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 J. Selzer, Benjamin K. Poulose, James G. Bittner, William W. Hope, Raymond M. Dunn, Robert G. Martindale, Matthew I. Goldblatt, David B. Earle, John R. Romanelli, Gregory 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)1929-1936
Number of pages8
JournalSurgical Endoscopy
Volume32
Issue number4
DOIs
StatePublished - Apr 1 2018

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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

All Science Journal Classification (ASJC) codes

  • Surgery

Cite this

Roth, J. S., Anthone, G. J., Selzer, D. J., Poulose, B. K., Bittner, J. G., Hope, W. W., ... Voeller, G. R. (2018). Prospective evaluation of poly-4-hydroxybutyrate mesh in CDC class I/high-risk ventral and incisional hernia repair: 18-month follow-up. Surgical Endoscopy, 32(4), 1929-1936. https://doi.org/10.1007/s00464-017-5886-1

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

In: Surgical Endoscopy, Vol. 32, No. 4, 01.04.2018, p. 1929-1936.

Research output: Contribution to journalArticle

Roth, JS, Anthone, GJ, Selzer, DJ, Poulose, BK, Bittner, JG, Hope, WW, Dunn, RM, Martindale, RG, Goldblatt, MI, Earle, DB, Romanelli, JR, Mancini, G, Greenberg, JA, Linn, JG, Parra-Davila, E, Sandler, BJ, Deeken, CR & Voeller, GR 2018, 'Prospective evaluation of poly-4-hydroxybutyrate mesh in CDC class I/high-risk ventral and incisional hernia repair: 18-month follow-up', Surgical Endoscopy, vol. 32, no. 4, pp. 1929-1936. https://doi.org/10.1007/s00464-017-5886-1
Roth, John Scott ; Anthone, Gary J. ; Selzer, Don J. ; Poulose, Benjamin K. ; Bittner, James G. ; Hope, William W. ; Dunn, Raymond M. ; Martindale, Robert G. ; Goldblatt, Matthew I. ; Earle, David B. ; Romanelli, John R. ; Mancini, Gregory ; 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. 2018 ; Vol. 32, No. 4. pp. 1929-1936.
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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.",
author = "Roth, {John Scott} and Anthone, {Gary J.} and Selzer, {Don J.} 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, {John R.} and Gregory Mancini 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 = "2018",
month = "4",
day = "1",
doi = "10.1007/s00464-017-5886-1",
language = "English (US)",
volume = "32",
pages = "1929--1936",
journal = "Surgical Endoscopy",
issn = "0930-2794",
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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 J.

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, John R.

AU - Mancini, Gregory

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 - 2018/4/1

Y1 - 2018/4/1

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.

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