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

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.

Conflict of interest statement

The funders had a role in the design of the study; in the collection, analyses, and interpretation of data; in the writing of the manuscript, and in the decision to publish the results. George DeNoto, Salvatore Pacella, Michael Sawyer, and Geoffrey Slayden are all consultants for TELA Bio, Inc.

© 2022 The Authors.

Figures

Fig. 1
Fig. 1
Patient accounting through 24 months.
Fig. 2
Fig. 2
Patient reported outcomes, HerQles, EQ-5D VAS, EQ-5D Index.
Fig. 3
Fig. 3
Kaplan-Meier curve for hernia recurrence over time (censored at day 730).

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Source: PubMed

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