrillator (ICD) or wearable cardioverter defibrillator (WCD) (TRANSITION JAPAN-ICD/WCD study): Rationale and design of a prospective, multicenter, observational, comparative study.

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.

Incidence and predictors of persistent iatrogenic atrial septal defect following catheter ablation.

BACKGROUND: The left atrium approach for atrial fibrillation (AF) ablation requires an atrial transseptal puncture that may cause an iatrogenic atrial septal defect (iASD). This study aimed to investigate the incidence and predictors of iASD in catheter ablation, assessed by transthoracic echocardiography (TTE), a relatively non-invasive technique frequently employed in follow-up. METHODS: This retrospective study included 639 patients (489 male; 60.2±10.7years) who underwent initial catheter ablation for AF between May 2005 and June 2018. All patients underwent preprocedural transesophageal echocardiography (pre-TEE), preprocedural TTE (pre-TTE), and TTE one day after the procedure (post-TTE). iASD incidence after 6months (6M), preprocedural characteristics, and procedure methods were evaluated. RESULTS: Patent foramen ovale (PFO) was diagnosed in 42 patients (6.6%) using pre-TEE and in 11 patients using pre-TTE (26.2% of the patients with PFO in pre-TEE). Among the 597 patients without PFO, 497 underwent 6M-TTE. iASD was observed in 59.6% of patients using post-TTE and 4.6% using 6M-TTE. In the univariate logistic regression analysis, the total diameter of the sheath through the septum (odds ratio 1.15, p<0.001) or two sheaths through a single puncture (odds ratio 4.17, p=0.001) were independent risk factors on iASD incidence in 6M-TTE. iASD was also more likely to occur via cryoballoon ablation using a larger sheath than radiofrequency catheter ablation. CONCLUSIONS: iASD was not a rare complication. A larger sheath diameter or two sheaths through a single puncture were associated with the incidence of iASD.

Simple risk scoring using sinus rhythm electrocardiograms predicts the incidence of atrial fibrillation in the general population.

Atrial fibrillation (AF) is an arrhythmic disease. Prediction of AF development in healthy individuals is important before serious complications occur. We aimed to develop a risk prediction score for future AF using participants' data, including electrocardiogram (ECG) measurements and information such as age and sex. We included 88,907 Japanese participants, aged 30-69 years, who were randomly assigned to derivation and validation cohorts in a ratio of 1:1. We performed multivariate logistic regression analysis and obtained the standardised beta coefficient of relevant factors and assigned scores to them. We created a score based on prognostic factors for AF to predict its occurrence after five years and applied it to validation cohorts to assess its reproducibility. The risk score ranged from 0 to 17, consisting of age, sex, PR prolongation, QT corrected for heart rate prolongation, left ventricular hypertrophy, premature atrial contraction, and left axis deviation. The area under the curve was 0.75 for the derivation cohort and 0.73 for the validation cohort. The incidence of new-onset AF reached over 2% at 10 points of the risk score in both cohorts. Thus, in this study, we showed the possibility of predicting new-onset AF using ECG findings and simple information.

Cardio-Ankle Vascular Index and Left Atrial Reverse Remodeling After Ablation for Atrial Fibrillation.

Arterial stiffness has been reported to cause left atrial (LA) remodeling due to increased left ventricular filling pressure, resulting in atrial fibrillation (AF). This study aimed to evaluate the association between LA reverse remodeling (LARR) after AF ablation and cardio-ankle vascular index (CAVI), an indicator of arterial stiffness.This study included 333 patients with AF (171 with paroxysmal AF and 162 with nonparoxysmal AF) and LA enlargement (LA volume index ≥ 34 mL/m2) who underwent AF ablation between December 2008 and July 2021. CAVI was evaluated preoperatively during AF (n = 155, 46.5%) or sinus rhythm (n = 178, 53.5%). Participants were divided into groups with LARR (n = 133, 39.9%) and without LARR (n = 200, 60.1%) according to whether the degree of decrease in LA volume index on transthoracic echocardiography 6 months after ablation was ≥ 15% or < 15%, respectively.Sinus rhythm was maintained in 168 (50.5%) patients within 3-6 months after the index procedure. Univariate analysis revealed that preoperative CAVI (7.80 ± 1.22 versus 8.57 ± 1.09, P < 0.001) was significantly lower, and the maintenance of sinus rhythm (61.6% versus 43.0%, P = 0.0011) was higher in the group with LARR. Multivariate logistic regression analysis revealed that preoperative CAVI was independently associated with LARR (odds ratio, 0.60, 95% confidence interval, 0.46-0.78, P < 0.001).In patients with AF and LA enlargement, CAVI is independently associated with LA reverse remodeling after catheter ablation.

