Key Results
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.
BIO|CONTINUE Clinical Trial
BIOtronik Study to Assess the CONTINUation of Existing Risk of Ventricular Arrhythmias After CRT-D Replacement for Patients With Primary Prevention Indication
Gras, D., Clémenty, N., Ploux, S. et al. CRT-D replacement strategy: results of the BioCONTINUE study. J Interv Card Electrophysiol (2022)
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 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 3
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 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 Details
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
Main 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 plans 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 Investigators
- Daniel Gras; Hôpital Privé du Confluent,Nantes, France