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

Research output: Contribution to journalArticlepeer-review

3 Scopus citations

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.

Original languageEnglish
Article number103156
JournalAnnals of Medicine and Surgery
Volume73
DOIs
StatePublished - Jan 2022

Bibliographical note

Funding Information:
As described by the Deeken & Lake Mesh Classification System in a recent review article, a multitude of possible combinations exist, with 7 sub-categories of “barrier” devices encompassing more than 40 designs [5]. One particularly novel design is P4HB-ST mesh (Phasix™ ST Mesh, C. R. Bard/Davol, Inc., Warwick, RI), which represents the only fully absorbable barrier mesh construct. P4HB-ST mesh is comprised of an absorbable polymer scaffold of poly-4-hydroxybutyrate (P4HB) combined with an absorbable hydrogel barrier layer (ST) of sodium hyaluronate, carboxymethylcellulose, and polyethylene glycol [6]. The barrier is absorbed over a period of approximately 30 days, while the underlying P4HB scaffold is absorbed by 12–18 months [6]. The predictable absorption of the components results in a gradual transfer of load from the mesh back to the remodeled abdominal wall. The medium-term absorption profile of P4HB meshes (Phasix™ Mesh & Phasix™ ST Mesh: 12–18 months) [6,7] provides support to the repair site longer than short-term absorbable materials such as glycolide:lactide (Vicryl®: 2–3 months) [8] and polyglycolic acid:trimethylene carbonate (Bio-A®: 6–7 months) [9]. This is an important benefit since a mesh that is absorbed before newly deposited host collagen has matured may result in a hernia recurrence due to a lack of mechanical support at the repair site.

Publisher Copyright:
© 2021 The Authors

Keywords

  • Laparoscopic incisional hernia repair
  • Laparoscopic ventral hernia repair
  • Poly-4-hydroxybutyrate
  • Recurrence
  • Surgical site infection
  • Surgical site occurrence

ASJC Scopus subject areas

  • Surgery

Fingerprint

Dive into the research topics of '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)'. Together they form a unique fingerprint.

Cite this