Incisional ventral hernias: Review of the literature and recommendations regarding the grading and technique of repair
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Incisional ventral hernias: Review of the literature and recommendations regarding the grading and technique of repair The Ventral Hernia Working Group: Karl Breuing, MD,a Charles E. Butler, MD, FACS,b Stephen Ferzoco, MD, FACS,a Michael Franz, MD,c Charles S. Hultman, MD, MBA, FACS,d Joshua F. Kilbridge,e Michael Rosen, MD,f Ronald P. Silverman, MD, FACS,g and Daniel Vargo, MD, FACS,h Boston, MA, Houston, TX, Ann Arbor, MI, Chapel Hill, NC, San Francisco, CA, Cleveland, OH, Baltimore, MD, and Salt Lake City, UT Despite advances in surgical technique and prosthetic technologies, the risks for recurrence and infection are high following the repair of incisional ventral hernias. High-quality data suggest that all ventral hernia repairs should be reinforced with prosthetic repair materials. The current standard for reinforced hernia repair is synthetic mesh, which can reduce the risk for recurrence in many patients. However, permanent synthetic mesh can pose a serious clinical problem in the setting of infection. Assessing patients’ risk for wound infection and other surgical-site occurrences, therefore, is an outstanding need. To our knowledge, there currently exists no consensus in the literature regarding the accurate assessment of risk of surgical-site occurrences in association with or the appropriate techniques for the repair of incisional ventral hernias. This article proposes a novel hernia grading system based on risk factor characteristics of the patient and the wound. Using this system, surgeons may better assess each patient’s risk for surgical-site occurrences and thereby select the appropriate surgical technique, repair material, and overall clinical approach for the patient. A generalized approach and technical considerations for the repair of incisional ventral hernias are outlined, including the appropriate use of component separation and the growing role of biologic repair materials. (Surgery 2010;148:544-58.) From Brigham and Women’s/Faulkner Hospital, Harvard Medical School,a Boston, MA; University of Texas, M. D. Anderson Cancer Center,b Houston, TX; University of Michigan Health System,c Ann Arbor, MI; University of North Carolina at Chapel Hill,d Chapel Hill, NC; Kilbridge Associates,e San Francisco, CA; University Hospital, Case Medical Center,f Cleveland, OH; University of Maryland School of Medicine,g Baltimore, MD; and University of Utah Health Science Center,h Salt Lake City, UT THE REPAIR OF INCISIONAL VENTRAL HERNIAS is a com- the repair should be reinforced, and, if so, what mon surgical procedure; in the United States, it type of material should be used. One reason for is estimated that 250,000 ventral hernia repairs these controversies is the lack of consensus as to are performed each year.1 The indications for when specific techniques and materials should be repair are well established. However, controversies applied. In addition, a controversy has developed exist with regard to technique of repair, whether as to what the most important endpoint is in the repair of a ventral hernia: surgical-site occurrence Supported by funding for the VHWG provided by LifeCell Cor- (SSO) or hernia recurrence. poration, Branchburg, NJ. Editorial support was provided by The American Medical Association published a Medisys Health Communications, High Bridge, NJ. Writing system for the development of evidence-based assistance provided by Joshua Kilbridge of Kilbridge Associates, San Francisco, CA. guidelines that provides for best-practice measures to be employed in patient care.2 Over the last 15 Accepted for publication January 14, 2010. years, this system has been used in various areas Reprint requests: Michael Franz, MD, University of Michigan Health System, 2922H Taubman Health Care Center, 1500 E. of medicine to arrive at best-care recommenda- Medical Center Drive, Ann Arbor, MI 48109-5331. E-mail: tions. To date, no guidelines have been established mfranz@umich.edu. to address ventral hernia repair. 0039-6060/$ - see front matter A Ventral Hernia Working Group (VHWG) has Ó 2010 Mosby, Inc. All rights reserved. been established to evaluate new technologies and doi:10.1016/j.surg.2010.01.008 techniques as they apply to ventral hernia repair. 544 SURGERY
Surgery Breuing et al 545 Volume 148, Number 3 Table I. Recommendations of the VHWG for the technique of repair of incisional ventral hernias3,6-9,31,32,62 Strength of Level of Recommendation recommendation evidence Evidence 6 1. Reinforcement recommended for repair 1 A/B Burger et al of all incisional ventral hernias Espinosa-de-los-Monteros et al7 Luijendijk et al3 2. Centralize and reapproximate rectus 1 C de Vries Reilingh et al8 muscles when feasible under physiologic Espinosa-de-los-Monteros et al7 tension Kolker et al9 VHWG opinion 3. Reduce bioburden prior to repair 1 B Mangram et al32 VHWG opinion 4. Placement of repair material: Underlay 2 B Awad et al31 is the recommended technique for the Espinosa-de-los-Monteros et al7 placement of appropriate repair material Korenkov et al62 for open and laparoscopic repairs; overlay VHWG opinion placement of repair material should only be considered when complete fascia-to- fascia repair has been achieved 5. In the setting of gross, uncontrolled 1 C VHWG opinion contamination, it is appropriate to consider delayed repair This group has a common interest in studying system and recommendations, and the application ventral hernia as a complex process, similar to that of the recommendations to clinical practice. for other surgical diseases. One of the topics that has been addressed is the stratification of patients BACKGROUND with a ventral hernia regarding risk for postoper- Despite significant advances in hernia repair ative SSO, specifically surgical-site infection. The techniques and technologies, recurrence rates goal of this review is to stratify patients by their risk following standard ventral herniorrhaphy remain for postoperative SSO and to identify the most unacceptably high. Evidence from the seminal favorable techniques for addressing ventral hernia randomized, prospective, controlled trial con- repair in each patient population. ducted by Luijendijk et al3 