Key result
INVICTA DF4 lead demonstrates high implant success and a ~96% complication-free rate over two years.
Why the study?
ICD therapy depends on reliable right ventricular leads, and the active-fixation quadripolar INVICTA DF4 lead was designed to optimize implant workflow, long-term safety, and performance.
Does the INVICTA DF4 lead provide safe and reliable performance in adults requiring de novo ICD or CRT-D implantation?
Observational (n=446)
Yes
Does the INVICTA DF4 lead provide safe and reliable performance in adults requiring de novo ICD or CRT-D implantation?
The INVICTA DF4 ventricular lead demonstrated high implant success, durable electrical performance, and low complication rates over 24 months in a real-world European cohort.
Supports INVICTA lead implantation in unselected patients; extends observational evidence but leaves randomized comparisons open.
Background Implantable cardioverter‐defibrillator (ICD) therapy relies on reliable right ventricular leads for pacing, sensing, and defibrillation. The INVICTA DF4 lead is an active‐fixation, quadripolar design intended to optimize implant workflow and long‐term safety and performance. Methods APOLLO was a prospective, multicenter, single‐arm, observational study enrolling adults across Europe with guideline‐based indications for de novo ICD or Cardiac Resynchronization Therapy Defibrillator (CRT‐D) implantation who received an INVICTA DF4 lead (single‐ or dual‐coil; 58 or 68 cm). The co‐primary endpoints focused on safety and performance at 3 months, while secondary endpoints included long‐term electrical variables, arrhythmia termination, and lead‐related complications through 24 months. Results Between June 4, 2021, and October 19, 2022, 446 patients were implanted across 45 sites in 8 European countries. The INVICTA lead was successfully implanted in 100% of the 446 enrolled patients. Leads were positioned either in the apex in 57.2% or right ventricle (RV) septum in 42.8%. Electrical variables stabilized after discharge and remained stable up to 24 months (M24 mean pacing threshold 0.85 ± 0.33 V at 0.5 ms; sensing 13.39 ± 3.17 mV; pacing impedance 525.5 ± 94.2 Ohms; right ventricular (RV) coil continuity 427.8 ± 82.7 Ohms). Of 86 arrhythmic episodes requiring defibrillation, 97.7% were successfully terminated. Lead‐related complication free rate was 97.5% at 30 days, 98.9% at 31–730 days, and 96.4% overall. Mortality was 8.5% (38/446) at two years, of which 63% was due to cardiovascular causes. Conclusions In a large, contemporary European cohort, the INVICTA DF4 ventricular lead demonstrated high implant success, durable electrical performance, effective arrhythmia termination, and low complication rates through 24 months. A trend toward less complication in septal positioning was observed compared to apical placement, with comparable electrical performance.
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Witte et al. (2026) conducted an observational in Guideline-based indications for de novo ICD or CRT-D implantation (n=446). INVICTA DF4 ventricular defibrillation lead was evaluated on Safety and performance at 3 months. The INVICTA DF4 ventricular lead demonstrated 100% implant success, 97.7% successful arrhythmia termination, and a 96.4% overall lead-related complication-free rate through 24 months.
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