Nicola Rocco

Developing guidelines in geriatric surgery: role of the grade system

In making healthcare management decisions, clinicians must weigh up the benefits and the harms of alternative strategies. Guidelines are useful tools for administrators, policy makers, managers, clinical leaders and care givers to achieve this aim. Guidelines recommendations may be produced in three different ways: small panels of experts, consensus conferences and on the basis of evidence. Expert clinicians and organisations offering recommendations to the clinical community have often erred as a result of not taking sufficient account of evidence. Moreover the so-called evidence-based guidelines are often inconsistent in how they rate the quality of evidence and the strength of recommendation. Systems used to assess quality of evidence in guidelines were only scales that reported the study design the evidence was provided from as a letter or a number (i.e. C1, IIb, etc). n nThis kind of evaluation gives great emphasis on RCTs and metanalysis as an a priori source of good evidence without a systematic evaluation of study quality. This drives to a lesser impact of observational studies, CCTs and case series of rare adverse events in guidelines. Geriatric patients are often excluded or underrepresented in trials mainly because comorbidity conditions and toxic effects of treatment are the greatest barriers to recruitment of older patients. Other studies have shown that physician refusal to enrol patients onto trials is among the top reasons for low protocol participation. n nThus evidences for geriatric guidelines are, according to such a rating scheme, of low level. Since 2006 the BMJ requested in its instruction to authors, that authors should preferably use the Grading of Recommendations Assessment, Development and Evaluation (GRADE) system for grading evidence when submitting a clinical guidelines article. The GRADE system separates decisions regarding the quality of evidence from strength of recommendations and allows upgrading or down grading of – level of evidence according to quality of evidence rather than to study design n nIn order to obtain reliable and evidence-based guidelines in geriatric surgery, the GRADE system for grading evidence should be used as consolidated standard.

Breast reconstruction in older women: a growing request

Results During this time period, 153 (27%) of patients with breast cancer were 60 years or older. Approximately, one third (49 patients) required or elected mastectomy as primary treatment. Of the 49 women evaluated, 17 (28%) elected delayed implant-based breast reconstruction. No patients experienced major complications at the longest follow up. Conclusion Elderly women undergoing with mastectomy should be offered breast reconstruction as part of their treatment. Physicians and patients need to be educated regarding surgical options, the minimal associated morbidity and mortality, and excellent functional and cosmetic outcomes. With extended life expectancy, breast reconstruction enhances these aspects of quality of life. Future management guidelines should include breast reconstruction in the algorithm. from XXI Annual Meeting of The Italian Society of Geriatric Surgery Terni, Italy. 4–6 December 2008

Understanding rare adverse sequelae of breast implants: Anaplastic large-cell lymphoma, late seromas, and double capsules

Breast implant-associated anaplastic large cell lymphoma (BI-ALCL) is a distinct type of T-cell lymphoma arising around breast implants. The United States FDA recently updated the 2011 safety communication, warning that women with breast implants may have a very low risk of developing ALCL adjacent to a breast implant. According to the World Health Organization, BI-LCL is not a breast cancer or cancer of the breast tissue; it is a lymphoma, a cancer of immune cells. BI-ALCL is highly curable in the majority of patients. Informed consent should include the risk of BI-ALCL with breast implant patients. Women with breast implants are encouraged to contact their plastic surgeon if they notice swelling, fluid collections, or unexpected changes in breast shape. Physicians are encouraged to send suspicious peri-prosthetic fluid for CD30 immunohistochemistry, cell block cytology, and culture in symptomatic patients. An observation from reported cases indicates a predominance of textured device involvement. More information is needed to fully understand risk factors and etiology. The association of bacteria and biofilm with ALCL is currently being investigated and one theory is that biofilm may play a role in this disease process stressing the importance of best practice techniques intraoperatively. Recent studies have reported clinical presentation, prognosis, and treatment outcomes with long term followup demonstrating the critical role for surgical management.

Primary angiosarcoma of the breast

Primary angiosarcoma (AS) of the breast is a rare neoplasia that is not related to radiation exposure. It represents less than 0.05% of all malignant breast tumors. This lesion is characterized by aggressive patterns and poor prognosis and by the absence of typical features at radiologic examination. Currently there are not evidence-based guidelines regarding surgical and adjuvant treatment for this tumor even though wide surgical resection followed by chemo- radiotherapy appears to improve both disease free survival and overall survival. The aim of this study was to analyze the available series of AS patients suggesting the most reliable treatment options for this rare neoplasia.

