Comparison of round smooth and shaped micro-textured implants in terms of quality of life and aesthetic outcomes in women undergoing breast reconstruction: a single-centre prospective study.

Breast cancer (BC) is the most frequent cancer among women, impacting 2.1 million women each year and having caused 627,000 deaths in 2018. In Italy, BC represents the first cancer diagnosis with 53,000 new cases in 2019 and the first cause of mortality for cancer among the female population. Breast implants represent the first reconstructive choice after mastectomy: in Italy, 411,000 prostheses have been implanted since 2010 and more than 95% of them are macro-texturized. The attempt to reduce complications such as capsular contracture, rotation and rupture of the prosthesis and the most recent BIA-ALCL association with macro-texturized implants have led to the development of new materials and the refinement of implants' coating techniques. We carried out a 1-year prospective single-centre study to evaluate patient-reported quality of life (QoL) and aesthetic outcomes after breast reconstructive surgery using two different prostheses: shaped micro-textured implants and round smooth implants. We treated 62 patients with radical or conservative mastectomy followed by reconstructive surgery performed with 44 shaped implants and 48 round implants. Quality of life evaluated through the Breast-Q®-questionnaire showed high scores of psycho-social well being in both groups, as well as pre- and post-operative aesthetic satisfaction and physical well being. Round smooth implants appear to be better in terms of softness, volume and less association with rippling, whereas shaped micro-textured implants prove to be better in the profile delineation. This study confirms the potentialities of both shaped micro-textured and round smooth implants in reconstructive surgery.

Biological acellular pericardial mesh regulated tissue integration and remodeling in a rat model of breast prosthetic implantation.

The use of biological meshes has proven beneficial in surgical restriction and periprosthetic capsular contracture following breast prosthetic-reconstruction. Three different types (smooth, texturized, and polyurethane) of silicone round mini prostheses were implanted under rat skin with or without two different bovine acellular pericardial biological meshes (APMs, BioRipar, and Tutomesh). One hundred eighty-six female rats were divided into 12 groups, sacrificed after 3, 6, and 24 weeks and tissue samples investigated by histology and immunohistochemistry. Implantation of both APMs, with or without prostheses, reduced capsular α-SMA expression and CD3+ inflammatory cell infiltration, increasing capillary density and cell proliferation, with some differences. In particular, Tutomesh was associated with higher peri-APM CD3+ inflammation, prosthetic capsular dermal α-SMA expression and less CD31+ vessels and cell proliferation compared with BioRipar. None differences were observed in tissue integration and remodeling following the APM + prostheses implantation; the different prostheses did not influence tissue remodeling. The aim of our study was to investigate if/how the use of different APMs, with peculiar intrinsic characteristics, may influence tissue integration. The structure of APMs critically influenced tissue remodeling after implantation. Further studies are needed to develop new APMs able to optimize tissue integration and neoangiogenesis minimizing periprosthetic inflammation and fibrosis.

Acute complications following endoscopic intragastric balloon insertion for treatment of morbid obesity in elderly patients. A single center experience.

BACKGROUND: Obesity is a serious disease, with an increasing incidence also among subjects over 60 years old; surgical management has proven to be the most effective in the production of significant and durable weight loss. Intragastric balloon (IGB) treatment promotes a reduction of five to nine Body Mass Index (BMI) units in 6 months with an impressive improvement of obesity-associated comorbidities. METHODS: Two hundred and twenty-five patients, 106 men (47.1%) and 119 women (52.9%), were evaluated at our institution to be submitted to a IGB positioning. Of these, 12 patients (8 women and 4 men) were more than 60 years old. For all patients BMI, comorbidities, weight loss and complications were recorded. χ2 test was used to evaluate differences in complications rate between elderly and other patients. RESULTS: For the 12 elderly patients, we recorded a mean excess weight loss rate (EWL%) of 31.4. About complications, we recorded 2 severe esophagitis requiring IGB removal and 1 late gastric perforation. A higher complications rate was found in elderly population and the comparison with other patients revealed a significant difference (P<0.001). CONCLUSIONS: Our results underline that IGB treatment in elderly patients is safe and effective in terms of weight loss and improvement in comorbidities. IGB can cause complications which, sometimes, can be severe such as esophageal damage and gastric perforation. For the management of complications, we highly recommend a close follow-up in all patients and a deepened instrumental study in every suspect case.

