Mapping and ablation of intramural premature ventricular complexes: state-of-the-art review.

Background Women are typically underrepresented in randomized clinical trials, including those focused on atrial fibrillation (AF). The efficacy and safety of pulsed field ablation (PFA) compared to conventional thermal ablation in women have not been well established. Purpose To evaluate the acute efficiency, safety, and long-term outcomes of AF ablation in female-only patients using the Farapulse PFA system versus thermal-based technologies. Methods We conducted a retrospective study on consecutive female patients undergoing AF ablation and enrolled in the ATHENA-CHARISMA registries. Thermal ablation systems (radiofrequency ablation - RF - or cryoablation - Cryo -) were compared to all initial cases approached with the Farapulse PFA system. The ablation approach followed standard clinical practice, with additional lesions performed at the operator’s discretion. Results A total of 1402 female patients (mean age 64±10 years, mean LVEF 59.5±7%, 1058 (75.5%) with paroxysmal AF, 344 (24.5%) with persistent AF) were included: 682 (48.0%) underwent RF ablation, 429 (30.2%) Cryo ablation, and 291 (20.5%) PFA. The PFA group had significantly shorter procedural times (60 [54-80] min) compared to both RF (120 [90-150] min, p<0.001) and Cryo (90 [60-100] min, p<0.001). Fluoroscopy time was lower in the RF group (13.1 [8.4-20] min) compared to both PFA (15 [11-20] min, p=0.0014) and Cryo (15.7 [11-20] min, p=0.0001). Time to PVI was similar between PFA (19 [13-25] min) and RF (18 [11-26] min, p=0.834), but higher in Cryo (22 [16-31] min, p=0.001 vs RF, p<0.001 vs PFA) cases. Overall complication rates were significantly higher with thermal ablation: 1.4% (n=6) with PFA, 4.4% (n=30) with RF (p=0.021 vs PFA), and 5.1% (n=22) with Cryo (p=0.0076 vs PFA). Complete follow-up information was available for 995 (71.0%) patients. During a median follow-up of 406 [349-571] days, 211 (21.1%) patients experienced AF recurrence (median time to recurrence 224 [143-342] days). The Kaplan-Meier estimated freedom from AF was 81.2% with PFA, 80.4% with Cryo, and 77.0% with RF (log-rank p-value: 0.411). Persistent AF patients had a higher AF recurrence rate than paroxysmal AF patients (28.9% vs 18.6%, p=0.0009; HR=1.72, 95% CI: 1.2 to 2.4, p=0.0002). No significant differences were observed among energy sources when separately analyzing paroxysmal and persistent AF patients. Conclusion In female patients undergoing AF ablation, pulsed field ablation resulted in significantly shorter procedural times and a lower rate of complications compared to conventional thermal ablation systems. Follow-up data showed similar rates of AF freedom across all ablation methods.