Decrease in red cell distribution width as a useful predictor of success after catheter ablation for atrial fibrillation: a retrospective multi-center study.

Red cell distribution width (RDW) is reportedly associated with cardiovascular events, including atrial fibrillation (AF). We investigated whether the RDW values were associated with the outcomes of catheter ablation for AF. This retrospective multicenter study included 501 patients with AF (239 paroxysmal AF cases, 196 persistent AF cases, and 66 long-standing persistent AF cases) who underwent initial AF ablation between March 2017 and May 2018. The RDW values were evaluated before and at 1-3 months after the procedure. The patients were stratified based on the recurrence of AF within 1 year after the index procedure with a blanking period of 3 months into recurrence group (107 patients, 21.4%) and no-recurrence group (394 patients, 78.6%). There were no significant differences in preoperative RDW values between the groups (p = 0.37). The RDW value did not change significantly after the ablation in the recurrence group (13.55-13.60%, p = 0.37), although it decreased significantly in the no-recurrence group (13.64-13.37%, p < 0.001). Multivariate Cox proportional hazards regression analyses revealed that a postoperative change in RDW (ΔRDW) was independently associated with AF recurrence (hazard ratio 2.00, 95% confidence interval 1.42-2.76, p < 0.001). Receiver operating characteristic curve analysis revealed that a ΔRDW cut-off value of - 0.1% provided a c-statistic of 0.65 for predicting AF recurrence. Decrease in RDW during the blanking period after ablation independently predicted the 1-year success of AF ablation.

Post-ablation left atrial function impacts long-term recurrence of atrial fibrillation after ablation.

Left atrial (LA) function can help predict various cardiovascular events. Catheter ablation for atrial fibrillation (AF) modifies baseline LA function through the maintenance of sinus rhythm and myocardial injury. We investigated the impact of post-ablation LA function on recurrence of AF after ablation and identified the predictors of reduced post-ablation LA function. A total of 616 patients who underwent AF ablation (paroxysmal, N = 310; non-paroxysmal, N = 306) were retrospectively examined with cardiac computed tomography at baseline and 3 months after the final ablation procedure. Post-ablation LA emptying fraction (LAEFpost) was calculated. We evaluated the association between LAEFpost and recurrence of AF after the final ablation procedure. Further, we assessed the predictors of reduced LAEFpost. The recurrence rate of AF was 72.7% after the final ablation procedure [median follow-up 48 months (48.0, 48.0), total number of ablation sessions: 1.4 ± 0.7]. Multivariate analysis revealed that LAEFpost was associated with the recurrence of AF (hazard ratio/10% increase: 0.62, 95% confidence interval: 0.51-0.75, P < 0.0001). LAEFpost had a mild predictive power for recurrence of AF (c-statistics: 0.670, optimal cutoff: 26.36%, P < 0.0001). The recurrence-free proportion among patients with reduced LAEFpost (< 26.36%, N = 100) and those with preserved LAEFpost (≥ 26.36%, N = 516) was 40% and 79%, respectively (P < 0.0001). The predictors of reduced LAEFpost were low pre-ablation LAEF, high pre-ablation LA volume, low body mass index (BMI), and female sex. Further, reduced LAEFpost was associated with the total number of ablation sessions and extra-pulmonary vein LA ablation. In conclusion, reduced LAEFpost was associated with recurrence of AF after ablation. Advanced LA remodeling, low BMI, and female sex could predict reduced LAEFpost. Although additional ablation was associated with reduced LAEFpost, it remains unclear whether reduced LAEFpost resulted from the additional ablation. Reduced LAEFpost might help stratify patients with ablation-refractory AF.

