|Year : 2021 | Volume
| Issue : 3 | Page : 90-94
A short-term preliminary evaluation of ventral hernia repair using a new prosthetic mesh
Rajavi S Parikh, Justin D Faulkner, Jordan A Bilezikian, W Borden Hooks, William W Hope
Department of Surgery, New Hanover Regional Medical Center, Wilmington, North Carolina, USA
|Date of Submission||17-Nov-2020|
|Date of Decision||18-Jan-2021|
|Date of Acceptance||21-May-2021|
|Date of Web Publication||30-Sep-2021|
Prof. William W Hope
Department of Surgery, New Hanover Regional Medical Center, 2131 South 17th Street, P O Box 9025, Wilmington, North Carolina.
Source of Support: None, Conflict of Interest: None
BACKGROUND: Syneco® (W.L. Gore and Associates, Flagstaff, AZ) is a new permanent synthetic mesh made of a combination of an absorbable synthetic component and a permanent synthetic component that can be used intraperitoneally or within the abdominal wall layers. Currently, there are little data on outcomes related to this mesh product. AIMS AND OBJECTIVES: The purpose of this project is to review our medical center’s outcomes using Synecor® mesh in ventral hernia repair. MATERIALS AND METHODS: We retrospectively reviewed all patients at our single medical center undergoing ventral hernia repair using Synecor® mesh included in the Americas Hernia Society Quality Collaborative (AHSQC) database from April 2016 through September 2019. Demographic, perioperative, and short-term outcomes (surgical site infection [SSI], surgical site occurrence [SSO], surgical site occurrence requiring procedural intervention [SSOPI]) were reviewed, and descriptive statistics were calculated. RESULTS: Forty-eight patients who underwent ventral hernia repairs using Synecor® mesh met study inclusion criteria. The average age of our patient population was 59 years (range: 29-78) with 50% female and 85% Caucasian. Ninety-six percent of cases were classed as clean cases. Comorbidities were present in 73% of patients. Open repairs were completed in 56% of cases and included retrorectus repair in 67% and transversus abdominis muscle release (TAR) in 30% of open cases. Repairs were laparoscopic in 27% of cases and robotic in 17%, with 85% having closure of the defect during repair. At 30 days follow-up, the rate of SSI was 8%, SSO 17%, and SSOPI 13%. There was an overall complication rate of 29%, a hernia recurrence rate of 4%, and an average follow-up of 97 days (range: 0 days to 1 year). CONCLUSION: Synecor® mesh is a new synthetic mesh that can be used for ventral hernia repair in an open, laparoscopic, or robotic approach. Short-term, preliminary results appear favorable; however, more study is needed to fully evaluate this new mesh prosthetic.
Keywords: Hernia, hybrid, mesh, repair
|How to cite this article:|
Parikh RS, Faulkner JD, Bilezikian JA, Hooks W B, Hope WW. A short-term preliminary evaluation of ventral hernia repair using a new prosthetic mesh. Int J Abdom Wall Hernia Surg 2021;4:90-4
|How to cite this URL:|
Parikh RS, Faulkner JD, Bilezikian JA, Hooks W B, Hope WW. A short-term preliminary evaluation of ventral hernia repair using a new prosthetic mesh. Int J Abdom Wall Hernia Surg [serial online] 2021 [cited 2021 Dec 6];4:90-4. Available from: http://www.herniasurgeryjournal.org/text.asp?2021/4/3/54/327067
| Introduction|| |
Rates of incisional hernia repair following laparotomy range from 2% to 20%. Primary hernia repair was the surgical treatment for abdominal wall hernias until 1958, when research showed that primary hernia repair had high recurrence rates ranging from 24% to 54%. The current literature regarding ventral hernia repair emphasizes the importance of hernia defect closure without excessive tension using component separation techniques and mesh prosthetics for reinforcement.
Permanent synthetic meshes, absorbable synthetic meshes, and biologic meshes have all been used for ventral and incisional hernia repair. Gore Synecor® is a new synthetic mesh with a unique combination of a macroporous knit of dense, monofilament PTFE fibers (1.59mm) and a bioabsorbable copolymer scaffold comprised of PGA and TMC on the parietal surface, and a PGA/ TMC nonporous film on the visceral surface that can be used intraperitoneally or within the abdominal wall layers. There are little data on outcomes related to this new mesh product. The goal of this study is to review our medical center’s outcomes using Synecor mesh in ventral hernia repair.
| Materials and Methods|| |
Following Institutional Board Review (IRB) approval, we undertook a single-institution, retrospective review of all patients at our medical center undergoing ventral hernia repair using Synecor mesh April 2016 through September 2019. Demographic, perioperative, and short-term outcomes were reviewed using the Americas Hernia Society Quality Collaborative (AHSQC) database. We evaluated the incidence of surgical site infection (SSI), surgical site occurrence (SSO), and SSO requiring procedural intervention (SSOPI).