suggests that nearly one There are few randomized controlled trials in quarter of ventral hernias repaired with synthetic this field and few head-to-head studies of devices mesh recur within 3 years; the rate approaches 50% or techniques. Many studies are limited by small for primary repair alone. In addition, the risk of sample size, lack of comparator group, short hernia recurrence increases with each additional follow-up, vague endpoints, variations in surgical operation. This relationship was illustrated in a ret- technique, and differing definitions of complica- rospective cohort study of a population-based hospi- tions. It is the contention of the VHWG, however, tal discharge database.24 The investigators reported that sufficient evidence exists to recommend that 12% of patients undergoing incisional hernia certain principles for an overall approach to the repair required at least 1 subsequent reoperation assessment and repair of incisional ventral hernias within 5 years; the length of time between reopera- and that these recommendations will contribute to tions was progressively shorter after each additional improved patient outcomes. hernia repair. The 5-year rate of reoperation was The recommendations of the VHWG describe 24% after the first reoperation, 35% after the sec- evidence-based options for the selection of surgical ond, and 39% after the third; the 7-year rate after techniques and appropriate reinforcement mate- 3 reoperations approached 50%. These data under- rial (Tables I and II).3-21 These guidelines are graded score the importance of minimizing the risk for sub- according to strength of recommendation and sequent reoperations by employing the best supporting evidence in accordance with previously evidence-based approach to the first hernia repair. described methods (Table III).1,22,23 This review In 1990, Ramirez et al published their work on outlines the history of the clinical problem, the local tissue transfer for the repair of ventral rationale and literature supporting the grading hernias.25 This demonstration ushered in a new
546 Breuing et al Surgery September 2010 Table II. Recommendations of the VHWG for choice of repair material for incisional ventral hernias, by grade4,5,11-21 Strength of Level of Recommendation recommendation evidence Evidence Grade 1 Choice of repair material by surgeon preference 1 C VHWG opinion and patient factors Grade 2 Increased risk for surgical site occurrence 1 B Dunne et al12 suggests additive risk of permanent synthetic Finan et al13 repair material, and potential advantage for Pessaux et al14 appropriate biologic reinforcement Petersen et al20 VHWG opinion Grade 3 Permanent synthetic repair material generally 1 B Diaz et al5 not recommended; potential advantage to Houck et al11 biologic repair material Jones et al18 Kim et al4 Grade 4 Permanent synthetic repair material not 1 A Diaz et al5 recommended; biologic repair material Jones et al18 should be considered Kim et al4 Paton et al16 Patton et al15 Sczczerba et al19 van’t Riet et al21 Voyles et al17 era in hernia repair, where incisions to release known best practices in each core area determined fascia allowed for a tension-free closure of the to be important to a successful ventral hernia midline. In an effort to improve recurrence rates, repair. These articles were graded based on level synthetic mesh was employed to reinforce hernia of evidence and used to develop the recommen- repairs.6 However, there were significant complica- dations, grading system, and treatment algorithm. tions associated with use of synthetic mesh, includ- ing infection of the prosthesis and the formation RESULTS OF LITERATURE REVIEW of enterocutaneous fistulae.17,26-28 In the late Initial discussions identified SSO and recur- 1990s, biologic repair materials were introduced rence as the 2 main issues in ventral hernia repair. as a possible ventral hernia solution. Although For SSO, patient factors, wound factors, and multiple products are available for use, no consen- choice of implant were deemed to be most impor- sus exists as to the indicated patient population, tant. For recurrence, surgical technique was how they should be implanted, and their overall thought to be most important, although patient risk of complication and recurrence. and wound factors should also be considered. A search of the literature identified various factors THE VHWG PROCESS related to the status of the patient and wound that In September 2008, the VHWG met for a 2-day should be addressed when evaluating the overall summit with the goal of developing an initial complication risk in a patient with ventral hernia statement regarding the repair of incisional ventral (discussed in the following paragraphs). hernias. The group consisted of 8 surgeons (4 Infection and other SSOs. Common SSO fol- general and 4 plastic), all of whom have extensive lowing ventral hernia repair include infection, experience in abdominal wall reconstruction. The seroma, wound dehiscence, and the formation of purpose of the summit was 2-fold: (1) to propose a enterocutaneous fistulae. Each of these complica- grading system to guide surgeons in the assessment tions conveys morbidity and the risk for additional of patients with incisional ventral hernias with sequelae. Each also relates to the management of regard to risk for SSO, especially infection; and the wound and to risks associated with the use of (2) to propose evidence-based recommendations repair materials. A wound dehiscence, for exam- regarding the approach to advanced surgical tech- ple, may lead to exposure of the repair material; if niques for the repair of incisional ventral hernia. the material is a permanent synthetic mesh, then it All aspects related to hernia repair were evaluated will likely require removal because of continued and broken down to their core components. A risk for infection.3 Infection is a common and sig- literature search was then undertaken to identify nificant postoperative occurrence that increases
