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BACKGROUND OR PURPOSE We report our single-center experience with percutaneous left atrial appendage closure (LAAC) in patients with non-valvular atrial fibrillation (NVAF) and primary hemostasis disorders (HD). METHODS Consecutive patients with primary HD who underwent a percutaneous LAAC were included. Baseline characteristics, procedural data, and clinical outcomes were prospectively collected and compared with the overall LAAC cohort without HD. RESULTS Since 2013, among 229 LAAC, 17 patients (7%) had a primary HD: thrombocytopenia (n = 5), myelodysplastic syndrome (n = 6), von Willebrand syndrome (n = 4), type A hemophilia (n = 1), and dysfibrinogenemia (n = 1). The HD population's age ranged from 61 to 87 years, and the median CHA2DS2VASc was 5. Periprocedural plasmatic management was required in 47% of patients. The immediate LAAC implantation success rate was 100%. Patients received a direct oral anticoagulant (DOA) (n = 9), dual antiplatelet (n = 6), aspirin (n = 1), or no therapy (n = 1) during the first six postoperative weeks, followed with single antiplatelet (n = 16) or no therapy (n = 1) during lifelong. After 20 months, the technical success rate and procedural success rate were 100% and 94%. Zero device-/procedure-related complication and only one life-threatening bleeding occurred. Compared to patients without HD (n = 212), a baseline history of bleeding was less frequent (53% vs 91%, p

Twiddler syndrome is an uncommon yet dangerous phenomenon usually resulting in lead displacement with loss of capture of cardiac implantable electronic devices. In this case report, we present an interesting case of Twiddler syndrome without lead dislodgment which was detected by an alert triggered by an increase in impedance on remote monitoring.

Background Guidelines recommend a trial of one or more antiarrhythmic drugs before catheter ablation is considered in patients with atrial fibrillation. However, first-line ablation may be...

Background Monitoring of cardiac implantable electronic devices was highly impacted by the COVID‐19 pandemic considering the high volume of in‐person visits for regular follow‐up. Recent recommendations highlight the important role of remote monitoring to prevent exposure to the virus. This study compared remote monitoring of implantable cardioverter defibrillators (ICDs) in patients whose in‐person annual visit was substituted for a remote monitoring session with patients who were already scheduled for a remote monitoring session. Methods This was a cross‐sectional observational study of 329 consecutive patients between 20 March and 24 April 2020. Group 1 included 131 patients whose in‐person annual visit was substituted for a remote monitoring session. Group 2 included 198 patients who underwent a remote monitoring session as scheduled in their usual device follow‐up. The time interval since the last in‐person visit was 13.3 ± 3.2 months in group 1 and 5.9 ± 1.7 months in group 2 (P .99). Conclusion Remote monitoring of ICDs is useful to identify clinical events and allows physicians to treat patients appropriately during the COVID‐19 pandemic regardless of the time interval since their last in‐person visit. It reduces significantly in‐person visit for regular follow‐up.

Background: The number of implantable cardioverter defibrillator (ICD) infections is increasing due to an increased number of ICD implants, higher-risk patients, and more frequent replacement procedures, which carry a higher risk of infection. Reducing the morbidity, mortality, and cost of ICD-related infections requires an understanding of the current rate of this complication and its predictors. Methods: The Shock Implant Evaluation Trial (SIMPLE) trial randomized 2500 ICD recipients to defibrillation testing or not. Over an average of 3.1 years, patients were seen every 6 months and examined for evidence of ICD infection, which was defined as requiring device removal and/or intravenous antibiotics. Results: Within 24 months, 21 patients (0.8%) developed infection. Fourteen patients (67%) with infection presented within 30 days, 20 patients by 12 months, and only 1 patient beyond 12 months. Univariate analysis demonstrated that patients with primary electrical disorders (3 patients, P = 0.009) and those with a secondary prevention indication (13 patients, P = 0.0009) were more likely to develop infection. Among the 2.2% of patients who developed an ICD wound hematoma, 10.4% developed an infection. Among the 8.3% of patients requiring an ICD reintervention, 1.9% developed an infection. Conclusions: This cohort of ICD recipients at high-volume centres have a low risk of device-related infection. However; strategies to reduce wound hematoma and the need for ICD reintervention could further reduce the rate of infection. Résumé: Contexte: L’incidence des cas d’infection du défibrillateur cardioverteur implantable (DCI) augmente en raison du nombre accru d’implantations, de l’emploi de ces dispositifs chez des patients exposés à un risque très élevé et de l’augmentation de la fréquence des interventions de remplacement, qui sont associées à un plus grand risque d’infections. Pour parvenir à réduire la morbidité, la mortalité et les coûts associés aux infections liées à un DCI, il faut connaître la fréquence de cette complication et les facteurs qui permettent de la prédire. Méthodologie: Lors de l’essai Shock Implant Evaluation Trial (SIMPLE), 2 500 patients ayant reçu un DCI ont été répartis aléatoirement en deux groupes, l’un subissant des tests de défibrillation et l’autre, non. Sur une période de 3,1 ans en moyenne, les patients ont été vus en consultation tous les 6 mois et examinés à la recherche de signes d’infection du DCI, définie comme étant une infection exigeant le retrait du dispositif et/ou l’administration d’antibiotiques par voie intraveineuse. Résultats: Au total, 21 patients (0,8 %) ont présenté une infection dans les 24 mois suivant l’implantation. Quatorze patients (67 %) ont présenté une infection dans les 30 jours suivant l’intervention; à 12 mois, 20 patients avaient présenté une infection. Un seul patient a présenté une infection plus de 12 mois après l’intervention. Les résultats d’une analyse univariée ont démontré qu’une infection était plus probable chez les patients qui présentaient un trouble électrique primaire (3 patients, p = 0,009) et chez ceux qui avaient reçu un dispositif en prévention secondaire (13 patients, p = 0,0009). Parmi les patients qui présentaient un hématome après l’implantation du DCI (2,2 %), 10,4 % ont présenté une infection. Parmi les patients qui ont eu besoin d’une nouvelle intervention relative au DCI (8,3 %), 1,9 % ont présenté une infection. Conclusions: Les patients de cette cohorte ayant reçu un DCI dans des établissements à haut volume étaient exposés à un faible risque d’infection du défibrillateur. Des stratégies visant à réduire les hématomes et la nécessité d’une nouvelle intervention sur les DCI pourraient toutefois contribuer à réduire encore plus la fréquence des infections.

Current guidelines recommend 4 weeks of private driving restriction after implantation of a primary-prevention implantable cardioverter-defibrillator (ICD). These driving restrictions result in significant inconvenience and social implications. Advances in medical treatment and ICD programming have lowered the overall rate of device therapies. The objective of this study was to assess the incidence of ICD therapies at 30, 60, and 180 days after implantation.Driving Restrictions and Early Arrhythmias in Patients Receiving a Primary-Prevention Implantable Cardioverter-Defibrillator (DREAM-ICD) was a retrospective cohort study conducted at 2 Canadian university centres enrolling patients with new implantation of a primary-prevention ICD. Device programming was standardised according to current guidelines. A total of 803 patients were enrolled.The cumulative rates of appropriate ICD therapies at 30, 60, and 180 days were 0.12%, 0.50%, and 0.75%, respectively. There was no syncope during the first 6 months. The median duration to the first appropriate ICD therapy was 208 (range 23-1109) days after implantation. The rate of inappropriate ICD therapies at 30 days was only 0.2%. Overall,13.6% of all appropriate ICD therapies occurred within the first 6 months after implantation.The rate of appropriate ICD therapies within the first 30 days after device insertion is extremely low in contemporary primary prevention cohorts with guideline-concordant device programming. There was no increased risk for ventricular arrhythmia early after ICD insertion. The results of DREAM-ICD suggest the need for a revision of the existing driving restrictions for primary-prevention ICD recipients.

