World J Surg DOI 10.1007/s00268-013-2232-1
Biologic Versus Nonbiologic Mesh in Ventral Hernia Repair: A Systematic Review and Meta-analysis Ali Darehzereshki • Melanie Goldfarb • Joerg Zehetner • Ashkan Moazzez • John C. Lipham • Rodney J. Mason • Namir Katkhouda
Ó Socie´te´ Internationale de Chirurgie 2013
Abstract Background The current standard of treatment for most ventral hernias is a mesh-based repair. Little is known about the safety and efficacy of biologic versus nonbiologic grafts. A meta-analysis was performed to examine two primary outcomes: recurrence and wound complication rates. Methods Electronic databases and reference lists of relevant articles were systematically searched for all clinical trials and cohort studies published between January 1990 and January 2012. A total of eight retrospective studies, with 1,229 patients, were included in the final analysis. Results Biologic grafts had significantly fewer infectious wound complications (p \ 0.00001). However, the recurrence rates of biologic and nonbiologic mesh were not different. In subgroup analysis, there was no difference in recurrence rates and wound complications between humanderived and porcine-derived biologic grafts. Conclusions Use of biologic mesh for ventral hernia repair results in less infectious wound complications but similar recurrence rates compared to nonbiologic mesh. This supports the application of biologic mesh for ventral
A. Darehzereshki M. Goldfarb J. Zehetner (&) J. C. Lipham R. J. Mason N. Katkhouda Division of Upper GI and General Surgery, Department of Surgery, Keck School of Medicine of USC, University of Southern California, 1510 San Pablo Street, Suite 514, Los Angeles, CA 90033, USA e-mail:
[email protected] A. Darehzereshki e-mail:
[email protected] A. Moazzez H. Claude Hudson Comprehensive Health Center, 2829 S. Grand Ave, Los Angeles, CA 90007, USA
hernia repair in high-risk patients or patients with a previous history of wound infection only when the significant additional cost of these materials can be justified and synthetic mesh is considered inappropriate. Abbreviations CST Component separation technique OR Odds ratio CI Confidence interval HADM Human acellular dermal matrix HBM Human biologic mesh PBM Porcine biologic mesh PCL Porcine cross-linked PNCL Porcine non-cross-linked AD AlloDerm FHD FlexHD
Introduction Ventral hernia represents one of the most frequently encountered surgical problems in the United States, with incisional hernias alone affecting up to 11 % of patients after major abdominal surgery [1]. Additionally, up to 23 % of patients who undergo a ventral hernia repair require a reoperation due to an incisional hernia within 13 years of their initial operation [2]. To combat this problem, many different approaches for repairing ventral hernias have been described, ranging from a simple fascial closure to the use of prosthetic materials to reinforce or bridge the fascial defect. Mesh-based repair has been shown to be superior to primary suture repair, with a lower reported recurrence rate (16 vs. 54 %), and is now the standard of care for all ventral hernias [3–5].
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Though the characteristics of an ideal mesh have been described, no ‘‘perfect’’ mesh has been developed, hence the myriad of prosthetic mesh choices, both synthetic and biologic, that are available for commercial use [6–9]. Synthetic-based mesh is the traditional and most commonly used material for all hernia repairs due to its low cost, strength, ease of handling, and versatility [10]. However, synthetic-based mesh is more prone to infectious and other postsurgical complications such as foreign body reaction and adhesion formation with an increased need for reoperation [11–16]. In contrast, over the past two decades, biologic prostheses have been increasingly promoted for the repair of abdominal wall defects due to their theoretical advantages of resistance to infection and incorporation into tissues [17]. However, biologic meshes are generally expensive and may not be cost-effective, and their true utility when compared to synthetics has not been established [10, 18]. Despite the widespread use and rapid acceptance of biologic materials for hernia repair, their efficacy and longevity as compared to synthetics has been studied only nominally. In addition, the most appropriate and useful clinical indications for use of biologic grafts remain unproven, with the current use of biologics based largely on surgeon preference, cost, and personal experience with a given material. There are no randomized prospective studies or controlled clinical trials in the literature, only retrospective studies with mainly small sample sizes and heterogeneous populations. Therefore, the goal of this study was to evaluate the clinical outcomes of biologic grafts versus nonbiologic grafts in ventral hernia repair by performing a meta-analysis of the best current evidence in this field.
