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Safety and Efficacy of Synthetic Mesh for Ventral Hernia Repair in a Contaminated Field
Journal Pre-proof Safety and Efficacy of Synthetic Mesh for Ventral Hernia Repair in a Contaminated Field Jeremy Warren, MD, FACS, Shivani S. Desai, BS, Nicole D. Boswell, BS, Benjamin H. Hancock, BS, Hamza Abbad, MD, Joseph A. Ewing, PhD, Alfredo M. Carbonell, AM DO, FACS, William S. Cobb, MD FACS PII:
S1072-7515(20)30069-7
DOI:
https://doi.org/10.1016/j.jamcollsurg.2019.12.008
Reference:
ACS 9701
To appear in:
Journal of the American College of Surgeons
Received Date: 16 December 2019 Accepted Date: 17 December 2019
Please cite this article as: Warren J, Desai SS, Boswell ND, Hancock BH, Abbad H, Ewing JA, Carbonell AM, Cobb WS, Safety and Efficacy of Synthetic Mesh for Ventral Hernia Repair in a Contaminated Field, Journal of the American College of Surgeons (2020), doi: https://doi.org/10.1016/ j.jamcollsurg.2019.12.008. This is a PDF file of an article that has undergone enhancements after acceptance, such as the addition of a cover page and metadata, and formatting for readability, but it is not yet the definitive version of record. This version will undergo additional copyediting, typesetting and review before it is published in its final form, but we are providing this version to give early visibility of the article. Please note that, during the production process, errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain. © 2020 by the American College of Surgeons. Published by Elsevier Inc. All rights reserved.
Safety and Efficacy of Synthetic Mesh for Ventral Hernia Repair in a Contaminated Field Jeremy Warren, MD, FACS1, Shivani S Desai BS1, Nicole D Boswell BS1, Benjamin H Hancock BS2, Hamza Abbad MD2, Joseph A Ewing PhD3, Alfredo M Carbonell AM DO, FACS1, 2, William S Cobb MD FACS1 1. University of South Carolina School of Medicine Greenville Department of Surgery, Prisma Health, Greenville, SC 2. Prisma Health, Department of Surgery Summer Program for Undergraduate Research in Surgery, Greenville, SC 3. Prisma Health, Department of Quality, Greenville, SC Disclosure Information: Nothing to disclose. Disclosures outside the scope of this work: Drs Cobb and Carbonell received payment from WL Gore Ethicon for lectures and consultancy, and Dr Warren received payment from CMR Surgical Ethicon for consultancy and from Intuitive for lectures. Presented at the Southern Surgical Association 131st Annual Meeting, Hot Springs, VA, December 2019. Corresponding Author Jeremy Warren, MD, FACS University of South Carolina School of Medicine Greenville Department of Surgery, Prisma Health 701 Grove Rd, ST 3, Greenville, SC, 29605 [email protected]
Brief Title: Mesh in Contaminated Ventral Hernia Repair
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Abstract Background Controversy remains over appropriate mesh selection during ventral hernia repair (VHR) in a contaminated field. Fear of mesh infection has led to increased use of biologic and absorbable synthetic mesh rather than permanent synthetic mesh in these cases. We report the safety and efficacy of permanent synthetic mesh during contaminated VHR. Study Design Retrospective review of our database identified all cases of contaminated VHR from 7/2007 to 5/2019. Student’s t-test and Wilcoxon rank-sum were used to analyze continuous variables, and discrete variables with Fisher’s or Kruskal-Wallis test. Results There were 541 contaminated cases: 245 clean-contaminated, 214 contaminated and 82 dirty cases. Suture repair was performed in 46 patients, biologic mesh used in 38, absorbable synthetic mesh in 55, and permanent synthetic mesh in 402. Mesh was extraperitoneal in 97% of cases. Incidence of surgical site infection (SSI) in each group was 17.4%, 36.8%, 32.7% and 14.2% respectively (p<0.001). Multivariate analysis showed no effect of mesh selection on SSI risk. Mesh was removed in 7 patients; 5 permanent synthetic (1.2%), one absorbable synthetic (1.8%) and one biologic (2.6%). Four were mesh-specific complications, and the remaining were removed during exploration for indications unrelated to the mesh. At a median follow-up of 30.2 months, recurrence occurred in 15.2% of patients and was significantly lower with permanent synthetic mesh. Conclusion Permanent synthetic mesh placed in an extraperitoneal position is not only safe for VHR in a contaminated field, but it confers a significantly lower rate of SSI and recurrence when compared to biologic or bioabsorbable meshes.
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Introduction Optimal mesh selection and technique for ventral hernia repair (VHR) in the setting of contamination remains a clinical dilemma. The consequences of infected permanent synthetic mesh (PSM) can be devastating, often requiring complex wound care, serial debridement or complete mesh removal, followed inevitably by hernia recurrence. Techniques and materials have evolved in an attempt to mitigate this cycle, with the development minimally invasive VHR, resurgence of retromuscular repair, and an expanding catalog of mesh products. However, high-quality data in such cases is deficient, leaving the surgeon to rely largely on expert opinion and personal experience. Better understanding of the factors that contribute to mesh infection, and more importantly those that ultimately require mesh removal, has produced a newer generation of PSM made of lighter-weight, monofilament material with larger interstices. Experimental and clinical data demonstrate their efficacy in hernia repair, particularly in the retromuscular space, and excellent ability to withstand infection and avoid explantation [1-3]. Perhaps most disruptive was the introduction of biologic mesh (BM) constructs, introduced with the promise of providing a scaffold for native tissue ingrowth and resistance to infection. Their use proliferated widely, particularly for contaminated VHR, despite a lack of clinical data to support this practice. Increased scrutiny of BM demonstrates higher hernia recurrence rates, increased cost, and no significant difference in infection risk compared to synthetic mesh repair [4-6]. Absorbable synthetic meshes (ASM) are somewhat of a middle ground: A cheaper alternative to BM with no remaining permanent material in the event of infection. Early data on these materials is positive, but is limited [7, 8]. Given the lack of high-quality comparative data regarding the optimal mesh selection in contaminated VHR, this study aims to compare clinical outcomes of suture repair, PSM, ASM and BM in these complex patients. We hypothesize that large-pore, monofilament polypropylene mesh in contaminated VHR provides a more durable hernia repair with comparable rates of infectious complications. Materials and Methods
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A retrospective review of all patients undergoing VHR between July 2007 and May 2019 by the investigators at a single institution (Prisma Health) was performed utilizing two hernia databases. The Americas Hernia Society Quality Collaborative (AHSQC) is a prospective hernia registry and contains data on all cases since June of 2013. The Hernia Center database, an internal prospectively maintained database, includes all cases prior to June of 2013. All ventral / incisional hernias repaired in which the wound, per Center for Disease Control (CDC) definition, was classified as clean-contaminated, contaminated, and dirty were included. All cases were classified by the surgeon in a prospective fashion and did not rely on operative nursing documentation. Patient demographics, operative technique, mesh selection, and clinical outcomes were assessed. Clinical outcomes analyzed were surgical site occurrence (SSO), surgical site infection (SSI), SSO or SSI requiring procedural intervention (SSO/I PI), hospital length of stay (LOS), operative time, readmission, reoperation, and hernia recurrence. In order to confirm long-term outcomes, chart review was performed for all patients. Any subsequent abdominal operations, radiographic studies, interventional procedures, emergency room visits, and progress notes were reviewed for documentation of hernia recurrence, delayed SSI or SSO, or interventions for SSI or SSO. Continuous variables were analyzed with Student’s t-test or Wilcoxon rank-sum. Discrete variables were analyzed with Fisher’s exact or Kruskal-Wallis test. The Prisma Health institution review board approved this study. Results
Demographics A total of 541 patients were identified who had repair of ventral hernias under cleancontaminated, contaminated, or dirty conditions. Mean age was 58.2 ± 13.4 years. Mean body mass index (BMI) was 32.0 + 8.4, 28.8% were current smokers, 29.2% had diabetes mellitus (DM), and 18.3% had chronic obstructive pulmonary disease (COPD). Patients in groups 3 and 4 had the highest rate of COPD (34.6 and 42.1%, respectively, compared to 10.9% in group 1 and 14.7% in group 2; p<0.001). Median American Society of Anesthesiologist score (ASA) was 3. Hernias were recurrent in 176 (32.5%) of patients, with a mean of 1.9 prior repairs. Table 1 summarizes patient characteristics.