Background Despite the widespread use of transesophageal echocardiography (TEE) to guide structural cardiac interventions, studies evaluating safety in this context are lacking. Objectives This study sought to determine the incidence, types of complications, and factors associated with esophageal or gastric lesions following TEE manipulation during structural cardiac interventions. Methods This was a prospective study including 50 patients undergoing structural cardiac interventions in which TEE played a central role in guiding the procedure (mitral and tricuspid valve repair, left atrial appendage closure, and paravalvular leak closure). An esophagogastroduodenoscopy (EGD) was performed before and immediately after the procedure to look for new injuries that might have arisen during the course of the intervention. Patients were divided in 2 cohorts according to the type of injury: complex lesions (intramural hematoma, mucosal laceration) and minor lesions (petechiae, ecchymosis). The factors associated with an increased risk of complications were assessed. Results Post-procedural EGD showed a new injury in 86% (n = 43 of 50) of patients, with complex lesions accounting for 40% (n = 20 of 50) of cases. Patients with complex lesions presented more frequently with an abnormal baseline EGD (70% vs. 37%; p = 0.04) and had a higher incidence of post-procedural dysphagia or odynophagia (40% vs. 10%; p = 0.02). Independent factors associated with an increased risk of complex lesions were a longer procedural time under TEE manipulation (for each 10-min increment in imaging time, odds ratio: 1.27; 95% confidence interval: 1.01 to 1.59) and poor or suboptimal image quality (odds ratio: 4.93; 95% confidence interval: 1.10 to 22.02). Conclusions Most patients undergoing structural cardiac interventions showed some form of injury associated with TEE, with longer procedural time and poor or suboptimal image quality determining an increased risk. Imaging experts performing this technique should be aware of the nature of potential complications, to take the necessary precautions to prevent their occurrence and facilitate early diagnosis and treatment.

Use of intraprocedural observation and pharmacologic challenges have been proposed as means to differentiate permanent pulmonary vein (PV)-left atrial conduction block from inadequate ablation lesions.The purpose of this study was to determine the prevalence and clinical impact of spontaneous and adenosine-provoked reconnection using contemporary atrial fibrillation (AF) ablation technologies.The CIRCA-DOSE (Cryoballoon vs. Irrigated Radiofrequency Catheter Ablation: Double Short vs. Standard Exposure Duration) study enrolled 346 patients with paroxysmal AF and randomized them to contact force-guided radiofrequency ablation (CF-RF) or cryoballoon ablation. Patients underwent provocative testing with adenosine after a 20-minute observation period. All patients received an implantable cardiac monitor for arrhythmia monitoring.Spontaneous reconnection was observed in 5.4% of PVs (71/1318) during the 20-minute postprocedure observation period, and dormant conduction was elicited in 5.7% of PVs (75/1318). Both spontaneous reconnection and dormant conduction were more common after CF-RF compared to cryoballoon ablation (P = .03 and P.0001, respectively). Acute PV reconnection (spontaneous or adenosine-provoked) was associated with a significantly higher incidence of recurrent atrial tachyarrhythmia in the cryoballoon group (hazard ratio [HR] 2.39; 95% confidence interval [CI] 1.44-3.96; P = .0007) but not in the CF-RF group (HR 1.47; 95% CI 0.84-2.58; P = .16). In the absence of acute reconnection, the freedom from recurrent arrhythmia did not differ between groups (HR 0.95; 95% CI 0.6057-1.495; P = .83).Patients without spontaneous or adenosine-provoked reconnection had better outcomes compared to those with acute PV reconnection, suggesting that efforts should be directed toward ensuring an ideal ablation lesion at the first attempt in order to achieve durable PV isolation.

Pulmonary vein isolation by catheter ablation is a class IA indication for the treatment of symptomatic, drug-refractory, paroxysmal atrial fibrillation (PAF). Quality of life (QoL) has been identified as a clinically meaningful endpoint but has not been comprehensively evaluated to date.The purpose of this study was to evaluate the effects of cryoballoon ablation on long-term QoL.As part of the STOP-AF Post-Approval Study, QoL was assessed using the Short Form-12 Health Survey (SF-12) along with evaluation of arrhythmia-related symptoms through 36 months. A multivariate linear mixed effects regression was used to determine the association between atrial fibrillation symptoms and QoL scores, and univariate linear regressions were used to assess predictors of 36-month change in QoL scores.Three hundred thirty-five subjects fully completed SF-12 forms at baseline, with 319, 308, 291, and 278 subjects completing surveys at the subsequent follow-up visits. Both physical and mental composite scores increased significantly from baseline (P.001), and all arrhythmia symptoms significantly decreased from baseline (P.001), with 62.0% of subjects reporting no symptoms at 6 months compared to 5.7% at baseline (P.001). Presence of dyspnea and fatigue at baseline were univariate predictors of physical QoL improvement (P = .045 and 0.0497, respectively), whereas each year of age and each year of PAF duration were predictors of a decrease in mental QoL (P = .014 and .04, respectively).Cryoballoon ablation for treatment of PAF results in a significant, and sustained, QoL improvement. The observed improvement in physical and mental health likely may be mediated by a reduction in symptom and arrhythmia burden.

IMPORTANCE: Patients with atrial fibrillation (AF) have impaired health-related quality of life primarily owing to symptoms related to AF episodes; however, quality of life can be influenced by AF therapies, AF complications, the frequency of follow-up visits and hospitalizations, illness perceptions, and patient factors, such as anxiety or depression. OBJECTIVE: To determine the association between change in AF burden and quality of life in the year following ablation. DESIGN, SETTING, AND PARTICIPANTS: The current study is a secondary analysis of a prospective, parallel-group, multicenter, single-masked randomized clinical trial (Cryoballoon vs Irrigated Radiofrequency Catheter Ablation: Double Short vs Standard Exposure Duration [CIRCA-DOSE] study), which took place at 8 Canadian centers. Between September 2014 and July 2017, 346 patients older than 18 years with symptomatic, primarily low-burden AF refractory to antiarrhythmic therapy referred for first catheter ablation were enrolled. All patients received an implantable cardiac monitor at least 30 days before ablation and were followed up with up to December 2018. Data were analyzed from April 2020 to June 2021. INTERVENTIONS: Patients were randomized 1:1:1 to contact force–guided radiofrequency ablation, 4-minute cryoballoon ablation, or 2-minute cryoballoon ablation. The exposure in the present analysis is the absolute difference in AF burden prior to ablation and 12 months following ablation, as evaluated by the Atrial Fibrillation Effect on Quality of Life (AFEQT) Score. MAIN OUTCOMES AND MEASURES: Absolute difference in quality of life from baseline to 12 months postablation. RESULTS: Of 346 included patients, 231 (66.7%) were male, and the median (interquartile range) age was 60 (52-66) years. A total of 328 patients (94.8%) had paroxysmal AF. The median (interquartile range) preablation AF burden was 2.0% (0.1-11.9), and the AF burden decreased to 0% at 12 months postablation. At 12 months, a 1-point improvement in AFEQT score was observed for every absolute reduction in daily AF burden of 15.8 minutes (95% CI, 7.2-24.4; P

