Abstract 78: Cardiovascular Implantable Electronic Device Lead Safety: Harnessing Real-world Remote Monitoring Data For Medical Device Evaluation

Background: Current important regulatory resources and methods to identify cardiac implantable electronic devices (CIED) lead failure include post-approval studies, which may be limited in scope, participant numbers, and by attrition; studies relying on administrative codes, which lack specificity in multi-chamber systems; and voluntary adverse event reporting, which cannot determine incidence or attribution to the lead. We determined whether adjudicated remote monitoring (RM) data can help to address these limitations and augment lead safety evaluation. Methods: We evaluated 48,148 patients from the Veterans Affairs National Cardiac Device Surveillance Program (VANCDSP), 4/1/19-4/1/21. We identified RM transmissions signifying incident lead abnormalities (possible lead failure, failure to capture, impedance out of range). We queried VA electronic health record (EHR) and Medicare fee-for-service claims data to determine if patients had administrative codes for lead failure. We verified structural lead failure through manual EHR review. Among patients with EHR-confirmed lead failure, we categorized subsequent clinical actions by cardiac chamber. Results: Of 48,148 actively monitored patients with CIEDs, 1174 (2.4%) had incident lead abnormalities detected on RM; 356 (30.3%) with administrative codes for lead failure and 818 (69.7%) without. Of the 356 patients, 220 (62%) had lead failure verified through chart review (positive predictive value [PPV], 62%). Among 276 patients randomly selected from 818 without administrative codes, 58 (26%) had EHR-confirmed lead failure (PPV, 21%). Patients with isolated right atrial or left ventricular lead failure were less likely to have claims and lead replacement procedures than those with right ventricular high-energy lead failure (Table). Conclusion: Remote monitoring may strengthen accurate real-world assessment of lead failure, particularly for leads where patients do not undergo replacement.