RU2743199C2 - Method of reconstructive plastic surgery of breast cancer patients using xenopericardium biolab-pp/pa and silicone endoprosthesis - Google Patents

Abstract

FIELD: medicine; oncology; reconstructive plastic surgery.SUBSTANCE: subcutaneous removal of mammary gland tissue, cutting off the lower edge of the pectoralis major muscle and the serratus anterior muscle and creating a sub-sectorial pocket are performed. At the same time, after the creation of a sub-sectorial pocket, strengthening of the submammary fold is performed with separate non-absorbable nodal stitches with the capture of the fascia of the anterior chest wall. The xenopericardial plate BioLAB-PP/PA, in accordance with the area of the lower pole of the silicone endoprosthesis, is projected onto the lower zone of mammary gland reconstruction. The edge of the xenopericardial plate is sutured with separate nodal stitches with an atraumatic vicril 3/0 thread to the fascia of the anterior chest wall, corresponding to the submammary fold. The width of the pocket for the choice of endoprosthesis is measured and, after hemostasis, silicon endoprosthesis is placed in the formed sub-sectorial pocket. The edge of xenopericardial is sutured to the lower and side edges of the pectoralis major muscle. The upper edge of the xenopericardial plate is pulled to mobilized lower edge of the pectoralis major muscle, and a silicone endoprosthesis is closed by it. Next, the edges of the pectoralis major muscle, the xenopericardial plate, and the serratus anterior muscle are connected by a continuous seam with a vicril 3/0 thread, creating a sealed muscle-xenopericardial pocket.EFFECT: method allows achieving several results: reducing the traumatic nature of surgical intervention during simultaneous reconstruction by eliminating the need for autologous transplants; reducing the operation time; reducing pain syndrome; optimizing the economic component of treatment of mammary gland cancer patients due to import substitution.1 cl, 9 dwg, 1 ex

Description

The invention relates to medicine, namely to oncology and reconstructive plastic surgery in patients with breast cancer.

Performing a one-stage reconstruction of the mammary gland allows a woman to achieve quick physical and psychological rehabilitation. According to the literature, 37% of breast reconstruction in breast cancer patients is performed using silicone implants (Albornoz CR, Bach PB, Mehrara BJ, Disa JJ, Pusic AL, McCarthy CM, Cordeiro PG and Matros R: A paradigm shift in US Breast reconstruction : increasing implant rates. Plast Reconstr Surg 131: 15-23, 2013; Dietrich M, Paepke S, Zwiefel K, Dietrich H, Blohmer J, Faridi A, Klein E, Gerber B and Nestle-Kratmling S: Implant-based breast reconstruction using a titanium-coated polypropylene mesh (TiLOOP Bra): a multicenter study of 231 cases. Plast Reconst Surg 132: 8e-19e, 2013).

However, the known methods are often associated with the development of early or late complications: infections, the development of fibrous capsular contracture after radiation therapy, as well as protrusion and extrusion of the implant.

For the prevention of these complications, it was proposed to use an additional shelter for the lower slope of the reconstructed breast.

Over the past 10 years, a wide variety of synthetic meshes and biological matrices have been introduced into the practice of reconstructive surgery to create an additional cover for the lower pole of a silicone implant during one-stage breast reconstruction. It is known that with the use of additional cover for the lower slope of the reconstructed breast (acellular dermal matrix, mesh implant, deepithelialized flap, thoracodorsal flap), the patient's quality of life is higher than in the group without additional endoprosthesis cover (Zikiryakhodzhaev A.D., Shirokikh I.M. , Ablitsova N.V., Ermoshchenkova M.V., Khakimova Sh.G., Khakimova G.G., Tukmakov A.Yu.Simultaneous breast reconstruction and postoperative radiation therapy: the development of capsular contracture. Oncology issues. 2019, volume 65 , No. 3. UDC 618.19-006). The use of one's own tissues to create additional shelter for a silicone implant is technically more difficult, more time-consuming, and often involves complications from donor areas, while the use of biological and synthetic materials for this purpose implies less trauma of surgery and faster rehabilitation of patients.

However, the biological matrices (human and porcine acellular dermal matrices) and synthetic meshes on the market are expensive materials, and therefore the search for alternative materials continues.