Background: Advanced generation ablation technologies have been developed to achieve more effective pulmonary vein isolation (PVI) and minimize arrhythmia recurrence after atrial fibrillation (AF) ablation. Methods: We randomly assigned 346 patients with drug-refractory paroxysmal AF to contact force–guided radiofrequency ablation (CF-RF; n=115), 4-minute cryoballoon ablation (Cryo-4; n=115), or 2-minute cryoballoon ablation (Cryo-2; n=116). Follow-up was 12 months. The primary outcome was time to first documented recurrence of symptomatic or asymptomatic atrial tachyarrhythmia (AF, atrial flutter, or atrial tachycardia) between days 91 and 365 after ablation or a repeat ablation procedure at any time. Secondary end points included freedom from symptomatic arrhythmia and AF burden. All patients received an implantable loop recorder. Results: One-year freedom from atrial tachyarrhythmia defined by continuous rhythm monitoring was 53.9%, 52.2%, and 51.7% with CF-RF, Cryo-4, and Cryo-2, respectively ( P =0.87). One-year freedom from symptomatic atrial tachyarrhythmia defined by continuous rhythm monitoring was 79.1%, 78.2%, and 73.3% with CF-RF, Cryo-4, and Cryo-2, respectively ( P =0.26). Compared with the monitoring period before ablation, AF burden was reduced by a median of 99.3% (interquartile range, 67.8%–100.0%) with CF-RF, 99.9% (interquartile range, 65.3%–100.0%) with Cryo-4, and 98.4% (interquartile range, 56.2%–100.0%) with Cryo-2 ( P =0.36). Serious adverse events occurred in 3 patients (2.6%) in the CF-RF group, 6 patients (5.3%) in the Cryo-4 group, and 7 patients (6.0%) in the Cryo-2 group, with no significant difference between groups ( P =0.24). The CF-RF group had a significantly longer procedure duration but significantly shorter fluoroscopy exposure ( P Conclusions: In this multicenter, randomized, single-blinded trial, CF-RF and 2 different regimens of cryoballoon ablation resulted in no difference in 1-year efficacy, which was 53% by time to first recurrence but >98% burden reduction as assessed by continuous cardiac rhythm monitoring. Clinical Trial Registration: URL: https://www.clinicaltrials.gov . Unique identifier: NCT01913522.

Objectives STOP AF PAS (Sustained Treatment of Paroxysmal Atrial Fibrillation Post-Approval Study) is the first prospective, multicenter, 3-year study in North America to assess long-term safety and effectiveness of the cryoballoon for treatment of patients with drug-refractory symptomatic pAF. Background The STOP AF PAS was required by the U.S. Food and Drug Administration at the time of approval of the first-generation cryoballoon for the treatment of paroxysmal atrial fibrillation (pAF). The second-generation cryoballoon (CB2) was commercially released shortly after this trial was initiated. Methods The study was nonrandomized. Enrollment was completed with 344 eligible patients undergoing pulmonary vein isolation (PVI) using the CB2. Procedure-related safety and freedom from AF and symptomatic atrial flutter/atrial tachycardia through 3 years were determined. Documented atrial arrhythmias ≥30 s were considered treatment failures. Results Acute PVI was achieved in 99.3% (1,341 of 1,350) of veins. Mean follow-up was 34 ± 7 months. The rate of major complications was 5.8%, including a 3.2% rate of phrenic nerve injury, which resolved in all but 1 patient by 36 months. At 36 months, 11.7% of patients were prescribed antiarrhythmic agents, inclusive of “pill-in-the-pocket” administration. Freedom from AF was 81.6% at 12 months, 73.8% at 24 months, and 68.1% at 36 months. Freedom from AF and symptomatic atrial flutter/atrial tachycardia was 79.0% at 12 months, 70.8% at 24 months, and 64.1% at 36 months. Freedom from a repeat ablation procedure was 80.9% at 36 months. Conclusions PVI using the CB2 was an effective treatment for patients with pAF, with freedom from all atrial arrhythmias of 64% at 36 months. (Sustained Treatment of Paroxysmal Atrial Fibrillation Post-Approval Study [STOP AF PAS]; NCT01456949)

Aims: Data on predictors of time-to-first appropriate implantable cardioverter-defibrillator (ICD) therapy in patients with Brugada Syndrome (BrS) and prophylactically implanted ICD's are scarce.Methods and results: SABRUS (Survey on Arrhythmic Events in BRUgada Syndrome) is an international survey on 678 BrS patients who experienced arrhythmic event (AE) including 252 patients in whom AE occurred after prophylactic ICD implantation. Analysis was performed on time-to-first appropriate ICD discharge regarding patients' characteristics. Multivariate logistic regression models were utilized to identify which parameters predicted time to arrhythmia ≤5 years. The median time-to-first appropriate ICD therapy was 24.8 ± 2.8 months. A shorter time was observed in patients from Asian ethnicity (P Conclusion: First appropriate therapy in BrS patients with prophylactic ICD's occurred during the first 5 years in 76.6% of patients. Syncope and spontaneous Type 1 Brugada ECG correlated with a shorter time to ICD therapy.

BACKGROUND We report our single center experience with percutaneous left atrial appendage closure (LAAC) in patients with non-valvular atrial fibrillation (NVAF) and primary hemostasis disorders (HD). In randomized percutaneous LAAC trials, this HD population is under-represented. METHODS AND RESULTS Consecutive patients with primary HD who underwent LAAC were included. Baseline procedural characteristics and clinical events during follow-up were prospectively collected. From 2013 to 2021, 205 patients underwent percutaneous LAAC and 17 (8.2%) had proven HD: thrombocytopenia (n=5), myelodysplastic syndrome (n=6), Von Willebrand syndrome (n=4), type A hemophilia (n=1) and dysfibrinogenemia (n=1). Median age was 78 YO, CHA2DS2VASc and HAS-BLED scores were 5 and 3, respectively. Periprocedural plasmatic management was required in 47% of patients. The LAAC device implantation was successful in all cases. Post-procedural antithrombotic regimen for the first six weeks consisted of reduced direct oral anticoagulant (DOA) in 8 patients, full dose DOA in 1, dual-antiplatelet in 6, aspirin in 1 and no therapy in 1. The transesophageal echocardiography, 45 days post-procedure, showed optimal device position, adequate sealing in all patients and no clots. After this initial period post-LAAC the long-term antithrombotic regimen was single-antiplatelet in 16 patients and no therapy in 1 patient. After a median follow-up of 1.0 year (25-75 IQR: 0.4-2.2), no thrombo-embolic or bleeding events occurred. CONCLUSION The percutaneous LAAC in patients with atrial fibrillation and primary hemostasis disorders appeared to be a safe and effective alternative for stroke and bleeding prevention at mid-term follow-up. These promising results warrant larger studies to confirm our experience.

Early recurrence of atrial tachyarrhythmia (ERAT) is common after pulmonary vein isolation (PVI) and has been associated with an increased risk of late atrial fibrillation (AF) recurrence.The purpose of this study was to determine the incidence and outcomes of patients experiencing ERAT after PVI using advanced-generation ablation technologies.This is a prespecified substudy of the CIRCA-DOSE (Cryoballoon vs Irrigated Radiofrequency Catheter Ablation: Double-Short vs Standard Exposure Duration) trial, a prospective, randomized, multicenter study comparing PVI with contact force-guided radiofrequency ablation to secondary-generation cryoballoon ablation for paroxysmal AF. All study patients received an implantable cardiac monitor to allow continuous rhythm monitoring. ERAT was defined as any recurrent atrial tachyarrhythmia within the first 90 days after AF ablation.ERAT occurred in 61% of the 346 patients at a median of 12 days (range 1-90 days) after ablation. ERAF was a significant predictor of late recurrence (60.1% with ER vs 25.9% without ER; P.001) and symptomatic atrial tachyarrhythmia (31.6% with ERAF vs 6.7% without ERAF; P.001). Receiver operating curve analyses revealed a strong correlation between ERAT timing and burden and late recurrence. Multivariate analysis identified ER timing (hazard ratio [HR] 2.90; 95% confidence interval [CI] 1.41-5.95; P = .004) and burden (HR 1.05 per 1% ER burden; 95% CI 1.04-1.07; P.001) as strong independent predictors of late recurrence. Incidence rate, timing, burden, and prognostic significance of ER did not differ between the study groups.ERAT remains common after PVI despite use of advanced-generation ablation technologies. Early AF recurrence beyond 3 weeks after ablation is associated with increased risk of late recurrence.

