The lumenless 4.1-Fr pacing lead was associated with lower rates of new or worsening valve insufficiency (12% vs 27%, P<0.05) and venous narrowing (11% vs 24%, P=0.0004) than standard 5-7-Fr leads.
Cohort (n=134)
Does a lumenless 4.1-Fr pacing lead reduce atrioventricular valve insufficiency and venous narrowing compared to standard 5-7-Fr pacing leads in patients with and without congenital heart disease?
Lumenless 4.1-Fr pacing leads are associated with significantly less atrioventricular valve insufficiency and venous narrowing compared to standard 5-7-Fr leads, particularly benefiting younger patients.
Absolute Event Rate: 12% vs 27%
p-value: p=<0.05
BACKGROUND: Standard, 5-7-Fr diameter pacing leads (PLs) can adversely affect atrioventricular valve (AVV) and venous (superior vena cava SVC, innominate INN) integrities. Although chronic pacing/sensing performances have been reported on the steroid-eluting, lumenless, 4.1-Fr PL (Model 3830, Medtronic Inc., Minneapolis, MN, USA), comparative valve and venous effects are largely unknown. METHODS: Patients (n = 134) were divided into two PL groups: Group 1 (n = 65, Model 3830) and Group 2 (n = 69, various 5-7 Fr models) and followed up to 9 years postimplant. Patient demographics, clinical findings, valve function, and venous dimensions were reviewed. Statistical significance was defined as P < 0.05. RESULTS: Patient implant age (mean 16.4 years vs 17.3 years), presence of congenital heart defect (CHD), and preexisting valve issues were comparable between groups. New or worsening valve insufficiency occurred in 12% of Group 1 patients (mean follow-up 4.3 ± 2.8 years) and 27% of Group 2 patients (mean follow-up 6.2 ± 3.5 years; P < 0.05). Significant SVC or INN narrowing was found in 11 % of Group 1 and 24% of Group 2 patients (P = 0.0004). All Group 1 patients <12 years of age showed normal while 50% of those from Group 2 exhibited stunted SVC or INN growth (P < 0.05). CONCLUSION: The lumenless, 4.1-Fr diameter PL offers improved clinical benefits, better AVV integrity, and venous development compared with larger 5-7-Fr diameter PL and should be considered especially in younger patients with/without CHD.
Bharmanee et al. (Sat,) conducted a cohort in Patients requiring pacing leads with and without congenital heart defect (n=134). Lumenless, 4.1-Fr pacing lead (Model 3830) vs. Standard 5-7-Fr diameter pacing leads was evaluated on New or worsening valve insufficiency (p=<0.05). The lumenless 4.1-Fr pacing lead was associated with lower rates of new or worsening valve insufficiency (12% vs 27%, P<0.05) and venous narrowing (11% vs 24%, P=0.0004) than standard 5-7-Fr leads.