The first report in the literature on the use of bovine pericardium in breast reconstruction belongs to the American surgeons MMMofid, MSMeininger and MSLacey, who in 2012 presented the results of their experience with the use of a collagen matrix based on the bovine pericardium Veritas ((Mofid MM, Meininger MS, Lacey MS . Veritas (bovine pericardium for immediate breast reconstruction: a xenograft alternative to acellular dermal matrix products. Eur J Plast Surg. 2012 Oct; 35 (10): 717-722. Doi: 10.1007 / s00238-012-0736-9. Epub 2012 Jun 17. PMID: 23002328; PMCID: PMC3443340).

Later, similar works were presented using other materials based on bovine pericardium: Tutopatch (and Tutomesh ((Castagnetti F, Bertani C, Foroni M, Falco G, Cenini E, De Bonis F, Ferrari G. The Bovine Pericardium Matrix in Immediate Implant- Based Breast Reconstruction.Aesthetic Plast Surg. 2020 Feb 28. doi: 10.1007 / s00266-020-01651-z. Epub ahead of print.PMID: 32112193; Semprini G, Cattin F, De Biasio F, Cedolini C, Parodi PC. The bovine pericardial patch in breast reconstruction: a case report. G Chir. 2012 Nov-Dec; 33 (11-12): 392-4. PMID: 23140923).

It should be noted that due to the use of different materials that differ in the technology of their manufacture, and, accordingly, in the degree of cleaning, thickness and other characteristics, as well as the short observation period for patients, the authors were not able to sufficiently analyze the nature and quantitative ratios of late complications. after using xenopericardium, incl. in combination with radiation therapy.

The closest is the method of simultaneous reconstruction of the breast in cancer using an acellular dermal matrix and a silicone endoprosthesis (RU 2584133 C2). The pectoralis major muscle is mobilized by cutting off from the lower edge of its attachment, laterally to a level corresponding to 9 o'clock on the dial, the inferolateral part of the pectoralis major muscle is separated from the anterior chest wall and a subpectoral pocket is formed by electrodissection to marked levels along the perimeter of the formed gland; after the successful creation of a subpectoral pocket with an approximate size of 4-8 cm × 14-16 cm, a sheet of acellular dermal matrix is prepared, its sharp edges are cut along a semicircle, immersed in 0.9% saline, then the edge of the matrix corresponding to the lower one is sutured with separate interrupted sutures Using an atraumatic thread to the fascia of the anterior chest wall corresponding to the submammary fold, after attaching the ADM to the submammary fold, measure the width of the pocket for choosing an endoprosthesis and place a silicone endoprosthesis into it, then the treated edge of the ADM is sutured to the lower and lateral edges of the pectoralis major muscle, while the upper edge of the ADM stretched to the lower mobilized edge of the pectoralis major muscle with the closure of the silicone endoprosthesis, then the edges of the ADM are placed under the pectoralis major muscle by different distances of the needle puncture from the edges of the muscle and ADM, while the distance from the needle injection to the ADM edge is 6 mm, and from the edge of the pectoralis major muscles before the needle is punctured - 12 mm, for the implementation of the location of muscle tissue above the sheet of the acellular dermal matrix, the edges of the pectoralis major muscle and ADM are connected with a continuous suture with an atraumatic thread, then a fragment of the serratus anterior muscle with dimensions of 6-10 cm × 3 × 6 cm is separated and the mobilized fragment of the serratus anterior muscle is moved to the edge of the ADM, fixed the edges of the serratus anterior muscle and ADM according to a similar fixation technique with the pectoralis major muscle to create the tightness of the muscle-matrix pocket, after which layer-by-layer suturing of the postoperative wound is performed, leaving vacuum drainages in the silicone endoprosthesis bed and in the area of lymphadenectomy.

However, the use of ADM has several disadvantages, including seromas, inflammatory reactions (red sendrome), and infectious complications. So, according to the largest meta-analysis on complications when using ADM (Kim T., Cho H. The suitability of absorbable mesh insertion for oncoplastic breast surgery in patients with breast cancer scheduled to be irradiated. // J. Breast Cancer. 2013; 16 (1): 84-9 PMID: 23593087 [PubMed - indexed for MEDLINE].) The occurrence of seromas was in 95% of cases (n = 2037), the occurrence of hematomas was in 11.1%. Also, a tangible disadvantage of using ADM is its cost. Depending on the manufacturer, the size and thickness of the matrix, its cost can vary from $ 1825 to $ 4856 (Becker S. et al. AlloDerm versus DermaMatrix in immediate expander-based breast reconstruction: a preliminary comparison of complication profiles and material compliance. // Plast. Reconstr. Surg. 2009; 123 (1): 1-6; 107-108.).

