Multicenter Imaging in Lead Extraction Study

Study Overview
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Brief Summary
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The primary objectives of this registry is to correlate the amount of fibrosis as documented on Electrocardiogram (ECG) gated Computed Tomography (CT) scans with ease of advancing sheaths over the leads through the SVC zone during lead extraction.

Detailed Description
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This is a multi-center, prospective, observational registry study which plans to enroll approximately 200 patients referred for Cardiac Implantable Electronic Device(CIED) lead extraction at one of the five study centers. The objective of this study is to determine whether a correlation exists between fibrosis detected on ECG gated cardiac CT and the ease of lead extraction as measured by need for extraction energy. All patients will be followed for 30 days post-lead extraction to assess vital status and re-hospitalizations via phone call

Official Title
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Multicenter Imaging in Lead Extraction Study

Conditions
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Mechanical Complication of Cardiac Electronic Device

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Referred for CIED (Cardiac Implantable Electronic Device) lead extraction with at least 1 lead with dwell time greater than one year ≥ 18 years of age Appropriate candidate for chest/cardiac CT with contrast and full lead analysis Exclusion Criteria: Atrial fibrillation with uncontrolled rate

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation of the presence and degree of fibrosis as determined by ECG gated cardiac CT with the presence and degree of fibrosis determined by ease of extraction sheath advancement | The presence and degree of fibrosis determined by the ease of extraction sheath advancement will be evaluated in three zones. Zone 1 will be the area before the Superior Vena Cava (SVC), Zone 2 in the SVC and Zone 3 after the SVC | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of ECG gated CT scans that show fibrosis | The percentage of ECG gated CT scans will be determined by scans that show little to no SVC (Zone 2) fibrosis, show little to no Zone 1 fibrosis, show little to no Zone 3 fibrosis, cardiac perforation, extravascular lead location | 30 days | 
| Major complications as defined by Heart Rhythm Society (HRS) 2017 consensus guidelines | major complications | 30 days | 
| Minor complications as defined by HRS 2017 consensus guidelines | minor complications | 30 days | 
| Mortality | Death assessed | 30 days | 
| Procedural outcomes | Operator ease of extraction (grade 1-5) | 30 days | 
| Fluoroscopy time | Fluoroscopy duration of time | 30 days | 
| Pathological reports from extracted leads | Pathology reports from extracted leads if available | 30 days | 
| Hospitalizations directly related to the extraction of leads or procedure related | Number of hospitalizations related to the extraction of leads or procedure related within 30 days post procedure | 30 days |