Internal versus external electrical cardioversion of atrial arrhythmia in patients with implantable cardioverter-defibrillator a randomized clinical trial

Jakob Lüker; Kathrin Kuhr; Arian Sultan; Georg Nölker; Hazem Omran; Stephan Willems; René Andrié; Jan W. Schrickel; Stefan Winter; Dirk Vollmann; Roland R. Tilz; Alexander Jobs; Christian H. Heeger; Andreas Metzner; Sven Meyer; Karl Mischke; Andreas Napp; Andreas Fahrig; Susanne Steinhauser; Johannes Brachmann; Stephan Baldus; Rajiv Mahajan; Prashanthan Sanders; Daniel Steven

doi:10.1161/CIRCULATIONAHA.119.041320

Internal versus external electrical cardioversion of atrial arrhythmia in patients with implantable cardioverter-defibrillator a randomized clinical trial

Jakob Lüker^*, Kathrin Kuhr, Arian Sultan, Georg Nölker, Hazem Omran, Stephan Willems, René Andrié, Jan W. Schrickel, Stefan Winter, Dirk Vollmann, Roland R. Tilz, Alexander Jobs, Christian H. Heeger, Andreas Metzner, Sven Meyer, Karl Mischke, Andreas Napp, Andreas Fahrig, Susanne Steinhauser, Johannes BrachmannStephan Baldus, Rajiv Mahajan, Prashanthan Sanders, Daniel Steven

^*Corresponding author for this work

Clinic of Internal Medicine II - Cardiology

12 Citations (Scopus)

Abstract

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.

Original language	English
Journal	Circulation
Volume	140
Issue number	13
Pages (from-to)	1061-1069
Number of pages	9
ISSN	0009-7322
DOIs	https://doi.org/10.1161/CIRCULATIONAHA.119.041320
Publication status	Published - 24.09.2019

Funding

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. 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.

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10.1161/CIRCULATIONAHA.119.041320

Cite this

Lüker, J., Kuhr, K., Sultan, A., Nölker, G., Omran, H., Willems, S., Andrié, R., Schrickel, J. W., Winter, S., Vollmann, D., Tilz, R. R., Jobs, A., Heeger, C. H., Metzner, A., Meyer, S., Mischke, K., Napp, A., Fahrig, A., Steinhauser, S., ... Steven, D. (2019). Internal versus external electrical cardioversion of atrial arrhythmia in patients with implantable cardioverter-defibrillator a randomized clinical trial. Circulation, 140(13), 1061-1069. https://doi.org/10.1161/CIRCULATIONAHA.119.041320

@article{f2d76ae232134cc1baa93a2206c51db8,

title = "Internal versus external electrical cardioversion of atrial arrhythmia in patients with implantable cardioverter-defibrillator a randomized clinical trial",

abstract = "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.",

author = "Jakob L{\"u}ker and Kathrin Kuhr and Arian Sultan and Georg N{\"o}lker and Hazem Omran and Stephan Willems and Ren{\'e} Andri{\'e} and Schrickel, \{Jan W.\} and Stefan Winter and Dirk Vollmann and Tilz, \{Roland R.\} and Alexander Jobs and Heeger, \{Christian H.\} and Andreas Metzner and Sven Meyer and Karl Mischke and Andreas Napp and Andreas Fahrig and Susanne Steinhauser and Johannes Brachmann and Stephan Baldus and Rajiv Mahajan and Prashanthan Sanders and Daniel Steven",

note = "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 L{\"u}ker 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: {\textcopyright} 2019 American Heart Association, Inc. Copyright: Copyright 2020 Elsevier B.V., All rights reserved.",

year = "2019",

month = sep,

day = "24",

doi = "10.1161/CIRCULATIONAHA.119.041320",

language = "English",

volume = "140",

pages = "1061--1069",

journal = "Circulation",

issn = "0009-7322",

publisher = "Lippincott Williams and Wilkins",

number = "13",

}

Lüker, J, Kuhr, K, Sultan, A, Nölker, G, Omran, H, Willems, S, Andrié, R, Schrickel, JW, Winter, S, Vollmann, D, Tilz, RR, Jobs, A, Heeger, CH, Metzner, A, Meyer, S, Mischke, K, Napp, A, Fahrig, A, Steinhauser, S, Brachmann, J, Baldus, S, Mahajan, R, Sanders, P & Steven, D 2019, 'Internal versus external electrical cardioversion of atrial arrhythmia in patients with implantable cardioverter-defibrillator a randomized clinical trial', Circulation, vol. 140, no. 13, pp. 1061-1069. https://doi.org/10.1161/CIRCULATIONAHA.119.041320

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 - https://www.scopus.com/pages/publications/85072587646

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 -

Internal versus external electrical cardioversion of atrial arrhythmia in patients with implantable cardioverter-defibrillator a randomized clinical trial

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