Key result
The Model 3830 4.1-Fr lumenless pacing lead demonstrated similar chronic performance to established leads, with early lead dislodgements occurring in 1% versus 6% of leads, respectively.
Why the study?
Does the Model 3830 4.1-Fr lumenless pacing lead maintain chronic electrical performance and safety compared to established leads in patients with congenital heart disease?
Cohort (n=119)
Does the Model 3830 4.1-Fr lumenless pacing lead maintain chronic electrical performance and safety compared to established leads in patients with congenital heart disease?
Absolute Event Rate: 1% vs 6%
The 4.1-Fr lumenless pacing lead demonstrates similar chronic electrical performance to established leads with potentially fewer dislodgements, facilitating alternative pacing site implantation in congenital heart disease patients.
May support alternative-site pacing in congenital heart disease; leaves open randomized confirmation of lower dislodgement rates.
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.
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Khan et al. (2010) conducted a cohort in Congenital heart disease (n=119). Model 3830 4.1-Fr lumenless pacing lead vs. Non-3830 established pacing leads was evaluated on Early lead dislodgements. The Model 3830 4.1-Fr lumenless pacing lead demonstrated similar chronic performance to established leads, with early lead dislodgements occurring in 1% versus 6% of leads, respectively.
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