Percutaneous Extraction for Misplacement of Pacemaker Leads Within the Coronary Artery and Left Ventricle.

A 75-year-old man, who underwent inadvertent misplacement of pacemaker leads into the left coronary artery and left ventricle through the subclavian artery, was referred to our hospital. We safely performed percutaneous lead extraction in collaboration with surgeons and with the patient under general anesthesia. (Level of Difficulty: Advanced.).

Usefulness of Post-Procedural Plasma Brain Natriuretic Peptide Levels to Predict Recurrence After Catheter Ablation of Atrial Fibrillation in Patients With Left Ventricular Systolic Dysfunction.

Catheter ablation (CA) of atrial fibrillation (AF) improves cardiac function, resulting in a decrease in plasma brain natriuretic peptide (BNP) levels in patients with reduced left ventricular ejection fraction (LVEF). This study sought to examine the pre-procedural and post-procedural correlations between BNP levels and cardiac function and the associations between the BNP levels and recurrence after CA in patients with AF and reduced LVEF. Of 3142 consecutive patients who underwent first-time CA of AF at our institute, a total of 217 patients with LVEF <50% were enrolled. Significant decrease in BNP levels (from a median of 198 [interquartile range 113 to 355] to 47.7 [22.7 to 135] pg/ml, p <0.001) and improvement in LVEF (from 39±9% to 61±16%, p <0.001) were observed 3 months after CA. There was a linear correlation between log-transformed BNP levels and cardiac measures (LVEF: r = -0.64; LV end-diastolic volume: r = 0.25; LV end-systolic volume: r = 0.43; left atrial volume: r = 0.52; all p <0.001). During a median follow-up of 35 months, AF recurrence after a 3-month blanking period was observed in 80 patients (37%). Cox proportional hazard regression analysis after adjustment for cardiac measures significant in univariate analysis revealed that early recurrence within the blanking period (hazard ratio, 4.88; 95% confidence interval, 2.89 to 8.25) and elevated post-procedural BNP levels (2.02 per unit log increase; 1.14 to 3.56) were significant predictors of AF recurrence, but pre-procedural BNP was not. In conclusion, post-procedural BNP levels at the end of the blanking period predicted subsequent AF recurrence in patients with reduced LVEF, independent of early recurrence.

A randomized comparison of two direct oral anticoagulants for patients undergoing cardiac ablation with a contemporary warfarin control arm.

BACKGROUND: The safety and efficacy of periprocedural use of direct oral anticoagulants (DOACs) for atrial fibrillation (AF) remain unclear. We compared the incidence of asymptomatic cerebral micro-thromboembolism and hemopericardium following AF ablation among patients receiving edoxaban, rivaroxaban, and warfarin and between normal- and low-dose use of edoxaban and rivaroxaban. METHODS: This prospective randomized study included 170 consecutive AF patients. Patients taking DOACs upon admission to our hospital were randomly assigned to an edoxaban group or to a rivaroxaban group. Warfarin was continued in patients receiving warfarin at admission. All patients underwent AF ablation, and cerebral MRI was performed to evaluate asymptomatic cerebral micro-thromboembolism the day after the procedure. RESULTS: Sixty-one patients were assigned to edoxaban and 63 to rivaroxaban. Warfarin was continued in 46 patients. Although asymptomatic cerebral micro-thromboembolism was detected in 25 patients (16.3%), there were no significant differences among the groups. Hemopericardium occurred in 2 patients (one each in the rivaroxaban and warfarin groups). The incidence of asymptomatic cerebral micro-thromboembolism was higher in the low-dose group (9 patients, 25.7%) than in the normal-dose group (8 patients, 10.0%) for patients prescribed either edoxaban or rivaroxaban (p < 0.05). The proportion of males (88.0%, 69.5%, p < 0.05), history of prior AF ablation (64.0%, 42.2%, p < 0.05), and hypertension (68.0%, 46.1%, p < 0.05) were significantly higher in patients with cerebral thromboembolism. CONCLUSIONS: The incidence of asymptomatic cerebral micro-thromboembolism and hemopericardium in AF ablation was similar among patients using edoxaban, rivaroxaban, and warfarin. However, low doses of DOACs may increase the risk of asymptomatic stroke.