Results following laparoscopic sleeve gastrectomy in elderly obese patients: a single center experience with follow-up at three years.

BACKGROUND: Laparoscopic sleeve gastrectomy (LSG) represents the most performed bariatric surgical procedure worldwide. Morbid Overweight in elderly patients is becoming a significant health problem even in Italy. As well as in younger age groups, bariatric surgery could be indicated even in this subset of patients. However the advantages and results of LSG in patients over 60 years old have received minimal attention. METHODS: The records of 375 patients underwent LSG between 2008 and 2016 were reviewed. In the entire series 18 patients were aged 60 years or older at the time of surgery. Since a 3 years follow-up was available for 12 patients out of the 18 aged over 60 we included in the study only these. General epidemiologic data, clinical findings, BMI and comorbidities surgical treatment and follow-up data were collected; postoperative measurements such as operative time, intraoperative complications, mortality rate, length of stay, incidence of early and late complications, Body mass Index (BMI), excess weight loss rate (EWL%) and comorbidities resolution were also recorded. RESULTS: LSG was successfully performed for all geriatric patients. Global complications rate was 16.6% At 3 years mean BMI was 34.4±3.8 with a mean EWL% 66.1±31.9. Postoperative resolution of obesity comorbidities was observed; Hypertension (71.4%), type 2 Diabetes Mellitus (T2DM) (50.0%), obstructive sleep apnea syndrome (OSAS) (66.6%) respectively. No intraoperative complications or mortality were recorded. CONCLUSIONS: LSG offered cure in geriatric patients affected by morbid obesity for weight loss and comorbidities resolution. Larger studies are necessary to analyze and minimize the incidence of postoperative complications associated to this surgical procedure in elderly patients.

Impact of Awake Breast Cancer Surgery on Postoperative Lymphocyte Responses.

BACKGROUND: Surgical stress and anesthesia affect the patient's immune system. Analysis of the lymphocyte response after breast-conserving surgery was conducted to investigate the differences between effects after general and local anesthesia. MATERIALS AND METHODS: Fifty-six patients with breast cancer were enrolled for BCS through local or general anesthesia. Total leukocytes, total lymphocytes, lymphocyte-subsets including CD3+, CD19+, CD4+, CD8+, CD16+CD56+ and CD4+/CD8+ ratio was examined at baseline and on postoperative days 1, 2 and 3. RESULTS: Baseline data showed no statistical difference between the two groups. Within-group ANOVA test showed significant differences for total leukocyte count (p<0.001), total lymphocyte count (p=0.009) and proportion of natural-killer cells (p=0.01) in the control group. Between-group analysis showed lower median values of total lymphocytes in the awake surgery group on postoperative days 1, 2 and 3 (p=0.001, p=0.02 and p=0.01, respectively) when compared to the control group. Patients who underwent surgery under general anesthesia had higher total lymphocyte counts on postoperative day 2 (p=0.04). CONCLUSION: In this randomized study, breast-conserving surgery plus local anesthesia had a lower impact on postoperative lymphocyte response when compared to the same procedure performed under general anesthesia.

Anastomotic leakage following laparoscopic resection of low and mid rectal cancer.

