TY - JOUR
T1 - Prospective, multicenter study of P4HB (Phasix™) mesh for hernia repair in cohort at risk for complications
T2 - 3-Year follow-up
AU - Roth, John Scott
AU - Anthone, Gary J.
AU - Selzer, Don J.
AU - Poulose, Benjamin K.
AU - Pierce, Richard A.
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 J.
AU - Greenberg, Jacob A.
AU - Linn, John G.
AU - Parra-Davila, Eduardo
AU - Sandler, Bryan J.
AU - Deeken, Corey R.
AU - Verbarg, Jasenka
AU - Salluzzo, Jennifer L.
AU - Voeller, Guy R.
N1 - Publisher Copyright:
© 2020
PY - 2021/1
Y1 - 2021/1
N2 - Background: This study represents a prospective, multicenter, open-label study to assess the safety, performance, and outcomes of poly-4-hydroxybutyrate (P4HB, Phasix™) mesh for primary ventral, primary incisional, or multiply-recurrent hernia in subjects at risk for complications. This study reports 3-year clinical outcomes. Materials and methods: P4HB mesh was implanted in 121 patients via retrorectus or onlay technique. Physical exam and/or quality of life surveys were completed at 1, 3, 6,12, 18, 24, and 36 months, with 5-year (60-month) follow-up ongoing. Results: A total of n = 121 patients were implanted with P4HB mesh (n = 75 (62%) female) with a mean age of 54.7 ± 12.0 years and mean BMI of 32.2 ± 4.5 kg/m2 (±standard deviation). Comorbidities included: obesity (78.5%), active smokers (23.1%), COPD (28.1%), diabetes mellitus (33.1%), immunosuppression (8.3%), coronary artery disease (21.5%), chronic corticosteroid use (5.0%), hypo-albuminemia (2.5%), advanced age (5.0%), and renal insufficiency (0.8%). Hernias were repaired via retrorectus (n = 45, 37.2% with myofascial release (MR) or n = 43, 35.5% without MR), onlay (n = 8, 6.6% with MR or n = 24, 19.8% without MR), or not reported (n = 1, 0.8%). 82 patients (67.8%) completed 36-month follow-up. 17 patients (17.9% ± 0.4%) experienced hernia recurrence at 3 years, with n = 9 in the retrorectus group and n = 8 in the onlay group. SSI (n = 11) occurred in 9.3% ± 0.03% of patients. Conclusions: Long-term outcomes following ventral hernia repair with P4HB mesh demonstrate low recurrence rates at 3-year (36-month) postoperative time frame with no patients developing late mesh complications or requiring mesh removal. 5-year (60-month) follow-up is ongoing.
AB - Background: This study represents a prospective, multicenter, open-label study to assess the safety, performance, and outcomes of poly-4-hydroxybutyrate (P4HB, Phasix™) mesh for primary ventral, primary incisional, or multiply-recurrent hernia in subjects at risk for complications. This study reports 3-year clinical outcomes. Materials and methods: P4HB mesh was implanted in 121 patients via retrorectus or onlay technique. Physical exam and/or quality of life surveys were completed at 1, 3, 6,12, 18, 24, and 36 months, with 5-year (60-month) follow-up ongoing. Results: A total of n = 121 patients were implanted with P4HB mesh (n = 75 (62%) female) with a mean age of 54.7 ± 12.0 years and mean BMI of 32.2 ± 4.5 kg/m2 (±standard deviation). Comorbidities included: obesity (78.5%), active smokers (23.1%), COPD (28.1%), diabetes mellitus (33.1%), immunosuppression (8.3%), coronary artery disease (21.5%), chronic corticosteroid use (5.0%), hypo-albuminemia (2.5%), advanced age (5.0%), and renal insufficiency (0.8%). Hernias were repaired via retrorectus (n = 45, 37.2% with myofascial release (MR) or n = 43, 35.5% without MR), onlay (n = 8, 6.6% with MR or n = 24, 19.8% without MR), or not reported (n = 1, 0.8%). 82 patients (67.8%) completed 36-month follow-up. 17 patients (17.9% ± 0.4%) experienced hernia recurrence at 3 years, with n = 9 in the retrorectus group and n = 8 in the onlay group. SSI (n = 11) occurred in 9.3% ± 0.03% of patients. Conclusions: Long-term outcomes following ventral hernia repair with P4HB mesh demonstrate low recurrence rates at 3-year (36-month) postoperative time frame with no patients developing late mesh complications or requiring mesh removal. 5-year (60-month) follow-up is ongoing.
KW - Hernia repair
KW - Infection
KW - Mesh
KW - Poly-4-hydroxybutyrate
KW - Recurrence
KW - Seroma
UR - http://www.scopus.com/inward/record.url?scp=85097791103&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85097791103&partnerID=8YFLogxK
U2 - 10.1016/j.amsu.2020.12.002
DO - 10.1016/j.amsu.2020.12.002
M3 - Article
AN - SCOPUS:85097791103
SN - 2049-0801
VL - 61
SP - 1
EP - 7
JO - Annals of Medicine and Surgery
JF - Annals of Medicine and Surgery
ER -
