IMPLANT-BASED BREAST CANCER RECONSTRUCTION WITH BIOLOGICAL MATRIC OR SYNTHETIC MESH.pdf INTRODUCTION Breast cancer accounts for 21,2% of malignant tumors of the female population in the RussianFederation [1]. Considerable success in complex treatment ofbreast cancer has been achieved in recent years. The quality of life in patients decreases dramatically as a result of the radical treatment. Reconstructive plastic surgery plays a significant role inthe rehabilitation of patients with breast cancer and is currently considered as causative treatment ofmental disorders associated with the loss of femininity and integrity of one’s own body [2-5]. About 50% of patients after mastectomy desire to restore their breast [6]. Recently there has been anincrease in the number of patients wishing immediate reconstruction as it might help to avoid psychological collapse and depression connected with theloss of femininity [7, 8]. A radical subcutaneous and skin-sparing mastectomy is an alternative to radicalmastectomy, which allows for primary rehabilitationif the selection of patients is correct. A compulsory condition for a good result is to achieve symmetry on the contralateral breast, whichmeans that surgery on it is necessary [9-11]. Methods of breast reconstruction can be classified into three groups: reconstruction with synthetic material (expanders and implants), those with patients’ own tissues and a combination of them [11-14]. The first group includes two-stepoperations with primary expander dermotensionand subsequent endoprosthesis replacement [15- 17]. The second group of operations includes autografts such as thoracodorsal flap (TDF), TRAM-flap, DIEP-flap, gluteal flap, lateral flap of thigh and Rubens flap. The third group is consi- doi 10.17223/1814147/60/03 dered to be a combination of these methods when, in addition to patients’ own tissues, an implant is used as well as techniques with the formation of a submuscular pocket when using mesh or biologicalimplants [18-20]. If immediate reconstruction is made, importantanatomical structures are maintained: such as submammary fold, the amount of skin remains themaximum required for the reconstructive phase, which improves the overall aesthetic result of theoperation [21]. Radical subcutaneous and skin-sparing mastectomy is an alternative to radical mastectomy, whichallows for primary rehabilitation in the correct selection of patients. In 1917, W. Bartlett performed the first subcutaneous mastectomy with simultaneous replacement of the removed breast tissue byadipose tissue [22]. B.S. Freeman., V.R. Pennisi, J.E. Woods and others developed this surgery method for breast reconstruction by using silicone implants in combination with local tissues. Different muscle autografts are used in the process of reconstruction with silicone prosthesis (TDF, TRAM). However, this method is often associated with increased risk of infection: it requires separation of the vascular pedicle and can cause a number ofcomplications such as long-lasting lymphorrhea in the donor area while separating the latissimus dorsimuscle flap, the scar in the donor area (often with the deformation of the contour of the back or the anterior abdominal wall), followed by reduction in the volume of the TDF due to denervation and reduction in TDF volume with preserved motor nerve, risk of marginal necrosis, liposclerosis, adiponecrosis when using TRAM-flap, risk of thrombosis of microvascular anastomoses in case of microsurgical TRAM technic. Вопросы реконструктивной и пластической хирургии № 2 (61) июнь’2017 26 Ермощенкова М.В., Чиссов В.И., Усов А.В. и др. Therefore, the use of artificial materials is relevant because they can replace muscle autograftsand by that can reduce trauma, blood loss, operation time and prevent the defect of donor areas. In 1950, Cumberland and Scales formulated the criteria for the ideal implant for the first time. Later, their ideas were developed and modified according to the requirements of modern surgery. Thus, the ideal implant should possess the following characteristics: chemical inertness, resistance toinfection (monofilament materials), histologicalinertness, minimal irritant effect on the surrounding tissue, the constancy of physical-chemical and mechanical properties, elasticity and flexibility to maintain the integrity in the modeling and mechanical strength. It should also allow collagen