Safety and Performance of the Micra VR Leadless Pacemaker in a Japanese Cohort　- Comparison With Global Studies.

BACKGROUND: The Micra leadless pacemaker has demonstrated favorable outcomes in global trials, but its real-world performance and safety in a Japan-specific population is unknown.Methods and Results: Micra Acute Performance (MAP) Japan enrolled 300 patients undergoing Micra VR leadless pacemaker implantation in 15 centers. The primary endpoint was the acute (30-day) major complication rate. The 30-day and 6-month major complication rates were compared to global Micra studies. All patients underwent successful implantation with an average follow-up of 7.23±2.83 months. Compared with previous Micra studies, Japanese patients were older, smaller, more frequently female, and had a higher pericardial effusion risk score. 11 acute major complications were reported in 10 patients for an acute complication rate of 3.33% (95% confidence interval: 1.61-6.04%), which was in line with global Micra trials. Pericardial effusion occurred in 4 patients (1.33%; 3 major, 1 minor). No procedure or device-related deaths occurred. Frailty significantly improved from baseline to follow-up as assessed by Japan Cardiovascular Health Study criteria. CONCLUSIONS: In a Japanese cohort, implantation of the Micra leadless pacemaker had a high success rate and low major complication rate. Despite the Japan cohort being older, smaller, and at higher risk, the safety and performance was in line with global Micra trials.

Effect of Catheter Ablation for Atrial Fibrillation in Heart Failure With Mid-Range or Preserved Ejection Fraction　- Pooled Analysis of the AF Frontier Ablation Registry and Hokuriku-Plus AF Registry.

BACKGROUND: A recent randomized trial demonstrated that catheter ablation for atrial fibrillation (AF) in patients with heart failure with reduced ejection fraction (EF) is associated with a reduction in death or heart failure. However, the effect of catheter ablation for AF in patients with heart failure with mid-range or preserved EF is unclear.Methods and Results: We screened 899 AF patients (72.4% male, mean age 68.4 years) with heart failure and left ventricular EF ≥40% from 2 Japanese multicenter AF registries: the Atrial Fibrillation registry to Follow the long-teRm Outcomes and use of aNTIcoagulants aftER Ablation (AF Frontier Ablation Registry) as the ablation group (525 patients who underwent ablation) and the Hokuriku-Plus AF Registry as the medical therapy group (374 patients who did not undergo ablation). Propensity score matching was performed in these 2 registries to yield 106 matched patient pairs. The primary endpoint was a composite of cardiovascular death and hospitalization for heart failure. At 24.6 months, the ablation group had a significantly lower incidence of the primary endpoint (hazard ratio 0.32; 95% confidence interval 0.13-0.70; P=0.004) than the medical therapy group. CONCLUSIONS: Compared with medical therapy, catheter ablation for AF in patients with heart failure and mid-range or preserved EF was associated with a significantly lower incidence of cardiovascular death or hospitalization for heart failure.

Different Determinants of the Recurrence of Atrial Fibrillation and Adverse Clinical Events in the Mid-Term Period After Atrial Fibrillation Ablation.

BACKGROUND: It is unclear whether there are differences in the clinical factors between atrial fibrillation (AF) recurrence and adverse clinical events (AEs), including stroke/transient ischemic attack (TIA), major bleeding, and death, after AF ablation.Methods and Results:We examined the data from a retrospective multicenter Japanese registry conducted at 24 cardiovascular centers between 2011 and 2017. Of the 3,451 patients (74.1% men; 63.3±10.3 years) who underwent AF ablation, 1,046 (30.3%) had AF recurrence and 224 (6.5%) suffered AEs (51 strokes/TIAs, 71 major bleeding events, and 36 deaths) over a median follow-up of 20.7 months. After multivariate adjustment, female sex, persistent and long-lasting persistent AF (vs. paroxysmal AF), and stepwise increased left atrial diameter (LAd) quartiles were significantly associated with post-ablation recurrences. A multivariate analysis revealed that an age ≥75 years (vs. <65 years), body weight <50 kg, diabetes, vascular disease, left ventricular (LV) ejection fraction <40% (vs. ≥50%), Lad ≥44 mm (vs. <36 mm), and creatinine clearance <50 mL/min were independently associated with AE incidences, but not with recurrences. CONCLUSIONS: This study disclosed different determinants of post-ablation recurrence and AEs. Female sex, persistent AF, and enlarged LAd were determinants of post-ablation recurrence, whereas an old age, comorbidities, and LV and renal dysfunction rather than post-ablation recurrence were AEs determinants. These findings will help determine ablation indications and post-ablation management.

