Internal Versus External Electrical Cardioversion of Atrial Arrhythmia in Patients With Implantable Cardioverter-Defibrillator: A Randomized Clinical Trial.


Journal

Circulation
ISSN: 1524-4539
Titre abrégé: Circulation
Pays: United States
ID NLM: 0147763

Informations de publication

Date de publication:
24 09 2019
Historique:
pubmed: 31 8 2019
medline: 18 6 2020
entrez: 31 8 2019
Statut: ppublish

Résumé

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. 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. N=230 patients were randomized. Shock efficacy was 93% in the external cardioversion group and 65% in the internal cardioversion group ( 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. URL: https://www.clinicaltrials.gov. Unique identifier: NCT03247738.

Sections du résumé

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 (
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.

Identifiants

pubmed: 31466479
doi: 10.1161/CIRCULATIONAHA.119.041320
doi:

Banques de données

ClinicalTrials.gov
['NCT03247738']

Types de publication

Journal Article Randomized Controlled Trial Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

1061-1069

Commentaires et corrections

Type : CommentIn
Type : CommentIn

Auteurs

Jakob Lüker (J)

University of Cologne, University Hospital Cologne, Department of Electrophysiology (J.L., A.S., D.S.), Germany.

Kathrin Kuhr (K)

Institute of Medical Statistics and Computational Biology (IMSB) (K.K., S.S.), Germany.

Arian Sultan (A)

University of Cologne, University Hospital Cologne, Department of Electrophysiology (J.L., A.S., D.S.), Germany.

Georg Nölker (G)

Herz- und Diabeteszentrum NRW, Ruhr-Universität Bochum, Clinic for Electrophysiology, Bad Oeynhausen, Germany (G.N., H.O.).

Hazem Omran (H)

Herz- und Diabeteszentrum NRW, Ruhr-Universität Bochum, Clinic for Electrophysiology, Bad Oeynhausen, Germany (G.N., H.O.).

Stephan Willems (S)

Department of Electrophysiology, University Heart Center, Hamburg, Germany (S.W.).

René Andrié (R)

Department of Internal Medicine II, University Hospital Bonn, Germany (R.A., J.W.S.).

Jan W Schrickel (JW)

Department of Internal Medicine II, University Hospital Bonn, Germany (R.A., J.W.S.).

Stefan Winter (S)

St. Vinzenz Hospital, Cologne, Germany (S.W.).

Dirk Vollmann (D)

Herz- & Gefäßzentrum Göttingen, Germany (D.V.).

Roland R Tilz (RR)

Department of Cardiology, University Hospital Lübeck, Germany (R.R.T., A.J., C.H.H.).

Alexander Jobs (A)

Department of Cardiology, University Hospital Lübeck, Germany (R.R.T., A.J., C.H.H.).
Department of Internal Medicine/Cardiology, Heart Center Leipzig at University of Leipzig, Germany (A.J.).

Christian-H Heeger (CH)

Department of Cardiology, University Hospital Lübeck, Germany (R.R.T., A.J., C.H.H.).

Andreas Metzner (A)

Department of Cardiology, Asklepios Klinik St. Georg, Hamburg, Germany (A.M.).

Sven Meyer (S)

Department of Cardiology, Heart Center Oldenburg, European Medical School Oldenburg-Groningen, Germany (S.M.).

Karl Mischke (K)

Medical Clinic I, Leopoldina Hospital, Schweinfurt, Germany (K.M.).

Andreas Napp (A)

Department of Internal Medicine I, RWTH Aachen University Hospital, Germany (A.N.).

Andreas Fahrig (A)

Klinikum Leverkusen, Germany (A.F.).

Susanne Steinhauser (S)

Institute of Medical Statistics and Computational Biology (IMSB) (K.K., S.S.), Germany.

Johannes Brachmann (J)

Medical Clinic II, Coburg Hospital, Germany (J.B.).

Stephan Baldus (S)

Department of Cardiology (S.B.), Germany.

Rajiv Mahajan (R)

Center for Heart Rhythm Disorders, South Australian Health and Medical Research Institute (SAHMRI), University of Adelaide, Australia (R.M., P.S.).

Prashanthan Sanders (P)

Center for Heart Rhythm Disorders, South Australian Health and Medical Research Institute (SAHMRI), University of Adelaide, Australia (R.M., P.S.).

Daniel Steven (D)

University of Cologne, University Hospital Cologne, Department of Electrophysiology (J.L., A.S., D.S.), Germany.

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