Objectives: We aimed to report a single center experience with percutaneous left atrial appendage closure (LAAC) in patients with non-valvular atrial fibrillation (NVAF) and blood dyscrasia (BD). Background: Although strong data supports the LAAC, patients with coagulopathy and BD were under-represented in randomized trials. Methods: Consecutive patients with BD who underwent LAAC were included. Baseline and procedural characteristics and follow-up outcomes were prospectively collected. Results: From 2013 to 2020, 180 patients underwent LAAC and 14 (7.8%) had proven BD: thrombocytopenia (n=5), myelodysplastic syndrome (n=5), Von Willebrand syndrome (n=2), type A hemophilia (n=1) and dysfibrinogenemia (n=1). Median age was 78 YO, CHA2DS2VASc and HAS-BLED scores were respectively 4 and 3. Periprocedural plasmatic management was required in 50% of the patients. The WATCHMANTM, AMPLATZER CARDIAC PLUGTM and CARDIA ULTRASTEALTM devices were used in 12, 1 and 1 patients, respectively, and the procedure was successful in all cases. Post-procedural antithrombotic regimen for the first six weeks consisted of reduced direct anticoagulant (DOA) in 7 patients, dual-antiplatelet in 5, aspirin in 1 and no therapy in 1. Following that period, single-antiplatelet was used in 13 patients and no therapy in 1 patient. A transesophageal echocardiography 45 days post-procedure showed optimal device position and sealing in all patients. After a median follow-up of 1.4 years, no thrombo-embolic or bleeding events occurred. Conclusion: LAAC in patients with BD appeared to be a safe and effective alternative for stroke and bleeding prevention at mid-term follow-up. These promising results warrants larger studies to confirm our findings.

Background In patients undergoing left atrial appendage (LAA) closure, an accurate sizing of the LAA is key to optimize device sizing, procedural success and reduce complications. Previous studies have shown that intraprocedural volume loading increases LAA dimensions and improves device sizing. However, the safety and effects on LAA and device sizing of administering a fluid bolus during pre-procedural transesophageal echocardiography (TEE) are unknown. The aim of this study was to determine the safety and impact on LAA dimensions and device sizing of an intravenous (IV) fluid bolus administered during TEE in the setting of the pre-procedural work-up for LAA closure. Methods The study included a total of 72 patients who underwent TEE to assess suitability for LAAC and received a 500 ml IV bolus of normal saline. The LAA landing zone (LZ) and depth were measured by TEE before and after volume loading, and these measurements were used to predict the device size implanted during a subsequent percutaneous LAAC procedure. Results There were no complications associated with volume loading. The baseline mean LZ was 19.6 ± 3.6 mm at 90o, and 20.2 ± 4.1 mm at 135o. Following fluid bolus, the maximum diameter increased 1.5 ± 1.0 mm at 90o (po (po, and 23.9 ± 5.8 mm at 135o. After fluid bolus, the mean depth increased by 1.5 ± 1.8 mm (ppo and 135o, respectively. Sizing based on post-bolus measurements of the LZ significantly improved the agreement with the final device size selection during the procedure in 71.0% of cases (vs. 42.0% with pre-bolus measurements). Conclusions Volume loading during ambulatory TEE as part of the pre-procedural work-up of LAAC is safe and significantly increases LAA dimensions. This strategy may become the new standard, particularly in centers performing LAAC with no TEE guidance, as it improves LAA sizing and more accurately predicts the final device size.

Introduction: Implantation of epicardial pacing leads remains a well-known alternative to the standard transvenous approach in several situations. However, long-term data on the performance and safety of epicardial pacing leads remain scarce. Methods: We conducted a retrospective cohort study at a single tertiary center including all patients with right or left ventricular epicardial lead implantation between 1996 to 2018; n=255. Electrophysiological lead parameters at implantation and during follow-up were analyzed and compared with clinical data from the electronic medical records. Results: 230 patients were included in the analysis. Implanted lead models included the Medtronic 4968 (n=202) and Medtronic 5071 (n=28). Indications for epicardial lead implantation included upgrade to CRT in 153/230 (67%) individuals and standard right or left ventricular pacing only in 76/230 (33%). Of the 153 epicardial CRT patients, 50 had a history of failed transvenous CRT and 103 had concomitant cardiac surgery for other indications and were thought to have a likely indication for CRT in the nearby future. Mean follow-up time was 4,7years±4,2. Lead impedances were significantly higher in the 4968 model compared to the 5071. Pacing thresholds for both lead models were similar at implantation but were subsequently significant higher in the 5071 model. Higher pacing thresholds in the 5071 model did not result in premature battery depletion. Periprocedural complications related to the epicardial lead insertion occurred in 3/230 patients. Epicardial lead related complications at follow-up remained low (8/230; 3 dysfunctions, 2 dislodgments, 1 impending skin erosion). There were only 2 cases of epicardial lead infections at follow-up requiring surgical extraction. 4,3% of all implanted leads remained unconnected at follow-up. Conclusions: Epicardial lead implantation for either CRT or pacing indications is a durable and safe alternative to transvenous lead insertion.

Background: Apical hypertrophic cardiomyopathy (aHCM) is thought to have a more benign clinical course compared to septal HCM (sHCM), but most data have been derived from Asian cohorts. Comparative data on clinical outcome in Caucasian aHCM cohorts are scarce, and the results are conflicting. The aim of this study was to estimate the prevalence and outcome of aHCM in French-Canadians of Caucasian descent.Methods and results: We conducted a retrospective, single-center cohort study. The primary endpoint was a composite of documented sustained ventricular arrhythmia (VA), appropriate ICD therapy, arrhythmogenic syncope, cardiac arrest, or all-cause mortality. A total of 301 HCM patients (65% males) were enrolled including 80/301 (27%) with aHCM and 221/301 (73%) with sHCM. Maximal wall thickness was similar in both groups. Left ventricular apical aneurysm was significantly more common in aHCM (10 vs. 0.5%; p < 0.001). The proportion of patients with myocardial fibrosis ≥ 15% of the left ventricular mass was similar between aHCM and sHCM (21 vs. 24%; p = 0.68). Secondary prevention ICDs were more often implanted in aHCM patients (16 vs. 7%; p = 0.02). The primary endpoint occurred in 26% of aHCM and 10.4% of sHCM patients (p = 0.001) and was driven by an increased incidence of sustained VA (10 vs. 2.3%; p = 0.01). Multivariate analysis identified apical aneurysm and a phenotype of aHCM as independent predictors of the primary endpoint and the occurrence of sustained ventricular tachycardia. Unexplained syncope and a family history of sudden cardiac death were additional predictors for sustained VA. Apical HCM was associated with an increased risk of ventricular arrhythmia even when excluding patients with apical aneurysm.Conclusions: The phenotype of apical HCM is much more common in French-Canadians (27%) of Caucasian descent compared to other Caucasian HCM populations. Apical HCM in French-Canadians is associated with an increased risk for ventricular arrhythmia.