Materials and methods
in a consensus meeting of the surgical faculty of the Upper GI and General Surgery Division of the Department of Surgery in the University of Southern California. Identification of studies for inclusion Studies were included for meta-analysis based on the following criteria: 1. 2.
3.
Study design was a clinical trial, prospective or retrospective cohort, or case–control. Population included two groups of patients undergoing ventral hernia repair or abdominal wall reconstruction using (a) biologic versus nonbiologic mesh or (b) human-derived biologic mesh versus porcinederived biologic mesh. There was a report of at least one outcome of interest, recurrence or wound complication, for both biologic and nonbiologic mesh. Patients were excluded if
1.
2.
In studies comparing biologic and nonbiologic mesh, the mesh was placed in a grossly contaminated field, defined as violation of the GI tract, intraoperative enterotomy, perforation, resection of tumors that originated from the GI tract, enterocutaneous fistula, or rectovaginal fistula. For studies that detailed wound classification data or reported separate outcomes for repairs in a clean field, only wound classification I or II and clean field data were included in the meta-analysis. Hernia repair was performed primarily (suture only, no mesh), the repair used both biologic and nonbiologic mesh or mesh plus a distant autologous tissue flap, or the repair was done with a biologic graft that is not commercially available.
Search strategy
Outcome measures
The electronic databases PubMed, Ovid MEDLINE, the Cochrane Central Register of Controlled Trials, and Google Scholar were searched for potentially relevant studies by using various combinations of the search terms ‘‘Biologic mesh’’ (including the name of all available biologic prostheses), ‘‘ventral hernia,’’ ‘‘incisional hernia,’’ ‘‘umbilical hernia,’’ and ‘‘abdominal wall reconstruction.’’ Search limitations included human studies, publication in the English language, and publication after January 1990. Titles and abstracts of all possible articles were reviewed and reference lists were examined for any additional pertinent articles. All potential studies were examined in detail to select only those papers meeting the strict inclusion criteria detailed below. Any discrepancy was resolved by discussion
Two primary outcomes were measured: hernia recurrence rate and wound complication rate. Recurrence was defined as any reported repair failure: postoperative hernia, laxity, bulge, eventration, or diastasis. Wound complications were divided into infectious and noninfectious complications for all studies. Infectious complications included purulence, cellulitis, positive culture, dehiscence, chronic wound infection, abscess, fistula, and mesh infection, whereas edema, subcutaneous hydrops, erosion, seroma, hematoma, bleeding, and fluid collections were considered noninfectious. Subset analyses were performed for patients who received a mesh with or without a component separation technique (CST) as well as for human-derived biologic mesh versus porcine-derived biologic mesh.
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World J Surg Fig. 1 Flow diagram of the search strategy
Statistical analysis Cochrane Collaboration Review Manager 5.0 software was used to perform the meta-analysis. Odds ratios (OR) were calculated for categorical variables and the Mantel–Haenszel method was used for calculating the pooled OR. A p \ 0.05 was considered statistically significant if the 95 % confidence interval (CI) did not include the value 1, with an OR \ 1 favoring the biologic mesh group. Random-effects models were calculated for all outcomes as studies were highly heterogeneous. Funnel plots were constructed to analyze the possibility of publication bias regarding the outcomes of interest.
total of 1,229 patients, 340 patients were excluded due to ventral hernia repair techniques that did not use biologic or nonbiologic mesh, leaving 889 patients for the final metaanalysis, 328 with biologic mesh and 561 with nonbiologic mesh. Four studies [24, 27–29] compared human versus porcine biologic grafts with 235 patients available for analysis, 154 with human biologic mesh and 81 with porcine biologic mesh. Outcomes Tables 1, 2 and 3 summarize the general characteristics and outcomes of each study used in the meta-analysis. Recurrence
Results Biologic versus nonbiologic mesh Search results Figure 1 details the article search strategy. Eight articles [19–26] were found with both biologic and nonbiologic mesh groups as well as at least one reported outcome of interest for both groups. While the eight studies contained a
The average recurrence rate for ventral hernia repair across all the studies was 17.1 % and was not significantly different between biologic mesh (18.6 %) and nonbiologic mesh (15.7 %) (p = 0.67, Fig. 2a). In a subgroup analysis, hernia repairs that used biologic mesh and a CST trended
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World J Surg Table 1 Characteristics of the studies comparing biologic and nonbiologic mesh Study
Total no.