Surgery Breuing et al 547 Volume 148, Number 3 Table III. Grading of recommendations22 Grade of recommendation Type of evidence Strength of recommendation 1: Strong A: High-quality evidence RCTs without important Strong recommendation that recommendation limitations, or can be applied to most overwhelming evidence patients and circumstances from observational studies B: Moderate-quality RCTs with important evidence limitations or strong evidence from observational studies C: Low-quality evidence Observational studies Strong recommendation, but or case series may change when higher quality evidence becomes available 2: Weak A: High-quality evidence RCTs without important Weak recommendation, best recommendation limitations, or action may depend on overwhelming evidence circumstances or other from observational factors studies B: Moderate-quality RCTs with important evidence limitations or strong evidence from observational studies C: Low-quality evidence Observational studies Very weak recommendation; or case series other alternatives may be equally reasonable RCT, Randomized controlled trial. the risk of hernia recurrence.29 Studies have re- Table IV. Comorbidities shown to increase the risk ported rates of infection following ventral hernia for postoperative infection12-14,32 repair ranging from 4% to 16%, compared with Smoking only 2% following other clean surgical proce- Diabetes dures.3,11-13,30 In a study by Houck et al, a history COPD of previous wound infection predicted greater CAD risk for new infection in a group of patients under- Nutritional status going incisional hernia repair.11 Forty-one percent Immunosuppression of patients with previous wound infection had a Chronic corticosteroid use new infection versus 12% of patients with no Low serum albumin Obesity history of wound infection (P < .05). Advanced age Wound infection appears to significantly in- crease the risk for hernia recurrence.29 In the COPD, Chronic obstructive pulmonary disease; CAD, coronary artery disease. study by Luijendijk et al, for example, the rate of recurrence among patients with postoperative in- fection was 80%, compared with 34% for those Comorbidities and risk for infection. Several without infection (relative risk [RR] versus no in- comorbidities have been identified that increase fection: 4.3; P = .007).3 Previously, Awad et al pro- the risk of infection following hernia repair (Table posed a classification system that cited 2 factors IV).12-14,32 Analyses of the National Surgical Qual- influencing recurrence following ventral hernia re- ity Improvement Program (NSQIP) database have pair with prosthetic repair material: patient factors reported that corticosteroid use, smoking, coro- (increased intra-abdominal pressure, diminished nary artery disease, chronic obstructive pulmonary tissue integrity) and technical factors (infection, disease, low preoperative serum albumin levels, lateral mesh distraction, missed hernia). They esti- prolonged operative time, and use of absorbable mated that more than 75% of all recurrence is due synthetic mesh (likely a surrogate for more com- to infection and inadequate repair material fixa- plex procedures) were significant independent tion and/or overlap.31 predictors of wound infection.12,13 Findings from
548 Breuing et al Surgery September 2010 other studies suggest that age and obesity are inde- matrix repair material was significantly superior pendent predictors of infectious complications.14 to polytetrafluoroethylene (PTFE) in terms of the Guidelines for the prevention of surgical-site infec- ability to allow for clearance of Staphylococcus aureus tions32 also cite altered immune response and nu- inoculate at the level expected for contamination tritional status as risk factors for wound infection. (P = .002).42 Studies in animal models also suggest The presence of individual comorbidities may that certain biologic repair materials can be placed increase the risk for postoperative infection as in contact with the bowel. In one study, acellular much as 4-fold.13 dermal matrices placed directly over the bowel Permanent synthetic mesh and infection. Syn- were shown to better resist visceral adhesions in thetic mesh is currently the most common repair ventral hernia repair sites compared with polypro- material used for reinforcement of ventral her- pylene mesh (P = .004).34 nias.1 However, despite significant advantages such Clinical studies have reported good outcomes as reduced recurrence rates, ease of use, and com- with some biologic repair materials for incisional paratively low cost, permanent synthetic mesh has hernia repair in high-risk patient groups. In these certain drawbacks. These disadvantages include in- reports, patients could be managed nonsurgically creased risk for visceral adhesions to the repair even when their wound became frankly in- site, erosion into the bowel leading to formation fected.4,5,15,38,39 Some biologic repair materials of enterocutaneous fistulae and/or bowel obstruc- have been used successfully to repair large contam- tion, extrusion of the repair material, and infec- inated and/or irradiated abdominal wall defects in tion.17,18,26,33-35 For example, permanent synthetic patients with cancer when placed directly over the mesh can complicate the treatment of postopera- bowel.43,44 tive infection. In this setting, permanent synthetic mesh often requires later surgical removal, necessi- GRADING SYSTEM tating reoperation.8,16,19-21,36 Following removal of The choice between synthetic and biologic an infected prosthesis, the surgeon is left with a repair material for many surgeons is often based contaminated field and a hernia deficit larger on several considerations including cost, choice of than the original that still requires a repair mate- technique (eg, open versus laparoscopic), techni- rial. Data suggest that reimplantation of synthetic cal expertise, and the risk for SSO. Due to these prostheses into contaminated fields leads to a complex considerations, surgeons would benefit high rate of reinfection.37 from an assessment tool that helps them develop Multiple pathways may lead to infection of patient assessment strategies, including the selec- synthetic mesh. Patients may have acute postoper- tion of appropriate repair material based on each ative mesh infection, or dehiscence of the wound patient’s risk for developing SSO. The VHWG that may expose the mesh, leading to colonization proposes an SSO-risk grading system as an instru- and infection of the prosthesis. Reoperation ment to help surgeons stratify patients’ risk of through synthetic mesh may also lead to infection. developing postoperative