to grow and unite with patients’ own tissues; it should have sufficient pore size for ingrowth of connectivetissue (>75 micron), should stimulate fibroblastgrowth, should be suitable for mass production and sterilization; its price should be affordable. Theimplant material must not be softened by the liquid extracted from the wound, it must not be a cause of inflammation or rejection, it must not shrink in the healing process, it must not cause allergy or sensitivity, be carcinogenic and initiate local complications [23-25]. The first propylene mesh - Marlex-50 - was introduced by Frencis C. Usher in 1958-59. Polypropylene mesh implants appeared in 1962, received the common name of “mesh” and started to be widely used because of high elasticity and optimal pore size. Thanks to the work of Lichtenstein(1989), polypropylene mesh, implants have become the standard material currently used in surgery [25, 27]. There are a large number of different types ofmesh implants on the market [26]. In 2002, C. Amanti (Italy) was the first to report results of using polypropylene mesh implantsfor one-stage breast reconstruction after mastectomy during which Madden’s technique was applied. This surgical technique was developed in1994 and consisted in the formation of submuscular pocket which was formed with a mesh implantplaced along the pectoralis major muscle edge. In 2005, results were presented from 67 onestep and 6 delayed reconstructions with nonabsorbable mesh implants to support the abdominal skin flap with extensive skin excision. 14 cases (19.2%) required a second surgical interventionunder general anesthesia due to the movement of the prosthesis, displacement of the nipple-areolacomplex and elimination of capsular contracture. M. Rietjens (2007) used non-absorbable mesh implants for tightening and maintaining the abdominal skin flap in extensive excision of the skin ofthe breast - “supporting technique”. During the operation, a broad flap of tissue from anterior abdominal wall on anterior surface of rectus abdominis was mobilized. In the same way, skin and subcutaneous adipose tissue at the bottom edge of mastectomy wounds were mobilized. The mobilized flap of an anterior abdominal wall was pulled up and stitched to a triangular non-absorbablemesh implant fixed at the level of forming inframammary fold. The implant was pulled up and placed behind the pectoralis major muscle, its upper edge fixed to the rib cartilage by two prolen`sseams. The prosthesis was installed at the front ofthe grid and behind the pectoralis major muscle. Basing their opinion on the results of the studies, the authors pointed out that the advantage of thisoperation is the ability to perform immediate reconstruction with extensive excision of the skin without prior skin stretching by expander and usinga musculocutaneous flap. H.D. Loustau put across an idea to performbreast reconstruction after radical subcutaneous mastectomy with a silicone implant with the formation of intra-muscular pockets using a mesh implant. The subpectoral pocket included the pectoralis major muscle (medial border), the serratus anterior (lateral margin) and the rectus abdominismuscles (lower edge). The author called this technique the “guaranteed subpectorally pocket” [28,29]. In his study, the author analyzed 34 breast reconstructions after subcutaneous mastectomy due to cancer treatment with the implantation of absorbable polyglycol mesh implant and silicone implant (the size is from 270 to 375 cm3). The average period of monitoring was 2.8 years. The formation of capsular contractures, infections, failures ofthe walls of the pocket for the implant were not observed. R. Wettstein used the method of forming thepocket worked out by H.D. Loustau. After a series of operations, it was recommended for further use [30]. Aesthetic results after breast reconstruction may be unstable in nature. Ptosis of the prosthesismay occur due to the individual characteristics of the connective tissue and its tendency to hyperextension [31]. V.G. Mishalov indicated that a significant percentage of recurrence of gravitationalptosis after mammoplasty reflects the quality offastening tissue, and remains an unsolved problem. The main idea proposed by Mr. V. Mishalov and co-authors in their method was to stimulate the formation of the connective tissue forming a“lock” to fix soft tissue to a stable structure