Randomized Single-Center Study of Effectiveness and Safety of a Resorbable Lysine-Based Urethane Adhesive for a Drain-Free Closure of the Abdominal Donor Site in a DIEP Flap Breast Reconstruction Procedure.

OBJECTIVE: The hypothesis of this parallel group randomized trial testifies if TissuGlu is a safe and an effective alternative to the conventional drainage placement in regard to post-operative fluid management in the abdominal donor site for autologous (DIEP flap) breast reconstruction with a higher postoperative patient quality of life. PATIENTS AND METHODS: Data was collected for 58 women who required to be at min.18 years old with a BMI < 30 and not taking any SSRIs (Selective Serotonin Reuptake Inhibitors).Exclusion criteria: Discharge with indwelling suction drains at the abdominal site or signs of wound infection during hospital stay.The patients were randomized into a study group (donor site closure with application of surgical adhesive without drains) and a control group (donor site closure with drains) using a randomly sorted sealed envelope system.Th e primary outcome was defined as the number of post-operative seroma formations.The secondary endpoint was the evaluation of patient satisfaction with both methods. RESULTS: 58 patients underwent a DIEP reconstruction (29 in the control- and 29 in the study group).Both groups were homogenous. Rate of seroma was 17%(5/29) in the study group and 10%(3/29) in the control group which showed no statistical significance (p-value = 0.71).Smoking and previous abdominal surgery turned out to be a risk factor for seroma formation in the study group.Overall satisfaction was evaluated with a questionnaire and was higher in the study group. CONCLUSION: The abdominal closure with the surgical adhesive seems to be a safe procedure that contributes to patient satisfaction and increases the independence upon discharge in patients with adequate inclusion criteria.

Risk Factor Analysis for Flap and Donor Site Related Complications in 1274 DIEP Flaps - Retrospective Single Center Study.

Background: Breast cancer is the most common cancer affecting women worldwide. In Germany, in almost 70% of cases, women require a complete mastectomy and wish for breast reconstruction which is especially difficult when the breast was previously irradiated. The DIEP flap is then the gold standard for autologous breast reconstruction and shows an overall low complication rate. This study aims to underline the safety of the procedure yet point out potential risk factors for flap edge and fat necrosis in a retrospective series of 1274 DIEP flaps in our center. Patients and Methods: 1274 autologous breast reconstructions with the DIEP flap were performed in 1124 patients between July 2004 and December 2014 in our department. Retrospective risk factor analysis included age, BMI, smoking, chemotherapy and/or radiotherapy and comorbidities. Mean follow-up constituted out of 24 months. Results: Out of 1274 free DIEP flap breast reconstructions, 150 were bilateral reconstructions. In 785 cases the primary indication was previous mastectomy, followed by prior implant-based reconstruction in 265 cases. The total flap loss rate was 0.6%. Patients with a higher BMI and smokers had significantly higher complication rates than the rest of the cohort. Elderly patients ( 65 years), patients with diabetes and ones who had undergone chemo-/ radiotherapy did not present with higher complication rates. Conclusions: The DIEP flap surgery is a well-established method for autologous breast reconstruction with a low complication rate. Yet patient characteristics in terms of risk factors need to be taken into account for result prognosis and satisfactory long-term reconstructive results.

The DIEP Flap as Well-established Method of Choice for Autologous Breast Reconstruction with a Low Complication Rate - Retrospective Single-centre 10-Year Experience.