Background Concerns remain regarding the effectiveness of PVI using the fixed diameter non-compliant cryoballoon in the presence of a left common pulmonary vein (LCPV). We sought to evaluate the effectiveness of PVI performed by contact-force guided radiofrequency (CF-RF) versus second-generation cryoballoon-based ablation in patients with LCPV. Methods and results We enrolled 346 patients with paroxysmal AF and randomized them to CF-RF or cryoballoon ablation. PV anatomy was not assessed prior to enrolment, and there were no exclusions based on PV anatomy. All patients received an implantable cardiac monitor. LCPV was observed in 13.6% of patients (47/346). Left atrial time and fluoroscopy time did not differ between those with and without LCPV (P=0.58 and P=0.06, respectively). Freedom from any atrial tachyarrhythmia at one year was observed in 46.8% with LCPV and 54.5% without LCPV (P=0.06). In those with LCPV the freedom from any atrial tachyarrhythmia did not differ between those randomized to CF-RF or cryoballoon ablation (HR for recurrence 1.19, 95% CI 0.53-2.65, P=0.69). In those with LCPV the AF burden was reduced to a similar extent with CF-RF and cryoballoon ablation (99.7% vs. 99.5%, respectively; P=0.97). Conclusions In this randomized clinical trial, the presence of a LCPV was associated with a trend towards higher rates of arrhythmia recurrence following PVI. No significant difference in arrhythmia recurrence was observed between patients with LCPV randomized to cryoballoon ablation or contact-force guided RF ablation, suggesting that either ablation modality is suitable in this population. (Cryoballoon vs. Irrigated Radiofrequency Catheter Ablation [CIRCA-DOSE], NCT01913522) This article is protected by copyright. All rights reserved.

Pulmonary vein isolation (PVI) is the cornerstone of catheter ablation to treat patients with symptomatic drug-refractory atrial fibrillation (AF).The purpose of this study was to assess the safety and efficacy of PVI using the cryoballoon catheter to treat patients with persistent AF.STOP Persistent AF (ClinicalTrials.gov Identifier: NCT03012841) was a prospective, multicenter, single-arm, Food and Drug Administration-regulated trial designed to evaluate the safety and efficacy of PVI-only cryoballoon ablation for drug-refractory persistent AF (continuous episodes6 months). The primary efficacy endpoint was 12-month freedom from ≥30 seconds of AF, atrial flutter (AFL), or atrial tachycardia (AT) after a 90-day blanking period. The prespecified performance goals were set at40% and13% for the primary efficacy and safety endpoints, respectively. Secondary endpoints assessed quality of life using the AFEQT (Atrial Fibrillation Effect on Quality of Life) and SF (Short Form)-12 questionnaires.Of 186 total enrollments, 165 subjects (70% male; age 65 ± 9 years; left atrial diameter 4.2 ± 0.6 cm; body mass index 31 ± 6) were treated at 25 sites in the United States, Canada, and Japan. Total procedural, left atrial dwell, and fluoroscopy times were 121 ± 46 minutes, 102 ± 41 minutes, and 19 ± 16 minutes, respectively. At 12 months, the primary efficacy endpoint was 54.8% (95% confidence [CI] 46.7%-62.1%) freedom from AF, AFL, or AT. There was 1 primary safety event, translating to a rate of 0.6% (95% CI 0.1%-4.4%). AFEQT and SF-12 assessments demonstrated significant improvements from baseline to 12 months postablation (P.001).The STOP Persistent AF trial demonstrated cryoballoon ablation to be safe and effective in treating patients with drug-refractory persistent AF characterized by continuous AF episodes6 months.

This study evaluated the impact of contact force-guided radiofrequency ablation versus cryoballoon ablation on quality of life and health care utilization.Traditional outcome parameters, such as arrhythmia-free survival, are insufficient to evaluate the clinical impact of atrial fibrillation (AF), as it fails to the capture patient- and health system-level differences in treatment approaches.The CIRCA-DOSE (Cryoballoon Vs. Contact-Force Atrial Fibrillation Ablation) study randomly assigned 346 patients with drug-refractory paroxysmal AF to contact force-guided radiofrequency or cryoballoon ablation. Health-related quality-of-life (HRQOL) was assessed at baseline, and at 6 and 12 months post-ablation using a disease-specific and generic HRQOL instruments. Health care utilization (hospitalization, emergency department visits, and cardioversion) and antiarrhythmic drug use for the 12 months preceding ablation was compared with the 12 months following ablation.Disease-specific and generic HRQOL was moderately to severely impaired at baseline and improved significantly at 6 and 12 months of follow-up (median improvement in AFEQT [Atrial Fibrillation Effect on QualiTy of Life] score 32.4 [interquartile range: 17.7 to 48.9]). When compared with the 12 months pre-ablation, the proportion and absolute number of cardioversions decreased significantly (41.1% vs. 10.1% of patients, 137 vs. 35 events; p 0.0001). Similar significant reductions in emergency department visits (66.7% vs. 25.1% of patients, 224 vs. 87 events; p 0.0001), and hospitalizations (25.5% vs. 14.5% of patients, 86 vs. 50 events; p 0.001) were observed. There were no significant differences between randomized groups.In this multicenter randomized trial, catheter ablation with advanced-generation technologies resulted in a significant improvement in HRQOL and a significant reduction in health care utilization in the year following AF ablation. (Cryoballoon vs. Irrigated Radiofrequency Catheter Ablation [CIRCA-DOSE]; NCT01913522).

Background Impact of contact force sensing (CFS) on ablation of persistent atrial fibrillation (PeAF) is unknown. Objective The purpose of the TOUCH AF (Therapeutic Outcomes Using Contact force Handling during Ablation of Persistent Atrial Fibrillation) randomized trial was to compare CFS-guided ablation to a CFS-blinded strategy. Methods Patients (n = 128) undergoing first-time ablation for persistent AF were randomized to a CFS-guided vs CFS-blinded strategy. In the CFS-guided procedure, operators visualized real-time force data. In the blinded procedure, force data were hidden. Wide antral pulmonary vein isolation plus a roof line were performed. Patients were followed at 3, 6, 9, and 12 months with clinical visit, ECG, and 48-hour Holter monitoring. The primary endpoint was cumulative radiofrequency (RF) time for all procedures. Atrial arrhythmia >30 seconds after 3 months was a recurrence. Results PeAF was continuous for 26 weeks (interquartile range [IQR] 13–52), and left atrial size was 45 ± 5 mm. Force in the CFS-blinded and CFS-guided arms was 12 g [IQR 6–20] and 14 g [IQR 9–20] ( P = .10), respectively. Total RF time did not differ between CFS-guided and CFS-blinded groups (49 ± 14 min vs 50 ± 20 min, respectively; P = .70). Single procedure freedom from atrial arrhythmia was 60% in the CFS-guided arm and 63% in the CFS-blinded arm off drugs. Lesions with gaps were associated with significantly less force (11.4 g [IQR 6–19] vs 13.2 g [IQR 8–20], respectively; P = .0007) and less force-time integral (174 gs [IQR 91–330] vs 210 gs [IQR 113–388], respectively; P Conclusion CFS-guided ablation resulted in no difference to RF time or 12-month outcome. Lower force/force-time integral was associated with significantly more gaps.