PURPOSE: Anastomotic leakage is considered the commonest major complication after surgery for rectal cancer. MATERIALS AND METHODS: Patients who underwent laparoscopic LAR or ULAR for rectal cancer were recruited. The primary outcome was the incidence of the AL during 30 days postoperative. RESULTS: Fifty-nine consecutive patients were included in the study. Fifty-three patients underwent LAR with stapled colorectal anastomoses, while the remaining 6 patients underwent ULAR with hand-sewn coloanal anastomoses. The median duration of operation was 195 minutes (range; 120-315). The defunctioning ileostomy was created in 24 (7%) patients. Overall, there was no recorded mortality. Only 10 (17%) patients developed complications. There were only 4 patients who developed AL. Three patients had a subclinical AL as they had defunctioning ileostomy at the time of the initial procedure, the diagnosis was made by CT with rectal contrast. They were treated conservatively with transanal anastomotic drainage under endoscopic guidance. One patient had a clinically significant AL, demonstrated as a peritonitis. This patient required reoperation during which pelvic abscess was drained, resection of the previous anastomosis, and hartmann's colostomy was performed. CONCLUSION: Standardization of a definition, as well as, criteria for the diagnosis of AL, will help in comparison of the results and the surgical techniques in order to optimize the required care offered to rectal cancer patients. On expert hands, it is feasible to perform a laparoscopic sphincter-saving total mesorectal excision, additionally, it provides the advantages of a clear view of the deep pelvis and facilitates a precise sharp dissection. KEY WORDS: Anastomosis, Anastomotic Leakage, Rectal cancer, Total mesorectal excision.

Endovascular repair versus open repair in the treatment of ruptured aortic aneurysms: a systematic review.

INTRODUCTION: Rupture of abdominal aortic aneurysm remains a fatal event in up to 65% of cases and emergency open surgery (ruptured open aneurysm repair or rOAR) has a great intraoperative mortality of about 30-50%. The introduction of endovascular repair of abdominal aortic aneurysm (ruptured endovascular aneurysm repair or rEVAR) has rapidly challenged the conventional approach to this catastrophic event. The purpose of this systematic review is to compare the outcomes of open surgical repair and endovascular interventions. EVIDENCE ACQUISITION: A literature search was performed using Medline, Scopus, and Science Direct from August 2010 to March 2017 using keywords identified and agreed by the authors. Randomized trials, cohort studies, and case-report series were contemplated to give a breadth of clinical data. EVIDENCE SYNTHESIS: Ninety-three studies were included in the final analysis. Thirty-five (50.7%) of the listed studies evaluating the within 30 days mortality rates deposed in favor of rEVAR, while the others (comprising all four included RCTs) failed detecting any difference. Late mortality rates were found to be lower in rEVAR group in seven on twenty-seven studies (25.9%), while one (3.7%) reported higher mortality rates following rEVAR performed before 2005, one found lower incidence of mortality at 6 months in the endovascular group but higher rates in the same population at 8 years of follow-up, and the remaining (66.7%) (including all three RCTs) failed finding any benefit of rEVAR on rOAR. A lower incidence of complications was reported by thirteen groups (46.4%), while other thirteen studies did not find any difference between rEVAR and rOAR. Each of these two conclusions was corroborated by one RCTs. Other two studies (7.2%) found higher rates of tracheostomies, myocardial infarction, and acute tubular necrosis or respiratory, urinary complications, and acute renal failure respectively in rOAR group. The majority of studies (59.0%, 72.7%, and 89.3%, respectively) and all RCTs found significantly lower rates of length of hospitalization, intensive care unit transfer, and blood loss with or without transfusion need in rEVAR group. The large majority of the studies did not specified neither the type nor the brands of employed stent grafts. CONCLUSIONS: The bulk of evidence regarding the comparison between endovascular and open surgery approach to RAAA points to: 1) non-inferiority of rEVAR in terms of early (within 30 days) and late mortality as well as rate of complications and length of hospitalization, with trends of better outcomes associated to the endovascular approach; 2) significantly better outcomes in terms of intensive care unit transfer and blood loss with or without transfusion need in the rEVAR group. These conclusions reflect the results of the available RCTs included in the present review. Thus rEVAR can be considered a safe method in treating RAAA and we suggest that it should be preferred when technically feasible. However, more RCTs are needed in order to give strength of these evidences, bring to definite clinical recommendations regarding this subject, and assess the superiority (if present) of one or more brands of stent grafts over the others.

Transanal Tube Drainage as a Conservative Treatment for Anastomotic Leakage Following a Rectal Resection.

