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Surg Endosc. 2018 Apr;32(4):1929-1936. doi: 10.1007/s00464-017-5886-1. Epub 2017 Oct 23.

Prospective evaluation of poly-4-hydroxybutyrate mesh in CDC class I/high-risk ventral and incisional hernia repair: 18-month follow-up.

Author information

1
Department of Surgery, University of Kentucky Medical Center, 800 Rose Street, #C225, Lexington, KY, 40536, USA. s.roth@uky.edu.
2
Department of Surgery, Methodist Health System, Omaha, NE, USA.
3
Department of Surgery, Indiana University School of Medicine, Indianapolis, IN, USA.
4
Department of Surgery, Vanderbilt University Medical Center, Nashville, TN, USA.
5
Department of Surgery, Virginia Commonwealth University, Richmond, VA, USA.
6
Department of Surgery, New Hanover Regional Medical Center, Wilmington, NC, USA.
7
Department of Surgery, University of Massachusetts Worcester, Worcester, MA, USA.
8
Department of Surgery, Oregon Health & Science University, Portland, OR, USA.
9
Department of Surgery, The Medical College of Wisconsin, Inc., Milwaukee, WI, USA.
10
Department of Surgery, Baystate Medical Center, Springfield, MA, USA.
11
Department of Surgery, The University of Tennessee Health Science Center, Memphis, TN, USA.
12
Department of Surgery, Board of Regents of the University of Wisconsin System, Madison, WI, USA.
13
Department of Surgery, North Shore University Health System, Evanston, IL, USA.
14
Department of Surgery, Celebration Health, Celebration, FL, USA.
15
Department of Surgery, The Regents of the University of California, San Diego, CA, USA.
16
Covalent Bio, LLC, St. Louis, MO, USA.

Abstract

BACKGROUND:

Long-term resorbable mesh represents a promising technology for complex ventral and incisional hernia repair (VIHR). Preclinical studies indicate that poly-4-hydroxybutyrate (P4HB) resorbable mesh supports strength restoration of the abdominal wall. This study evaluated outcomes of high-risk subjects undergoing VIHR with P4HB mesh.

METHODS:

This was a prospective, multi-institutional study of subjects undergoing retrorectus or onlay VIHR. Inclusion criteria were CDC Class I, defect 10-350 cm2, ≤ 3 prior repairs, and ≥ 1 high-risk criteria (obesity (BMI: 30-40 kg/m2), active smoker, COPD, diabetes, immunosuppression, coronary artery disease, chronic corticosteroid use, hypoalbuminemia, advanced age, and renal insufficiency). Physical exam and/or quality of life surveys were performed at regular intervals through 18 months (to date) with longer-term, 36-month follow-up ongoing.

RESULTS:

One hundred and twenty-one subjects (46M, 75F) with an age of 54.7 ± 12.0 years and BMI of 32.2 ± 4.5 kg/m2 (mean ± SD), underwent VIHR. Comorbidities included the following: obesity (n = 95, 78.5%), hypertension (n = 72, 59.5%), cardiovascular disease (n = 42, 34.7%), diabetes (n = 40, 33.1%), COPD (n = 34, 28.1%), malignancy (n = 30, 24.8%), active smoker (n = 28, 23.1%), immunosuppression (n = 10, 8.3%), chronic corticosteroid use (n = 6, 5.0%), advanced age (n = 6, 5.0%), hypoalbuminemia (n = 3, 2.5%), and renal insufficiency (n = 1, 0.8%). Hernia types included the following: primary ventral (n = 17, 14%), primary incisional (n = 54, 45%), recurrent ventral (n = 15, 12%), and recurrent incisional hernia (n = 35, 29%). Defect and mesh size were 115.7 ± 80.6 and 580.9 ± 216.1 cm2 (mean ± SD), respectively. Repair types included the following: retrorectus (n = 43, 36%), retrorectus with additional myofascial release (n = 45, 37%), onlay (n = 24, 20%), and onlay with additional myofascial release (n = 8, 7%). 95 (79%) subjects completed 18-month follow-up to date. Postoperative wound infection, seroma requiring intervention, and hernia recurrence occurred in 11 (9%), 7 (6%), and 11 (9%) subjects, respectively.

CONCLUSIONS:

High-risk VIHR with P4HB mesh demonstrated positive outcomes and low incidence of hernia recurrence at 18 months. Longer-term 36-month follow-up is ongoing.

KEYWORDS:

Hernia repair; Infection; Mesh; Poly-4-hydroxybutyrate; Recurrence; Seroma

PMID:
29063307
DOI:
10.1007/s00464-017-5886-1
[Indexed for MEDLINE]

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