loading page

EVALUATION OF THE SHORT TERM HOST RESPONSE AND BIOMECHANICS OF AN ABSORBABLE POLY-4-HYDROXYBUTYRATE SCAFFOLD IN A SHEEP MODEL FOLLOWING VAGINAL IMPLANTATION
  • +5
  • Chantal Diedrich,
  • Zeliha Guler,
  • Lucie Hajkova Hympanova,
  • Eva Vodegel,
  • Manuel Zundel,
  • Edoardo Mazza,
  • Jan Deprest,
  • Jan-Paul Roovers
Chantal Diedrich
Amsterdam UMC Locatie AMC
Author Profile
Zeliha Guler
Amsterdam UMC Locatie AMC
Author Profile
Lucie Hajkova Hympanova
KU Leuven
Author Profile
Eva Vodegel
Amsterdam UMC Locatie AMC
Author Profile
Manuel Zundel
ETH Zurich
Author Profile
Edoardo Mazza
ETH Zurich
Author Profile
Jan Deprest
Center for Surgical Technologies
Author Profile
Jan-Paul Roovers
Amsterdam UMC Locatie AMC
Author Profile

Abstract

Objective: To compare the host and biomechanical response to a fully absorbable poly-4-hydroxybutyrate (P4HB) scaffold to the response to PP mesh in an animal model of vaginal POP surgery. Design: A study employing a sheep model Setting: KU Leuven Center for Surgical Technologies Population: 14 parous female Mule sheep Methods: P4HB scaffolds were surgically implanted in the posterior vaginal wall of sheep. The comparative PP mesh data were obtained from an identical protocol. Main outcome measures: Gross necropsy, histological and biomechanical evaluation of explants, and the in vivo P4HB scaffold degradation were evaluated at 60- and 180-days post-implantation. Results: Gross necropsy revealed no implant related adverse events using P4HB scaffolds. The tensile stiffness of the P4HB explants increased at 180-days (12.498 ± 2.66 N/mm (P=0.019)) as compared to 60-days (4.585 ± 1.57 N/mm) post-implantation, while P4HB degraded gradually. P4HB scaffolds exhibited excellent tissue integration with dense connective tissue and a moderate initial host response. P4HB scaffolds induced a significantly higher M2/M1 ratio (1.70 ± 0.67 SD, score 0-4), as compared to PP mesh (0.99 ± 0.78 SEM, score 0-4) at 180-days. Conclusions: P4HB scaffold facilitated a gradual load transfer to vaginal tissue over time. The fully absorbable P4HB scaffold, in comparison to PP mesh, has a favorable host response with comparable load bearing capacity. If these results are also observed at longer follow-up, a clinical study for vaginal POP surgery may be warranted to demonstrate efficacy. Key words: Pelvic organ prolapse, vaginal surgery, Poly-4-hydroxybutyrate, degradable scaffold, host response, biomechanics.

Peer review status:UNDER REVIEW

16 Jun 2021Submitted to BJOG: An International Journal of Obstetrics and Gynaecology
18 Jun 2021Assigned to Editor
18 Jun 2021Submission Checks Completed
24 Jun 2021Reviewer(s) Assigned