Randomized Controlled Trial

. 2015 Oct 1;36(37):2500-7.

doi: 10.1093/eurheartj/ehv292. Epub 2015 Jun 25.

Intra-operative defibrillation testing and clinical shock efficacy in patients with implantable cardioverter-defibrillators: the NORDIC ICD randomized clinical trial

Collaborators, Affiliations

Collaborators

NORDIC ICD Trial Investigators:
T Demming, S Sandrock, A Ziomka, V Doupal, M Fedorco, P Heinc, T Skála, I Sovova, T Agdirlioglu, J Bleideck, C Busch, T Graf, L-C Harland, F Himmel, A Joost, W Lauer, A Pormarino, B Riedel, T von Lukowicz, T Kleinfeldt, J Lauschke, R Schneider, T Tischer, W Voss, I Wendig, W R Bauer, S Gkaniatsas, S Kaufmann, P Nordbeck, T Reiter, O Ritter, J Strasen, M Unzicker, J Aring, A Fahrig, M Hüsch, B Weidmann, K J Gutleben, J Heintze, G Nölker, J Vogt, F Behrendt, M Döring, S Hilbert, D Husser, S John, C Klaus, M Kreuzhuber, S Löbe, J Lucas, S Richter, C Rogge, S Rolf, F Schliephake, U Wetzel, Y van Belle, B Burger, F Burger, K Oppenländer, J Brachmann, M Held, S Mahfouz, Ch Mahnkopf, S Rube, A Sallam, B Schertel-Grünler, L Schwarzmann, S Schupp, M Busch, M Heukäfer, A Hummel, D Menzel, T Reffelmann, D Mörtsell, B Z Ostrowska, E Sciaraffia, P Teder, E Blank, F-H Güldner, V Pütz, D Schmitz, L Waidelich, S Asbach, J Biermann, T Faber, M Hartmann, J Steinfurt, D Lipskaite, F Schlegel, S Vogler, M Sepši, S Kääb, P Lange, E Martens, N Oversohl, U Pflugradt, S Sattler, T M Krüger, J Menne, S Sack, M Weber, J B Johansen, S Hartenstein, P Kahlert, T Konorza, N Reinsch, W Weissenberger, M Brezger, S Spencker, H H Petersen, B T Philbert, J Tfelt-Hansen, R Videbaeck, J Ansabergs, M Blumbergs, A Erglis, N Nesterovics, J Pudulis, S Sakne, M Vikmane, J Jung, O Köth, S Lange, U Bach, S Behrens, R Kittler, K Schneider, T Bauernfeind, W Haberbosch, C Nissel, D Reckel, A Woratschek, C Böwing, J Kaddatz, H Seyfert, J Brockmeier, S Hochreuther, U Tebbe, E Hoffmann, T Jahn, A Joeinig, P Landwehr, S Reif, M Schmidt, V Wagner, P Boye, H Schütt, S Strohm, M Wiedemann, J Fabian, S Fischer, D Selbig, O Vaisbord, T Beck, R Laszlo, M Maunz, S P Christow, M Kulzer, K Seidl, C A Correia Freitas, M Haude, Th M Lickfeld, C Pfeiffer, H Baumann, B D Gonska, C Pieper, L Eckardt, C Fischer, G Frommeyer, E Kaya, J Köbe, P Lange, S Ramtin, F Reinke, A Samol, R Borgquist, C-J Höljer, I Litterfeldt, L Wang, S Behrens, M Jereczek, H Seibt, P Zierock, J Haarbo, A Burger, N Rüb, S Trautmann, M Kloß, S Berndt, M Christoph, M Guenther, B Richter, R Strasser, E Helmling, A Langbein, B Schumacher, M Schneider, A Schoene, P Ganslmeier, R Molitoris, H J Schneider, C Berndt, J Buchholz, A Dorszewski, K Neven, V Pütz, A Aydin, N Gosau, F Hartel, I Wilke, S Willems, G Zengin, P Flach, E Frantz, H Langreck

