Current Status and Outcomes of Direct Oral Anticoagulant Use in Real-World Atrial Fibrillation Patients　- Fushimi AF Registry.

BACKGROUND: The current status and outcomes of direct oral anticoagulant (DOAC) use have not been widely evaluated in unselected patients with atrial fibrillation (AF) in the real world.Methods and Results:The Fushimi AF Registry is a community-based prospective survey of AF patients who visited the participating medical institutions (n=80) in Fushimi, Kyoto, Japan. Follow-up data with oral anticoagulant (OAC) status were available for 3,731 patients by the end of November 2015. We evaluated OAC status and clinical outcomes according to OAC status. The number (incidence rate) of stroke/systemic embolism (SE) and major bleeding events during the median follow-up of 3.0 years was 224 (2.3%/year) and 177 (1.8%/year), respectively. After the release of DOAC, the prevalence of DOAC use increased gradually and steadily, and that of warfarin, DOAC and no OAC was 37%, 26% and 36%, respectively in 2015. On Cox proportional hazards modeling incorporating change in OAC status as a time-dependent covariate for stroke/SE and major bleeding events, use of DOAC compared with warfarin was not associated with stroke/SE events (HR, 0.95; 95% CI: 0.59-1.51, P=0.82) or major bleeding events (HR, 0.82; 95% CI: 0.50-1.36, P=0.45). CONCLUSIONS: In real-world clinical practice, there were no significant differences in stroke/SE events or major bleeding events for DOAC compared with warfarin in patients with AF.

Sex-Related Differences in the Clinical Events of Patients With Atrial Fibrillation　- The Fushimi AF Registry.

BACKGROUND: Female sex is considered a risk factor for thromboembolism in patients with atrial fibrillation (AF), and is included in the risk stratification scheme, CHA2DS2-VASc score. The purpose of the present study was to investigate the clinical outcomes of female Japanese AF patients.Methods and Results:The Fushimi AF Registry is a community-based prospective survey of the AF patients in Fushimi-ku, Kyoto. Follow-up data were available for 3,878 patients. Female AF patients (n=1,551, 40.0%) were older (77.0 vs. 71.4 years; P<0.001) than male patients (n=2,327, 60.0%). Female patients were more likely to have heart failure (31.1% vs. 23.7%; P<0.001). Previous stroke incidence (19.2% vs. 21.4%; P=0.083) was comparable between male and female patients. During the median follow-up period of 1,102 days, Cox regression analysis demonstrated that female sex was not independently associated with a risk of stroke or systemic embolism (adjusted hazard ratio [HR] 0.74; 95% confidence interval [CI]: 0.54-1.00, P=0.051). However, female sex showed an association with a lower risk of intracranial hemorrhage (adjusted HR 0.54; 95% CI: 0.30-0.95, P=0.032) and all-cause death (adjusted HR 0.56; 95% CI: 0.46-0.68, P<0.001). CONCLUSIONS: We demonstrated that female sex is not independently associated with an increased risk of thromboembolism, but is associated with a decreased risk of intracranial hemorrhage and all-cause death in Japanese AF patients enrolled in the Fushimi AF Registry.

Clinical characteristics and outcomes of dialysis patients with atrial fibrillation: the Fushimi AF Registry.

Atrial fibrillation (AF) is common in dialysis patients. However, clinical characteristics and outcomes of dialysis patients with AF are poorly understood. The Fushimi AF Registry is a community-based prospective survey of AF patients in Japan. Follow-up data were available for 3713 patients with a median follow-up of 2.8 years. We compared clinical characteristics and outcomes between the dialysis group (n = 92; 2.5 %) and others. The dialysis group had more various co-morbidities, with a mean CHADS2 score of 2.5, and the rate of warfarin prescription was 38 %. The annual incidence rates of stroke or systemic embolism (SE), major bleeding, and all-cause death in the dialysis group were 4.0, 5.1, and 20.9 per 100 person-years, respectively. There was no significant difference in the incidence rate of stroke/SE between the dialysis group and the non-dialysis group [hazard ratio (HR) 1.74 (95 % confidence interval (CI) 0.74-3.42)]. The incidence rates of major bleeding, all-cause death, and the composite of stroke/SE and all-cause death in the dialysis group were higher than those in the non-dialysis group [major bleeding: HR 3.09 (95 % CI 1.46-5.72), all-cause death: HR 3.51 (95 % CI 2.48-4.81), the composite of stroke/SE and all-cause death: HR 2.99 (95 % CI 2.15-4.05)]. Among dialysis patients, warfarin did not affect major clinical events including stroke/SE, bleeding or all-cause death. Among AF patients, those receiving dialysis showed higher incidence of major bleeding and all-cause death compared with non-dialysis patients, but the risk of stroke/SE was not particularly high. CLINICAL TRIAL REGISTRATION: URL: http://www.umin.ac.jp/ctr/index.htm .

