Device Malfunction, ICD, Pacemaker Lead Dysfunction
Conditions
Keywords
CIED
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.
Interventions
DEVICEIVUS Imaging
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.
Sponsors
University of Chicago
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Single cohort of patients undergoing transvenous lead extraction
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Participant flow
Pre-assignment details
Enrollment closed across the study due to low enrollment.
Participants by arm
| Arm | Count |
|---|---|
| IVUS Imaging IVUS imaging will be used each patient undergoing transvenous lead extraction to visualize ILA
IVUS Imaging: 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. | 31 |
| Total | 31 |
Baseline characteristics
| Characteristic | IVUS Imaging |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 12 Participants |
| Age, Categorical Between 18 and 65 years | 18 Participants |
| Age, Continuous | 63.6 years STANDARD_DEVIATION 12.64 |
| Body mass index (BMI) | 29.68 kg/m^2 STANDARD_DEVIATION 6.29 |
| Height | 170.2 cm STANDARD_DEVIATION 12.64 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 17 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 12 Participants |
| Region of Enrollment United States | 31 Participants |
| Sex: Female, Male Female | 15 Participants |
| Sex: Female, Male Male | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 31 |
| other Total, other adverse events | 0 / 31 |
| serious Total, serious adverse events | 0 / 31 |
Outcome results
Primary
IVUS Grades
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
Time frame: 6 hours
Population: 3 patients did not have any ILA grades.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| IVUS Imaging | IVUS Grades | Right sided devices Zone1/2 | 1.33 Grade | Standard Deviation 0.58 |
| IVUS Imaging | IVUS Grades | Right sided devices Zone 3 | 1 Grade | Standard Deviation 0 |
| IVUS Imaging | IVUS Grades | Left sided devices Zone 1 | 1.57 Grade | Standard Deviation 0.81 |
| IVUS Imaging | IVUS Grades | Left sided devices Zone 2 | 1.44 Grade | Standard Deviation 0.58 |
| IVUS Imaging | IVUS Grades | Left sided devices Zone 3 | 1.32 Grade | Standard Deviation 0.63 |
| IVUS Imaging | IVUS Grades | All devices, all zones | 1.40 Grade | Standard Deviation 0.5 |
Comparison: H0: rho = 0 Spearman correlation coefficient calculated between average ILA grade and total time of lead extractionp-value: 0.2201Spearman Correlation Coefficient
Comparison: H0: rho = 0 Spearman Correlation coefficient calculated between average ILA grades and laser pulsationsp-value: 0.5157Spearman Correlation Coefficient
Secondary
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 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
Time frame: Through study completion, expected to be 6 months
Population: Means calculated for patients with left sided devices vs patients with right sided devices - 4 patients had missing data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| IVUS Imaging | Extraction Difficulty Metrics | Right sided devices | 26.5 minutes | Standard Deviation 21.92 |
| IVUS Imaging | Extraction Difficulty Metrics | Left sided devices | 34.91 minutes | Standard Deviation 36.94 |