Pepijn van der Voort

Aims: Oesophageal fistula (OF) is a rare but life-threatening complication of atrial fibrillation (AF) ablation. Data on sex-related differences in its management and outcomes are limited. Methods and results: The PrOgnosis following oesophageal fisTula formaTion in patients undergoing cathetER ablation for AF study is a global, multicentre study evaluating the incidence, management, and outcome of OF following AF ablation. Among 553 729 patients treated across 214 centres in 35 countries between 1996 and 2022, 138 developed OF. Sex-specific data on management and outcome were available in 117 cases and are analysed herein. Females comprised 47% of the analysed cohort. Baseline characteristics, ablation modality, and use of oesophageal temperature monitoring were not different between sexes in patients developing OF. Fewer women received proton pump inhibitors post-procedure (64.8% vs. 84.7%; P = 0.017). Among patients with OF, less women developed atrio-OF (90.9% vs. 100%; P = 0.021). Oesophageal perforation and oesophageal–pericardial fistula occurred exclusively in females. The median duration until symptoms onset was 20 days for women and 16.5 days for men (P = 0.14). Echocardiography was more frequently used in women (36.4% vs. 15%; P = 0.01). Stroke was more common in women (32.7% vs. 14.8%; P = 0.040), however only before adjusting for potential cofounders. Other complications were comparable. Women underwent endoscopic therapy more often (35.8% vs. 17.7%; P = 0.034) and surgical treatment alone less frequently (28.3% vs. 51.6%; P = 0.014). Fatality rates were high and not different (63.6% in women vs. 67.2% in men; P = 0.70). Conclusion: While OF incidence for each sex could not be calculated, nearly half of all patients with OF were female. Women underwent more often endoscopic and less often surgical interventions; outcomes were comparable.

Background: With the introduction of pulsed field ablation (PFA) to treat atrial fibrillation (AF), there is interest in studying workflow and sedation strategies to optimize integration into clinical practice. This sub-analysis characterizes early real-world use of general anesthesia versus deep sedation during AF ablation using the pentaspline PFA catheter. Methods: EU-PORIA is an all-comer AF registry enrolling consecutive patients at seven high-volume centers in Europe. Patients were treated based on institutional standard-of-care. During follow-up, any episode of atrial tachycardia (AT) or AF >30s was considered an arrhythmia recurrence. Results: EU-PORIA enrolled 1233 patients, of which 250 (20%) and 983 (80%) cases were performed using general anesthesia and deep sedation, respectively. Patients treated with general anesthesia were more often male and non-paroxysmal AF. In the general anesthesia group, 72% received pulmonary vein isolation (PVI)-only versus 90% in the deep sedation group (p<0.01), and 3D mapping was used in 60% of general anesthesia and 27% of deep sedation cases (p<0.01). Procedure and fluoroscopy times were shorter with deep sedation (51[36-84] vs 75[60-90] min; 13[8-19] vs 19[15-26] min; p<0.01). There were no differences in the incidence of serious adverse events. At 1-year follow-up, 74.8% and 73.8% of patients in the general anesthesia and deep sedation groups, respectively, were free from recurrent AF/AT (p=0.87). Conclusion: AF ablation using deep sedation with the pentaspline PFA catheter demonstrated a safety and efficacy profile consistent with procedures performed under general anesthesia. This characterization of real-world use warrants further evaluation to understand optimal sedation strategies with PFA technologies.

