NEW YORK (Reuters Health) – Using slow-resorbing biosynthetic mesh, rather than macroporous synthetic polypropylene mesh, for open ventral hernia repair may yield higher rates of surgical-site infections, surgical-site complications requiring intervention, and reoperation within 30 days, early research shows.
“While this trial is not conclusive as to what mesh should be utilized in every situation, it does add value to the discussion and lays the groundwork for further clinical evaluations,” corresponding author Dr. Michael J. Rosen, of the Cleveland Clinic Foundation’s Comprehensive Hernia Center, told Reuters Health by email.
Mesh reinforcement is the gold standard in ventral hernia repair, but mesh products aren’t approved for use in grade IIIa (clean-contaminated), grade IIIb (contaminated), and grade IIIc (dirty/infected) hernias. Decisions on mesh selection are primarily based on surgeon preference.
Use of biologic mesh has waned because of high cost and poor long-term outcomes, Dr. Rosen and his colleagues noted. Advances in biomaterials and better understanding of risk factors affecting wound outcomes in ventral hernia repair have renewed interest in synthetic meshes and the development of a new class of slow-resorbing biosynthetic meshes.
However, these relatively new products have not been evaluated in a large, well-matched cohort, Dr. Rosen said. To investigate the use of and short-term outcomes with biosynthetic and polypropylene meshes for elective open ventral hernia repair in clean-contaminated and contaminated cases, he and his colleagues analyzed prospectively collected data from the national Americas Hernia Society Quality Collaborative (AHSQC) registry.
The study included 2,051 adults who underwent elective open ventral hernia repair with placement of resorbable biosynthetic mesh or uncoated polypropylene mesh from 2013 to 2016. All had received prophylactic intravenous antibiotics within an hour before surgery and had 30-day follow-up data available.
Overall, 13.7% (281) had clean-contaminated hernias and 7.7% (157) had contaminated hernias, the researchers report in the Journal of the American College of Surgeons, online August 4.
Hernias were clean-contaminated or contaminated in about one-third of the 175 patients whose surgeons used biosynthetic mesh and in about 20% of the 1,876 patients whose surgeons used polypropylene mesh. The researchers conducted a 1:3 biosynthetic:polypropylene propensity-matched analysis to compare 30-day wound events according to the type of mesh used.
Compared with the polypropylene mesh group, the biosynthetic mesh group had significantly higher rates of surgical-site infection (22.4% vs. 10.9%); surgical-site occurrences requiring procedural intervention, such as wound debridement or suture excision (24.1% vs. 13.2%); and unplanned reoperation (13.8% vs. 4.0%).
The two groups did not differ significantly in their overall rates of 30-day surgical-site occurrences and their rates of unplanned readmission.
“These findings are important because there is very little published data on absorbable synthetic materials in ventral hernia repair,” Dr. Rosen said. “The ability of the AHSQC to amass a large volume of hernia surgeries utilizing real-world data also provided us a means to obtain a relatively comparable group to synthetic mesh to evaluate short-term outcomes in similar cohorts.”
Dr. Rosen stressed that the study looked only at 30-day outcomes and that long-term data are needed to draw definitive conclusions. However, he added, “as new products are released onto the market with little preclinical data, these types of registries are critical to answer clinical questions.”
“This study is very important, as it shows that biosynthetic meshes, like their biologic counterparts, did not perform as well in contaminated and infected fields, and possibly in clean cases as well,” Dr. Kamal M. F. Itani, of the Veterans Affairs Boston Healthcare System and Boston University, told Reuters Health by email.
However, placement of mesh was “less than ideal” for 15 patients, explained Dr. Itani, who was not involved with the new study. Other studies, such as the Repair of Infected or Contaminated Hernias (RICH) trial (http://bit.ly/2fIOj29), have shown that for optimal performance, “biologics need to be placed in between two layers of vascularized tissues,” Dr. Itani said. He and Dr. Rosen were the two lead authors of RICH.
According to the new study, Dr. Itani said, “It is clear that biosynthetic meshes have a less favorable outcome in the first 30 days and should not be used in clean-contaminated or contaminated cases.”
He noted that many surgeons will prefer not to use synthetic meshes for hernia repair in dirty and infected fields or when there is gross contamination.
“The stakes are very high when a synthetic mesh becomes infected,” he said.
SOURCE: http://bit.ly/2w85lhk
J Am Coll Surg 2017.
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