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Operative Details Wound classification was clean-contaminated in 245 patients (45.3%), contaminated in 214 (39.6%), and dirty in 82 (15.2%). Contamination was due to enterotomy in 32 cases, active infection in 82 (70 of which were mesh infections), presence of an ostomy in 282 cases, or other concurrent hepatobiliary, foregut or gynecologic procedure in the remainder. 42.1% of BM repair was in dirty wounds, which is the highest among mesh groups. Mean hernia width was 9.3 + 5.9cm, with a mean area of 151.4 + 244.8cm2. Mean mesh size was 512.6 + 446.9cm2.
Hernias were repaired using an open
approach in 93.9% of cases, robotically in 4.6%, and laparoscopically in 1.5%. Myofascial release was required in 79.1% of cases: retromuscular dissection was performed in 389 patients, transversus abdominis release (TAR) in 171, external oblique release in 36, and other (anterior sheath release, posterior component separation) in 43. A concurrent procedure was performed in 71% of patients, the majority of which (42.7%; n=231) were colorectal procedures. Mean operative time was 249.6 + 10 min. Tables 2 details patient and operative characteristics. Postoperative Outcomes Patients were divided into four groups for analysis: Group 1 (n=46) were repaired primarily with suture alone and no mesh reinforcement; group 2 (n=402) were repaired with PSM; group 3 (n=55) were repaired with ASM; group 4 (n=38) were repaired with BM. Median length of stay (LOS) was 5 days (IQR 3,7). There was no difference is readmissions between groups. Reoperation was required in 21.8% (n=118) of cases, and was lowest in groups 1 and 2 (group 1,19.6%; group 2, 19.9%; group 3, 34.6%, group 4, 26.3%; p=0.025). Incidence of SSI was also lowest in groups 1 and 2 (group 1, 17.9%; group 2, 14.2%; group 3, 32.7%; group 4, 36.8%; p<0.001). Incidence of SSO was no different between groups. Similarly, there was no difference in SSOPI / SSIPI. Wound opening for SSO was required for significantly fewer patients in groups 1 and 2 (group 1, 11.3%; group 2, 8.7%; group 3, 14.6%; group 4, 31.6%; p<0.001), as was the need for percutaneous drainage (group 1, 0%; group 2, 3.2%; group 3, 12.7%; group 4, 5.3%; p=0.009). Complete mesh removal was required in 8 (1.5%) total patients and was no different between groups: 5 (1.2%) patients repaired with PSM, 2 (3.6%) patients with ASM, and 1
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(2.6%) patient with BM (p=0.310). Partial mesh removal was performed in an additional 6 (1.3%) patients: 4 (1.0%) in group 2 and 2 (5.3%) in group 4 (p=0.489). With a mean follow-up of 55 + 64.6 mos (median 30.2 mos; IQR 6.1, 82.8), overall hernia recurrence rate was 15.2%. Recurrence was significantly lower after repair with PSM (group 1, 28.3%; group 2, 10.5%; group 3, 30.9%; group 4, 26.3%; p<0.001). Tables 3 and 4 details clinical outcomes and mesh explantation. Multivariate analysis was performed to analyze the primary determinants of SSI. Only COPD (OR 2.4 [95% CI; 1.387, 4.06]) and a dirty wound class (OR 2.3 [95% CI; 1.095, 4.685]) were significant risk factors for SSI. Mesh selection had no impact of mesh selection on SSI: PSM, OR 0.91 [95% CI; 0.377, 2.044] ASM, OR 1.95 [95% CI; 0.723, 5.587]; BM, OR 1.925 [95% CI; 0.675, 5.768] (Table 5). Discussion Permanent synthetic mesh can be safely employed for contaminated VHR. This study indicates comparable outcomes to BM or ASM, and adds to the growing body of literature supporting this conclusion. Though incongruent with common opinion, PSM infection does not necessarily require mesh removal. It cannot be overstated, however, that the mesh construct and surgical technique are critically important for successful mesh salvage, and this must be understood when selecting the appropriate mesh and operative approach for contaminated VHR. Microporous and multifilament mesh constructs exhibit the highest degree of bacterial adherence and are least able to clear a bacterial infection in experimental studies [9-13]. Additionally, bacterial clearance of barrier coated meshes designed to inhibit adhesion formation for intraperitoneal placement is unknown. Clinical evidence supports these experimental findings. Berrevoet, et al. demonstrated the ability to salvage large-pore polypropylene mesh in all cases of infection when placed in the retromuscular space [14]. Carbonell, et al. reported 100 cases of contaminated VHR with permanent synthetic mesh in the retromuscular space. Infection occurred in 14% of patients overall, and mesh removal was required in just 4 cases. In one patient, a peri-stomal fistula developed 1-year post-op and felt likely to be mesh related. Two patients required removal due to intraabdominal sepsis after anastomotic leak, and the remaining after mucocutaneous disruption of a newly created stoma, none of which were directly related
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to the mesh [1]. Furthermore, in a series of 255 retromuscular VHR, 104 of which were repaired with permanent synthetic mesh in the setting of contamination, only one mesh required removal [2]. When used in conjunction with enterostomy reversal, the authors similarly found permanent synthetic mesh to be safe and effective. In this series, 5 cases of periprosthetic infection occurred, but none required mesh removal. Mesh was removed in 5 other cases, all of which involved intraabdominal complications requiring laparotomy and necessitated mesh removal for peritoneal entry [15]. Other authors have reported similar success of permanent mesh use for contaminated VHR[16, 17] [18], emergency VHR[19, 20], emergency laparotomy[21], and with concurrent colorectal surgery[22, 23]. These studies confirm the ability of monofilament, large-pore polypropylene mesh to withstand contamination and infection when placed in an extraperitoneal position. The use of BM in contaminated VHR is commonplace. Recommendations of the Ventral Hernia Working Group indicated biologic mesh should be considered in patients at higher clinical risk of infection, and generally recommended for patients with contamination or infection [24]. In a survey of practicing surgeons, 80% of high-volume surgeons (>20 VHR/year) indicated that BM is preferred for clean-contaminated and contaminated VHR [25]. Interestingly, 40% or more of surgeons surveyed also reported poor mesh incorporation, infection, mesh disintegration, and mechanical failure. Reported clinical outcomes of BM vary widely. Sbitany, et al. reported an SSI rate of 15% and recurrence of just 12% using non-cross-linked porcine acellular dermal matrix (PADM) in the repair of 41 cases [26]. In the RICH study, PADM was used in 85 class 2,3 or 4 VHR with 2-year follow-up. In total, 35% of cases resulted in SSI, and 28% of cases recurred [27]. Shubinets, et al. recently reported favorable outcomes in 43 patients using retromuscular placement of BM during single-stage reconstruction at the time of infected mesh removal [28]. In both of these studies, repair technique was a significant factor. Bridged repairs, in which fascial closure was not achieved over the mesh, resulted in significantly higher rate of hernia recurrence. The BM construct likely impacts outcomes as well. Cross-linked porcine BM, demonstrated the highest rate of infection (50%) in the Shubinets study. Similarly Abdelfatah, et al. reported a 25% mesh removal rate due to infection and 66% rate of hernia recurrence using this mesh[29].
