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P039: FINAL OUTCOMES OF THE INITIAL 20 SUBJECTS REACHING 2 YEAR FOLLOW UP IN THE BRAVO VENTRAL HERNIA STUDY
George DeNoto, MD, FACS; St. Francis Hospital
Purpose: The BRAVO trial was designed to evaluate the clinical performance of a novel reinforced tissue matrix in variety of ventral hernia repairs. This abstract presents the final disposition of the initial 20 subjects reaching 2 year follow-up post implantation.
Methods: BRAVO is a prospective, single arm, multicenter study. Most patients presenting with a ventral hernia were eligible. Excluded were a BMI > 40, CDC wound class Grade IV, and defects requiring implants > 20 x 20 cm. The endpoints studied are real and apparent recurrences as evidenced by CT scan, and all post-operative surgical site occurrences (SSO) or wound related events. Other complications unrelated to the procedure occurring within the first three months following surgery were noted as well. At each follow up timepoint patients completed Quality of Life (QoL) questionnaires and pain assessments. Patients are being followed 2 years.
Results: In total ninety-two (92) patients were enrolled and underwent surgery. Twenty (20) subjects have now completed their two year follow-up. In this group, the average BMI was 31.1 with 70% of the patients classifying as obese. Fourteen (14) of the 20 had a VHWG grade 2 and three grade 3. Six (6) subjects experienced SSOs, five (5) infections and one (1) hematoma, all of which had resolved at the time of first analysis and did not require surgical intervention. No subject in this group has experienced a recurrence (0 of 20; 0%) through two years.
Conclusion: This first look at long-term outcomes in this prospective study is promising as in this group no further surgery was necessary to treat either complications or recurrences. With the initial 20% of the intended patient population having reached the two-year follow-up, the observed absence of any recurrence is extremely encouraging.
*On behalf of the BRAVO Study Group
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