The search for a new material that is relatively cheap and effective for covering the lower slope of the reconstructed breast in cancer patients is undoubtedly an important task for surgeons.

The applicant used a new material of domestic origin - bovine pericardium BioLAB-PP / PA.

The technical result of the proposed invention is to reduce the invasiveness of surgery in a one-stage reconstruction; avoidance of endoprosthesis reimplantation, reduction of operation time; reduction of pain syndrome; optimization of the economic component of the treatment of breast cancer patients through import substitution, as well as aesthetically satisfactory and stable long-term effect after breast reconstruction.

The specified technical result is solved by the fact that, as in the well-known method RU 2584133 C2, according to the preoperative marking, a periareolar incision at the border of the upper quadrants, a linear incision at the border of the outer quadrants 3 cm long, cut through the skin and subcutaneous tissue, the breast tissue is subcutaneously mobilized and remove, cut off the lower edges of the pectoralis major muscle and the serratus anterior muscle and create a subpectoral pocket.

The peculiarity of the proposed method is that after the creation of a subpectoral pocket, separate non-absorbable interrupted sutures with the capture of the fascia of the anterior chest wall strengthen the submammary fold, the plate of the xenopericardium BioLAB-PP / PA, in accordance with the area of the lower pole of the silicone endoprosthesis is projected onto the lower zone of reconstruction of the mammary glands, the edge of the xenopericardium plate is sutured with separate interrupted sutures with atraumatic 3/0 vicryl suture to the fascia of the anterior chest wall corresponding to the submammary fold, the width of the pocket is measured for choosing an endoprosthesis, and after hemostasis, a silicone endoprosthesis is placed in the formed subpectoral pocket, the edge of the xenopericardium is sutured to the lower and lateral edges the pectoralis major muscle, and the upper edge of the xenopericardial plate is pulled to the lower mobilized edge of the pectoralis major muscle and the silicone endoprosthesis is closed with it, then the edges of the pectoralis major muscle and the xenopericardium plate are connected continuously suture with vicryl 3/0 thread.

The invention is illustrated by a detailed description, a clinical example and illustrations, which depict:

Fig. 1 - Plate of xenopericardium BioLAB-PP / PA measuring 13.0x9.0 cm.

Figure 2 - View of the surgical wound after subcutaneous removal of breast tissue.

Fig. 3 - View of the surgical wound after the formation of the subpectoral pocket.

Figure 4 - View of the operating wound after suturing the pericardial plate BioLAB-PP / PA to the fascia of the anterior chest wall: a) outside view; b) inside view.

Fig. 5 - View of the operating wound after the installation of a silicone endoprosthesis.

Fig. 6 - View of the operating wound after creating a muscular-xenopericardial pocket for the endoprosthesis.

Fig. 7 - View of the operating wound on the 5th day after surgery

Fig. 8 - View of the patient before the operation: a) in frontal projection; b) in the lateral projection, on the left; c) in lateral projection, on the right.

Fig. 9 - View of the patient 3 weeks after surgery :) in frontal projection; b) in the lateral projection, on the left; c) in lateral projection, on the right.

Indications for this invention - stage 0-III breast cancer - both at stage I of treatment and after neoadjuvant drug therapy (depending on the nature of the local prevalence of the tumor process).

The applicant uses an alternative biological material - a plate made of xenopericardium BioLAB-PP / PA (TU 9444-003-01897446-01). This material was developed by the Scientific Center for Cardiovascular Surgery named after A.N. Bakuleva RAMS and is intended for the correction of defects of the atrial and interventricular septa, large arterial vessels, for the prevention of adhesions in the mediastinum, as well as for the correction of complex congenital heart defects, combined with stenosis of the pulmonary artery. Plates are used in healthcare and are manufactured to operate at nominal temperatures of 32 to 42 ° C and prolonged exposure to the blood environment. The plate "BioLAB-PP" is a solid rectangular sheet cut from the pericardium of a calf chemically stabilized with a solution of glutaraldehyde with additional sterilization with a 4% formalin solution.

