Efficacy of dotinurad in patients with severe renal dysfunction.

BACKGROUND: Although hyperuricemia is associated with the progression of chronic kidney disease (CKD), a reduction in CKD progression by uric acid (UA)-lowering therapy has been controversial. Recently, dotinurad, a uricosuric drug with selective urate reabsorption inhibitory properties, has been developed. However, its efficacy in lowering serum UA levels and its effects on renal function in patients with severe renal dysfunction are unclear. Thus, this study aimed to determine the effects of dotinurad on renal function in patients with severe renal dysfunction. METHODS: Data from 53 outpatients with hyperuricemia who newly received dotinurad between December 2020 and October 2022 were retrospectively analyzed. The mean baseline estimated glomerular filtration rate (eGFR) was 38.7 ± 17.0 mL/min/1.73 m2. The patients were divided into three groups based on their baseline eGFR: eGFR < 30 (n = 17), 30 ≤ eGFR < 45 (n = 17), and eGFR ≥ 45 (n = 19). RESULTS: The mean follow-up period was 9.8 ± 4.5 (range, 3-21) months. Serum UA levels significantly decreased in all groups. Although eGFR did not significantly change in patients with 30 ≤ eGFR < 45 and eGFR ≥ 45 (P = 0.918 and P = 0.535, respectively), it improved significantly in patients with eGFR < 30 (P = 0.032). The proportion of patients with improved eGFR was significantly higher in patients with eGFR < 30 (P = 0.038) than in patients with 30 ≤ eGFR < 45 and eGFR ≥ 45. In the multivariate logistic regression analysis, baseline eGFR < 30 and achieving a serum UA level of ≤ 6.0 mg/dL were significantly associated with improved eGFR (P = 0.033 and P = 0.015, respectively). CONCLUSIONS: Dotinurad may have UA-lowering effects and the potential to improve kidney function in patients with severe renal dysfunction.

Practical guide for safe sedation.

This practical guide has been developed to ensure safe and effective sedation performed in adult patients outside of the operating room, for instance in intensive care units and dental treatment rooms and in the field of palliative care. Sedation levels are classified based on level of consciousness, airway reflex, spontaneous ventilation, and cardiovascular function. Deep sedation induces loss of consciousness and protective reflexes, and can cause respiratory depression and pulmonary aspiration. Invasive medical procedures necessitating deep sedation include cardiac ablation, endoscopic submucosal dissection, and internal radiation therapy. Appropriate analgesia is necessary for procedures that require deep sedation. The sedationist should evaluate the risks of the planned procedure, explain the sedation process to the patient, and obtain the patient's informed consent. Major parameters to be evaluated preoperatively are the patient's airway and general condition. Equipment, instruments, and drugs necessary for emergency situations should be defined and routinely maintained. To prevent aspiration, patients scheduled for moderate or deep sedation should fast preoperatively. In both inpatients and outpatients, biological monitoring should be continued until the discharge criteria are met. Anesthesiologists should be involved in management systems that ensure safe and effective sedation even if they do not personally perform all sedation procedures.

Effect of Empagliflozin Versus Placebo on Body Fluid Balance in Patients With Acute Myocardial Infarction and Type 2 Diabetes Mellitus: Subgroup Analysis of the EMBODY Trial.