Incidence of Stroke or Systemic Embolism in Paroxysmal Versus Sustained Atrial Fibrillation: The Fushimi Atrial Fibrillation Registry.

BACKGROUND AND PURPOSE: There is controversy on the relationship of the type of atrial fibrillation (AF) to stroke. Although several studies show that patients with paroxysmal AF (PAF) have a stroke risk similar to those with persistent or permanent AF, recent studies suggest that PAF is associated with a lower rate of stroke. Limited data on stroke risk associated with PAF are evident in Asian populations. METHODS: The Registry Study of Atrial Fibrillation Patients in Fushimi-ku (Fushimi AF Registry) is a community-based survey of patients with AF in Fushimi-ku, Kyoto, Japan. Patients were categorized into 2 types of AF: PAF or sustained (persistent or permanent) AF. We compared clinical events between PAF (n=1588) and sustained AF (n=1716). RESULTS: Patients with PAF were younger, had less comorbidities, and received oral anticoagulants (OAC) less commonly. A lower risk of stroke/systemic embolism during follow-up period in the patients with PAF was consistently observed (non-OAC users: hazard ratio, 0.45; 95% confidence intervals, 0.27-0.75; P<0.01 and OAC users: hazard ratio, 0.59; 95% confidence interval, 0.35-0.93; P=0.03). The composite end point of stroke/systemic embolism/all-cause mortality was also lower in PAF, whether among OAC users (hazard ratio, 0.77; 95% confidence interval, 0.59-0.99; P=0.046) or non-OAC users (hazard ratio, 0.59; 95% confidence interval, 0.46-0.75; P<0.01). On multivariate analysis, PAF was an independent predictor of lower stroke/systemic embolism risk. CONCLUSIONS: In this large cohort of Japanese patients with AF, PAF was independently associated with lower incidence of stroke/systemic embolism than sustained AF. This may aid decision making for anticoagulation, especially in those patients with AF with few stroke risk factors. CLINICAL TRIAL REGISTRATION: URL: http://www.umin.ac.jp/ctr/index.htm. Unique identifier: UMIN000005834.

Low Body Weight Is Associated With the Incidence of Stroke in Atrial Fibrillation Patients - Insight From the Fushimi AF Registry.

BACKGROUND: Japanese patients with atrial fibrillation (AF) are generally small and lean, but knowledge of the clinical characteristics of those with low body weight (LBW: ≤50 kg) is limited. METHODS AND RESULTS: The Fushimi AF Registry is a community-based prospective survey of AF patients who visited the participating medical institutions in Fushmi-ku, Japan. The BW and follow-up data were available for 2,945 patients. We compared the background and the incidence of clinical events during a median follow-up of 746 days between a LBW and non-LBW group. Patients in the LBW group accounted for 26.8% (788 patients) of the total. The LBW group was more often female, older, and had higher CHADS2score. The incidence of stroke/systemic embolism (SE) during follow-up was higher in the LBW group (hazard ratio (HR): 2.19, 95% confidence interval (CI): 1.57-3.04; P<0.01), whereas that of major bleeding was comparable (HR: 1.05, 95% CI: 0.64-1.68; P=0.84). This trend was consistently observed in the subgroups stratified by age, sex, and oral anticoagulant prescription at baseline. Multivariate analysis as well as propensity-score matching analysis further supported the significance of LBW as a risk of stroke/SE. CONCLUSIONS: Patients in the LBW group had high risk profiles and showed a higher incidence of stroke/SE, but the incidence of major bleeding was not particularly high.

