Second-generation laser balloon ablation for the treatment of atrial fibrillation assessed by continuous rhythm monitoring: the LIGHT-AF study

Balloon-based technologies have been developed to simplify catheter ablation of atrial fibrillation (AF), to improve the clinical outcome of the procedure and to achieve durable pulmonary vein isolation (PVI). The objective of this study is to evaluate the safety and efficacy of second-generation laser balloon (LB2) ablation in the treatment of AF using a continuous cardiac rhythm monitoring strategy. Atrial tachyarrhythmias (ATas) recurrences were assessed with implantable cardiac monitors (ICMs) or devices

Sex differences in leadless pacemaker implantation: A propensity-matched analysis from the i-LEAPER registry

BACKGROUND: The impact of sex in clinical and procedural outcomes in leadless pacemaker (LPM) patients has not yet been investigated. OBJECTIVE: The purpose of this study was to investigate sex-related differences in patients undergoing LPM implantation. METHODS: Consecutive patients enrolled in the i-LEAPER registry were analyzed. Comparisons between sexes were performed within the overall cohort using an adjusted analysis with 1:1 propensity matching for age and comorbidities. The primary outcome was the comparison of major complication rates. Sex-related differences regarding electrical performance and all-cause mortality during follow-up were deemed secondary outcomes. RESULTS: In the overall population (n = 1179 patients; median age 80 years), 64.3% were men. After propensity matching, 738 patients with no significant baseline differences among groups were identified. During median follow-up of 25 [interquartile range 24-39] months, female sex was not associated with LPM-related major complications (hazard ratio [HR] 2.03; 95% confidence interval [CI] 0.70-5.84; P = .190) or all-cause mortality (HR 0.98; 95% CI 0.40-2.42; P = .960). LPM electrical performance results were comparable between groups, except for a higher pacing impedance in women at implant and during follow-up (24 months: 670 [550-800] Ω vs 616 [530-770] Ω; P = .014) that remained within normal limits. CONCLUSION: In a real-world setting, we found differences in sex-related referral patterns for LPM implantation with an underrepresentation of women, although major complication rate and LPM performance were comparable between sexes. Female patients showed higher impedance values, which had no impact on overall device performance. Electrical parameters remained within normal limits in both groups during the entire follow-up

Peri-procedural and mid-term follow-up age-related differences in leadless pacemaker implantation: Insights from a multicenter European registry

BACKGROUND Age-related differences on leadless pacemaker (LP) are poorly described. Aim of this study was to compare clinical indications, periprocedural and mid-term device-associated outcomes in a large real-world cohort of LP patients, stratified by age at implantation. METHODS Two cohorts of younger and older patients (≤50 and > 50 years old) were retrieved from the iLEAPER registry. The primary outcome was to compare the underlying indication why a LP was preferred over a transvenous PM across the two cohorts. Rates of peri-procedural and mid-term follow-up major complications as well as LP electrical performance were deemed secondary outcomes. RESULTS 1154 patients were enrolled, with younger patients representing 6.2% of the entire cohort. Infective and vascular concerns were the most frequent characteristics that led to a LP implantation in the older cohort (45.8% vs 67.7%, p < 0.001; 4.2% vs 16.4%, p = 0.006), while patient preference was the leading cause to choose a LP in the younger (47.2% vs 5.6%, p < 0.001). Median overall procedural (52 [40-70] vs 50 [40-65] mins) and fluoroscopy time were similar in both groups. 4.3% of patients experienced periprocedural complications, without differences among groups. Threshold values were higher in the younger, both at discharge and at last follow-up (0.63 [0.5-0.9] vs 0.5 [0.38-0-7] V, p = 0.004). CONCLUSION When considering LP indications, patient preference was more common in younger, while infective and vascular concerns were more frequent in the older cohort. Rates of device-related complications did not differ significantly. Younger patients tended to have a slightly higher pacing threshold at mid-term follow-up

Peri-procedural and mid-term follow-up age-related differences in leadless pacemaker implantation: Insights from a multicenter European registry

Age-related differences on leadless pacemaker (LP) are poorly described. Aim of this study was to compare clinical indications, periprocedural and mid-term device-associated outcomes in a large real-world cohort of LP patients, stratified by age at implantation

Leadless Pacemaker Implantation in the Emergency Bradyarrhythmia Setting: Results from a Multicenter European Registry

Background. Data on leadless pacemaker (LPM) implantation in an emergency setting are currently lacking. Objective. We aimed to investigate the feasibility of LPM implantation for emergency bradyarrhythmia, in patients referred for urgent PM implantation, in a large, multicenter, real-world cohort of LPM recipients. Methods. Two cohorts of LPM patients, stratified according to the LPM implantation scenario (patients admitted from the emergency department (ED+) vs. elective patients (ED−)) were retrieved from the iLEAPER registry. The primary outcome of the study was a comparison of the peri-procedural complications between the groups. The rates of peri-procedural characteristics (overall procedural and fluoroscopic duration) were deemed secondary outcomes. Results. A total of 1154 patients were enrolled in this project, with patients implanted due to an urgent bradyarrhythmia (ED+) representing 6.2% of the entire cohort. Slow atrial fibrillation and complete + advanced atrioventricular blocks were more frequent in the ED+ cohort (76.3% for ED+ vs. 49.7% for ED−, p = 0.025; 37.5% vs. 27.3%, p = 0.027, respectively). The overall procedural times were longer in the ED+ cohort (60 (45–80) mins vs. 50 (40–65) mins, p p p = 0.244). Conclusion. LPM implantation is a feasible procedure for the treatment of severe bradyarrhythmia in an urgent setting. Urgent LPM implantation was not correlated with an increase in the rate of major complications compared to the control group, but it was associated with longer procedural times