# Understanding Patients Decisions About Generator Exchanges for Implantable Defibrillators

> **NIH AHRQ F32** · EMORY UNIVERSITY · 2021 · $70,458

## Abstract

Project Summary/Abstract
Implantable cardioverter-defibrillators (ICDs) have been shown to improve mortality in selected patients with
heart failure. However, they do not improve quality of life and may even impair quality of life due to risks of
procedural complications and inappropriate shocks. As a result, clinicians are now required to engage in
shared decision-making with patients prior to implanting primary prevention ICDs. Efforts to promote shared
decision-making have completely excluded patients undergoing ICD generator exchanges. ICDs have battery
that require a surgical generator exchange every 5-7 years. There is evidence that generator exchanges are
being performed by default and these decisions are not patient centered. For instance, ICD generator
exchanges may not benefit all patients with an active ICD, and some procedural risks of ICD generator
exchanges, such as device infections, are higher. In addition, individualized risk stratification using 5-7 years
of data stored by the ICD may help identify patients for whom continued ICD therapy may not beneficial.
Finally, an ICD generator exchange exposes patients to procedural risk and does not improve quality of life. In
the intervening years following the initial ICD implant, patients’ goals of care may have changed and may no
longer cohere with ICD therapy. Therefore, as with the initial ICD implantation, ICD generator exchanges are
preference sensitive, but studies show that patients are not aware of the choice to not undergo an ICD
generator exchange. Given generator exchanges are currently performed without consideration of these
important factors, shared decision-making may provide the appropriate framework to ensure the decision is
consistent with patients’ expectations and values. To identify areas where shared decision-making can
improve decisions for ICD generator exchanges, this proposal will deliver a qualitative assessment of
patients’ experience and expectations regarding generator exchange decisions. In addition, clinical tools
to predict the individualized risk of needing continued ICD therapy at the time of a generator exchange are
being developed. This information is helpful to clinicians, but it is unclear whether presenting patients with
individualized risk would impact their generator exchange decisions. Given patients already have already been
living with an implanted ICD at the time of battery depletion, they may have strong preferences regarding the
GE and additional data may not impact their decision. To determine if providing patients’ individualized
risk assessments impact their willingness to undergo an ICD generator exchange, we will conduct a
series of iterative discrete choice experiments. This proposal aligns with AHRQ goals and will produce
high-impact data to drive intervention development for a prevalent but largely ignored decision with significant
resource implications and impact on patients’ lives.

## Key facts

- **NIH application ID:** 10314464
- **Project number:** 1F32HS028558-01
- **Recipient organization:** EMORY UNIVERSITY
- **Principal Investigator:** Birju Rao
- **Activity code:** F32 (R01, R21, SBIR, etc.)
- **Funding institute:** AHRQ
- **Fiscal year:** 2021
- **Award amount:** $70,458
- **Award type:** 1
- **Project period:** 2021-07-27 → 2022-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10314464

## Citation

> US National Institutes of Health, RePORTER application 10314464, Understanding Patients Decisions About Generator Exchanges for Implantable Defibrillators (1F32HS028558-01). Retrieved via AI Analytics 2026-06-12 from https://api.ai-analytics.org/grant/nih/10314464. Licensed CC0.

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