The AHSQC is a database originating from the Americas Hernia Society to be used for continuous quality improvement in hernia repair and relies on surgeons’ imported data that are routinely audited. The data provide surgeons’ real-time feedback on short-term and long-term outcome measures related to hernias for quality improvement and research purposes.
| Results|| |
Forty-eight patients underwent ventral hernia repair using Synecor mesh during the study period. The patients’ average age was 59 years (range: 29–78), with 50% of females and 85% of Caucasians. Fifty-eight percent of the patients had hypertension, and 35% were current or former tobacco users. The majority of the patients were American Society of Anesthesiologists class 2 (33%) or class 3 (58%). Average Body Mass Index (BMI) was 33.5 (Range 20.2-56). Fifty-six percent of the patients underwent open hernia repair, 38% underwent retrorectus repair, and 17% underwent transversus abdominis muscle release. Twenty-seven percent underwent laparoscopic repair [Figure 1], and 17% underwent robotic hernia repair. Twenty-one percent of the patients had laparoscopic converted to open repair of their ventral hernia. Eighty-five percent underwent fascial closure in addition to mesh placement [Table 1] and [Table 2]. The average hernia defect size was 75 cm2 (range 2-600 cm2) and average mesh size was 438 cm2 (range 36-2400 cm2).
The 30-day complication rate was 29%, with 8% SSI, 17% SSO, and 13% SSOPI [Table 3]. [Table 4] shows the additional breakdown of complications and treatment required. Two patients (4%) had a hernia recurrence at an average follow-up of 97 days (range: 0 days–1 year).
| Discussion|| |
In 2004, Burger et al. published a landmark paper showing a significant reduction in recurrence rates in patients with synthetic mesh compared with suture repair (10-year cumulative rate of recurrence 32% vs. 63%, P < 0.001). Patients with small incisional hernias had an even greater reduction in recurrence with synthetic mesh repair (17% vs. 67%, P = 0.003), making synthetic mesh the gold standard for incisional hernia repair.
While there is a general consensus for the use of mesh to reduce recurrence rates in incisional, umbilical, and epigastric hernias, the ideal mesh type has not been determined. There are a variety of meshes on the market that include permanent synthetic meshes, such as polypropylene, polyester and expanded polytetrafluoroethylene (ePTFE), absorbable synthetic meshes, and biologic meshes., These mesh types/categories all have advantages and disadvantages, which continue to be debated.
Usher et al. were the first to describe using polypropylene-based mesh in hernia repair in the 19th century. Polypropylene mesh has pores, which allow for native tissue ingrowth. Until recently, heavyweight mesh was the only type of polypropylene available; however, there has been a modification of the traditional polypropylene to allow for larger pores and less density/weight, which is referred to as light or medium weight mesh. It is thought that these larger pore polypropylene meshes allow better ingrowth, the potential for less foreign body reaction, and perhaps better quality of life because patients do not feel the mesh.
ePTFE is a chemically inert synthetic fluoropolymer, which does not adhere to water or oils, as it has a high negative charge. It is microporous, allowing bacteria passage, but preventing macrophage passage. ePTFE mesh was a major breakthrough in mesh development and allowed widespread adoption of the laparoscopic repair of ventral and incisional hernias. This was due to the favorable adhesion profile and low risk of bowel erosion which was thought to be a major risk of uncoated polypropylene mesh. ePTFE had a good profile to be placed intra-abdominally due to its low risk for adhesions and bowel erosion. ePTFE mesh has a proven track record with excellent outcomes associated with laparoscopic ventral hernia but has the potential downside of having to be removed if infection occurs.
