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2019 HSR&D/QUERI National Conference Abstract

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4146 — Using the VA National Cardiac Device Surveillance Program to Monitor and Improve Safety of Cardiovascular Implantable Electronic Devices in Veterans

Lead/Presenter: Sanket Dhruva
All Authors: Dhruva SS (San Francisco VA Health Care System; UCSF School of Medicine), Whooley, MA (San Francisco VA Health Care System; UCSF School of Medicine), Turakhia MP (Palo Alto VA Health Care System; Stanford University School of Medicine) Raitt MH (Portland VA Health Care System; Oregon Health Sciences University) Tarasovsky G (San Francisco VA Health Care System) Rosman L (Connecticut VA Health Care System; Yale University School of Medicine) Matheny ME (Tennessee Valley VA Health Care System; Vanderbilt University School of Medicine)

Objectives:
To characterize the proportion of veterans enrolled in the VA National Cardiac Device Surveillance Program (VANCDSP) between 2002-2018 who have been treated with a cardiovascular implantable electronic device (CIED: pacemakers or implantable-cardioverter-defibrillator [ICD]) that has a safety alert or recall.

Methods:
We queried the VANCDSP for patients treated with CIEDs 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 are 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 which 51,713 (26%) are currently monitored. 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. Of the 72,571 patients implanted with ICDs, 52,549 (72.4%) have available remote monitoring data. Of 128,808 patients implanted with pacemakers, 33,510 (26.0%) have available remote monitoring data. The mean age of these patients is 72 years and 98.3% are male. Of living veterans, the median duration of follow-up from initial implant to most recent RM transmission is 3.44 years. A total 158 FDA recalls or alerts for lead or generator safety concerns affect 13,835 devices implanted in 11,359 (22%) currently monitored patients.

Implications:
Safety recalls or alerts affect 22% of veterans who have been treated with CIEDs and are followed by VANCDSP.

Impacts:
As a large proportion of veterans who have been treated with CIEDs have a device under a recall or alert, there is a need to ensure that these patients are closely monitored to avoid adverse events and improve patient safety. Possible strategies to improve safety include increasing veteran enrollment in remote monitoring, and the engagement and frequency of remote monitoring among veterans who are already enrolled. VANCDSP could serve as an early warning system for CIEDs failures and outcomes assessment of alerted or recalled CIEDs.