Background Breast cancer is the most common cancer affecting women in Germany. Despite breast-conserving therapy (BCT) being carried out in almost 70% of cases, a high number of women still require complete mastectomy. Prophylactic mastectomy is also indicated for women with a BRCA 1/2 gene mutation. In addition to implant-based heterologous breast reconstruction, autologous breast reconstruction using a DIEP flap has been found to be beneficial, particularly for patients who had prior radiotherapy. This study aims to show that DIEP flap reconstruction surgery is the method of choice for autologous breast reconstruction with a low rate of complications. Patients and Methods Autologous breast reconstruction using a DIEP flap was performed in 1124 patients between July 2004 and December 2014. Retrospective study criteria included potential risk factors such as age, BMI, smoking, chemotherapy and/or radiotherapy, and comorbidities as well as outcome parameters such as postoperative complications. Outcomes were evaluated with a mean follow-up of 24 months. Results A total of 1124 patients underwent 1274 free DIEP flap breast reconstructions, of which 150 were bilateral reconstructions. The primary indication was previous mastectomy in 785 cases, followed by prior implant-based reconstruction in 265 cases. The total flap loss rate was 0.6%. Postoperative surgical revision for abdominal wall hernia was required in 0.2% of cases. The group with a higher BMI and the group of smokers had significantly higher complication rates. Elderly patients (> 65 years), patients who had undergone chemo-/radiotherapy and patients with diabetes did not have higher complication rates. Conclusion DIEP flap surgery is an excellent option for autologous breast reconstruction, with a low rate of donor site morbidity and low complication rates. DIEP flap surgery carried out in a specialised interdisciplinary breast centre in a standardised clinical setting after prior careful patient selection to take account of risk factors such as high BMI and smoking is a reliable method with a low complication rate and satisfactory long-term reconstruction results.

Autologous Breast Reconstruction with SIEA Flaps: An Alternative in Selected Cases.

BACKGROUND: The deep inferior epigastric perforator flap has been shown to be a reliable option for autologous breast reconstruction. A further refinement in the transfer of lower abdominal tissue is the superficial inferior epigastric artery (SIEA) flap that does not require any incision of the rectus abdominis fascia or muscle and is superior regarding donor-site morbidity. OBJECTIVES: We conducted a retrospective study to assess reliability and outcomes of autologous breast reconstruction using SIEA flaps. METHODS: We performed autologous breast reconstruction in 1708 patients at our department between 2009 and 2018. Of those, 28 patients that underwent breast reconstruction using a SIEA flap were included for a retrospective chart review. RESULTS: Given an overall flap loss rate of 1.8%, we observed total flap necrosis following a SIEA flap in four patients (13%). All cases were secondary to arterial thrombosis. We further recognized a significant correlation between flap failure and a history of spontaneous deep vein thrombosis (p < 0.0001). There was no statistically significant relationship between flap failure and obesity (BMI > 30 kg/m2;p = 0.9) or flap failure and a history of abdominal operations (p = 0.6). CONCLUSIONS: The SIEA flap provides a reasonable option for autologous breast reconstruction with the great advantage of minimal donor-site morbidity. Nevertheless, its use should be preserved to selected cases with favorable anatomy. We therefore recommend proper patient selection based on preoperative computed tomography angiography, intraoperative clinical evaluation and history of hypercoagulable state. LEVEL OF EVIDENCE IV: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266.

Influence of preadipocyte-conditioned medium on the proliferation and invasive potential of breast cancer cell lines in vitro.

PURPOSE: Autologous transplantation of adipose tissue into the breast is commonly performed in clinical practice, but its oncological safety has not been established. METHODS: We conducted an in vitro study to assess the influence of factors released by adipose-derived stem cells (ASCs), from multiple source tissues and harvested using different techniques, on proliferation and invasiveness of two breast cancer cell lines. RESULTS: Fat specimens of 66 donors (57 female, 9 male) were collected and 44 ASC cultures were established. ASC conditioning of the medium (CM) increased the proliferation of MCF-7 cells (178.4 ± 62.8%; P < 0.001), whereas MDA-MB321 proliferation was decreased (87.3 ± 15.3%; P = 0.032). We observed increased cell migration (174.0 ± 62.8%; P = 0.002), but not cell invasion (1.28 ± 0.51; P = 0.14) in MDA-MB231. Migration and invasion of MCF-7 cells were not affected by exposure to ASC-CM. For MCF-7 cell migration, lower BMI (< 25 kg/m2) was associated with increased migration, both in univariate (P = 0.015) and multivariate (P = 0.039) analyses. Regarding the cytokine secretome, proliferation of MCF-7 was positively correlated with levels of eotaxin 1 and insulin-like growth factor-binding protein 3 in the CM, and inversely correlated with levels of interleukin 1ß and transforming growth factor ß-3. In case of MDA-MB231, granulocyte colony-stimulating factor, angiogenin, eotaxin 1 and 3, neutrophil activating peptide 2, and neurotrophin-3 were positively correlated with proliferation. CONCLUSIONS: We conclude that fat tissue transplantation increases proliferation and migration, but not invasion, of breast cancer cells. These findings are consistent with clinical data regarding the safety of autologous fat transplantation in breast cancer patients.

