Understanding Patients Decisions About Generator Exchanges for Implantable Defibrillators

NIH RePORTER · AHRQ · F32 · $70,458 · view on reporter.nih.gov ↗

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
EMORY UNIVERSITY
Principal Investigator
Birju Rao
Activity code
F32
Funding institute
AHRQ
Fiscal year
2021
Award amount
$70,458
Award type
1
Project period
2021-07-27 → 2022-06-30