Poly-4-hydroxybutyrate mesh for High Risk Ventral and Incisional Hernias: Early outcomes.

J. Scott Roth, MD1, Gary Anthone, MD2, Don J Selzer, MD3, Ben K Poulose, MD4, James G Bittner, MD5, William W Hope, MD6, Raymond M Dunn, MD7, Robert G Martindale, MD, PhD8, Matthew I Goldblatt, MD9, David B Earle, MD10, Gregory J Mancini, MD11, Jacob A Greenberg, MD12, John G Linn, MD13, Eduardo Parra-Davila, MD14, Bryan J Sandler, MD15, Guy R Voeller, MD16. 1University of Kentucky Medical Center, 2Methodist Health System, Omaha, NE, 3The Trustees of Indiana University, Indianapolis, IN, 4Vanderbilt University Medical Center, Nashville, TN, 5Virginia Commonwealth University, Richmond, VA, 6New Hanover Regional Medical Center, Wilmington, NC, 7University of Massachusetts Worcester, Worcester, MA, 8Oregon Health & Science University, Portland, OR, 9The Medical College of Wisconsin, Inc., Milwaukee, WI, 10Baystate Medical Center, Springfield, MA, 11The University of Tennessee Medical Center, Knoxville, TN, 12Board of Regents of the University of Wisconsin System, Madison, WI, 13North Shore University Health System, Evanston, IL, 14Adventist Health System/Sunbelt, Inc. d/b/a Florida Hospital d/b/a Celebration Health, Celebration,, 15The Regents of the University of California, San Diego, CA, 16The University of Tennessee Health Science Center, Memphis, TN

­­Introduction: Slowly absorbable mesh prostheses represent a promising technology in the management of abdominal wall disease. Poly-4-hydroxybutyrate (P4HB) mesh is a long-lasting absorbable material with tensile strength exceeding the native abdominal wall at time of implantation and with full resorption within 2 years (in preclinical studies). This review evaluates six month outcomes using P4HB material in a high risk population undergoing ventral hernia repair.

Methods: An IRB approved, prospective, multi-center, observational trial is ongoing. Inclusion criteria include: 1. Primary ventral, incisional or recurrent (not to exceed 3) incisional hernias undergoing retro-rectus or onlay repair, 2. Presence of 1 or more comorbid conditions (obesity, smoking, DM, chronic steroid use, COPD, CAD, immunosuppression, hypoalbuminemia, renal insufficiency, age>75), 3. Hernia size > 10cm2 and < 350cm2, 4. CDC Class 1 wound. Demographic information, operative details, quality of life surveys, visual analog pain scores and postoperative outcomes are measured at 1, 3, 6, 12, 18 and 24 months.

Results: 112 patients have been enrolled to date of which 50 (18 Male, 32 Female) have completed 6-month follow-up evaluations. At baseline, patients had a mean BMI of 32.31 +/- 4.85 kg/m2) and on average, 2 comorbid conditions (range 1-5). Comorbid conditions and other medical history included hypertension (58%), CAD (42%), diabetes (34%), COPD (28%), active smoking (26%), immunosuppression (12%), renal insufficiency (6%), stroke (6%), and immunosuppression (6%). Hernia repairs were performed for initial incisional hernia (42%), recurrent incisional hernia (26%), primary ventral hernia (18%) and recurrent ventral hernia (7%). 32 patients (64%) underwent a retro-rectus repair, 17 (34%) underwent onlay repair and 1(2%) underwent preperitoneal repair for right flank hernia. Visual analog pain scores improved following hernia repair (preoperative mean– 4.51 cm, mean at 1 months – 4.04 cm, mean at 3 months – 2.0 cm, mean at 6 months – 1.46 cm). One patient had the mesh explanted due to pyrexia of unknown origin which was later determined to be due to pneumonia (resulted in death). Postoperative complications of special interest included skin dehiscence (16%), tissue ischemia (skin, musculature) (14%), hematoma (12%), seroma (12%), drain complications (10%), wound infection (superficial 10%, deep 4%, organ space 0%), and wound cellulitis (2%). There was one recurrence at 12 months in an onlay repair without CST.

Conclusions: Ventral and Incisional hernia repairs, in patients with underlying comorbid conditions, result in frequent complications. Postoperative wound complications following hernia repair with mesh may potentially result in mesh infection. Ventral hernia repair in comorbid patients utilizing a poly-4-hydroxybutyrate mesh utilized as additional reinforcement to primary fascial closure results in acceptable short-term outcomes. Visual analog pain scores improve following hernia repair and continue to improve 6 months postoperatively. Longer term follow-up is ongoing.

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