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Kaufmann, et al. report 28% hernia recurrence and 50.6% abdominal wall bulging after repair with crosslinked PADM [30]. Recent reviews indicate the lack of evidence in support of biologic mesh over synthetic mesh in contaminated VHR [31-35]. Absorbable synthetic mesh has demonstrated favorable results in some series. In the COBRA trial, 104 patients underwent contaminated VHR with BioA Tissue Reinforcement, W.L. Gore) with a resultant 18% SSI rate and 17% recurrence rate [7]. Roth, et al. recently reported 18-month outcomes of poly-4-hydroxybutyrate mesh (P4HB)(Phasix TM Mesh, Bard Inc) in high-risk, but clean cases with 9% SSI and 9% recurrence rate [8]. In the only study identified evaluating P4HB in contaminated VHR, SSI occurred in 10% of cases with no hernia recurrence reported at mean follow-up of 21.1 mos [36]. However, analysis of 30-day outcomes of patients undergoing repair of clean-contaminated and contaminated hernias from the AHSQC demonstrated a higher rate of SSI with ASM compared to polypropylene mesh (22.4 vs 10.9%; p=0.03), with a resultant increased rate of SSO requiring procedural intervention and reoperation (24.1 vs 13.2%; p=0.049) [37]. Few trials offer comparative data. Majumder, et al, reported superior outcomes of synthetic over biologic mesh in 126 cases of clean-contaminated and contaminated VHR [38]. A multicenter review by Bondre, et al. compared outcomes of suture (n=291), PSM (n=303), and BM (n=167) in contaminated VHR. Despite the authors conclusion the BM is favored in contaminated VHR, there was actually no difference in SSI (15.1%, 17.8%, 21.0%, respectively; p=0.280), or recurrence (17.8%, 13.5%, 21.5%, respectively; p=0.074) [39]. Chamieh, et al. reported no differences in SSI or recurrence between PSM and BM in their series, though there was significant heterogeneity in surgical technique [40]. Comparing P4HB to BM, Buell, et al, report higher rate of SSI and hernia recurrence with BM [41]. The variability in reported outcomes of cases series and comparative studies is likely due to significant selection bias, small sample sizes, and substantial heterogeneity in operative technique, patient characteristics, and mesh properties. Given the equivocal or even inferior outcomes of BM and ASM compared to PSM, consideration must be given to the high cost of BM or ASM and its overall impact on the healthcare economy [5, 42, 43].
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Though this is the largest study of contaminated VHR reporting outcomes of various mesh types and techniques, it is not without limitations. Clearly the vast majority of cases were performed using PSM in this series, representing a significant selection bias. Our choice of mesh has changed somewhat over time based on our evolving clinical experience, as the majority of BM and ASM cases were performed during the earlier time period of the study, with 78.5% of these cases performed prior to 2013. This is reflected most clearly in the wound class 4 cases, which have transitioned from primarily BM repairs historically to suture repairs with staged definitive VHR in most contemporary cases. This study significantly improves on the duration of follow-up, an important criticism of the authors’ previous work. However, there are still a number of patients with limited follow-up, with 266 patients (49.2%) completing less than 12-month follow-up. There are also differences between groups, most notably the highest rate of COPD in patients repaired with ASM and BM, which was an independent risk factor for SSI on multivariate analysis. However, there was no effect of mesh type on the risk of developing SSI, and the low mesh explantation rate for any mesh type indicates the negligible clinical impact of a mesh infection when the properly selected PSM and surgical technique are used. Finally, we await the results of a prospective randomized control trial of PADM versus large-pore polypropylene mesh in cleancontaminated and contaminated VHR that has now completed enrollment and in follow-up [clinicaltrials.gov] Conclusion The current study challenges the popular conception of biologic graft superiority in contaminated VHR, and the dogmatic notion that permanent synthetic mesh is to be avoided in such cases. In fact, the lowest rate of SSI in this series is seen with PSM, with only 1% of PSM requiring explantation. The low rate of infectious complications, coupled with a 3-fold increase in hernia recurrence with any other method of repair, confirms the superiority of retromuscular repair with monofilament, large-pore polypropylene mesh should be the Based on these findings and extensive clinical experience, the authors recommend the use of large-pore, monofilament polypropylene mesh in an extraperitoneal plane, ideally the retromuscular space, for repair of contaminated VHR.
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Acknowledgement Cameron Keramati BS Prisma Health, Department of Surgery Summer Program for Undergraduate Research in Surgery 701 Grove Rd, ST 3, Greenville, SC 29605 Reference
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Table 1: Patient Characteristics Variable Age, y, mean ± SD
All, n = 541
None, n = 46
PSM, n = 402
ASM, n = 55
BM, n = 38
p Value
58.2 ± 13.4
60.6 ± 15.8
57.8 ± 12.8
57.4 ± 14.9
60.1 ± 13.7
0.961
32.0 ± 8.4
33.5 ± 8.6
32.1 ± 8.0
28.9 ± 8.6
33.9 ± 11.0
0.349
2
BMI, kg/m , mean ± SD Sex, n (%) Male Female
0.702 247 (45.66) 294 (54.34)
18 (39.13) 28 (60.87)
184 (45.77) 218 (54.23)
28 (50.91) 27 (49.09)
17 (44.74) 21 (55.26)
Race, n (%)
0.922
White
458 (84.66)
38 (82.61)
337 (83.83)
49 (89.09)
34 (89.47)
Black
67 (12.38)
6 (13.04)
52 (12.94)
5 (9.09)
4 (10.53)
11 (2.03)
2 (4.35)
13 (3.23)
1 (1.82)
0 (0)
Other Smoking status, n (%)
0.051
Never/unknown
202 (37.34)
29 (63.04)
178 (44.28)
24 (43.64)
19 (50)
Current
153 (28.28)
5 (10.87)
121 (30.1)
20 (36.36)
7 (18.42)
Former
138 (25.51)
12 (26.09)
103 (25.62)
11 (20)
12 (31.58)
DM, n (%)
158 (29.21)
20 (43.48)
109 (27.11)
18 (32.73)
11 (28.95)
0.128
HTN, n (%)
298 (55.08)
26 (56.52)
232 (57.71)
25 (45.45)
15 (39.47)
0.073
Dialysis n (%)
14 (2.59)
0 (0)
9 (2.24)
4 (7.27)
1 (2.63)
0.108
COPD, n (%)
99 (18.3)
5 (10.87)
59 (14.68)
19 (34.55)
16 (42.11)
<0.001*
1
4 (0.74)
1 (2.17)
2 (0.5)
1 (1.82)
0 (0)
2
116 (21.44)
6 (13.04)
91 (22.64)
7 (12.73)
12 (31.58)
3
392 (72.46)
33 (71.74)
295 (73.38)
40 (72.73)
24 (63.16)
4
29 (5.36)
6 (13.04)
14 (3.48)
4 (7.27)
2 (5.26)
ASA, n (%)
0.009
* statistically significant DM, diabetes mellitus; HTN, hypertension; ASA, American Society of Anesthesiology score; PSM, permanent synthetic mesh; ASM, absorbable synthetic mesh; BM, biologic mesh
14
Table 2: Operative Details Variable
All, n = 541
None, n = 46
