Association of Atrial Fibrillation Burden With Health-Related Quality of Life After Atrial Fibrillation Ablation: Substudy of the Cryoballoon vs Contact-Force Atrial Fibrillation Ablation (CIRCA-DOSE) Randomized Clinical Trial.

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 < .001), or every 0.63% (95% CI, 0.30-0.95; P < .001) reduction in relative AF burden from baseline. Conclusions and Relevance: In patients with primarily low-burden paroxysmal AF, the reduction in AF burden following ablation may be associated with a clinically meaningful improvement in quality of life. Trial Registration: ClinicalTrials.gov Identifier: NCT01913522.

Prevalence and outcome of early recurrence of atrial tachyarrhythmias in the Cryoballoon vs Irrigated Radiofrequency Catheter Ablation (CIRCA-DOSE) study.

BACKGROUND: 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. OBJECTIVE: The purpose of this study was to determine the incidence and outcomes of patients experiencing ERAT after PVI using advanced-generation ablation technologies. METHODS: 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. RESULTS: 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. CONCLUSION: 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.

Impact of Left Common Pulmonary Veins in the Contact-Force vs. Cryoballoon Atrial Fibrillation Ablation (CIRCA-DOSE) Study.

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.

Association of Atrial Fibrillation Episode Duration With Arrhythmia Recurrence Following Ablation: A Secondary Analysis of a Randomized Clinical Trial.

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 < .001; 24 hours vs >7 days: HR, 0.23; 95% CI, 0.09-0.55; P < .001). Patients with preablation AF episodes limited to less than 24 continuous hours had a significantly lower median (interquartile range) postablation AF burden (0% [0%-0.1%]) compared with those with AF preablation episodes lasting 2-7 days (0.1% [0%-1.0%]; P = .003) and those with AF preablation episodes lasting more than 7 days (1.0% [0%-5.4%]; P = .008). There was no significant difference in arrhythmia recurrence or AF burden between the 3 groups with a baseline AF episode duration of longer than 24 hours. Conclusions and Relevance: In this study, patients with AF episodes limited to less than 24 continuous hours had a significantly lower incidence of arrhythmia recurrence following AF ablation. This suggests that current guidelines for classification of AF may not reflect clinical outcomes. Trial Registration: ClinicalTrials.gov Identifier: NCT01913522.

Prevalence and clinical impact of spontaneous and adenosine-induced pulmonary vein reconduction in the Contact-Force vs. Cryoballoon Atrial Fibrillation Ablation (CIRCA-DOSE) study.

BACKGROUND: 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. OBJECTIVE: 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. METHODS: 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. RESULTS: 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). CONCLUSION: 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.

Cryoballoon or Radiofrequency Ablation for Atrial Fibrillation Assessed by Continuous Monitoring: A Randomized Clinical Trial.

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<0.001 vs cryoballoon groups). 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.

Intracardiac echo-facilitated 3D electroanatomical mapping of ventricular arrhythmias from the papillary muscles: assessing the 'fourth dimension' during ablation.

AIMS: Ventricular arrhythmias (VA) originating from a papillary muscle (PM) have recently been described as a distinct clinical entity with peculiar features that make its treatment with catheter ablation challenging. Here, we report our experience using an intracardiac echo-facilitated 3D electroanatomical mapping approach in a case series of patients undergoing ablation for PM VA. METHODS AND RESULTS: Sixteen patients who underwent catheter ablation for ventricular tachycardia (VT) or symptomatic premature ventricular contractions originating from left ventricular PMs were included in the study. A total of 24 procedures (mean 1.5 per patient) were performed: 15 using a retrograde aortic approach and 9 using a transseptal approach. Integrated intracardiac ultrasound for 3D electroanatomical mapping was used in 15 of the 24 procedures. The posteromedial PM was the most frequent culprit for the clinical arrhythmia, and the body was the part of the PM most likely to be the successful site for ablation. The site of ablation was identified based on the best pace map matching the clinical arrhythmia and the site of earliest the activation. At a mean follow-up of 10.5 ± 7 months, only two patients had recurrent arrhythmias following a repeat ablation procedure. CONCLUSION: An echo-facilitated 3D electroanatomical mapping allows for real-time creation of precise geometries of cardiac chambers and endocavitary structures. This is useful during procedures such as catheter ablation of VAs originating from PMs, which require detailed representation of anatomical landmarks. Routine adoption of this technique should be considered to improve outcomes of PM VA ablation.