complications (Fig 1). Furthermore, seromas that develop may become The novel grading system described herein is infected, leading to subsequent contamination intended as a framework for the assessment of risk and removal of the prosthesis.8,17,18,33 for SSO based on characteristics of individual Choice of prosthetic repair material. When risk patients and hernia defects. The instrument is for SSO is deemed to be high based on assessment based on the best available evidence, but will benefit of risk factors, surgeons may consider the use of from vetting and validation through clinical use and biologic repair materials in place of permanent study. The grading system is proposed as an initial synthetic mesh, because of their ability to support stratification of risk factors and, it is hoped, to serve revascularization. Some biologic repair materials as a framework for future research. The system have been shown to remain intact even in the consists of 4 grades (Fig 1). These grades do not setting of active infection; these materials are more represent discrete or didactic categories, but rather, resistant to infection and do not require removal salient points along a continuum of risk from low- when exposed or infected.4,15,38,39 Some biologic risk (eg, healthy patients with uncomplicated repair materials have also demonstrated antimicro- wounds) to high-risk (eg, patients with multiple bial activity in vitro and in animal models,40 and comorbidities and uncontrolled infection). the ability of certain biologic prostheses to support Grade 1 (low risk) captures those patients who revascularization may contribute to clearance of have no comorbidities, no history of wound infec- bacteria.41 A recent study in a rabbit model, for ex- tion, and no evidence of contamination; typically ample, found that a human acellular dermal these are younger, healthy individuals.
Surgery Breuing et al 549 Volume 148, Number 3 Grade 1 Grade 2 Grade 3 Grade 4 Low Risk Co-Morbid Potentially Infected Contaminated • Low risk of • Smoker • Previous wound • Infected mesh complications • Obese infection • Septic dehiscence • No history of • Diabetic • Stoma present wound infection • Violation of the • Immunosuppressed gastrointestinal • COPD tract Fig 1. Hernia grading system: assessment of risk for surgical site occurrences. Wound infection defined as being con- tained within the skin or subcutaneous tissue (superficial), or involving the muscle and/or fascia (deep).13 Grade 2 (comorbid) includes patients who have because of the presence of active infection. Con- comorbidities that increase the risk for surgical-site versely, relatively large hernias in a healthy individ- infection (Table IV), but who do not have evidence ual may be considered grade 1 if there are no of wound contamination or active infection. The comorbidities or signs of contamination, such as relative contribution of different comorbidities is a violation of the bowel or history of wound infection. matter for consideration and debate. To our knowl- There are characteristics of the patient, defect, edge, no data currently exist that dictate which and surgical site that may influence the risk for comorbidities carry the most weight, or which recurrence as well as SSO. For example, a greater combination of comorbidities increases risk. number of previous repairs increases the risk of Similarly, there are only minimal data to delineate hernia recurrence.24 For the current statement, the tipping point for a characteristic to be consid- however, the VHWG concluded that there are still ered a comorbidity (eg, how recent a history of insufficient data in the literature to reliably grade infection, how much smoking, what degree of the risk of recurrence according to the proposed malnutrition, how much corticosteroid use). grading scale. It was also agreed that inclusion of Certain thresholds have been described. Thresh- hernia recurrence risk in the grading scale would olds at which the risk for infection increases include make it too complex for its intended purpose, blood glucose $110 mg/dL (hemoglobin A1c >7.0) which is to serve as a simple and memorable guide and age $75 years.45,46 Further research is required assessing a patient’s risk of SSO. to better understand the contribution of comorbid- ities to risk. Until such data become available, VHWG APPROACH TO THE TECHNIQUE FOR surgeons must rely on their clinical judgment. THE REPAIR OF INCISIONAL VENTRAL Grade 3 (potentially contaminated) is a higher- HERNIAS risk category based on evidence of contamination The application of advanced surgical techniques of the wound. Factors that suggest contamination and materials may reduce the risks of recurrence include the presence of a nearby stoma, violation and SSO such as infection. With the goal of mini- of the gastrointestinal tract, or history of wound mizing recurrence and complications, the VHWG infection. Grade 4 (infected) patients are at high- offers evidence-based recommendations regarding est risk for SSO. Characteristics in grade 4 include technical approaches to the repair of incisional active infection, especially infected synthetic mesh, ventral hernias (Table I). Although these recom- and septic dehiscence. Each of these grades rep- mendations pertain mainly to open repairs, laparo- resents a wide swath of risk and patient types. scopic approaches will be discussed briefly. Assessment of risk, therefore, will continue to rely The recommendations are not intended to be to some degree on individual surgeon judgment prescriptive or definitive but to serve as principles and experience. The inclusion criteria for each to guide the selection of surgical techniques. The grade will be further refined as new data regarding VHWG noted significant variation in technical comorbidities and outcomes become available. details between surgeons, both within the panel Each grade relates to the aforementioned risk and in the community, and concluded that any factors for SSO but does not consider the size or extensive discussion of technique is beyond the complexity of the defect or the proposed approach scope of this article. Therefore, the details of the to repair. For example, relatively small hernias with techniques cited in this statement are not fully infected mesh would still be considered grade 4 described herein.