Impact of contra-lateral breast reshaping on mammographic surveillance in women undergoing breast reconstruction following mastectomy for breast cancer

BACKGROUNDnThe ultimate goal of breast reconstruction is to achieve symmetry with the contra-lateral breast. Contra-lateral procedures with wide parenchymal rearrangements are suspected to impair mammographic surveillance. This study aims to evaluate the impact on mammographic detection of mastopexies and breast reductions for contralateral adjustment in breast reconstruction.nnnPATIENTS AND METHODSnWe retrospectively evaluated 105 women affected by uni-lateral breast cancer who underwent mastectomy and immediate two-stage reconstruction between 2002 and 2007. We considered three groups according to the contra-lateral reshaping technique: mastopexy or breast reduction with inferior dermoglandular flap (group 1); mastopexy or breast reduction without inferior dermoglandular flap (group 2); no contra-lateral reshaping (group 3). We assessed qualitative mammographic variations and breast density in the three groups.nnnRESULTSnStatistically significant differences have been found when comparing reshaped groups with non reshaped groups regarding parenchymal distortions, skin thickening and stromal edema, but these differences did not affect cancer surveillance. The surveillance mammography diagnostic accuracy in contra-lateral cancer detection was not significantly different between the three groups (pxa0=xa00.56), such as the need for MRI for equivocal findings at mammographic contra-lateral breast (pxa0=xa00.77) and the need for core-biopsies to confirm mammographic suspect of contra-lateral breast cancer (pxa0=xa00.90).nnnCONCLUSIONSnThis study confirms previous reports regarding the safety of mastopexies and breast reductions when performed in the setting of contra-lateral breast reshaping after breast reconstruction. Mammographic accuracy, sensitivity and specificity are not affected by the glandular re-arrangement. These results provide a further validation of the safety of current reconstructive paradigms.

What is the evidence behind conservative mastectomies

INTRODUCTIONnBesides the diffusion of breast reconstructive techniques, several conservative approaches in mastectomy have been developed, in order to perform an immediate reconstruction with better aesthetic results: the skin-sparing mastectomy (SSM), the nipple-areola complex (NAC)-sparing mastectomy (NSM) and the skin-reducing mastectomy (SRM). During the last decade, SSMs and NSMs have gained widespread acceptance and are currently considered standard treatment for early breast cancer. We would like to investigate the evidence behind this radical shift towards conservative mastectomies, where there has been a renewed interest worldwide.nnnMETHODSnWe reviewed English literature by consulting the following databases: Medline, Embase, Cochrane Register of Controlled Trials, the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) search portal and Clinicaltrials.gov. The objective is to include any randomized controlled trial (RCT) comparing a conservative mastectomy technique to breast conservative surgery or modified radical mastectomy (MRM) for the treatment of early-stage breast cancer. In the absence of randomized trials, we took into account prospective cohorts and retrospective series for a narrative description of available evidence.nnnRESULTSnOur review included 58 studies [19 prospective cohorts (34%) and 39 retrospective series (66%)] considering NSM and immediate reconstruction and ten studies [1 prospective cohort (10%) and 9 (90%) retrospective series] considering SSM and immediate reconstruction. In the NSM group, 29 studies reported data about complication rates and 42 studies presented data on NAC partial or complete necrosis. In the NSM group 45 studies and all the studies in the SSM group presented data on local and NAC recurrence.nnnCONCLUSIONSnIn order to achieve higher levels of evidence, RCTs comparing conservative mastectomies to traditional mastectomy and breast conservative surgery would be desirable. However we can conclude that conservative mastectomies offer the psychological advantages of good cosmetics and maintenance of woman body image without compromising the oncological safety of mastectomy.

Role of Mitomycin C in Preventing Capsular Contracture in Implant-Based Reconstructive Breast Surgery: A Randomized Controlled Trial.

