A prospective, multicenter trial of a long-term bioabsorbable mesh with Sepra technology in cohort of challenging laparoscopic ventral or incisional hernia repairs (ATLAS trial)

William W. Hope; Adel G. El-Ghazzawy; Brad A. Winterstein; Jeffrey A. Blatnik; S. Scott Davis; Jacob A. Greenberg; Noel C. Sanchez; Eric M. Pauli; Daniel M. Tseng; Karl A. LeBlanc; Kurt E. Roberts; Curtis E. Bower; Eduardo Parra-Davila; J. Scott Roth; Corey R. Deeken; Eric F. Smith

doi:10.1016/j.amsu.2021.103156

A prospective, multicenter trial of a long-term bioabsorbable mesh with Sepra technology in cohort of challenging laparoscopic ventral or incisional hernia repairs (ATLAS trial)

William W. Hope, Adel G. El-Ghazzawy, Brad A. Winterstein, Jeffrey A. Blatnik, S. Scott Davis, Jacob A. Greenberg, Noel C. Sanchez, Eric M. Pauli, Daniel M. Tseng, Karl A. LeBlanc, Kurt E. Roberts, Curtis E. Bower, Eduardo Parra-Davila, J. Scott Roth, Corey R. Deeken, Eric F. Smith

Research output: Contribution to journal › Article › peer-review

Abstract

Background: This prospective, multicenter, single-arm, open-label study evaluated P4HB-ST mesh in laparoscopic ventral or incisional hernia repair (LVIHR) in patients with Class I (clean) wounds at high risk for Surgical Site Occurrence (SSO). Methods: Primary endpoint was SSO requiring intervention <45 days. Secondary endpoints included: surgical procedure time, length of stay, SSO >45 days, hernia recurrence, device-related adverse events, reoperation, and Quality of Life at 1, 3, 6, 12, 18, and 24-months. Results: 120 patients (52.5% male), mean age of 55.0 ± 14.9 years, and BMI of 33.2 ± 4.5 kg/m² received P4HB-ST mesh. Patient-reported comorbid conditions included: obesity (86.7%), active smoker (45.0%), COPD (5.0%), diabetes (16.7%), immunosuppression (2.5%), coronary artery disease (7.5%), chronic corticosteroid use (2.5%), hypoalbuminemia (0.8%), advanced age (10.0%), and renal insufficiency (0.8%). Hernia types were primary ventral (44.2%), primary incisional (37.5%), recurrent ventral (5.8%), and recurrent incisional (12.5%). Patients underwent LVIHR in laparoscopic (55.8%) or robotic-assisted cases (44.2%), mean defect size 15.7 ± 28.3 cm², mean procedure time 85.9 ± 43.0 min, and mean length of stay 1.0 ± 1.4 days. There were no SSOs requiring intervention beyond 45 days, n = 38 (31.7%) recurrences, n = 22 (18.3%) reoperations, and n = 2 (1.7%) device-related adverse events (excluding recurrence). Conclusion: P4HB-ST mesh demonstrated low rates of SSO and device-related complications, with improved quality of life scores, and reoperation rate comparable to other published studies. Recurrence rate was higher than expected at 31.7%. However, when analyzed by hernia defect size, recurrence was disproportionately high in defects ≥7.1 cm² (43.3%) compared to defects <7.1 cm² (18.6%). Thus, in LVIHR, P4HB-ST may be better suited for small defects. Caution is warranted when utilizing P4HB-ST in laparoscopic IPOM repair of larger defects until additional studies can further investigate outcomes.