Impact of sinus rhythm maintenance on major adverse cardiac and cerebrovascular events after catheter ablation of atrial fibrillation: insights from AF frontier ablation registry.

The impact of catheter ablation for atrial fibrillation (AF) on cardiovascular events and mortality is controversial. We investigated the impact of sinus rhythm maintenance on major adverse cardiac and cerebrovascular events after AF ablation from a Japanese multicenter cohort of AF ablation. We investigated 3326 consecutive patients (25.8% female, mean age 63.3 ± 10.3 years) who underwent catheter ablation for AF from the atrial fibrillation registry to follow the long-term outcomes and use of anti coagulants after ablation (AF frontier ablation registry). The primary endpoint was a composite of stroke, transient ischemic attack, cardiovascular events, and all-cause death. During a mean follow-up of 24.0 months, 2339 (70.3%) patients were free from AF after catheter ablation, and the primary composite endpoint occurred in 144 (4.3%) patients. The AF nonrecurrence group had a significantly lower incidence of the primary endpoint (1.8 per 100 person-years) compared with the AF recurrence group (3.0 per 100 person-years, p = 0.003). The multivariate analysis revealed that freedom from AF (hazard ratio 0.61, 95% confidence interval 0.44-0.86, p = 0.005) was independently associated with the incidence of the composite event. In the multicenter cohort of AF ablation, sinus rhythm maintenance after catheter ablation was independently associated with lower rates of major adverse cardiac and cerebrovascular events.

Clinical outcomes of ablation versus non-ablation therapy for atrial fibrillation in Japan: analysis of pooled data from the AF Frontier Ablation Registry and SAKURA AF Registry.

Whether ablation for atrial fibrillation (AF) is, in terms of clinical outcomes, beneficial for Japanese patients has not been clarified. Drawing data from 2 Japanese AF registries (AF Frontier Ablation Registry and SAKURA AF Registry), we compared the incidence of clinically relevant events (CREs), including stroke/transient ischemic attack (TIA), major bleeding, cardiovascular events, and death, between patients who underwent ablation (n = 3451) and those who did not (n = 2930). We also compared propensity-score matched patients (n = 1414 in each group). In propensity-scored patients who underwent ablation and those who did not, mean follow-up times were 27.2 and 35.8 months, respectively. Annualized rates for stroke/TIA (1.04 vs. 1.06%), major bleeding (1.44 vs. 1.20%), cardiovascular events (2.15 vs. 2.49%) were similar (P = 0.96, 0.39, and 0.35, respectively), but annualized death rates were lower in the ablation group than in the non-ablation group (0.75 vs.1.28%, P = 0.028). After multivariate adjustment, the risk of CREs was statistically equivalent between the ablation and non-ablation groups (hazard ratio [HR] 0.89, 95% confidence interval [CI] 0.71-1.11), but it was significantly low among patients who underwent ablation for paroxysmal AF (HR 0.68 [vs. persistent AF], 95% CI 0.49-0.94) and had a CHA2DS2-VASc score < 3 (HR 0.66 [vs. CHA2DS2-VASc score ≥ 3], 95% CI 0.43-0.98]). The 2-year risk reduction achieved by ablation may be small among Japanese patients, but AF ablation may benefit those with paroxysmal AF and a CHA2DS2-VASc score < 3.

Low prevalence of colonic mucosal injury and bleeding in patients taking direct oral anticoagulants for non-valvular atrial fibrillation.

