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CRT-D replacement strategy: results of the BioCONTINUE study

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Journal of Interventional Cardiac Electrophysiology Aims and scope Submit manuscript

Abstract

Background

In patients with cardiac resynchronization therapy defibrillators (CRT-Ds), the need for implantable cardioverter-defibrillator (ICD) back-up may be questionable at time of CRT-D replacement (REP) if ICD implant criteria are no longer met due to an improved left ventricular ejection fraction (LVEF) and if no major ventricular arrhythmic event (VAE) occurred during the CRT-D lifetime. The aim of our study was to assess the relevance of ICD back-up and predictors of VAE after REP in primary prevention CRT-D patients.

Methods

The prospective, observational, international BioCONTINUE study investigated the rate of patients with at least 1 sustained VAE (sVAE) post-REP and searched for predictive factors of sVAE.

Results

Two hundred seventy-six patients (70 ± 10 years, 77% men, mean LVEF 40.6 ± 12.6%) were followed for 28.4 ± 10.2 months. The rate of patients with sVAE was 8.3%, 10.3%, and 21.2% at 1, 2, and 4 years post-REP. Patients without persistent ICD indication at REP still had a sVAE rate of 5.7% (95% CI 2.3–11.5%) at 2 years. In multivariate analysis, predictive factors of subsequent sVAE were (i) persistent ICD indication (hazard ratio (HR) 3.6; 95% CI 1.6–8.3; p = 0.003); (ii) 64–72 years of age as compared to ≥ 79 years (HR 3.7; 95% CI 1.4–9.7; p = 0.008); and (iii) ischemic heart disease (HR 4.4; 95% CI 2.1–9.3; p < 0.0001).

Conclusions

The risk of sVAE (21.2% at 4 years post-REP) depends on age, ischemic heart disease, and ICD indication at the time of REP. A non-trivial risk of sVAE remains in patients without persistent ICD indication.

Clinical trial registration

NCT02323503.

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Data availability

The data underlying this article will be shared on reasonable request to the corresponding author.

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Acknowledgements

The authors thank Mr. Nicolas Canot, Clinical Study Manager; Ms. Sophie Fauquembergue, Clinical Study Team Leader and project manager; and Ms. Tatiana Bayan, Biostatistician, Biotronik France SAS, for their assistance in the conduct of the BioCONTINUE study.

Funding

This work was supported by an unrestricted grant from Biotronik SE & Co. KG.

Author information

Authors and Affiliations

  1. Hôpital Privé du Confluent, 2-4 Rue Eric Tabarly, 44200, Nantes, France

    Daniel Gras

  2. Centre Hospitalier Universitaire Tours, Tours, France

    Nicolas Clémenty

  3. IHU Liryc, Electrophysiology and Heart Modeling Institute, Fondation Bordeaux Université, Bordeaux University Hospital (CHU), Cardio-Thoracic Unit, 33600, Pessac, France

    Sylvain Ploux

  4. Centre Hospitalier Saint Philibert, Lomme, France

    Yves Guyomar

  5. Centre Hospitalier Universitaire Caen, Caen, France

    Damien Legallois

  6. Hospital Santa Chiara, Cisanello, Italy

    Luca Segreti

  7. Hôpital Brabois, Nancy, France

    Hugues Blangy

  8. Centre Hospitalier Universitaire du Bocage, Dijon, France

    Gabriel Laurent

  9. Centre Hospitalier Régional Orléans La Source, Orléans, France

    Olivier Bizeau

  10. BIOTRONIK France SAS, Rungis, France

    Sophie Fauquembergue

  11. Clinique Ambroise Paré, Neuilly Sur Seine, France

    Arnaud Lazarus

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  1. Daniel Gras
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Consortia

for the BioCONTINUE study Investigators

Contributions

Daniel Gras, Arnaud Lazarus, and Sophie Fauquembergue contributed to the study conception, design, and supervision. Investigation and data collection were performed in part by Daniel Gras, Nicolas Clémenty, Sylvain Ploux, Yves Guyomar, Damien Legallois, Luca Segreti, and Hugues Blangy. The endpoint adjudication was performed by Arnaud Lazarus, Gabriel Laurent, and Olivier Bizeau. The first draft of the manuscript was written by Arnaud Lazarus, Sophie Fauquembergue, and Daniel Gras, and all authors commented on previous versions of the manuscript. All authors read and approved the final manuscript.

Corresponding author

Correspondence to Daniel Gras.

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Conflict of interest

DG received consulting fees from Abbott (St Jude Medical), Boston Scientific, Biotronik, and Zoll; NC received consulting fees from Biotronik; HB received consulting fees from Abbott (St Jude Medical), Boston Scientific, Biotronik, Medtronic, and Microport. GL received consulting fees from Abbott (St Jude Medical), Boston Scientific, Biotronik, Microport, and Medtronic; OB received consulting fees from Biotronik and Boston Scientific. SF is an employee of Biotronik France. AL is minor part-time employee of Biotronik France. SP, YG, DL, and LS have no conflict of interests.

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Gras, D., Clémenty, N., Ploux, S. et al. CRT-D replacement strategy: results of the BioCONTINUE study. J Interv Card Electrophysiol 66, 1201–1209 (2023). https://doi.org/10.1007/s10840-022-01440-5

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  • DOI: https://doi.org/10.1007/s10840-022-01440-5

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