Key result
Domestic active-fixation pacing leads show acceptable safety with a reoperation rate under ~5%.
Why the study?
The study was conducted to evaluate the long-term results of implanting domestic active-fixation endocardial leads (ELBI 233C-53 in the atrial position and ELBI 233C-58 in the ventricular position).
Do domestic active-fixation endocardial leads (ELBI 233C-53 and ELBI 233C-58) provide acceptable long-term pacing parameters and safety in patients requiring pacing?
Observational (n=165)
No
Do domestic active-fixation endocardial leads (ELBI 233C-53 and ELBI 233C-58) provide acceptable long-term pacing parameters and safety in patients requiring pacing?
These domestic leads may be considered where cost constrains options; leaves open need for randomized comparisons to established devices.
Aim. The aim of the study was to evaluate the long-term results of implantation of domestic endocardial leads (EL) with active fixation ELBI 233C-53 and ELBI 233C-58, implanted in the atrial and ventricular positions, respectively. Methods. A total of 165 patients were included in the retrospective, single-center study. 239 EL were implanted from 2016 to 2018 (55 ELBI 233C-53 and 184 ELBI 233C-58). The median age was 78 years (43 to 92 years). 846 programming protocols were analyzed, which were carried out on the 1st day after implantation, and then every 6 months. Complications are divided into early (1-7 days) and late (8 days or more). Results. In the EL ELBI 233C-53 group, there were no statistically significant changes in the pacing parameters during the observation period. There were 6 complications (10.9%): exit block (n=1, 1.8%), dislocation of the EL (n=3, 5.4%), damage to the EL structure (n=2, 3.7%). The number of reoperations was 3 (5.4%). In the ELBI 233C-58 group, a statistically significant increase in the pacing threshold was found (p=0.026). 13 (7.0%) complications were registered, including an increase in the pacing threshold (n=11.6%), exit block (n=1, 0.5%), damage to the EL structure (n=1, 0.5%). The number of reoperations in this group was 2 (1%). Conclusion. EL ELBI 233C-53 and ELBI 233C-58 demonstrated acceptable pacing parameters and safety during observation. Complications occurred mainly in the first year after implantation. The number of repeated operations was low. There were no deaths caused by complications after lead implantation.
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Repnikov et al. (2023) conducted an observational in Bradyarrhythmia / Cardiac pacing indication (n=165). ELBI 233C-53 and ELBI 233C-58 active-fixation endocardial pacing leads was evaluated on Lead replacement, lead removal, or patient death. Implantation of domestic active-fixation endocardial pacing leads ELBI 233C-53 and ELBI 233C-58 demonstrated acceptable safety and pacing parameters, with low reoperation rates of 5.4% and 1.0%, respectively.
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