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BIO|CONTINUE

BIOtronik Study to Assess the CONTINUation of Existing Risk of Ventricular Arrhythmias After CRT-D Replacement for Patients With Primary Prevention Indication

Study Design

  • Prospective, observational, international, multicenter study
  • Assess the relevance of a defibrillator back-up in CRT-D patients with an ICD indication for primary prevention after the replacement of the first CRT-D
  • 276 patients
  • ≥ 24 months follow-up after device replacement

Key Result 1

The rate of patients with sustained ventricular arrhythmia events (sVAE) was 8.3%, 10.3%, and 21.2% at 1, 2, and 4 years post replacement.

Key Result 2

Patients without persistent ICD indication at replacement still had a sVAE rate of 5.7% (95% CI 2.3–11.5%) at 2 years.

Key Result 2

In multivariate analysis, predictive factors of subsequent sVAE were: 

  • persistent ICD indication (hazard ratio (HR) 3.6; 95% CI 1.6–8.3; p = 0.003) 
  • 64–72 years of age as compared to ≥ 79 years (HR 3.7; 95% CI 1.4–9.7; p = 0.008)
  • ischemic heart disease (HR 4.4; 95% CI 2.1–9.3; p < 0.0001)

Clinical Relevance

  • BioCONTINUE shows a persistent risk of sVAE after in patients with and also without persistent ICD indication at the time of device replacement
  • The risk of sVAE depends on age, a persistent ICD indication at the time of dervice replacement, and on the presence of an ischemic heart disease

Study Objective
  • BIO|CONTINUE is a study designed to assess the incidence and predictors of sustained ventricular arrhythmia (sVAE) following a replacement in primary prevention CRT-D patients.
Primary endpoint
  • Rate of patients with at least one sustained ventricular arrhythmic event (sVAE) defined as a VT > 30 s and/or a ventricular arrhythmic event treated either by antitachycardia pacing (ATP) or ICD shock.
Secondary endpoints

Rate of patients with at least one sustained ventricular arrhythmic event (sVAE) in patients with a

  • history of sVAE during the lifetime of the first CRT-D or
  • a LVEF ≥ 40% vs. LVEF < 40% or
  • a persistent ICD indication (LVEF < 40% and/or previous VAE) at the time of replacement
Clinical Sites
  • 37 sites in 8 countries including Belgium, France, Germany, Hungary, Israel, Italy, Portugal, and Spain.
Sample Size
  • 276 patients
Inclusion Criteria
  • Patient with primary prevention indication for defibrillation at the time of the first CRT-D implantation
  • Patient implanted as first replacement by a CRT-D device (CRT-D by CRT-D)
  • Lifetime of the previous CRT-D > 3 years
  • Patient willing and able to comply with the protocol and who has provided written informed consent
  • Patient whose medical situation is stable
Main Exclusion Criteria
  • Patient with an ICD lead under advisory (e.g. Fidelis lead)
  • Right or left ventricular leads exchange during CRT-D replacement
  • Non functional atrial or right/left ventricular leads
  • Life expectancy < 1 year
  • Age < 18 years
  • Pregnant woman or woman who plan to become pregnant during the trial
  • Participation in another interventional clinical study
Devices
  • BIOTRONIK CRT-Ds
Follow-Up
  • ≥ 24 months follow-up after device replacement
Study Duration
  • June 2015 - February 2020
Reference No.
  • NCT02323503
Principal Investigator
  • Daniel Gras; Hôpital Privé du Confluent,Nantes, France

Gras, D., Clémenty, N., Ploux, S. et al. CRT-D replacement strategy: results of the BioCONTINUE study. J Interv Card Electrophysiol (2022). https://doi.org/10.1007/s10840-022-01440-5