Affiliations

¹ Heart Center Rostock, Department of Internal Medicine I, Divisions of Cardiology, University Hospital Rostock, Ernst-Heydemann-Str. 6, Rostock 18057, Germany dietmar.baensch@med.uni-rostock.de.
² Department of Internal Medicine III Cardiology and Angiology, University Hospital Schleswig-Holstein, Campus Kiel, Kiel, Germany.
³ Arrhythmia Department, Skane University Hospital, Lund, Sweden.
⁴ Medical Clinic II Cardiology, Angiology and Intensive Care Medicine, University Hospital Schleswig-Holstein, Campus Lübeck, Lübeck, Germany.
⁵ Heart Center, Department of Cardiology, Rigshospitalet Copenhagen University Hospital, Copenhagen, Denmark Danish Arrhythmia Research Centre, University of Copenhagen, Copenhagen, Denmark.
⁶ Department of Internal Medicine I Cardiology, Faculty Hospital Olomouc, Olomouc, Czech Republic.
⁷ Department of Internal Medicine, Cardiology, DRK Hospital Mölln-Ratzeburg, Ratzeburg, Germany.
⁸ Department of Cardiology, Uppsala University, Uppsala, Sweden.
⁹ Biotronik, Berlin, Germany.
¹⁰ Department of Medical Biometry and Epidemiology, University Medical Center Hamburg Eppendorf, Hamburg, Germany.

PMID: 26112885
PMCID: PMC4589656
DOI: 10.1093/eurheartj/ehv292

Randomized Controlled Trial

Intra-operative defibrillation testing and clinical shock efficacy in patients with implantable cardioverter-defibrillators: the NORDIC ICD randomized clinical trial

Dietmar Bänsch et al. Eur Heart J. 2015.

. 2015 Oct 1;36(37):2500-7.

doi: 10.1093/eurheartj/ehv292. Epub 2015 Jun 25.

Collaborators

NORDIC ICD Trial Investigators:
T Demming, S Sandrock, A Ziomka, V Doupal, M Fedorco, P Heinc, T Skála, I Sovova, T Agdirlioglu, J Bleideck, C Busch, T Graf, L-C Harland, F Himmel, A Joost, W Lauer, A Pormarino, B Riedel, T von Lukowicz, T Kleinfeldt, J Lauschke, R Schneider, T Tischer, W Voss, I Wendig, W R Bauer, S Gkaniatsas, S Kaufmann, P Nordbeck, T Reiter, O Ritter, J Strasen, M Unzicker, J Aring, A Fahrig, M Hüsch, B Weidmann, K J Gutleben, J Heintze, G Nölker, J Vogt, F Behrendt, M Döring, S Hilbert, D Husser, S John, C Klaus, M Kreuzhuber, S Löbe, J Lucas, S Richter, C Rogge, S Rolf, F Schliephake, U Wetzel, Y van Belle, B Burger, F Burger, K Oppenländer, J Brachmann, M Held, S Mahfouz, Ch Mahnkopf, S Rube, A Sallam, B Schertel-Grünler, L Schwarzmann, S Schupp, M Busch, M Heukäfer, A Hummel, D Menzel, T Reffelmann, D Mörtsell, B Z Ostrowska, E Sciaraffia, P Teder, E Blank, F-H Güldner, V Pütz, D Schmitz, L Waidelich, S Asbach, J Biermann, T Faber, M Hartmann, J Steinfurt, D Lipskaite, F Schlegel, S Vogler, M Sepši, S Kääb, P Lange, E Martens, N Oversohl, U Pflugradt, S Sattler, T M Krüger, J Menne, S Sack, M Weber, J B Johansen, S Hartenstein, P Kahlert, T Konorza, N Reinsch, W Weissenberger, M Brezger, S Spencker, H H Petersen, B T Philbert, J Tfelt-Hansen, R Videbaeck, J Ansabergs, M Blumbergs, A Erglis, N Nesterovics, J Pudulis, S Sakne, M Vikmane, J Jung, O Köth, S Lange, U Bach, S Behrens, R Kittler, K Schneider, T Bauernfeind, W Haberbosch, C Nissel, D Reckel, A Woratschek, C Böwing, J Kaddatz, H Seyfert, J Brockmeier, S Hochreuther, U Tebbe, E Hoffmann, T Jahn, A Joeinig, P Landwehr, S Reif, M Schmidt, V Wagner, P Boye, H Schütt, S Strohm, M Wiedemann, J Fabian, S Fischer, D Selbig, O Vaisbord, T Beck, R Laszlo, M Maunz, S P Christow, M Kulzer, K Seidl, C A Correia Freitas, M Haude, Th M Lickfeld, C Pfeiffer, H Baumann, B D Gonska, C Pieper, L Eckardt, C Fischer, G Frommeyer, E Kaya, J Köbe, P Lange, S Ramtin, F Reinke, A Samol, R Borgquist, C-J Höljer, I Litterfeldt, L Wang, S Behrens, M Jereczek, H Seibt, P Zierock, J Haarbo, A Burger, N Rüb, S Trautmann, M Kloß, S Berndt, M Christoph, M Guenther, B Richter, R Strasser, E Helmling, A Langbein, B Schumacher, M Schneider, A Schoene, P Ganslmeier, R Molitoris, H J Schneider, C Berndt, J Buchholz, A Dorszewski, K Neven, V Pütz, A Aydin, N Gosau, F Hartel, I Wilke, S Willems, G Zengin, P Flach, E Frantz, H Langreck