Original language	English
Article number	103156
Journal	Annals of Medicine and Surgery
Volume	73
DOIs	https://doi.org/10.1016/j.amsu.2021.103156
State	Published - Jan 2022

Bibliographical note

Funding Information:
As described by the Deeken & Lake Mesh Classification System in a recent review article, a multitude of possible combinations exist, with 7 sub-categories of “barrier” devices encompassing more than 40 designs [5]. One particularly novel design is P4HB-ST mesh (Phasix™ ST Mesh, C. R. Bard/Davol, Inc., Warwick, RI), which represents the only fully absorbable barrier mesh construct. P4HB-ST mesh is comprised of an absorbable polymer scaffold of poly-4-hydroxybutyrate (P4HB) combined with an absorbable hydrogel barrier layer (ST) of sodium hyaluronate, carboxymethylcellulose, and polyethylene glycol [6]. The barrier is absorbed over a period of approximately 30 days, while the underlying P4HB scaffold is absorbed by 12–18 months [6]. The predictable absorption of the components results in a gradual transfer of load from the mesh back to the remodeled abdominal wall. The medium-term absorption profile of P4HB meshes (Phasix™ Mesh & Phasix™ ST Mesh: 12–18 months) [6,7] provides support to the repair site longer than short-term absorbable materials such as glycolide:lactide (Vicryl®: 2–3 months) [8] and polyglycolic acid:trimethylene carbonate (Bio-A®: 6–7 months) [9]. This is an important benefit since a mesh that is absorbed before newly deposited host collagen has matured may result in a hernia recurrence due to a lack of mechanical support at the repair site.

Publisher Copyright:
© 2021 The Authors

Keywords

Laparoscopic incisional hernia repair
Laparoscopic ventral hernia repair
Poly-4-hydroxybutyrate
Recurrence
Surgical site infection
Surgical site occurrence

ASJC Scopus subject areas

Surgery

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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10.1016/j.amsu.2021.103156

Cite this

Hope, W. W., El-Ghazzawy, A. G., Winterstein, B. A., Blatnik, J. A., Davis, S. S., Greenberg, J. A., Sanchez, N. C., Pauli, E. M., Tseng, D. M., LeBlanc, K. A., Roberts, K. E., Bower, C. E., Parra-Davila, E., Roth, J. S., Deeken, C. R., & Smith, E. F. (2022). A prospective, multicenter trial of a long-term bioabsorbable mesh with Sepra technology in cohort of challenging laparoscopic ventral or incisional hernia repairs (ATLAS trial). Annals of Medicine and Surgery, 73, [103156]. https://doi.org/10.1016/j.amsu.2021.103156

@article{619603fb39ff429f8caad228a8b03ed5,

title = "A prospective, multicenter trial of a long-term bioabsorbable mesh with Sepra technology in cohort of challenging laparoscopic ventral or incisional hernia repairs (ATLAS trial)",

abstract = "Background: This prospective, multicenter, single-arm, open-label study evaluated P4HB-ST mesh in laparoscopic ventral or incisional hernia repair (LVIHR) in patients with Class I (clean) wounds at high risk for Surgical Site Occurrence (SSO). Methods: Primary endpoint was SSO requiring intervention <45 days. Secondary endpoints included: surgical procedure time, length of stay, SSO >45 days, hernia recurrence, device-related adverse events, reoperation, and Quality of Life at 1, 3, 6, 12, 18, and 24-months. Results: 120 patients (52.5% male), mean age of 55.0 ± 14.9 years, and BMI of 33.2 ± 4.5 kg/m2 received P4HB-ST mesh. Patient-reported comorbid conditions included: obesity (86.7%), active smoker (45.0%), COPD (5.0%), diabetes (16.7%), immunosuppression (2.5%), coronary artery disease (7.5%), chronic corticosteroid use (2.5%), hypoalbuminemia (0.8%), advanced age (10.0%), and renal insufficiency (0.8%). Hernia types were primary ventral (44.2%), primary incisional (37.5%), recurrent ventral (5.8%), and recurrent incisional (12.5%). Patients underwent LVIHR in laparoscopic (55.8%) or robotic-assisted cases (44.2%), mean defect size 15.7 ± 28.3 cm2, mean procedure time 85.9 ± 43.0 min, and mean length of stay 1.0 ± 1.4 days. There were no SSOs requiring intervention beyond 45 days, n = 38 (31.7%) recurrences, n = 22 (18.3%) reoperations, and n = 2 (1.7%) device-related adverse events (excluding recurrence). Conclusion: P4HB-ST mesh demonstrated low rates of SSO and device-related complications, with improved quality of life scores, and reoperation rate comparable to other published studies. Recurrence rate was higher than expected at 31.7%. However, when analyzed by hernia defect size, recurrence was disproportionately high in defects ≥7.1 cm2 (43.3%) compared to defects <7.1 cm2 (18.6%). Thus, in LVIHR, P4HB-ST may be better suited for small defects. Caution is warranted when utilizing P4HB-ST in laparoscopic IPOM repair of larger defects until additional studies can further investigate outcomes.",

