Feasibility of a cardiologist-only approach to sedation for electrical cardioversion of atrial fibrillation: A randomized, open-blinded, prospective study

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Highlights

  • A cardiologist-only approach to DCC appears to be safe.

  • No need of intubation or other advanced resuscitation techniques were experienced.

  • Midazolam and propofol-induced sedations have a similar tolerability.

  • A cardiologist-only approach to DCC is correlated with fewer costs.

Abstract

Background/objectives

Sedation with propofol should be administered by personnel trained in advanced airway management. To overcome this limitation, the use of short acting benzodiazepines by cardiologists spread widely, causing concerns about the safety of this procedure in the absence of anesthesiology assistance. The aim of the study was to compare feasibility of a cardiologist-only approach with an anesthesiologist-assisted sedation protocol during elective direct-current cardioversion (DCC) of persistent atrial fibrillation (AF).

Methods

This prospective, open-blinded, randomized study included 204 patients, which were admitted for scheduled cardioversion of persistent AF, and randomized in a 1:1 fashion to either propofol or midazolam treatment arm. Patients in the propofol group underwent DCC with anesthesiologist assistance, while patients in the midazolam group saw the cardiologist as the only responsible for both sedation and DCC.

Results

Twenty-three adverse events occurred: 13 in the propofol group and 10 in the midazolam group (p = NS). Most of them were related to bradyarrhythmias and respiratory depressions. There was no need of intubation or other advanced resuscitation techniques in any of these patients. No differences were found regarding procedure tolerability and safety endpoints between the two groups. DCC procedures with anesthesiology support were burdened by higher delay from scheduled time and higher costs.

Conclusions

Sedation with midazolam administered by cardiologist-only appears to be as safe as sedation with propofol and anesthesiologist assistance. Adverse events were few in both groups and easily handled by the cardiologist alone. A cardiologist-only approach to sedation provides less procedural delay, thus being easier to schedule and correlated with fewer costs.

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.

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    Funding: This work was supported by the Marche Polytechnic University.

    1

    All authors take responsibility for all aspects of the reliability and freedom from bias of the data presented and their discussed interpretation.

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