Jim Hansen

Aims: Little is known regarding strategies to improve influenza vaccination uptake among individuals with atrial fibrillation (AF). We assessed the effect of electronically delivered behavioural nudges on influenza vaccination uptake and clinical outcomes according to AF status. Methods and results: This is a prespecified analysis of the nationwide randomized NUDGE-FLU-CHRONIC trial in which citizens aged 18–64 years with a chronic disease were randomized to usual care or six different electronic nudge letters aiming to increase influenza vaccination uptake during the 2023–2024 influenza season. The primary endpoint was receipt of an influenza vaccine on or before 1 January 2024. We reported absolute differences and relative risks (RRs) of each intervention letter vs. usual care on influenza vaccination uptake and assessed effect modification by AF status using binomial regression. Among 299 881 randomized participants, 19 481 (6.5%) had a history of AF (median age 58.5 years, 27.8% female). During follow-up, 41.5% of participants with a history of AF received influenza vaccination compared with 35.8% of those without (P < 0.001). In the overall population, influenza vaccination uptake was higher among those receiving any electronic nudge letter compared with usual care. AF status modified the absolute effect of any electronic letter on influenza vaccination uptake (P interaction < 0.001): the effect of any electronic letter was higher among those who had a history of AF [45.9 vs. 31.1%; difference: +14.8% points; 99.29% confidence interval (CI) (12.8–16.8), RR: 1.48, 99.29% CI (1.39–1.56)] compared with those without AF [39.1 vs. 27.7%; difference: +11.4% points; 99.29% CI (10.9–12.0), RR: 1.41, 99.29% CI (1.39–1.44)]. Similar results were observed for the individual electronic letter-based nudges. Conclusion: In this prespecified, secondary analysis, electronic nudge letters highlighting the importance of influenza vaccination were especially effective in increasing influenza vaccination uptake among young and middle-aged adults with AF, supporting simple electronic letters as an efficient public health strategy to improve vaccination coverage in high-risk groups.

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.

Aims: Catheter ablation (CA) is widely used for atrial fibrillation (AF), but pulmonary vein isolation (PVI) alone is less effective in persistent AF (peAF) than paroxysmal AF (PAF). Real-world data on patient selection, outcomes, and complications with PVI or PVI plus (≥1 additional line or CFAE/ganglionated plexi ablation) are limited. We examined characteristics, trends, recurrence, and complications in peAF ablations. Methods and results: Patients with peAF undergoing first-time catheter ablation between 2010 and 2020 were identified from the Danish National Ablation Database. They were categorized by ablation strategy (PVI or PVI plus), and baseline characteristics and trends were assessed. AF recurrence was analysed using cumulative incidence at one and five years, and across procedural years. Major adverse cardiovascular events (MACE) and procedure-related complications were also examined. Among 4144 peAF patients, 3.417 received PVI and 727 PVI plus. Baseline characteristics were similar, except the PVI plus group had longer diagnosis-to-ablation-time (mean 5.67 years vs. 3.9 years, P < 0.001) and more severe atrial enlargement (14.8% vs. 9.8%, P < 0.001). AF recurrence was higher with PVI plus at one- and five-years (54% vs. 46%, 77% vs. 68%). Recurrence rates declined over time (2010–2013 vs. 2018–2020). PVI plus use decreased from 58% to 15%. MACE and complication rates were low and similar. Conclusion: PVI plus was used less frequently over time and was associated with longer diagnosis-to-ablation times and larger left atria. We observed a proportional decline for both groups in AF recurrence across procedural years, and complication rates were low and similar.