using[32]. Currently reticulated polymeric titanium andpolyester implants are widely used for reconstructive surgery, including breast reconstruction. Titanium mesh implants are made of a unique patented composite material with covalently bound coating № 2 (61) июнь’2017 Вопросы реконструктивной и пластической хирургии Пластическая хирургия 27 titanium. Macroporous prosthetic mesh consists of polypropylene monofilaments with a covalently bound coating of titanium (30 nanometers, whileretaining the flexibility of the polymer), tensile strength and elongation correspond to the dynamics of body tissues and it is used to support and enhance connective tissue structures and ligaments. The main methodical purpose of using meshimplants in breast reconstruction is to increasesubpectoral space for the installation of siliconeprosthesis, reduction of the pressure on the skin, toensure good coverage of the prosthesis. Due to theformation of a new tissue layer, whose cells growout through the pores of the mesh implant are surrounded by patients' own tissue. The frequency of postoperative complications when performing onestep breast reconstruction after subcutaneous mastectomy with mesh implant and silicone implant is not higher than the one observed during othertypes of reconstruction [33-35], which allows toimplement this method. Plastic and reconstructive surgery has beencontinuously developing, improving the existing methods due to the advanced scientific research. A promising area in the reconstructive breast surgeryis the use of biological implant acellular dermal matrix (ADM). ADM was originally designed to correct the shape of the breast after augmentation toeliminate all roughness and contour abnormalities. Its use in implantation became popular after Brueing et al. published several cases of its application to cover the lower lateral pole of the breast [36]. Several cases of the application in two-step reconstruction with tissue expander were published later. The use of ADM became common in 2005. Using biomaterial made it possible to create a pocketfor prosthesis/tissue expander without using anterior serratus muscle or rectus abdominis [37]. The advantages of ADM are as follows: it decreases the postoperative pain syndrome intensity, prevents damage of the donor area and improvesaesthetic results [36-41]. However, there are indications in medical articles about an increase in the number of postoperative infectious complications, seromas, and explantations [37, 39, 43-45]. Nowadays, the majority of dermal matrices used for breast reconstruction include the human matrix, porcine matrix or matrix from cattle. Human matrix is made by Alloderm (LifeCell, Branchburg, NJ), Flex HD (Ethicon, Sommerville, NJ), Neoform (Mentor, Santa Barbara, CA), andDermaMatrix (Synthes, West Chester, PA);theporcine matrix - by Strattice (LifeCell, Branchburg, NJ) and Permacol (Covidien, Boulder, CO). The matrix of cattle is only presented on the market in the form of Surgimend (TEI Biosciences, Boston, MA). ADM can be used in immediate and delayed breast reconstruction. Immediate reconstruction has certain advantages: preservationof skin case and favorable conditions for the formation of a pocket for a prosthesis [46]. The method of using ADM was firstdescribedfor one-step reconstruction with a permanent implant to reduce or eliminate installation of a tissueexpander. In the original report of Breuing as wellas in five subsequent randomized studies the effectiveness and success of immediate reconstruction when using ADM were proven [38, 41, 42, 47-49]. In these retrospective studies, the overall incidenceof complications was between 6.9% and 25%. Breuing reported 6.9% (2/30) of complications afterprimary reconstructions, Zienowicz's et al. reported 25% (6/24) of complications due to the necrosis ofskin grafts, the treatment of which was carried out using local methods. The greatest review of onestep reconstruction with implants and ADM waspresented by Colwell et al.: the complication rate was 14.8% (49/331), including 9.1 percent(30/331) cases of the necrosis of skin grafts. Skin graft necrosis that required the removal of the prosthesis occurred in 1.5%. These results demonstrated the successful application of ADM in onestage breast reconstruction. A proper selection of patients is required toachieve the best possible results. Excellent condition of skin grafts is