Background: Real‐life data on efficacy and safety of pulsed‐field ablation (PFA) using the pentaspline multi‐electrode catheter in symptomatic atrial fibrillation (AF) patients is still scarce. Objective: This study aims to assess the efficacy and safety of PFA in patients with persistent AF. Methods: Data from early commercial use across seven European centers were collected in a registry. To confirm the efficacy and safety of extra pulmonary vein (PV) ablation, patients were categorized into two groups: those undergoing pulmonary vein isolation (PVI) alone and those receiving additional ablation. Procedural and follow‐up data were collected. Results: The study included 448 patients (347 PVI only, 101 PVI + α ). In the PVI + α group, extra PV ablation included left atrial posterior wall isolation (87%), mitral isthmus ablation (37%), and cavo‐tricuspid isthmus ablation (3%). At 1‐year follow‐up, the PVI only group showed significantly fewer atrial tachyarrhythmia recurrences compared to PVI + α group (69% vs. 56%, p = 0.013). While AF recurrence did not significantly differ (25% vs. 28%, p = 0.713), PVI + α group had a significantly higher atrial tachycardia recurrence (8% vs. 22%, p < 0.001). Major complications occurred in 2.0% versus 1.0% (PVI only vs. PVI + α ), including pericardial tamponade (6 vs. 0; p = 0.345) and stroke (1 vs. 1; p = 0.400). Conclusions: PVI plus extra PV ablation using a pentaspline PFA catheter is associated with a higher incidence of atrial tachycardia recurrences. For persistent AF, a simpler approach of performing only PVI may be more effective.

Aims: Initial clinical studies of pulsed field ablation (PFA) to treat atrial fibrillation (AF) indicated a >90% durability rate of pulmonary vein isolation (PVI). However, these studies were largely conducted in single centres and involved a limited number of operators. We aimed to describe the electrophysiological findings and outcomes in patients undergoing repeat ablation after an initial PF ablation for AF. Methods and results: In the MANIFEST-REDO study, we investigated patients who underwent repeat ablation due to clinical recurrence—AF or atrial tachycardia (AT)—following first-ever PVI with a pentaspline PFA catheter (Farawave, Boston Scientific Inc.). At 22 centres, 427 patients (age 64 ± 11 years; 37% female) were included. Of note, the recurrent arrhythmia leading to the repeat ablation was paroxysmal AF (51%), persistent AF (30%), or AT (19%). At the repeat procedure, the PV reconnection rates were 30% (left superior pulmonary vein), 28% (left inferior pulmonary vein), 33% (right superior pulmonary vein), and 32% (right inferior pulmonary vein). In 45% of patients, all PVs were durably isolated at the beginning of the repeat procedure, with the previous use of any imaging or mapping modality being univariately associated with durable PVI. After a post-redo follow-up period of 284 (90–366) days, the primary effectiveness endpoint (freedom from documented AF/AT lasting ≥30 s after 3-month blanking without class I/III antiarrhythmic drugs or symptoms) was achieved in 65% of patients, with significant differences between groups (PAF 65% vs. PersAF 56% vs. AT 76%; P = 0.04). Persistent AF as recurrent arrhythmia after the initial PFA ablation predicted AT/AF recurrence after repeat ablation [hazard ratio 1.241 (95% confidence interval 1.534–1.005); P = 0.045]. The procedural complication rate was 2.8%. Conclusion: In repeat procedures for AF/AT performed after an index procedure with PFA for AF, PV reconnections are not uncommon. Repeat procedures can be performed safely and with an acceptable subsequent success rate.

BACKGROUND: Recent studies have demonstrated the benefit of early ablation in preventing the progression of atrial fibrillation (AF). Clinical practice has reflected this shift in AF management and no longer requires patients to fail antiarrhythmic drugs (AADs) before receiving ablation. However, there is limited evidence on outcomes with pulsed field ablation (PFA) as a first-line therapy. Examination of real-world data may shed light on clinical practices and the effectiveness of PFA with and without a prior history of AAD usage. METHODS: European Real World Outcomes with Pulsed Field Ablation is an all-comer AF registry enrolling consecutive patients treated with the pentaspline PFA catheter at 7 high-volume centers in Europe. This subanalysis evaluates patients with a history of class I/III AAD use versus those with no documented history of class I/III AAD use (first-line patients). Patients with incomplete AAD history, long-standing persistent AF, and those undergoing a repeat ablation procedure were excluded. Patients were treated and followed based on institutional standard of care. Any episode of atrial tachycardia or AF lasting longer than 30 s was considered an arrhythmia recurrence. RESULTS: Of 1233 patients enrolled in European real world outcomes with pulsed field ablation, 1091 met the inclusion criteria (mean age, 66 years; 40% females; and persistent AF, 36%). Pulmonary vein isolation-only was used in 90% of the patients, and 10% received extra-PV ablation. Ablation as the first-line approach was chosen in 589 patients, and 502 patients had prior class I/III AAD use. In the first-line PFA group, paroxysmal AF was more frequent (68% versus 59%; P P P =0.076). CONCLUSION: In this large real-world PFA registry, freedom from AF/atrial tachycardia recurrence after 1 year was similar in patients undergoing PFA as a first-line treatment and those with prior failed AAD therapy. REGISTRATION: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT05823818.