Introduction Pulsed field ablation (PFA) has emerged as a novel strategy to achieve ablation of cardiac tissue. Clinical evidence suggests a remarkable lesion durability and safety profile for AF ablation. Nonetheless, a growing interest exists in broadening its field of application for catheter ablation of ventricular arrhythmias (VA). The CENTAURI system arises as a promising PFA system for targeting VA as it allows pulsed electric field (PEF) delivery via standard, commercially available focal ablation catheters and concomitant coupling with their mapping systems. Purpose To assess, for the first time, the feasibility of focal PFA via the CENTAURI system for premature ventricular complex (PVC) ablation. Methods We conducted a prospective analysis of patients with either high burden (>10%) or symptomatic idiopathic PVC undergoing focal PFA using CENTAURI system at our institution. Procedures were performed between December 2022 and August 2023. Acute and long-term success were defined as no PVC recurrence during a 24h in-hospital monitoring period, and ≥80% burden reduction with absence of symptoms after at least 30 days post-ablation, respectively. PVC monitoring was performed by implantable loop recorder (ILR) or surface ECG Holter monitoring. Results Fourteen patients (age range: 16-87 years; 10 females) were included. Procedures were performed via the CENTAURI system in combination with CARTO 3 system and EnSite X EP system in 4 (28.6%) and 10 cases (71.4%) respectively. Targeted ablation sites were the right ventricular outflow tract (6 cases), right moderator band (2 cases), left postero-medial papillary muscle -PM- (2 cases), and right posterior PM, tricuspid annulus, left posterior fascicle and aortomitral continuity (AMC) in one case. On average, 6.5 applications were delivered to the site of origin with a mean contact force of 11g. Procedural duration and fluoroscopy time were 102 and 8.9 minutes. Two minor complications were observed: one transitory ST depression (solved after i.v. nitrate administration) after repeated applications to AMC, and a femoral pseudoaneurysm. The remaining 12 procedures were uneventful. Although most of the procedures were performed under general anesthesia due to concerns about potential significant muscular contraction, 3 cases (21.4%) were successfully managed with light sedation, without significant muscular contraction nor map shift. Incomplete abolishment of PVC during first 24 h was observed in 2 patients (14.3%). After a median follow-up of 113 days (IQR: 83-188), recurrences were detected in one patient (7.14%). Conclusion Herein we report the feasibility and efficacy of PVC ablation using a focal PEF delivery system (CENTAURI). Furthermore, we describe the possibility of performing PVC ablation with this technology under light sedation, which might be important for minimizing anesthesia impact on PVC burden.Table of characteristicsPVC morphologies

Funding AcknowledgementsType of funding sources: Private company. Main funding source(s): Boris Schmidt, KR Julian Chun and Stefano Bordignon received speaking honoraria from Medtronic and Boston ScientificBackgroundThe cryoballoon (CB) is one of the most commonly used single shot devices for pulmonary vein isolation in patients with atrial fibrillation (AF). Pulsed field ablation (PFA) is a new non-thermal, tissue selective approach for pulmonary vein isolation.PurposeWe sought to compare procedural safety and efficacy of these single shot ablation techniques.MethodsConsecutive AF patients (paroxysmal / persistent AF) who underwent CB based pulmonary vein isolation (PVI) between November 2020 and February 2022 were enrolled and compared with patients who underwent PFA ablation in the same time period. Patients that underwent ablation beyond PVI (except for cavo-tricuspid isthmus ablation) were excluded. CB PVI was performed using the second-generation CB (CB 28 mm) with 240 sec based freeze protocol and bonus freeze delivery in case of time-to-isolation (TTI) >75 sec. PFA was performed using the Farawave catheter, using the 31 or 35 mm device. All procedures were performed under deep sedation.ResultsData from 400 consecutive patients were collected. Most baseline characteristics like age (CB: 67,5 ± 15,3; PFA: 68,4 ± 11; p=0,49), BMI (CB: 28,6 ± 6,3; PFA: 27,9 ± 5,6; p=0,27) and gender (male) (CB: 54%; PFA: 59%; p=0,31) were comparable between the two groups. All PVIs were successfully completed.In 98% (196) of patients in the CB group and 100% (200) in the PFA group, PVI was performed using solely CB or PFA respectively, meaning additional touch up ablation was only needed in 4 CB patients (2%; p=0,044) and 4 veins.Procedure time was significantly shorter in the PFA group (CB: 53 ± 15,3 minutes; PFA: 36,8 ± 13,5 minutes; p<0,001), whereas no difference in fluoroscopy time (CB: 8,1 ± 4,4 minutes; PFA: 7,8 ± 3,3 minutes; p=0,2) was observed. The rate of concomitant CTI-ablation was equal in both groups (CB: 1,5%; PFA: 1,5%; p=1,0). Complication rate was 3,5% with PFA and 6,5% in CB (p=0,17), a difference mostly driven by persistent phrenic nerve palsies (CB: 1,5%; PFA: 0%; p=0,08).All patients are out of the blanking period. There were 80 recurrences in blanking time (CB: 41; PFA: 39; p=0,8). In CB 19,5% of blanking time recurrences were atrial tachycardias compared to 35,9% in PFA (p=0,1). The average time to blanking recurrence was 14,1 ± 21,5 days in CB and 20,5 ± 23,2 in PFA (p=0,2). In total, there were 7 repeat procedures (4 in CB and 3 in PFA; p=0,7) during blanking time due to arrhythmias, despite of antiarrhythmic drugs and/or cardioversion.At the time of this analysis, the first hundred patients in each group reached one-year follow-up. Recurrence free survival after one year for patients with PAF was 82,6% in CB and 80,0% in PFA. In patients with persistent AF it was 70,8% in CB and 67,8% in PFA.ConclusionCryoballoon and pulsed field ablation are both highly effective and safe techniques for PVI. PFA had a shorter procedure time, whereas the one year follow up was similar for both techniques.Procedural dataProcedural complications