PSM, n = 402
ASM, n = 55
BM, n = 38
Wound classification Clean-contaminated Contaminated Dirty Operative approach, n (%)
245 (45.29) 214 (39.56) 82 (15.16)
15 (32.61) 6 (13.04) 25 (54.35)
212 (52.74) 167 (41.54) 23 (5.72)
15 (27.27) 22 (40) 18 (32.73)
3 (7.89) 19 (50) 16 (42.11)
Open
p Value <0.001*
<0.001* 472 (87.25)
34 (73.91)
346 (86.07)
54 (98.18)
38 (100)
Robotic
25 (4.62)
1 (2.17)
24 (5.97)
0 (0)
0 (0)
Laparoscopic Unknown
8 (1.48) 36 (6.65)
5 (10.87) 6 (13.04)
2 (0.5) 30 (7.46)
1 (1.82) 0 (0)
0 (0) 0 (0)
9.3 ± 5.9
10.2 ± 8.3
9.2 ± 5.8
8.6 ± 4.8
10.4 ± 5.4
0.59
428 (79.11)
4 (8.7)
346 (86.07)
48 (87.27)
30 (78.95)
<0.001*
36 (6.65)
1 (2.17)
25 (6.22)
8 (14.55)
2 (5.26)
0.065
Transversus abdominis release
171 (31.61)
1 (2.17)
153 (38.06)
5 (9.09)
12 (31.58)
<0.001*
Anterior rectus sheath incision
12 (2.22)
1 (2.17)
11 (2.74)
0 (0)
0 (0)
0.456
Posterior rectus sheath incision
389 (71.9)
4 (8.7)
320 (79.6)
40 (72.73)
25 (65.79)
<0.001*
Posterior component separation
31 (5.73)
0 (0)
17 (4.23)
11 (20)
3 (7.89)
<0.001*
Fascia closed, n (%)
515 (95.19)
45 (97.83)
380 (94.53)
54 (98.18)
36 (94.74)
0.536
Concurrent procedure, n (%)
384 (70.98)
30 (65.22)
293 (72.89)
40 (72.73)
21 (55.26)
0.107
Separate hernia
11 (2.03)
2 (4.35)
8 (1.99)
1 (1.82)
0 (0)
0.564
Foregut/endocrine
4 (0.74)
1 (2.17)
3 (0.75)
0 (0)
0 (0)
0.576
Hepatobiliary
18 (3.33)
4 (8.7)
13 (3.23)
1 (1.82)
0 (0)
0.12
Small intestine
58 (10.72)
10 (21.74)
33 (8.21)
12 (21.82)
3 (7.89)
0.001*
Colorectal
231 (42.7)
8 (17.39)
175 (43.53)
31 (56.36)
17 (44.74)
<0.001*
OB/GYN
25 (4.62)
1 (2.17)
24 (5.97)
0 (0)
0 (0)
0.079
Vascular
2 (0.37)
0 (0)
2 (0.5)
0 (0)
0 (0)
0.875
Soft tissue/plastic
23 (4.25)
0 (0)
22 (5.47)
1 (1.82)
0 (0)
0.112
Other
22 (4.07)
3 (6.52)
18 (4.48)
1 (1.82)
0 (0)
0.301
Onlay
23 (4.25)
0 (0)
17 (4.23)
6 (10.91)
0 (0)
Inlay
1 (0.18)
0 (0)
0 (0)
0 (0)
1 (2.63)
406 (75.05)
0 (0)
342 (85.07)
41 (74.55)
23 (60.53)
Hernia width, cm, mean ± SD Myofascial release, n (%) External oblique release
Mesh position, n (%)
Retromuscular
0.01*
Preperitoneal
29 (5.36)
0 (0)
25 (6.22)
3 (5.45)
1 (2.63)
Intraperitoneal
16 (2.96)
0 (0)
11 (2.74)
2 (3.64)
10 (26.32)
<0.001*
* statistically significant PSM, permanent synthetic mesh; ASM, absorbable synthetic mesh; BM, biologic mesh
15
Table 3: Clinical Outcomes
Variable LOS, d, median (IQR) Readmission, n (%) Reoperation, n (%) Any SSO, n (%) SSO management Oral antibiotic IV antibiotic Wound opening Wound debridement Percutaneous drainage Any SSI, n (%) Superficial Deep
All, n = 541
None, n = 46
PSM, n = 402
ASM, n = 55
BM, n = 38
p Value
5 (3-7) 83 (15.34) 118 (21.81) 237 (43.8)
5 (2, 10) 5 (10.87) 9 (19.57) 21 (45.6)
5 (3, 7) 69 (17.16) 80 (19.9) 171 (42.5)
6 (4, 10) 4 (7.27) 19 (34.55) 27 (49.1)
5 (3, 9) 5 (13.16) 10 (26.32) 18 (47.4)
0.005* 0.219 0.025* 0.755
35 (6.5) 2 (0.4) 61 (11.3) 8 (1.5)
4 (8.7) 4 (8.7) 6 (13.0) 0
19 (4.7) 11 (2.7) 35 (8.7) 4 (1)
7 (12.7) 10 (18.2) 8 (14.6) 2 (3.6)
5 (13.2) 4 (10.5) 12 (31.6) 2 (5.3)
0.021* <0.001* <0.001* 0.069
22 (4.1)
0
13 (3.2)
7 (12.7)
2 (5.3)
0.009*
97 (17.93)
8 (17.39)
57 (14.18)
18 (32.73)
14 (36.84)
<0.001*
65 (12.01)
3 (6.52)
64 (15.92)
13 (23.64)
12 (31.58)
<0.001*
24 (4.44)
2 (4.35)
18 (4.48)
2 (3.64)
2 (5.26)
0.975
1 (2.17)
11 (2.74)
9 (16.36)
3 (7.89)
<0.001*
4 (8.7) 2 (4.4) 4 (8.7) 1 (2.2) 2 (4.4) 0 (0) n/a n/a n/a 13 (28.26)
28 (7.0) 9 (2.2) 26 (6.5) 7 (1.7) 15 (3.7) 10 (2.4) 4 (1.0) 6 (1.5) 6 (1.5) 42 (10.45)
4 (7.3) 4 (7.3) 6 (10.9) 2 (3.6) 5 (9.1) 2 (3.64) 0 2 (3.6) 0 17 (30.91)
8 (21.1) 2 (5.3) 7 (18.4) 2 (5.3) 3 (7.9) 3 (2.63) 2 (5.2) 1 (2.6) 2 (5.2) 10 (26.32)
0.044* 0.089 0.055 0.216 0.162 0.189
<0.001*
36.2 ± 36.9
46.6 ± 57.2
96.1 ± 71.2
107.8 ± 99.2
<0.001*
23.9 (6.1, 64.7)
21.3 (5.8, 65.4)
91.2 (43.8, 148.6)
63.3 (29.2, 184.2)
<0.001*
Organ space 24 (4.44) SSI management Oral antibiotic 44 (8.1) IV antibiotic 17 (3.1) Wound opening 43 (8.0) Wound debridement 12 (2.2) Percutaneous drainage 25 (4.6) Mesh removal 14 (1.29) Partial 6 (1.1) Complete 8 (1.5) Mesh related 8 (1.5) Recurrence, n (%) 82 (15.16) Follow-up time (months) Mean ± SD 55.0 ± 64.6 Median (IQR) 30.2 (6.1, 82.8) * statistically significant
LOS, length of stay; SSO, surgical site occurrence; SSI, surgical site infection; IQR, inter-quartile range; PSM, permanent synthetic mesh; ASM, absorbable synthetic mesh; BM, biologic mesh
16
Table 4: Details of Mesh Explants Patient no. 1 2 3
Mesh removed PADM HADM HADM
Mesh position RM RM IPOM
Partial/complete Partial Partial Complete
4
ASM
RM
Complete
5
ASM + LWPP
RM
Complete
6 7
LWPP LWPP
RM RM
Complete Complete
8 9
MWPP MWPP
Onlay RM
Complete Complete
10
HWPP
Onlay
Complete
11 12 13 14
MWPP MWPP MWPP MWPP
Onlay RM RM RM
Partial Partial Partial Partial
Reason for mesh explantation Chronic deep space SSI Deep space SSI Parastomal hernia with colostomy necrosis; mesh removed at time of revision Mesh placed for closure of open abdomen in patient with necrotizing pancreatitis; subsequent abdominal compartment syndrome requiring laparostomy Parastomal hernia with mucocutaneous disruption; mesh removed at time of revision Peristomal enterocutaneous fistula 1-year post-op Missed enterotomy; mesh removed at time of laparotomy for intraabdominal sepsis Superficial SSI Anastomotic leak; mesh removed at time of laparotomy for intraabdominal sepsis Peristomal enterocutaneous fistula and chronic superficial SSI Superficial SSI Deep space SSI Chronic SSI at gastrostomy tube site Vesicocutaneous fistula after urologic intervention for chronic ureteral stenosis; partial mesh removal at time of bladder repair
PADM, porcine acellular dermis; HADM, human acellular dermis; ASM, absorbable synthetic mesh; LWPP, light-weight polypropylene mesh (macroporous); MWPP, mid-weight polypropylene mesh (macroporous); HWPP, heavy-weight polypropylene mesh (microporous); SSI, surgical site infection; RM, retromuscular; IPOM, intraperitoneal onlay of mesh
17
Table 5: Multivariate Analysis for Risk of Surgical Site Infection Variable
Odds Ratio
95% CI
Intercept
0.138
(0.022, 0.77)
Age
0.989
(0.972, 1.007)
BMI
1.014
(0.985, 1.043)
DM
0.793
(0.449, 1.369)
COPD
2.386
(1.387, 4.06)*
Current smoker
1.249
(0.737, 2.093)
Contaminated
1.644
(0.971, 2.809)
Dirty
2.27
(1.095, 4.685)*
PSM
0.905
(0.377, 2.404)
ASM
1.946
(0.723, 5.587)
BM
1.925
(0.675, 5.768)
* statistically significant DM, diabetes mellitus; PSM, permanent synthetic mesh; ASM, absorbable synthetic mesh; BM, biologic mesh
18
Precis: Optimal mesh choice in contaminated ventral hernia repair is unsettled. We compare outcomes of permanent synthetic, absorbable synthetic, biologic or no mesh in contaminated cases, demonstrating equivalent risk of surgical site infection and mesh removal and the lowest risk of hernia recurrence with use of permanent synthetic mesh.
