Intravascular Ultrasound (IVUS) Imaging During Transvenous Lead Extraction
- Conditions
- Device MalfunctionICDPacemaker Lead Dysfunction
- Interventions
- Device: IVUS Imaging
- Registration Number
- NCT04055740
- Lead Sponsor
- University of Chicago
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 28
- Patients at least 21 years of age
- Patients with at least one lead over 1 year dwell time requiring extraction
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description IVUS imaging IVUS Imaging IVUS imaging will be used each patient undergoing transvenous lead extraction to visualize ILA
- Primary Outcome Measures
Name Time Method IVUS Grades 6 hours Operators will be able to successfully grade the degree of intravascular lead adherence (ILA) seen using IVUS imaging.
Using the following scale, grading of ILA in each zone of interest, based on relative motion of lead will be performed:
i. Grade 1: Freely mobile, Rarely adjacent to vasculature ii. Grade 2: Restricted mobility, Frequently adjacent to vasculature iii. Grade 3: Immobile, Always adjacent to vasculature iv. Grade L, added to number: Lead-to-lead binding
- Secondary Outcome Measures
Name Time Method Extraction Difficulty Metrics Through study completion, expected to be 6 months 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
Extraction difficulty was measured by correlating IVUS ILA grade to lead dwell time - the amount of time it took to extract the lead.
Using the following scale, grading of ILA in each zone of interest, based on relative motion of lead was performed:
i. Grade 1: Freely mobile, Rarely adjacent to vasculature ii. Grade 2: Restricted mobility, Frequently adjacent to vasculature iii. Grade 3: Immobile, Always adjacent to vasculature iv. Grade L, added to number: Lead-to-lead binding
Trial Locations
- Locations (1)
The University of Chicago
🇺🇸Chicago, Illinois, United States