Dataset Information

A Qualitative Analysis of Patient-Related Factors Associated With Implantable Cardioverter Defibrillator Acceptance.

ABSTRACT:

Introduction

Patient-related factors determining implantable cardioverter-defibrillator (ICD) use for primary prevention of sudden cardiac death in patients with cardiomyopathy have not been well explored. To assess race and sex differences regarding ICD preferences in this patient population, we sought to analyze a diverse cohort of patients with heart failure (HF) with reduced ejection fraction.

Methods

We conducted qualitative interviews of 28 adults with severe HF and either (1) an ICD or (2) no ICD. Interviews were recorded, transcribed, and coded using an inductively developed codebook by independent investigators. Coding was fully adjudicated and transcripts were reviewed to identify themes.

Results

We recruited patients between 12/2015 and 06/2017, primarily from the outpatient cardiology clinic (24/28 = 86%). Half were women (50%) and 13/28 (46%) were black. Eight did not have an ICD. Neither race nor sex was associated with ICD. Four themes emerged: (1) HF requiring an ICD is profoundly disruptive to patients' lives; (2) patients had positive, yet unrealistic opinions of ICDs; or (3) Patients had negative/ambivalent opinions of ICDs; (4) medical decision-making included aspects of shared decision-making and informed consent.

Conclusions

Patients without ICDs perceived less benefit from ICDs and had less decision support. Participants viewed conversations with providers as insufficient. Needed interventions include the development and validation of processes for informed decisions about ICDs.

SUBMITTER: Johnson AE

PROVIDER: S-EPMC7584700 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:Background One third of primary prevention implantable cardioverter-defibrillator patients receive appropriate therapy, but all remain at risk of defibrillator complications. Information on these complications in contemporary cohorts is limited. This study assessed complications and their risk factors after defibrillator implantation in a Dutch nationwide prospective registry cohort and forecasts the potential reduction in complications under distinct scenarios of updated indication criteria. Methods and Results Complications in a prospective multicenter registry cohort of 1442 primary implantable cardioverter-defibrillator implant patients were classified as major or minor. The potential for reducing complications was derived from a newly developed prediction model of appropriate therapy to identify patients with a low probability of benefitting from the implantable cardioverter-defibrillator. During a follow-up of 2.2 years (interquartile range, 2.0-2.6 years), 228 complications occurred in 195 patients (13.6%), with 113 patients (7.8%) experiencing at least one major complication. Most common ones were lead related (n=93) and infection (n=18). Minor complications occurred in 6.8% of patients, with lead-related (n=47) and pocket-related (n=40) complications as the most prevailing ones. A surgical reintervention or additional hospitalization was required in 53% or 61% of complications, respectively. Complications were strongly associated with device type. Application of stricter implant indication results in a comparable proportional reduction of (major) complications. Conclusions One in 13 patients experiences at least one major implantable cardioverter-defibrillator-related complication, and many patients undergo a surgical reintervention. Complications are related to defibrillator implantations, and these should be discussed with the patient. Stricter implant indication criteria and careful selection of device type implanted may have significant clinical and financial benefits.