Pacing and clinical electrophysiology : PACE · 2026
Safety and Performance of INVICTA DF4 Ventricular Defibrillation Lead: Results From APOLLO Prospective Multicenter Study.
СтатьяМногоцентровое исследованиеНаблюдательное исследованиеНазвание и аннотация: Перевод пока не подготовлен
Обработка статьи · этапы, ошибки и управление
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Witte Klaus K, Martínez Juan Gabriel, Oliveira Mário M, Barrera Alberto, Izquierdo Maite, Mandurino Cosimo, Trucco Maria Emilce, García Salvador José Juan, Dompnier Antoine, Jean Frédéric, Millán Pablo J Sánchez, Israel Carsten, Martino Maria, Marques Pedro
Аннотация
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.
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.