Technique of repair Biologic mesh repair AD
StratticeTM
Surgisis
Nonbiologic Permacol
Other
a
Total
Component separation technique Biologic
Nonbiologic
Brewer et al. [19]
104
34
0
0
0
34
26
44
0
0
Espinosa et al. [20]
78
32
0
0
0
32
10
36
32
0
Ghazi et al. [21] Ko et al. [22]
165 200
103 13
0
0 0
0 0
103 13
30 23
32 164
36 13
17 23
Raftopoulos et al. [23]
27
0
0
15
0
15
11
1
0
0
Sailes et al. [24]
545
100
0
0
13
113
432
0
113
432
Tang et al. [25]
27
1
0
0
0
1
1
25
0
0
Vertrees et al. [26]
83
17
0
0
0
17
28
38
0
0
Total [n (%)]
1229
300 (91.5)
15 (4.6)
13 (3.9)
328 (26.7)
561 (45.6)
340 (27.7)
194 (59.1)
472 (84.1)
AlloDerm and Strattice (LifeCell, Bridgewater, NJ), Surgisis (Cook Medical, Bloomington, IN) AD AlloDermÒ a
Other techniques included primary repair (no mesh), use of a combined biologic and nonbiologic mesh, or mesh plus distant autologous tissue flap. All were excluded from this study
Table 2 Outcomes of studies comparing biologic and nonbiologic mesh Study
Wound complications
Recurrence (n = 844)
Infectious (n = 240)
Noninfectious (n = 180)
Biologic
Biologic
Nonbiologic
Nonbiologic
Biologic
Follow-up (m)
Nonbiologic
Brewer et al. [19]
5/34
17/26
NA
NA
8/34
20/26
Mean 26
Espinosa et al. [20]
NA
NA
NE
NE
0/32
3/10
Median: Biologic 15 Nonbiologic 13
Ghazi et al. [21]
11/103
10/30
16/103
1/30
22/103
5/30
Ko et al. [22]
NE
NE
NE
NE
5/13
1/23
Mean 34 (0.5–90) Mean (5.4–13.8) Biologic 14.7 Nonbiologic 10.3
Raftopoulos et al. [23]
NE
NE
NA
NA
3/15
2/11
Mean 14.9 (3–32)
Sailes et al. [24]
NE
NE
NE
NE
20/113
53/432
Mean 66
Tang et al. [25]
0/1
0/1
0/1
1/1
0/1
0/1
Biologic 21
Vertrees et al. [26]
1/17
4/28
0/17
0/28
(2/17)a
NA
Nonbiologic 7 Mean 26 (1–60) Biologic 15 ± 9 Nonbiologic 29 ± 12 Total [n (%)]
17/155 (10.9)
31/85 (36.5)
48/240 (20.0)
16/121 (13.2) 18/180 (10.0)
2/59 (3.4)
58/311 (18.6)
84/533 (15.7)
–
144/844 (17.1)
66/420 (15.7) NA not available, NE not estimable a
Data not included in the final meta-analysis
toward having a higher recurrence rate than repairs with nonbiologic mesh and CST (18.5 vs. 11.4 %, OR 3.42, 95 % CI 077–15.24, p = 0.11) (Fig. 2b). In contrast, in
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patients repaired without the use of CST, there was a trend toward a higher recurrence rate for nonbiologic mesh (OR 0.34, 95 % CI 0.08–1.47, p = 0.15) (Fig. 2c).