To date, data about pulsed field ablation (PFA) for ventricular arrhythmias are limited, and cardiac magnetic resonance (CMR) characteristics of acute and chronic PFA lesions in the ventricles have not been described. This study sought to examine feasibility and efficacy of premature ventricular complex (PVC) ablation using focal PFA, as well as assess acute and chronic lesion characteristics using CMR. This was a prospective, single-arm study performed at two centers in China. Consecutive patients with frequent, symptomatic PVCs were consented and recruited. All procedures were performed using a comprehensive cardiac PFA system. PVC burden evaluation and CMR were performed before the procedure, within 3days, and at approximately 6months post-procedure. Twelve patients (mean age 54 ± 14years, 41.7% female) were included and underwent ablation. The PVCs originated in the right ventricular outflow tract in seven (58.3%) patients, the left ventricular outflow tract in three (25%) patients, the left anterior papillary muscle in one (8.3%) patient and para-Hisian septum in one (8.3%) patient, respectively. Nine (75%) patients had complete elimination of PVCs after PFA. The PFA lesions were visualized and quantified by CMR in 6 out of 12 patients. The median volume evaluated by acute late gadolinium enhancement was 726 (430, 1544) mm3 and significantly decreased to 445 (288, 715) mm3 in the chronic stage (P = 0.031). PFA showed favorable efficacy and safety in patients with frequent PVCs. CMR imaging allows clear visualization and quantitative analysis of PFA lesions, which showed a significant size regression from acute to chronic period.

Relationship of frequent postinfarction premature ventricular complexes to the reentry circuit of scar-related ventricular tachycardia

BackgroundRadiofrequency ablation of outflow (OT) of premature ventricular contractions (PVC) is well established and showed satisfactory acute success with reasonable long term recurrence rates. There is little data regarding PVCs ablation using pulsed field energy. Due to increased transmurality, pulsed field ablation (PFA) may have an advantage in cases of mid- and epimyocardial origins, yet proximity to the coronary arteries may increase the risk of PFA related vasospasms.ObjectiveTo assess safety and acute efficacy of focal PFA for OT PVCsMethodsA prospective cohort of 35 patients referred for PVC ablation was enrolled. All procedures were performed using the CENTAURI™ System in combination with contact-force sensing catheters and 3D-electroanatomic mapping systems. Acute success was defined as ≥ 80% reduction of the PVC burden during a 24h in-hospital continuous ECG monitoring period.ResultsPatients (median age: 65 (IQR: 56, 73) years, 69% males) presented with symptomatic monomorphic (72,5%) or pleomorphic PVCs with a main morphology arising from the OT (28,5%). Acute success was achieved in 88% (31/35) of the cases. The ablation target side was left sided in 60% of the cases, ablation in both ventricles was performed in 31%. The median procedural time was 120 (IQR 90,145) minutes. All procedures were performed fluoroless, unless a coronary angiogram was needed to locate the coronary arteries before ablation in the anterior interventricular vein. On average, eleven applications were delivered to the site of origin. Three of the patients who experienced acute recurrence had a left ventricular origin of their PVCs, while one patient had recurrence of RVOT PVCs. All patients received intravenous (i.v.) nitroglycerine before energy application. In three cases, additional epicardial ablation in the anterior interventricular vein was required, in one patient this additional ablation resulted in acute cessation of the PVCs, while the other two had acute recurrences. During an ablation attempt in the anterior interventricular vein, severe spasm of the left anterior descending artery ensued which quickly recovered after additional administration of i.v. nitroglycerine. No additional complications were encountered.ConclusionsFocal PFA is feasible and quite successful in a cohort of symptomatic patients with OT PVCs. Coronary vasospasm is a possible complication despite nitroglycerine application.