PURPOSE: We evaluate the role of transanal tube drainage (TD) as a conservative treatment for patients with anastomotic leakage (AL). METHODS: Patients treated for AL who had undergone a low or an ultralow anterior resection with colorectal or coloanal anastomosis for the treatment of rectal cancer between January 2013 and January 2017 were enrolled in this study. The data were collected prospectively and analyzed retrospectively. The primary outcomes were the diagnosis and the management of AL. RESULTS: Two hundred thirteen consecutive patients, 122 males and 91 females, were included. The mean age was 66.91 ± 11.15 years, and the median body mass index was 24 kg/m2 (range, 20-35 kg/m2 ). The median tumor distance from the anal verge was 8 cm (range, 4-12 cm). Ninety-three patients (44%) received neoadjuvant therapy for nodal disease and/or locally advanced rectal cancer. Only 13 patients (6%) developed AL. Six patients developed subclinical AL as they had a defunctioning ileostomy at the time of the initial procedure. They were treated conservatively with TD under endoscopic guidance in the endoscopy unit and received intravenous antibiotics. Six weeks after discharge, these 6 patients underwent follow-up flexible sigmoidoscopy which showed a completely healed anastomotic defect with no residual stenosis. Seven patients developed a clinically significant AL and required reoperation with pelvic abscess drainage and Hartmann colostomy formation. CONCLUSION: These results suggest that TD for management of patients with AL is safe, cheap, and effective. Salvaging the anastomosis will help decrease the need for Hartmann colostomy formation. Proper patient selection is important.

Evaluation of the Usefulness of FDG-PET/CT for Nodal Staging of Breast Cancer.

BACKGROUND/AIM: Positron emission tomography/computed tomography (PET/CT) with 18F-fluorodeoxyglucose (18F-FDG) has recently been used to investigate lymph node (LN) metastases and several predictive features in patients with breast cancer (BC). The aim of this study was to assess the value of this non-invasive imaging procedure for axillary staging. PATIENTS AND METHODS: Fifty patients with early primary unilateral, locally advanced, or recurrent invasive operable BC were enrolled. All patients underwent preoperative 18F-FDG PET/CT, and the results were compared with the histopathology of dissected axillary LNs and their biological and immunohistochemical characteristics. The diagnostic performance of 18F-FDG PET/CT in detecting LN metastases from primary or recurrent BC was analyzed. The mean values of the initial PET/CT parameters, including the primary tumour (SUV T) and ipsilateral axillary LNs (SUV LN), were compared with the clinicopathological features of patients to determine their usefulness for predicting clinical interactions. RESULTS: The sensitivity, specificity, overall accuracy, positive predictive value, and negative predictive value of 18F-FDG PET/CT for axillary LN staging were 87%, 90%, 88%, 93%, and 82%, respectively. Bivariate analyses showed strong interactions of nuclear grade (p=0.05), progesterone receptor expression (p=0.001), Ki-67 index (0.027), and local relapse with the SUV T. A high SUV LN value was significantly correlated with a higher nuclear grade score (p=0.05), oestrogen receptor negativity (p=0.001), progesterone receptor negativity (p=0.014), a high Ki-67 index (>20%; p=0.048), LN metastasis (p<0.001), a basal tumour (p=0.04), and locoregional recurrence (p<0.001). CONCLUSION: PET/CT is a reproducible, non-invasive imaging modality that is useful for evaluating a primary BC mass and its relationship with metastatic axillary LNs, thereby predicting tumour behaviour and guiding clinical practice.

No Difference in Ghrelin-Producing Cell Expression in Obese Versus Non-obese Stomach: a Prospective Histopathological Case-Control Study.

BACKGROUND: To understand the role of ghrelin in the mechanism of action of laparoscopic sleeve gastrectomy (LSG), a prospective cohort case-control study to assess the expression of ghrelin-producing cells (GPC) in two groups of patients was designed. METHODS: Specimens of resected stomach from 26 obese patients who underwent LSG (group A), were compared by immunohistochemistry to control stomach samples from 26 non-obese patients (group B) resected for other pathologies or during autopsy; (GIST: 6 cases, inflammatory diseases: 4 cases, post-mortem autopsy cases with stomachs from healthy persons victims of traumatic accidents: 16 cases). Immunohistochemistry investigation was performed with the use of Ventana Benchmark ultra, anti-ghrelin antibody NOVUS, mouse monoclonal 2F4, diluted at 1:100. RESULTS: No significant difference in the expression of GPC number between group A and B was found (p = 0.87). No significant correlation between patients presenting a GPC number above (subgroup 1) or below (subgroup 2) the average, and EWL% changes, both at 1 and 6 years of follow-up, was recorded. CONCLUSIONS: Our study has shown that the expression of GPC is similar in the stomach of obese and non-obese controls, being mostly influenced by the inflammatory status of the gastric mucosa. A variation in the preoperative number of GPC has not influenced the weight loss in patients who underwent LSG.