Immediate-DElayed AutoLogous (IDEAL) Breast Reconstruction with the DIEP Flap.

Background: The most common cancer worldwide in women is breast cancer. The increasing number of cases each year, requires a novel curative approach that can combine oncological treatments and breast reconstruction yielding a pleasing and aesthetic breast that is a definitive and long lasting solution. Thus, the Immediate-DElayed AutoLogous (IDEAL) breast reconstruction principle was created to hold up to the standards of the needs of contemporary women. METHOD: The IDEAL protocol for breast reconstruction was developed in our department in cooperation with our breast surgery unit and describes a two-stage approach that implicates neoadjuvant radio-/ chemotherapy treatment regimes and tumor staging before the mastectomy in order to avoid post-mastectomy radiation. In a second step the breast is then reconstructed with autologous tissue for optimal and natural results. CONCLUSION: More and more patients decide to undergo breast reconstruction after breast cancer. The IDEAL concept offers a life-long and safe solution with a low rate of late complications.

Increased risk of recurrence associated with certain risk factors in breast cancer patients after DIEP-flap reconstruction and lipofilling-a matched cohort study with 200 patients.

BACKGROUND: Lipofilling is performed in breast cancer patients to optimize the aesthetic outcome following breast reconstruction after mastectomy. Despite its common usage worldwide, little is known about the interaction of the lipoaspirate and dormant cancer cells. Up to date, no risk factors that increase the risk for cancer recurrence have been established. This study aims to identify risk factors for lipofilling candidates after breast cancer and questions the oncological safety of lipofilling in lymph node positive disease. METHODS: Matched retrospective cohort study: the disease-free survival (DFS) between 100 breast cancer patients undergoing a lipofilling after their DIEP-flap reconstruction and 100 matched control patients with no subsequent lipofilling was analyzed. Further, patients were subdivided according to risk factors, which were categorized as patient-dependent factors (PDFs) and tumor-dependent factors (TDFs). DFS and hazard ratios (HR) were compared to identify potential risk factors that may increase cancer recurrence. RESULTS: Median follow-up was 76.5 months from the mastectomy, and 31 months from the startpoint to the end of follow-up. Seven and eleven patients had recurrence in the lipofilling and control group, respectively, presenting with comparable DFS rates and an insignificant HR =0.57, 95% confidence interval (CI): 0.22-1.47, P=0.24. According to subgroup survival analysis, lipofilling increased the risk of recurrence in women with a positive nodal status (P=0.035) and a high-grade neoplasia (P=0.049). CONCLUSIONS: No general increased recurrence risk was observed between the lipofilling and control group. The subgroup analysis identified high-grade neoplasia and positive nodal status to be a risk factor for cancer recurrence. Patients with a known node positive disease have an increased risk of occult micrometastases in their lymph nodes. Further studies are necessary to clarify whether dormant breast cancer cells in form of micrometastases in the lymph nodes can be reactivated by the factors secreted by adipose derived stem cells.

Conservative mastectomies and Immediate-DElayed AutoLogous (IDEAL) breast reconstruction: the DIEP flap.

BACKGROUND: With the development of conservative mastectomies, there are an increasing number of women seeking immediate implant based and autologous breast reconstruction. Despite the oncologic safety of the procedures, the focus will be on the timing of reconstruction. METHODS: Our plastic surgery unit is focused primarily on autologous breast reconstruction and is part of an interdisciplinary breast center. We offer immediate breast reconstruction (IBR) with autologous tissue for patients with positive BRCA 1 and 2, ductal carcinoma in situ (DCIS), invasive cancer without margin problems to the skin, as well as to correct poor oncologic and aesthetic breast conserving therapy (BCT) outcomes. In the majority of cases we prefer an Immediate-DElayed AutoLogous (IDEAL) breast reconstruction concept with a two-stage procedure. RESULTS: Over the last 10 years we performed more than 1,600 breast reconstructions with free flaps, performing the deep inferior epigastric perforator (DIEP) flap as our first choice for autologous tissue. We recommend IDEAL breast reconstruction, however approximately 15% of our cases are immediate one stage conservative mastectomies and breast reconstruction with the DIEP flap. CONCLUSIONS: For immediate reconstruction, the aesthetic outcome should not take precedence over oncologic considerations. Immediate one-stage, breast reconstruction with autologous tissue can be offered to the suitable patients which is most likely a healthy women with a small-to-medium sized non ptotic breast receiving a conservative mastectomy. In all other cases, we recommend an IDEAL breast reconstruction approach in order to achieve a final result that is both satisfyingly pleasing and oncologically safe.