Only patients with wound classification I and II were included in this study. Number of patients and outcomes was not estimable for component separation technique
Biologic versus nonbiologic mesh The incidence of infectious wound complications was 10.9 % with biologic mesh compared to 36.5 % with nonbiologic mesh (p \ 0.00001, OR 0.18, 95 % CI 0.09–0.37) (Fig. 3a). However, there was no significant difference in the rate of noninfectious wound complications: 13.2 versus 3.4 % (p = 0.88). As such, the rate of total wound complications showed only a trend toward fewer complications with use of biologic mesh (OR 0.35, 95 % CI 0.09–1.40, p = 0.14). Human biologic versus porcine biologic mesh Recurrence rate and follow-up data were available in 14 and 19 patients with HBM and PBM, respectively
All patients received a component separation technique
Wound complications
c
b
a
235 Total (%)
HBM human biologic mesh, PBM porcine biologic mesh, PCL porcine cross-linked, PNCL porcine non-cross-linked, AD AlloDerm, FHD FlexHD, NE not estimable
– 5/75 (6.7) 45/149 (30.2)
50/224 (22.3)
17/43 (39.5) 3/35 (8.6)
20/78 (25.6)
15/68 (22.1) 6/54 (11.1) 18 (22.2) 2 (1.3) 152 (98.7)
63 (77.8)
20 0 19 44b Shah et al. [29]
21/122 (17.2)
12
Mean 66
4c 3c 5
15
NE
NE
PBM mean 29
113a Sailes et al. [24]
100
0
5
NE
NE
NE
1 19 NE
HBM mean 18
0
13
0
0
0
23
0
17 2
1 0
0 0
1 0
0
2
41
2
0 74 Gupta et al. [27]
0 4a Bachman et al. [28]
33
PBM HBM PBM HBM PNCL FHD AD
HBM
PBM
PCL
Infectious (n = 122)
Wound complications
There was no difference in recurrence rates for humanderived and porcine-derived biologic grafts (p = 0.21) (Fig. 2d).
Total no.
Technique of repair
Human biologic versus porcine biologic mesh
Study
Table 3 Outcomes of studies comparing human-derived and porcine-derived biologic mesh
Noninfectious (n = 78)
HBM
PBM
Recurrence (n = 224)
Follow-up (m)
Median 6 (0.25–9)
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There was no significant difference in ventral hernia repair with human-derived biologic grafts compared with porcine biologic mesh with respect to infectious (p = 0.75), noninfectious (p = 0.69), and overall (p = 0.25) wound complication rates (Fig. 3b). Quality assessment and publication bias analysis The possibility of publication bias from using a fixed-effects model was analyzed with a funnel plot. Analysis of recurrence and wound complication rates showed that 30–50 % of the studies were outside the 95 % CI axis (Fig. 4). Therefore, a random-effects model was performed. Since all the studies had a retrospective design, we were not able to evaluate the quality of the studies by any validated scoring system. Instead, a qualitative assessment was performed (Table 4).
Discussion In this meta-analysis, biologic mesh was an effective alternative to synthetic mesh for the repair of ventral hernias. Biologic mesh demonstrated a lower rate of infectious wound complications and an equivalent rate of both recurrence and noninfectious wound complications when compared to nonbiologic mesh. Biologic prostheses were developed for their infectionresistant properties. Their structural arrangement acts as a scaffold for cellular infiltration, fibroblast incorporation, and collagen deposition that promotes tissue regeneration and
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a
b
c
d
Fig. 2 Recurrence rate after ventral hernia repair: biologic versus nonbiologic mesh (a), biologic mesh?CST versus nonbiologic mesh?CST (b), biologic versus nonbiologic mesh without CST (c),
and human-derived versus porcine-derived biologic mesh (d). CST component separation technique
revascularization. In animal models, the increased revascularization in biologic prostheses enhanced resistance to infection while maintaining the same tensile strength as synthetic materials [30–33]. Additionally, the fibrovascular incorporation and tissue remodeling are thought to reduce the risks associated with an ongoing foreign body response such as chronic infection, erosion, and enterocutaneous fistula [30, 31, 34]. In the literature, infection rates range from 5.4 to 57.1 % when biologic mesh is used for ventral hernia
repair, though these numbers include patients with varying comorbidities as well as both clean and dirty surgical fields [35–40]. The infectious wound complication rate of 10.9 % for biologic mesh in the present meta-analysis falls at the lower end of this infection range, which is not surprising based on the chosen inclusion criteria, and it is well below the 36.5 % infectious complication rate for nonbiologic mesh. In practice, human acellular dermal matrix (HADM) in ventral hernia repairs is commonly used in combination with
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a
b
Fig. 3 Infectious and noninfectious wound complications: biologic versus nonbiologic mesh (a) and human versus porcine biologic mesh (b)
