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 & 4 others Stephan Baldus, Rajiv Mahajan, Prashanthan Sanders, Daniel Steven

Research output: Contribution to journalArticle

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. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT03247738.

LanguageEnglish
Pages1061-1069
Number of pages9
JournalCirculation
Volume140
Issue number13
DOIs
Publication statusPublished - 24 Sep 2019

Keywords

  • arrhythmia
  • atrial fibrillation
  • cardioversion
  • implantable cardioverter-defibrillator

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine
  • Physiology (medical)

Cite this

Lüker, Jakob ; Kuhr, Kathrin ; Sultan, Arian ; Nölker, Georg ; Omran, Hazem ; Willems, Stephan ; Andrié, René ; Schrickel, Jan W. ; Winter, Stefan ; Vollmann, Dirk ; Tilz, Roland R. ; Jobs, Alexander ; Heeger, Christian H. ; Metzner, Andreas ; Meyer, Sven ; Mischke, Karl ; Napp, Andreas ; Fahrig, Andreas ; Steinhauser, Susanne ; Brachmann, Johannes ; Baldus, Stephan ; Mahajan, Rajiv ; Sanders, Prashanthan ; Steven, Daniel. / Internal Versus External Electrical Cardioversion of Atrial Arrhythmia in Patients With Implantable Cardioverter-Defibrillator : A Randomized Clinical Trial. In: Circulation. 2019 ; Vol. 140, No. 13. pp. 1061-1069.
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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. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT03247738.",
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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

Internal Versus External Electrical Cardioversion of Atrial Arrhythmia in Patients With Implantable Cardioverter-Defibrillator : A Randomized Clinical Trial. / Lüker, Jakob; Kuhr, Kathrin; Sultan, Arian; Nölker, Georg; Omran, Hazem; Willems, Stephan; Andrié, René; Schrickel, Jan W.; Winter, Stefan; Vollmann, Dirk; Tilz, Roland R.; Jobs, Alexander; Heeger, Christian H.; Metzner, Andreas; Meyer, Sven; Mischke, Karl; Napp, Andreas; Fahrig, Andreas; Steinhauser, Susanne; Brachmann, Johannes; Baldus, Stephan; Mahajan, Rajiv; Sanders, Prashanthan; Steven, Daniel.

In: Circulation, Vol. 140, No. 13, 24.09.2019, p. 1061-1069.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Internal Versus External Electrical Cardioversion of Atrial Arrhythmia in Patients With Implantable Cardioverter-Defibrillator

T2 - Circulation

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

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. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT03247738.

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. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT03247738.

KW - arrhythmia

KW - atrial fibrillation

KW - cardioversion

KW - implantable cardioverter-defibrillator

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U2 - 10.1161/CIRCULATIONAHA.119.041320

DO - 10.1161/CIRCULATIONAHA.119.041320

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JO - Circulation

JF - Circulation

SN - 0009-7322

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