Inappropriate use of oral anticoagulants for patients with atrial fibrillation.

BACKGROUND: Atrial fibrillation (AF) is a common arrhythmic disorder among the elderly, and increases the risk of stroke. Oral anticoagulants (OAC) are highly effective in preventing stroke, and there are evidence-based guidelines for the optimal use of OAC in patients with AF. METHODS AND RESULTS: The Fushimi AF Registry is a community-based prospective survey of the AF patients in Fushimi-ku, Kyoto, a typical urban community in Japan with a total population of 283,000. Of the 3,282 patients enrolled by October 2012, 1-year follow-up was completed for 2,914 patients. OAC, mainly warfarin, were given to 1,546 patients (53.1%); overused for low-risk patients, and underused for patients at risk, based on the guidelines. Moreover, warfarin was sometimes given at a sub-therapeutic dose; only 54.4% of patients were within the optimal therapeutic range. The 1-year outcomes revealed that the incidences of both stroke and major bleeding were equivalent between patients taking OAC and those without; major clinical events were as follows: (OAC vs. non-OAC) stroke 2.7% vs. 2.8%, ischemic stroke 2.1% vs. 2.0% and major bleeding 1.4% vs. 1.5% (NS for all). CONCLUSIONS: The Fushimi AF Registry provides a unique snapshot of current AF management in an urban community in Japan. The present study reveals inappropriate use of OAC for patients with AF, indicating discordance between guideline recommendations and real-world clinical practice.

Benefit to decrease esophageal damage using an ablation catheter with increased irrigation channels for pulmonary vein isolation.

INTRODUCTION: An ablation catheter has been developed with six additional irrigation channels at the proximal end of the ablating electrode. We investigated the potential improvement of esophageal damage when the number of irrigation channels of the ablation catheter was increased during pulmonary vein isolation (PVI). METHODS: This study included a total of 296 consecutive patients with atrial fibrillation. One hundred forty-eight patients were randomly assigned to receive PVI using an ablation catheter with six distal irrigation channels (6C) and 148 patients to receive PVI using an ablation catheter with 12 distal irrigation channels (12C). The luminal esophageal temperature (LET) was monitored in all patients. RESULTS: A total of 639 radiofrequency energy applications (in 225 out of 296 patients) reached the cut-off temperature. The time for the LET to reach the cut-off temperature was shorter for the 6C than the 12C group, and the 6C group had a higher T max of the LET than the 12C group. Some patients experienced a transient drop in the LET (TDLET) just before the delivery of the energy. The site that caused a TDLET before the energy delivery always reached the cut-off temperature. TDLET was more frequent in the 6C group than in the 12C group. CONCLUSIONS: The LET only showed a small difference between the 6C and 12C groups. In contrast, there may be a lower risk of esophageal injury with the 6C than the 12C if we use TDLET.

Electrogram characteristics of the coronary sinus in cases requiring epicardial ablation within the coronary sinus for creating a conduction block at the left lateral mitral isthmus.

BACKGROUND: Left lateral mitral isthmus (LLMI) linear ablation is a safe and effective technique for treating left mitral flutter. LLMI linear ablation with pulmonary vein isolation may reduce the recurrence of persistent atrial fibrillation. However, epicardial ablation within the coronary sinus (CS) is often required to create the LLMI block line. If the necessity for epicardial ablation is checked before ablation, complications may be reduced. METHODS: We recruited 135 patients who underwent their first LLMI ablation and divided them into two groups, one group not requiring epicardial ablation for creating a conduction block at the LLMI (Endo group) and another requiring it (Epi group). These two groups were compared in terms of the electrogram characteristics of the CS. RESULTS: Bidirectional block through the LLMI was achieved in 94.8% of patients. In 42% of these patients, not only the endocardium but also the epicardium was ablated. As for the electrogram, the Endo group had lower atrium voltage and atrioventricular voltage ratios (p = 0.009) than the Epi group before LLMI ablation. By contrast, there were no significant differences in the atrium voltage and the atrioventricular voltage ratio between these two groups after LLMI ablation. CONCLUSIONS: For creating a conduction block at the LLMI, the atrium voltage and the atrioventricular voltage ratio in the CS before ablation are important. The atrioventricular voltage ratio is a crucial criterion for determining whether epicardial ablation is necessary; furthermore, the atrioventricular voltage ratio in the CS must be reduced with or without epicardial ablation.