some type of musculofascial component separation [18, 41]. Reported recurrence rates associated with this combination vary from 0 to 20 % in the literature. However, with the multitude of different CSTs and the wide range of patient follow-up, it is difficult to directly compare all the studies [18, 22, 41]. In examining the studies included in this metaanalysis, some differences in rates may arise from the use of HADM as a bridge or interposition as opposed to
reinforcement after primary fascial reapproximation [18, 24, 27, 28, 37, 42, 43]. The 18.5 % recurrence rate for biologic mesh?CST in the present meta-analysis falls within this range and is higher than the 11.4 % recurrence rate with nonbiologic mesh?CST. One theory to explain this discrepancy proposes that the stress shielding of the midline closure by AlloDermÒ (a biologic mesh) (LifeCell, Bridgewater, NJ), in conjunction with its loss of tensile
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a
b
Fig. 4 Funnel plot analysis of recurrence rates (a) and wound complication (b) between biologic mesh and nonbiologic mesh
strength over time, may contribute to higher recurrence rates when used in conjunction with CST for hernia repair [22, 44]. Specifically with respect to AlloDermÒ, poor handling of the material during suturing, due to its thin borders, as well as incomplete incorporation of the mesh with native tissue may also impact recurrence [27]. Within the biologic mesh group there are both human and porcine derivatives, and little research has explored what differences in outcomes may exist between these two biologic graft entities. In experimental studies, human-derived grafts have demonstrated adequate fibroblast infiltration and resultant angiogenesis with decreased inflammatory response compared to porcine grafts that have shown higher fibroblast proliferation and inflammatory response but limited infiltration into the implant [29, 40, 45, 46]. While the current metaanalysis supports these animal experiments, AlloDermÒ, a human acellular dermal matrix and the most commonly used biologic mesh in the current study, showed only a trend toward fewer wound complications compared with that of porcine biologic mesh. Additionally, some small animal and human studies have reported stretching of AlloDermÒ over time,
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leading to enlargement in the middle of the graft and hernialike bulging, which could potentially lead to separation of the graft from the fascial edges [18, 47]. However, while there was a trend toward a higher recurrence rate with human-derived biologic mesh than with porcine grafts, the difference did not reach statistical significance. There are a few important limitations to this study. First, there are no prospective controlled trials in the English literature comparing biologic and nonbiologic mesh for ventral hernia repair in humans. Thus, all included studies were retrospective (level III evidence) and carry all the potential biases inherent in retrospective reviews. Second, there was a significant amount of variation among the studies relating to outcome definitions, length of follow-up, patient population, and hernia repair technique (see the last column in Table 4). Many even lacked data on one of the primary outcomes investigated in this meta-analysis, making detailed comparisons difficult, and certain exclusions were made in attempt to equalize the two comparison groups. For instance, the location of the mesh (underlay/sublay/inlay vs. overlay/onlay vs. interposition vs. sandwiched) was routinely and variably reported in all studies (Table 4); however, outcomes are not often identifiable based on different repair techniques. On the other hand, when there are distinct subgroups and repair techniques, a comparison is not possible (e.g., onlay biomesh vs. underlay synthetic). Similarly, a comparison among the different types of meshes utilized in this study based on different types of fascial repair (bridged vs. reinforced) was not feasible and not even reported in some studies (Table 4). Third, the distinction between different types of biomesh has been considerably hampered by the fact that the majority of the studies in this analysis used AlloDermÒ for their biologic mesh. Thus, the results of this analysis might not be applicable to all biologic mesh products. This can be addressed only by a large randomized prospective trial. Fourth, biologic mesh is more difficult to manipulate and there is currently no welldescribed study comparing the laparoscopic use of these materials versus synthetic meshes in ventral hernia repair. Hence, this study is limited by the lack of distinction between the different types of mesh and the use of laparoscopic versus open technique. Lastly, there is a considerable difference in cost for each of the various mesh products, yet limited data are available to justify the cost–benefit for the use of biologic meshes. That is beyond the scope of this meta-analysis and requires long-term outcome studies.