Background and Aims: The multicentre, single-arm SmartfIRE study assessed the safety and effectiveness of the novel dual-energy THERMOCOOL SMARTTOUCH SF (DE STSF) contact-force sensing catheter with multimodality generator to deliver radiofrequency (RF) and unipolar biphasic pulsed field (PF) ablation. Three-month follow-up showed a 100% acute success rate with an acceptable safety profile. Results at 12 months post-ablation are summarised here. Methods: Patients with symptomatic paroxysmal atrial fibrillation underwent pulmonary vein isolation (PVI) with the recommendation of PF ablation at posterior/inferior and RF ablation at the anterior/ridge/carina segments. The 12-month effectiveness endpoint was freedom from documented symptomatic and asymptomatic atrial arrhythmia on or off antiarrhythmic therapy (assessed by electrocardiogram, remote arrhythmia monitoring, and 24-hour Holter), including acute procedural failures. Safety was assessed as the incidence of serious adverse events (SAEs) related to device and/or procedure. Quality of life was evaluated via Atrial Fibrillation Effect on Quality-of-Life (AFEQT) scores and healthcare utilisation was assessed as hospitalisation for cardiovascular events and antiarrhythmic drug (AAD) use. Results: Of 149 patients enrolled, 140 had the study catheter inserted (safety population analysis set) and 136 met the eligibility criteria and had ablation energy delivered (per-protocol analysis set). Freedom from symptomatic and asymptomatic atrial arrhythmia at 12 months was 71.5% (84.2% when using standard-of-care monitoring only). The clinical success rate (freedom from symptomatic arrhythmia) was 86.4%, and single procedural success was 81.0% (n=136). The rate of device and/or procedure related SAEs was 3.6% (5/140 patients; 2 cardiac tamponades, 2 pulmonary vein stenosis, 1 anaphylactic shock). At 12 months, the overall AFEQT score increased by a median 26.9 points versus baseline. Cardiovascular hospitalisation rate reduced from 20.1% to 11.9% during the 12 months before versus after ablation, respectively. The use of Class I/III AAD decreased from 60.3% at baseline to 23.9% at 6 to 12 months post-ablation. Post hoc analysis showed that patients with high adherence to recommended inter-tag distance and PF/RF index during ablation (n=47) had a 12-month freedom from atrial arrhythmia recurrence of 86.9%, while the remaining patients (n=88) had the rate of 64.0%. Conclusion: The 12-month follow-up of the SmartfIRE study demonstrated the effectiveness, safety, and healthcare benefits of ablation using the DE STSF platform.

Introduction: Pulmonary vein isolation (PVI) is the cornerstone in atrial fibrillation (AF) ablation but achieving durable PVI remains a challenge. The radiofrequency balloon (RFB) is a “single‐shot” ablation catheter for PVI that offers selective energy titration from 10 surface electrodes and 3D mapping system integration. The durability of RFB PVI has not been investigated.Methods: The objective of this study was to evaluate the durability of RFB PVI by protocol‐mandated remaps in patients with paroxysmal or persistent AF referred for AF ablation at a high‐volume center. RFB procedures were performed under conscious sedation, PVI assessed by high‐density mapping, bidirectional block confirmed after a waiting period of ≥ 20 min, and dormant conduction assessed by adenosine injections. After 4–6 months patients underwent a remap study for assessment of PVI durability by high‐density mapping and assessment of bidirectional block.Results: Forty‐five patients were enrolled, 43 completed the RFB PVI, and 35/43 (81%) completed the remap study: 26% female, 43% persistent AF, median age 65 (interquartile range: 61–69) years, median CHA₂DS₂‐VASc score 1 (0–2), and median left atrial volume 31 (25–42) mL/m². Acute PVI was achieved in 99% of pulmonary veins (PVs) but focal radiofrequency touch‐up lesions were required in 31% of patients. After 5.4 (4.9–6.1) months, 71% of PVs were durably isolated, and 29% of patients had all PVs durably isolated; 86% of patients were free from documented atrial tachyarrhythmias.Conclusion: The durability of RFB PVI achieved under conscious sedation was relatively low. However, medium‐term freedom from clinical recurrent arrhythmia was favorable.Trial Registration: URL: https://www.clinicaltrials.gov. Unique Identifier: NCT06296888.

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.

Aims: Catheter ablation (CA) is a well-established treatment option for atrial fibrillation (AF), where sedation and analgesia are pivotal for patient comfort and lesion formation. The impact of anaesthesia type on AF recurrence rates remains uncertain. This study aimed to examine AF recurrence rates depending on conscious sedation (CS) vs. general anaesthesia (GA) during CA. Methods and results: Utilizing nationwide data from the Danish healthcare registries, we conducted this cohort study involving adults (≥18 years) undergoing first-time CA for AF between 2010 and 2018. Patients were categorized by anaesthesia type (CS or GA), with the primary endpoint being AF recurrence, defined by a composite endpoint of either antiarrhythmic drug (AAD) prescriptions, AF-related hospital admissions, electrical cardioversions, or AF re-ablation. The impact of anaesthesia type was evaluated using multivariable Cox proportional hazards analysis. The study cohort comprised 7957 (6421 CS and 1536 GA) patients. Persistent AF, hypertension, and heart failure, as well as use of AAD, were more prevalent in the GA group. Cumulative incidences of recurrent AF were higher in the CS group at 1 (46% vs. 37%) and at 5 (68% vs. 63%) years. Multivariate analysis revealed CS as significantly associated with increased risk of AF recurrence at 5-year follow-up [hazard ratio 1.26 (95% confidence interval 1.15–1.38)], consistent across paroxysmal and persistent AF subtypes. Conclusion: This nationwide cohort study suggests a higher risk of AF recurrence with CS during CA compared to GA. These results advocate for considering GA as the preferred anaesthesia type for improved CA outcomes.