The plate is characterized by a high degree of biocompatibility; elastic and at the same time provides sufficient mechanical strength; is produced sterile and shows resistance to the development of infectious complications.

There are no analogues of the use of xenopericardium BioLAB-PP / PA in oncology and reconstructive plastic surgery in patients with breast cancer in the domestic and foreign literature.

The method is carried out as follows.

According to the attached manufacturer's instructions, a xenopericardium plate BioLAB-PP / PA is preliminarily prepared - washed for 90 minutes with vigorous stirring in a sterile glass container with 500 ml of sterile 0.85% sodium chloride solution (solution temperature 25 ° C) with a solution change every 15 minutes (Fig. 1).

In the position of the patient on the back under general anesthesia according to the preoperative marking by a periareolar incision at the border of the upper quadrants, a linear incision at the border of the outer quadrants with a length of 3 cm cut through the skin and subcutaneous tissue, the breast tissue is subcutaneously mobilized and removed (Figure 2).

The pectoralis major muscle is mobilized by cutting from the lower edge of its attachment, lateral to the level corresponding to 9 o'clock on the dial. The inferolateral part of the pectoralis major muscle is separated from the anterior chest wall. By means of electrodissection, a subpectoral pocket is formed to marked levels along the perimeter of the formed gland (Figure 3).

After creating a subpectoral pocket, a plate of xenopericardium BioLAB-PP / PA corresponding to the size of the lower pole of the endoprosthesis is projected onto the lower zone of breast reconstruction. The edge of the xenopericardium plate corresponding to the lower one is sutured with separate interrupted sutures with atraumatic 3/0 vicryl suture to the fascia of the anterior chest wall corresponding to the submammary fold (Fig. 4 a, b).

After reliable attachment of the xenopericardium to the submammary fold, the width of the pocket is measured to select the endoprosthesis. A thorough hemostasis is performed in the formed subpectoral pocket and a silicone endoprosthesis is placed (Fig. 5).

After careful hemostasis and placement of the endoprosthesis into the formed subpectoral pocket, the edge of the xenopericardium is sutured to the lower and lateral edges of the pectoralis major muscle. The upper edge of the xenopericardial plate is pulled up to the lower mobilized edge of the pectoralis major muscle and the silicone endoprosthesis is closed. The edges of the pectoralis major muscle and the plate of the xenopericardium are connected with a continuous suture with a 3/0 vicryl thread. (Fig. 6). The wound is sutured in layers with an intradermal suture (Fig. 7).

Thus, a double reliable coating is created for the silicone endoprosthesis: the muscular-xenopericardial sheath and the skin.

Clinical example.

Patient E., 54 years old. Clinical diagnosis: left breast cancer stage IA, cT1 (m) N0M0G3, luminal type B Her2-negative.

Complaints on admission: for the presence of tumors in the left breast.

Anamnesis of the present disease: according to the patient, a tumor in the left mammary gland was first discovered in February 2020; in March 2020, she independently applied to the Moscow Oncological Research Institute. P.A. Herzen, where, according to a comprehensive examination, the diagnosis was made - left breast cancer stage IA, cT1 (m) N0M0G3, luminal type B, Her2-negative. Taking into account the nature and prevalence of the tumor process, an interdisciplinary consultation with the participation of a surgeon, chemotherapist and radiologist recommended surgical treatment at the first stage of complex treatment of the patient.

01/30/2020 - Protocol for a comprehensive examination of the mammary glands. With clinical X-ray ultrasound examination of both mammary glands, a picture of developed glandular tissue, against the background of which a hypoechoic formation with fuzzy contours of 10x19 mm is determined on the left in the lower outer quadrant. On the border of the outer quadrants, a similar formation with indistinct contours of a non-uniform structure is 14x11x15 mm. Ultrasound examination of the axillary regions did not reveal enlarged lymph nodes. Conclusion. Left breast cancer pattern. Multicentric shape.