OBJECTIVE: Direct oral anticoagulants are frequently used to prevent systemic embolism associated with atrial fibrillation. Gastrointestinal bleeding is a common adverse event of this pharmacotherapy, especially in the lower gastrointestinal tract. However, the prevalence of mucosal injury of the colon in patients taking direct oral anticoagulants has remained unknown. MATERIALS AND METHODS: This was a retrospective study using endoscopic records of the colon from patients taking oral anticoagulants. Records from colonoscopies for 120 patients with non-valvular atrial fibrillation who had been prescribed direct oral anticoagulants between April 2011 and June 2017 were reviewed to determine the prevalence of mucosal injury and other findings, compared with those of 140 patients on warfarin. RESULTS: The prevalence of mucosal injury was 1.6% in patients taking direct oral anticoagulants and 1.4% in those taking warfarin, lower than other findings such as diverticula, hemorrhoids, and polyps. Bleeding was more frequent with direct oral anticoagulants (18 patients; 15%) than with warfarin (9 patients; 6.4%). Colonic diverticulum was the most common cause of bleeding in patients on direct oral anticoagulants. The prevalence of mucosal injury and causes of bleeding did not differ among direct oral anticoagulants. CONCLUSION: Colonic mucosal injury was infrequent in patients on direct oral anticoagulants. Bleeding was more frequent with direct oral anticoagulants than with warfarin. Colonic diverticulum and vascular ectasia were common causes of bleeding in patients on direct oral anticoagulants. Little difference in cause of bleeding was evident among oral anticoagulants.

Clinical Outcomes of Off-Label Underdosing of Direct Oral Anticoagulants After Ablation for Atrial Fibrillation.

Direct oral anticoagulants (DOACs) are sometimes prescribed at off-label under-doses for patients who have undergone ablation for atrial fibrillation (AF). This practice may be an attempt to balance the risk of bleeding against that of stroke or AF recurrence.We examined outcomes of 1163 patients who continued use of a DOAC after ablation. The patients were enrolled in a large (3530 patients) multicenter registry in Japan. The study patients were classified as 749 (64.4%) appropriate standard-dose DOAC users, 216 (18.6%) off-label under-dose DOAC users, and 198 (17.0%) appropriate low-dose DOAC users.Age and CHA2DS2-VASc scores differed significantly between DOAC dosing regimens, with patients given an appropriate standard-dose being significantly younger (63.3 ± 9.4 versus 64.8 ± 9.5 versus 73.2 ± 6.8 years, P < 0.0001) and lower (2.1 ± 1.5 versus 2.4 ± 1.6 versus 3.4 ± 1.4, P < 0.0001) than those given an off-label under-dose or an appropriate low-dose. During the median 19.0-month follow-up period, the AF recurrence rate was similar between the appropriate standard-dose and off-label under-dose groups but relatively low in the appropriate low-dose group (42.5% versus 41.2% versus 35.4%, P = 0.08). Annualized rates of thromboembolic events, major bleeding, and death from any cause were 0.47%, 0.70%, and 0.23% in the off-label under-dose group, while those rates were 0.74%, 0.73%, and 0.65% in the appropriate standard-dose, and 1.58%, 2.12%, and 1.57% in the appropriate low-dose groups.In conclusion, the clinical adverse event rates for patients on an off-label under-dose DOAC regimen after ablation, predicated on careful patient evaluations, was not high as seen with that of patients on a standard DOAC dosing regimen.

Current Status and Clinical Outcomes of Oral Anticoagulant Discontinuation After Ablation for Atrial Fibrillation in Japan　- Findings From the AF Frontier Ablation Registry.

BACKGROUND: The safety of discontinuing oral anticoagulant (OAC) after ablation for atrial fibrillation (AF) in Japanese patients has not been clarified.Methods and Results:A study based on the Atrial Fibrillation registry to Follow the long-teRm Outcomes and use of aNTIcoagulants aftER Ablation (AF Frontier Ablation Registry) was conducted. Data were collected from 3,451 consecutive patients (74.1% men; age, 63.3±10.3 years) who had undergone AF ablation at any of 24 cardiovascular centers in Japan between August 2011 and July 2017. During a 20.7-month follow-up period, OAC therapy was discontinued in 1,836 (53.2%) patients; 51 patients (1.5%) suffered a stroke/transient ischemic attack (TIA), 71 (2.1%) suffered major bleeding, and 36 (1.0%) died. Patients in whom OAC therapy was discontinued were significantly younger than those in whom OACs were continued, and their CHA2DS2-VASc scores were significantly lower. The incidences of stroke/TIA, major bleeding, and death were significantly lower among these patients. Upon multivariate adjustment, stroke events were independently associated with relatively high baseline CHA2DS2-VASc scores but not with OAC status. CONCLUSIONS: Although the incidences of stroke/TIA, major bleeding, and death were relatively low among patients for whom OAC therapy was discontinued, stroke/TIA occurrence was strongly associated with a high baseline stroke risk rather than with OAC status. Thus, discontinuation of OAC therapy requires careful consideration, especially in patients with a high baseline stroke risk.

