William W Hope, MD1, A G El-Ghazzazy, MD2, B A Winterstein, MD3, J A Blatnik, MD4, S S Davis, MD5, J A Greenberg, MD6, N C Sanchez, MD7, E M Pauli, MD8, D M Tseng, MD9, K A LeBlanc, MD10, K E Roberts, MD11, C E Bower, MD12, E Parra-Davila, MD13, J S Roth, MD14, E F Smith, MD15. 1New Hanover Regional Medical Center, 2Overalake Medical Center, 3Methodist Hospital, 4Washington University, 5Emory University, 6University of Wisconsin, 7VIa-Christi Hospital, 8Hershey Penn Sate Medical Center, 9Legacy Health, 10OUr Lady of the Lake Regional Medical Center, 11Yale-New Haven Medical Center, 12Carillion Clinic, 13Celebration Health, 14University of Kentucky, 15Georgetown Community Hospital
Objective: The objective of this prospective, multi-center, single-arm, open-label study is to assess the safety, performance and effectiveness of Phasix™ ST in laparoscopic ventral or incisional hernia repair in subjects at high risk for Surgical Site Occurrence (SSO). Subjects at high risk for SSO are defined as having one or more of the following comorbid conditions: body mass index (BMI) between 30-40 kg/m2(inclusive), active smokers, chronic obstructive pulmonary disease (COPD), diabetes, immunosuppression, coronary artery disease, chronic corticosteroid use, low pre-operative serum albumin, advanced age, or renal insufficiency.
Methods: The primary endpoint is SSO requiring intervention within 45 days post-implantation, including Surgical Site Infection (SSI), seroma, hematoma, wound dehiscence, skin necrosis, mesh infection and fistula. Secondary endpoints include: surgical procedure time, length of stay, SSO > 45 days post-implantation, hernia recurrence rate, device-related adverse event incidence, rate of reoperation due to the index hernia repair, and Quality of Life assessments (Surgical Pain Scale-VAS, Carolinas Comfort Scale®, and SF-12®), assessed at 1, 3, 6, 12, 18, and 24-months postoperatively.
Results: A total of 90 subjects (54/90, 60% male) with a mean age of 55 ± 14.6 years and BMI of 33.4 ± 4.4 kg/m2 were implanted with Phasix™ ST Mesh. Comorbid conditions included: obesity (74/90, 82.2%), active smoker (13/90, 14.4%), COPD (5/90, 5.6%), diabetes (13/90, 14.4%), immunosuppression (3/90, 3.3%), coronary artery disease (7/90, 7.8%), chronic corticosteroid use (3/90, 3.3%), low preoperative serum albumin (1/90, 1.1%), advanced age (8/90, 8.9%), and renal insufficiency (0/90, 0.0%), and hernia types were primary ventral (42/90, 46.7%), primary incisional (32/90, 35.6%), first time recurrent ventral (6/90, 6.7%), first time recurrent incisional (7/90, 7.8%), multiply recurrent ventral (1/90, 1.1%), and multiply recurrent incisional (2/90, 2.2%). Subjects underwent laparoscopic ventral or incisional hernia repair with Phasix™ ST Mesh in laparoscopic only (48/90, 53.3%) or robotic assisted cases (42/90, 46.7%) with mean defect 9.2 ± 11.4 cm2, 84.4 ± 42.3 minute procedure time, and 1.2 ± 1.7 day length of stay. There were no SSOs requiring intervention within 45 days post-implantation, including SSI, seroma, hematoma, wound dehiscence, skin necrosis, mesh infection and fistula (0/90, 0.0% in all cases).
Conclusion: Phasix™ ST Mesh demonstrated promising early results in subjects at high risk of SSO with no SSOs requiring intervention within 45 days post-implantation. Longer-term 24-month follow-up is ongoing.
Presented at the SAGES 2017 Annual Meeting in Houston, TX.
Abstract ID: 86758
Program Number: P014
Presentation Session: iPoster Session (Non CME)
Presentation Type: Poster