Comparison of Monopolar and Bipolar Pulsed Field vs Radiofrequency Ablation on Coronary Artery Injury in a Swine Model.

BackgroundPulmonary vein isolation (PVI) is the key procedure in managing atrial fibrillation (AF), utilizing different ablation techniques: Pulsed Field Ablation (PFA), Cryoballoon (Cryo), and Radiofrequency (RF). Each modality has distinct cost and procedural efficiency profiles. Although PFA carries higher material costs than Cryo and RF, it significantly reduces procedure duration, potentially offsetting expenses through reduced staffing costs for physicians and nurses in the electrophysiology (EP) lab.PurposeThis study evaluates the cost-effectiveness of PFA compared to Cryo and RF, particularly in light of potential savings from reduced staff time.MethodsWe retrospectively analyzed AF patients undergoing PVI between January 2024 and October 2024 in our center. The primary endpoint was total EP lab time, with secondary analysis focusing on adjusted costs accounting for procedural duration. Specifically, the study examined cost savings related to reduced physician and nursing time in the EP lab and the financial impact relative to RF.ResultsOf 467 patients (63% male, 45% PAF, 68±11 years) undergoing PVI, 133 were treated with PFA, 40 with Cryo, and 294 with RF. PFA patients spent an average of 101±22 min in the EP lab, compared to 156±39 min for Cryo and 195±61 min for RF (p<0.001). Accordingly, procedure duration was lower in PFA (41±12 min) than for Cryo (75±23 min) and RF (119±39 min) [p<0.001]. After accounting for reduced procedural time and the associated savings in physician and nursing costs, the per-procedure cost for PFA remained €721 higher than RF, while Cryo exceeded RF by €474 (p<0.001).ConclusionIn our analysis the shorter lab time of PFA and Cryo did not result in an alignment to cost effectiveness to RF PVI but partly compensated for the higher costs for disposables. Though PFA incurs higher procedural costs compared to RF and Cryo, its shorter EP lab time offers cost-saving potential through reduced physician and nurse time, enhancing operational efficiency. Increased procedural capacity with PFA may also drive additional DRG revenue, which should be investigated in further large-scaled studies.