Histological examination of biopsies of tumors of the left breast from 02/03/2020 Invasive unspecified breast cancer grade 3 of the Nottingham system, multifocal growth. IHC from 02/14/2020. ER-8 b., RP-7 b., Her2 neu-negative expression, Ki67 - 27%, E-cadherin positive expression.

02/05/2020 - Genetic testing: no mutations in the BRCA1, BRCA2 and CHEK2 genes were detected.

According to a comprehensive survey of systems and organs, data for regional and distant metastasis were not obtained.

On examination, the mammary glands are small in size, there is a slight asymmetry - D <S; the nipple-areola complexes of both mammary glands are not changed, there is no discharge from the nipples. On palpation of the mammary glands: on the right, clear nodules are not defined; on the left, in the projection of the lower-outer quadrant and the border of the outer quadrants, two seal areas up to 1.5 cm in diameter are determined. On palpation of regional areas on both sides, enlarged lymph nodes are not detected (Fig. 8 a, 6, c).

According to the decision of the council, on March 13, 2020, a surgical operation was performed - subcutaneous mastectomy on the left with one-stage reconstruction with a silicone endoprosthesis (Mentor 150 cc Siltex ™ Round Moderate Profile) in combination with xenopericardium BioLAB-PP / PA.

In the position of the patient on the back under general anesthesia according to the preoperative marking with a periareolar incision at the border of the upper quadrants, a linear incision at the border of the outer quadrants with a length of 3 cm cut through the skin and subcutaneous tissue, the breast tissue is subcutaneously mobilized and removed (Figure 2).

The pectoralis major muscle is mobilized by cutting off from the lower edge of its attachment, lateral to the level corresponding to 9 o'clock on the dial. The inferolateral part of the pectoralis major muscle is separated from the anterior chest wall. By means of electrodissection, a subpectoral pocket is formed to marked levels along the perimeter of the formed gland (Figure 3).

After the successful creation of a subpectoral pocket, a Xenopericardium plate BioLAB-PP / PA measuring 13.0x9.0 cm was projected onto the lower zone of breast reconstruction, corresponding to the lower pole. The edge of the xenopericardium plate corresponding to the lower one is sutured with separate interrupted sutures with atraumatic 3/0 Vicryl thread to the fascia of the anterior chest wall corresponding to the submammary fold (Fig. 4 a, b).

After reliable attachment of the xenopericardium to the submammary fold, the width of the pocket was measured to select the endoprosthesis. A thorough hemostasis was performed in the formed subpectoral pocket. In the latter, a silicone endoprosthesis is placed (Fig. 5).

After careful hemostasis and placement of the prosthesis, the edge of the xenopericardium is sutured to the lower and lateral edges of the pectoralis major muscle. The upper edge of the xenopericardial plate is stretched to the lower mobilized edge of the pectoralis major muscle with the closure of the silicone endoprosthesis. The edges of the pectoralis major muscle and the xenopericardium plate are connected by a continuous suture with a 3/0 vicryl thread. A fragment of the serratus anterior muscle with dimensions of 6-10 cm × 3 × 6 cm was separated. The mobilized fragment of the serratus anterior muscle was moved to the edge of the xenopericardium plate. The edges of the serratus anterior muscle and xenopericardium were fixed to create tightness of the musculo-xenopericardial pocket (Fig. 6). Layer-by-layer closure of the wound with an intradermal suture with 4/0 monocryl thread (Fig. 7).

The postoperative period was uneventful. The drainage tube was removed on the 5th day after the operation. Healing of postoperative wounds by primary intention. The patient is satisfied with the received cosmetic effect (Fig.9 a, 6, c).

Morphological examination of the operating material. Macro Description 1 .:

1. "Sentinel" lymph node - a fragment of adipose tissue measuring 3x1x0.8 cm with a soft-elastic lymph node 1 cm in diameter (cut by a surgeon, delivered after cytological examination). Also a fragment of adipose tissue measuring 2.5x1.5x0.5 cm, with a lymph node with a diameter of 0.5 cm.