Simple and novel technique to confirm complete mitral isthmus block.

BACKGROUND: Differential pacing technique to confirm mitral isthmus (MI) block is sometimes challenging due to destroyed tissues after extensive ablation. The purpose of this study is to set an endpoint of MI ablation using conduction time around the mitral annulus (MA). METHODS: Forty-five consecutive patients with persistent atrial fibrillation who received MI linear ablation were included. The geometry and activation times of the left atrium around the MA were collected using a multipolar catheter before ablation. During coronary sinus (CS) pacing, the time between the stimulus and the wave-front collision at the opposite side of the MA (defined as T/2) was calculated, and the doubled value was defined as the estimated perimitral conduction time (E-PMCT). The endpoint for complete MI block was when the stimulus (at distal CS) minus the maximal delayed potential (St-MDP) on the MI interval reached the E-PMCT. RESULTS: St-MDP reached E-PMCT during MI ablation in 44/45 patients. Among these 44 patients, differential pacing revealed bidirectional block in 39/44 (88.6%), whereas in 5/44 (11.4%), the differential pacing was not possible because of the loss of capture of local potentials due to extensive applications around the linear line. In one patient, the St-MDP did not reach E-PMCT (E-PMCT: 148 ms, St-MDP :130 ms) and differential pacing revealed no MI block. E-PMCT values (median 176 ms) correlated strongly with St-MDP (median 185 ms, P < 0.0001, R = 0.98). CONCLUSIONS: Although E-PMCT differs between individuals, the value is significantly correlated with the St-MDP. This technique may be useful in providing an individual endpoint of MI ablation as an alternative to differential pacing.

The proportion of asymptomatic recurrence after catheter ablation of atrial fibrillation in patients with a pacemaker for sick sinus syndrome.

BACKGROUND: Catheter ablation (CA) of paroxysmal atrial fibrillation (PAF) is an effective treatment. However, the frequency of asymptomatic AF recurrence after CA in patients with PAF and sick sinus syndrome (SSS) is not clear. The aim of this study was to elucidate the real AF recurrence after CA in patients with PAF and a pacemaker for SSS. METHODS AND RESULTS: Fifty-one consecutive patients (mean age 66.6 ± 7.0 years, male 34) with PAF and SSS and pacemakers underwent CA. All patients were followed at 1, 3, 6, 9, and 12 months after the CA using a 12-lead ECG, Holter-ECG, and 1-month event recorder as a conventional follow-up. In addition, the pacemakers were interrogated every 12 months. During a 5-year follow-up after the final CA procedure, AF recurrences were observed in 7 patients (13.7%) with a conventional follow-up, including 1 (2.0%) asymptomatic patient. Pacemaker-interrogation revealed another 10 patients (19.6%) with asymptomatic AF recurrences. Ultimately, the conventional follow-up plus pacemaker-interrogation provided a higher incidence of AF recurrences (P = 0.009). Multiple CA procedures contributed to a significant increase in the AF-free survival rate at 5 years: 58.6% after a single CA and 86.0% after multiple CA procedures with a conventional follow-up, but which decreased to 40.6% and 60.9% with a conventional follow-up plus a pacemaker interrogation, respectively. CONCLUSIONS: One-third of PAF patients with SSS and pacemakers recurred after multiple CA sessions. However, 65% of them were asymptomatic and difficult to be identified with conventional follow-up. Pacemaker interrogation significantly increased the detection rate of AF-recurrence.

