BACKGROUND:Conduction system pacing (CSP) is an increasingly used approach for physiological ventricular pacing. We conducted a nationwide survey aimed to evaluate the adoption of CSP in the Italian clinical practice. METHODS:An online survey consisting of 20 questions, distributed to Italian centres performing cardiac pacing, was conducted from October to November 2024. RESULTS:A total of 136 centres took part in the survey (37% of all arrhythmia centres operating in Italy), 119 of which (86%) declared to perform CSP implants. The lack of trained operators was the main perceived barrier to CSP adoption, reported by 58% of the centres that did not perform CSP implants. Forty-seven percent of the centres had started performing CSP implants within the last 2 years. Sixty-three percent of the operators declared to be independent in CSP implant procedures, however, 45% of them still had little experience, having performed ≤10 procedures. The median rate of pacemakers (PMs) with CSP on the total PMs implanted per year was 10%. Left bundle branch area pacing (LBBAP) was the pacing strategy used in 98% of CSP implants. The main indication for CSP implantation was atrioventricular block (46%), followed by cardiac resynchronisation therapy (17%), ablate and pace (15%), and upgrading (14%). CONCLUSIONS:CSP appears to be widely used in the Italian clinical practice, although most centres have only begun adopting it in the past few years, and many operators are still not very experienced. LBBAP is the CSP strategy most commonly chosen by the Italian operators.
BACKGROUND:Predicting cardiac resynchronization therapy (CRT) response remains problematic. A fluoroscopy imaging-based method to reconstruct the 3-dimensional trajectory (3DTraj) of the coronary sinus (CS) lead pacing cathode throughout the cardiac cycle was used in this study. OBJECTIVE:The aim was to assess the correlation of left ventricular (LV) reverse remodeling with site-specific short-term change in 3DTraj geometry induced by biventricular pacing at the start of CRT. 3DTraj potential as an intraprocedural guide for CS pacing site choice was thus evaluated. METHODS:In CRT implants in 6 centers, pacing cathode 3DTraj was reconstructed just before (T-1) and immediately after (T0) biventricular pacing start at fixed atrio-ventricular and interventricular intervals. The TRAJ-index was calculated as the percentage variation of the ratio between the 2 main axes of 3DTraj between T-1 and T0. The TRAJ-index was compared with the volumetric response at echocardiography defined as a less than -15% decrease in LV end-systolic volume at follow-up. Receiver-operator analysis found the TRAJ-index optimal threshold value at -17%. RESULTS:Among 82 patients, 50 (61%) were responders at 8-month median follow-up (interquartile range 7‒10). TRAJ-index predicted positive response in 88% of cases and negative response in 66% of cases, with 77% overall accuracy value (area under curve = 0.86). The TRAJ-index prediction of response was less effective in large LV volumes and, not significantly, in major mitral regurgitations. CONCLUSION:TRAJ-index seems to aid the intra-operative choice of CS-pacing site at CRT implant, with no additional tools.
Catheter ablation is the mainstay of rhythm control in atrial fibrillation (AF), and its use is steadily increasing worldwide. To optimize procedural safety and efficacy, an appropriate sedation or anesthesia regimen is essential, ensuring adequate analgesia and a stable respiratory pattern while minimizing patient movement. However, the optimal sedation strategy remains a matter of debate, with approaches ranging from general anesthesia to deep or conscious sedation. Since anesthesiologists administer general anesthesia, attention focuses on hypnotics, defined as drugs that induce and/or maintain sleep by depressing the central nervous system, and analgesics. In many centers, these agents are administered by electrophysiology laboratory staff in accordance with local regulations and institutional protocols, which vary among countries. This warrants caution, as individual responses to commonly combined agents are unpredictable and may result in deeper-than-intended sedation. Therefore, respiratory or hemodynamic support may become necessary in selected patients. Notably, protocols incorporating hypnotic communication have also been proposed and implemented. The selection of sedation and analgesia strategies for AF ablation has become increasingly important for balancing patient safety, procedural effectiveness, and resource utilization. The approach should be individualized based on patient characteristics, procedural complexity, energy source, institutional resources, and the relevant national regulatory framework.