required. Moreover, patients should be informed that for the best possible result the breast size has to be similar to natural or smaller 48]. One of the advantages of ADM is the reductionof pain syndrome due to the reduction of pectoralis major muscle tension [36, 50]. The use of ADM was first described for capsular contracture treatment. Currently, there are nodata proving the prevention the development ofcapsular contracture when using ADM [36, 41, 51- 53]. Some authors point out that ADM providesthe best aesthetic results, but there are only 2 studies that support this assertion. Spear et al. got identical results according to the reconstruction withimplants and ADM (a mean of 3,68 out of a possible 5) and the contralateral unreconstructed breast(a mean of 3.98 out of a possible 5) (p = 0.3) [54, 55]. Vardanian et al. also showed that the overall aesthetic result, evaluated by independentobservers on a scale of 1-4 was, statistically, significantly larger in the group with ADM's - 3.26, compared with the group without ADM - 2.87. According to the author, the submammary fold was in thebest position in the group with ADM - 3.35, compared with the group without ADM - 2.94 [50]. Complications in the application of ADM aresimilar to those of breast reconstruction with implants, and should be divided into early ones - hematoma, seroma, infection, necrosis of skin grafts, rejection of the prosthesis, and late complicationssuch as asymmetry, wrinkling of the implant, wrong Вопросы реконструктивной и пластической хирургии № 2 (61) июнь’2017 28 Ермощенкова М.В., Чиссов В.И., Усов А.В. и др. position, capsular contracture, and late infectiouscomplications. Hematoma occurs in less than 5% of cases, and treatment of that is standardized for all reconstructions. ADM implies the increased risk of developing seroma, and there are two studies which have shown a statistically increased frequency of that [36, 40]. Chun points out the development of seroma - 14.1% in the group with ADM compared with 2.7% in the group without ADM [36]. Similarly, Parks reported a 29.9% seromas in ADM group and 15.7% in the group without ADM[40]. However, there are many studies that showno statistically significant difference in the development of seromas caused by ADM [37, 41, 45, 52,54, 56]. Thus, according to Liu et al., seroma frequency was 7.1% in the ADM group versus 3.9% inthe group without ADM, while according to Lanieret al., it was 13.4% versus 6.7%, respectively, thedata did not reach the statistical significance. Taking into account these conclusions, it should bepointed out that in order to minimize the risk ofseroma development the installation of vacuum drainage without its premature removal should beused. Infectious complications when using ADM areobserved in a high percentage of patients - 35.4percent, which may be explained by the presence ofthe second foreign material, in addition to theendoprosthesis. There are many reports that demonstrate increase in the number of infectious complications in patients with ADM [36, 37, 44, 45,57-59]. Timely antibiotic therapy is important. Contraindications for ADM use are similar to those with endoprosthesis mammoplasty. Selectionfactors include an assessment of the need for unilateral or bilateral reconstruction, body type, body mass index, width of the chest, comorbidities, and psychological portrait of the patient. Ideal candidates for reconstruction with implants and ADMare skinny patients who are undergoing bilateral reconstruction after adequate mastectomy skinflaps and skinny patients with breast without pthosis undergoing unilateral reconstruction. With increasing size and ptosis of the breast, it is more difficult to achieve symmetry, therefore contralateral mastopexy or reduction mammoplasty become necessary Nowadays, there are no absolute contraindications for ADM using, however, obesity, smoking and breast size more than 600 grams mean increased risk of postoperative complications. Thecombination of ablasticity and surgery reconstructive techniques is necessary to achieve the best results. All cuts must be pre-marked, submammary fold must be marked and, if possible, preserved during the mastectomy, skin flaps should be thickenough to preserve adequate circulation and toprevent possible loss of the skin graft [37, 44, 45]. In our opinion, the selection criterion forstrengthening the lower slope of the