BACKGROUND: The literature on fever-related arrhythmic events (AEs) in Brugada syndrome (BrS) is currently limited to few case reports and small series. OBJECTIVE: The present study aimed to describe the characteristics of fever-related AE in a large cohort of patients with BrS. METHODS: The Survey on Arrhythmic Events in Brugada Syndrome is a multicenter study on 678 patients with BrS with first AE documented at the time of aborted cardiac arrest (n = 426) or after prophylactic implantable cardioverter-defibrillator implantation (n = 252). RESULTS: In 35 of 588 patients (6%) with available information, the AE occurred during a febrile illness. Most of the 35 patients were male (80%), Caucasian (83%), and proband (70%). The mean age at the time of AE was 29 ± 24 years (range 0.3-76 years). Most patients (80%) presented with aborted cardiac arrest and 6 (17%) with arrhythmic storm. Family history of sudden death, history of syncope, and spontaneous type 1 Brugada electrocardiogram were noted in 17%, 40%, and 71% of patients, respectively. Ventricular fibrillation was induced at electrophysiology study in 9 of 19 patients (47%). An SCN5A mutation was found in 14 of 28 patients (50%). The highest proportion of fever-related AE was observed in the pediatric population (age

BACKGROUND In patients with refractory atrial fibrillation (AF) rate control strategy, atrioventricular node (AVN) ablation and permanent pacemaker implantation is recommended. The Micra Transcatheter Pacing System (TPS) is a single chamber leadless pacemaker implanted from the femoral vein and thus offers the possibility of AVN ablation in the same procedure. Here, we describe two cases of acute Micra TPS ventricular pacing threshold elevation immediately following radiofrequency AVN ablation at distance from the TPS requiring device retrieval and re-implantation of new Micra systems. METHODS AND RESULTS All consecutive patients with a Micra TPS implantation, at a single center, from November 2014 to March 2020, were analyzed retrospectively (n=56). Among them, 36% had a prior complication from a transvenous implant and in 16% lead extraction was performed concurrently with the TPS implantation. A total of ten patients (18%) underwent AVN ablation within the same procedure. Among them, two (20%) presented acute increase in the right ventricular pacing threshold after radiofrequency delivery requiring retrieval of the initial TPS and deployment of a new device. The first case was a 48 years-old man with previous heart transplantation. A Micra TPS was implanted in a mid-septal position (threshold 0,5 Volts x 0,24 milliseconds; impedance 800 Ohms; correct pull and hold test). To obtain a complete atrioventricular block, a retrograde arterial approach with an 8 mm nonirrigated catheter (60 degrees Celsius for 294 seconds) was required. After RF delivery, a loss of capture was observed. The second case included a 69 years-old woman. The TPS was implanted at an apico-septal position (Threshold 0,75 Volts x 0,24 milliseconds; impedance 720 Ohms; correct pull and hold test). The AVN ablation was achieved (52 degrees Celsius for 136 seconds) with a 4 mm nonirrigated catheter. Immediately, a threshold elevation >2 Volts x 0,24 milliseconds was observed. In both cases, continuous fluoroscopic control confirmed no direct interaction between the ablation catheter and the TPS. The device was successfully recaptured, and a new leadless PPM was immediately implanted with good results in these two cases. CONCLUSION We described two cases of acute threshold elevation during a combined procedure of TPS implantation and AVN ablation. This complication was not reported in series assessing safety of combining AVN ablation and Micra TPS implantation. We hypothesize a possible shunt of current to the distal electrode. An in vitro study is currently underway to explain the mechanism of indirect interaction between radiofrequency delivery and Micra TPS dysfunction.

The recommendations for antithrombotic treatment after left atrial appendage closure (LAAC) remain empirical, and no data exist on the changes in hemostatic markers associated with LACC. The objective of the present study is to determine the presence, degree, and timing of changes in the markers of platelet and coagulation activation after LAAC. Forty-three patients (mean age 76 ± 9 years, 23 men) with atrial fibrillation who underwent successful LACC with the Watchman (n = 27) or Amplatzer Cardiac Plug (n = 16) devices were included in the study. Patients received antiplatelet therapy after LAAC (aspirin + clopidogrel: 27 patients; single antiplatelet therapy with aspirin or clopidogrel: 16 patients). Prothrombin fragment 1+2 and thrombin-antithrombin III were used as markers of coagulation activation, and soluble P-selectin and soluble CD40 ligand were used as markers of platelet activation. Measurements of all hemostatic markers were performed at baseline just before the procedure, followed by days 7, 30, and 180 after LAAC. Prothrombin fragment 1+2 and thrombin-antithrombin levels increased from 0.27 nmol/L and 4.68 ng/ml, respectively, at baseline to peak values of 0.43 nmol/L and 9.76 ng/ml, respectively, at 7 days, partially returning to baseline levels at days 30 and 180 after LAAC (p

Although there have been several reports documenting complications related with transesophageal echocardiography (TEE) manipulation following cardiac surgery, there is a paucity of data regarding the safety of TEE used to guide catheter-based interventions. The aim of this study was to determine the prevalence, types and risk factors of complications associated with procedures requiring active TEE guidance.This study included 1249 consecutive patients undergoing either transcatheter aortic valve implantation (TAVI), Mitraclip, left atrial appendage occlusion (LAAO) or paravalvular leak closure (PVLC). Patients were divided into 2 cohorts based on the degree of probe manipulation required to guide the procedure and the risk of developing a TEE-related complication: low-risk (TAVI, n = 1037) and high-risk (Mitraclip, LAAO and PVLC, n = 212). Patients were further analyzed according to the occurrence of major and minor TEE-related complications.The overall incidence of TEE-related complications was 0.9% in the TAVI group and 6.1% in the rest of the cohort (P .001). Patients in the high-risk cohort had also a higher incidence of major-complications (2.8% vs 0.6%, P = .008), and factors associated with an increased risk were being underweight, having a prior history of gastrointestinal bleeding and the use of chronic steroids/immunosuppressive medications. Procedural time under TEE-manipulation was longer in patients exhibiting complications and was an independent predictor of major complications (OR = 1.13, 95% CI 1.01-1.25, for each 10 minutes increments in imaging time). Patients with major complications undergoing Mitraclip had the longest median time under TEE-manipulation (297 minutes) and a risk of developing a major-complication that was 10.64 times higher than the rest of the cohort (95% CI 3.30-34.29, P .001).The prevalence of TEE-related complications associated with interventional procedures is higher than previously reported. Undergoing a prolonged procedure, particularly in the setting of Mitraclip, was the main factor linked to TEE-related complications.

OBJECTIVES: The authors studied the response rates and relative sensitivity of the most common agents used in the sodium-channel blocker (SCB) challenge. BACKGROUND: A type 1 Brugada electrocardiographic pattern precipitated by an SCB challenge confers a diagnosis of Brugada syndrome. METHODS: Patients undergoing an SCB challenge were prospectively enrolled across Canada and the United Kingdom. Patients with no prior cardiac arrest and family histories of sudden cardiac death or Brugada syndrome were included. RESULTS: Four hundred twenty-five subjects underwent SCB challenge (ajmaline, n = 331 [78%]; procainamide, n = 94 [22%]), with a mean age of 39 ± 15 years (54% men). Baseline non-type 1 Brugada ST-segment elevation was present in 10%. A total of 154 patients (36%) underwent signal-averaged electrocardiography, with 41% having late potentials. Positive results were seen more often with ajmaline than procainamide infusion (26% vs. 4%, p < 0.001). On multivariate analysis, baseline non-type 1 Brugada ST-segment elevation (odds ratio [OR]: 6.92; 95% confidence interval [CI]: 3.15 to 15.2; p < 0.001) and ajmaline use (OR: 8.76; 95% CI: 2.62 to 29.2; p < 0.001) were independent predictors of positive results to SCB challenge. In the subgroup undergoing signal-averaged electrocardiography, non-type 1 Brugada ST-segment elevation (OR: 9.28; 95% CI: 2.22 to 38.8; p = 0.002), late potentials on signal-averaged electrocardiography (OR: 4.32; 95% CI: 1.50 to 12.5; p = 0.007), and ajmaline use (OR: 12.0; 95% CI: 2.45 to 59.1; p = 0.002) were strong predictors of SCB outcome. CONCLUSIONS: The outcome of SCB challenge was significantly affected by the drug used, with ajmaline more likely to provoke a type 1 Brugada electrocardiographic pattern compared with procainamide. Patients undergoing SCB challenge may have contrasting results depending on the drug used, with potential clinical, psychosocial, and socioeconomic implications.