BACKGROUND:Women are frequently underrepresented in studies investigating atrial fibrillation (AF) ablation. We evaluated the acute efficacy, safety, and mid-term outcomes of de novo paroxysmal AF ablation in female patients using a pentaspline pulsed-field ablation (PFA) versus thermal-based technologies. METHODS:In a cohort of consecutive female patients with paroxysmal AF undergoing de novo pulmonary vein isolation, enrolled in the ATHENA-CHARISMA (Advanced Technologies For Successful Ablation of AF in Clinical Practice - Catheter Ablation of Arrhythmias With High-DensityMapping System in the Real WorldPractice) registries, thermal ablation systems (radiofrequency or cryoablation) were compared to the PFA by means of a propensity score matching (ratio 1:1:1). RESULTS:One-thousand one female patients (mean age 63±10 years, mean left ventricular ejection fraction 60.8±6%) were included: 376 (37.6%) underwent cryoablation ablation, 342 (34.2%) radiofrequency ablation, and 283 (28.3%) PFA. Propensity score matching yielded 684 patients (228 per group). The PFA group had significantly shorter skin-to-skin time (60 [50-75] minutes) compared with both radiofrequency (120 [90-145] minutes, P<0.001) and cryoablation (75 [60-100] minutes, P<0.001), while fluoroscopy time was similar among groups (15 [11-21] minutes for PFA, 14 [10-20] minutes for cryoablation, P=0.599 versus PFA and 14 [9-20] minutes for radiofrequency, P=0.454 versus PFA). Overall complication rate was 3.4% and it was significantly higher after thermal ablation than PFA (4.6% versus 0.9%, OR, 5.5, 95% CI, 1.3-23.5, P=0.0227). During a median follow-up of 413 [277-589] days, 139 (20.3%) patients experienced AF recurrence. The Kaplan-Meier estimated freedom from AF at 1-year follow-up was 86.8% with PFA, 84.6% with cryoablation, and 83.3% with radiofrequency (log-rank P value: 0.839). CONCLUSIONS:Among this cohort of female patients, de novo paroxysmal AF using a pentaspline PFA system demonstrated significantly shorter procedural times, and a lower complication rate compared with thermal ablation systems. One-year follow-up revealed comparable rates of AF freedom across all ablation modalities. REGISTRATION:ATHENA (Advanced Technologies For Successful Ablation of AF in Clinical Practice). URL: http://clinicaltrials.gov/; Unique identifier: NCT05617456. CHARISMA (Catheter Ablation of Arrhythmias With High-Density Mapping System in the Real World Practice). URL: http://clinicaltrials.gov/; Unique Identifier: NCT03793998.
BACKGROUND:Despite being the most effective option for maintaining sinus rhythm, atrial fibrillation (AF) catheter ablation reaches few patients. For this reason, identifying candidates with the highest likelihood of success or individualizing counselling to a specific patient to improve procedural outcome could enhance clinical benefits and cost-effectiveness. OBJECTIVE:To integrate machine learning (ML) into an outcome prediction model based on a large cohort of AF patients undergoing pulsed field ablation (PFA). METHODS:Consecutive AF patients undergoing transcatheter PFA between June 2022 and December 2024 were prospectively enrolled in the ATHENA registry. All procedures were performed with a penta-splines 12F over-the-wire PFA catheter (FARAWAVE™, Boston Scientific). Clinical and procedural variables were collected to train five predictive models estimating 1 year arrhythmic recurrence; model interpretability was assessed using SHAP (SHapley Additive exPlanations) analysis. RESULTS:The study included 1688 AF patients with a median follow-up of 365 days (interquartile range 202-393), arrhythmic recurrence occurred in 314 patients (18.6%). The Boruta algorithm identified diagnosis-to-ablation time (DAT), CHA₂DS₂-VASc score, age, and body mass index (BMI) as most significant predictors. Among the five ML models developed to predict 1 year arrhythmic recurrence probability, Random Forest achieved the best performance (AUC = 0.75, 95% CI 0.69-0.82). SHAP analysis confirmed DAT, BMI, and indexed left atrial volume as major contributors to recurrence. CONCLUSION:This is the first ML model exclusively trained and validated on AF patients undergoing PFA providing actionable insights for personalized treatment planning. Routine use of the model holds the potential to optimize patient selection and improve procedural outcome, supporting individualized counselling and outcome-driven care pathways, moving from static to interactive risk prediction. CLINICAL TRIAL REGISTRATION:Advanced TecHnologies For SuccEssful AblatioN of AF in Clinical Practice (ATHENA). URL: http://clinicaltrials.gov/ Identifier: NCT05617456.
