Feasibility of a cardiologist-only approach to sedation for electrical cardioversion of atrial fibrillation: A randomized, open-blinded, prospective study☆
Introduction
Despite its old origin in the early 1960s, [1] direct current cardioversion (DCC) is still the most effective and widely used method for restoring sinus rhythm in patients with persistent atrial fibrillation (AF) [2], [3]. DCC is preferred over anti-arrhythmic drugs because of its high rate of success, lower risk of pro-arrhythmia and shorter overall procedure duration. However, DCC is a painful procedure requiring sedation and analgesia. Although a variety of agents may be employed for the provision of sedation, the most popular agent used in this setting is propofol, an intravenous hypnotic–amnestic drug exclusively administered by trained professionals such as anesthesiologists [4]. To overcome this limitation, the use of short acting benzodiazepines for procedural sedation and analgesia (PSA) spread widely, following general recommendations and international guidelines regarding PSA management by non-anesthesiologists [5], [6], [7]. Nowadays, recent AF guidelines provide no specific recommendations concerning PSA for DCC, [8], [9] and many concerns still exist about the safety of this procedure in the absence of anesthesiology assistance [10].
The purpose of this prospective, open-blinded, randomized study is to compare safety, tolerability, efficacy, and costs of a cardiologist-only approach with a more traditional anesthesiologist-assisted deep sedation protocol during elective DCC of persistent AF.
Section snippets
Study population
This prospective, randomized, open-blinded, single-center study included 204 patients, admitted to our center from February 2011 to November 2013. Inclusion criteria were age ≥ 18 years, and hospital admission for scheduled elective cardioversion of persistent AF. The only exclusion criterion was a known or suspected allergy or adverse reaction to either midazolam or propofol. No patients were excluded based on concomitant diseases, such as obesity, chronic obstructive pulmonary disease and liver
General population
The whole population consisted of 204 patients, 100 of which were randomized to propofol and 104 to midazolam. General characteristics of the population are shown in Table 1. There were no significant differences between the two groups in terms of risk factors, concomitant illnesses, or drug therapy. Mean drug doses were 0.16 mg/kg for the midazolam group and 1.2 mg/kg for the propofol group.
Primary safety endpoint: adverse events
Twenty-three adverse events occurred in the whole population: 13 in the propofol group and 10 in the
Discussion
Adequate sedation is of the utmost importance in order to relief acute pain, prevent recall of the unpleasant experience, and attenuate catecholamine stress response. For the first time in a randomized, open-blinded, prospective study, the present data demonstrate that a cardiologist-only approach to both PSA and DCC is as safe and effective as a more traditional approach with anesthesiologist assistance. This finding is especially important, as PSA administered by non-anesthesiologists is
Conclusion
Sedation with midazolam administered by cardiologist-only appears to be as safe as sedation with propofol and anesthesiologist assistance. Adverse events were overall few in both groups and all were easily manageable by the cardiologist alone without the need of an advanced training in invasive ventilation. DCC is safe and the use of flumazenil could contribute to make it safer. A cardiologist-only approach to sedation reduces costs, as it needs less physicians involved, thus being easier to
Conflicts of interest
The authors have no conflicts of interest to declare.
Acknowledgments
Authors would like to thank the medical and nursing staff of the Cardiology and Arrhythmology Clinic for their precious and excellent contribution to the present paper, and Drs. Vincenzo Menditto, Vania Carignani and Michela Ricci for their support regarding costs-analysis.
References (26)
- et al.
Contemporary real life cardioversion of atrial fibrillation: results from the multinational RHYTHM-AF study
Int J Cardiol
(2014) - et al.
DC cardioversion of persistent atrial fibrillation: a comparison of two protocols
Int J Cardiol
(2007) - et al.
Anterior–posterior versus anterior–lateral electrode positions for external cardioversion of atrial fibrillation: a randomised trial
Lancet
(2002) - et al.
Propofol for adult procedural sedation in a UK emergency department: safety profile in 1008 cases
Br J Anaesth
(2013) - et al.
Electrical cardioversion of atrial fibrillation: evaluation of sedation safety with midazolam by means of EtCO₂ and IPI algorithm analysis
Int J Cardiol
(2013) - et al.
Ambulatory electrical external cardioversion with propofol or etomidate
J Clin Anesth
(2003) - et al.
“Cardioversion” of atrial fibrillation. A report on the treatment of 65 episodes in 50 patients
N Engl J Med
(1963) - et al.
Cardioversion for atrial fibrillation in current European practice: results of the European Heart Rhythm Association survey
Europace
(2013) Non-anaesthesiologists should not be allowed to administer propofol for procedural sedation: a Consensus Statement of 21 European National Societies of Anaesthesia
Eur J Anaesthesiol
(2011)- et al.
Practice guidelines for sedation and analgesia by non-anesthesiologists
Anesthesiology
(2002)
Guidelines for sedation and/or analgesia by non-anaesthesiology doctors
Eur J Anaesthesiol
Guidelines for the management of atrial fibrillation: the Task Force for the Management of Atrial Fibrillation of the European Society of Cardiology (ESC)
Eur Heart J
Management of patients with atrial fibrillation (compilation of 2006 ACCF/AHA/ESC and 2011 ACCF/AHA/HRS recommendations): a report of the American College of Cardiology/American Heart Association Task Force on practice guidelines
Circulation
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Funding: This work was supported by the Marche Polytechnic University.
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All authors take responsibility for all aspects of the reliability and freedom from bias of the data presented and their discussed interpretation.