24-Month results of the BRAVO study: A prospective, multi-center study evaluating the clinical outcomes of a ventral hernia cohort treated with OviTex® 1S permanent reinforced tissue matrix

George DeNoto 3rd; Eugene P Ceppa; Salvatore J Pacella; Michael Sawyer; Geoffrey Slayden; Mark Takata; Gary Tuma; Jonathan Yunis

doi:10.1016/j.amsu.2022.104745

24-Month results of the BRAVO study: A prospective, multi-center study evaluating the clinical outcomes of a ventral hernia cohort treated with OviTex® 1S permanent reinforced tissue matrix

Ann Med Surg (Lond). 2022 Sep 27:83:104745. doi: 10.1016/j.amsu.2022.104745. eCollection 2022 Nov.

Authors

George DeNoto 3rd¹, Eugene P Ceppa², Salvatore J Pacella³, Michael Sawyer⁴, Geoffrey Slayden⁵, Mark Takata⁶, Gary Tuma⁷, Jonathan Yunis⁸

Affiliations

¹ Department of General Surgery, St. Francis Hospital, Roslyn, NY, 11576, USA.
² Department of Surgery, Indiana University School of Medicine, Indianapolis, IN, 46202, USA.
³ Scripps Clinic and Scripps M.D. Anderson Cancer Center, Division of Plastic and Reconstructive Surgery, San Diego, CA, 92130, USA.
⁴ Department of Surgery, Comanche County Memorial Hospital, Lawton, OK, 73505, USA.
⁵ St. Luke's Surgical Specialists, St. Luke's Health System, Overland Park, KS, 66213, USA.
⁶ Scripps Clinic Medical Group, Department of Surgery, La Jolla, CA, 92037, USA.
⁷ Capital Health Medical Group, Department of Plastic Surgery, Pennington, NJ, 08534, USA.
⁸ Hernia Specialist, Center for Hernia Repair, Sarasota, FL, 34239, USA.

Abstract

Background: This study evaluated the performance of OviTex® 1S (TELA Bio Inc., Malvern, PA, USA) over 24 months when used for ventral hernia repair.

Methods: This was a prospective, single-arm, multi-center clinical trial (ClinicalTrials.gov/NCT03074474). A ninety-two patient cohort with ventral hernias were enrolled. The surgical approach (open, laparoscopic, or robotic) and plane of placement (retrorectus, intraperitoneal, or pre-peritoneal) were at the discretion of the surgeon. Patients were characterized as high risk for a surgical site occurrence (SSO) based on the following comorbidities: BMI between 30 and 40, active smoker, chronic obstructive pulmonary disease (COPD), diabetes mellitus, coronary artery disease, advanced age ( ≥ 75 years). Subjects underwent physical examinations to evaluate safety events and completed quality of life surveys at 1 months, 3 months, 12 months, and 24 months post-surgery.

Results: Sixty-five of the 92 enrolled patients (70.7%) completed 24-month follow-up. The Kaplan Meier estimate for risk of recurrence at day 730 (24 months) was 2.6%; among subjects who completed their 24-month visit or had a previous recurrence, the unadjusted rate of recurrence was 4.5% (3/66). SSOs were observed in 38.0% of patients (35/92). The most prevalent SSO was surgical site infection occurring in 20.7% (19/92) of patients, followed by seroma formation, which occurred in 13.0% of patients; however, only 3.3% required intervention. HerQLes and EQ-5D assessments showed improvement from baseline as soon as 3 months post-surgery. Continued improvement was observed through 24 months.

Conclusions: Overall the BRAVO study demonstrates that use of the ovine reinforced tissue matrix OviTex 1S is a viable option for use in ventral hernia repair. Additional studies with longer term follow-up data are needed to draw definitive conclusions on the use of OviTex 1S.

Keywords: Hernia recurrence; Ovine reinforced tissue matrix; Reinforced biologic; Ventral hernia repair.

Associated data

ClinicalTrials.gov/NCT03074474