550 Breuing et al Surgery September 2010 Table V. Principles for the repair of incisional reapproximate the rectus muscles along the mid- ventral hernia line for ventral hernia repairs to the extent possi- Optimize patient condition ble. This step attempts to restore the functional, Nutritional status innervated abdominal wall and create a true dy- Blood sugar levels namic repair without undue tension. The phrase Smoking cessation ‘‘without undue tension’’ refers to the attempt to Prepare wound restore normal physiologic tension. The abdomi- Reduce bioburden nal wall is a load-bearing structure and reacts Take down adhesions, fistulae dynamically to internal and external forces (hence Reapproximate midline to the extent possible using ‘‘dynamic repair’’). Too little tension in a hernia component separation when appropriate repair results in wound edge separation and poor Use appropriate reinforcement material collagen organization in the incision; too much Consider biologic repair material in patients at tension leads to ischemia and wound dehiscence. increased risk for surgical-site occurrences Physiologic tension attempts to achieve a balance between these opposing outcomes.48 The overall principles agreed on by the VHWG Techniques for the repair of ventral hernias (Table V) are optimization of the patient, preparation commonly used by the VHWG and community of the wound, centralization and reapproximation of surgeons include retrorectus (ie, Rives-Stoppa pro- the rectus muscles along the midline to the extent cedure) and component separation. Retrorectus possible, and the use of appropriate prosthetic repair repair has been widely employed in Europe and is material to reinforce the closure. Surgical principles considered by some surgeons to be the standard are described in relation to each of the 4 grades of for repair of ventral hernias. The technique allows risk in the grading system described above and will for placement of repair material behind the defect focus primarily on open repair. without contacting the viscera. The technique of Patient optimization. Patient optimization in- retrorectus repair is described in detail by other cludes encouraging smoking cessation ($4 weeks authors.49,50 Consideration should be given to the preoperatively), maintaining blood glucose levels use of biologic or synthetic repair materials with (
Surgery Breuing et al 551 Volume 148, Number 3 biologic repair material overlay.7 This study re- preferred over synthetic mesh for use in infected ported a significantly lower recurrence rate when fields and should be strongly considered when component separation was reinforced with bio- contamination is suspected (Table II). The logic repair material (0%, component separation VHWG also notes that the increased risk for SSO plus overlay versus 13%, component separation associated with comorbidities within grade 2 may alone; P = .006). One randomized, prospective trial suggest potential advantages to some biologic re- compared component separation to primary re- pair materials, depending on choice of technique pair with expanded PTFE (ePTFE).8 An interim (eg, open versus laparoscopic) and the balance analysis reported hernia recurrence in 10 of 19 pa- of benefits and risks. It should be emphasized tients in the component separation group (mean that this suggestion is based on the presumption time to recurrence, 7 months) and 4 of 18 in the that certain patients with comorbidities (ie, grade ePTFE group (mean time to recurrence, 22 2) will, in fact, develop SSOs such as wound infec- months). Seven patients in the ePTFE group had tion, and that biologic repair materials may facili- an infection of the mesh that required removal tate management of infection without of the prosthesis, followed by reconstruction using necessitating removal. To date, we have found no component separation. It should be noted, how- published controlled clinical studies comparing bi- ever, that no published data have been found ologic and synthetic repair materials in this patient directly comparing component separation to pri- population. mary repair alone (or any other repair technique), Although the VHWG does not make any recom- nor are there any prospective data evaluating the mendation regarding choice of specific prosthetic addition of prosthetic repair material to compo- repair materials, certain features of synthetic and nent separation. biologic repair materials should be considered dur- ing the selection process. The VHWG calls attention SELECTION AND USE OF PROSTHETIC to specific characteristics such as adequate strength, REPAIR MATERIAL ease of handling during procedures, ability to resist Level 1A data from the study by Luijendijk et al adhesions when placed in contact with the bowel, indicate that all clean, grade 1 ventral hernia and reduced risk of infection through support for repairs should be reinforced with some type of tissue incorporation and revascularization. repair material.3,6 Even in the small hernias in rel- Synthetic repair materials. Synthetic meshes are atively healthy patients included in this study (fas- most often categorized as macroporous, micropo- cial defect length or width #6 cm), the use of rous, or composite.61,62 Macroporous meshes prosthetic repair material halved the rate of recur- include monofilament and double-filament polypro- rence, both over short-term (23% vs 46%; P = pylene, among many others. These materials have .005)3 and longer-term (32% vs 63%; P < .001) fol- large pore sizes that allow for in-growth of scar tissue. low-up.6 Based on these data, the VHWG recom- When placed in contact with abdominal viscera, mac- mends the use of prosthetic repair material to roporous meshes are associated with the formation reinforce the repair of all incisional ventral her- of bowel adhesions and obstructions and enterocuta- nias, regardless of whether or not the midline fas- neous fistulae.63,64 Therefore, these materials cia can be reapproximated. should be avoided or used in