Affiliations

¹ Heart Center Rostock, Department of Internal Medicine I, Divisions of Cardiology, University Hospital Rostock, Ernst-Heydemann-Str. 6, Rostock 18057, Germany dietmar.baensch@med.uni-rostock.de.
² Department of Internal Medicine III Cardiology and Angiology, University Hospital Schleswig-Holstein, Campus Kiel, Kiel, Germany.
³ Arrhythmia Department, Skane University Hospital, Lund, Sweden.
⁴ Medical Clinic II Cardiology, Angiology and Intensive Care Medicine, University Hospital Schleswig-Holstein, Campus Lübeck, Lübeck, Germany.
⁵ Heart Center, Department of Cardiology, Rigshospitalet Copenhagen University Hospital, Copenhagen, Denmark Danish Arrhythmia Research Centre, University of Copenhagen, Copenhagen, Denmark.
⁶ Department of Internal Medicine I Cardiology, Faculty Hospital Olomouc, Olomouc, Czech Republic.
⁷ Department of Internal Medicine, Cardiology, DRK Hospital Mölln-Ratzeburg, Ratzeburg, Germany.
⁸ Department of Cardiology, Uppsala University, Uppsala, Sweden.
⁹ Biotronik, Berlin, Germany.
¹⁰ Department of Medical Biometry and Epidemiology, University Medical Center Hamburg Eppendorf, Hamburg, Germany.

PMID: 26112885
PMCID: PMC4589656
DOI: 10.1093/eurheartj/ehv292

Abstract

Aims: This trial was designed to test the hypothesis that shock efficacy during follow-up is not impaired in patients implanted without defibrillation (DF) testing during first implantable cardioverter-defibrillator (ICD) implantation.

Methods and results: Between February 2011 and July 2013, 1077 patients were randomly assigned (1 : 1) to first time ICD implantation with (n = 540) or without (n = 537) DF testing. The intra-operative DF testing was standardized across all participating centres, and all ICD shocks were programmed to 40 J irrespective of DF test results. The primary end point was the average first shock efficacy (FSE) for all true ventricular tachycardia and fibrillation (VT/VF) episodes during follow-up. The secondary end points included procedural data, serious adverse events, and mortality. During a median follow-up of 22.8 months, the model-based FSE was found to be non-inferior in patients with an ICD implanted without a DF test, with a difference in FSE of 3.0% in favour of the no DF test [confidence interval (CI) -3.0 to 9.0%, Pnon-inferiority <0.001 for the pre-defined non-inferiority margin of -10%). A total of 112 procedure-related serious adverse events occurred within 30 days in 94 patients (17.6%) tested compared with 89 events in 74 patients (13.9%) not tested (P = 0.095).

