Intravascular Ultrasound (IVUS) Imaging During Transvenous Lead Extraction

Study Overview
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Brief Summary
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The purpose of this study is to prospectively evaluate intravascular ultrasound (IVUS) imaging as a tool for grading the presence and characterization of intravascular lead adherence (ILA, or scarring) to cardiovascular implantable electronic device (CIED) leads during transvenous lead extraction (TLE) procedures in a multi-center study. IVUS should identify the location and severity of these adhesions, which the investigators will then correlate to difficulty of the extraction procedure using metrics like pulses of laser energy delivered and time required to traverse an area of fibrosis or ILA. The investigators will be focusing primarily on the section from innominate vein (INNV) down through the superior vena cava (SVC) to the right atrium. Using IVUS to view blood vessels and the heart structure is approved by the Food and Drug Administration (FDA). Using it as described in this study is off label because of the manner in which it is advanced to the SVC, through the right atrium. While it is not restricted from use in this way, it is not specifically on-label. It should be noted that the use of IVUS during TLE procedures as proposed in this study is routine at the University of Chicago and patients will undergo this procedure regardless of participation in this study. The EP physician team regards the use of IVUS during TLE to be nonsignificant risk.

Official Title
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Intravascular ultraSound (IVUS) Imaging During transvEnous Lead Extraction (ISEE)

Conditions
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Device Malfunction, ICD, Pacemaker Lead Dysfunction

Intervention / Treatment
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* Device: IVUS Imaging


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients at least 21 years of age Patients with at least one lead over 1 year dwell time requiring extraction Exclusion Criteria: Inability of patient capacity to provide consent for themselves either due to medical or psychiatric comorbidity Venous occlusion to the extent that the IVUS catheter cannot pass Leads < 1 year dwell time requiring extraction

Ages Eligible for Study
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Minimum Age: 21 Years

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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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Single cohort of patients undergoing transvenous lead extraction
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IVUS imaging<br>IVUS imaging will be used each patient undergoing transvenous lead extraction to visualize ILA | Device: IVUS Imaging<br>* IVUS or radial-ICE (intracardiac echocardiography) is a visualization tool used in many cardiac procedures including electrophysiology procedures (catheter ablation). Its utility in identifying ILA will be assessed in this study.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IVUS Grades | Operators will be able to successfully grade the degree of intravascular lead adherence (ILA) seen using IVUS imaging. | 6 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Extraction Difficulty Metrics | Operators will record the energy and time necessary to traverse binding sites and will be able to correlate these two metrics to IVUS ILA grade | Through study completion, expected to be 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CIED