keywords = "Laparoscopic incisional hernia repair, Laparoscopic ventral hernia repair, Poly-4-hydroxybutyrate, Recurrence, Surgical site infection, Surgical site occurrence",

author = "Hope, {William W.} and El-Ghazzawy, {Adel G.} and Winterstein, {Brad A.} and Blatnik, {Jeffrey A.} and Davis, {S. Scott} and Greenberg, {Jacob A.} and Sanchez, {Noel C.} and Pauli, {Eric M.} and Tseng, {Daniel M.} and LeBlanc, {Karl A.} and Roberts, {Kurt E.} and Bower, {Curtis E.} and Eduardo Parra-Davila and Roth, {J. Scott} and Deeken, {Corey R.} and Smith, {Eric F.}",

note = "Funding Information: As described by the Deeken & Lake Mesh Classification System in a recent review article, a multitude of possible combinations exist, with 7 sub-categories of “barrier” devices encompassing more than 40 designs [5]. One particularly novel design is P4HB-ST mesh (Phasix{\texttrademark} ST Mesh, C. R. Bard/Davol, Inc., Warwick, RI), which represents the only fully absorbable barrier mesh construct. P4HB-ST mesh is comprised of an absorbable polymer scaffold of poly-4-hydroxybutyrate (P4HB) combined with an absorbable hydrogel barrier layer (ST) of sodium hyaluronate, carboxymethylcellulose, and polyethylene glycol [6]. The barrier is absorbed over a period of approximately 30 days, while the underlying P4HB scaffold is absorbed by 12–18 months [6]. The predictable absorption of the components results in a gradual transfer of load from the mesh back to the remodeled abdominal wall. The medium-term absorption profile of P4HB meshes (Phasix{\texttrademark} Mesh & Phasix{\texttrademark} ST Mesh: 12–18 months) [6,7] provides support to the repair site longer than short-term absorbable materials such as glycolide:lactide (Vicryl{\textregistered}: 2–3 months) [8] and polyglycolic acid:trimethylene carbonate (Bio-A{\textregistered}: 6–7 months) [9]. This is an important benefit since a mesh that is absorbed before newly deposited host collagen has matured may result in a hernia recurrence due to a lack of mechanical support at the repair site. Publisher Copyright: {\textcopyright} 2021 The Authors",

year = "2022",

month = jan,

doi = "10.1016/j.amsu.2021.103156",

language = "English",

volume = "73",

}

Hope, WW, El-Ghazzawy, AG, Winterstein, BA, Blatnik, JA, Davis, SS, Greenberg, JA, Sanchez, NC, Pauli, EM, Tseng, DM, LeBlanc, KA, Roberts, KE, Bower, CE, Parra-Davila, E, Roth, JS, Deeken, CR & Smith, EF 2022, 'A prospective, multicenter trial of a long-term bioabsorbable mesh with Sepra technology in cohort of challenging laparoscopic ventral or incisional hernia repairs (ATLAS trial)', Annals of Medicine and Surgery, vol. 73, 103156. https://doi.org/10.1016/j.amsu.2021.103156

A prospective, multicenter trial of a long-term bioabsorbable mesh with Sepra technology in cohort of challenging laparoscopic ventral or incisional hernia repairs (ATLAS trial). / Hope, William W.; El-Ghazzawy, Adel G.; Winterstein, Brad A. et al.