Safety and efficacy of direct oral anticoagulants over warfarin in Japanese patients with acute venous thromboembolism: A meta-analysis.

BACKGROUND: Direct oral anticoagulants (DOACs) have been developed as alternatives to conventional therapy with warfarin for the treatment of acute venous thromboembolism (VTE) events. The safety and efficacy of DOACs in Japanese patients with acute VTE has been investigated in small trials or subgroups from global randomized controlled trials (RCTs). METHODS AND RESULTS: We conducted a systematic review and meta-analysis of RCTs, to compare the safety and efficacy of DOACs to those of conventional therapy in Japanese patients with acute VTE. Published research was systematically searched for RCTs that compared DOAC to conventional therapy in Japanese patients with acute VTE. Random-effects models were used to pool safety and efficacy data across RCTs. Three studies, including 386 patients, were identified. Patients randomized to DOAC had a decreased risk for all bleeding [risk ratio (RR) 0.69, 95% confidential interval (CI) 0.50-0.95], without any significant differences in recurrent VTE (RR 0.84, 95% CI 0.29-2.43) and recurrent VTE/all-cause death (RR 0.60, 95% CI 0.23-1.56). CONCLUSION: DOACs offer clinical benefit over conventional therapy in Japanese patients with acute VTE, showing a significant difference in their bleeding profile.

Clinical Impact of Asymptomatic Presentation Status in Patients With Paroxysmal and Sustained Atrial Fibrillation: The Fushimi AF Registry.

BACKGROUND: The clinical characteristics and outcomes of asymptomatic patients with paroxysmal or persistent/permanent atrial fibrillation (AF) are largely unknown. METHODS: The Fushimi AF Registry is a community-based prospective survey of patients with AF who visited the participating medical institutions in Fushimi-ku, Japan. We investigated the clinical characteristics and outcomes of asymptomatic vs symptomatic patients in the paroxysmal AF (PAF; n = 1,837) and persistent/permanent (sustained atrial fibrillation [SAF]; n = 1,912) subgroups. RESULTS: In the PAF group, asymptomatic patients were older (asymptomatic vs symptomatic group, 74.1 vs 71.1 years of age; P < .01), more often male (62.1% vs 55.6%; P < .01), and had a higher CHA2DS2-VASc (congestive heart failure, hypertension, age ≥ 75 years, diabetes mellitus, history of stroke, vascular disease, age 65-74 years, and female sex) score (mean, 3.37 ± 1.73 vs 2.99 ± 1.63; P < .01), whereas the prevalence of major co-morbidities and CHA2DS2-VASc scores were comparable in the SAF group. Multivariable analysis indicated that age (≥ 75 years), history of stroke/systemic embolism, male sex, and chronic kidney disease were independent determinants of asymptomatic status in the PAF group, whereas age was nonsignificant in the SAF group. During the follow-up period, all-cause mortality was significantly higher (hazard ratio, 1.71 [95% CI, 1.31-2.29]; P < .01) in asymptomatic patients compared with symptomatic patients in the PAF group, whereas it was comparable in the SAF group. CONCLUSIONS: Asymptomatic clinical status is associated with older age, male sex, more co-morbidities with a higher stroke risk profile, and a higher incidence of all-cause death in patients with PAF; these characteristics and outcomes were not seen in the SAF group. TRIAL REGISTRY: UMIN Clinical Trials Registry; No.: UMIN000005834; URL: www.umin.ac.jp/ctr/index.htm.

Relation of Stroke and Major Bleeding to Creatinine Clearance in Patients With Atrial Fibrillation (from the Fushimi AF Registry).

