In the last three decades, ablation of atrial fibrillation (AF) has become an evidence-based safe and efficacious treatment for managing the most common cardiac arrhythmia. In 2007, the first joint expert consensus document was issued, guiding healthcare professionals involved in catheter or surgical AF ablation. Mounting research evidence and technological advances have resulted in a rapidly changing landscape in the field of catheter and surgical AF ablation, thus stressing the need for regularly updated versions of this partnership which were issued in 2012 and 2017. Seven years after the last consensus, an updated document was considered necessary to define a contemporary framework for selection and management of patients considered for or undergoing catheter or surgical AF ablation. This consensus is a joint effort from collaborating cardiac electrophysiology societies, namely the European Heart Rhythm Association, the Heart Rhythm Society, the Asia Pacific Heart Rhythm Society, and the Latin American Heart Rhythm Society .

In the last three decades, ablation of atrial fibrillation (AF) has become an evidence-based safe and efficacious treatment for managing the most common cardiac arrhythmia. In 2007, the first joint expert consensus document was issued, guiding healthcare professionals involved in catheter or surgical AF ablation. Mounting research evidence and technological advances have resulted in a rapidly changing landscape in the field of catheter and surgical AF ablation, thus stressing the need for regularly updated versions of this partnership which were issued in 2012 and 2017. Seven years after the last consensus, an updated document was considered necessary to define a contemporary framework for selection and management of patients considered for or undergoing catheter or surgical AF ablation. This consensus is a joint effort from collaborating cardiac electrophysiology societies, namely the European Heart Rhythm Association, the Heart Rhythm Society, the Asia Pacific Heart Rhythm Society, and the Latin American Heart Rhythm Society.

We have recently shown that a contact force (CF)-guided ablation protocol respecting region-specific criteria of lesion contiguity and lesion depth (‘CLOSE’ protocol) is associated with high incidence of acute durable pulmonary vein (PV) isolation (PVI) and a high single-procedure arrhythmia-free survival at 1 year. In the present study, we compared efficiency, safety, and efficacy of ‘CLOSE’-guided PVI to conventional CF-guided PVI (CONV-CF). Fifty consecutive paroxysmal atrial fibrillation (AF) patients underwent PV encircling using a CF-sensing catheter targeting an interlesion distance (ILD) ≤6 mm and ablation index (AI) ≥400 and ≥550 at posterior and anterior wall (‘CLOSE’ group). Results were compared to the last 50 patients undergoing ‘CONV-CF’. All patients underwent adenosine testing after PVI. Arrhythmia recurrence was defined as any atrial tachyarrhythmia (ATA) >30 s on Holter at 3, 6, and 12 months. Clinical characteristics did not differ. Contact force variability was comparable in between both groups (proportion of applications with intermittent contact 2% in ‘CLOSE’ vs. 1% in CONV-CF, P = 0.67). In the ‘CLOSE’ group, procedure time and radiofrequency (RF) time per circle were shorter (respectively 149 ± 33 min vs. 192 ± 42 min, P < 0.0001 and 18 ± 4 min vs 28 ± 7.5 min, P < 0.0001) and incidence of adenosine-proof isolation was higher (97% vs. 82%, P < 0.001). No complications were observed in the ‘CLOSE’ group, one tamponade in the ‘CONV-CF’ group. At 12 months, single-procedure freedom from ATA was 94% in ‘CLOSE’ vs. 80% in ‘CONV-CF’ group (P < 0.05). In both groups, the majority of reconnections at repeat were associated with either ILD > 6 mm and/or AI < 400/550 (100% vs. 83%, P = 0.99). ‘CLOSE’-guided PVI improves procedural and 1 year outcome in CF-guided PVI while shortening procedure time. Improvement cannot be explained by differences in CF variability and is most likely due to the strict application of criteria for contiguity and ablation index. A randomized controlled trial is needed to exclude the possible contribution of a learning curve.