Clinical significance of left ventricular reverse remodeling after catheter ablation of atrial fibrillation in patients with left ventricular systolic dysfunction.

BACKGROUND: Left ventricular (LV) reverse remodeling (LVRR) after catheter ablation of atrial fibrillation (AFCA) has not been fully described. This study investigated the predictors and clinical outcomes of LVRR after AFCA in patients with LV systolic dysfunction. METHODS: Of 3319 consecutive patients who underwent first-time AFCA between January 2012 and October 2019, 376 with a baseline LV ejection fraction of <50% were retrospectively evaluated. They were subjected to 256-slice multidetector computed tomography (MDCT) scanning at baseline and 3 months after AFCA. The LVRR was defined as a decrease in the LV end-systolic volume of ≥15%. RESULTS: The prevalence of LVRR was 83% (n = 306). Multivariate logistic regression analysis including age, body mass index, diabetic status, beta-blocker use, and LV diastolic diameter revealed that the predictors of LVRR were non-paroxysmal atrial fibrillation (AF) (odds ratio, 2.68; 95% confidence interval, 1.42-5.05; p = 0.002) and absence of apparent underlying structural heart disease (4.81; 2.31-10.0; p <0.001). The prevalence of LVRR differed depending on AF recurrence pattern prior to the post-MDCT [no episode vs. paroxysmal episode (lasting <7 days) vs. persistent episode (lasting ≥7 days), 84% vs. 81% vs. 63%, respectively, p = 0.023]. During a median follow-up of 32 months, the incidence of paroxysmal form of AF recurrence was similar, whereas persistent form of AF recurrence was less frequent in patients with LVRR (10.5% vs. 18.6%, p = 0.018). Heart failure hospitalizations (2.3% vs. 15.7%, p <0.001), cardiovascular deaths (0.7% vs. 4.3%, p = 0.015), and all-cause deaths (1.3% vs. 5.7%, p = 0.018) were similarly less frequent in those with LVRR. CONCLUSIONS: LVRR after AFCA, which was predicted by non-paroxysmal AF without any apparent structural heart disease at baseline, was associated with persistent form of AF recurrence prior to the evaluation. LVRR was associated with favorable clinical outcomes.

Home Sleep Apnea Test to Screen Patients With Atrial Fibrillation for Sleep Apnea Prior to Catheter Ablation.

BACKGROUND: Whether all atrial fibrillation (AF) patients should be evaluated for sleep apnea before catheter ablation (CA) remains controversial. Watch-type peripheral arterial tonometry (W-PAT) is a home sleep testing device and an easier tool for diagnosing sleep apnea than polysomnography. We investigated the prevalence and predictors of sleep apnea using W-PAT in unscreened sleep apnea patients with AF before CA.Methods and Results:The study was conducted under a retrospective, single-center, observational design. We included 776 consecutive patients who underwent both W-PAT and AF ablation. Sleep apnea assessments were successfully performed in 774 patients (99.7%; age 65±11 years, 73.3% male; body mass index [BMI] 24.1±3.5, 56.8% paroxysmal AF). The mean apnea-hypopnea index (AHI) was 20.1±15.6. Although 81.7% of the patients had normal Epworth sleepiness scores (mean 6.5), only 88 (11.4%) had a normal AHI (AHI <5) and 412 (53.2%) had moderate-severe sleep apnea (AHI ≥15). Obesity, male sex, nonparoxysmal AF, hypertension, and a left atrial diameter (LAd) ≥40 mm were predictors of moderate-severe sleep apnea. However, the prevalence of moderate-severe sleep apnea in patients without those predictors (i.e., non-obesity (44.2%), female sex (43.0%), paroxysmal AF (43.9%), no hypertension (45.5%)), and LAd <40 mm (41.0%) was considerably high. CONCLUSIONS: Almost all patients successfully underwent W-PAT to diagnose sleep apnea. Patients undergoing AF ablation had a high prevalence of sleep apnea, and screening for sleep apnea was important in those patients even if they did not have sleepiness or risk factors.