Diagnosis of arrhythmic disorders is challenging because of their short-lasting, intermittent character. Conventional technologies of noninvasive ambulatory rhythm monitoring are limited by modest sensitivity. We present a novel form of wearable electrocardiogram (ECG) sensors providing an alternative tool for long-term rhythm monitoring with the potential of increased sensitivity to detect intermittent or subclinical arrhythmia. The objective was to assess the signal quality and R-R coverage of a wearable ECG sensor system compared to a standard 3-lead Holter. In this phase-1 trial, healthy individuals underwent 24-h simultaneous rhythm monitoring using the OMsignal system together with a 3-lead Holter recording. The OMsignal system consists of a garment (bra or shirt) with integrated sensors recording a single-lead ECG and an acquisition module for data storage and processing. Head-to-head signal quality was assessed regarding adequate P-QRS-T distinction and was performed by three electrophysiologists blinded to the recording technology. The accuracy of signal coverage was assessed using Bland-Altman analysis. Fifteen individuals underwent simultaneous 24-h recording. Signal quality and accuracy of the OMgaments was equivalent to Holter-monitoring (84% vs 93% electrophysiologists rating, p = 0.06). Signal coverage of R-R intervals showed a very close overlay between the OMsignal system and Holter signals, mean difference in heart rate of 2 5 bpm. The noise level of OMgarments was comparable to Holter recording. OMgarments provide high signal quality for adequate rhythm analysis, representing a promising novel technology for long-term non-invasive ECG monitoring.

Objectives We report the initial experience of percutaneous left atrial appendage (LAA) closure with the Ultraseal device. Background LAA closure is an alternative to oral anticoagulation for stroke prevention in patients with nonvalvular atrial fibrillation (NVAF) and high risk of bleeding. The Ultraseal device is a new LAA closure prosthesis that consists of a distal soft bulb and a proximal sail attached by an articulating joint that allows a high degree of device conformability to the different variations of the LAA anatomy. Methods We included 12 consecutive patients with NVAF who underwent LAA closure with the Ultraseal device between January and December 2015 in our center. Patients had clinical and transesophageal echocardiography (TEE) examinations at baseline and at 45 days following LAA closure. Results The device was successfully implanted in all patients, with no periprocedural complications. There were no episodes of bleeding, stroke, pericardial effusion, or device embolization at 45-day follow-up. No cases with residual leaks >5 mm were observed at TEE. One patient presented a device related thrombus without clinical consequences. Conclusions This initial experience with the Ultraseal LAA closure device demonstrates preliminary safety and feasibility. Further larger studies with longer follow-up are warranted. © 2016 Wiley Periodicals, Inc.

Contact-force (CF) catheters appear to be more effective compared to standard ablation catheters for complex radiofrequency ablation including atrial fibrillation (AF) ablation when optimal CF >10 g is achieved. Some have suggested that this technology could also improve procedural safety. We report 2 cases of atrioesophageal fistulae (AEF), a rare but catastrophic complication of AF ablation. These are to our knowledge the first cases of AEF described after using CF catheters.

Background— The role of programmed ventricular stimulation in identifying patients with Brugada syndrome at the highest risk for sudden death is uncertain. Methods and Results— We performed a systematic review and pooled analysis of prospective, observational studies of patients with Brugada syndrome without a history of sudden cardiac arrest who underwent programmed ventricular stimulation. We estimated incidence rates and relative hazards of cardiac arrest or implantable cardioverter-defibrillator shock. We analyzed individual-level data from 8 studies comprising 1312 patients who experienced 65 cardiac events (median follow-up, 38.3 months). A total of 527 patients were induced into arrhythmias with up to triple extrastimuli. Induction was associated with cardiac events during follow-up (hazard ratio, 2.66; 95% confidence interval [CI], 1.44–4.92, P Conclusions— In patients with Brugada syndrome, arrhythmias induced with programmed ventricular stimulation are associated with future ventricular arrhythmia risk. Induction with fewer extrastimuli is associated with higher risk. However, clinical risk factors are important determinants of arrhythmia risk, and lack of induction does not necessarily portend low ventricular arrhythmia risk, particularly in patients with high-risk clinical features.

Key Points Question What is the association between preablation atrial fibrillation (AF) episode duration and arrhythmia recurrence outcomes following AF ablation? Findings In this prespecified subanalysis of a randomized clinical trial of 346 patients with symptomatic AF undergoing catheter ablation, patients with AF episodes limited to less than 24 continuous hours had a significantly lower rate of recurrence following an ablation procedure. Arrhythmia recurrence and AF burden after ablation did not differ between patients with persistent AF (episodes lasting >7 days) and those with paroxysmal AF (episodes lasting 24 to 48 hours or 2 to 7 days). Meaning The findings of this study suggest that the contemporary definition of paroxysmal AF does not reflect post-AF ablation arrhythmia outcomes., This secondary analysis of a randomized clinical trial evaluates the association of baseline atrial fibrillation episode duration with post–atrial fibrillation ablation arrhythmia outcomes., Importance Contemporary guidelines recommend that atrial fibrillation (AF) be classified based on episode duration, with these categories forming the basis of therapeutic recommendations. While pragmatic, these classifications are not based on pathophysiologic processes and may not reflect clinical outcomes. Objective To evaluate the association of baseline AF episode duration with post-AF ablation arrhythmia outcomes. Design, Setting, and Participants The current study is a secondary analysis of a prospective, parallel-group, multicenter, single-masked randomized clinical trial (the Cryoballoon vs Irrigated Radiofrequency Catheter Ablation: Double Short vs Standard Exposure Duration [CIRCA-DOSE] study), which took place at 8 Canadian centers. Between September 2014 and July 2017, 346 patients older than 18 years with symptomatic AF referred for first catheter ablation were enrolled. All patients received an implantable cardiac monitor at least 30 days before ablation. Data analysis was performed in September 2019. Exposure Before ablation, patients were classified based on their longest AF episode. Ablation consisted of circumferential pulmonary vein isolation using standard techniques. Main Outcomes and Measures Time to first recurrence of symptomatic or asymptomatic atrial tachyarrhythmia (AF, atrial flutter, or atrial tachycardia) following ablation and AF burden (percentage of time in AF) on preablation and postablation continuous rhythm monitoring. Results The study included 346 patients (mean [SD] age, 59 [10] years; 231 [67.7%] men). Overall, 263 patients (76.0%) had AF episode duration of less than 24 hours; 25 (7.2%), 24 to 48 hours; 40 (11.7%), 2 to 7 days; and 18 (5.2%), more than 7 days. Documented recurrence of any atrial tachyarrhythmia following ablation was significantly lower in patients with baseline AF episode duration of less than 24 continuous hours compared with those with longer AF episodes (24 hours vs 24-48 hours: hazard ratio [HR], 0.41; 95% CI, 0.21-0.80; P = .009; 24 hours vs 2-7 days: HR, 0.25; 95% CI, 0.14-0.45; P 7 days: HR, 0.23; 95% CI, 0.09-0.55; P

Current guidelines recommend pulmonary vein isolation (PVI) as the cornerstone of atrial fibrillation (AF) ablation, including persistent AF (PerAF). Multiple examinations support cryoablation for paroxysmal AF, however, there are limited evaluations in PerAF patients. The STOP PERSISTENT AF study

Background Cardiostat™ is a single lead ambulatory ECG monitor. Recording is made through 2 electrodes positioned in a lead 1-like configuration. We first validated its accuracy for atrial fibrillation detection compared to a 12-lead ECG. In the second phase of the study, arrhythmia detection accuracy was compared between Cardiostat™ ambulatory ECG and a standard 24 h Holter ECG monitoring. Method/results Phase one of the study included patients undergoing cardioversion for atrial fibrillation (AF) or atrial flutter. Cardiostat™ tracings were compared with standard 12-lead ECG. In the second phase, patients undergoing 24 h ambulatory Holter ECG monitoring for control or suspicion of atrial fibrillation (AF) were included. Simultaneous Holter monitoring and Cardiostat™ ECG recordings were performed. Tracings were analysed and compared. Two hundred twelve monitoring were compared. AF was diagnosed in 73 patients. Agreement between Cardiostat™ ECG and standard Holter monitoring was 99% for AF detection with kappa = 0.99. Kappa correlation for atrial flutter detection was only moderate at 0.51. AF burden was similar in both recordings. Noise hindered analysis in a greater proportion with Cardiostat™ compared to Holter ambulatory ECG (8.5 vs 3.8%). Conclusion Cardiostat™ ambulatory ECG device showed excellent correlation with the standard Holter ECG monitoring for AF detection. Holter monitoring was however superior to discriminate premature atrial and ventricular beats and to qualify the morphology of PVCs since it has more vectors for analysis. Added value of Cardiostat™ includes longer monitoring duration, less cumbersome installation and water resistance.

