BACKGROUND: Deep analgosedation (DAS) or general anesthesia is mandatory for pulsed-field ablation of atrial fibrillation. In contrast to DAS, general anesthesia (conventional or total intravenous anesthesia [TIVA]) requires airway management. To find the optimal sedation regimen, this study compared ketamine-remimazolam DAS and propofol-opioid TIVA with propofol-opioid DAS, focusing on sedation-related adverse events. METHODS: Patients indicated for atrial fibrillation catheter ablation were randomly assigned at a 1:1:1 ratio to: (1) DAS using intermittent propofol-opioid boluses (arm P), (2) continuous remimazolam-ketamine DAS (arm R), or (3) continuous propofol-opioid TIVA with secured airway (arm TIVA). Catheter ablation was performed using the FARAPULSE system (Boston Scientific, MA). The major exclusion criterion was obstructive sleep apnea syndrome. The primary end point was defined as a composite of hypoxemia, hypotensive, or hypertensive events requiring intervention or leading to procedure discontinuation. Secondary end points included hemodynamic instability events, procedure time, serious adverse events, and patient satisfaction. RESULTS: One-hundred twenty-seven patients (mean age 62.9±10.3 years, 35.1% women, 47.2% with paroxysmal atrial fibrillation) were enrolled and randomized to the P (n=42), R (n=43), or TIVA (n=42) arms. The primary end point occurred in 85.7% of P patients, 27.9% of R patients, and 66.7% of TIVA patients (P<0.001), driven by hypoxemia in the P arm (100% of patients with the primary end point) and by hypotension in the TIVA arm (100%). The R arm showed a similar distribution of hypoxemia (50%) and hypotensive (66.7%) events. No differences were observed in mean procedural time, rate of serious adverse events, and assessment of patient satisfaction. CONCLUSIONS: In pulsed-field ablation procedures for atrial fibrillation, remimazolam-ketamine DAS was superior to propofol-opioid regimens (either boluses or continuous) and had the lowest risk of hypoxemia and hypotensive events. More than 80% of patients undergoing conventional propofol-opioid analgosedation experienced hypoxemia. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT06013345.

Cardiocenter 3rd Faculty of Medicine Charles University Prague and University Hospital Kralovske Vinohrady Prague Czech Republic

Department of Anesthesia and Intensive Care Medicine 3rd Faculty of Medicine Charles University Prague and University Hospital Kralovske Vinohrady Prague Czech Republic

Circulation. 2025 Jul 22;152(3):160-162. doi: 10.1161/CIRCULATIONAHA.125.075339. PubMed

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Van Gelder IC, Rienstra M, Bunting KV, Casado-Arroyo R, Caso V, Crijns HJGM, De Potter TJR, Dwight J, Guasti L, Hanke T, et al. ; ESC Scientific Document Group. 2024 ESC Guidelines for the Management of Atrial Fibrillation Developed in Collaboration with the European Association for Cardio-Thoracic Surgery (EACTS): developed by the Task Force for the Management of Atrial Fibrillation of the European Society of Cardiology (ESC), with the special contribution of the European Heart Rhythm Association (EHRA) of the ESC. Endorsed by the European Stroke Organisation (ESO). Eur Heart J. 2024;45:3314–3414. doi: 10.1093/eurheartj/ehae176 PubMed

Joglar JA, Chung MK, Armbruster AL, Benjamin EJ, Chyou JY, Cronin EM, Deswal A, Eckhardt LL, Goldberger ZD, Gopinathannair R, et al. ; Peer Review Committee Members. 2023 ACC/AHA/ACCP/HRS Guideline for the Diagnosis and Management of Atrial Fibrillation: a report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation. 2024;149:e1–e156. doi: 10.1161/CIR.0000000000001193 PubMed PMC

Dello Russo A, Compagnucci P, Anselmino M, Schillaci V, Campanelli F, Ascione MR, Volpato G, Cipolletta L, Parisi Q, Valeri Y, et al. Pulsed field vs very high-power short-duration radiofrequency ablation for atrial fibrillation: results of a multicenter, real-world experience. Heart Rhythm. 2024;21:1526–1536. doi: 10.1016/j.hrthm.2024.05.042 PubMed

Reddy VY, Neuzil P, Koruth JS, Petru J, Funosako M, Cochet H, Sediva L, Chovanec M, Dukkipati SR, Jais P. Pulsed field ablation for pulmonary vein isolation in atrial fibrillation. J Am Coll Cardiol. 2019;74:315–326. doi: 10.1016/j.jacc.2019.04.021 PubMed

Ekanem E, Reddy VY, Schmidt B, Reichlin T, Neven K, Metzner A, Hansen J, Blaauw Y, Maury P, Arentz T, et al. ; MANIFEST-PF Cooperative. Multi-national survey on the methods, efficacy, and safety on the post-approval clinical use of pulsed field ablation (MANIFEST-PF). Europace. 2022;24:1256–1266. doi: 10.1093/europace/euac050 PubMed PMC