Arrhythmic Risk Following Recovery of Left Ventricular Ejection Fraction in Patients with Primary Prevention ICD.

BACKGROUND: Left ventricular ejection fraction (LVEF) recovers during follow-up in a significant proportion of patients implanted with a cardioverter defibrillator (ICD) for primary prevention. Little is known about the midterm arrhythmic risk in this population, particularly in relation to the presence or absence of ischemic cardiomyopathy. METHODS AND RESULTS: We retrospectively analyzed 286 patients with an ICD implanted for primary prevention between 2002 and 2010. Patients were divided into two groups based on their last LVEF assessment: (1) Recovery, defined as an LVEF > 35%; and (2) No-Recovery, defined as an LVEF ≤ 35%. Kaplan-Meir curves and multivariate Cox regression analysis were performed separately for patients with ischemic (211 patients) and nonischemic (75 patients) cardiomyopathy. Forty-nine patients (17.1%) had LVEF recovery to >35% at last follow-up. Overall, 72 patients (25.2%) experienced ventricular arrhythmias requiring ICD therapy during a median follow-up of 4.4 years. With multivariate Cox regression, LVEF recovery was associated with a lower arrhythmic risk in the whole cohort (hazard ratio [HR]: 0.38 [0.13-0.85]; P = 0.02) and in the nonischemic cardiomyopathy cohort (HR: 0.10 [0.005-0.55]; P = 0.005), but not in the ischemic cardiomyopathy cohort (HR: 0.84 [0.25-2.10]; P = 0.74). CONCLUSION: In conclusion, patients with nonischemic cardiomyopathy who improved their LVEF to >35% after primary prevention ICD implantation were at very low absolute arrhythmic risk. Our study raises the possibility that the LVEF cutoff to safely withhold ICD replacement might be higher in patients with ischemic compared to nonischemic cardiomyopathy. This will need to be confirmed in prospective studies.

Real-life experience with a new anticoagulation regimen for patients undergoing left-sided ablation procedures.

BACKGROUND: Current guidelines for anticoagulation during left-sided procedures recommend the administration of unfractionated heparin (UFH) with an initial bolus of 50-100 U/kg, followed by continuous infusion to maintain an activated clotting time (ACT) ≥ 300 s. Our objective was to compare the effectiveness of this standard regimen (100 U/kg bolus) to a more aggressive approach (200 U/kg bolus). METHODS: We collected data on a series of consecutive patients undergoing left sided ablation procedures. Patients with an INR ≥2.0 on the day of the procedure were excluded. Procedural anticoagulation was performed using one of two UFH regimens: 1) 100 U/kg bolus, followed by 10 U/kg/hour infusion or 2) 200 U/kg bolus, followed by 20 U/kg/hour infusion. ACT was measured 10 min after the second bolus and then controlled every 20 min. Heparin was titrated throughout the procedure to maintain an ACT 300-400 s. RESULTS: 145 consecutive patients were included in the study: 34 received an initial bolus of 100 U/kg and 111 received 200 U/kg. The mean time required to reach an ACT ≥300 s was 15.25 min (95% CI 12.97-17.03) in the 200 U/kg group and 51.23 min (95% CI 40.65-61.81) in the 100 U/kg group (p < 0.001). There was no difference between groups with regard to thromboembolic or hemorrhagic complications. CONCLUSION: Current anticoagulation guidelines for left-sided ablation procedures almost universally fail to achieve an initial ACT ≥300 s. A 200 U/kg heparin bolus is much more effective to promptly reach the target ACT, with a low rate of overshoot.

Multidetector cardiac tomography: a useful tool before cardiac resynchronization therapy.

