Italian Biological Prosthesis Work-Group (IBPWG): proposal for a decisional model in using biological prosthesis

  • Federico Coccolini1,

    Affiliated with

    • Ferdinando Agresta2,

      Affiliated with

      • Andrea Bassi3,

        Affiliated with

        • Fausto Catena4,

          Affiliated with

          • Feliciano Crovella3,

            Affiliated with

            • Roberto Ferrara5,

              Affiliated with

              • Francesco Gossetti6,

                Affiliated with

                • Domenico Marchi7,

                  Affiliated with

                  • Gabriele Munegato8,

                    Affiliated with

                    • Paolo Negro6,

                      Affiliated with

                      • Micaela Piccoli7,

                        Affiliated with

                        • Gianluigi Melotti7,

                          Affiliated with

                          • Massimo Sartelli9,

                            Affiliated with

                            • Michele Schiano di Visconte8,

                              Affiliated with

                              • Mario Testini10,

                                Affiliated with

                                • Paolo Bertoli1,

                                  Affiliated with

                                  • Michela Giulii Capponi1,

                                    Affiliated with

                                    • Marco Lotti1,

                                      Affiliated with

                                      • Roberto Manfredi1,

                                        Affiliated with

                                        • Michele Pisano1,

                                          Affiliated with

                                          • Elia Poiasina1,

                                            Affiliated with

                                            • Eugenio Poletti1 and

                                              Affiliated with

                                              • Luca Ansaloni1Email author

                                                Affiliated with

                                                World Journal of Emergency Surgery20127:34

                                                DOI: 10.1186/1749-7922-7-34

                                                Received: 19 October 2012

                                                Accepted: 22 October 2012

                                                Published: 2 November 2012

                                                Abstract

                                                Introduction

                                                Indications for repair of abdominal hernia are well established and widely diffused. Controversies still exist about the indication in using the different prosthetic materials and principally about the biological ones.

                                                Material and methods

                                                In February 2012, the Italian Biological Prosthesis Work-Group (IBPWG), counting a background of 264 biologic implants, met in Bergamo (Italy) for 1-day meeting with the aim to elaborate a decisional model on biological prosthesis use in abdominal surgery.

                                                Results

                                                A diagram to simplify the decisional process in using biologics has been elaborated.

                                                Conclusion

                                                The present score represents a first attempt to combine scientific knowledge and clinical expertise in order to offer precise indications about the kind of biological mesh to use.

                                                Keywords

                                                Biological prosthesis Work-group Indication Cross-linked Non-cross-linked Surgery Reconstruction Infection Tissue loss Mesh

                                                Introduction

                                                Prosthetic abdominal wall surgical repair is a common procedure [1, 2]. Actually, about one million prostheses per year for abdominal wall repair are used worldwide [3]. Since the first description of a mesh use for abdominal wall repairing [4] plenty of new material have been introduced, first synthetic, but later biologic. Indications for repair are well established and widely diffused [5]. However controversies still exist about the indication in using the different materials and principally about the biological ones. More than a dozen of biological prosthesis (BP) are currently available (Table  1). All of them are derived from human or mammalian tissues [6]. It has already been noted the major variability among human dermis prosthesis than among the animal ones in terms of mechanical and physical properties [6]. In fact xenograft products are obtained from a more uniform animal population with similar age and life histories, this allows producers to obtain more consistent implants than from humans donors [6].
                                                Table 1