Catheter ablation (CA) of post-ablation left atrial tachycardias (LATs) can be challenging. So far, pulsed field ablation (PFA) has not been compared to standard point-by-point radiofrequency current (RFC) energy for LAT ablation. To compare efficacy of PFA vs. RFC in patients undergoing CA for LAT. Consecutive patients undergoing LAT-CA were prospectively enrolled (09/2021-02/2023). After electro-anatomical high-density mapping, ablation with either a pentaspline PFA catheter or RFC was performed. Patients were matched 1:1. Ablation was performed at the assumed critical isthmus site with additional ablation, if necessary. Right atrial tachycardia (RAT) was ablated with RFC. Acute and chronic success were assessed. Fifty-six patients (n = 28 each group, age 70 ± 9 years, 75% male) were enrolled.A total of 77 AT (n = 67 LAT, n = 10 RAT; 77% macroreentries) occurred with n = 32 LAT in the PFA group and n = 35 LAT in the RFC group. Of all LAT, 94% (PFA group) vs. 91% (RFC group) successfully terminated to sinus rhythm or another AT during ablation (P = 1.0). Procedure times were shorter (PFA: 121 ± 41 vs. RFC: 190 ± 44 min, P < 0.0001) and fluoroscopy times longer in the PFA group (PFA: 15 ± 9 vs. RFC: 11 ± 6 min, P = 0.04). There were no major complications. After one-year follow-up, estimated arrhythmia free survival was 63% (PFA group) and 87% (RFC group), [hazard ratio 2.91 (95% CI: 1.11-7.65), P = 0.0473]. Pulsed field ablation of post-ablation LAT using a pentaspline catheter is feasible, safe, and faster but less effective compared to standard RFC ablation after one year of follow-up. Future catheter designs and optimization of the electrical field may further improve practicability and efficacy of PFA for LAT.

Background Women are frequently underrepresented in studies investigating atrial fibrillation (AF) ablation. In addition, the comparative efficacy and safety of pulsed-field ablation (PFA) versus conventional thermal ablation techniques in women remain inadequately characterized. Purpose We evaluated the safety and long-term outcomes of de novo paroxysmal AF ablation in female patients using PFA versus thermal-based technologies. Methods Consecutive female patients with paroxysmal AF undergoing de novo pulmonary vein isolation (PVI), enrolled in the ATHENA-CHARISMA registries, were compared by means of a propensity score matching according to thermal ablation systems (radiofrequency [RF] or cryoablation [Cryo]) or the Farapulse PFA system (ratio 1:1:1). Results One-thousand one female patients (mean age 63±10 years, mean LVEF 60.8±6%) were included: 376 (37.6%) underwent Cryo ablation, 342 (34.2%) RF ablation, and 283 (28.3%) PFA. Propensity score matching yielded 684 patients (228 per group). The Kaplan-Meier estimated freedom from AF at 1-year follow-up was 84.9%, with similar rate between PFA and conventional thermal energy (Cryo and RF) and among energy sources considering separately: 86.8% with PFA vs 84% with thermal energy (log-rank p-value: 0.642); 84.6% with Cryo, and 83.3% with RF (overall log-rank p-value: 0.839). At multivariate logistic analysis adjusted for baseline confounders indexed left atrial volume was associated with AF recurrence (HR=1.03, 95%CI: 1.002 to 1.05, p=0.0328). Recurrence free-rate from atrial tachycardia/atrial flutter (AT/AFL) after the 90-day blanking period was 93.9%: 96.1% with PFA vs 92.8% with thermal energy (log-rank p-value: 0.185); 94.3% with Cryo (OR=0.68, 95%CI: 0.28 to 1.62, p=0.385 vs PFA), and 91.2% with RF (OR=0.43, 95%CI: 0.19 to 0.98, p=0.039 vs PFA), overall log-rank p-value=0.182 with a trend in favor of PFA vs RF, log-rank p-value=0.082. Overall complication rate was 3.4% and it was significantly higher after thermal ablation (4.6%) than PFA (0.9%, OR=5.5, 95%, CI: 1.3 to 23.5, p=0.0227). Conclusion In female patients with de novo paroxysmal AF, ablation using the Farapulse PFA system was associated with a lower complication rate compared to thermal ablation modalities. At the one-year follow-up, AF freedom rates were comparable across all ablation techniques. However, AT and AFL recurrences were twice as frequent in the RF ablation group compared to PFA, with a trend toward higher recurrence rates in the Cryo group compared to PFA.

