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.
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
Study Type
OBSERVATIONAL
Enrollment
200
United Heart and Vascular Clinic
Saint Paul, Minnesota, United States
Northwell Health
Manhasset, New York, United States
Duke University
Durham, North Carolina, United States
Cleveland Clinic
Cleveland, Ohio, United States
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
Time frame: 30 days
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
Time frame: 30 days
Major complications as defined by Heart Rhythm Society (HRS) 2017 consensus guidelines
major complications
Time frame: 30 days
Minor complications as defined by HRS 2017 consensus guidelines
minor complications
Time frame: 30 days
Mortality
Death assessed
Time frame: 30 days
Procedural outcomes
Operator ease of extraction (grade 1-5)
Time frame: 30 days
Fluoroscopy time
Fluoroscopy duration of time
Time frame: 30 days
Pathological reports from extracted leads
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Asklepios Klinik St. Georg
Hamburg, Germany
Pathology reports from extracted leads if available
Time frame: 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
Time frame: 30 days