TY - JOUR
T1 - Internal versus external electrical cardioversion of atrial arrhythmia in patients with implantable cardioverter-defibrillator a randomized clinical trial
AU - Lüker, Jakob
AU - Kuhr, Kathrin
AU - Sultan, Arian
AU - Nölker, Georg
AU - Omran, Hazem
AU - Willems, Stephan
AU - Andrié, René
AU - Schrickel, Jan W.
AU - Winter, Stefan
AU - Vollmann, Dirk
AU - Tilz, Roland R.
AU - Jobs, Alexander
AU - Heeger, Christian H.
AU - Metzner, Andreas
AU - Meyer, Sven
AU - Mischke, Karl
AU - Napp, Andreas
AU - Fahrig, Andreas
AU - Steinhauser, Susanne
AU - Brachmann, Johannes
AU - Baldus, Stephan
AU - Mahajan, Rajiv
AU - Sanders, Prashanthan
AU - Steven, Daniel
N1 - Funding Information:
This work was funded by the University of Cologne and supported by a research grant from Medtronic Germany. The University of Cologne was the sole sponsor of the study.
Funding Information:
Dr Lüker reports a research grant from Medtronic (significant), for the conduct of the study; research grants and honoraria from Medtronic, personal fees from St Jude Medical/Abbott, outside the submitted work (modest). Dr Sanders reports honoraria from Medtronic, Abbott, and Boston Scientific. The University of Adelaide reports receiving on behalf of Dr Sanders honoraria from Medtron-ic, Abbott, and Boston Scientific. The University of Adelaide reports receiving on behalf of Dr Sanders research grants from Medtronic, Abbott, Boston Scientific, Biotronik and Liva Nova. All outside the submitted work (significant). Dr Mahajan reports the University of Adelaide receiving on behalf of Dr Mahajan honoraria from Abbott, Medtronic, outside the submitted work. The University of Adelaide reports receiving on behalf of Dr Mahajan research grants from Abbott and Medtronic, outside the submitted work (significant). Dr Heeger reports research grants and honoraria from Medtronic, outside the submitted work (modest). Prof Willems reports honoraria from Boston Scientific and Abbott, outside the submitted work (modest). Prof Vollmann reports honoraria from Abbott, outside the submitted work (modest). Prof Tilz reports research grants from Medtronic, Biotronik and Abbott, outside the submitted work; honoraria from Medtronic, Abbott, and Biotronik, outside the submitted work (modest). Prof Steven reports research grants from Abbott and Boston, outside the submitted work; honoraria from Abbott and Boston Scientific, outside the submitted work; (modest) Research grants from Medtronic (significant), during the conduct of the study. The other authors report no conflicts.
Publisher Copyright:
© 2019 American Heart Association, Inc.
Copyright:
Copyright 2020 Elsevier B.V., All rights reserved.
PY - 2019/9/24
Y1 - 2019/9/24
N2 - 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. RESULTS: N=230 patients were randomized. Shock efficacy was 93% in the external cardioversion group and 65% in the internal cardioversion group (P<0.001). 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.
AB - 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. RESULTS: N=230 patients were randomized. Shock efficacy was 93% in the external cardioversion group and 65% in the internal cardioversion group (P<0.001). 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.
UR - http://www.scopus.com/inward/record.url?scp=85072587646&partnerID=8YFLogxK
U2 - 10.1161/CIRCULATIONAHA.119.041320
DO - 10.1161/CIRCULATIONAHA.119.041320
M3 - Journal articles
C2 - 31466479
AN - SCOPUS:85072587646
SN - 0009-7322
VL - 140
SP - 1061
EP - 1069
JO - Circulation
JF - Circulation
IS - 13
ER -
