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

John Scott Roth, Gary J. Anthone, Don Selzer, Benjamin K. Poulose, James G. Bittner, William W. Hope, Raymond M. Dunn, Robert G. Martindale, Matthew I. Goldblatt, David B. Earle, J. R. Romanelli, Gregory J. Mancini, Jacob A. Greenberg, John G. Linn, Eduardo Parra-Davila, Bryan J. Sandler, Corey R. Deeken, Guy R. Voeller

Research output: Contribution to journalArticle

9 Citations (Scopus)

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.

Original languageEnglish (US)
Pages (from-to)1-8
Number of pages8
JournalSurgical Endoscopy and Other Interventional Techniques
DOIs
StateAccepted/In press - Oct 23 2017

Fingerprint

Ventral Hernia
Herniorrhaphy
Centers for Disease Control and Prevention (U.S.)
Inlays
Hernia
Hypoalbuminemia
Immunosuppression
Chronic Obstructive Pulmonary Disease
Renal Insufficiency
Adrenal Cortex Hormones
Obesity
Seroma
Surgical Wound Infection
Recurrence
Abdominal Wall
poly(4-hydroxybutanoate)
Incisional Hernia
Comorbidity
Coronary Artery Disease
Cardiovascular Diseases

Keywords

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

ASJC Scopus subject areas

  • Surgery

Cite this

Prospective evaluation of poly-4-hydroxybutyrate mesh in CDC class I/high-risk ventral and incisional hernia repair : 18-month follow-up. / Roth, John Scott; Anthone, Gary J.; Selzer, Don; Poulose, Benjamin K.; Bittner, James G.; Hope, William W.; Dunn, Raymond M.; Martindale, Robert G.; Goldblatt, Matthew I.; Earle, David B.; Romanelli, J. R.; Mancini, Gregory J.; Greenberg, Jacob A.; Linn, John G.; Parra-Davila, Eduardo; Sandler, Bryan J.; Deeken, Corey R.; Voeller, Guy R.

In: Surgical Endoscopy and Other Interventional Techniques, 23.10.2017, p. 1-8.

Research output: Contribution to journalArticle

Roth, JS, Anthone, GJ, Selzer, D, Poulose, BK, Bittner, JG, Hope, WW, Dunn, RM, Martindale, RG, Goldblatt, MI, Earle, DB, Romanelli, JR, Mancini, GJ, Greenberg, JA, Linn, JG, Parra-Davila, E, Sandler, BJ, Deeken, CR & Voeller, GR 2017, 'Prospective evaluation of poly-4-hydroxybutyrate mesh in CDC class I/high-risk ventral and incisional hernia repair: 18-month follow-up', Surgical Endoscopy and Other Interventional Techniques, pp. 1-8. https://doi.org/10.1007/s00464-017-5886-1
Roth, John Scott ; Anthone, Gary J. ; Selzer, Don ; Poulose, Benjamin K. ; Bittner, James G. ; Hope, William W. ; Dunn, Raymond M. ; Martindale, Robert G. ; Goldblatt, Matthew I. ; Earle, David B. ; Romanelli, J. R. ; Mancini, Gregory J. ; Greenberg, Jacob A. ; Linn, John G. ; Parra-Davila, Eduardo ; Sandler, Bryan J. ; Deeken, Corey R. ; Voeller, Guy R. / Prospective evaluation of poly-4-hydroxybutyrate mesh in CDC class I/high-risk ventral and incisional hernia repair : 18-month follow-up. In: Surgical Endoscopy and Other Interventional Techniques. 2017 ; pp. 1-8.
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title = "Prospective evaluation of poly-4-hydroxybutyrate mesh in CDC class I/high-risk ventral and incisional hernia repair: 18-month follow-up",
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",
author = "Roth, {John Scott} and Anthone, {Gary J.} and Don Selzer and Poulose, {Benjamin K.} and Bittner, {James G.} and Hope, {William W.} and Dunn, {Raymond M.} and Martindale, {Robert G.} and Goldblatt, {Matthew I.} and Earle, {David B.} and Romanelli, {J. R.} and Mancini, {Gregory J.} and Greenberg, {Jacob A.} and Linn, {John G.} and Eduardo Parra-Davila and Sandler, {Bryan J.} and Deeken, {Corey R.} and Voeller, {Guy R.}",
year = "2017",
month = "10",
day = "23",
doi = "10.1007/s00464-017-5886-1",
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TY - JOUR

T1 - Prospective evaluation of poly-4-hydroxybutyrate mesh in CDC class I/high-risk ventral and incisional hernia repair

T2 - 18-month follow-up

AU - Roth, John Scott

AU - Anthone, Gary J.

AU - Selzer, Don

AU - Poulose, Benjamin K.

AU - Bittner, James G.

AU - Hope, William W.

AU - Dunn, Raymond M.

AU - Martindale, Robert G.

AU - Goldblatt, Matthew I.

AU - Earle, David B.

AU - Romanelli, J. R.

AU - Mancini, Gregory J.

AU - Greenberg, Jacob A.

AU - Linn, John G.

AU - Parra-Davila, Eduardo

AU - Sandler, Bryan J.

AU - Deeken, Corey R.

AU - Voeller, Guy R.

PY - 2017/10/23

Y1 - 2017/10/23

N2 - 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.

AB - 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.

KW - Hernia repair

KW - Infection

KW - Mesh

KW - Poly-4-hydroxybutyrate

KW - Recurrence

KW - Seroma

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