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Comparison of mid-term clinical experience with steroid-eluting active and passive fixation ventricular electrodes in
N Ceviz1, A Celiker, O Küçükosmanoğlu
1Department of Pediatric Cardiology, Hacettepe University Medical School, Ankara, Turkey.
Insights
Active fixation ventricular leads, like Accufix II DEC, show easier implantation and lower stimulation thresholds compared to passive fixation leads in children. This makes them a superior choice for single-chamber ventricular pacemakers in pediatric patients.
Area of Science:
- Pediatric Cardiology
- Biomedical Engineering
- Implantable Medical Devices
Background:
- Active fixation ventricular leads are often considered advantageous over passive fixation leads.
- Limited comparative follow-up data exists for these lead types specifically in pediatric populations.
- Steroid-eluting leads aim to reduce inflammation and improve chronic lead performance.
Purpose of the Study:
- To compare the implantation and follow-up outcomes of active fixation versus passive fixation ventricular leads in children.
- To evaluate lead performance metrics including pacing thresholds, R wave amplitude, and impedance.
- To assess lead stability and complication rates in a pediatric cohort.
Main Methods:
- Retrospective evaluation of 41 pediatric patients implanted with either active fixation (Accufix II DEC) or passive fixation (Membrane E) steroid-eluting ventricular leads.
- Data collected included implantation parameters and follow-up assessments up to 12 months.
- Key metrics analyzed: pacing thresholds, R wave amplitude, lead impedance, and lead-related complications.
Main Results:
- At implantation, no significant differences were observed in pacing threshold, R wave amplitude, or impedance between the groups, except for higher impedance in the passive group.
- After the first week, active fixation leads demonstrated significantly lower acute and chronic stimulation thresholds compared to passive fixation leads.
- The active fixation lead group experienced fewer lead dislodgements and easier removal in case of infection, with no helix deformation.
Conclusions:
- The steroid-eluting active fixation lead (Accufix II DEC) offers advantages in easier implantation and superior acute and chronic stimulation thresholds over the passive fixation lead (Membrane E) in children.
- Accufix II DEC is recommended as a preferred choice for single-chamber ventricular pacemaker implantation in pediatric patients.
- Active fixation leads provide improved reliability and potentially better long-term pacing outcomes in the pediatric population.
Abstract:
Although active fixation ventricular leads seem to have advantages over passive fixation leads, this study compares the follow-up results of active and passive fixation leads in children. We evaluated the implantation and follow-up data of 41 children with active (Accufix II DEC, group 1) (n = 20) or passive (Membrane E, group 2) (n = 21) fixation, steroid-eluting ventricular leads. All but one of the patients in group 1 completed the 12-month follow-up. The mean follow-up period in group 2 was 10.4 +/- 2.9 months (range 3-12 months, median 12 months). In both groups the mean pacing threshold was measured as 0.51 +/- 0.09 V versus 0.48 +/- 0.15 V (P > 0.05) at 0.5-ms pulse width, mean R wave amplitude as 9.9 +/- 2.5 mV versus 9.4 +/- 3.2 mV (P > 0.05), and mean impedance as 557 +/- 92 omega versus 664 +/- 160 omega (P < 0.05), respectively, at implantation. After the first week of pacing, mean threshold values in group 1 were significantly lower than those of group 2 (P < 0.01 and P < 0.05, respectively). During the follow-up period, lead impedance measurements did not show a significant difference between the two groups. In one patient from group 1, the lead (by unscrewing) was removed easily because of pacemaker pocket infection. No lead dislodgement or helix deformation occurred in group 1. Nevertheless, in one patient from group 2, the lead was extracted at 4-month postimplantation because of lead displacement. We conclude that the steroid-eluting active fixation lead (Accufix II DEC) have advantages of easier implantation and lower acute and chronic stimulation thresholds compared to the passive fixation lead (Membrane E). Therefore, Accufix II DEC is superior to Membrane E, and it is a better first choice in children with an implanted single chamber ventricular pacemaker.