Key result
External cardioversion was superior to internal cardioversion for the restoration of sinus rhythm in patients with implantable cardioverter-defibrillators (P<0.001).
Why the study?
Data are limited comparing the efficacy of external versus internal cardioversion and their risk of lead and device malfunction in patients with an ICD.
Does external cardioversion improve restoration of sinus rhythm and maintain safety compared to internal cardioversion in patients with ICDs undergoing elective cardioversion for atrial arrhythmias?
RCT
1:1
Yes
Does external cardioversion improve restoration of sinus rhythm and maintain safety compared to internal cardioversion in patients with ICDs undergoing elective cardioversion for atrial arrhythmias?
External cardioversion is superior to internal cardioversion for restoring sinus rhythm in ICD patients with atrial arrhythmias, without increasing clinically relevant adverse events.
Answers are grounded in this paper and cite their sources.
External cardioversion should be preferred for elective cardioversion in ICD patients; extends RCT evidence of superior efficacy with comparable safety.
BACKGROUND: Atrial arrhythmias are common in patients with implantable cardioverter-defibrillator (ICD). External shocks and internal cardioversion through commanded ICD shock for electrical cardioversion are used for rhythm-control. However, there is a paucity of data on efficacy of external versus internal cardioversion and on the risk of lead and device malfunction. We hypothesized that external cardioversion is noninferior to internal cardioversion for safety, and superior for successful restoration of sinus rhythm. METHODS: Consecutive patients with ICD undergoing elective cardioversion for atrial arrhythmias at 13 centers were randomized in 1:1 fashion to either internal or external cardioversion. The primary safety end point was a composite of surrogate events of lead or device malfunction. Conversion of atrial arrhythmia to sinus rhythm was the primary efficacy end point. Myocardial damage was studied by measuring troponin release in both groups. Clinically relevant adverse events caused by external or internal cardioversion were not observed. Three cases of pre-existing silent lead malfunction were unmasked by internal shock, resulting in lead failure. Troponin release did not differ between groups. CONCLUSIONS: This is the first randomized trial on external vs internal cardioversion in patients with ICDs. External cardioversion was superior for the restoration of sinus rhythm. The unmasking of silent lead malfunction in the internal cardioversion group suggests that an internal shock attempt may be reasonable in selected ICD patients presenting for electrical cardioversion. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT03247738.
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Lüker et al. (2019) conducted an RCT in Atrial arrhythmias in patients with implantable cardioverter-defibrillator. External electrical cardioversion vs. Internal electrical cardioversion was evaluated on Composite of surrogate events of lead or device malfunction (primary safety) and conversion of atrial arrhythmia to sinus rhythm (primary efficacy) (p=<0.001). External cardioversion was superior to internal cardioversion for the restoration of sinus rhythm in patients with implantable cardioverter-defibrillators (P<0.001).
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