In: Annals of Medicine and Surgery, Vol. 73, 103156, 01.2022.

Research output: Contribution to journal › Article › peer-review

TY - JOUR

T1 - A prospective, multicenter trial of a long-term bioabsorbable mesh with Sepra technology in cohort of challenging laparoscopic ventral or incisional hernia repairs (ATLAS trial)

AU - Hope, William W.

AU - El-Ghazzawy, Adel G.

AU - Winterstein, Brad A.

AU - Blatnik, Jeffrey A.

AU - Davis, S. Scott

AU - Greenberg, Jacob A.

AU - Sanchez, Noel C.

AU - Pauli, Eric M.

AU - Tseng, Daniel M.

AU - LeBlanc, Karl A.

AU - Roberts, Kurt E.

AU - Bower, Curtis E.

AU - Parra-Davila, Eduardo

AU - Roth, J. Scott

AU - Deeken, Corey R.

AU - Smith, Eric F.

N1 - Funding Information: As described by the Deeken & Lake Mesh Classification System in a recent review article, a multitude of possible combinations exist, with 7 sub-categories of “barrier” devices encompassing more than 40 designs [5]. One particularly novel design is P4HB-ST mesh (Phasix™ ST Mesh, C. R. Bard/Davol, Inc., Warwick, RI), which represents the only fully absorbable barrier mesh construct. P4HB-ST mesh is comprised of an absorbable polymer scaffold of poly-4-hydroxybutyrate (P4HB) combined with an absorbable hydrogel barrier layer (ST) of sodium hyaluronate, carboxymethylcellulose, and polyethylene glycol [6]. The barrier is absorbed over a period of approximately 30 days, while the underlying P4HB scaffold is absorbed by 12–18 months [6]. The predictable absorption of the components results in a gradual transfer of load from the mesh back to the remodeled abdominal wall. The medium-term absorption profile of P4HB meshes (Phasix™ Mesh & Phasix™ ST Mesh: 12–18 months) [6,7] provides support to the repair site longer than short-term absorbable materials such as glycolide:lactide (Vicryl®: 2–3 months) [8] and polyglycolic acid:trimethylene carbonate (Bio-A®: 6–7 months) [9]. This is an important benefit since a mesh that is absorbed before newly deposited host collagen has matured may result in a hernia recurrence due to a lack of mechanical support at the repair site. Publisher Copyright: © 2021 The Authors

PY - 2022/1

Y1 - 2022/1

N2 - Background: This prospective, multicenter, single-arm, open-label study evaluated P4HB-ST mesh in laparoscopic ventral or incisional hernia repair (LVIHR) in patients with Class I (clean) wounds at high risk for Surgical Site Occurrence (SSO). Methods: Primary endpoint was SSO requiring intervention <45 days. Secondary endpoints included: surgical procedure time, length of stay, SSO >45 days, hernia recurrence, device-related adverse events, reoperation, and Quality of Life at 1, 3, 6, 12, 18, and 24-months. Results: 120 patients (52.5% male), mean age of 55.0 ± 14.9 years, and BMI of 33.2 ± 4.5 kg/m2 received P4HB-ST mesh. Patient-reported comorbid conditions included: obesity (86.7%), active smoker (45.0%), COPD (5.0%), diabetes (16.7%), immunosuppression (2.5%), coronary artery disease (7.5%), chronic corticosteroid use (2.5%), hypoalbuminemia (0.8%), advanced age (10.0%), and renal insufficiency (0.8%). Hernia types were primary ventral (44.2%), primary incisional (37.5%), recurrent ventral (5.8%), and recurrent incisional (12.5%). Patients underwent LVIHR in laparoscopic (55.8%) or robotic-assisted cases (44.2%), mean defect size 15.7 ± 28.3 cm2, mean procedure time 85.9 ± 43.0 min, and mean length of stay 1.0 ± 1.4 days. There were no SSOs requiring intervention beyond 45 days, n = 38 (31.7%) recurrences, n = 22 (18.3%) reoperations, and n = 2 (1.7%) device-related adverse events (excluding recurrence). Conclusion: P4HB-ST mesh demonstrated low rates of SSO and device-related complications, with improved quality of life scores, and reoperation rate comparable to other published studies. Recurrence rate was higher than expected at 31.7%. However, when analyzed by hernia defect size, recurrence was disproportionately high in defects ≥7.1 cm2 (43.3%) compared to defects <7.1 cm2 (18.6%). Thus, in LVIHR, P4HB-ST may be better suited for small defects. Caution is warranted when utilizing P4HB-ST in laparoscopic IPOM repair of larger defects until additional studies can further investigate outcomes.

