The objective of this study is to gather information on participants returning at time of CIED change-out or revision who underwent a device implantation with either a CanGaroo® envelope, TYRX™ envelope, or no envelope.
This multi-center study will enroll up to approximately 100 participants who have undergone one or more implantations of a CIED with either CanGaroo®, TYRX™, or no envelope (up to approximately 30-35 participants per cohort) and are returning for a CIED change-out or revision procedure at least 4 months or longer from their prior procedure. Once enrolled, each participant will have their medical history data collected (baseline demographics, medical history, prior CIED exchanges/revisions, and post implant clinical events). Prior to the scheduled change-out/revision procedure, there will be an assessment of the current healed implant site skin incision independently by both the participant and investigator using the Patient and Observer Scar Assessment Scale (POSAS), as well as photographs taken of the current skin scar. During the change-out/revision procedure, additional investigator assessments will include photographic documentation of CIED implant pocket lining, classification of the extent of lead adhesions in the implant pocket, and biopsies of the anterior and posterior capsule walls for histologic analysis. Procedural details and any complications/AEs that occur during the change-out/revision procedure will also be captured.
Study Type
OBSERVATIONAL
Enrollment
46
Evaluation of the difference in cohorts for soft tissue healing surrounding the CIED implant and clinical outcomes and complications.
Valley Heart Rhythm Specialists
Chandler, Arizona, United States
Bay Pines VA
Bay Pines, Florida, United States
Baptist Medical Center
Jacksonville, Florida, United States
Blinded Histologic Evaluation of Biopsies Taken from the Anterior and Posterior Capsule Wall
Microscopic analysis of cellularity, vascularity, collagen density, necrosis, infectious agents, remnant device material, giant cells, and fibrotic capsule thickness will be evaluated for each biopsy site using a quantitative scoring system with an attempt to distinguish between remnant envelope collagen (if ECM envelope was used) and neocollagen from the participant. Composite (total) and average scores will be determined based on the individual scores from each biopsy site. The quantitative thickness of each fibrotic capsule biopsy will be measured using digital image software. Four (4) thickness measurements will be performed across the image for each biopsy sample, and the average fibrotic thickness will be reported for each sample. In addition, the total average thickness across the four samples will be determined based on the average individual recordings.
Time frame: Surgical Procedure Visit
Documented CIED Complications
Comparison between cohorts of documented clinical outcomes and complications since the most recent CIED procedure through the current change-out/revision procedure. Assessment of the clinical outcomes \& events of the 3 cohorts will inform on potential differences in clinical outcomes that may be related to the cohort treatment. For example: infection, Twiddler's syndrome, CIED migration, CIED erosion, lead revision, lead dislodgement, pocket revision, device reprogramming, pocket revision.
Time frame: Pre-Surgery Visit
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University of Florida
Jacksonville, Florida, United States
Prairie Education & Research Cooperative / St. John's Hospital
Springfield, Illinois, United States
U of L Health/Jewish Hospital
Louisville, Kentucky, United States
Columbia University Irving Medical Center
New York, New York, United States
Atrium Health
Concord, North Carolina, United States
East Carolina University/Vidant Medical Center
Greenville, North Carolina, United States
Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, United States
...and 1 more locations