LAUSR

BACKGROUND Current methods to identify cardiac implantable electronic devices (CIED) lead failure include post-approval 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. OBJECTIVE To determine whether adjudicated remote monitoring (RM) data can address these limitations and augment lead safety evaluation. METHODS Among 48,191 actively monitored patients with CIEDs, we identified RM transmissions signifying incident lead abnormalities and, separately, identified all leads abandoned or extracted between 4/1/19-4/1/21. We queried electronic health record (EHR) and Medicare fee-for-service claims data to determine if patients had administrative codes for lead failure. We verified lead failure through manual EHR review. RESULTS Of 48,191 patients, 1170 (2.4%) had incident lead abnormalities detected on RM. Of these, 409 patients had administrative codes for lead failure, and 233 (57.0%) of these patients had structural lead failure verified through chart review. Among the 761 patients without administrative codes, 167 (21.9%) had structural lead failure verified through chart review. Thus, 400 (66.7%) total patients with RM transmissions suggestive of lead abnormalities had structural lead failure. In addition, 200 patients without preceding abnormal remote transmissions had leads abandoned or extracted for structural failure. Patients with isolated right atrial or left ventricular lead failure were less likely to have lead replacement and administrative codes reflective of lead failure. CONCLUSION Remote monitoring may strengthen real-world assessment of lead failure, particularly for leads where patients do not undergo replacement.