Rapid Mapping of Right Atrial Tachycardia Using a New Multielectrode Basket Catheter.

INTRODUCTION: The mapping of atrial tachycardia (AT) can often be challenging and time-consuming, especially in patients with ATs that develop following cardiac surgery or are concomitant with atrial fibrillation. Recently, a new multielectrode basket catheter (MBC) has become available; we hypothesized that the MBC could be utilized to diagnose AT circuits. METHODS AND RESULTS: This study included 51 consecutive patients undergoing catheter ablation of clinically documented right-sided ATs (including 17 cases following cardiac surgery). Using a NavX system, 2 activation maps of the ATs were created, one using the new MBC (32 mm, 31 poles) and the other using a circular catheter. The time needed to complete the activation maps and the points acquired with both mapping catheters were compared. In all 64 ATs, including 34 non-cavotricuspid isthmus-dependent ATs, the AT activation maps created by both catheters were essentially identical. The number of points acquired to complete the activation maps did not differ significantly between the MBC and the circular catheter (387 [285-511] vs. 374 [269-533], P = 0.19), but the mapping time was significantly shorter using the MBC (4.0 [3.0-6.0] minutes vs. 8.0 [6.5-10.0] minutes, P < 0.0001). Inadvertent mechanical AT termination (n = 6) was observed only during mapping with the circular catheter. CONCLUSION: In patients with right-sided ATs, the use of an MBC could save mapping time.

Impact of Non-Pulmonary Vein Foci on the Outcome of the Second Session of Catheter Ablation for Paroxysmal Atrial Fibrillation.

BACKGROUND: Paroxysmal atrial fibrillation (AF) is primarily triggered by pulmonary veins (PVs). However, non-PV AF foci may also trigger AF. METHODS: We examined 207 patients (mean age, 62 ± 11 years; 166 men) who underwent a second catheter ablation (CA) and evaluated the clinical significance of non-PV AF foci on the outcomes. RESULTS: Electrical reconnections between the PVs and left atrium (LA) were observed in 162 patients (78.3%). Non-PV AF foci were identified in 95 patients (45.9%, 60 patients with successfully ablated non-PV AF foci and 35 with unmappable non-PV AF foci). During a median follow-up period of 22.7 months, 61 patients (29.5%; 18/112 [16.1%] without non-PV AF foci vs. 20/60 [33.3%] with successfully ablated non-PV AF foci vs. 23/35 [65.7%] with unmappable non-PV AF foci, P < 0.0001) developed AF recurrence; 52 (85.2%) developed recurrence within 1 year. The presence of non-PV AF foci was a significant clinical predictor of AF recurrence after the second CA; successfully ablated non-PV AF foci increased the AF recurrence risk by 2.24 times (95% confidence interval [CI], 1.12-4.54; P = 0.02), and unmappable AF foci increased this risk by 5.58 times (95% CI, 2.73-11.63; P < 0.0001). CONCLUSION: Nearly half of the patients had non-PV AF foci at the second CA session. AF recurred after the second CA session in approximately 30%, with most recurrences happening within 1 year. The presence of non-PV AF foci significantly increased the AF recurrence risk after a second CA. When non-PV AF foci were unmappable, the AF recurrence rate was extremely high.

Simultaneous isolation of superior and inferior pulmonary veins on both the left and right sides could yield better outcomes in patients with paroxysmal atrial fibrillation.