Creatinine clearance (CrCl) has been widely used to adjust the dosage of non-vitamin K antagonist oral anticoagulants in patients with atrial fibrillation (AF) and exclude contraindicated patients. However, there are few available real-world data on the relation between CrCl and adverse clinical outcomes in patients with AF. Therefore, we evaluated the clinical characteristics and adverse events in Japanese patients with AF stratified by CrCl. We categorized patients in the Fushimi AF Registry, a large prospective community-based Japanese cohort of patients with AF, into 3 groups as follows: (1) CrCl <30 ml/min, (2) CrCl 30 to 49 ml/min, and (3) CrCl ≥50 ml/min. We evaluated 3,080 patients after a median follow-up of 1,076 days. Comparing with patients with CrCl ≥50 ml/min, patients with AF with CrCl <30 ml/min showed increased risks of stroke/systemic embolism (SE) (hazard ratio [HR] 1.68; 95% confidence interval [CI] 1.04 to 2.65; p = 0.04) and major bleeding (HR, 2.08; 95% CI 1.23 to 3.39; p = 0.008) after adjustment for prespecified factors. Patients with AF with CrCl <30 ml/min were also associated with higher risks of all-cause death, hospitalization for heart failure, myocardial infarction, or the composite of all-cause death and stroke/SE. However, no excess risk of stroke/SE (HR 1.10; 95% CI 0.76 to 1.58; p = 0.6) or major bleeding (HR 0.98; 95% CI 0.63 to 1.48; p = 0.9) was noted for patients with CrCl 30 to 49 ml/min. In conclusion, Japanese patients with AF with CrCl <30 ml/min were closely associated with adverse clinical events including stroke/SE and major bleeding.

Relationship of Hypertension and Systolic Blood Pressure With the Risk of Stroke or Bleeding in Patients With Atrial Fibrillation: The Fushimi AF Registry.

BACKGROUND: Hypertension is considered a major risk factor of stroke and systemic embolism (SE) as well as bleeding in patients with atrial fibrillation (AF). The purpose of this study was to investigate the relationship of hypertension and systolic blood pressure (SBP) with the risk of stroke/SE or bleeding in AF patients. METHODS: The Fushimi AF Registry, a community-based prospective survey, was designed to enroll all of the AF patients in Fushimi-ku, Kyoto. Fushimi-ku is densely populated with a total population of 283,000. Follow-up data were available for 3,713 patients (follow-up rate 90.0%) as of August 2015, and the median follow-up period was 1,035 days. RESULTS: We compared the clinical backgrounds at baseline, and follow-up outcomes of AF patients between those with hypertension (HTN; n = 2,304, 62.1% of total) and those without (non-HTN; n = 1,409). History of hypertension was neither associated with the incidence of stroke/SE, ischemic stroke, hemorrhagic stroke nor major bleeding. However, when we divided the HTN group by baseline SBP ≥150 mm Hg (HTN-high blood pressure [HBP]: n = 305, 13.3% of HTN group) or <150 mm Hg (HTN-low blood pressure [LBP]: n = 1,983), HTN-HBP group was significantly associated with a higher incidence of both stroke/SE (hazard ratio [HR]: 1.74, 95% confidence interval [CI]: 1.08-2.72) and major bleeding (HR: 2.01, 95% CI: 1.21-3.23) compared with the non-HTN group. In contrast, HTN-LBP group was not associated with the risk of stroke/SE or major bleeding, compared with the non-HTN group. CONCLUSION: The incidences of stroke/SE and bleeding were higher in AF and hypertension patients with elevated SBP. UMIN Clinical Trials Registry: UMIN000005834.

Clinical Characteristics and Outcomes in Extreme Elderly (Age ≥ 85 Years) Japanese Patients With Atrial Fibrillation: The Fushimi AF Registry.