2. The edges of the resection are marked by the surgeon. A fragment of breast tissue measuring 13x12x1.7 cm.In the section, in the gland tissue, in the lower-outer quadrant, 2 cm from the lower, 0.3 cm from the fascial, 0.1 cm from the subcutaneous edges of the resection - a dense tumor node I is whitish, with fuzzy borders, dimensions 1.2x0.9x0.8 cm.Also on the border of the outer quadrants, 1.5 cm from node I, 0.1 cm from the subcutaneous, 0.1 cm from the fascial, 2 cm from the bottom, 3 cm from the top, 1 cm from the lateral, 7 cm from the medial margins of the resection - dense tumor node II, whitish, without clear contours, with a granular cut surface, dimensions 3x1.5x1.3 cm. Surrounding tissue The gland is represented by lobular adipose tissue with thin, whitish layers, dilated ducts. Separately - a fragment of breast tissue measuring 2.5x1.5x1 cm.

3. Axillary tissue - a fragment of adipose tissue measuring 3x2x1 cm.

Microdescription. 2: Both tumor nodes have the same structure - invasive cancer without signs of grade II specificity, with areas of micropapillary carcinoma, with structures of intraductal cancer. Perineural cancer growth and cancerous vascular embolism are noted. In the "path" between the nodes - structures of intraductal invasive cancer. In the lateral edge of the resection, there are cancer complexes, in the lower, medial, and upper edges of the tumor. In one "sentry" and one separately delivered lymph nodes from No. 1, and in 4 of No. 2, cancer metastases were not detected. Conclusion: invasive breast cancer of combined structure with areas of micropapillary cancer. With repeated IHC on surgical material No. AZH41: ER-8 points, PgR-3 points, Her2 / neu-negative expression, Ki67-22%, E-cadherin-positive expression. Conclusion: Luminal type B, Her2 / neu-negative. The final clinical diagnosis was established: stage IIA left breast cancer, pT2 (m) N0M0R1, luminal type B, Her2-negative.

The clinical situation was re-discussed at the interdisciplinary council of 04/08/2020. It was recommended to conduct radiation therapy (due to the patient's refusal from the proposed reoperation for a positive margin of resection) on the area of the reconstructed left breast ROD 2-2.5 Gy, SOD 50 Gy- eq; PCT according to the 4AC or 4TC scheme: 4 courses of doxorubicin 60 mg / m2 and cyclophosphamide 600 mg / m2 (courses are repeated every 21 days) or 4 courses of docetaxel 75-100 mg / m2 and cyclophosphamide 600 mg / m2 (courses every 21 days ); determination of the patient's hormonal status, and if menopause is confirmed, hormone therapy (HT) for 5 years with aromatase inhibitors (letrozole 2.5 mg / day or anastrazole 1 mg / day). The decision to continue HT after 5 years, taking into account the clinical picture.

The use of the proposed method of breast reconstruction with the use of xenopericardium BioLAB-PP / PA in clinical practice can achieve several results:

- reducing the trauma of surgical intervention in a one-stage reconstruction by eliminating the need to use autologous grafts;

- reduction of operation time;

- reduction of pain syndrome;

- optimization of the economic component of treatment of patients with breast cancer through import substitution.

Claims (1)

A method of reconstructive plastic surgery in patients with breast cancer using xenopericardium BioLAB-PP / PA and a silicone endoprosthesis, including subcutaneous removal of breast tissue, cutting off the lower edge of the pectoralis major muscle and anterior serratus muscle and creating a subpectoral pocket, characterized in that after creation of the subpectoral pocket with separate non-absorbable interrupted sutures with the capture of the fascia of the anterior chest wall, the submammary fold is strengthened, the xenopericardial plate BioLAB-PP / PA in accordance with the area of the lower pole of the silicone endoprosthesis is projected onto the lower zone of breast reconstruction, the edge of the xenopericardium plate is sutured with separate interrupted sutures 3/0 to the fascia of the anterior chest wall, corresponding to the submammary fold, measure the width of the pocket for choosing the endoprosthesis and after hemostasis, a silicone endoprosthesis is placed in the formed subpectoral pocket, the edge of the xenopericardium is p They are sewn to the lower and lateral edges of the pectoralis major muscle, and the upper edge of the xenopericardial plate is pulled to the lower mobilized edge of the pectoralis major muscle and the silicone endoprosthesis is closed with it, then the edges of the pectoralis major muscle, the plates of the xenopericardium and the serratus anterior muscle are connected with a continuous suture with vicryl 3/0 thread, creating a sealed musculo-xenopericardial pocket.

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