Correction to: Outcomes after rectosigmoid resection for endometriosis: a systematic literature review.

The authors of the published version of this article missed to add the second affiliation of Mostafa Shalaby. The new affiliation is now added and presented correctly in this article. The remainder of the article remains unchanged.

Emergent treatment of carotid stenosis: an evidence-based systematic review.

INTRODUCTION: Stroke is one of the major causes of death in the world, but above all is the condition most associated with severe long-term disabilities. It is clear that this condition therefore requires the best therapeutic approach possible to minimize the consequences that this can lead to. The major issues concern the type of treatment to be used for revascularization (carotid endarterectomy [CEA] or stenting of the carotid artery [CAS]) and the timing of the treatment itself. Many studies have been conducted on this issue, but a definitive and unanimous verdict has not yet been reached on account of the great variety of results obtained from the various study group. The aim of this review is to analyze the latest scientific findings focused on revascularization following a symptomatic carotid stenosis (SCS). EVIDENCE ACQUISITION: We searched all publications addressing treatments and timing of approach to SCS. Randomized trials, cohort studies and reviews were contemplated in order to give a breadth of clinical data. Medline and Science Direct were searched from January 2013 to April 2017. EVIDENCE SYNTHESIS: Of the 819 records found, 76 matched our inclusion criteria. After reading the full-text articles, we decided to exclude 54 manuscripts because of the following reasons: 1) no innovative or important content; 2) insufficient data; 3) no clear potential biases or strategies to solve them; 4) no clear endpoints; and 5) inconsistent or arbitrary conclusions. The final set included 22 articles. CONCLUSIONS: CEA is considered a less problematic method than CAS, especially for patients over the age of 75; CAS remains recommended in patients with a favorable anatomy or high surgical risks. Studies that showed more solid results seem to lead to the conclusion that optimal timing may be between 2 days and the end of the first week from the onset of symptoms in patients who are appropriate candidates for surgery.

Outcomes after rectosigmoid resection for endometriosis: a systematic literature review.

PURPOSE: "Endometriosis" is defined such as the presence of endometrial glands and stroma outside the uterine cavity. This ectopic condition may develop as deeply infiltrating endometriosis (DIE) when a solid mass is located deeper than 5 mm underneath the peritoneum including the intestinal wall. The ideal surgical treatment is still under search, and treatment may range from simple shaving to rectal resection. The aim of the present systematic review is to report and analyze the postoperative outcomes after rectosigmoid resection for endometriosis. METHODS: We performed a systematic review according to Meta-analysis of Observational Studies in Epidemiology guidelines. The search was carried out in the PubMed database, using the keywords: "rectal resection" AND "endometriosis" and "rectosigmoid resection" AND "endometriosis." The search revealed 380 papers of which 78 were fully analyzed. RESULTS: Thirty-eight articles published between 1998 and 2017 were included. Three thousand seventy-nine patients (mean age 34.28 ± 2.46) were included. Laparoscopic approach was the most employed (90.3%) followed by the open one (7.9%) and the robotic one (1.7%). Overall operative time was 238.47 ± 66.82. Conversion rate was 2.7%. In more than 80% of cases, associated procedures were performed. Intraoperative complications were observed in 1% of cases. The overall postoperative complications rate was 18.5% (571 patients), and the most frequent complication was recto-vaginal fistula (74 patients, 2.4%). Postoperative mortality rate was 0.03% and mean hospital stay was 8.88 ± 3.71 days. CONCLUSIONS: Despite the large and extremely various number of associated procedures, rectosigmoid resection is a feasible and safe technique to treat endometriosis.