19
S1072-7515(20)30069-7
DOI:
https://doi.org/10.1016/j.jamcollsurg.2019.12.008
Reference:
ACS 9701
To appear in:
Journal of the American College of Surgeons
Received Date: 16 December 2019 Accepted Date: 17 December 2019
Please cite this article as: Warren J, Desai SS, Boswell ND, Hancock BH, Abbad H, Ewing JA, Carbonell AM, Cobb WS, Safety and Efficacy of Synthetic Mesh for Ventral Hernia Repair in a Contaminated Field, Journal of the American College of Surgeons (2020), doi: https://doi.org/10.1016/ j.jamcollsurg.2019.12.008. This is a PDF file of an article that has undergone enhancements after acceptance, such as the addition of a cover page and metadata, and formatting for readability, but it is not yet the definitive version of record. This version will undergo additional copyediting, typesetting and review before it is published in its final form, but we are providing this version to give early visibility of the article. Please note that, during the production process, errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain. © 2020 by the American College of Surgeons. Published by Elsevier Inc. All rights reserved.
Safety and Efficacy of Synthetic Mesh for Ventral Hernia Repair in a Contaminated Field Jeremy Warren, MD, FACS1, Shivani S Desai BS1, Nicole D Boswell BS1, Benjamin H Hancock BS2, Hamza Abbad MD2, Joseph A Ewing PhD3, Alfredo M Carbonell AM DO, FACS1, 2, William S Cobb MD FACS1 1. University of South Carolina School of Medicine Greenville Department of Surgery, Prisma Health, Greenville, SC 2. Prisma Health, Department of Surgery Summer Program for Undergraduate Research in Surgery, Greenville, SC 3. Prisma Health, Department of Quality, Greenville, SC Disclosure Information: Nothing to disclose. Disclosures outside the scope of this work: Drs Cobb and Carbonell received payment from WL Gore Ethicon for lectures and consultancy, and Dr Warren received payment from CMR Surgical Ethicon for consultancy and from Intuitive for lectures. Presented at the Southern Surgical Association 131st Annual Meeting, Hot Springs, VA, December 2019. Corresponding Author Jeremy Warren, MD, FACS University of South Carolina School of Medicine Greenville Department of Surgery, Prisma Health 701 Grove Rd, ST 3, Greenville, SC, 29605 [email protected]
Brief Title: Mesh in Contaminated Ventral Hernia Repair
1
Abstract Background Controversy remains over appropriate mesh selection during ventral hernia repair (VHR) in a contaminated field. Fear of mesh infection has led to increased use of biologic and absorbable synthetic mesh rather than permanent synthetic mesh in these cases. We report the safety and efficacy of permanent synthetic mesh during contaminated VHR. Study Design Retrospective review of our database identified all cases of contaminated VHR from 7/2007 to 5/2019. Student’s t-test and Wilcoxon rank-sum were used to analyze continuous variables, and discrete variables with Fisher’s or Kruskal-Wallis test. Results There were 541 contaminated cases: 245 clean-contaminated, 214 contaminated and 82 dirty cases. Suture repair was performed in 46 patients, biologic mesh used in 38, absorbable synthetic mesh in 55, and permanent synthetic mesh in 402. Mesh was extraperitoneal in 97% of cases. Incidence of surgical site infection (SSI) in each group was 17.4%, 36.8%, 32.7% and 14.2% respectively (p<0.001). Multivariate analysis showed no effect of mesh selection on SSI risk. Mesh was removed in 7 patients; 5 permanent synthetic (1.2%), one absorbable synthetic (1.8%) and one biologic (2.6%). Four were mesh-specific complications, and the remaining were removed during exploration for indications unrelated to the mesh. At a median follow-up of 30.2 months, recurrence occurred in 15.2% of patients and was significantly lower with permanent synthetic mesh. Conclusion Permanent synthetic mesh placed in an extraperitoneal position is not only safe for VHR in a contaminated field, but it confers a significantly lower rate of SSI and recurrence when compared to biologic or bioabsorbable meshes.
2
Introduction Optimal mesh selection and technique for ventral hernia repair (VHR) in the setting of contamination remains a clinical dilemma. The consequences of infected permanent synthetic mesh (PSM) can be devastating, often requiring complex wound care, serial debridement or complete mesh removal, followed inevitably by hernia recurrence. Techniques and materials have evolved in an attempt to mitigate this cycle, with the development minimally invasive VHR, resurgence of retromuscular repair, and an expanding catalog of mesh products. However, high-quality data in such cases is deficient, leaving the surgeon to rely largely on expert opinion and personal experience. Better understanding of the factors that contribute to mesh infection, and more importantly those that ultimately require mesh removal, has produced a newer generation of PSM made of lighter-weight, monofilament material with larger interstices. Experimental and clinical data demonstrate their efficacy in hernia repair, particularly in the retromuscular space, and excellent ability to withstand infection and avoid explantation [1-3]. Perhaps most disruptive was the introduction of biologic mesh (BM) constructs, introduced with the promise of providing a scaffold for native tissue ingrowth and resistance to infection. Their use proliferated widely, particularly for contaminated VHR, despite a lack of clinical data to support this practice. Increased scrutiny of BM demonstrates higher hernia recurrence rates, increased cost, and no significant difference in infection risk compared to synthetic mesh repair [4-6]. Absorbable synthetic meshes (ASM) are somewhat of a middle ground: A cheaper alternative to BM with no remaining permanent material in the event of infection. Early data on these materials is positive, but is limited [7, 8]. Given the lack of high-quality comparative data regarding the optimal mesh selection in contaminated VHR, this study aims to compare clinical outcomes of suture repair, PSM, ASM and BM in these complex patients. We hypothesize that large-pore, monofilament polypropylene mesh in contaminated VHR provides a more durable hernia repair with comparable rates of infectious complications. Materials and Methods
3
A retrospective review of all patients undergoing VHR between July 2007 and May 2019 by the investigators at a single institution (Prisma Health) was performed utilizing two hernia databases. The Americas Hernia Society Quality Collaborative (AHSQC) is a prospective hernia registry and contains data on all cases since June of 2013. The Hernia Center database, an internal prospectively maintained database, includes all cases prior to June of 2013. All ventral / incisional hernias repaired in which the wound, per Center for Disease Control (CDC) definition, was classified as clean-contaminated, contaminated, and dirty were included. All cases were classified by the surgeon in a prospective fashion and did not rely on operative nursing documentation. Patient demographics, operative technique, mesh selection, and clinical outcomes were assessed. Clinical outcomes analyzed were surgical site occurrence (SSO), surgical site infection (SSI), SSO or SSI requiring procedural intervention (SSO/I PI), hospital length of stay (LOS), operative time, readmission, reoperation, and hernia recurrence. In order to confirm long-term outcomes, chart review was performed for all patients. Any subsequent abdominal operations, radiographic studies, interventional procedures, emergency room visits, and progress notes were reviewed for documentation of hernia recurrence, delayed SSI or SSO, or interventions for SSI or SSO. Continuous variables were analyzed with Student’s t-test or Wilcoxon rank-sum. Discrete variables were analyzed with Fisher’s exact or Kruskal-Wallis test. The Prisma Health institution review board approved this study. Results
Demographics A total of 541 patients were identified who had repair of ventral hernias under cleancontaminated, contaminated, or dirty conditions. Mean age was 58.2 ± 13.4 years. Mean body mass index (BMI) was 32.0 + 8.4, 28.8% were current smokers, 29.2% had diabetes mellitus (DM), and 18.3% had chronic obstructive pulmonary disease (COPD). Patients in groups 3 and 4 had the highest rate of COPD (34.6 and 42.1%, respectively, compared to 10.9% in group 1 and 14.7% in group 2; p<0.001). Median American Society of Anesthesiologist score (ASA) was 3. Hernias were recurrent in 176 (32.5%) of patients, with a mean of 1.9 prior repairs. Table 1 summarizes patient characteristics.
