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CRT-D replacement strategy: results of the BioCONTINUE study
Daniel Gras1, Nicolas Clémenty2, Sylvain Ploux3
1Hôpital Privé du Confluent, 2-4 Rue Eric Tabarly, 44200, Nantes, France. dangras@aol.com.
Insights
The BioCONTINUE study found that sustained ventricular arrhythmic events (sVAE) occur even after cardiac resynchronization therapy defibrillator (CRT-D) replacement, highlighting the continued need for implantable cardioverter-defibrillator (ICD) backup in certain patients.
Area of Science:
- Cardiology
- Electrophysiology
- Medical Devices
Background:
- Cardiac resynchronization therapy defibrillators (CRT-Ds) are used in heart failure patients.
- The necessity of implantable cardioverter-defibrillator (ICD) backup during CRT-D replacement is questioned if initial implant criteria are no longer met.
- Improved left ventricular ejection fraction (LVEF) and absence of ventricular arrhythmic events (VAE) may reduce the need for continued ICD therapy.
Purpose of the Study:
- To evaluate the relevance of ICD backup in primary prevention CRT-D patients undergoing replacement.
- To identify predictors of VAE after CRT-D replacement.
Main Methods:
- Prospective, observational, international BioCONTINUE study.
- Followed 276 patients for a mean of 28.4 months post-CRT-D replacement (REP).
- Assessed the rate of sustained VAE (sVAE) and analyzed predictive factors.
Main Results:
- The cumulative incidence of sVAE was 8.3% at 1 year, 10.3% at 2 years, and 21.2% at 4 years post-REP.
- Even patients without a persistent ICD indication at REP had a 2-year sVAE rate of 5.7%.
- Predictors of subsequent sVAE included persistent ICD indication (HR 3.6), age 64-72 years (HR 3.7), and ischemic heart disease (HR 4.4).
Conclusions:
- The risk of sVAE after CRT-D replacement is significant, reaching 21.2% at 4 years.
- Age, ischemic heart disease, and persistent ICD indication at replacement are key predictors of sVAE.
- A non-trivial risk of sVAE persists even in patients without a continued ICD indication, underscoring the importance of careful risk assessment.
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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