Evaluation of a novel permanent capped helical coil fastener in a porcine model of laparoscopic ventral hernia repair

Existing permanent helical coil fasteners, although commonly employed for mesh fixation during laparoscopic hernia repair, are associated with peritoneal tissue attachment formation and resultant visceral complications. We evaluated attachment formation, fastener engagement, and mesh/tissue integration associated with laparoscopic fixation using a novel permanent capped helical coil fastener (HC-Capped) compared to permanent non-capped helical coil fasteners (HC-Non-Capped) in a porcine model. Twelve female pigs underwent bilateral laparoscopic intraperitoneal fixation of Composix™ L/P Mesh (10 × 15 cm oval) with HC-Capped or HC-Non-Capped fasteners. Thirty-two fasteners were used to secure each mesh utilizing a “double-crown” technique. Laparoscopy at 30 days was used to evaluate the presence and area coverage of attachments (Diamond Score) and percentage of engaged fasteners. At 90 days, following necropsy, each mesh was evaluated for the presence, percentage, and tenacity (Butler Score) of attachments and fastener engagement. Samples were biomechanically evaluated to assess tissue integration via T-peel testing. HC-Capped fasteners demonstrated a significantly lower attachment area score compared to the HC-Non-Capped group at 30 days (0.92 ± 0.26 vs. 2.50 ± 0.29/3.00, p= 0.002) and 90 days (0.60 ± 0.22 vs. 2.08 ± 0.29/3.00, p= 0.004). At 90 days, the HC-Capped group evidenced significantly lower attachment tenacity score (1.00 ± 0.37 vs. 2.75 ± 0.33/4.00, p= 0.013). Furthermore, at 30 and 90 days, a significantly greater percentage of HC-Capped fasteners remained properly engaged (30 days: 99.7 % vs. 86.5 %, p< 0.001 and 90 days: 99.4 % vs. 74.5 %, p= 0.001). T-peel biomechanical testing demonstrated significantly greater mesh/tissue integration for HC-Capped group (2.16 ± 0.24 vs. 1.16 ± 0.29 N/cm, p= 0.038). In a porcine model, HC-Capped fasteners demonstrated significantly less attachment coverage and tenacity in the early postoperative period. Furthermore, the HC-Capped cohort evidenced significantly greater percentage of properly engaged fasteners and greater mesh/tissue integration. Data suggest that shielding exposed fastener points on the visceral mesh surface with polymer caps may reduce attachment formation and aid in mesh fixation and integration.