Abstract 119: Using the VA National Cardiac Device Surveillance Program to Monitor the Safety of Cardiovascular Implantable Electronic Devices

Abstract

Background: Hundreds of thousands of cardiovascular implantable electronic devices (CIEDs: pacemakers and implantable-cardioverter-defibrillators [ICDs]) have been the subject of Class 1 FDA recalls, which indicate “a reasonable chance that a product will cause serious health problems or death.” Unfortunately, these recalls occurred only after many patients had experienced adverse events. The Department of Veterans Affairs (VA) has established the VA National Cardiac Device Surveillance Program (VANCDSP), a prospective registry that provides remote monitoring surveillance of enrolled veterans with CIEDs. Objective: To describe the characteristics of veterans enrolled in the VANCDSP between 2002 - 2018 and the prevalence of CIED recalls among currently monitored patients. Methods: We queried the VANCDSP and used descriptive statistics to summarize the characteristics of patients, use of remote monitoring, and prevalence of recalls or alerts for CIED generators and leads. Patient and device characteristics are entered by local VAs when they request remote monitoring. Follow-up data were obtained from scheduled and patient- or alert-initiated remote monitoring transmissions, which are adjudicated and continuously uploaded. Results: VANCDSP has enrolled 197,642 veterans with CIEDs. Of all veterans, 72,571 have had ICDs and 128,808 pacemakers, while 3737 have had both (almost always upgrades from pacemakers to ICDs); 15.2% were implanted outside of VA. A total 351,836 leads and 260,636 generators have been monitored. On average, 1.32 generators and 1.78 leads have been implanted per patient. Of the 72,571 patients implanted with ICDs, 52,549 (72.4%) have available remote monitoring data, with a total of 833,345 transmissions (mean 15.9 [SD 16.2] per patient). Of 128,808 patients implanted with pacemakers, 33,510 (26.0%) have available remote monitoring data, with a total of 356,528 transmissions (mean 10.6 [SD 12.1] per patient), along with 1.3 million trans-telephonic monitoring transmissions. Among the 197,642 enrolled veterans, 51,713 (26%) are currently monitored (nearly all others have died). The mean age of these patients is 72 years and 98.3% are male. The median duration of follow-up from initial implant to most recent RM transmission is 3.44 years. A total of 158 FDA recalls or alerts for lead or generator safety concerns currently affect 13,835 devices implanted in 11,359 (22%) currently monitored patients. This database can also be linked to the VA electronic health record for longitudinal outcome ascertainment. Conclusion: The VANCDSP contains data since 2002 on 197,642 veterans implanted with CIEDs, including 51,713 currently monitored patients. Safety recalls or alerts affect 22% of currently monitored patients. VANCDSP could serve as an early warning system for lead or generator failures and outcomes assessment of alerted or recalled leads or generators.