A prospective, multicenter trial of a long-term bioabsorbable mesh with Sepra technology in cohort of challenging laparoscopic ventral or incisional hernia repairs (ATLAS trial)

William W Hope; Adel G El-Ghazzawy; Brad A Winterstein; Jeffrey A Blatnik; S Scott Davis; Jacob A Greenberg; Noel C Sanchez; Eric M Pauli; Daniel M Tseng; Karl A LeBlanc; Kurt E Roberts; Curtis E Bower; Eduardo Parra-Davila; J Scott Roth; Corey R Deeken; Eric F Smith

doi:10.1016/j.amsu.2021.103156

A prospective, multicenter trial of a long-term bioabsorbable mesh with Sepra technology in cohort of challenging laparoscopic ventral or incisional hernia repairs (ATLAS trial)

Ann Med Surg (Lond). 2021 Dec 6:73:103156. doi: 10.1016/j.amsu.2021.103156. eCollection 2022 Jan.

Authors

William W Hope¹, Adel G El-Ghazzawy², Brad A Winterstein³, Jeffrey A Blatnik⁴, S Scott Davis⁵, Jacob A Greenberg⁶, Noel C Sanchez⁷, Eric M Pauli⁸, Daniel M Tseng⁹, Karl A LeBlanc¹⁰, Kurt E Roberts¹¹, Curtis E Bower¹², Eduardo Parra-Davila¹³, J Scott Roth¹⁴, Corey R Deeken¹⁵, Eric F Smith¹⁶

Affiliations

¹ New Hanover Regional Medical Center, Department of Surgery, Wilmington, NC, United States.
² Overlake Medical Center, Department of Surgery, Bellevue, WA, United States.
³ Methodist Hospital, Department of Surgery, Omaha, NE, United States.
⁴ Washington University, Department of Surgery, St. Louis, MO, United States.
⁵ Emory University, Department of Surgery, Atlanta, GA, United States.
⁶ University of Wisconsin, Department of Surgery, Madison, WI, United States.
⁷ Via-Christi Hospital, Department of Surgery, Wichita, KS, United States.
⁸ Penn State Hershey Medical Center, Department of Surgery, Hershey, PA, United States.
⁹ Legacy Health, Department of Surgery, Portland, OR, United States.
¹⁰ Our Lady of the Lake Regional Medical Center, Department of Surgery, Baton Rouge, LA, United States.
¹¹ St. Francis Hospital, Department of Surgery, Hartford, CT, United States.
¹² Carilion Clinic, Department of Surgery, Roanoke, VA, United States.
¹³ Celebration Health, Department of Surgery, Celebration, FL, United States.
¹⁴ University of Kentucky, Department of Surgery, Lexington, KY, United States.
¹⁵ Covalent Bio, LLC, St. Louis, MO, United States.
¹⁶ Georgetown Community Hospital, Department of Surgery, Georgetown, KY, United States.

Abstract

Background: This prospective, multicenter, single-arm, open-label study evaluated P4HB-ST mesh in laparoscopic ventral or incisional hernia repair (LVIHR) in patients with Class I (clean) wounds at high risk for Surgical Site Occurrence (SSO).

Methods: Primary endpoint was SSO requiring intervention <45 days. Secondary endpoints included: surgical procedure time, length of stay, SSO >45 days, hernia recurrence, device-related adverse events, reoperation, and Quality of Life at 1, 3, 6, 12, 18, and 24-months.

Results: 120 patients (52.5% male), mean age of 55.0 ± 14.9 years, and BMI of 33.2 ± 4.5 kg/m² received P4HB-ST mesh. Patient-reported comorbid conditions included: obesity (86.7%), active smoker (45.0%), COPD (5.0%), diabetes (16.7%), immunosuppression (2.5%), coronary artery disease (7.5%), chronic corticosteroid use (2.5%), hypoalbuminemia (0.8%), advanced age (10.0%), and renal insufficiency (0.8%). Hernia types were primary ventral (44.2%), primary incisional (37.5%), recurrent ventral (5.8%), and recurrent incisional (12.5%). Patients underwent LVIHR in laparoscopic (55.8%) or robotic-assisted cases (44.2%), mean defect size 15.7 ± 28.3 cm², mean procedure time 85.9 ± 43.0 min, and mean length of stay 1.0 ± 1.4 days. There were no SSOs requiring intervention beyond 45 days, n = 38 (31.7%) recurrences, n = 22 (18.3%) reoperations, and n = 2 (1.7%) device-related adverse events (excluding recurrence).

Conclusion: P4HB-ST mesh demonstrated low rates of SSO and device-related complications, with improved quality of life scores, and reoperation rate comparable to other published studies. Recurrence rate was higher than expected at 31.7%. However, when analyzed by hernia defect size, recurrence was disproportionately high in defects ≥7.1 cm² (43.3%) compared to defects <7.1 cm² (18.6%). Thus, in LVIHR, P4HB-ST may be better suited for small defects. Caution is warranted when utilizing P4HB-ST in laparoscopic IPOM repair of larger defects until additional studies can further investigate outcomes.

Keywords: Laparoscopic incisional hernia repair; Laparoscopic ventral hernia repair; Poly-4-hydroxybutyrate; Recurrence; Surgical site infection; Surgical site occurrence.