                                                Biological prosthesis currently on the market

                                                Name

                                                Manufacturer

                                                Tissue source

                                                Material

                                                X-linking

                                                Alloderm

                                                LifeCell

                                                Human

                                                Acellular dermis

                                                No

                                                AlloMax

                                                Bard

                                                Human

                                                Acellular dermis

                                                No

                                                Flex HD

                                                Ethicon/MTF¥

                                                Human

                                                Acellular dermis

                                                -

                                                DermaMatrix

                                                MTF¥

                                                Human

                                                Acellular dermis

                                                No

                                                Permacol

                                                Covidien

                                                Porcine

                                                Acellular dermis

                                                Yes

                                                CollaMend

                                                Davol/Bard

                                                Porcine

                                                Acellular dermis

                                                Yes

                                                Strattice

                                                KCI/LifeCell

                                                Porcine

                                                Acellular dermis

                                                No

                                                XenMatrix

                                                Brennan Medical

                                                Porcine

                                                Acellular dermis

                                                No

                                                Surgisis

                                                Cook

                                                Porcine

                                                Small intestine submucosa

                                                No

                                                Surgisis Gold

                                                Cook

                                                Porcine

                                                Small intestine submucosa

                                                No

                                                Lyosis

                                                Cook

                                                Porcine

                                                Lyophilized small intestine submucosa

                                                No

                                                FortaGen

                                                Organogenesis

                                                Porcine

                                                Small intestine submucosa

                                                Yes

                                                SurgiMend

                                                TEI bioscience

                                                Bovine

                                                Fetal dermis

                                                No

                                                Periguard

                                                Synovis

                                                Bovine

                                                Pericardium

                                                Yes

                                                Veritas

                                                Synovis

                                                Bovine

                                                Pericardium

                                                No

                                                Tutomesh

                                                Tutogen

                                                Bovine

                                                Pericardium

                                                No

                                                Tutopatch

                                                Tutogen

                                                Bovine

                                                Pericardium

                                                No

                                                ¥ MTF: Muscoloskeletal Transplant Foundation.

                                                BP, independently from the origin, could be further and basically divided into two main groups: cross-linked and non-cross-linked. The difference between these two groups is the proceeding the cross-linked are submitted to. The introduction of chemical cross-linking between the collagen chains, strengthens the prosthesis reducing the efficacy of bacterial and host collagenase enzymes, thus the implant is less prone to degradation in vivo [7, 8].

                                                On the basis of either the presence or not of the cross-linking, biological prosthesis are divided into two subgroups: the partially remodeling (over time) and the completely remodeling ones. The partially remodeling (cross-linked) prosthesis are made of porcine or human dermal collagen and bovine pericardium collagen [6]. The completely remodeling (not cross-linked) ones are principally made of swine intestinal sub-mucosa, swine dermis, human dermis, fetal bovine dermis and bovine pericardium. The differences in remodeling times should be kept in mind when these materials are chosen for abdominal wall repair [6]. Each type of prosthesis allows and encourages host tissue ingrowth, although different prostheses can feature different clinical attributes. Thanks to the presence of additional linkages the partially remodeling ones resist better and for a longer period to mechanical stress. Moreover BP have the lowest adhesiogenic potential among all prosthetic materials available for intra-peritoneal use [9]. Post-operative pain and discomfort have been demonstrated to be inferior when biological prosthetic materials are used in groin hernia repair [10]. Implants would act as a scaffold inside which the host tissue cells and fibroblasts can replicate. They also provide resistance to tension and stress by supporting the abdominal wall until it is fully recovered. Times of remodeling range between a few months and few years [11]. It depends on prosthesis characteristics and host tissues properties.

                                                Surgeons have not widely assumed the capability to manage with BP. The way to consider them should be completely different from the standard synthetic meshes. These last ones are as a “patch to apply on a hole”; essentially they trigger a foreign body host response leading to encapsulation of the prosthesis with intense fibrous reaction. On the contrary BP activate a remodeling process in which the host remodels the prosthesis and his own tissues by producing new healthy tissue. By using BP the surgeon starts a real tissue engineering process [12]. The scarcity of knowledge about BP is also due to the lack of high-evidence level literature about the topic. For this reason the Italian Chapter of the European Hernia Society has founded the Italian Register of Biological Prosthesis (IRBP) to archive and study the BP use in Italy. A similar registry associated with the European Hernia Society, the European Register of Biological Prosthesis (ERBP), is currently recruiting cases all over Europe [3].

                                                To give an answer to the many different questions about the BP use in abdominal surgery we promoted a meeting of the Italian Biological Prosthesis Work-Group (IBPWG) constituted by surgeons with a wide experience in abdominal surgery either in elective or in emergency setting and in the use of BP. The purpose of the summit was mainly to give a few simple and reproducible indications about the correct use of BP in abdominal wall surgery keeping into consideration the two main challenges: the infected fields and the loss of tissue.