AIMS:Data on pulsed-field ablation (PFA) for atrial fibrillation (AF) in patients with heart failure (HF) are limited. To evaluate clinical outcomes of PFA in patients with AF and HF, stratified by HF subtype. METHODS AND RESULTS:Consecutive patients undergoing first-time pentaspline PFA within the ATHENA registry were analyzed. Patients were stratified into three groups: no HF, HF with preserved ejection fraction (HFpEF, LVEF ≥50%), and HF with mildly reduced or reduced EF (HFmrEF/rEF, LVEF <50%). The primary endpoint was freedom from documented atrial arrhythmias >30 s after a 2-month blanking period. AAD use was left to physician discretion. Among 1,224 patients included (68.5% with paroxysmal AF and 31.5% with persistent AF), 176 (14.4%) had HF: 40 (3.3%) with HFpEF and 136 (11.1%) with HFmrEF/rEF. The Kaplan-Meier estimated freedom from any atrial arrhythmias at 1-year follow-up was 79.9%, with higher rate in the no-HF group (81.0%) vs the HF group (73.3%, HR = 1.5, 95% CI: 1.1-2.1, P = 0.0133). Considering separately paroxysmal and persistent AF form, paroxysmal AF patients with no sign of HF showed significantly higher freedom from atrial arrhythmias (82.2%) than patients with HF (68.6%, 2.0, 1.3-3.1, P = 0.0028), while no differences were found in patients with persistent AF (77.9% vs 76.4%, 1.1, 0.7-1.7, P = 0.7065). CONCLUSION:PFA with the pentaspline catheter appears to be an effective treatment for AF in patients with HF. Freedom from AF and atrial arrhythmias post-PFA was highest in patients with paroxysmal AF and no history of HF, with no significant differences observed in persistent AF patients. CLINICAL TRIAL REGISTRATION:Advanced TecHnologies For SuccEssful AblatioN of AF in Clinical Practice (ATHENA). URL: http://clinicaltrials.gov/Identifier: NCT05617456.
BACKGROUND:Factors contributing to early recurrence after atrial fibrillation (AF) ablation, particularly with pulsed-field ablation (PFA), are poorly understood. PURPOSE:This study aimed to evaluate the significance of early recurrence and identify factors associated with its occurrence, focusing on predicting late recurrence in AF patients treated with PFA. METHODS:A total of 620 consecutive patients referred for their first paroxysmal or early persistent AF ablation underwent the procedure using the FARAPULSE PFA system (Boston Scientific) across 10 centers. Early recurrence was defined as atrial arrhythmia of > 30-s duration during the 3-month blanking period, and any recurrence beyond 3 months was considered as late recurrence. RESULTS:In total, 44 (7.1%) patients experienced early recurrences (median time to recurrence: 56 [22-75] days). At multivariate logistic analysis adjusted for baseline confounders larger left atrial volume index (LAVi) (1.03, 1.01-1.06, p = 0.0034) was significantly associated with early recurrences. In total, 113 (18.2%) patients experienced late recurrences. Factors independently associated with late recurrences included age (1.03, 1.01-1.05, p = 0.0077), sleep apnea (3.17, 1.73-5.81, p = 0.002), and early recurrences (3.26, 2.01-5.29, p < 0.0001). Early recurrences were associated to late recurrences also in paroxysmal AF only patients (40.0% vs. 16.9%, p < 0.0001). CONCLUSION:In this cohort of AF patients undergoing PFA, early recurrences significantly increased the risk of late recurrences, highlighting their potential as a predictive marker for long-term outcomes. Moreover, larger LAVi was associated with early recurrences. TRIAL REGISTRATION:Advanced TecHnologies For SuccEssful AblatioN of AF in Clinical Practice (ATHENA). URL: http://clinicaltrials.gov/. Identifier: NCT05617456.