combination with vas- The diversity of synthetic and biologic repair cularized tissue (eg, greater omentum, hernia sac) materials available for the reinforcement of hernia or antiadhesive barriers when contact with the bowel repair complicates the selection of an appropriate is likely. Microporous meshes, such as ePTFE, have a prosthesis. At least 80 different prosthetic mate- smaller pore size that does not allow for tissue in- rials are available for hernia repair,60 and the char- growth, but may lead to encapsulation and the persis- acteristics and types of prostheses vary considerably tence of bacteria. Therefore, microporous mesh has even within the classes of synthetic and biologic a lower affinity for adhesions, but may be more sus- materials. The choice of material may be based ceptible to infection. on a variety of considerations, including character- A wide variety of composite materials is now istics of the patient and defect, surgeon familiarity available that combine different qualities, such as with material, and cost. The risk for SSO and sub- having macroporous mesh on one side to promote sequent infection may determine the selection of a tissue in-growth and microporous mesh on the synthetic versus a biologic repair material. Based other to reduce risk for adhesions to the mesh (eg, on the grading system described above, the polypropylene/ePTFE). Synthetic meshes with VHWG recommends that biologic repair materials antiadhesive coatings have also been developed. with specific characteristics (see below) are Such coatings include nonabsorbable (eg, titanium,
552 Breuing et al Surgery September 2010 polyurethane) and absorbable coatings (eg, omega- cross-linked, intact biologic repair material into na- 3 fatty acid, collagen hydrogel, oxygenated regen- tive tissue was demonstrated in the same nonhuman erated cellulose). Preclinical evidence suggests primate model. These results are similar to those re- reduced risk of adhesions to composite and coated ported in clinical studies.44,79 In one study of ab- synthetic meshes compared with traditional dominal repair following harvest of transverse synthetic meshes.65-69 The relative benefits of these rectus abdominus musculocutaneous flaps for different prostheses with regard to adhesion forma- breast reconstruction, biopsies of the biologic re- tion and risk for infection vary according to pair material showed similar cell density, vascula- different study models, methodologies, and out- ture, and collagen orientation to those of normal comes.63,67,70-73 Furthermore, prospective data are abdominal fascial tissue.79 A second study found lacking regarding the clinical benefits of these that explanted biologic repair material from an irra- prostheses for ventral hernia repair, and no compar- diated, contaminated abdominal wall repair site 14 ative clinical data are currently available. months after implantation demonstrated remodel- Finally, a new category of lightweight mesh is ing of the biologic repair material, including revas- currently being used in both open and laparo- cularization and cellular repopulation.44 scopic hernia repairs. There are data to suggest It should be emphasized that no comparative better functional outcomes than those achieved trials have been performed to date evaluating with traditional synthetic mesh, although definitive different biologic repair materials in incisional studies are lacking.74 hernia repair, and differentiation between pro- Biologic repair materials. Biologic repair mate- ducts is based on early findings with a limited rials are an equally diverse and expanding class. number of the available prostheses. Data describ- Certain specific characteristics are thought to con- ing the qualities of biologic repair materials are tribute to the successful use of particular biologic only available for certain prostheses. Similar ani- repair materials in the setting of contamination or mal and clinical studies are awaited for the major- low-grade infection, whereas others are contra- ity of products in this class. indicated. These properties include intact extra- cellular matrix and the ability to support tissue TECHNIQUE OF PLACEMENT regeneration through revascularization and cell There are technical aspects of the use of bio- repopulation in a clinically relevant timeframe. It logic repair material that must be considered in has been hypothesized that resistance to infection order to achieve successful outcomes. Studies have for some biologic repair materials may be related documented high rates of seroma, diastasis, bulg- to the in-growth of cells and vasculature.75 Numer- ing, and recurrence with biologic repair mate- ous animal studies have shown that altering the ex- rials80,81; critical techniques of placement were tracellular matrix through suboptimal processing described that may influence the risk of these com- and/or crosslinking may have a negative impact plications.43 In one study, recurrence was reduced on host response to the repair material.76,77 The when component separation was combined with neovascularization demonstrated in studies of biologic repair material; conversely, bridging with some biologic repair materials may allow these biologic repair material without reducing the size materials to better resist infection when placed in of the defect was associated with a recurrence a potentially contaminated field.42,75 rate of 80%.81 The tensile qualities of repair mate- The ability of some biologic repair materials to rials differ and may impact technique. The VHWG support regeneration is based on studies in animal notes that most biologic repair materials should be models that describe the immunologic response of implanted under appropriate tension to help pre- the host to the prosthesis. Positive recognition (ie, vent the development of laxity. (This use of tension recognition of the prosthesis as ‘‘self’’) leads to for repair material implantation should be distin- regeneration and integration of the repair