BACKGROUND: The development of heart failure is associated with fluid balance, including that of extracellular water (ECW) and intracellular water (ICW). This study determined whether sodium-glucose cotransporter 2 inhibitors affect fluid balance and improve heart failure in patients after acute myocardial infarction. METHODS AND RESULTS: EMBODY was a prospective, randomized, double-blinded, placebo-controlled trial of Japanese patients with acute myocardial infarction and type 2 diabetes. Overall, 55 patients who underwent bioelectrical impedance analysis were randomized to receive once daily 10 mg empagliflozin or placebo 2 weeks after acute myocardial infarction onset. We investigated the time course of body fluid balance measured using the bioelectrical impedance analysis device, InBody. The primary end points were changes in body fluid balance from weeks 0 to 24. Changes between baseline and week 24 in the empagliflozin and placebo groups were -0.21 L (P = .127) and +0.40 L (P = .001) in ECW (P = .001) and -0.23 L (P = .264) and +0.74 L (P < .001) in ICW (P < .001), respectively. In a stratified analysis, the rise in ECW and ICW was significantly attenuated in the empagliflozin group in contrast to the placebo group in participants with a body mass index of 25 or higher but not in those with a body mass index of less than 25. CONCLUSIONS: Early sodium-glucose cotransporter 2 inhibitor administration may attenuate changes in ECW and ICW.

HotBalloon Pulmonary Vein Isolation Registry Study　- Real-World Efficacy and Safety of HotBalloon Ablation.

BACKGROUND: Radiofrequency hotballoon (RHB) is an ablation device used for atrial fibrillation (AF) treatment. The efficacy and safety of RHB-based pulmonary vein isolation (PVI) in real-world practice are unknown.Methods and Results: A multicenter, prospective registry study (UMIN000029567) enrolled AF patients who underwent RHB-PVI. The primary endpoint was the AF recurrence-free survival rate at 12 months after PVI. Of the 679 patients enrolled, 613 (90.3%; paroxysmal AF, n=370; persistent AF, n=136; long-standing AF, n=107) underwent initial RHB-PVI. Acute isolation using only the RHB was successful for 55.6% of patients and 83.5% of pulmonary veins (PVs). The acute isolation rate was higher for patients with paroxysmal AF and more experienced centers. Antiarrhythmic drugs were prescribed after 3 months for 47.5% of patients. The AF recurrence-free survival rate at 12 months was 83.7%. Procedure-related complications including atrio-esophageal fistula (n=1) and phrenic nerve injury (persistent; n=4, permanent; n=2) were observed in 19 (3.1%) patients. Five (1.7%) of the 302 patients who underwent pre-procedural and post-procedural multidetector computed tomography had severe PV stenosis. CONCLUSIONS: The size-adjustable RHB has been used for the treatment of various AF types. The arrhythmia recurrence-free rate at 12 months, with the use of antiarrhythmic drugs in approximately half of the patients, was acceptable, but the acute isolation rate using the RHB requires further improvement.

Distal type of nodo-ventricular pathway: Unique electrophysiological characteristics mimicking fasciculo-ventricular pathway.

Fasciculo-ventricular and nodo-ventricular pathways (FVP and NVP) are rare preexcitation variants. Normally, NVP is electrophysiologically different from FVP. We describe a unique type of NVP emerging from the distal part of the slow pathway, designated as "distal type" NVP. The distal type NVP resembled FVP but was proven by unexpected elimination of the NVP during the slow pathway ablation. Also, NVP was distinguishable from FVP by a careful comparison of the HV intervals during conduction over the fast and slow pathways. Demonstration of this novel type NVP provides insights into how the insertion site of NVP affects its electrophysiologic behaviors.

Efficacy of electrical isolation of the left atrial posterior wall depends on the existence of left atrial low-voltage zone in patients with persistent atrial fibrillation.

