Po-05-050 biologic cardiovascular electronic device envelopes enhance pocket healing and simplify reoperative procedures

Implantation of cardiovascular electronic devices (CIED) can trigger fibrous encapsulation, increasing the difficulty of reoperative procedures and potentially exposing patients to complications. A biologic device envelope (CanGaroo®, Aziyo Biologics), derived from decellularized porcine extracellular matrix, used during CIED implantation facilitates physiologic pocket healing and may decrease potential future reoperative complications. To determine implant pocket differences at reoperation between patients who received the CanGaroo biologic envelope (BIO), the TYRX non-biologic envelope (NON-BIO), or no envelope (NO-E) during their previous device implantation. Patient profiles, procedural notes, physician intraoperative assessment scoring of the pocket, and implant pocket tissue biopsy histology were analyzed in 43 patients undergoing reoperative CIED procedures (11 BIO, 15 NON-BIO, 17 NO-E). No significant group differences were observed in mean age, gender, race, or prior implant history, aside from median time of implant prior to the reoperative procedure: 4.8 years for BIO (range 0.7 – 8.6), 3.6 years for NON-BIO (0.7 – 7.6), and 9.5 years for NO-E (0.9 – 15.1) (p<.001). On a 10-point scale, implanting physicians scored BIO reoperations as 46% easier during generator mobilization (p=.02), 41% easier for leads mobilization (p=.01), and 43% less overall procedural difficulty (p=.04) compared to NO-E, and also easier compared to NON-BIO reoperations (respectively 39%, p=.06; 23%, p=.28; 33%, p=.15). Lead adhesion classification was scored as significantly less severe in the BIO group compared to NO-E (p=.003). Significantly fewer capsulectomy procedures were required in the BIO vs NON-BIO group (83% less, p=.04) and numerically less compared to NO-E (78% less, p=.10) [Fig. 1, arrows]. Independent, blinded histologic evaluation of pocket biopsies (6 BIO, 12 NO-BIO, 14 NO-E with complete datasets) showed 30% thinner capsules in BIO implant pockets vs NO-E (p=0.12), and 32% thinner capsules vs NON-BIO (p=.09) [Fig. 1, asterisks]. Using biologic envelopes (vs non-biologic or no envelope) during CIED implantation resulted in fewer lead adhesions, easier generator and lead mobilization, thinner tissue capsules, and reduced the need for capsulectomy during reoperation. The use of biologic envelopes may be a promising tool for long-term wound healing to decrease potential complications and improve patient care following device implantation.