Look inside the slow or no conduction zones.

When using coherent activation mapping, adjusting scar settings even below the noise level (bipolar voltage amplitude ≤0.03 mV) should be considered to obtain the important information contained in the SNO zone.

Early recurrence during the blanking period and left atrial reverse remodeling after catheter ablation for non-paroxysmal atrial fibrillation.

BACKGROUND: Early recurrence of atrial tachyarrhythmia (ERAT) during a 90-day blanking period (BP) often occurs after atrial fibrillation (AF) ablation. Left atrial reverse remodeling (LARR), which is the reduction in LA volume (LAV), also occurs during the BP. Both ERAT and LARR are associated with late recurrence (LR, greater than 90 days after ablation). We investigated the association between ERAT and LARR following non-paroxysmal AF (NPAF) ablation. METHODS: We retrospectively reviewed 330 consecutive patients undergoing initial NPAF ablation (median follow-up: 4.0 years). Based on the timing of the final ERAT, we divided the patients into No-ERAT (N = 154, without ERAT), Early (N = 39, 0-7 days after ablation), Intermediate (N = 67, 8-30), and Late-ERAT (N = 70, 31-90) groups. We assessed the extent of LARR, defined as the percentage of decrease in LAV (%ΔLAV). The %ΔLAV cutoff value was determined by receiver operating characteristic analysis, and incorporated into a multivariate analysis to assess the association between ERAT and LARR. RESULTS: Late-ERAT was associated with LR (hazard ratio: 6.31, 95% confidence interval (CI): 4.21-9.47, p = 0.0001). The %ΔLAV in the Late-ERAT group was significantly smaller than the other groups (p < 0.0001). The predictive power of %ΔLAV for LR was slight (AUC, 0.604; best cutoff, 18.8% decrease; p = 0.0011). In the multivariate logistic regression analysis, Late-ERAT was associated with poor LARR (%ΔLAV < 18.8% decrease) (odds ratio, 0.13; 95%CI, 0.06-0.27; p < 0.001), whereas Early- and Intermediate-ERAT did not show any correlation. CONCLUSIONS: Late-ERAT was strongly associated with poor LARR after NPAF ablation. Both Late-ERAT and poor LARR might reflect a residual arrhythmogenic substrate causing LR.

Characterization of the effect of serum bilirubin concentrations on coronary endothelial function via measurement of high-sensitivity C-reactive protein and high-density lipoprotein cholesterol.

Bilirubin can prevent oxidation of low-density lipoprotein (LDL) and may protect against atherosclerosis and coronary heart disease (CHD). The goal of this study was to characterize the relationship between bilirubin and CHD through measurements of bilirubin concentration, coronary endothelial function, and markers of oxidative stress, inflammation, and lipid/glucose metabolism. The study population consisted of 141 patients without CHD who underwent Doppler flow study. Vascular reactivity was examined by intracoronary administration of papaverine, acetylcholine (ACh) and nitroglycerin using a Doppler guide wire. Serum bilirubin, high-sensitivity C-reactive protein (hsCRP), malondialdehyde-modified LDL, LDL cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), fasting plasma glucose (FPG), and immunoreactive insulin were also measured. Homeostasis model assessment insulin resistance index and estimated glomerular filtration rate (eGFR) were calculated. Univariate analysis revealed that both percent change in coronary blood flow (CBF) and coronary artery diameter induced by ACh correlated positively with log-transformed bilirubin (r = 0.22, P < 0.05; r = 0.20, P < 0.05, respectively). Percent change in CBF in response to ACh correlated positively with eGFR (r = 0.24, P < 0.05) and correlated inversely with age, LDL-C, and log-transformed FPG (r = -0.24, P < 0.05; r = -0.17, P < 0.05, r = -0.22, P < 0.05, respectively). Multivariate analysis revealed that log-transformed bilirubin was the only independent predictor of percent change in CBF in response to ACh. Multivariate analysis revealed that log-transformed hsCRP and HDL-C were independent predictors of log-transformed bilirubin. These results suggest that a high level of bilirubin is associated with favorable coronary endothelial function, which may be mediated via the effect of bilirubin on inflammation and HDL-C.