Performance of the Lumenless 4.1‐Fr Diameter Pacing Lead Implanted at Alternative Pacing Sites in Congenital Heart: A Chronic 5‐Year Comparison

Purpose: United States approval of the Model 3830, 4.1‐French (Fr) diameter, lumenless, pacing lead (Medtronic Inc., Minneapolis, MN, USA) in patients under 17 years of age, and those with congenital heart disease (CHD), was in 2005. To date, long‐term performance at alternative pacing sites (APS) is limited and chronic efficacy comparisons with more established leads is lacking. The purpose of this study was to evaluate these factors. Methods: Implant and follow‐up data on leads were compared: group 1 (non‐3830 leads) and group 2 (Model 3830 leads). These included acute and chronic sensing and pacing, impedances, implant sites, and complications. Groups were compared using Fischer's exact test, paired, and nonpaired t‐tests, with significance defined at P < 0.05. Results: A total of 119 patients (ages 5–48 years) received 171 leads: group 1 (n = 80) and group 2 (n = 91). At implant, there were no differences in patient age, CHD, sensing, or pacing thresholds between groups. Implant lead impedances differed between groups but all were within normal values for each lead design. Chronic data showed no difference in sensing, pacing thresholds, or impedances. There were five (6%) early lead dislodgements in group 1 and one (1%) in group 2. APS were achieved in group 2 with mean 1.6 ± 1.3 minutes fluoroscopy time. Conclusion: The new 4.1‐Fr lumenless lead shows similar performance indices to established leads even at APS, yet is thinner and achieves APS with technical ease, permitting more efficient chronic pacing in children and all patients with CHD. (PACE 2010; 33:1467–1474)