# Improving Safety of Cardiovascular Implantable Electronic Devices in Veterans

> **NIH VA IK2** · VETERANS AFFAIRS MED CTR SAN FRANCISCO · 2022 · —

## Abstract

Background: This proposal is intended to support the career development of Sanket Dhruva, MD, MHS, a
Staff Cardiologist at the San Francisco VA and Assistant Professor of Medicine at the University of California,
San Francisco into an independent VA health services researcher with the training and experience necessary
to conduct innovative research and develop interventions that improve safety of Veterans with cardiovascular
implantable electronic devices (CIEDs: pacemakers and implantable cardioverter defibrillators [ICDs]). Even
though more than 10% of the 55,000 Veterans followed by VA have suffered CIED-related complications, there
has not been any systematic evaluation to identify failed CIED leads using VA’s data systems.
Significance/Impact: This research will close Dr. Dhruva’s knowledge gaps in biostatistics, data science, and
qualitative methods, enabling him to generate actionable, high-quality evidence to inform VA cardiac
electrophysiologists to implant the safest devices in Veterans. This research will also enable him to identify
CIED leads that have already been implanted in Veterans but are at risk for failure, thereby informing
strategies to avoid clinical sequelae of failure (such as inappropriate shocks and death) for individual Veterans.
This proposal is directly aligned with operational priorities set forth in VHA Directive 1189 (published in January
2020) to “monitor the safety of CIEDs,” HSR&D Priorities of a Learning Healthcare System and improving
Veteran Quality of Care and Safety, and supports VHA’s priority of becoming a High-Reliability Organization.
Innovation: This research is innovative through its application of advanced statistical methods to leverage a
comprehensive, longitudinal database of Veterans with CIEDs, the VA National Cardiac Device Surveillance
Program (NCDSP), including temporally dense CIED-generated data, to address the large-scale, complex
problem of identifying CIED lead failure. Additionally, this research provides information about the unexplored
question of physician selection of manufacturer and model of device to implant and the role of safety data.
Specific Aims: Aim 1: To compare risk-adjusted failure rates of different cardiovascular implantable
electronic device (CIED) lead models among Veterans.
H1: We will detect one or more CIED lead models with statistically and clinically significantly higher failure
rates when compared to other leads of the same type (e.g. ICD lead when compared to all other ICD leads).
Aim 2: To develop risk prediction models of all-cause CIED lead failure among Veterans by applying
supervised machine learning methods to repeated measures from CIED remote monitoring data.
H2: Risk prediction models will detect lead failure with high discrimination (area under the curve [AUC] ≥0.85)
and adequate calibration at 3 months and 12 months post-assessment.
Aim 3: To conduct a pilot study to determine the effect of an academic detailing and audit and
feedback intervention ...

## Key facts

- **NIH application ID:** 10312661
- **Project number:** 1IK2HX003357-01A1
- **Recipient organization:** VETERANS AFFAIRS MED CTR SAN FRANCISCO
- **Principal Investigator:** Sanket S Dhruva
- **Activity code:** IK2 (R01, R21, SBIR, etc.)
- **Funding institute:** VA
- **Fiscal year:** 2022
- **Award amount:** —
- **Award type:** 1
- **Project period:** 2022-02-01 → 2027-01-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10312661

## Citation

> US National Institutes of Health, RePORTER application 10312661, Improving Safety of Cardiovascular Implantable Electronic Devices in Veterans (1IK2HX003357-01A1). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10312661. Licensed CC0.

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