BACKGROUND: Atrial fibrillation (AF) is increasingly prevalent with age, and increasing age is an independent risk factor for ischemic stroke. Oral anticoagulant (OAC) therapy use in the extreme elderly (aged ≥ 85 years) is challenging. METHODS: The Fushimi AF Registry is a community-based prospective study of Japanese patients with AF (79 participating medical institutions in Fushimi-ku, Kyoto, Japan). Patient enrollment started in March 2011, and follow-up data were available for 3,304 patients as of July 2014. We compared clinical characteristics and outcomes between the extreme elderly group (n = 479 [14.5%]) and other age-groups. RESULTS: The extreme elderly group had a higher prevalence of major comorbidities and risk scores for stroke but received fewer OACs. After a mean follow-up of 2.0 years, end points in the extreme elderly group were as follows: all-cause death, 17.6; stroke/systemic embolism, 5.1; and major bleeding, 2.0 per 100 person-years. Extreme age was associated with a higher incidence of combined stroke/systemic embolism and all-cause death (hazard ratio [HR], 3.20; 95% CI, 2.66-3.84; P < .01) and higher incidences of stroke/systemic embolism (HR, 2.57; 95% CI, 1.77-3.65; P < .01) and mortality (HR, 3.48; 95% CI, 2.84-4.25; P < .01) compared with other patients (aged ≤ 84 years). The incidence of major bleeding was not significantly different (HR, 1.40; 95% CI, 0.78-2.36; P = .25). CONCLUSIONS: In the present community-based prospective cohort, Japanese extreme elderly patients with AF had a higher incidence of stroke but similar major bleeding risks compared with the younger AF population. TRIAL REGISTRY: UMIN Clinical Trials Registry; No.: UMIN000005834; URL: http://www.umin.ac.jp/ctr/index.htm.

Left atrial enlargement is an independent predictor of stroke and systemic embolism in patients with non-valvular atrial fibrillation.

Controversy exists regarding whether left atrial enlargement (LAE) is a predictor of stroke/systemic embolism (SE) in atrial fibrillation (AF) patients. The Fushimi AF Registry, a community-based prospective survey, enrolled all AF patients in Fushmi-ku, Japan, from March 2011. Follow-up data and baseline echocardiographic data were available for 2,713 patients by August 2015. We compared backgrounds and incidence of events over a median follow-up of 976.5 days between patients with LAE (left atrial diameter > 45 mm; LAE group) and those without in the Fushimi AF Registry. The LAE group accounted for 39% (n = 1,049) of cohort. The LAE group was older and had longer AF duration, with more prevalent non-paroxysmal AF, higher CHADS2/CHA2DS2-VASc score, and oral anticoagulant (OAC) use. A higher risk of stroke/SE during follow-up in the LAE group was found (entire cohort; hazard ratio (HR): 1.92, 95% confidence interval (CI): 1.40-2.64; p < 0.01; without OAC; HR: 1.97, 95% CI: 1.18-3.25; p < 0.01; with OAC; HR: 1.83, 95% CI: 1.21-2.82; p < 0.01). LAE was independently associated with increased risk of stroke/SE (HR: 1.74, 95% CI: 1.25-2.42; p < 0.01) after adjustment by the components of CHA2DS2-VASc score and OAC use. In conclusion, LAE was an independent predictor of stroke/SE in large community cohort of AF patients.

Predictors for Stroke and Death in Non-Anticoagulated Asian Patients with Atrial Fibrillation: The Fushimi AF Registry.