4
Operative Details Wound classification was clean-contaminated in 245 patients (45.3%), contaminated in 214 (39.6%), and dirty in 82 (15.2%). Contamination was due to enterotomy in 32 cases, active infection in 82 (70 of which were mesh infections), presence of an ostomy in 282 cases, or other concurrent hepatobiliary, foregut or gynecologic procedure in the remainder. 42.1% of BM repair was in dirty wounds, which is the highest among mesh groups. Mean hernia width was 9.3 + 5.9cm, with a mean area of 151.4 + 244.8cm2. Mean mesh size was 512.6 + 446.9cm2.
Hernias were repaired using an open
approach in 93.9% of cases, robotically in 4.6%, and laparoscopically in 1.5%. Myofascial release was required in 79.1% of cases: retromuscular dissection was performed in 389 patients, transversus abdominis release (TAR) in 171, external oblique release in 36, and other (anterior sheath release, posterior component separation) in 43. A concurrent procedure was performed in 71% of patients, the majority of which (42.7%; n=231) were colorectal procedures. Mean operative time was 249.6 + 10 min. Tables 2 details patient and operative characteristics. Postoperative Outcomes Patients were divided into four groups for analysis: Group 1 (n=46) were repaired primarily with suture alone and no mesh reinforcement; group 2 (n=402) were repaired with PSM; group 3 (n=55) were repaired with ASM; group 4 (n=38) were repaired with BM. Median length of stay (LOS) was 5 days (IQR 3,7). There was no difference is readmissions between groups. Reoperation was required in 21.8% (n=118) of cases, and was lowest in groups 1 and 2 (group 1,19.6%; group 2, 19.9%; group 3, 34.6%, group 4, 26.3%; p=0.025). Incidence of SSI was also lowest in groups 1 and 2 (group 1, 17.9%; group 2, 14.2%; group 3, 32.7%; group 4, 36.8%; p<0.001). Incidence of SSO was no different between groups. Similarly, there was no difference in SSOPI / SSIPI. Wound opening for SSO was required for significantly fewer patients in groups 1 and 2 (group 1, 11.3%; group 2, 8.7%; group 3, 14.6%; group 4, 31.6%; p<0.001), as was the need for percutaneous drainage (group 1, 0%; group 2, 3.2%; group 3, 12.7%; group 4, 5.3%; p=0.009). Complete mesh removal was required in 8 (1.5%) total patients and was no different between groups: 5 (1.2%) patients repaired with PSM, 2 (3.6%) patients with ASM, and 1
5
(2.6%) patient with BM (p=0.310). Partial mesh removal was performed in an additional 6 (1.3%) patients: 4 (1.0%) in group 2 and 2 (5.3%) in group 4 (p=0.489). With a mean follow-up of 55 + 64.6 mos (median 30.2 mos; IQR 6.1, 82.8), overall hernia recurrence rate was 15.2%. Recurrence was significantly lower after repair with PSM (group 1, 28.3%; group 2, 10.5%; group 3, 30.9%; group 4, 26.3%; p<0.001). Tables 3 and 4 details clinical outcomes and mesh explantation. Multivariate analysis was performed to analyze the primary determinants of SSI. Only COPD (OR 2.4 [95% CI; 1.387, 4.06]) and a dirty wound class (OR 2.3 [95% CI; 1.095, 4.685]) were significant risk factors for SSI. Mesh selection had no impact of mesh selection on SSI: PSM, OR 0.91 [95% CI; 0.377, 2.044] ASM, OR 1.95 [95% CI; 0.723, 5.587]; BM, OR 1.925 [95% CI; 0.675, 5.768] (Table 5). Discussion Permanent synthetic mesh can be safely employed for contaminated VHR. This study indicates comparable outcomes to BM or ASM, and adds to the growing body of literature supporting this conclusion. Though incongruent with common opinion, PSM infection does not necessarily require mesh removal. It cannot be overstated, however, that the mesh construct and surgical technique are critically important for successful mesh salvage, and this must be understood when selecting the appropriate mesh and operative approach for contaminated VHR. Microporous and multifilament mesh constructs exhibit the highest degree of bacterial adherence and are least able to clear a bacterial infection in experimental studies [9-13]. Additionally, bacterial clearance of barrier coated meshes designed to inhibit adhesion formation for intraperitoneal placement is unknown. Clinical evidence supports these experimental findings. Berrevoet, et al. demonstrated the ability to salvage large-pore polypropylene mesh in all cases of infection when placed in the retromuscular space [14]. Carbonell, et al. reported 100 cases of contaminated VHR with permanent synthetic mesh in the retromuscular space. Infection occurred in 14% of patients overall, and mesh removal was required in just 4 cases. In one patient, a peri-stomal fistula developed 1-year post-op and felt likely to be mesh related. Two patients required removal due to intraabdominal sepsis after anastomotic leak, and the remaining after mucocutaneous disruption of a newly created stoma, none of which were directly related
6
to the mesh [1]. Furthermore, in a series of 255 retromuscular VHR, 104 of which were repaired with permanent synthetic mesh in the setting of contamination, only one mesh required removal [2]. When used in conjunction with enterostomy reversal, the authors similarly found permanent synthetic mesh to be safe and effective. In this series, 5 cases of periprosthetic infection occurred, but none required mesh removal. Mesh was removed in 5 other cases, all of which involved intraabdominal complications requiring laparotomy and necessitated mesh removal for peritoneal entry [15]. Other authors have reported similar success of permanent mesh use for contaminated VHR[16, 17] [18], emergency VHR[19, 20], emergency laparotomy[21], and with concurrent colorectal surgery[22, 23]. These studies confirm the ability of monofilament, large-pore polypropylene mesh to withstand contamination and infection when placed in an extraperitoneal position. The use of BM in contaminated VHR is commonplace. Recommendations of the Ventral Hernia Working Group indicated biologic mesh should be considered in patients at higher clinical risk of infection, and generally recommended for patients with contamination or infection [24]. In a survey of practicing surgeons, 80% of high-volume surgeons (>20 VHR/year) indicated that BM is preferred for clean-contaminated and contaminated VHR [25]. Interestingly, 40% or more of surgeons surveyed also reported poor mesh incorporation, infection, mesh disintegration, and mechanical failure. Reported clinical outcomes of BM vary widely. Sbitany, et al. reported an SSI rate of 15% and recurrence of just 12% using non-cross-linked porcine acellular dermal matrix (PADM) in the repair of 41 cases [26]. In the RICH study, PADM was used in 85 class 2,3 or 4 VHR with 2-year follow-up. In total, 35% of cases resulted in SSI, and 28% of cases recurred [27]. Shubinets, et al. recently reported favorable outcomes in 43 patients using retromuscular placement of BM during single-stage reconstruction at the time of infected mesh removal [28]. In both of these studies, repair technique was a significant factor. Bridged repairs, in which fascial closure was not achieved over the mesh, resulted in significantly higher rate of hernia recurrence. The BM construct likely impacts outcomes as well. Cross-linked porcine BM, demonstrated the highest rate of infection (50%) in the Shubinets study. Similarly Abdelfatah, et al. reported a 25% mesh removal rate due to infection and 66% rate of hernia recurrence using this mesh[29].
7
Kaufmann, et al. report 28% hernia recurrence and 50.6% abdominal wall bulging after repair with crosslinked PADM [30]. Recent reviews indicate the lack of evidence in support of biologic mesh over synthetic mesh in contaminated VHR [31-35]. Absorbable synthetic mesh has demonstrated favorable results in some series. In the COBRA trial, 104 patients underwent contaminated VHR with BioA Tissue Reinforcement, W.L. Gore) with a resultant 18% SSI rate and 17% recurrence rate [7]. Roth, et al. recently reported 18-month outcomes of poly-4-hydroxybutyrate mesh (P4HB)(Phasix TM Mesh, Bard Inc) in high-risk, but clean cases with 9% SSI and 9% recurrence rate [8]. In the only study identified evaluating P4HB in contaminated VHR, SSI occurred in 10% of cases with no hernia recurrence reported at mean follow-up of 21.1 mos [36]. However, analysis of 30-day outcomes of patients undergoing repair of clean-contaminated and contaminated hernias from the AHSQC demonstrated a higher rate of SSI with ASM compared to polypropylene mesh (22.4 vs 10.9%; p=0.03), with a resultant increased rate of SSO requiring procedural intervention and reoperation (24.1 vs 13.2%; p=0.049) [37]. Few trials offer comparative data. Majumder, et al, reported superior outcomes of synthetic over biologic mesh in 126 cases of clean-contaminated and contaminated VHR [38]. A multicenter review by Bondre, et al. compared outcomes of suture (n=291), PSM (n=303), and BM (n=167) in contaminated VHR. Despite the authors conclusion the BM is favored in contaminated VHR, there was actually no difference in SSI (15.1%, 17.8%, 21.0%, respectively; p=0.280), or recurrence (17.8%, 13.5%, 21.5%, respectively; p=0.074) [39]. Chamieh, et al. reported no differences in SSI or recurrence between PSM and BM in their series, though there was significant heterogeneity in surgical technique [40]. Comparing P4HB to BM, Buell, et al, report higher rate of SSI and hernia recurrence with BM [41]. The variability in reported outcomes of cases series and comparative studies is likely due to significant selection bias, small sample sizes, and substantial heterogeneity in operative technique, patient characteristics, and mesh properties. Given the equivocal or even inferior outcomes of BM and ASM compared to PSM, consideration must be given to the high cost of BM or ASM and its overall impact on the healthcare economy [5, 42, 43].
