Abstract
The incidence and clinical burden of lead-related venous obstruction (LRVO) remains poorly understood despite rising implant rates for cardiovascular implantable electronic devices (CIEDs). Determine the incidence and predictors of symptomatic LRVO after CIED implant in the US; describe contemporary practice patterns in CIED extraction and revascularization; quantify the burden of LRVO-related healthcare utilization, based on each type of intervention. LRVO status, comorbidities, and healthcare visits were defined in Medicare beneficiaries who received a CIED from October 1, 2015 to December 31, 2020. Cumulative incidence functions of LRVO development were estimated by Fine-Gray methods. Independent associations between patient factors and LRVO were identified using multivariable logistic regression. Incidence rates for LRVO-related healthcare utilization (i.e. hospitalizations, emergency department and clinic visits) were calculated with Poisson models. Among 649,524 Medicare beneficiaries who received their first transvenous CIED, 28,214 developed LRVO – generating a cumulative incidence of 5.0% (95% confidence interval [CI] 4.9%-5.1%) at a maximum follow-up time of 5.2 years after CIED implant. Patients with LRVO had a mean age of 77.6 years, with 41.5% females. Cardiovascular comorbidities were common and similarly distributed among patients with and without LRVO. Independent predictors of LRVO included having a CIEDs with >1 lead (adjusted odds ratio [AOR] 1.07, 95% CI 1.02-1.11), chronic kidney disease (AOR 1.13, 95% CI 1.10-1.16) and malignancies (AOR 1.24, 95% CI 1.20, 1.27). Among 28,214 patients with LRVO, most were managed conservatively (85.2%). Of the 14.8% (N=4,186) who received an invasive intervention, the majority consisted of CIED extraction (74%) followed by percutaneous revascularization (26%). Of the 3,111 patients who underwent extraction, 90% did not receive a second CIED, with low use (2.2%) of leadless pacemakers. In adjusted models, extraction was associated with a significant reduction in LRVO-related healthcare utilization compared to conservative management (adjusted rate ratio 0.58, 95% CI 0.52, 0.66). In a large nationwide sample, the incidence of LRVO was substantial, affecting 1 of every 20 patients with CIEDs. Most events occurred within 2 years of device placement. Among patients treated for LRVO, device extraction was most commonly used and allowed for the greatest long-term reduction in recurrent healthcare utilization.
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