AIMS: This study investigated whether disappearance patterns of pulmonary vein (PV) potentials (PVPs) during PV isolation (PVI) affect the outcome of catheter ablation (CA) in patients with paroxysmal atrial fibrillation (PAF). METHODS AND RESULTS: Extensive PVI was performed in 1149 PAF patients (age, 61 ± 10 years). Clinical and demographic characteristics, ablation data, and follow-up outcomes were prospectively collected. During an initial CA, simultaneous disappearance of superior and inferior PVPs in both right and left PVs was observed in 464 (40.4%) patients (Group S). Atrial fibrillation-recurrence free rates at 1, 3, and 5 years after the initial CA in Group S were 78.9, 71.9, and 68.1%, respectively, which were higher than those in Group Non-S (P = 0.004). However, those were similar after the final CA between both groups. The incidence of PV-left atrium (LA) electrical reconnection was significantly lower in Group S than in Group Non-S in the second (Group S, 65.6% vs. Group Non-S, 82.1%; P = 0.004) and third (Group S, 8.3% vs. Group Non-S, 47.6%; P = 0.03) CAs. Furthermore, the reconnections more frequently occurred on the side of PVs where simultaneous PVP elimination had not been achieved at the initial CA. Simultaneous disappearance of superior and inferior PVPs in both right and left PVs independently reduced the risk of AF recurrence after the initial CA by 26%. CONCLUSIONS: The simultaneous disappearance of superior and inferior PVPs in both right and left PVs is associated with less frequent PV-left atrium reconnection and may yield a better clinical outcome after the initial CA.

The impact of haemodialysis on the outcomes of catheter ablation in patients with paroxysmal atrial fibrillation.

AIMS: The outcomes of catheter ablation (CA) in patients with paroxysmal atrial fibrillation (PAF) who are undergoing haemodialysis (HD) have not been fully elucidated. This study aimed to determine the impact of HD on CA outcome in these patients. METHODS AND RESULTS: We examined 1364 consecutive PAF patients (mean age, 61 ± 10 years) who underwent CA, including 32 (2.3%) patients undergoing HD. The patients undergoing HD had a significantly lower body mass index (P < 0.0001), higher CHADS2 score (P = 0.006), and higher prevalence of structural heart disease (P < 0.0001), hypertension (P = 0.002), and congestive heart failure (P = 0.02). Echocardiography indicated a larger left atrial diameter (P < 0.0001) and left ventricular diameter (P = 0.0002) in the HD patients. Haemodialysis was a significant predictor of AF recurrence (hazard ratio 2.56; 95% confidence interval 1.56-4.03; P = 0.0004) in the overall population. Sinus rhythm maintenance rates in the HD patients at 1, 3, and 5 years were 42.3, 37.6, and 19.7%, respectively, after the first procedure, and 64.7, 54.9, and 47.1%, respectively, after the final procedure (median, 2; range, 1-2 procedures); these rates were significantly lower than those in the non-HD patients (P < 0.0001). The 5-year survival rate was 78.1% in the HD patients. CONCLUSION: Haemodialysis was significantly associated with AF recurrence after CA for PAF. However, an ∼50% success rate for sinus rhythm maintenance without antiarrhythmic drug therapy in HD patients suggested that CA could be an option for the treatment of AF.

Oesophageal cooling with ice water does not reduce the incidence of oesophageal lesions complicating catheter ablation of atrial fibrillation: randomized controlled study.

AIM: Atrial fibrillation (AF) ablation can result in oesophageal injuries that lead to atrio-oesophageal fistulae, a life-threatening complication. This study aimed to evaluate whether oesophageal cooling could prevent oesophageal lesions complicating AF ablation. METHODS AND RESULTS: We randomly assigned 100 patients with drug-resistant AF to an oesophageal cooling group or a control group. In the oesophageal cooling group, we injected 5 mL of ice water into the oesophagus prior to radiofrequency (RF) energy delivery adjacent to the oesophagus. If the oesophageal temperature reached 42°C, the RF energy delivery was stopped, and the ice water injection was repeated. In the control group, oesophageal cooling was not applied. Oesophageal endoscopy was performed 1 day after the catheter ablation, and lesions were qualitatively assessed as mild, moderate, or severe. The numbers of ablation sites with an oesophageal temperature of >42°C were 1.7 ± 1.4 and 2.6 ± 1.7 in the oesophageal cooling group and the control group, respectively (P = 0.04), and the maximal oesophageal temperature at those sites was 43.0 ± 0.6 and 44.7 ± 0.9°C (P < 0.0001). Oesophageal lesions occurred almost equally between the oesophageal cooling group [10 of 50 patients (20%)] and the control group [11 of 50 patients (22%)]. However, the severity of the oesophageal lesions was slightly milder in the oesophageal cooling group (three moderate, seven mild) than in the control group (three severe, one moderate, seven mild). CONCLUSION: Oesophageal cooling may alleviate the severity of oesophageal lesions but does not reduce the incidence of this complication under the specific protocol evaluated here.