8
Though this is the largest study of contaminated VHR reporting outcomes of various mesh types and techniques, it is not without limitations. Clearly the vast majority of cases were performed using PSM in this series, representing a significant selection bias. Our choice of mesh has changed somewhat over time based on our evolving clinical experience, as the majority of BM and ASM cases were performed during the earlier time period of the study, with 78.5% of these cases performed prior to 2013. This is reflected most clearly in the wound class 4 cases, which have transitioned from primarily BM repairs historically to suture repairs with staged definitive VHR in most contemporary cases. This study significantly improves on the duration of follow-up, an important criticism of the authors’ previous work. However, there are still a number of patients with limited follow-up, with 266 patients (49.2%) completing less than 12-month follow-up. There are also differences between groups, most notably the highest rate of COPD in patients repaired with ASM and BM, which was an independent risk factor for SSI on multivariate analysis. However, there was no effect of mesh type on the risk of developing SSI, and the low mesh explantation rate for any mesh type indicates the negligible clinical impact of a mesh infection when the properly selected PSM and surgical technique are used. Finally, we await the results of a prospective randomized control trial of PADM versus large-pore polypropylene mesh in cleancontaminated and contaminated VHR that has now completed enrollment and in follow-up [clinicaltrials.gov] Conclusion The current study challenges the popular conception of biologic graft superiority in contaminated VHR, and the dogmatic notion that permanent synthetic mesh is to be avoided in such cases. In fact, the lowest rate of SSI in this series is seen with PSM, with only 1% of PSM requiring explantation. The low rate of infectious complications, coupled with a 3-fold increase in hernia recurrence with any other method of repair, confirms the superiority of retromuscular repair with monofilament, large-pore polypropylene mesh should be the Based on these findings and extensive clinical experience, the authors recommend the use of large-pore, monofilament polypropylene mesh in an extraperitoneal plane, ideally the retromuscular space, for repair of contaminated VHR.
9
Acknowledgement Cameron Keramati BS Prisma Health, Department of Surgery Summer Program for Undergraduate Research in Surgery 701 Grove Rd, ST 3, Greenville, SC 29605 Reference
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Bondre IL, Holihan JL, Askenasy EP, et al. Suture, synthetic, or biologic in contaminated ventral hernia repair. J Surg Res 2016; 200:488–494.
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13
Table 1: Patient Characteristics Variable Age, y, mean ± SD
All, n = 541
None, n = 46
PSM, n = 402
ASM, n = 55
BM, n = 38
p Value
58.2 ± 13.4
60.6 ± 15.8
57.8 ± 12.8
57.4 ± 14.9
60.1 ± 13.7
0.961
32.0 ± 8.4
33.5 ± 8.6
32.1 ± 8.0
28.9 ± 8.6
33.9 ± 11.0
0.349
2
BMI, kg/m , mean ± SD Sex, n (%) Male Female
0.702 247 (45.66) 294 (54.34)
18 (39.13) 28 (60.87)
184 (45.77) 218 (54.23)
28 (50.91) 27 (49.09)
17 (44.74) 21 (55.26)
Race, n (%)
0.922
White
458 (84.66)
38 (82.61)
337 (83.83)
49 (89.09)
34 (89.47)
Black
67 (12.38)
6 (13.04)
52 (12.94)
5 (9.09)
4 (10.53)
11 (2.03)
2 (4.35)
13 (3.23)
1 (1.82)
0 (0)
Other Smoking status, n (%)
0.051
Never/unknown
202 (37.34)
29 (63.04)
178 (44.28)
24 (43.64)
19 (50)
Current
153 (28.28)
5 (10.87)
121 (30.1)
20 (36.36)
7 (18.42)
Former
138 (25.51)
12 (26.09)
103 (25.62)
11 (20)
12 (31.58)
DM, n (%)
158 (29.21)
20 (43.48)
109 (27.11)
18 (32.73)
11 (28.95)
0.128
HTN, n (%)
298 (55.08)
26 (56.52)
232 (57.71)
25 (45.45)
15 (39.47)
0.073
Dialysis n (%)
14 (2.59)
0 (0)
9 (2.24)
4 (7.27)
1 (2.63)
0.108
COPD, n (%)
99 (18.3)
5 (10.87)
59 (14.68)
19 (34.55)
16 (42.11)
<0.001*
1
4 (0.74)
1 (2.17)
2 (0.5)
1 (1.82)
0 (0)
2
116 (21.44)
6 (13.04)
91 (22.64)
7 (12.73)
12 (31.58)
3
392 (72.46)
33 (71.74)
295 (73.38)
40 (72.73)
24 (63.16)
4
29 (5.36)
6 (13.04)
14 (3.48)
4 (7.27)
2 (5.26)
ASA, n (%)
0.009
* statistically significant DM, diabetes mellitus; HTN, hypertension; ASA, American Society of Anesthesiology score; PSM, permanent synthetic mesh; ASM, absorbable synthetic mesh; BM, biologic mesh
14
Table 2: Operative Details Variable
All, n = 541
None, n = 46
PSM, n = 402
ASM, n = 55
BM, n = 38
Wound classification Clean-contaminated Contaminated Dirty Operative approach, n (%)
245 (45.29) 214 (39.56) 82 (15.16)
15 (32.61) 6 (13.04) 25 (54.35)
212 (52.74) 167 (41.54) 23 (5.72)
15 (27.27) 22 (40) 18 (32.73)
3 (7.89) 19 (50) 16 (42.11)
Open
p Value <0.001*
<0.001* 472 (87.25)
34 (73.91)
346 (86.07)
54 (98.18)
38 (100)
Robotic
25 (4.62)
1 (2.17)
24 (5.97)
0 (0)
0 (0)
Laparoscopic Unknown
8 (1.48) 36 (6.65)
5 (10.87) 6 (13.04)
2 (0.5) 30 (7.46)
1 (1.82) 0 (0)
0 (0) 0 (0)
9.3 ± 5.9
10.2 ± 8.3
9.2 ± 5.8
8.6 ± 4.8
10.4 ± 5.4
0.59
428 (79.11)
4 (8.7)
346 (86.07)
48 (87.27)
30 (78.95)
<0.001*
36 (6.65)
1 (2.17)
25 (6.22)
8 (14.55)
2 (5.26)
0.065
Transversus abdominis release
171 (31.61)
1 (2.17)
153 (38.06)
5 (9.09)
12 (31.58)
<0.001*
Anterior rectus sheath incision
12 (2.22)
1 (2.17)
11 (2.74)
0 (0)
0 (0)
0.456
Posterior rectus sheath incision
389 (71.9)
4 (8.7)
320 (79.6)
40 (72.73)
25 (65.79)
<0.001*
Posterior component separation
31 (5.73)
0 (0)
17 (4.23)
11 (20)
3 (7.89)
<0.001*
Fascia closed, n (%)
515 (95.19)
45 (97.83)
380 (94.53)
54 (98.18)
36 (94.74)
0.536
Concurrent procedure, n (%)
384 (70.98)
30 (65.22)