AB - Background: This prospective, multicenter, single-arm, open-label study evaluated P4HB-ST mesh in laparoscopic ventral or incisional hernia repair (LVIHR) in patients with Class I (clean) wounds at high risk for Surgical Site Occurrence (SSO). Methods: Primary endpoint was SSO requiring intervention <45 days. Secondary endpoints included: surgical procedure time, length of stay, SSO >45 days, hernia recurrence, device-related adverse events, reoperation, and Quality of Life at 1, 3, 6, 12, 18, and 24-months. Results: 120 patients (52.5% male), mean age of 55.0 ± 14.9 years, and BMI of 33.2 ± 4.5 kg/m2 received P4HB-ST mesh. Patient-reported comorbid conditions included: obesity (86.7%), active smoker (45.0%), COPD (5.0%), diabetes (16.7%), immunosuppression (2.5%), coronary artery disease (7.5%), chronic corticosteroid use (2.5%), hypoalbuminemia (0.8%), advanced age (10.0%), and renal insufficiency (0.8%). Hernia types were primary ventral (44.2%), primary incisional (37.5%), recurrent ventral (5.8%), and recurrent incisional (12.5%). Patients underwent LVIHR in laparoscopic (55.8%) or robotic-assisted cases (44.2%), mean defect size 15.7 ± 28.3 cm2, mean procedure time 85.9 ± 43.0 min, and mean length of stay 1.0 ± 1.4 days. There were no SSOs requiring intervention beyond 45 days, n = 38 (31.7%) recurrences, n = 22 (18.3%) reoperations, and n = 2 (1.7%) device-related adverse events (excluding recurrence). Conclusion: P4HB-ST mesh demonstrated low rates of SSO and device-related complications, with improved quality of life scores, and reoperation rate comparable to other published studies. Recurrence rate was higher than expected at 31.7%. However, when analyzed by hernia defect size, recurrence was disproportionately high in defects ≥7.1 cm2 (43.3%) compared to defects <7.1 cm2 (18.6%). Thus, in LVIHR, P4HB-ST may be better suited for small defects. Caution is warranted when utilizing P4HB-ST in laparoscopic IPOM repair of larger defects until additional studies can further investigate outcomes.

KW - Laparoscopic incisional hernia repair

KW - Laparoscopic ventral hernia repair

KW - Poly-4-hydroxybutyrate

KW - Recurrence

KW - Surgical site infection

KW - Surgical site occurrence

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UR - http://www.scopus.com/inward/citedby.url?scp=85121682405&partnerID=8YFLogxK

U2 - 10.1016/j.amsu.2021.103156

DO - 10.1016/j.amsu.2021.103156

M3 - Article

AN - SCOPUS:85121682405

VL - 73

M1 - 103156

ER -

A prospective, multicenter trial of a long-term bioabsorbable mesh with Sepra technology in cohort of challenging laparoscopic ventral or incisional hernia repairs (ATLAS trial)

Abstract

Bibliographical note

Keywords

ASJC Scopus subject areas

UN SDGs

Access to Document

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