Deep sedation in single-shot pulmonary vein isolation: a head-to-head look at two pulsed field vs. cryoballoon ablation approaches
J Kheir, A U Andrea Urbani, D S David Schaack, L U Lukas Urbanek, J A M Julia Alexandra Marx, J L Julia Lurz, M R Matteo Rocchetti, S N Najafi Soroosh, S A Alexandra Steyer, B S Boris Schmidt, J C Julian Chun, M G Melanie GunawardeneAbstract
Background
Deep sedation (DS) is routinely used during single-shot pulmonary vein isolation (PVI) to optimize patient comfort and procedural stability. While cryoballoon (CB) ablation has long been established as a safe and effective thermal modality, pulsed field ablation (PFA) has recently emerged as a non-thermal alternative capable of myocardial-selective lesion formation. The recently introduced balloon-in-basket PFA system was designed to minimize skeletal muscle activation and optimize energy delivery. The impact of ablation technology on sedative requirements and procedural tolerance under DS compared with other ablation technologies remains limited.
Methods
In this single-centre study, 96 consecutive patients undergoing first-time PVI were included and treated with one of three technologies: CB, PFA using a pentaspline catheter (PC), or PFA using the novel balloon-in-basket system (BC). All procedures were performed under DS with midazolam, fentanyl, and propofol, administered by electrophysiology staff without anaesthesiologist supervision. Propensity score matching (1:1:1) was applied for age, sex, body mass index (BMI), and hypertension. Procedural characteristics, sedative and analgesic requirements, and peri-procedural complications were analysed.
Results
All patients achieved acute PVI with no major complications. Compared with PC, BC procedures were associated with lower body-weight- and time-adjusted requirements for propofol (CB: 0.11 ± 0.04 mg/kg/min, p= 0.0008; BC: 0.11 ± 0.03 mg/kg/min, p<0.0001) and fentanyl (CB: 0.012 ± 0.005 µg/kg/min, p < 0.0001; BC: 0.012 ± 0.006 µg/kg/min, p < 0.0001), Figure 1, reaching values comparable to those observed in the CB group. Procedural (CB: 56 ± 20, PC: 29 ± 10, BC: 55 ±24 minutes; p <0.0001) and fluoroscopy times (CB: 10 ± 5; PC: 6 ± 3; BC: 9 ± 4 minutes; p = 0.0004) were shortest in the PC group, while sedation-related hemodynamic stability and safety profiles were comparable across all cohorts. Despite slightly longer procedural durations, overall safety and sedation profiles were equivalent across all cohorts.
Conclusions
The novel balloon-in-basket PFA system demonstrated excellent feasibility under DS, with reduced sedative requirements compared with the pentaspline PFA catheter and a safety profile comparable to cryoballoon ablation. These findings suggest that optimized waveform design and field homogeneity may enable safe and comfortable PVI under DS without the need for general anaesthesia. Further studies are warranted to confirm these results and to explore the potential of lighter sedation strategies with next-generation PFA technologies.