BACKGROUND: Modification of the low-voltage zone in the left atrium (LA-LVZ) in addition to pulmonary vein isolation (PVI) has not shown sufficient improvement in arrhythmia-free survival in patients with persistent atrial fibrillation (PerAF). Further, the effect of electrical posterior wall isolation (PWI) is controversial. We investigated the impact of existence of LA-LVZ on the outcome of patients undergoing additional PWI for PerAF. METHODS: A total of 347 patients with PerAF who underwent primary catheter ablation with LA-LVZ based strategy were retrospectively analyzed. Voltage mapping in the left atrium (LA) was performed during sinus rhythm. Additional LVZ ablation was performed in patients with LA-LVZ. The operators decided whether additional PWIs were to be performed. RESULTS: Of 347 patients, 108 had LA-LVZ. In the LVZ group, patients with additional PWI (N = 70) had higher rates of freedom from tachyarrhythmia recurrence than those without (77.1% vs. 42.1%, p < 0.001). Furthermore, even when patients were limited to those with LA-LVZ in areas other than the posterior wall (N = 85), PWI had higher success rates (80.9% vs. 42.1%, p < 0.001). In contrast, in patients without LVZ (N = 239), there was no significant difference in the rate of successful outcome between those with and without PWI (81.3% vs. 88.1%, p = 0.112). On the other hand, the patients with PWI had greater atrial tachycardia (AT) recurrence rate than those without PWI (10.0% vs. 2.5%, p = 0.003). CONCLUSIONS: PWI, in addition to PVI and LVZ modification, may improve single procedural outcomes in patients with PerAF who have LVZ, regardless of the distribution in the LA. A combination of voltage-guided ablation and PWI may be a simple, tailored, and effective ablation strategy.

Helicopter emergency medical service for patients with acute coronary syndrome: selection validity and impact on clinical outcomes.

Helicopter emergency medical service (HEMS) has the potential to improve prognosis for acute coronary syndrome (ACS). However, adequacy and effectiveness of HEMS have not been fully evaluated. A total of 862 ACS patients transferred by emergency medical services were divided into two groups: patients transferred by HEMS (n = 171) or by ground ambulance (GA; n = 691). Among them, angiography images for 718 patients (149 in HEMS and 569 in GA group) and optical coherence tomography (OCT) images for 374 patients (75 in HEMS and 299 in GA groups) were analyzed. Additional analysis to compare 2-year cardiac mortality between groups was conducted following propensity score matching to adjust for inter-group differences. ST-segment elevation myocardial infarction (81% vs. 66%, p < 0.001) and cardiogenic shock (Killip IV; 20% vs. 10%, p < 0.001) at admission were more prevalent in HEMS than GA group. Time from admission to balloon angioplasty was shorter in HEMS group (median 54 min vs. 69 min, p < 0.001). Antegrade coronary flow was worse in HEMS group (TIMI flow grade 0 or 1; 68% vs. 51%, p < 0.001). Plaque rupture was more frequently detected by OCT in HEMS group (68% vs. 49%, p = 0.029). Following propensity score matching, the incidence of cardiac death was significantly lower in HEMS group (6.3% vs. 14.9%, p = 0.019). In conclusion, severe ACS patients requiring early reperfusion were appropriately triaged and transferred more rapidly by HEMS. Lower mortality in HEMS group after propensity score matching suggests that HEMS may improve cardiac mortality in ACS patients.

Characteristics of patients with atrial flutter and spontaneous 1:1 atrioventricular conduction with and without anti-arrhythmic drug treatment.

Atrial flutter (AFL) is a large reentrant circuit located in the right atrium. Anti-arrhythmic drugs (AADs) can provoke AFL with 1:1 atrioventricular conduction (AVC) to cause hemodynamic collapse. We elucidated the characteristics of patients with AFL exhibiting spontaneous 1:1 AVC. Fifteen patients (1:1 AFL group; 11 males, 52.4 ± 13.7 years old) who documented AFL with 1:1 AVC were enrolled and compared to 153 patients without 1:1 AVC (Control group; 137 males, 68.9 ± 11.2 years old). AFL cycle length during maximum AVC was significantly longer in the 1:1 AFL group than in the control group (274.7 ± 37.0 vs. 216.2 ± 25.6 ms, p < 0.001). Among 1:1 AVC group, 9 patients had AADs, and AFL cycle length was significantly longer during 1:1 AVC as compared with 2:1 AVC documented the other day (284.4 ± 41.3 vs. 233.3 ± 26.0 ms, p < 0.001), suggesting enhancement effect of the AADs during 1:1 AVC. Remaining 6 patients who did not take AADs, 2 patients showed enlargement of the tricuspid annulus and 3 patients developed 1:1 AVC during exercise. Multivariate analysis revealed that younger age and the use of AADs was independent risk factors for the development of 1:1 AFL group. Prolonged AFL cycle length associated with the class Ia/Ic AAD use, slower heart rate during sinus rhythm and younger age were important risk factors for the development of 1:1 AVC during AFL.