A single center prospective study of bilateral breast reconstruction with free abdominal flaps: a critical analyses of 144 patients.

BACKGROUND: Bilateral breast reconstruction utilising autologous free tissue transfer is a complex procedure with multiple options for donor tissue available. Autogenous breast reconstruction techniques have evolved over the last three decades to meet this goal. The aim of this study was to determine the outcomes of patients undergoing bilateral breast reconstruction with DIEAP, TRAM or SIEA flaps. MATERIAL AND METHODS: A prospective study was performed in our Interdisciplinary Breast Centre from July 2004 until December 2011 in 144 patients. Demographic information, diabetes mellitus type I status, tobacco use, tumor stage, primary/secondary reconstruction, operative technique, adjuvant therapy received, length of follow-up, and complications were evaluated. Complications were divided into donor site and recipient site. To investigate which risk factors were independently related to flap loss (complete or partial), multiple linear regression analysis was performed. RESULTS: The study identified 144 patients who had bilateral breast reconstruction with DIEAP, TRAM or SIEA flaps. For all flaps (n=248), outcome included 98.4% survival and 0.7% vein microanastomosis revision. Recipient site complications included 1.6% complete flap loss, 0.8% fat necrosis, 2.9% partial skin loss/dehiscence flap necrosis and 2.0% haematoma rate. Donor site complications included 3.7% partial skin loss/dehiscence. There was evidence of abdominal bulges in TRAM patients (1.1%) but no hernias in any patients. BMI is a major determinant of flap loss (complete or partial) in these patients. CONCLUSIONS: The primary goal of bilateral breast reconstruction is to provide a treatment option that can create a natural, symmetric breast mounds with minimal donor-site morbidity following bilateral mastectomies. These results support weight loss therapy prior to bilateral breast reconstruction.

Skin-sparing mastectomy and immediate reconstruction with DIEP flap after breast-conserving therapy.

BACKGROUND: Currently about 70% of women who suffer from breast cancer undergo breast-conserving therapy (BCT) without removing the entire breast. Thus, this surgical approach is the standard therapy for primary breast cancer. If corrections are necessary, the breast surgeon is faced with irritated skin and higher risks of complications in wound healing. After radiation, an implant-based reconstruction is only recommended in selected cases. Correction of a poor BCT outcome is often only solved with an additional extended operation using autologous reconstruction. MATERIAL/METHODS: In our plastic surgery unit, which focuses on breast reconstruction, we offer a skin-sparing or subcutaneous mastectomy, followed by primary breast reconstruction based on free autologous tissue transfer to correct poor BCT outcomes. Between July 2004 and May 2011 we performed 1068 deep inferior epigastric artery perforator (DIEP) flaps for breast reconstruction, including 64 skin-sparing or subcutaneous mastectomies, followed by primary DIEP breast reconstruction procedures after BCT procedures. RESULTS: In all free flap-based breast reconstruction procedures, we had a total flap loss in 0.8% (9 cases). Within the group of patients after BCT, we performed 41 DIEP flaps and 23 ms-2 TRAM flaps after skin-sparing or subcutaneous mastectomies to reconstruct the breast. Among this group we had of a total flap loss in 1.6% (1 case). CONCLUSIONS: In cases of large tumour sizes and/or difficult tumour locations, the initial oncologic breast surgeon should inform the patients of a possibly poor cosmetic result after BCT and radiation. In our opinion a skin-sparing mastectomy with primary breast reconstruction should be discussed as a valid alternative.