BACKGROUND: Left ventricular lead placement in a suitable coronary vein is a key determi-nant of responsiveness to cardiac resynchronization therapy (CRT). Multidetector cardiac tomography (MDCT) is a non-invasive alternative to depict cardiac venous anatomy although coronary sinus (CS) retrograde venography (RV) is the gold standard. The aim of this study was to evaluate the accuracy of MDCT to determine the presence of CS tributaries before CRT. METHODS: A retrospective analysis of 41 consecutive patients eligible to CRT was performed. MDCT was assessed in all patients before CRT and RV was achieved in 39 patients. Both methods evaluated the presence of the inferior interventricular vein (IIV), posterior vein (PV) and lateral main vein (LMV). CS ostium diameter and distance between the CS ostium and right atrium (RA) lateral wall were also measured. RESULTS: The IIV was identified in 100% of MDCT and in 43.6% of RV. In comparison to RV, the MDCT's sensitivity to identify PV and LMV was 100% for both, kappa coefficient of 0.792 (CI 95% 0.46-0.93) and 0.69 (CI 95% 0.46-0.91), respectively. There was no significant difference between ischemic and non-ischemic patients regarding the presence of PV or LMV. Median CS antero-posterior diameter was 10.3 mm (IQR 7.5-13) and supero-inferior was 14.1 mm (IQR 11.5-17) (p < 0.01). A positive correlation (p < 0.001) between echocardiographic RA area and the distance from CS ostium to the RA lateral wall in the MDCT was observed. CONCLUSIONS: MDCT is as accurate as RV to depict CS and its tributaries (IIV, PV, LMV), and it could be useful as a non-invasive technique before CRT.

[Endocarditis of pacemaker or implantable cardioverter-defibrillator leads]. / Endocarditis relacionada a cables de marcapasos o cardiodesfibriladores implantables.

BACKGROUND: Infective endocarditis includes the endovascular devices infection. The main objective was to evaluate the clinical characteristics and evolution of the endocarditis related to electronics devices. CASE REPORTS: Between 2002 - 2007 periods were identified 7 patients, age average of 56.5 years. The clinical presentation was fever of unknown origin in 85.7%, with a mean of 28 days of evolution. The microbiology isolated was coagulase-negative staphylococci in 6 patients and staphylococcus aureus in 1 patient. The treatment was complete system extraction and antibiotic therapy, except in 1 case that only received antibiotics. There were 2 deaths (28,5%) during in hospital follow-up. CONCLUSION: The endocarditis related to devices is a disease with high mortality. Early diagnosis and system extraction are very important for the treatment and prognosis.

Endocarditis relacionada a cables de marcapasos o cardiodesfibriladores implantables / Endocarditis of pacemaker or implantable cardioverter-defibrillator leads

Antecedentes: Dentro del síndrome de endocarditis infecciosa, se incluyen la infección de dispositivos endovasculares. el objetivo de la presentación fue avaluar las características clínicas y la evolución de la endocarditis relacionada a dispositivos electrónicos endovasculares. Casos clínicos: entre 2002 - 2007 fueron identificados 7 pacientes con edad promedio de 56,5 años. La presentación clínica fue en el 85,7% fiebre de origen desconocido, con un promedio de 28 días de evolución del cuadro. Los germenes aislados fueron estafilococo coagulasa negativo en 6 pacientes y estafilococo aureus en 1 paciente. El tratamiento se baso en la extracción del sistema y terapia antibiótica, salvo 1 caso que solo recibió tratamiento antibiótico. Hubo 2 (28,5%) muertes intrahospitalarias durante el seguimiento. Conclusión: La endocarditis relacionada a dispositivos es una entidad con elevada mortalidad. el diagnóstico temprano y la extracción del sistema son de vital importancia para el tratamiento y pronóstico.

BACKGROUND: Infective endocarditis includes the endovascular devices infection. The main objective was to evaluate the clinical characteristics and evolution of the endocarditis related to electronics devices. CASE REPORTS: Between 2002 - 2007 periods were identified 7 patients, age average of 56.5 years. The clinical presentation was fever of unknown origin in 85.7%, with a mean of 28 days of evolution. The microbiology isolated was coagulase-negative staphylococci in 6 patients and staphylococcus aureus in 1 patient. The treatment was complete system extraction and antibiotic therapy, except in 1 case that only received antibiotics. There were 2 deaths (28,5%) during in hospital follow-up. CONCLUSION: The endocarditis related to devices is a disease with high mortality. Early diagnosis and system extraction are very important for the treatment and prognosis.