Reddy VY, Dukkipati SR, Neuzil P, Anic A, Petru J, Funasako M, Cochet H, Minami K, Breskovic T, Sikiric I, et al. Pulsed field ablation of paroxysmal atrial fibrillation: 1-year outcomes of IMPULSE, PEFCAT, and PEFCAT II. JACC Clin Electrophysiol. 2021;7:614–627. doi: 10.1016/j.jacep.2021.02.014 PubMed

Schmidt B, Bordignon S, Neven K, Reichlin T, Blaauw Y, Hansen J, Adelino R, Ouss A, Füting A, Roten L, et al. European real-world outcomes with pulsed field ablation in patients with symptomatic atrial fibrillation: lessons from the multi-centre EU-PORIA registry. Europace. 2023;25. doi: 10.1093/europace/euad185 PubMed PMC

Lee JG, Yoo KS, Byun YJ. Continuous infusion versus intermittent bolus injection of propofol during endoscopic retrograde cholangiopancreatography. Korean J Intern Med. 2020;35:1338–1345. doi: 10.3904/kjim.2018.233 PubMed PMC

Iacopino S, Colella J, Dini D, Mantovani L, Sorrenti PF, Malacrida M, Filannino P. Sedation strategies for pulsed-field ablation of atrial fibrillation: focus on deep sedation with intravenous ketamine in spontaneous respiration. Europace. 2023;25. doi: 10.1093/europace/euad230 PubMed PMC

Leffler DA, Bukoye B, Sawhney M, Berzin T, Sands K, Chowdary S, Shah A, Barnett S. Development and validation of the PROcedural Sedation Assessment Survey (PROSAS) for assessment of procedural sedation quality. Gastrointest Endosc. 2015;81:194–203.e1. doi: 10.1016/j.gie.2014.07.062 PubMed PMC

Bode K, Whittaker P, Lucas J, Müssigbrodt A, Hindricks G, Richter S, Doering M. Deep sedation for transvenous lead extraction: a large single-centre experience. Europace. 2019;21:1246–1253. doi: 10.1093/europace/euz131 PubMed

Qiu Y, Gu W, Zhao M, Zhang Y, Wu J. The hemodynamic stability of remimazolam compared with propofol in patients undergoing endoscopic submucosal dissection: a randomized trial. Front Med (Lausanne). 2022;9. doi: 10.3389/fmed.2022.938940 PubMed PMC

Dossa F, Medeiros B, Keng C, Acuna SA, Baxter NN. Propofol versus midazolam with or without short-acting opioids for sedation in colonoscopy: a systematic review and meta-analysis of safety, satisfaction, and efficiency outcomes. Gastrointest Endosc. 2020;91:1015–1026.e7. doi: 10.1016/j.gie.2019.12.047 PubMed

Karanth H, Murali S, Koteshwar R, Shetty V, Adappa K. Comparative study between propofol and dexmedetomidine for conscious sedation in patients undergoing outpatient colonoscopy. Anesth Essays Res. 2018;12:98–102. doi: 10.4103/aer.AER_206_17 PubMed PMC

Tang RB, Dong JZ, Zhao WD, Liu XP, Kang JP, Long DY, Yu RH, Hu FL, Liu XH, Ma CS. Unconscious sedation/analgesia with propofol versus conscious sedation with fentanyl/midazolam for catheter ablation of atrial fibrillation: a prospective, randomized study. Chin Med J (Engl). 2007;120:2036–2038. PubMed

Behrens A, Kreuzmayr A, Manner H, Koop H, Lorenz A, Schaefer C, Plauth M, Jetschmann JU, von Tirpitz C, Ewald M, et al. Acute sedation-associated complications in GI endoscopy (ProSed 2 Study): results from the prospective multicentre electronic registry of sedation-associated complications. Gut. 2019;68:445–452. doi: 10.1136/gutjnl-2015-311037 PubMed

van Loon K, van Rheineck Leyssius AT, van Zaane B, Denteneer M, Kalkman CJ. Capnography during deep sedation with propofol by nonanesthesiologists: a randomized controlled trial. Anesth Analg. 2014;119:49–55. doi: 10.1213/ANE.0b013e3182a1f0a2 PubMed

Lin Y, Zhang X, Li L, Wei M, Zhao B, Wang X, Pan Z, Tian J, Yu W, Su D. High-flow nasal cannula oxygen therapy and hypoxia during gastroscopy with propofol sedation: a randomized multicenter clinical trial. Gastrointest Endosc. 2019;90:591–601. doi: 10.1016/j.gie.2019.06.033 PubMed