Increasing numbers of overweight and obese patients undergo pulmonary vein isolation (PVI), despite the association between higher body mass index (BMI) and adverse PVI outcomes. Evidence on complications and quality of life in different bodyweight groups is limited. This study aims to clarify the impact of BMI on repeat ablations, periprocedural complications and change in quality of life. This multicentre study analysed prospectively collected data from 15 ablation centres, covering all first-time PVI patients in the Netherlands from 2015 to 2021. Patients were categorized by BMI: normal weight (18.5-24.9 kg/m²), overweight (25-29.9 kg/m²) and obesity (≥30 kg/m²). Quality of life was assessed using the AFEQT questionnaire at baseline and one-year post-PVI. Among 20,725 patients, 30% were of normal weight, 47% overweight and 23% obese. Within the first year after PVI, obese patients had a higher incidence of repeat ablations than normal-weighing and overweight patients (17.8% versus 15.6% and 16.1%, P P = 0.03). This association remained apparent after 3 years. Complication rates were 3.8% in normal weight, 3.0% in overweight, and 4.6% in obese, with weight class not being an independent predictor. Quality of life improved in all weight groups post-PVI, but remained lowest in obese patients. Obesity is independently associated with a higher rate of a repeat ablations. PVI is equally safe in all weight classes. Despite lower quality of life among obese individuals, substantial improvements occur for all weight groups after PVI.

Aims: Pulsed field ablation (PFA) is a new, non-thermal ablation modality for pulmonary vein (PV) isolation in patients with atrial fibrillation (AF). The multi-centre EUropean Real World Outcomes with Pulsed Field AblatiOn in Patients with Symptomatic AtRIAl Fibrillation (EU-PORIA) registry sought to determine the safety, efficacy, and learning curve characteristics for the pentaspline, multi-electrode PFA catheter. Methods and results: All-comer AF patients from seven high-volume centres were consecutively enrolled. Procedural and follow-up data were collected. Learning curve effects were analysed by operator ablation experience and primary ablation modality. In total, 1233 patients (61% male, mean age 66 ± 11years, 60% paroxysmal AF) were treated by 42 operators. In 169 patients (14%), additional lesions outside the PVs were performed, most commonly at the posterior wall (n = 127). Median procedure and fluoroscopy times were 58 (interquartile range: 40–87) and 14 (9–21) min, respectively, with no differences due to operator experience. Major complications occurred in 21/1233 procedures (1.7%) including pericardial tamponade (14; 1.1%) and transient ischaemic attack or stroke (n = 7; 0.6%), of which one was fatal. Prior cryoballoon users had less complication. At a median follow-up of 365 (323–386) days, the Kaplan–Meier estimate of arrhythmia-free survival was 74% (80% for paroxysmal and 66% for persistent AF). Freedom from arrhythmia was not influenced by operator experience. In 149 (12%) patients, a repeat procedure was performed due to AF recurrence and 418/584 (72%) PVs were durably isolated. Conclusion: The EU-PORIA registry demonstrates a high single-procedure success rate with an excellent safety profile and short procedure times in a real-world, all-comer AF patient population.