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Updated: Nov 11, 2025
A New Single Chamber Implantable Defibrillator with Atrial Sensing: A Practical Demonstration of Sensing and Ease of Implantation
Published on: February 28, 2012
Dutch Outcome in Implantable Cardioverter-Defibrillator Therapy: Implantable Cardioverter-Defibrillator-Related
Marit van Barreveld1,2, Tom E Verstraelen1, Pascal F H M van Dessel3
1Department of Cardiology, Heart Center Amsterdam UMC, University of Amsterdam the Netherlands.
Insights
One in 13 patients experiences major implantable cardioverter-defibrillator complications, often requiring reintervention. Stricter criteria for defibrillator implantation could reduce these risks and offer clinical benefits.
Area of Science:
- Cardiology
- Medical Device Technology
- Public Health
Background:
- Implantable cardioverter-defibrillator (ICD) therapy is crucial for primary prevention, yet patients face defibrillator complications.
- Contemporary data on ICD complications in real-world settings are limited, necessitating updated risk assessments.
- Understanding complication rates and risk factors is vital for optimizing patient selection and device management.
Purpose of the Study:
- To assess the incidence and types of complications following ICD implantation in a nationwide prospective registry.
- To identify risk factors associated with these complications.
- To forecast potential complication reductions by applying updated indication criteria and device selection strategies.
Main Methods:
- A prospective multicenter registry cohort of 1442 primary prevention ICD patients was analyzed.
- Complications were classified as major or minor, with detailed recording of types and outcomes.
- A prediction model for appropriate therapy was developed to simulate the impact of stricter implant indications.
Main Results:
- During a median follow-up of 2.2 years, 13.6% of patients experienced complications, with 7.8% having major complications.
- Lead-related issues (93 cases) and infections (18 cases) were the most frequent major complications.
- Surgical reintervention was needed in 53% of complications, and 61% required additional hospitalization.
Conclusions:
- Approximately 1 in 13 patients experiences a major ICD-related complication, often necessitating surgical intervention.
- Complication rates are linked to defibrillator implantation procedures and device characteristics.
- Implementing stricter implant criteria and optimizing device selection can yield significant clinical and financial advantages.
Abstract:
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.
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