Transanal Hemorrhoidal Dearterialization Versus Stapled Hemorrhoidopexy: Long-Term Follow-up of a Prospective Randomized Study.

AIM: This study aims to compare the early and late outcomes of transanal hemorrhoidal dearterialization (THD) versus stapled hemorrhoidopexy (SH) for the treatment of hemorrhoidal disease. METHODS: From January 2013 to December 2014, 100 patients-50 patients on each arm-were randomly allocated to THD or SH groups. The inclusion criteria were grade III and IV hemorrhoids diagnosed by clinical examination and proctoscopy. The primary outcome was to compare the recurrence rate with a minimum follow-up of 2 years, and the secondary outcome was to compare complications rate, time to return to work postsurgery, procedure length, and patient's satisfaction between the 2 techniques. RESULTS: The mean follow-up period was 33.7 ± 7.6. The recurrence rate was 4% in the SH group and 16% in the THD group ( P = .04). There was no difference in the intraoperative and postoperative complications rate; the pain score was significantly higher in the THD group. The mean operative time was significantly shorter in the SH group compared with the THD group. Patients in the THD group returned to work or routine activities significantly later compared with patients in the SH group. The overall satisfaction rate was also higher in the SH group. CONCLUSION: Both procedures are simple and easy to perform for the treatment of grade III and IV hemorrhoids. SH showed better results in terms of lower rate of recurrence, lower postoperative pain, quicker return to work, and higher patient satisfaction.

Additional Nodal Disease Prediction in Breast Cancer with Sentinel Lymph Node Metastasis Based on Clinicopathological Features.

AIM: The standard-of-care in breast cancer (BC) with positive sentinel lymph node (SLN) metastasis includes complete axillary lymph node dissection (ALND); however, almost half of such cases have no further tumor burden. This study aimed to assess the clinicopathological factors that predict non-SLN metastasis to define subgroups of SLN-positive patients in whom the axilla may be staged by SLN biopsy alone, while avoiding unnecessary overtreatment. PATIENTS AND METHODS: The records of 191 patients with histologically-proven primary BC who underwent a positive (SLN) biopsy between 2005 and 2017 were reviewed. Patients with at least one tumor-involved SLN who underwent completion ALND were enrolled. Demographic and clinicopathological characteristics, including age, primary tumor size and histological grade, lymphovascular invasion, ratio of positive SLNs to the harvested SLNs, SLN metastasis size, and molecular subtype classification according to immunohistochemical biomarker status [estrogen receptor (ER), progesterone receptor (PR), and human epidermal growth factor receptor 2 (HER2)], were evaluated. Data were collected retrospectively and analyzed using the Mann-Whitney and Chi-square tests (statistical significance: p<0.05). RESULTS: The incidence of non-SLN metastasis associated with positive SLN was 48.6% (93/191). The risk of additional nodal spread correlated with high sentinel nodal ratio >0.67 [odds ratio (OR)=2.55, p=0.032], luminal BC subtype (OR=2.67, p=0.06), HER2 overexpression (OR=0.4, p=0.016), and ER+PR-HER2- profile (OR=2.95, p=0.027). There was a tendency (statistically insignificant; p>0.05) toward higher incidence of non SLN metastasis with increasing age and histological grade, which could be attributed to the small sample size. CONCLUSION: According to this study, sentinel nodal ratio and BC subtypes as per ER, PR, and HER2 status significantly predicted the likelihood of additional lymphatic involvement. Validation of these parameters in prospective studies is indicated, and may help individualize treatment modalities.

Muzi's Tension Free Primary Closure of Pilonidal Sinus Disease: Updates on Long-Term Results on 514 Patients.

