Loading ...

TOPLINE:

The combination of remimazolam and ketamine for deep analgosedation during pulsed-field ablation for atrial fibrillation was associated with fewer adverse events than propofol-based methods, with the regimen significantly reducing hypoxemia and hypotension.

METHODOLOGY:

• Czech researchers conducted a prospective randomized controlled trial involving 127 patients (mean age, 62.9 years; 35.1% women) with an indication for catheter ablation for atrial fibrillation between October 2023 and September 2024.
• Patients were randomly assigned to one of the three groups:
  • Propofol-opioid sedation (n = 42), which involved the intravenous administration of midazolam, sufentanil, and propofol boluses as needed during the procedure
  • Continuous remimazolam-ketamine sedation (n = 43), which involved a loading dose of intravenous remimazolam followed by continuous infusion, with ketamine boluses administered before ablation
  • Total intravenous anesthesia (n = 42), for which patients were sedated with a propofol infusion and a sufentanil bolus, and general anesthesia was induced using a target-controlled infusion system
• The primary endpoint was a composite of hypoxemia, hypotensive, or hypertensive events requiring intervention or that lead to discontinuation of the procedure.
• Secondary endpoints were the total number of events of hemodynamic instability, total number of serious adverse events, total procedure time, and patient and operating physician satisfaction.

TAKEAWAY:

• The incidence of the primary endpoint was significantly lower among patients in the remimazolam-ketamine group than among those in the propofol-opioid sedation (27.9% vs 85.7%; P < .001) or total intravenous anesthesia (27.9% vs 66.7%; P = .002) group.
• Hypotension was more prevalent in the total intravenous anesthesia group (66.7%) than in remimazolam-ketamine (18.6%) and propofol-opioid (23.8%) groups (P < .001 for both).
• Hypoxemia was most prevalent in the propofol-opioid group (85.7%), with significantly fewer events in remimazolam-ketamine (14.0%) and total intravenous anesthesia (7.1%) groups (P < .001 for both).
• No significant differences were observed in procedure time or patient satisfaction across the three sedation regimens. Operating physicians noted the best sedation quality in patients who received total intravenous anesthesia, whereas attending anesthesiologists found sedation most challenging in patients who received conventional propofol.
• Two serious adverse events were noted in the patients who underwent total intravenous anesthesia, but the rates of adverse events did not differ significantly between the groups. Five procedure-related complications were observed (two in the remimazolam-ketamine group), all of which were managed conservatively or resolved spontaneously.

IN PRACTICE:

“Our trial’s results highlight the need to reconsider conventional sedation practices” for pulsed-field ablation, the researchers reported.

“Regardless of the sedation regimen, we observed high rates of adverse events requiring immediate interventions, suggesting that a dedicated anesthesia provider needs to be present for the safe conduction of the procedure,” they added.

SOURCE:

This study was led by Veronika Sochorová, MD, and Veronika Kunštátová, MD, of the Charles University and University Hospital Královské Vinohrady, both in Prague, Czech Republic. It was published online on April 27, 2025, in Circulation.

LIMITATIONS:

This study was conducted at a single center, and the levels of expertise may have differed between centers. The lack of blinding for anesthesiologists and cardiologists could have introduced bias, particularly in subjective measures such as “difficult sedation” scores. The exclusion of high-risk patients such as those with obstructive sleep apnea or heart failure may have affected the applicability of the results to broader populations.

DISCLOSURES:

This study was supported by Charles University Research programs “Cooperatio–Cardiovascular Science” and “Cooperatio–Intensive Care Medicine” and by the project National Institute for Research on Metabolic and Cardiovascular Diseases (CarDia), Programme EXCELES. This study also received funding from the European Union – Next Generation EU. The authors reported no conflicts of interest related to this study.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.