Abstract
Introduction: Fibrous encapsulation of implanted cardiovascular implantable electronic devices (CIED) may create a hostile environment during device reoperation. An acellular biologic extracellular tissue CIED envelope (CanGaroo®, Aziyo Biologics) may attenuate host foreign body response to the implant, decrease fibrosis and enable adaptive vascularized healing to facilitate reoperation & decrease complications. Hypothesis: CIED implant site findings at reoperation differ in patients who previously received a biologic envelope (BIO) vs no envelope (NO-BIO) at time of device implant. Methods: Patients undergoing reoperative CIED procedures (9 BIO, 12 NO-BIO) were assessed (medical profiles, procedural notes, scaled scoring of intra-operative assessments & tissue biopsy histology of the implant pocket). Results: There were no significant cohort differences in mean age, gender or implant location. Median capsular lead adhesion classification (semi-qualitative scale) was significantly lower (less severe) for BIO implants (p=0.02) [Fig. 1, double arrows]. Physicians scored BIO reoperations (10-pt scale) as 39% less difficult in generator mobilization (p=0.04), 43% less difficult in lead mobilization (p=0.04) and 45% less overall procedural difficulty (p=0.01). BIO pockets required 63% fewer capsulectomies (p=0.18). Multipoint histologic assessment of fibrotic capsule thickness (16 matrixed measurements, 5 BIO vs 11 NO-BIO with complete datasets) revealed a 39% reduction in BIO implant pockets (p=0.05), with no significant differences between groups in capsule mature collagen density [Fig. 1, single arrows]. Conclusions: When a BIO envelope was used at initial CIED implantation (vs no envelope), we observed significantly less fibrous lead entrapment, easier generator & lead mobilization, and thinner mature fibrotic capsules at reoperation. Biologic tissue envelopes may prevent operative complications and enhance clinical outcomes.
Published Version
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