material guished from the avoidance of undue tension---or into native tissue. Negative recognition (ie, recog- physiologic tension---that describes the fascial clo- nition of the prosthesis as foreign) may lead to sure.) Surgeons should be aware that the use of a resorption or encapsulation.76,78 Resorption and biologic repair material necessitates technical encapsulation have been demonstrated with several familiarity with its appropriate placement. biologic repair materials in a nonhuman primate Overlay, underlay, or interpositional placement model of abdominal wall repair.76 The investigators of prosthetic repair material. In open incisional suggested that the lack of integration and tissue re- hernia repair, prosthetic repair material may be generation with these materials may account for placed to reinforce a primary repair or to bridge a poor initial wound healing. Integration of 1 non-- remaining defect if reapproximation of the
Surgery Breuing et al 553 Volume 148, Number 3 midline is not possible. The repair material may be should be based on surgeon preference and pa- sutured superficial to the primary repair or fascial tient factors. Grade 2 encompasses patients with edges (overlay), deep to the primary repair or comorbidities, such as smoking, diabetes, or mal- fascial edges (underlay), or to the edge of the nutrition (Table IV). Data from analyses of the defect with minimal overlap (interpositional). The NSQIP database and other studies suggest that pa- overlay technique is easier to perform, does not tients in grade 2 have a wound infection rate that is require devascularization of the rectus, and pre- 4-fold greater than what is predicted based solely vents contact between the repair material and the on wound classification.12,13 Current published ev- underlying viscera. Overlay placement also allows idence does not delineate the relative contribution for reinforcement of the lateral releasing incisions of each comorbidity to increased risk. Ongoing after component separation, if desired. Overlay and future clinical studies may provide a more placement, therefore, may be preferred for types thorough evidence-based estimate of which and of synthetic mesh that are associated with forma- how many comorbidities contribute most signifi- tion of bowel adhesions to minimize the risk that cantly to increased risk of SSO. In the absence of the mesh may erode into the abdominal compart- more definitive data, the VHWG notes that the in- ment and become exposed to the viscera. creased risk associated with these comorbidities There are also theoretical advantages to the suggests a potential advantage for the use of appro- placement of repair material as an underlay. When priate biologic repair material for reinforcement the material is placed deep to the abdominal of open repairs. musculature, increases in intra-abdominal pressure Grade 3 includes patients with contamination of press the repair material into the defect and the wound or suspicion of contamination, includ- against the native tissue, rather than away from ing a previous wound infection. Based on the the defect. Intra-abdominal forces may also be increased risk for infection associated with contam- more evenly distributed across the repair material inated wounds, the VHWG notes that permanent when placed as an underlay.82 Furthermore, cuta- synthetic mesh is generally not recommended for neous exposure does not result in exposure of patients considered to be grade 3. Appropriate the repair material, because the prosthesis remains biologic repair material is a good option for rein- below the musculofascial layer. forcement in these patients, because it does not Bridging of defects, which refers to the use of necessitate removal even in the setting of active prosthetic repair material to span tissue gaps when infection. reapproximation of the fascial edges is not possi- Grade 4 patients have frankly infected wounds, ble, has been associated with high rates of recur- most notably those associated with an existing rence and complications. Bridging may not infected synthetic mesh. Studies suggest that the generally be recommended except in cases where replacement of infected synthetic mesh with new component separation is not feasible or is insuffi- permanent synthetic mesh leads to a high rate of cient to bring the fascial edges together (see reoperation and additional mesh infection and discussion of algorithm, below).83 replacement.8 The use of permanent synthetic The VHWG notes that underlay may be pre- mesh in patients considered to be grade 4, there- ferred because of the theoretical advantages of this fore, is not recommended by the VHWG. In accor- technique. However, there are no reliable data dance with the surgical principles outlined above supporting the use of one technique over an- and in Table V, infected wounds should be thor- other.83 Patient factors and surgeon preference oughly prepared by meticulously reducing the bio- should also be considered. Regardless of place- burden prior to placement of repair material and ment, repair material should overlap with intact definitive closure. No repair material should be fascia by at least 3--5 cm.34,84-89 used in the setting of gross, uncontrolled contam- ination, and surgeons may consider a delayed TECHNICAL OPTIONS BY GRADE repair in such situations. The overriding recommendation of the VHWG regarding the repair of incisional ventral hernia is LAPAROSCOPIC REPAIR OF INCISIONAL to reinforce the primary fascial closure with a VENTRAL HERNIA prosthetic repair material.6 The selection of type This statement focuses primarily on the open of repair material between biologic and synthetic repair of incisional ventral hernia. However, the with regard to hernia grade should be based on growing popularity of laparoscopic techniques de- risk for SSO (Table II). For patients at low risk serves discussion with relation to the grading for SSO (grade 1), the choice of reinforcement system and recommendations of the VHWG.