                                                Material and methods

                                                In February 2012, the IBPWG met in Bergamo (Italy) for 1-day summit with the aim to elaborate a decisional model on BP use in abdominal surgery. The group is constituted by general surgeons, all with extensive experience in abdominal wall surgery either in elective or in emergency setting, added to a wide experience in the use of BP (at the time of the meeting the participants had collectively implanted 284 BP).

                                                Results

                                                A diagram to simplify the decisional process in using BP has been elaborated (Figures  1, 2). It keeps into consideration the different kind of BP, the infection of the surgical field and the tissue loss.
                                                http://static-content.springer.com/image/art%3A10.1186%2F1749-7922-7-34/MediaObjects/13017_2012_270_Fig1_HTML.jpg
                                                Figure 1

                                                Decisional model diagram: the product of the infection and the loss of tissue scores gives as a result the value which indicate the kind of biological prosthesis to use.

                                                http://static-content.springer.com/image/art%3A10.1186%2F1749-7922-7-34/MediaObjects/13017_2012_270_Fig2_HTML.jpg
                                                Figure 2

                                                Decisional line: the different results indicate the kind of biological prosthesis to use.

                                                The diagram suggests the type of BP that should be used by combining these three variables together on the basis of scientific literature and expert opinions.

                                                Discussion

                                                Complex abdominal hernia repair represents a significant challenge for surgeons. Complex hernia could be differently defined. The complexity of hernias could derive from contamination/infection, tissue loss, dimensions, anatomic position and clinical or pharmacological data.

                                                For sure the introduction of tension-free techniques, thanks to the use of prosthetic materials, has greatly facilitated the duty. On one hand prosthetic techniques have been demonstrated to reduce the recurrence rate, on the other hand they introduced a series of new variables to take into consideration when repairing abdominal wall defects: actually prosthetic infection, dislocation, chronic pain, shrinkage, adhesions formation, fistula formation and skin erosion complicate the decision process in abdominal wall repair surgery. With the introduction of resorbable materials some of these factors have been eliminated with an increased recurrence rate as a counterpart. BP has completely changed the way to face the abdominal hernia surgery. They introduced the tissue engineering in field of the surgical practice [12]. The implant of biologic materials elicits a cascade of events leading to new healthy tissue deposition and prosthesis remodeling. It also allows to blood, growth and pro-/anti-inflammatory factors and drugs to reach the surgical field during the first phases of healing process. This for sure enhances the effect against potential or definite contamination/infection. Moreover the adhesiogenic power of BP is absolutely lower than the one of the other synthetic materials [13, 14]. On the contrary there are a few doubts about the intra-peritoneal use of BP from the biomechanical point of view. It has been demonstrated that the best integration is reached if they are placed pre-peritoneally with a greater incorporation strength, less adhesion area and lower adhesion scores compared with intra-peritoneal placement [15]. Given that the long-term persistence of the prosthesis is crucial, some authors stated that the BP durability has a direct impact on the recurrence rate [16]. However durability depends on the implant intrinsic properties and also on the environment into which the BP are placed [16]. It has been demonstrated in animal models as the tensile strength is different between cross-linked and non-cross-linked meshes during the first months after the implant. However it reaches similar values after 12 months with the two kind of implants [8]. Moreover the strength of the repair sites doesn’t change over time. This might indicate that new tissue is deposited in the repair site as the scaffold is degraded, preventing the site from weakening over time [8]. Another factor that should be kept into account in choosing which kind of BP to use is the demonstration that non-cross-linked material exhibits more favourable remodeling characteristics [8]. This has a great importance when BP are used as bridging or alternatively as reinforcement. In fact discordant data have been published about the use of BP to bridge wide defects [16]. Few different non-randomized studies have been published reporting recurrence rate ranging between 100% and 0% if the prosthesis are placed respectively either as a bridge or not [1619]. Even if high-quality comparative data about BP exist in animal models, only clinical reports of a restricted number of cases are reported for humans. Moreover only the recurrence rate is registered as outcome in almost all studies. Other data regarding the use of BP as wound classification, contamination risk/grade, associated therapy or comorbidity are seldom reported. These data are needed to completely assess the usefulness, the efficacy and the versatility of BP. All reported data derived by retrospective uncontrolled series of limited number of patients. The methodology is seldom reported and/or poorly described. Moreover the time to recurrence is rarely evaluated [16]. One last observation is that the different studies reported data about non-homogeneous cohorts of patients. Different surgical techniques, different surgeons’ skill and expertise in using BP and different hernia sites are often mixed together. These inconsistencies are probably due to the poorness of cases for each single centre. No definitive evidence based conclusions could be obtained from the literature. The majority of surgeons stated that they use BP in “difficult” situations, especially those with contaminated or infected field [16, 20, 21].

