Operator-directed sedation for AF ablation using a fixed loop PFA catheter: an institutional protocol
G Giacomini, P Compagnucci, L Cipolletta, G Volpato, Q Parisi, Y Valeri, L D'angelo, F Campanelli, L Finori, R Grandin, F Cardinali, G Castellucci, L Sabatelli, M Casella, A Dello RussoAbstract
Background
Pulsed Field Ablation (PFA) is an emerging technology for transcatheter ablation of atrial fibrillation (AF). It is highly myocardium-selective and employs ultrafast electrical pulses (microseconds to nanoseconds) to generate strong electric fields that induce non-thermal cellular injury through membrane microporation. This myocardial selectivity increases procedural safety by reducing the risk of complications such as esophageal injury and phrenic nerve damage. Most PFA procedures are currently performed under general anesthesia (GA) however, given the potential risks of GA, we report our experience with a deep sedation (DS) protocol.
Purpose
The aim of this study was to evaluate the safety and feasibility of a DS protocol as an alternative to GA for patients undergoing catheter ablation with a fixed loop PFA catheter for atrial fibrillation, with the goal of minimizing GA-associated risks.
Methods
This observational study reports our center’s experience using DS for PFA in patients with AF. The DS protocol included intramuscular morphine administered 30 minutes before the procedure, followed by lidocaine and dexmedetomidine (bolus and continuous infusion), and fentanyl and midazolam in refracted boluses. A total of 57 consecutive patients (mean age 62.1 ± 9 years; 40% female; 89.4% paroxysmal AF) were included: 46 underwent ablation under GA and 11 under DS. Baseline echocardiographic data were comparable between groups.
Results
Indexed left atrial volume averaged 32.9 ± 8 mL/m² (34 ± 8 mL/m² in GA vs 28.5 ± 8 mL/m² in DS), and LVEF was 56.7 ± 10 % (59.8 ± 5 % in GA vs 59 ± 3 % in DS). Structural heart disease was present in two patients (one per group), and a history of oncologic disease in five (four GA, one DS). Operator satisfaction was high, with 70 % reporting being "very satisfied," and 9 % "satisfied." Similarly, 90 % of patients were "very satisfied" and 8 % "satisfied." If ablation were to be repeated, 70.9 % of operators and 81.8 % of patients would choose the same sedation protocol.
Sedation scores confirmed optimal management: 91 % of patients reported no or minimal pain, 94 % no anxiety, and 94 % no discomfort during the procedure. Post-awakening feedback was highly positive, with satisfaction 96.5 ± 4, and mean anxiety, discomfort, and pain scores all = 0. DS was associated with improved comfort during the immediate recovery phase.
Conclusions
Both GA and DS protocols provided safe and effective anesthesia for AF ablation using a fixed loop PFA catheter. Deep sedation ensured excellent intra-procedural tolerance and patient comfort, with highly positive feedback from both patients and operators. These findings support DS as a feasible and safe alternative to general anesthesia for PFA procedures.