Background: Capsular contracture represents the most frequent complication after implant-based breast reconstruction. An experimental study on mice demonstrated that capsule formation around breast implants is considerably diminished after topical application of mitomycin C. The authors conducted a randomized controlled clinical trial investigating the efficacy of mitomycin C in reducing capsular contracture rates following implant-based breast reconstruction after mastectomy for breast cancer. Methods: The authors randomized all women older than 18 years scheduled for the second stage of an implant-based breast reconstruction after mastectomy for breast cancer at the National Cancer Institute in Milan from October of 2005 to February of 2010 to receive or not receive the topical application of mitomycin C during surgery. The authors assessed capsular contracture, major postoperative complications, and aesthetic outcome. Results: The authors randomized 322 patients to receive mitomycin C or not at the second stage of implant-based breast reconstruction. One hundred sixty-two patients were allocated to the mitomycin C group and 160 patients were allocated to the control group. The relative risk of capsular contracture in the mitomycin C group was 0.92 (95 percent CI, 0.60 to 1.41). Major complications leading to reintervention, oncologic outcomes, and aesthetic outcomes were comparable between the two groups. Conclusions: This is the first trial reporting data about the use of mitomycin C in breast reconstructive surgery in a clinical setting. Mitomycin C seems not to significantly affect capsular contracture rate and severity following implant-based reconstructive breast surgery at the tested doses. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, I.

Innovative Management of Implant Exposure in ADM/Implant-Based Breast Reconstruction with Negative Pressure Wound Therapy.

IntroductionOne-stage implant-based breast reconstruction has been recently improved by the introduction of biological [acellular dermal matrix (ADM)] and synthetic meshes. Advantages of ADMs in implant-based breast reconstruction derive from the expansion of the space available for the direct positioning of an implant, but their use could be associated with several complications. Although the majority of complications can be easily managed, mistakes in dealing with the first clinical signs of a potential adverse event can lead to implant loss.Case PresentationWe report a case of ADM/implant exposure following NAC-sparing mastectomy and immediate implant-based reconstruction, successfully managed with an innovative staged treatment using negative pressure wound therapy, which allowed a rapid re-positioning of the prosthesis after complete clearance of bacteria from the implant pocket.DiscussionThe safest strategy to manage implant exposure and concomitant bacterial growth is reported to be implant removal and delayed re-positioning after several months, following prolonged targeted antibiotic therapy. Our case shows how a short-time implant re-positioning following implant removal for implant exposure could be successfully pursued thanks to the shrewd use of negative pressure wound therapy with great advantages in terms of patient satisfaction and post-operative quality of life, offering women experiencing this complication the option of not delaying reconstruction for months after resolution of the complication, potentially avoiding major surgical procedures such as autologous tissue reconstructions.Level of Evidence VThis 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.

Contralateral risk reducing mastectomy in Non-BRCA-Mutated patients

Abstract The use of contralateral risk reducing mastectomy (CRRM) is indicated in women affected by breast cancer, who are at high risk of developing a contralateral breast cancer, particularly women with genetic mutation of BRCA1, BRCA2 and P53. However we should consider that the genes described above account for only 20-30% of the excess familiar risk. What is contralaterally indicated when genetic assessment results negative for mutation in a young patient with unilateral breast cancer? Is it ethically correct to remove a contralateral “healthy” breast? CRRM rates continue to rise all over the world although CRRM seems not to improve overall survival in women with unilateral sporadic breast cancer. The decision to pursue CRRM as part of treatment in women who have a low-to-moderate risk of developing a secondary cancer in the contralateral breast should consider both breast cancer individual-features and patients preferences, but should be not supported by the surgeon and avoided as first approach with the exception of women highly worried about cancer. Prospective studies are needed to identify cohorts of patients most likely to benefit from CRRM.

