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ICD implantation without intraoperative testing does not increase the rate of system modifications and does not impair defibrillation efficacy tested in follow-up

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Herzschrittmachertherapie + Elektrophysiologie Aims and scope Submit manuscript

Abstract

Aim

The need for implantable cardioverter-defibrillator (ICD) defibrillation testing (DT) and subsequent intraoperative system modifications is discussed controversially. The study’s goal was to prove that consequent abdication of intraoperative DT does not impair defibrillation efficacy and does not increase the rate of postoperative system revisions.

Methods

In a prospective single-center observational study, 609 out of 648 consecutive patients underwent transvenous ICD implantation (left-sided, active can, dual coil lead, and biphasic shock waveform) waiving intraoperative DT. Defibrillation efficacy was validated prior to hospital discharge (PHD) by applying two 10 J safety margin (SM) shocks.

Results

Following “schockless” implantation 580 out of 609 patients (95.2 %) met a 10 J SM with default programming. Shock path reversal provided 10 J SM in 13 out of 29 cases with initially failed DT. In four patients (0.7 %) maximum energy shocks were ineffective. There was no morbidity or mortality related to DT. The total rate of surgical ICD revisions was 1.8 %.

Conclusion

Routine ICD implantation without intraoperative DT does not lead to an increased rate of postoperative system modifications and does not decrease defibrillation efficacy as tested PHD.

Zusammenfassung

Hintergrund

Der Nutzen der intraoperativen ICD-Testung sowie resultierender Systemmodifikationen wird nach wie vor kontrovers diskutiert. Ziel der Studie war es nachzuweisen, dass der Verzicht auf eine intraoperative Routine-Testung in einem konsekutiven Patientengut 1) die Defibrillationseffektivität nicht beeinträchtigt und 2) nicht zu einer Erhöhung der Rate postoperativer Revisionen führt.

Patienten und Methoden

In der prospektiven monozentrischen Beobachtungsstudie wurde bei 609 aus 648 konsekutiven Patienten ein transvenöser 1- oder 2-Kammer-ICD (links pectoral, active can, dual-coil-Elektrode, biphasische Schocks) konsequent ohne intraoperative Testung implantiert. Die Defibrillationseffektivität wurde vor stationärer Entlassung mittels Testung der 10 Joule Sicherheitsmarge überprüft.

Ergebnisse

In der Standardkonfiguration ließ sich bei 580 von 609 Patienten (95,2 %) eine 10 J Sicherheitsmarge nachweisen. Bei 13 der 29 Patienten mit initial negativem Test wurde nach Umkehr des Schockpfades eine adäquate Sicherheitsmage dokumentiert. In 4 Fällen (0,7 %) waren Schocks mit maximaler Energie ineffektiv. Die Gesamtrate notwendiger chirurgischer Revisionen lag bei lediglich 1,8 %.

Schlußfolgerung

Der Verzicht auf eine intraoperative Testung führte in einem unselektionierten Kollektiv von ICD-Patienten nicht zu einer Reduktion der vor stationärer Entlassung überprüften Defibrillationseffektiviät und erhöhte nicht die Rate notwendiger Systemmodifikationen.

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Conflict of interest and ethics.

All authors have seen and approved the paper. S. Kracker is Field Clinical Research Specialist of the Medtronic Bakken ResearchCenter, Maastricht, The Netherlands. D. Bastian received research grant from Medtronic, speaker fees from BSCI, Medtronic, SJM and serves as a consultant for Biotronik. M. Pauschinger and K. Göhl declare thatthere are no actual or potential conflicts of interest in relation to this article. The authors affirm that the manuscript is not under simultaneous consideration elsewhere and has not been previously published in similarform. The study complies with the Declaration of Helsinki.

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Authors and Affiliations

  1. Division of Cardiology and Electrophysiology, Medizinische Klinik 8, Klinikum Nürnberg Süd, Breslauer Str. 201, 90471, Nuremberg, Germany

    Dirk Bastian MD, Matthias Pauschinger MD & Konrad Göhl MD

  2. Medtronic Bakken Research Center, Maastricht, The Netherlands

    Stefan Kracker PhD

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  1. Dirk Bastian MD
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Correspondence to Dirk Bastian MD.

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Bastian, D., Kracker, S., Pauschinger, M. et al. ICD implantation without intraoperative testing does not increase the rate of system modifications and does not impair defibrillation efficacy tested in follow-up. Herzschr Elektrophys 24, 125–130 (2013). https://doi.org/10.1007/s00399-013-0267-5

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