Conclusion Use of biologic mesh for ventral hernia repair results in fewer infectious wound complications but similar recurrence rates compared to nonbiologic mesh. This supports
Retrospective/chart review
Retrospective/chart review for biomesh group, systematic random sampling method with SAS for control group
Retrospective/chart review
Prospective/non-randomized
Retrospective/chart review
Retrospective/unclear
Retrospective/chart review
Retrospective/chart review by two independent observers
Retrospective/unclear
Retrospective/unclear
Brewer et al. [19]
Espinosa et al. [20]
Ghazi et al. [21]
Gupta et al. [27]
Ko et al. [22]
Raftopoulos et al. [23]
Sailes et al. [24]
Shah et al. [29]
Tang et al. [25]
Vertrees et al. [26]
c
b
Electronic medical records
Unclear
Unclear
Unclear
Physical exam and CT scan
Unclear
Visit at 1 and 6 weeks, then as needed, late interview of all patients at the end
Unclear
Unclear
Unclear
Clinic notes
Methods of follow-up
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Location of mesh reporteda
Absorbable versus permanent suture/tack/fibrin sealant
Bridged versus reinforced
Underlay/sublay/inlay vs. interposition vs. overlay/onlay versus sandwiched
Retrospective/chart review
Bachman et al. [28]
a
Design/recruitment
Study
Table 4 Qualitative assessment of the included studies
Yes
Not for all cases
Yes
Yes
No
Yes
No
Yes
Yes
No
Yes
Type of fascial repair reportedb
No
Not for all cases
No
Yes
Yes
Yes
Yes
No
No
No
Yes
Fixation technique reportedc
No
Yes
Yes
Yes
No
No
No
No
No
No
No
Incomplete outcome data addressed
No
No
No
No
No
No
No
No
No
No
No
Free of selective reporting
No formal treatment protocol; different follow-up durations
Different types and sizes of defect; different repair techniques; different meshes; different demographics and risk factors; different followup durations
Different mesh location and repair techniques
Different synthetic meshes; different demographics and risk factors
Different hernia type and size; different surgical settings; different synthetic mesh; use of different fixation techniques; inadequate mesh overlap
Different hernia sizes; different follow-up durations
Heterogeneous complex abdominal wall defects; different repair technique; different demographics and risk factors; AlloDerm and Strattice reported together Use of perforated and nonperforated Surgisis; different mesh location; different follow-up durations
Medium hernia size/reinforcement in biologic group vs. large hernia size/bridge in nonbiologic group; more concomitant procedures in biologic group; different follow-up durations
Heterogeneous transplant population; different mesh location; different repair techniques; different demographics and risk factors; type of nonbiologic not reported
Small sample size; different demographics and risk factors
Description of method weakness and other bias
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the application of biologic mesh for ventral hernia repair in high-risk patients or patients with a previous history of wound infection only when the significant additional cost of these materials can be justified and synthetic prosthesis is considered inappropriate. Appendix: Search strategy PubMed (1990–2012): 473 biologic mesh OR biologic prosthesis OR bioprosthesis OR biologic prosthetic materials OR biologic implant OR biologic graft OR alloderm OR surgisis OR SIS Gold OR Lyosis OR Fortagen OR small intestine submucosa OR Permacol OR Strattice OR FlexHD OR Veritas OR PeriGuard OR perigaurd OR SureDerm OR collaMend OR AlloMax OR Biomesh OR Tutoplast OR Tutopatch OR Tutomesh OR SurgiMend OR XenMatrix OR Xenograft OR Allograft OR acellular dermal matrix OR Porcine mesh)(ventral hernia OR incisional hernia OR umbilical hernia OR abdominal wall reconstruction OR abdominal wall defect). OvidMedline(English language and humans and yr = ’’1990–2012’’): 874 hernia, ventral /or hernia, umbilical/: 2934 AND exp Surgical Mesh/(english language and humans and year = ’’1990–2012’’): 5327 Cochrane Central Register of Controlled Trials (1990–2012): 172 Biologic mesh And ventral hernia or incisional hernia or umbilical hernia or abdominal wall defect Google scholar (1992–2012): articles excluding patents: 435 (biologic mesh OR biologic prosthesis OR bioprosthesis OR biologic materials OR biologic implant OR biologic graft OR alloderm OR acellular dermal matrix) AND (ventral hernia OR incisional hernia OR umbilical hernia OR abdominal wall defect) Reference list
Conflict of interest
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None.
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