CLINICAL TRIAL REGISTRATION:Advanced TecHnologies For SuccEssful AblatioN of AF in Clinical Practice (ATHENA). URL: http://clinicaltrials.gov/Identifier: NCT05617456.
There is limited evidence on efficiency, effectiveness, and safety outcomes in the context of pulsed-field ablation (PFA) of atrial fibrillation (AF) when a 3D mapping system is used. To assess the impact of non-integrated 3D mapping systems in PFA for the treatment of AF. Consecutive patients undergoing PFA (FARAPULSE system) at 17 centers were included. Procedures were stratified according to the use of 3D mapping system (MAP vs standard; STD). A total of 1804 patients were included, 484 (26.8
Repeated procedures are often needed for long-term success of atrial fibrillation (AF) ablation. There are scarce data regarding electroporation by means of pulsed-field ablation (PFA) use for such procedure. We analyzed procedural workflow and long-term outcomes of the Farapulse PFA system as a repeat procedure in comparison with conventional radiofrequency (RF) ablation in patients with paroxysmal AF. Consecutive patients undergoing repeat ablation for paroxysmal AF, enrolled in the ATHENA-CHARISMA registries with complete follow-up data, were included. RF ablation cases were matched to initial PFA cases based on age, sex, left ventricular ejection fraction (LVEF), and comorbidities. In the PFA group, pulmonary vein isolation (PVI) was conducted following a protocol with 8 applications per PV. For RF ablation, circular lesions were created at each PV antrum with 45-50W. Additional lesions were applied at the operator's discretion. A total of 253 patients were included: 175 (69%) underwent RF ablation, and 78 (31%) underwent PFA. Mean age was 61±11 years, mean LVEF was 58±6%, 26.9% (n=68) of the patients were female and 19% (n=48) had a history of AT/AFL. In the PFA group, extended lesion sets beyond PVI were more commonly applied (29.5% for PFA vs. 14.3% for RF, p=0.006), while use of a 3D mapping system was lower (41% for PFA vs. 100% for RF, p<0.0001). Skin-to-skin procedural time and time to achieve PVI were shorter in the PFA group (75[51-94] min vs. 120[74-150] min, p<0.0001, and 20[15-26] min vs. 29[10-60] min, p<0.0001, respectively), whereas fluoroscopy time was longer (17[12-24] min vs. 12[8-17] min, p<0.001). No differences were observed between groups in the total number of PFA/RF energy applications (32[32-42] vs. 33[13-55], p=0.0851). PVI was achieved in all patients. Over a median follow-up of 377[302-450] days, 40 patients (15.8%) experienced AF recurrence beyond the 90-day blanking period. Energy source (PFA vs. RF) was not associated with AF recurrence (hazard ratio=1.43, 95% CI: 0.73 to 2.77, p=0.296). No major complications, including death, renal failure, esophageal complications, PV stenosis, or persistent phrenic nerve injury, were reported. Our analysis indicates that the PFA system, when used for repeat ablation of paroxysmal AF, offers improved procedural efficiency compared to conventional RF ablation, with long-term outcomes comparable to those observed with RF ablation.
Background There is no evidence evaluating efficiency, effectiveness, and safety outcomes in older patients in the context of pulsed‐field ablation technology for the ablation of atrial fibrillation. We aimed to compare safety, efficacy, and acute and long‐term outcomes of pulsed‐field ablation in older patients (≥75 years) with younger ones. Methods We enrolled consecutive patients who had undergone atrial fibrillation ablation with the pulsed‐field ablation FARAPULSE system (Boston Scientific) at 15 centers. Patients were stratified by age (<65, 65–74, and ≥75 years) and efficacy and safety profiles of these groups were compared. Results A total of 1082 patients were included: 108 (10%) were ≥75 years old, 374 (34.6%) were 65–74 years old and 600 (55.4%) were <65 years old. Older patients displayed a more pronounced risk profile compared with their younger counterparts, characterized by a significant higher burden of comorbidities. No differences in terms of procedural metrics were found. Pulmonary vein isolation was achieved in all patients. An overall low rate of procedural‐related complications was reported (3.0%) without difference between young and older patients (P=0.241). During a mean follow‐up of 342±111 days, a primary efficacy end point occurred in 605 of 748 (80.9%) patients with available outcome information. The arrhythmia recurrence rate ranged from 14.4% in patients <65 years old to 26.9% of older patients (P=0.011). Conclusions Drawing from these findings, using the FARAPULSE system for atrial fibrillation ablation in older patients demonstrated swift, safe, and effective acute outcomes, mirroring a comparable pattern observed in younger patients and recurrence rates in line with the literature in older patients. Registration URL: clinicaltrials.gov; Unique Identifier: NCT05617456.