554 Breuing et al Surgery September 2010 Patient assessment for risk of SSO (Grade 1, 2, 3 or 4) Decide on best approach for repair (Open versus Laparascopic) Laparascopic Open Defect small enough to close Most often repaired primarily (≤2 cm): Defect too large w/synthetic mesh Reinforce with prosthetic for primary repair repair material Component separation Component separation w/complete rectus closure w/incomplete rectus closure, plus reinforcement some bridging w/prosthetic w/prosthetic is unavoidable Grade 1: Choice of repair material by surgeon preference and patient factors Grade 2: Increased risk for surgical site occurrence suggests additive risk of permanent synthetic repair material, and potential advantage for appropriate biologic reinforcement Grade 3: Permanent synthetic repair material generally not recommended; potential advantage to biologic repair material Grade 4: Permanent synthetic repair material not recommended; biologic repair material should be considered Fig 2. Algorithm for repair of incisional ventral hernia. Although recurrence rates following reinforced .01) over a mean follow-up period of 30--36 laparoscopic hernia repair are comparable to months, respectively.91 Postoperative inpatient ad- those of open repair with reinforcement,90,91 there mission was also more frequent in the open group are several documented advantages of the laparo- (28% vs 16%; P < .05). However, seromas may be scopic approach, including smaller incisions, lower more common following laparoscopic hernia re- risk for complications, shorter hospital stay, and pair. In the aforementioned cohort study, seromas patient preference.90-92 A recent meta-analysis of were significantly more common in the laparo- randomized controlled trials comparing open scopic group (16% vs 8%; P = .01). Indeed, higher and laparoscopic incisional hernia repairs re- rates of seroma have been widely reported with lap- ported a significantly higher rate of complications aroscopic repairs. Lower incidence of seroma in with open repair (RR .49, P < .001 by fixed-effects open procedures may relate to the use of drains, model; RR .53, P = .028 by random-effects which are not generally placed in laparoscopic re- model).89 Reported complications included se- pairs. Seromas often resolve uneventfully, and roma, abscess, incarceration, hematoma, cellulitis, many surgeons do not consider this occurrence wound infection, bowel obstruction, and ileus. A to be pathologic unless intervention is required single-institution cohort study comparing open due to the risk of contamination and subsequent and laparoscopic ventral hernia repair (N = 360) infection of the seroma.82 reported major morbidities in 15% of the open In addition to a higher rate of seroma forma- group and 7% of the laparoscopic group (P = tion, the limitations of laparoscopic repair include
Surgery Breuing et al 555 Volume 148, Number 3 the inability to restore functional abdominal wall repair. For surgeons who practice laparoscopic anatomy. Other difficulties include the inability to repairs, patients in grade 1, many in grade 2, and manage skin redundancy and the hernia sac. some in grade 3 may be suitable for this approach, Current approaches to laparoscopic repair do not depending on individual risk for infection and routinely employ extensive mobilization of tissue, other considerations. Hernias in grade 4 should be meaning that the repair material is almost always repaired with open procedures. The same princi- bridging some aspect of the defect. Laparoscopi- ples of selecting prosthetic repair material apply cally inserted repair material is placed intraperito- regardless of technique (open versus laparo- neally as an underlay below the fascial defect.82 scopic): most patients in grade 1, some in grade These repairs do not recreate an innervated 2, and a few in grade 3 may be suitable for repair abdominal wall under physiologic tension. with permanent synthetic mesh; all patients con- Recently, several investigators have described sidered at increased risk for SSO (including some minimally invasive techniques of component sep- in grade 2, most in grade 3, and all in grade 4) aration.54 Experience with these techniques has should be considered for repair with appropriate been reported in studies of cadavers,55 a porcine biologic repair material. model,56 select patients with infected repair mate- rial,57 and small comparative groups.54 Preliminary OTHER CONSIDERATIONS IN SELECTION OF results suggest that minimally invasive techniques REPAIR MATERIAL AND TECHNIQUE are feasible, and may be associated with fewer One key consideration in the selection of pros- complications. thetic repair material deserves mention. Currently, there is wide variation in the cost of available TREATMENT ALGORITHM prostheses. For some institutions and practices, The first step in the treatment of ventral hernia cost may limit or eliminate the use of more is patient assessment, starting with risk factors and expensive devices. A thorough discussion of cost size of the defect. Smaller defects (#2 cm) may be considerations is not the intended purpose of this suitable for primary repair; larger defects where article. However, future analyses of the cost-benefit the fascia does not meet without undue tension relationship accounting for the expense of mate- should be reduced as much as possible. Each rials, surgical procedures, and potential complica- patient’s risk for SSO should be assessed using tions would be greatly beneficial to practitioners the grading system. and administrators alike. A proposed algorithm for the treatment of inci- Many of the advanced techniques described in sional ventral hernias is illustrated in Fig 2. Following this consensus statement require extensive hospital assessment for risk of SSO, patients are categorized resources and a high level of training. Surgeons in by size of defect. Very small defects may be closed pri- settings with less extensive resources may give marily along with reinforcing prosthetic repair mate- consideration to the referral of resource-intensive rial, potentially using a retrorectus repair. Most patients to tertiary care centers that have appro- defects too large for primary repair can be closed priate surgical resources. with component separation and reinforced with prosthetic repair material. For the rare cases in SUMMARY which component separation is not feasible or is in- Incisional ventral hernias are common and sufficient to completely reduce the defect, surgeons challenging for surgeons. The lack of high-quality may consider bridging the defect with prosthetic re- evidence leaves surgeons without clear guidance pair material. (The repair material should underlie regarding the selection of technique or material. the rectus muscles by at least 5 cm.) Examples of pa- The ultimate goal of this effort was to produce a tients for whom component separation may not be simple, generally accepted grading system and feasible include those with intensive radiation treat- surgical technique recommendations for the re- ment of the abdominal wall or extensive scarring of pair of incisional ventral hernias. The first step in the rectus muscles. Surgeons should exercise their this effort was the creation of an initial literature judgment when considering the feasibility of compo- review and set of recommendations. This state- nent separation. When using component separation ment represents the current state-of-the-art tech- and/or other techniques to reapproximate the rec- nique and materials as described by thought tus muscles, the authors find that bridging of defects leaders in the field and supported by the best with biologic repair material is rarely necessary. available evidence. It is hoped that the grading The nature of a laparoscopic ventral hernia system and recommendations will serve to assist repair as currently performed leads to a bridged surgeons and stimulate discussion and research.
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