Carvalho PH, Otoch JP, Khan MA, Sakai P, Guedes HG, Artifon EL. Sedation in colonoscopy by using three different propofol infusion methods and analysis of plasma concentration levels: a prospective comparative study. Arq Bras Cir Dig. 2016;29:264–268. doi: 10.1590/0102-6720201600040012 PubMed PMC

Garcia R, Waldmann V, Vanduynhoven P, Nesti M, Jansen de Oliveira Figueiredo M, Narayanan K, Conte G, Guerra JM, Boveda S, Duncker D. Worldwide sedation strategies for atrial fibrillation ablation: current status and evolution over the last decade. Europace. 2021;23:2039–2045. doi: 10.1093/europace/euab154 PubMed

Guarracino F, Bertini P. Perioperative hypotension: causes and remedies. J Anesth Analg Crit Care. 2022;2:17. doi: 10.1186/s44158-022-00045-8 PubMed PMC

Lu K, Wei S, Ling W, Wei Y, Ran X, Huang H, Wang M, Wei N, Liao Y, Qin Z, et al. Remimazolam versus propofol for deep sedation/anaesthesia in upper gastrointestinal endoscopy in elderly patients: a multicenter, randomized controlled trial. J Clin Pharm Ther. 2022;47:2230–2236. doi: 10.1111/jcpt.13797 PubMed PMC

Medical Advisory Secretariat. Bispectral index monitor: an evidence-based analysis. Ont Health Technol Assess Ser. 2004;4:1–70. PubMed PMC

Choi S, Lee G, Jung J, Lee T, Park S. Monitored anesthesia care using remimazolam and ketamine combination for brief gynecological surgeries: a report for four cases. J Clin Med. 2023;12:3558. doi: 10.3390/jcm12103558 PubMed PMC

Hu Q, Liu X, Wen C, Li D, Lei X. Remimazolam: an updated review of a new sedative and anaesthetic. Drug Des Devel Ther. 2022;16:3957–3974. doi: 10.2147/DDDT.S384155 PubMed PMC

Antonik LJ, Goldwater DR, Kilpatrick GJ, Tilbrook GS, Borkett KM. A placebo- and midazolam-controlled phase I single ascending-dose study evaluating the safety, pharmacokinetics, and pharmacodynamics of remimazolam (CNS 7056): part I. Safety, efficacy, and basic pharmacokinetics. Anesth Analg. 2012;115:274–283. doi: 10.1213/ANE.0b013e31823f0c28 PubMed

Peng X, Liu C, Zhu Y, Peng L, Zhang X, Wei W, Zhu T. Hemodynamic influences of remimazolam versus propofol during the induction period of general anesthesia: a systematic review and meta-analysis of randomized controlled trials. Pain Physician. 2023;26:E761–E773. PubMed

Peltoniemi MA, Hagelberg NM, Olkkola KT, Saari TI. Ketamine: a review of clinical pharmacokinetics and pharmacodynamics in anesthesia and pain therapy. Clin Pharmacokinet. 2016;55:1059–1077. doi: 10.1007/s40262-016-0383-6 PubMed

Lippmann M, Appel PL, Mok MS, Shoemaker WC. Sequential cardiorespiratory patterns of anesthetic induction with ketamine in critically ill patients. Crit Care Med. 1983;11:730–734. doi: 10.1097/00003246-198309000-00012 PubMed

Sener S, Eken C, Schultz CH, Serinken M, Ozsarac M. Ketamine with and without midazolam for emergency department sedation in adults: a randomized controlled trial. Ann Emerg Med. 2011;57:109–114.e2. doi: 10.1016/j.annemergmed.2010.09.010 PubMed

Sharif S, Kang J, Sadeghirad B, Rizvi F, Forestell B, Greer A, Hewitt M, Fernando SM, Mehta S, Eltorki M, et al. Pharmacological agents for procedural sedation and analgesia in the emergency department and intensive care unit: a systematic review and network meta-analysis of randomised trials. Br J Anaesth. 2024;132:491–506. doi: 10.1016/j.bja.2023.11.050 PubMed

Belrose JC, Noppens RR. Anesthesiology and cognitive impairment: a narrative review of current clinical literature. BMC Anesthesiol. 2019;19:241. doi: 10.1186/s12871-019-0903-7 PubMed PMC

Furniss SS, Sneyd JR. Safe sedation in modern cardiological practice. Heart. 2015;101:1526–1530. doi: 10.1136/heartjnl-2015-307656 PubMed

Thiele H, Kurz T, Feistritzer H-J, Stachel G, Hartung P, Lurz P, Eitel I, Marquetand C, Nef H, Doerr O, et al. ; SOLVE-TAVI Investigators. General versus local anesthesia with conscious sedation in transcatheter aortic valve implantation. Circulation. 2020;142:1437–1447. doi: 10.1161/CIRCULATIONAHA.120.046451 PubMed

Zobrazit více v PubMed

ClinicalTrials.gov
NCT06013345