BACKGROUND:Catheter ablation (CA) of atrial fibrillation is routinely used to obtain rhythm control. Evidence suggest that catheter ablation should be done during uninterrupted oral anticoagulation. METHODS:Italian Registry in the setting of atrial fibrillation ablation with rivaroxaban (IRIS) is an Italian multicenter, non-interventional, prospective study which enrolled 250 consecutive atrial fibrillation patients eligible for catheter ablation on rivaroxaban. The decision for rivaroxaban management was left to the physician: uninterrupted or shortly interrupted prior to Catheter ablation. Patients received a follow-up visit at 1 month and 12 months after the procedure. RESULTS:The primary outcome, represented by all-cause death and systemic embolism at 1 month and 12 months was characterized by one transient ischemic attack and one myocardial infarction in the first 30 days. Both events happened in patients with shortly interrupted strategy (P=0.147), and both in patients who underwent radiofrequency ablation (P=0.737). In the primary safety outcome represented by major bleeding we did not register any event in the 12-month follow-up. The secondary outcome constituted by minor bleeding registered 1 event, after the first 30 days since CA. CONCLUSIONS:IRIS is the biggest real-life data registry regarding CA ablation on rivaroxaban in Italian setting, proving the safety and efficacy of rivaroxaban.
Abstract Background It is well known that age affects the efficacy of pharmacological treatment for atrial fibrillation (AF). Thermal ablation (radiofrequency or cryoballoon) is an established strategy for AF. However, there is no evidence evaluating efficiency, effectiveness, and safety outcomes in elderly patients in the context of the novel pulsed-field ablation (PFA) technology. Purpose We aimed to analyze the efficacy and safety of PFA in elderly (age≥75 years) patients with AF compared to non-elderly (age<75 years) patients with AF. Methods All consecutive patients undergoing AF ablation with the Farapulse system at 10 centers were included. Protocol-directed PVI was delivered using 2000 V with eight applications per vein, that is, four applications each in the basket and flower poses. Additional lesions were performed at the operator’s discretion. Results A total of 851 consecutive patients were included: 83 (9.8%) had ≥75 years (median of 77[75-78] years) whereas 768 (90.2%) had <75 years (median of 62[56-68] years, p<0.0001). Older patients had more comorbidities compared to younger patients (kidney disease: 9.6% vs 1.2%, p<0.0001; chronic obstructive pulmonary disease: 8.4% vs 3%, p=0.021; cancer history: 18.1% vs 6.1%, p=0.0004; hypertension: 61.4% vs 43.8%, p=0.002), whereas they exhibited a higher LVEF (60±6% vs 57±8%, p=0.0243). No differences between older and younger patients were found in terms of underlying AF type (paroxysmal AF: 66.3% vs 68.9%, p=0.62), procedure type (repeat ablation: 8.4% vs 13.4%, p=0.29), more extensive lesion set than PVI only (28.9% vs 22.5%, p=0.22) and the use of 3D mapping system (22.9% vs 21.1%, p=0.67). By looking at procedural metrics, no differences were also found between groups: 73±28 min vs 72±32 min for skin-to-skin time, p=0.41; 93±41 min vs 88±43 min for preparation plus skin-to-skin time, p=0.11; 18±9 min vs 17±9 min for fluoroscopy time, p=0.61 and 32[32-40] vs 32[32-38] PFA spots to achieve PVI, p=0.29. PVI was achieved in all patients. No major procedure-related adverse events were reported. Conclusion In our experience, the use of Farapulse PFA system for AF ablation in elderly patients was rapid, safe and effective, with no differences compared to the younger population.