Background: The inspIRE study (Study for Treatment of Paroxysmal Atrial Fibrillation [PAF] by Pulsed Field Ablation [PFA] System With Irreversible Electroporation [IRE]) evaluated safety and effectiveness of a fully integrated biphasic pulsed field ablation (PFA) system with a variable-loop circular catheter for the treatment of drug-refractory paroxysmal atrial fibrillation. Methods: Subjects underwent pulmonary vein (PV) isolation with the PFA system, using at least 12 applications per vein; adenosine/isoproterenol was administered to confirm entrance block. Wave I assessed initial safety, including for esophageal lesions, silent cerebral lesions, and PV stenosis. Wave II (pivotal phase) tested (1) primary safety, incidence of early-onset primary adverse events, and (2) primary effectiveness, confirmed PV isolation with freedom from documented atrial arrhythmia at 12 months. The study design specified an interim analysis to determine early success once 30 subjects reached the 12-month follow-up and all subjects reached 3-month follow-up. Results: Across 13 centers in Europe/Canada, 226 subjects were enrolled, met criteria for safety and effectiveness evaluations, and received PFA (Wave I, 40; Wave II, 186). Wave I demonstrated no esophageal thermal lesions or PV stenosis. Among 39 subjects with cerebral magnetic resonance imaging, silent cerebral lesions were detected in 4 of the first 6 subjects, after which workflow enhancements, including a 10-second pause between PFA applications, were implemented; subsequently, only 4 of 33 subjects had silent cerebral lesions. In the Wave II phase, no primary adverse events were reported. Upon declaring early success, 83 subjects reached 12-month follow-up. With 100% entrance block, PV isolation without acute reconnection was achieved in 97.1% of targeted veins. For Wave II, the primary effectiveness end point per Kaplan-Meier at the time of interim analysis was 70.9%; 12-month freedom from symptomatic atrial fibrillation/atrial flutter/atrial tachycardia recurrence and repeat ablation was 78.9% and 92.3%, respectively. Total procedure and transpired PFA times were 70.1±27.7 and 26.7±14.0 minutes, respectively. Conclusions: The inspIRE trial confirmed the safety and effectiveness of the novel mapping-integrated PFA system. Registration: URL: https://www.clinicaltrials.gov ; unique identifier: NCT04524364.

Background—: Pulmonary vein reconnection (PVR) still determines recurrences of atrial fibrillation after contact force (CF)–guided pulmonary vein isolation. We studied whether acute PVR (adenosine and waiting time) and late PVR (at repeat) are explained by incomplete transmurality and contiguity within the deployed radiofrequency circle. Methods and Results—: We analyzed 42 CF-guided ipsilateral pulmonary vein isolation procedures. For each radiofrequency tag within the circle, we collected data reflecting lesion depth (time of application, power, impedance drop [Δ-Imp], CF, force–time integral [FTI], and ablation index [AI]) and contiguity (automated interlesion distance [ILD]). Ablation line contiguity index (ALCI) was developed as a novel automated algorithm combining depth and contiguity into one single criterion. Each circle was subdivided into 10 segments. For each segment, we determined its weakest link by annotating time _min , power _min , Δ-Imp _min , CF _min , FTI _min , AI _min , ILD _max , and ALCI _min . Compared with segments without PVR (n=758), PVR segments (n=44) were characterized by lower Δ-Imp _min (4.8 versus 7.4 Ω), CF _min (8.5 versus 11.8 g), FTI _min (351 versus 473 gs), AI _min (367 versus 408 arbitrary unit [au]), and higher ILD _max (6.8 versus 5.5 mm). ALCI _min was significantly lower in segments with PVR (74% versus 104%; P <0.001) and was associated with the highest accuracy to predict durable segments (area under the curve=0.73). Conclusions—: In CF-guided pulmonary vein isolation, PVR is explained by lack of both lesion depth and contiguity within the deployed radiofrequency circle. ALCI, a novel measure combining contiguity and depth, is the most accurate predictor for durable segments. By avoiding weak links in the ablation chain, ALCI-guided ablation is expected to improve success rate of point-by-point radiofrequency ablation.