Background Catheter ablation is a feasible option for treatment of patients with high burden of monomorphic idiopathic premature ventricular complexes (PVCs) or with idiopathic ventricular tachycardia (VT) and may be considered as a first line treatment in selected patients. Pulsed field ablation (PFA) is a new type of nonthermal energy source delivered to the underlying tissue via the ablation catheter and used for ablation of arrhythmic substrates (1, 2). Purpose The purpose of this retrospective, single-center, observational study was to report on some of the procedural aspects and determine the safety and effectiveness of ablation for idiopathic PVCs of different localizations and VT using a focal PFA. Methods Procedures were performed in deep sedation for all patients. Focal PFA was delivered through a commercially available force-sensing ablation catheters. Ablation site was identified by either activation mapping using 3D electroanatomical system or in combination with pace mapping. Energy output was typically 25A/30 packets while in subset of patients, radiofrequency or low dose PFA were used to identify succesful sites. Number of applications was left to the operators discretion. Patient follow-up was scheduled 3 months after the ablation with mandatory 24-hour Holter ECG and follow up in clinic at 6 and 12 months after the procedure. PVC burden reduction of 90% or more on 3-month 24-hour Holter ECG was used as a primary effectiveness outcome. Results Twenty three patients were enrolled (Table 1). Acute termination of PVCs was achieved in all procedures. Concomitant PFA and RF ablation was performed in 3 patients. In 22 patients transvenous (right ventricle, transseptal or coronary sinus) approach was used, while in 1 patient approach was retrograde transsaaortic. Anatomical arrhythmia localization is shown in Table 2. Two patients acquired left posterior hemiblock due to intended ablation of left posterior fascicle and one patient acquired right bundle branch block after RVOT ablation. Median follow-up was 12 months (Q1-Q3; 8-17 months). Primary effectiveness outcome was achieved in 20 out of 23 patients. During the follow-up period 3 patients additionally reported subjective symptoms of significant arrhythmia burden. Conclusion Focal PFA for idiopathic ventricular arrhythmias shows promising results in terms of acute and 3-month effectiveness and safety. Our mid-term follow up suggests that treatment effect persists up to 12-month follow up in majority of the patients. Larger studies are necessary to confirm these findings and to assess long-term outcomes of the procedure.

AimsWhen it occurs, pulmonary vein (PV) stenosis after atrial fibrillation (AF) ablation is associated with significant morbidity. Even mild-to-moderate PV narrowing may have long-term implications. Unlike thermal ablation energies, such as radiofrequency (RF) or cryothermy, pulsed field ablation (PFA) is a non-thermal modality associated with less fibrotic proliferation. Herein, we compared the effects of PFA vs. thermal ablation on PV narrowing after AF ablation.Methods and resultsADVENT was a multi-centre, randomized, single-blind study comparing PFA (pentaspline catheter) with thermal ablation—force-sensing RF or cryoballoon (CB)—to treat drug-refractory paroxysmal AF. Pulmonary vein diameter and aggregate cross-sectional area were obtained by baseline and 3-month imaging. The pre-specified, formally tested, secondary safety endpoint compared a measure of PV narrowing between PFA vs. thermal groups, with superiority defined by posterior probability > 0.975. Among subjects randomized to PFA (n = 305) or thermal ablation (n = 302), 259 PFA and 255 thermal ablation (137 RF and 118 CB) subjects had complete baseline and 3-month PV imaging. No subject had significant (≥70%) PV stenosis. Change in aggregate PV cross-sectional area was less with PFA (−0.9%) than thermal ablation (−12%, posterior probability > 0.999)—primarily driven by the RF sub-cohort (−19.5%) vs. CB sub-cohort (−3.3%). Almost half of all PFA PV diameters did not decrease, but the majority (80%) of RF PVs decreased, regardless of PV anatomic location.ConclusionIn this first randomized comparison of PFA vs. thermal ablation, PFA resulted in less PV narrowing—thereby underscoring the qualitatively differential and favourable impact of PFA on PV tissue.

