First Human Experience with a Hybrid Biologic and Synthetic Mesh: Zenapro(tm) Hernia Repair Device for Ventral Hernia Repair

Kevin El-Hayek1, Melissa Phillips2, Jin Yoo3, Eric Pauli4, James Bittner5, Matthew Kroh1. 1Cleveland Clinic, 2University of Tennessee, 3Duke University, 4Pennsylvania State University, 5Virginia Commonwealth University

INTRODUCTION: The management of patients with complex hernias, often with multiple recurrences and comorbidities, is challenging and often requires abdominal wall reconstruction or closure with a bridged repair. Previous hernia repair devices include permanent synthetic with or without barriers, absorbable synthetic, and biologic. Zenapro™, a novel hernia repair device, combines the elements of biologic grafts with synthetic material to create a device that is available for use in these challenging cases. The objective of this report is to analyze interim results of the first patients who underwent Zenapro™ implantation for hernia repair.

METHODS AND PROCEDURES: A prospective, multicenter, single-arm study (NCT01784822) has completed recruitment of 63 patients to study the clinical outcomes of ventral hernia repair with the Zenapro™ Hybrid Hernia Repair Device.  This graft is comprised of seven layers of porcine small intestine submucosa (SIS) covering a core of  open-pore lightweight polypropylene. Inclusion criteria were broad and included patients with primary or recurrent hernias who required the addition of a reinforcement or bridging material to perform hernia repair. The primary study endpoint was hernia recurrence at 12 months, with secondary endpoints to measure device related occurrences.

RESULTS: Sixty-three patients completed at least 6 months follow-up (range 6-12 months). 46% were male and 79% were Caucasian. Mean age was 54.8 ± 10.9 years (range: 33-81) and Body Mass Index was 34.5 ± 7.8 kg/m2 (range: 17.5-57.5). Significant comorbidities included smoking history (57.1%), hypertension (63.5%), and insulin-dependent diabetes (25.4%). The majority of patients (53/63, 84%) had previous abdominal surgery. Laparoscopic repair was performed in 38/63 (60.3%) of patients with conversion to open in six cases (9.5%). Graft position was intraperitoneal onlay (IPOM) in 44/63 (69.8%).  Component separation was performed in 22 patients (34.9%). Complete fascial closure was achieved in 74.6%. To date, there have been no device infections and 4 (6.3%) recurrences.  Post-operative seroma occurred in 28.5%, though only one patient required aspiration.  Other complications included ileus or bowel obstruction (4.7%), surgical site infections [C3] (3%), hematoma (1.5%), and wound dehiscence in (1.5%).[C4]  There was one death due to fulminant C. difficile infection after antibiotic therapy for post-operative pneumonia.

CONCLUSIONS: ZenaproTM Hybrid Hernia Repair Device offers surgeons a durable and biocompatible alternative for challenging hernia cases where previous operations and multiple comorbidities are common. Interim follow-up of these  patients demonstrates  an acceptable recurrence and complication rate. Further analysis will be completed after 12 month follow-up.

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