Late-phase thromboembolism after catheter ablation for paroxysmal atrial fibrillation.

BACKGROUND: The aim of this study was to investigate the incidence and predictors (which have not previously been fully elucidated) of late-phase thromboembolism (TE) after catheter ablation (CA) for paroxysmal atrial fibrillation (AF). METHODS AND RESULTS: We studied 1,156 consecutive patients (61±10 years; 891 men; CHADS2score, 0.8±1.0) after CA for symptomatic paroxysmal AF and examined the details of late-phase TE. During a follow-up of 49.5±21.9 months (median, 47 months; range, 6-113 months) after CA, 9 patients (0.78%) developed late-phase TE, all of which were ischemic stroke. Of these, 5 patients with AF recurrence experienced cardioembolism; the AF was asymptomatic at recurrence. The remaining 4 without AF recurrence experienced cardioembolism (n=1), small-vessel occlusion (n=1), large-artery atherosclerosis (n=1), and stroke of other determined etiology (n=1). On Kaplan-Meier analysis patients with structural heart disease (P=0.003), AF recurrence after the final CA (P=0.01), prior stroke (P=0.002), CHADS2score ≥2 (P=0.0002), left ventricular ejection fraction <50% (P<0.0001), and spontaneous echo contrast on transesophageal echocardiogram (P=0.0004) had a significantly higher risk of late-phase TE. Multivariate analysis indicated that CHADS2score ≥2 (HR, 4.49; 95% CI: 1.08-22.56; P=0.04) independently predicted late-phase TE. CONCLUSIONS: The incidence of TE was low after CA for paroxysmal AF, but CHADS2score ≥2 independently increased the risk of late-phase TE.

Takotsubo cardiomyopathy in siblings.

We report the case of apical ballooning syndrome (ABS) in a female sibling. A 64-year-old woman was admitted to our hospital with sudden-onset chest pain. Cardiac enzymes were mildly elevated and an electrocardiogram showed broad ST-T changes. Emergency coronary angiography revealed no culprit lesion and left ventriculography demonstrated focal akinesis of the apical wall, which was consistent with ABS. Myocardial functional sympathetic innervations assessed using [(123)I]metaiodobenzylguanidine was severely impaired in the apical region. Her clinical symptoms and cardiac dysfunction recovered spontaneously. Just 1 year prior to our patient's cardiac event, her elder sister had the same symptoms and was also diagnosed with ABS. Both sisters were postmenopausal. The familial case of ABS is exceedingly rare, but these cases suggest a possible genetic etiology.

Prevention of periprocedural ischemic stroke and management of hemorrhagic complications in atrial fibrillation ablation under continuous warfarin administration.

INTRODUCTION: This study aimed to determine the effects of continuing warfarin administration during the periprocedural period of catheter ablation for atrial fibrillation (AF) on the prevention of stroke complications and to evaluate the management of hemorrhagic complications occurring with this approach. METHODS AND RESULTS: A total of 3,280 patients undergoing AF catheter ablation at our institution were divided into 2 groups: the first 1,953 patients who discontinued warfarin 3-4 days before AF ablation and were bridged with heparin (warfarin-discontinued group), and the last 1,327 patients who continued warfarin throughout the periprocedural period (warfarin-continued group). Symptomatic stroke or transient ischemic attack occurred in 13/1,953 patients (0.67%) in the warfarin-discontinued group and in 2/1,327 patients (0.15%) in the warfarin-continued group (P = 0.021). None of the patients with therapeutic international normalized ratio at the time of the procedure had periprocedural thromboembolism in the warfarin-continued group. Major hemorrhagic complications occurred in 26/1,953 patients in the warfarin-discontinued group (1.3%; 25 with cardiac tamponade and 1 with retroperitoneal bleeding), and in 15/1,327 patients in the warfarin-continued group (1.1%; 14 with cardiac tamponade and 1 with abdominal wall bleeding) (P = 0.80). Of the 14 warfarin-continued patients with cardiac tamponade, 13 were administered prothrombin complex concentrate (PCC) and vitamin K; the bleeding was stopped safely without surgical repair. CONCLUSION: The continuation of warfarin during the periprocedural period of AF ablation could reduce the incidence of stroke without increasing hemorrhagic complications. When cardiac tamponade occurred with this approach, it was safely treated with PCC and vitamin K.