breast in subcutaneous or skin-saving mastectomy with silicone implant in the cancer treatment with one-step reconstruction is the value of pinch-test. When the value of the pinch-test is more than 0,5 cm, a synthetic implant and ADM can be used. When the value of the pinch-test is less than 0,5 cm, the preference should be given to ADM. MATERIAL AND METHODS During 2013-2016, in the Department of Oncology and reconstructive surgery of breast andskin of the P.A. Herzen Moscow Cancer Research Institute, 104 implant-based immediate reconstructive operations with mesh and ADM were performed in breast cancer patients after subcutaneousor skin-sparing, nipple-sparing mastectomies. Theaverage age of patients is 47, 2 years old. Stage 0 was diagnosed in 2% of patients, I - 30%, IIA - 33%, IIB - 16%, IIIA - 15%, IIIB - 2%, IIIC - 2%. To strengthen the lower slope of the breast, operated on for cancer, titanium meshes were used in 12 cases and polyester 3D meshes in 68 cases, acellular dermal matrix Permacol - in 24 cases.Silicone implant volume ranged from 120 to 585 cm3 and depended on the individual anatomy of the patient. Mutations of the BRCA1 gene were found in 5 patients, and therefore prophylactic contralateral subcutaneous mastectomy was made with thestrengthening of the lower slope of the reconstructed mesh implant. To achieve symmetry, augmentation of the contralateral breast was performed in 8 cases. The technique of using a biological implant in breast reconstruction After mastectomy, and careful hemostasis, pockets of skin were formed (Fig. 1, 2). Inferolateral part of the pectoralis major muscle was separated from the anterior chest wall. By using electro-dissection the subpectoral pocket wasformed, up to the marked levels on the perimeter ofthe modeled breast. After successfully creating the subpectoral pocket we performed preparation ofADM sheet, according to the manufacturer's recommendations. On the next stage ADM washemmed to the chest wall with reconstruction of the lateral and lower submammary fold (Fig. 3). Most surgeons prefer using absorbable seam materials, in particular, 2-0 polydioxanone (PDS) orVicryl 2-0. After reliable attachment of the ADM to inframammary fold, the width of the pocket was measured in order to select a prosthesis. After careful hemostasis in the pocket and a prosthesisplacement, the edge of ADM was hemmed to the № 2 (61) июнь’2017 Вопросы реконструктивной и пластической хирургии Пластическая хирургия 29 bottom and the side edges of the pectoralis majormuscle. For a reliable cover, silicone prosthesis wasisolated on the serratus anterior and ADM was fixed to the last one in the lateral section. In all cases, a closed space was formed with a tight fit of the prosthesis, but without pressure on the skinflaps (Fig. 4, 5). The wound was seamed in layers, with two vacuum drains left (Fig. 6). The reconstruction step when using silicone implant and ADM Fig. 1. The wound view after subcutaneous mastectomy and axillary subscapular lymph node dissection Fig. 2. The wound view of the cavity after completing a subcutaneous mastectomy Fig. 3. ADM is fixed to the inframammary fold Fig. 4. The step of pocket forming using the major pectoral muscle, and acellular dermal matrix, serratus anterior, fascia of musclus rectus abdominis Fig. 5. The final view of the pocket formed with endoprosthesis Fig. 6. The view of postoperative wounds The technique of radical subcutaneous mastectomy with simultaneous reconstruction with the mesh implant and silicone implant According to the preoperative marking byperiareolar line in the case of a subcutaneous mastectomy or by two radial cuts at skin-saving mastectomy, we dissected the skin and subcutaneous tissues were cut. Skin flaps were separated widely. Mammary gland with a tumor was mobilized andremoved subcutaneously. Axillary-subscapular tissue Вопросы реконструктивной и пластической хирургии № 2 (61) июнь’2017 30 Ермощенкова М.В., Чиссов В.И., Усов А.