Trial reportEuropace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology2023
Deep sedation protocol during atrial fibrillation ablation using a novel variable-loop biphasic pulsed field ablation catheter.
Trial report in Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06836999 (Using Deep Sedation vs. Conscious Sedation in Catheter Ablation in Patients With Atrial Fibrillation), which is not on this map. Cited by 28 papers, 3 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Using Deep Sedation vs. Conscious Sedation in Catheter Ablation in Patients With Atrial Fibrillation: Intraprocedural Management and Outcome Evaluation
Who cites it
28 citing papers in PubMed, 3 syntheses or guidelines pooled it.
- Practical guide on the use of the PulseSelect pulsed field ablation system for atrial fibrillation ablation procedures.Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology · 2026Guideline
- Pulsed field ablation for the interventional treatment of atrial fibrillation: a scientific statement of the European Heart Rhythm Association of the European Society of Cardiology, the Heart Rhythm Society, the Asia Pacific Heart Rhythm Society, the Latin American Heart Rhythm Society, and the Canadian Heart Rhythm Society.Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology · 2026Guideline
- Sedation vs. general anaesthesia in patients with atrial fibrillation undergoing catheter ablation: a systematic review and meta-analysis.Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology · 2025Pooled it
- Predictors of Success for Pulmonary Vein Isolation With Pulsed-field Ablation Using a Variable-loop Catheter With 3D Mapping Integration: Complete 12-month Outcomes From inspIRE.Circulation. Arrhythmia and electrophysiology · 2024Trial
- Anaesthetic Techniques for Cardiac Ablation-A Scoping Review.Acta anaesthesiologica Scandinavica · 2026Article
- Single-shot ablation for AF: Real-world procedural and one-year outcomes with the newly adopted PulseSelect PFA compared with cryoballoon from the 1STOP project.Journal of interventional cardiac electrophysiology : an international journal of arrhythmias and pacing · 2026Article
- Comparative Outcomes of Deep Sedation Versus General Anesthesia in Cryoablation for Atrial Fibrillation: Insights From the Korean Heart Rhythm Society Cryoablation Registry.Korean circulation journal · 2026Article
- Feasibility of hypnosis for analgosedation during atrial fibrillation ablation, including pulsed field and radiofrequency techniques: a pilot study.Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology · 2026Article
- Relationship between coughing and bispectral index-guided sedation during pulsed field ablation for atrial fibrillation and its impact on mid-term outcomes.Heart rhythm O2 · 2026Article
- Sedation Strategies, Drugs, and Protocols Used in Catheter Ablation of Atrial Fibrillation: A Focused Review.Reviews in cardiovascular medicine · 2026Review
- Fundamentals of System Design for Cardiac Pulsed Field Ablation: Optimization of Safety, Efficacy, and Usability.Pacing and clinical electrophysiology : PACE · 2026Review
- Ablation Methods and Catheter Settings for Ventricular Tachycardia Ablation: A Bench to Bedside Review: Part 2.Arrhythmia & electrophysiology review · 2026Review
- Fundamentals of System Design for Cardiac Pulsed Field Ablation: Optimization of Safety, Efficacy, and Usability.Pacing and clinical electrophysiology : PACE · 2026Review
- Single-Center Real World Experience with the VARIPULSE Platform for Pulsed Field Ablation of Atrial Fibrillation, Atrial Flutter, and Redo Procedures.Journal of clinical medicine · 2025Article
- Minimizing Atrioesophageal Fistula Risk After AF Ablation: Risk Factors, Prevention, and Emerging Mini-Thermal Technology.Pacing and clinical electrophysiology : PACE · 2025Review
- Minimizing Atrioesophageal Fistula Risk After AF Ablation: Risk Factors, Prevention, and Emerging Mini-Thermal Technology.Pacing and clinical electrophysiology : PACE · 2025Review
- Minimizing Atrioesophageal Fistula Risk After AF Ablation: Risk Factors, Prevention, and Emerging Mini-Thermal Technology.Pacing and clinical electrophysiology : PACE · 2025Review
- Impact of pulsed field vs. radiofrequency on atrial fibrillation ablation workflow and organization: a single high-volume centre experience.Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology · 2025Article
- Ganglionated plexi ablation impact on atrial fibrillation mechanisms and outcomes in patients with low scar burden.Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology · 2025Article
- Real-world experience with the pentaspline pulsed field ablation system: one-year outcomes of the FARADISE registry.Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology · 2025Observational
Corrections and comments
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Authors and funding
7 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundPulsed field ablation (PFA) is a novel, largely nonthermal ablative modality that, by virtue of its putative preferential action on myocardial tissue through the process of irreversible electroporation (IRE), may replace conventional thermal ablation for atrial fibrillation (AF). The recent inspIRE study confirmed safety and effectiveness of a fully integrated biphasic PFA system with a variable loop circular catheter for the treatment of paroxysmal AF. The majority of PFA procedures were performed using general anesthesia. However, due to the risks of general anesthesia we report the data regarding our sedation protocol used during inspIRE study.
methodsA total of 29 patients (mean age 55±9 years; 72% male) were enrolled as part of this analysis within the inspIRE trial. The sedation protocol is reported in the manuscript. The Richmond Agitation-Sedation Scale (RASS), the Visual Analogue Scale (VAS) and the Patient State Index were collected during sedation. Each patient was monitored using the Masimo Sedline. At the end of ablation, the Likert Scale Questionnaire (LSQ) was used to assess the patients' satisfaction with intraoperative analgesia-sedation.
resultsNo procedural complications were documented. Sufficient oxygen saturation was maintained in all patients during procedure. Non-invasive ventilation or tracheal intubation were not required for any patient. The RAAS score between -1 to -5 was obtained in 27 patients (93%) while the value 0 was obtained in 2 patients (7%). The VAS score between 0 to 2 was obtained in 24 patients (83%); the VAS score 3 in 3 patients (10%) and the VAS score 4 in 2 patients (7%). The PSI score <50 was achieved in 16 patients (55%) while the PSI between 50 and 70 was achieved in 9 patients (31%). Positive answers to LSQ were obtained in most patients.
conclusionDuring PFA ablation procedures with the variable-loop circular catheter and its accompanying biphasic pulse, our deep sedation protocol is a valid alternative to general anesthesia.
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