Introduction Atrial fibrillation (AF) is the most common sustained arrhythmia, and pulmonary vein isolation (PVI) remains the cornerstone of treatment. Thermal-based ablation techniques, such as cryoballoon ablation (CBA) and radiofrequency ablation (RFA), are widely used for PVI but show notable recurrence rates, particularly in obese patients. One possible reason for these suboptimal outcomes is the reduced efficacy of thermal energy in tissues with significant epicardial fat, which can impede effective lesion formation and insulation of targeted areas. Recently, pulsed field ablation (PFA), a non-thermal modality, has shown promise for AF treatment, providing effective isolation with a favorable safety profile. This study investigates the clinical and safety outcomes of PFA compared to CBA in obese patients with AF. Methods This retrospective propensity-matched study included symptomatic paroxysmal and persistent AF patients with a body mass index (BMI) &amp;gt;30 kg/m² who underwent PFA or CBA at a single institution between January 2020 and September 2024. Procedural workflows for both PFA and CBA were standardized, focusing solely on PV isolation. Post-procedural follow-up involved 72-hour Holter monitoring at 3, 6, and 12 months. Key outcomes assessed were procedural efficiency, recurrence rates, and complications. Results Pre-matching, no significant differences in 1-year recurrence rates were observed between the two methods. However, post-matching revealed lower recurrence rates in the PFA group (25%) compared to the CBA group (42.9%, p=0.02). PFA was associated with significantly shorter left atrial (LA) time (33.8 min. vs. 49.7 min., p&amp;lt;0.01) and procedural time (46.8 min. vs. 69.3 min., p&amp;lt;0.01) than CBA, although fluoroscopy time showed no significant difference. Safety outcomes were similar across both groups. Conclusion PFA offers a viable alternative to CBA in obese patients, with superior recurrence outcomes and shorter procedural durations post-matching in this single-center cohort. Both methods demonstrate comparable safety profiles. Given the procedural and clinical benefits observed, PFA may serve as a preferred approach for AF management in this high-risk population. Future randomized trials are warranted to validate these findings and optimize treatment protocols for obese AF patients.

This trial compared single-procedure efficacy and safety of pulsed field ablation (PFA) vs radiofrequency ablation (RFA) in patients with drug-resistant paroxysmal atrial fibrillation (AF). BEAT PAROX-AF is a European, multicentre, open-label, randomized, controlled, superiority trial conducted across nine European sites. Eligible patients (aged 18-80 years) with symptomatic, drug-resistant paroxysmal AF were randomized (1:1) to either PFA (pentaspline) or RFA following the CLOSE protocol (contact force sensing catheter and electro-anatomical mapping system). The primary endpoint was the single-procedure success rate after 12 months defined as the absence of ≥30 s atrial arrhythmia recurrence, cardioversion, class I/III antiarrhythmic drug resumption after a 2-month blanking period, or any repeat ablation. From December 2021 to January 2024, 292 patients were randomized and 289 (median age 63.5 years, 58% male) were analysed (PFA n = 145, RFA n = 144). Single-procedure success at 12 months was 112/145 (77.2%) in the PFA group and 111/143 (77.6%) in the RFA group (adjusted difference 0.9%; 95% confidence interval -8.2% to 10.1%; P = .84). Procedure-related serious adverse events occurred in 5 (3.4%) PFA vs 11 (7.6%) RFA patients (difference -3.3% [-8.4%, 1.8%]). No deaths, persistent phrenic palsy nor stroke occurred. In the RFA group, two patients had pulmonary vein stenosis >70% and 12 > 50%, two tamponades, and one oesophageal bleed. This randomized trial performed in patients with paroxysmal AF did not demonstrate superior efficacy of single-shot PFA vs point-by-point RFA using the CLOSE protocol regarding single-procedure freedom from atrial arrhythmias, despite fewer safety events being observed in this study with PFA.

Comparison of cerebral safety after atrial fibrillation using pulsed field and thermal ablation: Results of the neurological assessment subgroup in the ADVENT trial