Different types of implants for reconstructive breast surgery

BACKGROUNDnBreast cancer is the most common cancer in women worldwide, and is a leading cause of cancer death among women. Prophylactic or curative mastectomy is often followed by breast reconstruction for which there are several surgical approaches that use breast implants with which surgeons can restore the natural feel, size and shape of the breast.nnnOBJECTIVESnTo assess the effects of different types of breast implants on capsular contracture, surgical short- and long-term complications, postoperative satisfaction level and quality of life in women who have undergone reconstructive breast surgery after mastectomy.nnnSEARCH METHODSnWe searched the Cochrane Breast Cancer Groups Specialised Register on 20 July 2015, MEDLINE (1985 to 20 July 2015), EMBASE (1985 to 20 July 2015) and the Cochrane Central Register of Controlled Trials (CENTRAL; Issue 8, 2015). We also searched the World Health Organizations International Clinical Trials Registry Platform (WHO ICTRP) and ClinicalTrials.gov on 16 July 2015.nnnSELECTION CRITERIAnWe included randomised controlled trials (RCTs) and quasi-RCTs that compared different types of breast implants for reconstructive surgery. We considered the following types of intervention: implant envelope surfaces - texturised versus smooth; implant filler material - silicone versus saline, PVP-Hydrogel versus saline; implant shape - anatomical versus round; implant volume - variable versus fixed; brands - different implant manufacturing companies and implant generation (fifth versus previous generations).nnnDATA COLLECTION AND ANALYSISnTwo review authors independently assessed methodological quality and extracted data. We used standard Cochrane methodological procedures. The quality of the evidence was assessed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) system.nnnMAIN RESULTSnFive RCTs with 202 participants met the inclusion criteria. The women participants were typically in their 50s, and the majority of them (about 82%) received reconstructive surgery following breast cancer, while the others had reconstructive surgery after prophylactic mastectomy. The studies were heterogenous in terms of implant comparisons, which prevented us from pooling the data.The studies were judged as being at an unclear risk of bias for most risk of bias items owing to poor quality of reporting in the trial publications. Three of the five RCTs were judged to be at high risk of attrition bias, and one at high risk of detection bias.Textured silicone versus smooth silicone implants: textured implants were associated with worse outcomes when compared to smooth implants (capsular contracture: risk ratio (RR) 0.82, 95% CI 0.14 to 4.71; 1 study, 20 participants; very low quality evidence; reintervention: RR 0.82, 95% CI 0.14 to 4.71; 1 study, 20 participants; very low quality evidence). No results in this comparison were statistically significant.Silicone versus saline implants: saline-filled implants performed better than silicone-filled implants for some outcomes; specifically, they produced less severe capsular contracture (RR 3.25, 95% CI 1.24 to 8.51; 1 study, 60 participants; very low quality evidence) and increased patient satisfaction (RR 0.60, 95% CI 0.41 to 0.88; 1 study, 58 participants; very low quality evidence). However reintervention was significantly more frequent in the saline-filled implant group than in the silicone-filled group (OR 0.08, 95% CI 0.01 to 0.43; 1 study, 60 participants; very low quality evidence).Poly(N-vinyl-2-pyrrolidone) hydrogel-filled (PVP-hydrogel) versus saline-filled implants: PVP-hydrogel-filled implants were associated with worse outcomes when compared to saline-filled implants (capsular contracture: RR 3.50, 95% CI 0.83 to 14.83; 1 study, 40 participants; very low quality evidence; short-term complications: RR 2.10, 95% CI 0.21 to 21.39; 1 study, 41 participants; very low quality evidence).Anatomical versus round implants: anatomical implants were associated with worse outcomes than round implants (capsular contracture: RR 2.00, 95% CI 0.20 to 20.15; 1 study, 36 participants; very low quality evidence; short-term complications: RR 2.00, 95% CI 0.42 to 9.58; 1 study, 36 participants; very low quality evidence; reintervention: RR 1.50, 95% CI 0.51 to 4.43; 1 study, 36 participants; very low quality evidence). No results in this comparison were statistically significant.Variable-volume versus fixed-volume implants: data about one-stage reconstruction using variable-volume implants were compared with data about fixed-volume implants positioned during the second surgical procedure of two-stage reconstructions. Fixed-volume implant reconstructions were possibly associated with a greater number of women reporting that their reconstruction corresponded with expected results (RR 0.25, 95% CI 0.10 to 0.62; 1 study, 40 participants; very low quality evidence) and fewer reinterventions (RR 7.00, 95% CI 1.82 to 26.89; 1 study, 40 participants; very low quality evidence) when compared to variable-volume implants. A higher patient satisfaction level (rated from 1 to 6, with 1 being very bad and 6 being very good) was found with the fixed-volume implants for overall aesthetic result (mean difference (MD) -1.10, 95% CI -1.59 to -0.61; 1 study, 40 participants; very low quality evidence).There were no studies that examined the effects of recent (fifth) generation silicone implants versus previous generations or different implant manufacturing companies.nnnAUTHORS CONCLUSIONSnDespite the central role of breast reconstruction in women with breast cancer, the best implants to use in reconstructive surgery have been studied rarely in the context of RCTs. Furthermore the quality of these studies and the overall evidence they provide is largely unsatisfactory. Some of our results can be interpreted as early evidence of potentially large differences between different surgical approaches, which should be confirmed in new high-quality RCTs that include a larger number of women. These days - even after a few million women have had breasts reconstructed - surgeons cannot inform women about the risks and complications of different implant-based breast reconstructive options on the basis of results derived from RCTs.