Pacemaker and Defibrillator Lead Extraction Registry

Study Overview
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Brief Summary
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Implanted cardiac devices are commonly used to treat a wide variety of heart diseases, including arrhythmias, cardiac resynchronization in select heart failure patients, and life threatening heart rhythms. Approximately 400,000 devices are implanted annually, and more than 3 million patients currently have implanted devices1. Implanted cardiac devices are made to 2 components, the can and the leads. The can contains the electric circuits and the battery, which must be replaced every 5-10 years. The can is connected to external leads which pass through the subclavian vein, and depending on the device, into the vena cava, right atrium, right ventricle, and/or coronary sinus. Leads typically last longer than the battery, and are simply reconnected to a new can at the time of replacement. Certain clinical situations necessitate lead removal, including pocket infection, device related endocarditis, venous stenosis or occlusion with the need for new access, and removal of abandoned or malfunctioning leads. Removing the leads is technically difficult due to fibrosis, and requires specialized equipment. Compared to lead implantation, extraction of leads is relatively rare, with a life time risk of a device patient needing an extraction in the 1-5% range. Given that this is a relatively rare procedure and is only done at a few centers, documentation of our experiences with lead extraction can lead to ongoing improvements in both procedural techniques and outcomes.

Detailed Description
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Study Procedures This is a retrospective review of data on patient characteristics (such as age, gender, co-morbidities), procedure specifications and indications, and outcomes of lead extraction done at OHSU. Patients who have undergone either pacemaker or defibrillator lead extraction will have their charts reviewed for the desired data, which will then be compiled into a database. All procedures will be part of routine clinical care. Data Analysis: This is an observational registry study; there are no primary or secondary outcomes. Data will be analyzed to determine patient and procedural characteristics, procedure indications, complications and outcomes

Official Title
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The Oregon Health & Science University Cardiac Implantable Electronic Device Extraction Registry

Conditions
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Lead Extraction Procedures

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Undergoing lead extraction Exclusion Criteria: registry--n/a
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Lead extraction<br>Patients undergoing clinically indicated lead extraction procedures. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| safety (acute complications, per HRS consensus document) | Primary outcome is safety of the lead extraction procedure, in terms of acute complications, per HRS consensus document. | duration of hospitalization, typically 2 days to 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pacemaker, Implantable cardioverter defibrillator, Lead extraction