Cardiovascular implantable electronic device lead safety: Harnessing real-world remote monitoring data for medical device evaluation

Current methods to identify cardiovascular implantable electronic device lead failure include postapproval studies, which may be limited in scope, participant numbers, and attrition; studies relying on administrative codes, which lack specificity; and voluntary adverse event reporting, which cannot determine incidence or attribution to the lead. The purpose of this study was to determine whether adjudicated remote monitoring (RM) data can address these limitations and augment lead safety evaluation. Among 48,191 actively monitored patients with a cardiovascular implantable electronic device, we identified RM transmissions signifying incident lead abnormalities and, separately, identified all leads abandoned or extracted between April 1, 2019, and April 1, 2021. We queried electronic health record and Medicare fee-for-service claims data to determine whether patients had administrative codes for lead failure. We verified lead failure through manual electronic health record review. Of the 48,191 patients, 1170 (2.4%) had incident lead abnormalities detected by RM. Of these, 409 patients had administrative codes for lead failure, and 233 of these 409 patients (57.0%) had structural lead failure verified through chart review. Of the 761 patients without administrative codes, 167 (21.9%) had structural lead failure verified through chart review. Thus, 400 patients with RM transmissions suggestive of lead abnormalities (34.2%) had structural lead failure. In addition, 200 patients without preceding abnormal RM transmissions had leads abandoned or extracted for structural failure, making the total lead failure cohort 600 patients (66.7% with RM abnormalities, 33.3% without). Patients with isolated right atrial or left ventricular lead failure were less likely to have lead replacement and administrative codes reflective of lead failure. RM may strengthen real-world assessment of lead failure, particularly for leads where patients do not undergo replacement. [Display omitted]