В. и др. was removed. In case of a lymph node, axillarysubclaviansubscapular lymphadenectomy was performed. The pectoralis major muscle was separated from the pectoralis minor to 3 and 9 o'clock positions. Mesh implant was fixed to the great pectoralmuscle edge by non-absorbable suture atraumatic thread. The silicone implant was placed under pectoralis major muscle and covered by mesh implant. A duplicator of the mesh implant was formed. Atthe lateral side, mesh was fixed to anterior serratus muscle to prevent its displacement. Vacuum drainage was placed in the space of the prosthesis andaxillar region. After an aseptic dressing, patients were asked to wear elastic compression underwear. RESULTS In the group of patients with ADM, the development of skin grafts necrosis at lower quadrants was found in 1 patient at the early postoperativeperiod. Because of that, three necrotomies with theimposition of secondary sutures were carried outwith a temporary positive result. Progressive marginal necrosis required secondary sutures, autodermoplasty and subsequent replacement of thecutaneous-subcutaneous flap from the anterior chest wall, which led to good result. It should bepointed out that the development of seromas andinfectious complications in this patient were notobserved, and 2 courses of antibiotic prophylaxis were conducted. The only change in the aestheticresult is only due to the appearance of additional seams after autodermoplasty in the area of thelower quadrants; significant changes in the shape of a breast were not marked. The presence of ADM, which covered the endoprosthesis, allowed to avoid the re-implantation of the last one. The development of a long-standing small seroma in the central parts of the postoperative scaroccurred in 1 patient during early postoperativeperiod. A puncture was performed and topicaltreatment provided with seroma regression noted amonth after surgery. In 1 case, during adjuvantchemotherapy, within 4 months after the operation, the development of skin reactions, such asredness in the area reconstructed with the endoprosthesis and ADM breast, required hormonaland anti-inflammatory topical treatment, a common antihistamine therapy with a positive result. In 2 (18%) cases, ADM and implant were removed inconnection with suppuration of postoperativewound. Cosmetic result was rated as excellent in 67.3% cases, good in 19.2%, satisfactory in 7.7%, as unsatisfactoryin 5.8%. The frequency of implant loss was5.8% when titanium breast mesh was used and 0% with polyester mesh. Seroma was diagnosed in 1.9% when using pork ADM and 2.9% when usingtitanium mesh. Necrosis of a nipple was in 1.9% when using titanium mesh. Infection of the implantwas recorded in 2.9% cases. A capsular contracture developed in 5.8% cases after radiotherapy. Views of a patients before and after surgerywith ADM is given in Fig. 7, 8. a b c Fig. 7. The view of a patient in the three projections prior to surgery. Clinical diagnosis: left side breast cancer ypT2N0M0G2L0V0PR. stage IIA, Her2/neu-positive subtype, the state after a 8 courses of neoadjuvant drug therapy a b c Fig. 8. View of the patient in the three projections a month after radical subcutaneous mastectomy on the left breast with one-stage reconstruction with silicone implant and ADM № 2 (61) июнь’2017 Вопросы реконструктивной и пластической хирургии Пластическая хирургия 31 a b c Fig. 9. The view of a patient in the three projections prior to surgery. Clinical diagnosis: left side breast cancer ypT1N0M0G2L0V0,stage I, luminal type, Her2/neu-negative subtype a b c Fig. 10. View of the patient in the three projections a 6 month after radical subcutaneous mastectomy on the left breast with immediate reconstruction of the silicone implant and mesh implant View of the patient before and after surgery The value of pinch-test is the selection criterion with mesh implant is given in Fig. 9, 10. to strengthen the lower slope of breast during skinsparing subcutaneous mastectomy in cancer treat- CONCLUSIONS ment with one-step reconstruction with silicone implant. When the value of the pinch-test is over 0,5 cm Biological and synthetic materials are signifi-a synthetic implant can be used as well as ADM. cantly important options for breast reconstruction.When the value of the pinch-test is lower than 0,5 cm Their advantages are as follows: they reduce surgi-the preference should be given to ADM. cal trauma during one-step reconstruction by mak-According to certain articles, there is increased ing the use of autologous muscle grafts unneces-risk of infection in the reconstruction area whenussary, they reduce operation time and pain, they ing ADM, surgeons should be aware of and take make it possible to expand the prosthesis pocket. timely preventive measures.

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