Clinical characteristics and management of periesophageal vagal nerve injury complicating left atrial ablation of atrial fibrillation: lessons from eleven cases.

INTRODUCTION: This study aimed to elucidate the clinical characteristics and management of periesophageal vagal nerve injury complicating the ablation of atrial fibrillation (AF). METHODS AND RESULTS: A total of 3,695 patients with drug-resistant AF underwent extensive pulmonary vein isolation at our institution. Either a nonirrigated or an irrigated ablation catheter was employed, with radiofrequency power of 25-40 W. Esophageal temperature was monitored in 3,538 patients: when the esophageal temperature reached 42°C radiofrequency delivery was stopped. A total of 11 patients (60 ± 11 years, 10 males) were diagnosed as having a periesophageal vagal nerve injury after the AF ablation. Symptoms included nausea, vomiting, bloating, constipation, and gastric pain, which occurred within 72 hours after the procedure. Gastrointestinal fluoroscopy and/or endoscopy revealed gastric hypomotility (10 patients) and pyloric spasm (1 patient). Intravenous erythromycin (3 mg/kg every 8 hours) was effective in relieving symptoms in 5 patients, and the patient with pyloric spasm underwent esophagojejunal anstomosis. Eight patients almost fully recovered within 40 days; however, 3 patients suffered from severe symptoms for 3-12 months. This complication occurred in 4 of the 157 patients (2.5%) who did not have esophageal temperature monitoring, and 7 of the 3,538 (0.2%) who did (P = 0.0007). The 3 patients with persistent severe symptoms received no esophageal temperature monitoring. CONCLUSION: The clinical course and severity of the periesophageal vagal nerve injury varied, but most patients finally recovered with conservative treatment. Radiofrequency delivery under esophageal temperature monitoring might reduce both the incidence and the severity of this complication.

Registry for Evaluating Healthy Life Expectancy and Long-Term Outcomes after Catheter Ablation of Atrial Fibrillation in the Very Elderly (REHEALTH AF) study: rationale and design of a prospective, multicentre, observational, comparative study.

INTRODUCTION: Data are lacking on the extent to which patients with non-valvular atrial fibrillation (AF) who are aged ≥80 years benefit from ablation treatment. The question pertains especially to patients' postablation quality of life (QoL) and long-term clinical outcomes. METHODS AND ANALYSIS: We are initiating a prospective, registry-based, multicentre observational study that will include patients aged ≥80 years with non-valvular AF who choose to undergo treatment by catheter ablation and, for comparison, such patients who do not choose to undergo ablation (either according to their physician's advice or their own preference). Study subjects are to be enrolled from 52 participant hospitals and three clinics located throughout Japan from 1 June 2022 to 31 December 2023, and each will be followed up for 1 year. The planned sample size is 660, comprising 220 ablation group patients and 440 non-ablation group patients. The primary endpoint will be the composite incidence of stroke/transient ischaemic attack (TIA) or systemic embolism (SE), another cardiovascular event, major bleeding and/or death from any cause. Other clinical events such as postablation AF recurrence, a fall or bone fracture will be recorded. We will collect standard clinical background information plus each patient's Clinical Frailty Scale score, AF-related symptoms, QoL (Five-Level Version of EQ-5D) scores, Mini-Mental State Examination (optional) score and laboratory test results, including measures of nutritional status, on entry into the study and 1 year later, and serial changes in symptoms and QoL will also be secondary endpoints. Propensity score matching will be performed to account for covariates that could affect study results. ETHICS AND DISSEMINATION: The study conforms to the Declaration of Helsinki and the Ethical Guidelines for Clinical Studies issued by the Ministry of Health, Labour and Welfare, Japan. Results of the study will be published in one or more peer-reviewed journals. TRIAL REGISTRATION NUMBER: UMIN000047023.