                                                The present decisional model suggests, at the best of our knowledge, the way to apply scientific knowledge to the clinical practice in order to choose which type of BP use in abdominal wall defects repair. This should always be a dynamic process mediated by the surgeon decisional capability. We resumed the principal variables to keep in mind in deciding the kind of BP to use. Infection has been divided into three possible grades:
                                                • 1: potentially contaminated

                                                • 2: contaminated

                                                • 3: infected

                                                The same three steps division has been adopted for the tissue loss:
                                                • 1: no tissue loss (only reinforcement)

                                                • 2: 05 cm defect

                                                • 3: >5 cm defect

                                                By combining together these variables (multiplication) we obtained a score which determine the necessity to use either a cross-linked or a non-cross-linked BP (Figures  1, 2).

                                                Operating field has been divided into three groups. In a previous grading system by the Ventral Hernia Working Group (VEWG) the four grade of risk for surgical site occurrences have been differentiated by considering also the comorbidity of the patients [5]. Clinical conditions are to be kept in mind in evaluating the use of prosthesis but in the present decisional model the principal aim is to help the surgeon to decide whether use cross-linked or non-cross-linked BP.

                                                Undefined situations still exist. Cases with a score between 2 and 6 represent all that patients with a big tissue loss and a potential/low grade infection or vice-versa cases with an high grade infection and a low or null tissue loss. These cases need a cautious evaluation by the surgeon to establish if the priority has to be given to the tissue loss or to the grade of infection. The VEWG score could help in deciding. Infected fields with no residual loss of tissue don’t represent an absolute indication for BP use. On the contrary a small tissue loss with concomitant low/null infection but high comorbidity could suggest using a non-cross-linked BP. The higher resistance to protease enzyme action and to mechanical stress of cross-linked BP suggest using them in situation of high infection and/or big defects. As counterpart, however even in presence of a high grade infection with a low grade tissue loss could be suggested to place a non-cross-linked BP.

                                                Conclusion

                                                The present score represents the first combination of scientific knowledge and clinical expertise that gives some indications about the kind of BP to use. However no definitive recommendations could be given in complicated abdominal wall reconstructive surgery. The lack of definitive evidence-based data and the high costs of the BP suggest to cautiously evaluate each single case.

                                                Declarations

                                                Authors’ Affiliations

                                                (1)
                                                General and Emergency Surgery Department, Ospedali Riuniti
                                                (2)
                                                General Surgery Department, Adria Hospital
                                                (3)
                                                General Surgery Department, Cotugno Hospital-CTO
                                                (4)
                                                General and Emergency Surgery Department, Ospedale Maggiore
                                                (5)
                                                General Surgery Department, Ospedale Centrale
                                                (6)
                                                General Surgery Department, La Sapienza Univesity Hospital
                                                (7)
                                                General Surgery Department, New Sant’Agostino Hospital
                                                (8)
                                                General Surgery Department, Conegliano Hospital
                                                (9)
                                                General Surgery Department, Macerata Hospital
                                                (10)
                                                Endocrine, Digestive and Emergency Surgery Department, Aldo Moro University Hospital

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                                                Copyright

                                                © Coccolini et al.; licensee BioMed Central Ltd. 2012

                                                This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( http://​creativecommons.​org/​licenses/​by/​2.​0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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