A preliminary pilot study investigating the impact of endovascular treatment on leg muscle volume in peripheral artery disease and its relation to baseline glycemic control.

BACKGROUND AND AIMS: Peripheral artery disease (PAD), intermittent claudication, and impaired mobility contribute to the loss of skeletal muscle. This study investigated the impact of endovascular treatment (EVT) in patients suffering from PAD above the knee and its relation to baseline glycemic control. METHODS AND RESULTS: Mid-thigh muscle volume was measured before EVT, 3 months after EVT and 6 months after EVT. Mid-thigh muscle volumes of ipsilateral PAD patients with ischemic and non-ischemic legs were compared. Correlations between total thigh muscle volume and clinical characteristics were analyzed using univariable and multivariable analysis. Overall, thigh muscle volume increased after EVT. The mid-thigh muscle volume was significantly lower in patients with ipsilateral lesions and in those with ischemic lower limbs. The thigh muscle volume of those with ischemic lower limbs increased after EVT. Baseline glycated hemoglobin was the only factor that was negatively correlated with changes in the muscle volume after EVT. Muscle volume significantly increased in normoglycemic HbA1c<6.5% (47 mmol/mol) patients. There was no significant alteration in the muscle volume of hyperglycemic HbA1c ≥ 6.5% patients. CONCLUSION: Ischemic muscle atrophy was ameliorated after EVT in normoglycemic patients. There is a need for a large-scale trial to investigate whether EVT can protect or delay skeletal muscle loss.

Re-definition of blanking period in radiofrequency catheter ablation of atrial fibrillation in the contact force era.

INTRODUCTION: Early recurrence (ER) of atrial fibrillation (AF) is defined as the recurrence of atrial tachyarrhythmias within 3 months after AF ablation, however, this definition is based on data from the era of radiofrequency catheter ablation (RFCA), without contact force (CF) technology. We investigated the significance of ER as a risk factor for late recurrence (LR) in paroxysmal AF (PAF) patients treated with CF and non-CF-guided ablation. METHODS AND RESULTS: We studied 395 patients with PAF who underwent RFCA. Of these, 97 patients underwent RFCA without-CF technology (non-CF group) and 298 underwent with CF technology (CF group). Over a 2-year postablation follow-up period, LR occurred in 54 (55.7%) patients in the non-CF group, and in 105 (35.2%) patients in the CF group. ER had a more significant relationship with LR in the CF group, and all patients in the CF group with ER in the third month developed LR. CONCLUSION: PAF patients with ER who have undergone CF-guided ablation have a greater risk of LR than those who have undergone non-CF-guided ablation. ER in the third month after CF-guided ablation may indicate an absolute risk of LR. Blanking period could be defined as 2 months in the CF era.

Effects of empagliflozin versus placebo on cardiac sympathetic activity in acute myocardial infarction patients with type 2 diabetes mellitus: the EMBODY trial.

