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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.To determine whether adjudicated remote monitoring (RM) data can address these limitations and augment lead safety evaluation.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.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.Remote monitoring may strengthen real-world assessment of lead failure, particularly for leads where patients do not undergo replacement.

Cardiogenic shock (CS) is a highly morbid condition with mortality remaining greater than 30% despite improved pathophysiologic understanding and access to mechanical circulatory support (MCS). In response, shock teams modeled on successful multidisciplinary care structures for other diseases are being implemented nationwide.Primary data supporting a benefit of shock team implementation on patient outcomes are relatively limited and entirely observational. Four single-center before-and-after studies and one multicenter registry study have demonstrated improved outcomes in patients with CS, potentially driven by increased pulmonary artery catheter (PAC) utilization and earlier (and more appropriate) initiation of MCS. Shock teams are also supported by a growing body of literature recognizing the independent benefit of the interventions they seek to implement, including patient phenotyping with PAC use and an algorithmic approach to CS care. Though debated, MCS is also highly likely to improve CS outcomes when applied appropriately, which further supports a multidisciplinary shock team approach to patient and device selection.Shock teams likely improve patient outcomes by facilitating early patient phenotyping and appropriate intervention. Institutions should strongly consider adopting a multidisciplinary shock team approach to CS care, though additional data supporting these interventions are needed.

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.