Drug-coated balloon venoplasty for symptomatic lead-related venous stenosis

Lead-related venous stenosis (LRVS) affects up to 35% of patients with cardiac implantable electronic devices, although most remain asymptomatic. Progressive stenosis in some patients leads to symptomatic venous obstruction and edema, often refractory to anticoagulation. Percutaneous balloon venoplasty with traditional balloons offers transient relief but is limited by symptom recurrence when transvenous leads remain in place. Drug-coated balloons (DCBs) may improve outcomes by inhibiting endothelial proliferation.

This study aimed to evaluate the safety and efficacy of DCB venoplasty in patients with symptomatic LRVS.

This retrospective study included 15 patients with symptomatic LRVS treated with DCB venoplasty at a single tertiary center from 2022 to 2025. Clinical presentation, procedural details, and follow-up outcomes were compared with a historical traditional percutaneous balloon venoplasty cohort.

15 patients underwent 18 DCB venoplasty procedures. Lead extraction was rarely required (11%), and 93% retained leads across the treated segment. Complete symptom resolution occurred in 87% of cases despite a significantly higher proportion of patients in the DCB group having leads remaining across the stenosis (92% vs 15%, P ≤ .01). The remainder experienced persistent symptoms attributed to secondary lymphedema. The long-term success rate of a single procedure with leads remaining was 71% compared with 33% in a historical cohort treated with traditional balloons.

DCB venoplasty is a safe, effective treatment for symptomatic LRVS, providing durable symptom relief even in the presence of retained transvenous leads. Compared with traditional balloon venoplasty, DCB use was associated with improved long-term outcomes, including higher success rates after a single procedure.