BACKGROUND: Protection from lethal ventricular arrhythmias leading to sudden cardiac death (SCD) is a crucial challenge after acute myocardial infarction (AMI). Cardiac sympathetic and parasympathetic activity can be noninvasively assessed using heart rate variability (HRV) and heart rate turbulence (HRT). The EMBODY trial was designed to determine whether the Sodium-glucose cotransporter 2 (SGLT2) inhibitor improves cardiac nerve activity. METHODS: This prospective, multicenter, randomized, double-blind, placebo-controlled trial included patients with AMI and type 2 diabetes mellitus (T2DM) in Japan; 105 patients were randomized (1:1) to receive once-daily 10-mg empagliflozin or placebo. The primary endpoints were changes in HRV, e.g., the standard deviation of all 5-min mean normal RR intervals (SDANN) and the low-frequency-to-high-frequency (LF/HF) ratio from baseline to 24 weeks. Secondary endpoints were changes in other sudden cardiac death (SCD) surrogate markers such as HRT. RESULTS: Overall, 96 patients were included (46, empagliflozin group; 50, placebo group). The changes in SDANN were + 11.6 and + 9.1 ms in the empagliflozin (P = 0.02) and placebo groups (P = 0.06), respectively. Change in LF/HF ratio was - 0.57 and - 0.17 in the empagliflozin (P = 0.01) and placebo groups (P = 0.43), respectively. Significant improvement was noted in HRT only in the empagliflozin group (P = 0.01). Whereas intergroup comparison on HRV and HRT showed no significant difference between the empagliflozin and placebo groups. Compared with the placebo group, the empagliflozin group showed significant decreases in body weight, systolic blood pressure, and uric acid. In the empagliflozin group, no adverse events were observed. CONCLUSIONS: This is the first randomized clinical data to evaluate the effect of empagliflozin on cardiac sympathetic and parasympathetic activity in patients with T2DM and AMI. Early SGLT2 inhibitor administration in AMI patients with T2DM might be effective in improving cardiac nerve activity without any adverse events. TRIAL REGISTRATION: The EMBODY trial was registered by the UMIN in November 2017 (ID: 000030158). UMIN000030158; https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034442 .

Postprandial Hyperchylomicronemia and Thin-Cap Fibroatheroma in Nonculprit Lesions.

Objective- Although postprandial hypertriglyceridemia can be a risk factor for coronary artery disease, the extent of its significance remains unknown. This study aimed to investigate the correlation between the postprandial lipid profiles rigorously estimated with the meal tolerance test and the presence of lipid-rich plaque, such as thin-cap fibroatheroma (TCFA), in the nonculprit lesion. Approach and Results- A total of 30 patients with stable coronary artery disease who underwent a multivessel examination using optical coherence tomography during catheter intervention for the culprit lesion were enrolled. Patients were divided into 2 groups: patients with TCFA (fibrous cap thickness ≤65 µm) in the nonculprit lesion and those without TCFA. Serum remnant-like particle-cholesterol and ApoB-48 (apolipoprotein B-48) levels were measured during the meal tolerance test. The value of remnant-like particle-cholesterol was significantly greater in the TCFA group than in the non-TCFA group ( P=0.045). Although the baseline ApoB-48 level was similar, the increase in the ApoB-48 level was significantly higher in the TCFA group than in the non-TCFA group ( P=0.028). In addition, the baseline apolipoprotein C-III levels was significantly greater in the TCFA group ( P=0.003). These indexes were independent predictors of the presence of TCFA (ΔApoB-48: odds ratio, 1.608; 95% confidence interval, 1.040-2.486; P=0.032; apolipoprotein C-III: odds ratio, 2.581; 95% confidence interval, 1.177-5.661; P=0.018). Conclusions- Postprandial hyperchylomicronemia correlates with the presence of TCFA in the nonculprit lesion and may be a residual risk factor for coronary artery disease.

Electrocardiographic characteristics in the patients with a persistent left superior vena cava.