BACKGROUND: Atrial fibrillation (AF) increases the risk of stroke and death. Data on the predictors for stroke and death in 'real-world' AF patients are limited, especially from large prospective Asian cohorts. METHODS: The Fushimi AF Registry is a community-based prospective survey designed to enroll all AF patients who visited the participating medical institutions in Fushimi-ku, Kyoto, Japan. Follow-up data were available for 3,304 patients (median follow-up period 741 days). We explored the predictors for 'death, stroke, and systemic embolism (SE)' during follow-up in 1,541 patients not receiving oral anticoagulants (OAC) at baseline. RESULTS: The mean age was 73.1 ± 12.5 years, and 673 (44%) patients were female. The mean CHADS2 and CHA2DS2-VASc scores were 1.76 and 3.08, respectively. Cumulative events were as follows: stroke/SE in 61 (4%) and death in 230 (15%), respectively. On multivariate analysis, advanced age (hazard ratio (HR): 1.68, 95% confidence interval (CI): 1.24-2.29), underweight (body mass index <18.5 kg/m2) (HR: 1.71, 95% CI: 1.25-2.32), previous stroke/SE/transient ischemic attack (HR: 1.70, 95% CI: 1.25-2.30), heart failure (HR: 1.59, 95% CI: 1.17-2.15), chronic kidney disease (HR: 1.53, 95% CI: 1.16-2.02), and anemia (HR: 2.41, 95% CI: 1.78-3.28) were independent predictors for death/stroke/SE. Cumulative numbers of these 6 risk predictors could stratify the incidence of death/stroke/SE in patients without OAC, as well as those with OAC in our registry. CONCLUSIONS: Advanced age, underweight, previous stroke/SE/transient ischemic attack, heart failure, chronic kidney disease, and anemia were independently associated with the risk of death/stroke/SE in non-anticoagulated Japanese AF patients.

Current status of clinical background of patients with atrial fibrillation in a community-based survey: the Fushimi AF Registry.

BACKGROUND: Atrial fibrillation (AF) increases the risks of stroke and death, and the prevalence of AF is increasing significantly. Until recently, warfarin was the only oral anticoagulant for stroke prevention, but novel anticoagulants are now under development. METHODS AND RESULTS: The Fushimi AF Registry is a community-based survey of AF patients. We aimed to enroll all of the AF patients in Fushimi-ku, which is located at the southern end of the city of Kyoto. Fushimi-ku is densely populated with a total population of 283,000, and is assumed to represent a typical urban community in Japan. On the basis of the general prevalence of AF in the Japanese (0.6%), we estimated the total number of AF patients as 1700. A total of 76 institutions, a large proportion of which were private clinics, participated in the study. At present, we have enrolled 3183 patients from March 2011 to June 2012 (approximately 1.12% of total population). The mean age was 74.2±11.0 years, and 59.3% of subjects were male. The mean body weight was 58.5±13.2 kg, and the proportions with a body weight of less than 50 kg and 60 kg were 25.7% and 55.0%, respectively. The type of AF was paroxysmal in 46.0%, persistent in 7.3%, and permanent in 46.7%. Major co-existing diseases were hypertension (60.6%), heart failure (27.9%), diabetes (23.2%), stroke (19.4%), coronary artery disease (15.0%), myocardial infarction (6.4%), dyslipidemia (42.4%), and chronic kidney disease (26.4%). The mean CHADS2 score was 2.09±1.35: 0 in 11.8% of patients, 1 in 27.1%, and 2 in 29.1%. Warfarin was prescribed in only 48.5% of patients, whereas anti-platelet drugs, mainly aspirin, were prescribed for more than 30% of the patients. CONCLUSIONS: The Fushimi AF Registry provides a unique snapshot of current AF management in an urban community in Japan.

Measuring luminal esophageal temperature during pulmonary vein isolation of atrial fibrillation.

AIM: To investigate the luminal esophageal temperature (LET) at the time of delivery of energy for pulmonary vein isolation (PVI). METHODS: This study included a total of 110 patients with atrial fibrillation who underwent their first PVI procedure in our laboratory between March 2010 and February 2011. The LET was monitored in all patients. We measured the number of times that LET reached the cut-off temperature, the time when LET reached the cut-off temperature, the maximum temperature (T max) of the LET, and the time to return to the original pre-energy delivery temperature once the delivery of energy was stopped. RESULTS: Seventy-eight patients reached the cut-off temperature. It took 6 s at the shortest time for the LET to reach the cut-off temperature, and 216.5 ± 102.9 s for the temperature to return to the level before the delivery of energy. Some patients experienced a transient drop in the LET (TDLET) just before energy delivery. Ablation at these sites always produced a rise to the LET cut-off temperature. TDLET was not observed at sites where the LET did not rise. Thus, the TDLET before the energy delivery was useful to distinguish a high risk of esophageal injury before delivery of energy. CONCLUSION: Sites with a TDLET before energy delivery should be ablated with great caution or, perhaps, not at all.