Objectives This study explored early repolarization (ER) pattern inheritance between survivors of unexplained cardiac arrest (UCA) and their first-degree relatives. Background ER is considered a factor that confers an increased risk of sudden death. A monogenic explanation for ER is seldom evident after cascade screening. Methods UCA survivors and their first-degree relatives enrolled in the CASPER (Cardiac Arrest Survivors With Preserved Ejection Fraction Registry) were included in the study. ER was defined and characterized according to accepted criteria. Logistic regression was performed to explore the association between ER status in the UCA survivor and first-degree relative groups based on the presence of an ER pattern in their related family members after adjusting for age, sex, and ethnicity. Results A total of 289 patients from 14 Canadian sites were studied (age: 43.0 ± 15.9 years; 148 women), and 945 electrocardiograms were analyzed. Seventy-five patients had the ER pattern. There was a significantly higher prevalence of the ER pattern in UCA survivors who had first-degree relatives with the ER pattern (adjusted odds ratio: 5.79; 95% confidence intervals [CIs]: 1.79 to 18.7). There was also a nonsignificant higher prevalence of the ER pattern in first-degree relatives of UCA survivors with the ER pattern (OR: 2.43; 95% CI: 0.70 to 8.43). The highest prevalence of the ER pattern was seen in first-degree relatives of UCA survivors with ER syndrome (29%). Conclusions The ER pattern appeared to be more common among UCA survivors and first-degree relatives whose related family members had similar changes on electrocardiography, which suggested that genetically complex factors contribute to electrocardiographic patterns that predispose to cardiac arrest.

Background: There is limited information on gender differences in patients with Brugada syndrome (BrS) who experienced arrhythmic events (AEs). Objective: The purpose of this study was to compare clinical, electrocardiographic (ECG), electrophysiological, and genetic characteristics between males and females in patients with BrS with their first AE. Methods: The multicenter Survey on Arrhythmic Events in BRUgada Syndrome collected data on the first AE in 678 patients with BrS including 619 males (91.3%) and 59 females (8.7%) aged 0.27–84 years (mean age 42.5 ± 14.1 years) at the time of AE occurrence. Results: After excluding pediatric patients, it was found that females were older than males (49.5 ± 14.4 years vs 43 ± 12.7 years, respectively; P =.001). Higher proportions of females were observed in the pediatric and elderly populations. In Asians, the male to female ratio for AEs was ≈9-fold higher than that in White. Spontaneous type 1 BrS ECG was associated with an earlier onset of AEs in pediatric females. A similar prevalence (≈65%) of spontaneous type 1 BrS ECG was present in males and females above the age of 60 years. Females less frequently showed spontaneous type 1 BrS ECG (41% vs 69%; P, SCOPUS: ar.j, info:eu-repo/semantics/published

Background Infections of cardiac implantable electronic devices (CIED) are associated with significant morbidity and mortality. Despite many preventive measures, this condition is associated with significant costs for the health care system. Methods We retrospectively analyzed all infection cases referred for lead extraction at a single university hospital over 1 year (2015-2016). We then calculated all costs related to the infection episode per patient using hospital databases and charts review. Results Thirty-eight patients with CIED infections (29% women—mean age 71 ± 14 years) were referred for lead extraction (27 pocket infections, 11 endocarditis). Devices were mainly pacemakers (60%). When the pathogen was identified, Staphylococcus aureus methicillin sensitive was the main cause. Extraction was performed in all but 3 cases (92%). One death occurred in the nonextracted group. Respective durations of hospitalization and intravenous and antibiotic administration for patients undergoing extraction were 21 and 36 days. The calculated mean total cost for CIED infection management was CAD$29,907 (median: 26,879; range: CAD$4,827-$62,585). Mean hospital charges were CAD$12,291, accounting for 41% of the total costs. Conclusions This study represents the first analysis of the direct costs associated with lead extraction in Canada. Device infections are associated with significant costs and increased morbidity. Any preventive measure will have a significant impact on the economic burden of the health care system and patient outcome after lead extraction.

Background The ideal management of patients with newly diagnosed symptomatic atrial fibrillation (AF) remains unknown. Current practice guidelines recommend a trial of antiarrhythmic drugs (AAD) prior to considering an invasive ablation procedure. However, earlier ablation offers an opportunity to halt the progressive patho-anatomical changes associated with AF, as well as impart other important clinical benefits. Objective The aim of this study is to determine the optimal initial management strategy for patients with newly diagnosed, symptomatic atrial fibrillation. Methods/Design The EARLY-AF study ( ClinicalTrials.gov NCT02825979 ) is a prospective, open label, multicenter, randomized trial with a blinded assessment of outcomes. A total of 298 patients will be randomized in a 1:1 fashion to first-line AAD therapy, or first-line cryoballoon-based pulmonary vein isolation. Patients with symptomatic treatment naive AF will be included. Arrhythmia outcomes will be assessed by implantable cardiac monitor (ICM). The primary outcome is time to first recurrence of AF, atrial flutter, or atrial tachycardia (AF/AFL/AT) between days 91 and 365 following AAD initiation or AF ablation. Secondary outcomes include arrhythmia burden, quality of life, and healthcare utilization. Discussion The EARLY-AF study is a randomized trial designed to evaluate the optimal first management approach for patients with AF. We hypothesize that catheter ablation will be superior to drug therapy in prevention of AF recurrence.

Percutaneous left atrial appendage (LAA) closure has become a valid alternative to anticoagulation therapy for the prevention of thromboembolic events in patients with atrial fibrillation (AF). However, scarce data exist on the impact of LAA closure on left atrial and ventricular function. We sought to assess the acute hemodynamic changes associated with percutaneous LAA closure in patients with paroxysmal AF. The study population consisted of 31 patients (mean age 73 ± 10 years; 49% women) with paroxysmal AF who underwent successful percutaneous LAA closure. All patients were in sinus rhythm and underwent 2D transthoracic echocardiography at baseline and the day after the procedure. A subset of 14 patients underwent preprocedural cardiac computed tomography (CT) with 3D LA and LAA reconstruction. Left ventricular systolic function parameters and LA volumetric indexes remained unchanged after the procedure. No significant changes in left ventricular stroke volume (72.4 ± 16.0 vs. 73.3 ± 15.7 mL, p = 0.55) or LA stroke volume (total 15.6 ± 4.2 vs. 14.6 ± 4.2 mL, p = 0.21; passive 9.0 ± 2.8 vs. 8.3 ± 2.6 mL, p = 0.31; active 10.3 ± 5.6 vs. 10.0 ± 6.4 mL, p = 0.72) occurred following LAA closure. Mean ratio of LAA to LA volume by 3D CT was 10.2 ± 2.3%. No correlation was found between LAA/LA ratio and changes in LA stroke volume (r = 0.35, p = 0.22) or left ventricular stroke volume (r = 0.28, p = 0.33). The LAA accounts for about 10% of the total LA volume, but percutaneous LAA closure did not translate into any significant changes in LA and left ventricular function.