A persistent left superior vena cava (PLSVC) is a congenital venous abnormality and is usually asymptomatic and does not cause hemodynamic disturbances. Therefore, it is difficult to identify it by routine examinations in clinical practice. This study aimed to elucidate the electrocardiographic characteristics for the prediction of a PLSVC. Twelve patients (9 males, 56.2 ± 18.3 years) who were diagnosed with a PLSVC were enrolled. The electrocardiographic parameters, including the P-wave duration, axis, and morphology of the P waves, were automatically measured and compared to 150 controls (77 males, 57.3 ± 14.6 years). There were no significant differences in the P-wave duration. Negative or positive/negative P waves in lead III predicted a PLSVC with a sensitivity of 100% and specificity of 81%. The P-wave axis in PLSVC exhibited a significant leftward deviation as compared to the controls (14.8 ± 21.1 vs. 54.0 ± 17.4°, p < 0.001). A receiver operating characteristic curve analysis of the P-wave axis for predicting a PLSVC exhibited an area under curve of 0.93 [CI 95% (0.87-0.98), p < 0.001), and identified a P-wave axis of less than 37.5° to have a 92% sensitivity and 83% specificity in predicting a PLSVC. A negative or positive/negative P-wave morphology in lead III was a useful finding for suggesting the presence of a PLSVC.

Effects and Risks of Heparin Bridging and Different Modes of Interruption/Resumption of Rivaroxaban on Perioperative Complications of Catheter Ablation for Atrial Fibrillation　- Another Analysis of the JACRE-R Registry.

BACKGROUND: The JACRE-R Registry, in which 42 Japanese institutions participated, monitored the efficacy and safety of rivaroxaban in catheter ablation (CA) of atrial fibrillation (AF). In the present analysis, we sought to elucidate the effects and risks of heparin bridging and different patterns of interruption/resumption of rivaroxaban on complications of CA.Methods and Results:We administered rivaroxaban during the perioperative period and recorded the incidence of complications up to 30 days after CA. A total of 1,118 patients were registered; 546 received heparin bridging and 572 did not. The bridging group showed a significantly higher incidence of non-major bleeding than the no-bridging group (4.03% vs. 0.87%; P=0.001). In the group receiving their last dose of rivaroxaban at 8-28 h before CA, neither thromboembolism nor major bleeding was observed during or after CA and the incidence of non-major bleeding was low (4/435, 0.92%). The incidence of non-major bleeding was significantly higher in the group resuming rivaroxaban ≥12 h after CA than in the group resuming <12 h (1.79% vs. 0.27%, P=0.045). CONCLUSIONS: Heparin bridging increased the risk of non-major bleeding perioperatively. It was safe to stop rivaroxaban 8-28 h before the CA procedure, whereas resumption of the drug within 12 h of CA was associated with a lower incidence of non-major bleeding.

Blanking Period Phenomenon After a Second Atrial Fibrillation Ablation Session: The Application and Factors Related to It.

INTRODUCTION: The concept of a 3-month blanking period is widely accepted after the first radiofrequency catheter ablation (RFCA) session for atrial fibrillation (AF). We sought to investigate whether this phenomenon was also observed after a 2nd session, and which factors were related to it. METHODS AND RESULTS: We conducted a prospective observational study including all AF patients who underwent RFCA since 2010. The patients who underwent a second RFCA were followed without any antiarrhythmic drugs. Their clinical background, laboratory data, echocardiographic parameters, ablation procedures, and arrhythmia recurrences were analyzed. Recurrences were classified into early period recurrences (EPRs) and late period recurrences (LPRs) recorded within and after the first 3 months postablation, respectively. Among 925 patients who underwent an initial AF ablation, 2nd sessions were performed in 250 patients, and EPRs and LPRs occurred in 53 (21.2%) and 54 (21.6%) patients, respectively. Although EPRs were an independent predictor of LPRs (hazard ratio [HR], 8.01; 95% confidence interval [CI] 4.03-15.93, P < 0.001), 20 of the patients with EPRs (37.7%) did not experience LPRs, supporting the concept of a blanking period. Among 53 patients with EPRs, the E/E' ratio on echocardiography (HR, 1.156; 95% CI 1.00-1.33, P = 0.04) was an independent predictor of LPRs, while other parameters including the maximum serum C-reactive protein level after the session and the ablation procedure details were not. CONCLUSION: A 3-month blanking period was also applicable after the 2nd AF ablation session. This phenomenon was related to a lower left atrial pressure demonstrated by the E/E' ratio.