Due to the potential issues of a permanent foreign body and concern for their use in clean-contaminated and contaminated cases, a novel category of mesh called biologic meshes was developed. These meshes were again a major breakthrough for surgeons as they can be used in complex cases. In addition, they have mostly been promoted to be used in clean-contaminated and contaminated cases, although they are also used in clean cases for specific patient populations. While these meshes remain very popular, they are limited by the high cost and concern for long-term efficacy associated with most of these products. Due to some of the concerns stated above and as we continue the quest for an ideal mesh product, a new class of mesh has recently evolved. The absorbable synthetic mesh category has recently emerged and has challenged surgeons and industry to examine how long mesh is needed to help reduce recurrence because these products resorb in the body at varying times. While these are fairly new products, preliminary data show some favorable initial outcomes; however, long-term outcomes of these resobable products are needed.,,
Because there is no single ideal mesh for all types of hernias, variations and/or combinations of available meshes have emerged. The Zenapro Hybrid Hernia Repair Device™ (Cook Medical, Bloomington, IN) was the first mesh to combine permanent synthetic mesh with a biologic graft. The large-pore, lightweight polypropylene mesh is inserted between layers of porcine small intestinal submucosa to allow neovascularization, tissue ingrowth, and fluid passage through the graft. The goal is to decrease the potential for contamination and allow the synthetic mesh to more fully incorporate into tissue and ultimately add strength to the repair. A prospective, multicenter clinical trial was published by Bittner et al. in 2017 evaluating the outcomes of ventral and incisional hernias using this mesh and found a recurrence rate of 7% at 12 months. Thirty-nine percent suffered surgical site events at 12 months; 24% were seromas (the most common surgical site event) (P < 0.01). The rate of seroma requiring procedural intervention was 9%. This study showed promise for the theoretical advantage of promoting tissue remodeling and initial sparing of the synthetic mesh from contamination.
Gore® Synecor is an intraperitoneal biomaterial composed of a layer of polytetrafluoroethylene (PTFE) between a nonporous, bioabsorbable polyglycolic acid/trimethylene carbonate (PGA: TMC) copolymer film on the visceral side and a porous, bioabsorbable PGA: TMC web on the parietal side. PGA: TMC biosynthetic material has been shown to encourage early vascularization and ingrowth and has adequate long-term tissue generation. The goal is to combine the long-term strength of PTFE with the rapid tissue ingrowth of GORE® BIO-A® web scaffold in single-stage, complex hernia repairs. The macroporous knit of dense, monofilament PTFE fiber is hypothesized to reduce the risk of harboring bacteria due to the solid fiber, while the nonporous film on the visceral side minimizes visceral attachments to the mesh. When compared with other hybrid meshes in a rabbit bacterial inoculation model, Synecor had a significantly lower abscess score and little recoverable bacteria 7 days after implantation/inoculation. Overall, Gore Synecor mesh appears to provide strength while reducing the risk of infection and other mesh-related complications.
Our study goal was to evaluate our short-term outcomes with the hybrid mesh Synecor. The preliminary outcomes associated with mesh appear favorable and comparable with similar types of hernia meshes;, however, there are some outcome measures that require further discussion. There were two unrecognized enterotomies for a rate of 4%, which is much higher than the published rate of 1.8%. The missed enterotomies in this study were not specifically related to the mesh product; however, in both cases when the patients underwent reoperation, the well-incorporated meshes were removed due to the clinical circumstances. Both patients recovered well despite this devastating complication. The other unique and rare complication that requires discussion is that of an intraparietal hernia that presented as a small bowel obstruction following an open retrorectus repair of recurrent ventral hernia. The patient required diagnostic laparoscopy on postoperative day 6 and had an intraperitoneal hernia with a piece of small bowel being obstructed as it was going into the disrupted posterior sheath. The small bowel was reduced, and the posterior sheath was fixed to the Synecor mesh to close the potential space. Since the Synecor mesh can be placed intra-abdominally, we were comfortable with having some of the mesh exposed. Another higher than expected outcome was the high rate of conversion from minimally invasive to open of 21%. This can be explained by the authors approach to hernias which includes a liberal use of diagnostic laparoscopy to evaluate for adhesions and hernia characterics and low threshold to perform an open repair.
There are several limitations to this study. It is a single center/single surgeon study that can limit the generalizability of results and outcomes. Also, the decision to use this mesh was determined by the attending surgeon and was based on patient and hernia characteristics that may benefit from this novel mesh construct but there was no comparison group to show efficacy. Lastly, the cost of this mesh is more than the standard polypropylene or polyester based meshes and more research is needed to see if the extra cost associated with this mesh will result in improved outcomes or other advantages.
| Conclusion|| |
Synecor mesh is a new synthetic mesh that can be used for ventral hernia repair in either an open, laparoscopic, or robotic approach. Short-term, preliminary results show relatively few mesh-related complications and minimal hernia recurrences; however, more study is needed to fully evaluate this new mesh prosthetic.
Declaration of ethical approval and patient consent
This study was approved by our local Institutional Review Board (IRB) at New Hanover Regional Medical Center in January 2019. As this was a retrospective review written informed consent was not required.
Financial support and sponsorship
Conflicts of interest
Prof. William W. Hope is an Editor of International Journal of Abdominal Wall and Hernia Surgery. The article was subject to the journal’s standard procedures, with peer review handled independently of this Editor and their research groups.
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[Table 1], [Table 2], [Table 3], [Table 4]