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Phrenic nerve stimulation in CRT patients and benefits of electronic lead repositioning: the ERACE trial

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Journal of Interventional Cardiac Electrophysiology Aims and scope Submit manuscript

Abstract

Purpose

Despite novel left ventricular (LV) lead technologies, phrenic nerve stimulation (PNS) remains an adverse effect observed in many patients with cardiac resynchronization therapy (CRT). Beyond anatomic repositioning, modern CRT devices allow avoidance of PNS also by software-based adaption of the pacing configuration. The Electronic Repositioning With Acuity and Easytrak Leads study evaluated the incidence of PNS in a CRT population and examined how often LV lead relocation can be avoided by “electronic repositioning” (ER).

Methods

Patients who had an indication for implantation of a first CRT defibrillator with the option of ER were enrolled. Primary endpoint was the efficiency of ER determined by the frequency of PNS with the standard pacing configuration (LV tip to RV coil) avoidable by ER. PNS and pacing parameters were evaluated during implant, predischarge, and first routine follow-up (FU) using four different pacing configurations available by ER.

Results

In total, 292 patients were enrolled and provided with a transvenous LV lead (82.2 % male, 65.5 ± 9.2 years old). The majority of the population was in NYHA III (84.2 %) with a LV ejection fraction of 25.3 ± 6.8 % and mean QRS width of 155 ± 27 ms, ischemic cardiomyopathy was present in 43.6 %. Median FU was 116 days. In the standard pacing configuration, PNS was inducible in 19.0/25.6/24.6 % at implant/predischarge/FU, respectively, resulting in 32.2 % of the patients presenting at least once with PNS. The safety margin for the standard pacing configuration between LV and PNS threshold was <1.0 V at 0.5 ms in 5.6/7.0/5.0 % of the patients, corresponding with a total rate of 11.6 % during the FU. In the finally chosen configuration, clinically relevant PNS occurred in 1.0/2.2/1.3 %. The four vector configurations allowed all but 6 of 292 (2 %) patients to be reprogrammed using ER without reoperation.

Conclusions

The incidence of inducible PNS in CRT patients is considerable. In this study, PNS could be avoided in the majority of the patients by means of electronic repositioning. Thus, the use of ER should be considered for CRT patients.

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Acknowledgments

We wish to thank the centers for their participation in the ERACE study (enrolled number of patients in brackets). The logistic support for the centers by the responsible study coordinator Mrs. Andrea Ungefehr as well as the data management by Dr. Carsten Morkel (both employees of Boston Scientific) were highly appreciated.

Participating centers: Berlin, Charité—Universitaetsmedizin Berlin, Campus Benjamin Franklin (4), Berlin, Deutsches Herzzentrum Berlin (35), Coburg, Klinikum Coburg gGmbH (7), Dachau, Amper Kliniken AG (2), Duesseldorf, Universitaetsklinikum Duesseldorf (6), Erfurt, Kardiologie am Fischmarkt (3), Erfurt, Kardiologische Gemeinschaftspraxis Dr. Bischoff und Dr. Lang (4), Frankfurt am Main, CCB Cardioangiologisches Centrum Bethanien (8), Hamburg, Asklepios Kliniken Hamburg (5), Hannover, Medizinische Hochschule Hannover (2), Heidelberg, Universitaetsklinikum Heidelberg (24), Karlsruhe, Staedt. Klinikum Karlsruhe gGmbH (16), Landshut, Krankenhaus Landshut-Achdorf (8), Mainz, Johannes-Gutenberg-Universitaet Mainz (4), Muenchen, KGP Dr. Boedigheimer, Dr. Muehling, Prof. Silber (4), Muenchen, Klinik Augustinum Muenchen (1), Muenster, Westf. Wilhelms-Universitaet Muenster Med. Klinik u. Poliklinik C (9), Oldenburg, Klinikum Oldenburg gGmbH (9), Stuttgart, Klinikum Stuttgart Katharinenhospital (8), all Germany

Amiens, CHRU Amiens—Hôpital Sud (4), Angers, CHU (11), Avignon, CH Henri Duffaut (3), Caen, CHU Caen (2), Clamart, Hopital A Béclère (4), Clermont Ferrand, Cl des Dômes (1), Dijon, Hopital du Bocage (4), Fort de France, CHU (2), Grenoble, CHU Albert Michallon (29), La Roche sur Yon, CHD La Roche Yon (6), Lyon, Hopital de la Croix Rousse (1), Marseille, CHP Clairval (2), Marseille, La Timone (1), Nantes, Nouvelles cliniques Nantaises (9), Orleans, CHR Orleans, Hopital La Source (13), Paris, Clinique Bizet (7), Paris, Pitie Salpetrière (4), Pau, Sise au Centre Hospitalier de Pau ( 18), Rennes, Hôpital Pontchaillou (1), Rouen, CHU de Rouen (1), Toulouse, Clinique Pasteur (9), Toulouse, Hopital Rangueil (4), Tours, CHU—Hôpital Trousseau (10), all France.

Conflict of interest

Sven Treusch, MD, and Klaus Contzen, PhD are employees of Boston Scientific Corporation.

Funding

This study was sponsored by Guidant/Boston Scientific Int. Inc.

Author information

Authors and Affiliations

  1. German Heart Institute, Berlin, Germany

    Stephan Goetze

  2. University of Grenoble, Grenoble, France

    Pascal Defaye

  3. University of Heidelberg, Heidelberg, Germany

    Alexander Bauer

  4. Municipal Hospital, Karlsruhe, Germany

    Matthias Merkel

  5. CHR Orleans, Orleans, France

    Olivier Bizeau

  6. Boston Scientific, Diegem, Belgium

    Sven Treusch & Klaus Contzen

  7. Institute for Research on Myocardial Infarction, Ludwigshafen, Germany

    Claus Juenger

  8. University of Duesseldorf, Duesseldorf, Germany

    Joachim Winter

  9. Deutsches Herzzentrum Berlin, Augustenburger Platz 1, 13353, Berlin, Germany

    Stephan Goetze

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  1. Stephan Goetze
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on behalf of the ERACE study investigators

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Correspondence to Stephan Goetze.

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Goetze, S., Defaye, P., Bauer, A. et al. Phrenic nerve stimulation in CRT patients and benefits of electronic lead repositioning: the ERACE trial. J Interv Card Electrophysiol 38, 1–9 (2013). https://doi.org/10.1007/s10840-013-9811-9

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  • DOI: https://doi.org/10.1007/s10840-013-9811-9

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