Noninvasive evaluation of reverse atrial remodeling after catheter ablation of atrial fibrillation by P wave dispersion.

Atrial fibrillation (AF) itself creates structural and electrophysiological changes such as atrial enlargement, shortening of refractory period and decrease in conduction velocity, called "atrial remodeling", promoting its persistence. Although the remodeling process is considered to be reversible, it has not been elucidated in detail. The aim of this study was to assess the feasibility of P wave dispersion in the assessment of reverse atrial remodeling following catheter ablation of AF. Consecutive 126 patients (88 males, age 63.0 ± 10.4 years) who underwent catheter ablation for paroxysmal AF were investigated. P wave dispersion was calculated from the 12 lead ECG before, 1 day, 1 month, 3 months and 6 months after the procedure. Left atrial diameter (LAD), left atrial volume index (LAVI), left ventricular ejection fraction (LVEF), transmitral flow velocity waveform (E/A), and tissue Doppler (E/e') on echocardiography, plasma B-type natriuretic peptide (BNP) concentrations, serum creatinine, and estimated glomerular filtration rate (eGFR) were also measured. Of all patients, 103 subjects remained free of AF for 1 year follow-up. In these patients, P wave dispersion was not changed 1 day and 1 month after the procedure. However, it was significantly decreased at 3 and 6 months (50.1 ± 14.8 to 45.4 ± 14.4 ms, p < 0.05, 45.2 ± 9.9 ms, p < 0.05, respectively). Plasma BNP concentrations, LAD and LAVI were decreased (81.1 ± 103.8 to 44.8 ± 38.3 pg/mL, p < 0.05, 38.2 ± 5.7 to 35.9 ± 5.6 mm, p < 0.05, 33.3 ± 14.2 to 29.3 ± 12.3 mL/m2, p < 0.05) at 6 months after the procedure. There were no significant changes in LVEF, E/A, E/e', serum creatinine, and eGFR during the follow up period. P wave dispersion was decreased at 3 and 6 months after catheter ablation in patients without recurrence of AF. P wave dispersion is useful for assessment of reverse remodeling after catheter ablation of AF.

Efficacy and Safety of Rivaroxaban and Warfarin in the Perioperative Period of Catheter Ablation for Atrial Fibrillation　- Outcome Analysis From a Prospective Multicenter Registry Study in Japan.

BACKGROUND: Catheter ablation (CA) is a common treatment for atrial fibrillation (AF). Although rivaroxaban is increasingly used as a substitute for warfarin, its safety and efficacy during CA have not been established in Japanese patients. In the present study we explored the efficacy/safety of rivaroxaban during the CA perioperative period.Methods and Results:We prospectively enrolled Japanese AF patients scheduled for CA who had received either rivaroxaban (rivaroxaban cohort, JACRE-R) or warfarin (warfarin cohort, JACRE-W) during the perioperative period. Primary outcome was a composite of thromboembolism and major bleeding within 30 days after CA. In JACRE-R and JACRE-W, 1,118 (median age, 65 years) and 204 patients (median, 69 years) were enrolled from 42 and 22 institutions, respectively. In JACRE-R, the primary outcome occurred in 7 patients (0.6%), comprising thromboembolism in 2 and major bleeding in 5. Non-major bleeding occurred in 27 patients (2.4%), and the incidence was significantly lower in patients without heparin bridging (n=572) than in those with heparin bridging (n=546). In JACRE-W, the primary outcome occurred in 3 patients (1.5%), all of which were major bleeding. After adjustment for patients' characteristics, no significant difference was observed between the JACRE-R and JACRE-W cohorts for the primary outcome. CONCLUSIONS: The rates of thromboembolism and major bleeding events during the AF ablation perioperative period in Japanese patients treated with rivaroxaban was as low as in those treated with warfarin. (Circ J 2016; 80: 2295-2301).