Conclusion: Defibrillation efficacy during follow-up is not inferior in patients with a 40 J ICD implanted without DF testing. Defibrillation testing during first time ICD implantation should no longer be recommended for routine left-sided ICD implantation.

Keywords: Defibrillation testing; Implantable cardioverter-defibrillator.

PubMed Disclaimer

Figures

**Figure 1**
CONSORT flow diagram. *With at least one delivered appropriate ICD shock. ITT, full analysis set (all patients as randomized); EFS, evaluated for safety set (all patients randomized, who had a successful primary ICD implantation); PPS, per protocol set (all patients randomized, who are compliant with the study protocol); P-PPS, all randomized patients at least one day at risk before protocol deviation (includes all sufficiently documented shocked episodes until time point of protocol deviation).

**Figure 2**
Primary outcome in the per protocol population.

See this image and copyright information in PMC

Comment in

Device therapy: Defibrillation testing unnecessary during routine cardioverter-defibrillator implantation.
Lim GB. Lim GB. Nat Rev Cardiol. 2015 Sep;12(9):501. doi: 10.1038/nrcardio.2015.111. Epub 2015 Jul 14. Nat Rev Cardiol. 2015. PMID: 26169792 No abstract available.
Defibrillation testing is not required during routine ICD implantation.
Kutyifa V, Moss AJ. Kutyifa V, et al. Eur Heart J. 2015 Oct 1;36(37):2508-9. doi: 10.1093/eurheartj/ehv324. Epub 2015 Jul 22. Eur Heart J. 2015. PMID: 26201511 No abstract available.

References

1. Russo AM, Chung MK. Is defribrillation testing necessary? Cardiol Clin 2014;32:211–224. - PubMed
1. Pires LA, Johnson KM. Intraoperative testing of the implantable cardioverter-defibrillator: how much is enough? J Cardiovasc Electrophysiol 2006;17:140–145. - PubMed
1. Christ G, Becker R, Voss F, Kelemen K, Senges-Becker J, Hauck M, Schoels W, Bald I, Katus H, Bauer A. Indications for predismissal testing with arrhythmia-induction in patients receiving an implatable cardioverter defibrillator. Clin Res Cardiol 2007;96:613–620. - PubMed
1. Brignole M, Raciti G, Bongiorni MG, De Martino G, Favale S, Gasparini M, Luise R, Occhetta E, Proclemer A. Defibrillation testing at the time of implantation of cardioverter defibrillator in the clinical practice: a nation-wide survey. Europace 2007;9:540–543. - PubMed
1. Healey JS, Dorian P, Mitchell LB, Talajic M, Philippon F, Simpson C, Yee R, Morillo CA, Lamy A, Basta M, Birnie DH, Wang X, Nair GM, Crystal E, Kerr CR, Connolly SJ, CREDIT Investigators. Canadian Registry of ICD Implant Testing procedures (CREDIT): current practice, risks, and costs of intraoperative defibrillation testing. J Cardiovasc Electrophysiol 2010;21:177–182. - PubMed

Publication types

Actions
Actions
Actions

MeSH terms

Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions

LinkOut - more resources

Full Text Sources
Other Literature Sources
- scite Smart Citations
Medical
- MedlinePlus Health Information
Miscellaneous
- NCI CPTAC Assay Portal

Save citation to file

Email citation

Add to Collections

Add to My Bibliography

Your saved search

Create a file for external citation management software

Your RSS Feed

Intra-operative defibrillation testing and clinical shock efficacy in patients with implantable cardioverter-defibrillators: the NORDIC ICD randomized clinical trial

Collaborators

Affiliations

Intra-operative defibrillation testing and clinical shock efficacy in patients with implantable cardioverter-defibrillators: the NORDIC ICD randomized clinical trial

Authors

Collaborators

Affiliations

Abstract

Figures

Comment in

References

Publication types

MeSH terms

LinkOut - more resources

Full Text Sources

Other Literature Sources

Medical

Miscellaneous