293 (72.89)
40 (72.73)
21 (55.26)
0.107
Separate hernia
11 (2.03)
2 (4.35)
8 (1.99)
1 (1.82)
0 (0)
0.564
Foregut/endocrine
4 (0.74)
1 (2.17)
3 (0.75)
0 (0)
0 (0)
0.576
Hepatobiliary
18 (3.33)
4 (8.7)
13 (3.23)
1 (1.82)
0 (0)
0.12
Small intestine
58 (10.72)
10 (21.74)
33 (8.21)
12 (21.82)
3 (7.89)
0.001*
Colorectal
231 (42.7)
8 (17.39)
175 (43.53)
31 (56.36)
17 (44.74)
<0.001*
OB/GYN
25 (4.62)
1 (2.17)
24 (5.97)
0 (0)
0 (0)
0.079
Vascular
2 (0.37)
0 (0)
2 (0.5)
0 (0)
0 (0)
0.875
Soft tissue/plastic
23 (4.25)
0 (0)
22 (5.47)
1 (1.82)
0 (0)
0.112
Other
22 (4.07)
3 (6.52)
18 (4.48)
1 (1.82)
0 (0)
0.301
Onlay
23 (4.25)
0 (0)
17 (4.23)
6 (10.91)
0 (0)
Inlay
1 (0.18)
0 (0)
0 (0)
0 (0)
1 (2.63)
406 (75.05)
0 (0)
342 (85.07)
41 (74.55)
23 (60.53)
Hernia width, cm, mean ± SD Myofascial release, n (%) External oblique release
Mesh position, n (%)
Retromuscular
0.01*
Preperitoneal
29 (5.36)
0 (0)
25 (6.22)
3 (5.45)
1 (2.63)
Intraperitoneal
16 (2.96)
0 (0)
11 (2.74)
2 (3.64)
10 (26.32)
<0.001*
* statistically significant PSM, permanent synthetic mesh; ASM, absorbable synthetic mesh; BM, biologic mesh
15
Table 3: Clinical Outcomes
Variable LOS, d, median (IQR) Readmission, n (%) Reoperation, n (%) Any SSO, n (%) SSO management Oral antibiotic IV antibiotic Wound opening Wound debridement Percutaneous drainage Any SSI, n (%) Superficial Deep
All, n = 541
None, n = 46
PSM, n = 402
ASM, n = 55
BM, n = 38
p Value
5 (3-7) 83 (15.34) 118 (21.81) 237 (43.8)
5 (2, 10) 5 (10.87) 9 (19.57) 21 (45.6)
5 (3, 7) 69 (17.16) 80 (19.9) 171 (42.5)
6 (4, 10) 4 (7.27) 19 (34.55) 27 (49.1)
5 (3, 9) 5 (13.16) 10 (26.32) 18 (47.4)
0.005* 0.219 0.025* 0.755
35 (6.5) 2 (0.4) 61 (11.3) 8 (1.5)
4 (8.7) 4 (8.7) 6 (13.0) 0
19 (4.7) 11 (2.7) 35 (8.7) 4 (1)
7 (12.7) 10 (18.2) 8 (14.6) 2 (3.6)
5 (13.2) 4 (10.5) 12 (31.6) 2 (5.3)
0.021* <0.001* <0.001* 0.069
22 (4.1)
0
13 (3.2)
7 (12.7)
2 (5.3)
0.009*
97 (17.93)
8 (17.39)
57 (14.18)
18 (32.73)
14 (36.84)
<0.001*
65 (12.01)
3 (6.52)
64 (15.92)
13 (23.64)
12 (31.58)
<0.001*
24 (4.44)
2 (4.35)
18 (4.48)
2 (3.64)
2 (5.26)
0.975
1 (2.17)
11 (2.74)
9 (16.36)
3 (7.89)
<0.001*
4 (8.7) 2 (4.4) 4 (8.7) 1 (2.2) 2 (4.4) 0 (0) n/a n/a n/a 13 (28.26)
28 (7.0) 9 (2.2) 26 (6.5) 7 (1.7) 15 (3.7) 10 (2.4) 4 (1.0) 6 (1.5) 6 (1.5) 42 (10.45)
4 (7.3) 4 (7.3) 6 (10.9) 2 (3.6) 5 (9.1) 2 (3.64) 0 2 (3.6) 0 17 (30.91)
8 (21.1) 2 (5.3) 7 (18.4) 2 (5.3) 3 (7.9) 3 (2.63) 2 (5.2) 1 (2.6) 2 (5.2) 10 (26.32)
0.044* 0.089 0.055 0.216 0.162 0.189
<0.001*
36.2 ± 36.9
46.6 ± 57.2
96.1 ± 71.2
107.8 ± 99.2
<0.001*
23.9 (6.1, 64.7)
21.3 (5.8, 65.4)
91.2 (43.8, 148.6)
63.3 (29.2, 184.2)
<0.001*
Organ space 24 (4.44) SSI management Oral antibiotic 44 (8.1) IV antibiotic 17 (3.1) Wound opening 43 (8.0) Wound debridement 12 (2.2) Percutaneous drainage 25 (4.6) Mesh removal 14 (1.29) Partial 6 (1.1) Complete 8 (1.5) Mesh related 8 (1.5) Recurrence, n (%) 82 (15.16) Follow-up time (months) Mean ± SD 55.0 ± 64.6 Median (IQR) 30.2 (6.1, 82.8) * statistically significant
LOS, length of stay; SSO, surgical site occurrence; SSI, surgical site infection; IQR, inter-quartile range; PSM, permanent synthetic mesh; ASM, absorbable synthetic mesh; BM, biologic mesh
16
Table 4: Details of Mesh Explants Patient no. 1 2 3
Mesh removed PADM HADM HADM
Mesh position RM RM IPOM
Partial/complete Partial Partial Complete
4
ASM
RM
Complete
5
ASM + LWPP
RM
Complete
6 7
LWPP LWPP
RM RM
Complete Complete
8 9
MWPP MWPP
Onlay RM
Complete Complete
10
HWPP
Onlay
Complete
11 12 13 14
MWPP MWPP MWPP MWPP
Onlay RM RM RM
Partial Partial Partial Partial
Reason for mesh explantation Chronic deep space SSI Deep space SSI Parastomal hernia with colostomy necrosis; mesh removed at time of revision Mesh placed for closure of open abdomen in patient with necrotizing pancreatitis; subsequent abdominal compartment syndrome requiring laparostomy Parastomal hernia with mucocutaneous disruption; mesh removed at time of revision Peristomal enterocutaneous fistula 1-year post-op Missed enterotomy; mesh removed at time of laparotomy for intraabdominal sepsis Superficial SSI Anastomotic leak; mesh removed at time of laparotomy for intraabdominal sepsis Peristomal enterocutaneous fistula and chronic superficial SSI Superficial SSI Deep space SSI Chronic SSI at gastrostomy tube site Vesicocutaneous fistula after urologic intervention for chronic ureteral stenosis; partial mesh removal at time of bladder repair
PADM, porcine acellular dermis; HADM, human acellular dermis; ASM, absorbable synthetic mesh; LWPP, light-weight polypropylene mesh (macroporous); MWPP, mid-weight polypropylene mesh (macroporous); HWPP, heavy-weight polypropylene mesh (microporous); SSI, surgical site infection; RM, retromuscular; IPOM, intraperitoneal onlay of mesh
17
Table 5: Multivariate Analysis for Risk of Surgical Site Infection Variable
Odds Ratio
95% CI
Intercept
0.138
(0.022, 0.77)
Age
0.989
(0.972, 1.007)
BMI
1.014
(0.985, 1.043)
DM
0.793
(0.449, 1.369)
COPD
2.386
(1.387, 4.06)*
Current smoker
1.249
(0.737, 2.093)
Contaminated
1.644
(0.971, 2.809)
Dirty
2.27
(1.095, 4.685)*
PSM
0.905
(0.377, 2.404)
ASM
1.946
(0.723, 5.587)
BM
1.925
(0.675, 5.768)
* statistically significant DM, diabetes mellitus; PSM, permanent synthetic mesh; ASM, absorbable synthetic mesh; BM, biologic mesh
18
Precis: Optimal mesh choice in contaminated ventral hernia repair is unsettled. We compare outcomes of permanent synthetic, absorbable synthetic, biologic or no mesh in contaminated cases, demonstrating equivalent risk of surgical site infection and mesh removal and the lowest risk of hernia recurrence with use of permanent synthetic mesh.
19