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).

Autor:	Hope WW; New Hanover Regional Medical Center, Department of Surgery, Wilmington, NC, United States., El-Ghazzawy AG; Overlake Medical Center, Department of Surgery, Bellevue, WA, United States., Winterstein BA; Methodist Hospital, Department of Surgery, Omaha, NE, United States., Blatnik JA; Washington University, Department of Surgery, St. Louis, MO, United States., Davis SS; Emory University, Department of Surgery, Atlanta, GA, United States., Greenberg JA; University of Wisconsin, Department of Surgery, Madison, WI, United States., Sanchez NC; Via-Christi Hospital, Department of Surgery, Wichita, KS, United States., Pauli EM; Penn State Hershey Medical Center, Department of Surgery, Hershey, PA, United States., Tseng DM; Legacy Health, Department of Surgery, Portland, OR, United States., LeBlanc KA; Our Lady of the Lake Regional Medical Center, Department of Surgery, Baton Rouge, LA, United States., Roberts KE; St. Francis Hospital, Department of Surgery, Hartford, CT, United States., Bower CE; Carilion Clinic, Department of Surgery, Roanoke, VA, United States., Parra-Davila E; Celebration Health, Department of Surgery, Celebration, FL, United States., Roth JS; University of Kentucky, Department of Surgery, Lexington, KY, United States., Deeken CR; Covalent Bio, LLC, St. Louis, MO, United States., Smith EF; Georgetown Community Hospital, Department of Surgery, Georgetown, KY, United States.
Jazyk:	angličtina
Zdroj:	Annals of medicine and surgery (2012) [Ann Med Surg (Lond)] 2021 Dec 06; Vol. 73, pp. 103156. Date of Electronic Publication: 2021 Dec 06 (Print Publication: 2022).
DOI:	10.1016/j.amsu.2021.103156
Abstrakt:	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/m 2 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 cm 2 , 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 cm 2 (43.3%) compared to defects <7.1 cm 2 (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. Competing Interests: Drs. Davis, Tseng, Winterstein, Roberts, and El-Ghazzawy have no financial disclosures or conflicts of interest. Dr. Blatnik is a paid consultant for BD, Intuitive, and Surgimatrix and receives research support from Cook and Ethicon. Dr. Pauli is a paid consultant for Boston Scientific, Actuated Biomedical, Baxter, Wells Fargo, Cook Biotech, CMR Surgical, Neptune Medical, Surgimatix, Boehringer Laboratories, Allergan, and Noah Medical, receives speaking or teaching honoraria from Becton Dickinson (BD), Medtronic, Ovesco, and Boston Scientific, and receives royalties from UpToDate and Springer. Dr. Smith is a paid speaker/teacher for BD and Intuitive Surgical. Dr. Bower receives honoraria from BD. Dr. Sanchez is a paid consultant for BD. Dr. LeBlanc is a paid speaker for BD, Intuitive, and W.L. Gore. Dr. Roth reports an institutional grant from C.R. Bard, Inc./Davol/Becton Dickinson (BD) during the conduct of this study. Dr. Roth also reports consulting fees (Johnson & Johnson and C.R. Bard, Inc./Davol/Becton Dickinson), institutional grant (Advanced Medical Solutions), stock (Miromatrix), and speaking fees (Allergan) outside of the current work. Dr. Hope reports consulting fees and research support from C.R. Bard, Inc./Davol/Becton Dickinson (BD) during the conduct of the study. Dr. Hope also reports consulting fees, honoraria, and research support (Intuitive, W.L. Gore, and Medtronic) outside of the current work and participates in the Surgeon Advisory Board for Mesh Suture and Deep Blue. Dr. Greenberg reports a grant from C.R. Bard, Inc./Davol/Becton Dickinson (BD) during the conduct of the study. Dr. Greenberg also reports grants (Becton Dickinson (BD) and Medtronic), as well as course registration, travel, and lodging (Intuitive) outside of the current work. Dr. Parra-Davila has no conflicts of interest to disclose related to the current study. Dr. Parra-Davila reports consulting/speaking fees (C.R. Bard, Inc./Davol/Becton Dickinson (BD), Intuitive, Johnson & Johnson, and Medtronic), research funds (C.R. Bard, Inc./Davol/Becton Dickinson (BD)), and proctoring (Intuitive and C.R. Bard, Inc./Davol/Becton Dickinson (BD)) outside of the current work. Dr. Deeken reports consulting fees from C.R. Bard, Inc./Davol/Becton Dickinson (BD) during the conduct of the study. Dr. Deeken also reports consulting fees from C.R. Bard, Inc./Davol/Becton Dickinson (BD), Johnson & Johnson, Medtronic, SurgiMatrix, Tissium, Surgical Innovation Associates, Americas Hernia Society Quality Collaborative, Colorado Therapeutics, TelaBio, and Aran Biomedical outside the submitted work. In addition, Dr. Deeken is the owner of Covalent Bio, LLC and holds the following issued patents: 2009293001, 2334257, 2,334,257UK, 602009046407.8, 2,334,257FR, 16/043,849 and 2,737,542. (© 2021 The Authors.)
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