BACKGROUND: The aim of this study is to evaluate the long-term results of Muzi's tension free primary closure technique for pilonidal sinus disease (PSD), in terms of patients' discomfort and recurrence rate. METHODS: This study is a retrospective analysis of prospectively collected data. Five hundred fourteen patients were treated. Postoperative pain (assessed by a visual analog scale, VAS), complications, time needed to return to full-day activities, and recurrence rate were recorded. At 12, 22, and 54 months postoperative, patients' satisfaction was evaluated by a questionnaire scoring from 0 (not satisfied) to 12 (greatly satisfied). RESULTS: The median operative time was 30 min. The overall postoperative complication rate was 2.52%. Median VAS score was 1. The mean of resumption to normal activity was 8.1 days. At median follow-up of 49 months, recurrence rate was 0.4% (two patients). At 12 months' follow-up, the mean satisfaction score was 10.3 ± 1.7. At 22 and 54 months' follow-up, the score was confirmed. CONCLUSIONS: Muzi's tension free primary closure technique has proved to be an effective treatment, showing in the long-term follow-up low recurrence rate and high degree of patient satisfaction. Therefore, we strongly recommend this technique for the treatment of PSD.

Characterization of a new decellularized bovine pericardial biological mesh: Structural and mechanical properties.

Implants made from naturally-derived biomaterials, also called biological meshes or biomeshes, typically derive from decellularized extracellular matrix of either animal or human tissue. Biomeshes have many biomedical applications such as ligament repair, bone and cartilage regeneration and soft tissue replacement. Bovine collagen is one of the most widely used and abundantly available xenogenic materials. In particular, bovine pericardium is widely used as extracellular matrix bioprosthetic tissue. The efficiency of a pericardial mesh to function as scaffold depends on the quality of the decellularization protocol used. Moreover, the biomesh mechanical features are critical for a successful surgical repair process, as they must reproduce the biological properties of the autologous tissue. Different methods of physical, chemical, or enzymatic decellularization exist, but no one has proved to be ideal. Therefore, in the present study, we developed a novel decellularization protocol for a bovine pericardium-derived biomesh. We characterized the biomesh obtained by comparing some ultrastructural, physical and mechanical features to a reference commercial biomesh. Quantification revealed that our novel decellularization process removed about 90% of the native pericardial DNA. Microscopic and ultrastructural analysis documented the maintenance of the physiological structure of the pericardial collagen. Moreover, mechanical tests showed that both the extension and resilience of the new biomesh were statistically higher than the commercial control ones. The results presented in this study demonstrate that our protocol is promising in preparing high quality bovine pericardial biomeshes, encouraging further studies to validate its use in tissue engineering and regenerative medicine protocols.

New insights into the metastatic behavior after breast cancer surgery, according to well-established clinicopathological variables and molecular subtypes.

Despite advances in treatment, up to 30% of patients with early breast cancer (BC) experience distant disease relapse. However, a comprehensive understanding of tumor spread and site-specific recurrence patterns remains lacking. This retrospective case-control study included 103 consecutive patients with metastatic BC admitted to our institution (2000-2013). Cases were matched according to age, tumor biology, and clinicopathological features to 221 patients with non-metastatic BC (control group). The median follow-up period among the 324 eligible patients was 7.3 years. While relatively low values for sensitivity (71%) and specificity (56%) were found for axillary lymph node (ALN) involvement as an indicator of risk and pattern of distant relapse, nodal status remained the most powerful predictor of metastases (OR: 3.294; CL: 1.9-5.5). Rates of dissemination and metastatic efficiency differed according to molecular subtype. HER2-positive subtypes showed a stronger association with systemic spread (OR: 2.127; CL: 1.2-3.8) than other subgroups. Classification as Luminal or Non-Luminal showed an increased risk of lung and distant nodal recurrence, and a decreased risk in bone metastases in the Non-Luminal group (OR: 2.9, 3.345, and 0.2, respectively). Tumors with HER2 overexpression had a significantly high risk for distant relapse (OR: 2.127) compared with HER2-negative tumors and also showed higher central nervous system (CNS) and lung metastatic potential (OR: 5.6 and 2.65, respectively) and low risk of bone disease progression (OR: 0.294). Furthermore, we found significant associations between biological profiles and sites of recurrence. A new process of clinical/diagnostic staging, including molecular subtypes, could better predict the likelihood of distant relapses and their anatomical location. Recognition and appreciation of clinically distinct molecular subtypes may assist in evaluation of the probability of distant relapses and their sites. Our analysis provides new insights into management of metastatic disease behavior, to lead to an optimal disease-tailored approach and appropriate follow-up.