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Annals of Surgical Oncology Oct 2015Nipple-sparing mastectomy (NSM) is an increasingly common procedure; however, concerns exist regarding its oncological safety due to the potential for residual breast... (Meta-Analysis)
Meta-Analysis Review
Overall Survival, Disease-Free Survival, Local Recurrence, and Nipple-Areolar Recurrence in the Setting of Nipple-Sparing Mastectomy: A Meta-Analysis and Systematic Review.
BACKGROUND
Nipple-sparing mastectomy (NSM) is an increasingly common procedure; however, concerns exist regarding its oncological safety due to the potential for residual breast tissue to harbor occult malignancy or future cancer.
METHODS
A systematic literature review was performed. Studies with internal comparison arms evaluating therapeutic NSM versus skin-sparing mastectomy (SSM) and/or modified radical mastectomy (MRM) were included in a meta-analysis of overall survival (OS), disease-free survival (DFS), and local recurrence (LR). Studies lacking comparison arms were only included in the systematic review to evaluate mean OS, DFS, LR, and nipple-areolar recurrence (NAR).
RESULTS
The search yielded 851 articles. Twenty studies with 5594 patients met selection criteria. The meta-analysis included eight studies with comparison arms. Seven studies that compared OS found a 3.4% risk difference between NSM and MRM/SSM, five studies that compared DFS found a 9.6% risk difference between NSM and MRM/SSM, and eight studies that compared LR found a 0.4% risk difference between NSM and MRM/SSM. Risk differences for all outcomes were not statistically significant. The systematic review included all 20 studies and evaluated OS, DFS, LR, and NAR. Studies with follow-up intervals of <3 years, 3-5 years, and >5 years had mean OS of 97.2, 97.9, and 86.8%; DFS of 93.1, 92.3, and 76.1%; LR of 5.4, 1.4, and 11.4%; and NAR of 2.1, 1.0, and 3.4%, respectively.
CONCLUSIONS
This study did not detect adverse oncologic outcomes of NSM in carefully selected women with early-stage breast cancer. Use of prospective data registries, notably the Nipple-Sparing Mastectomy Registry, will add clarity to this important clinical question.
Topics: Breast Neoplasms; Disease-Free Survival; Female; Humans; Mammaplasty; Mastectomy, Modified Radical; Neoplasm Recurrence, Local; Nipples; Organ Sparing Treatments; Prognosis; Survival Rate
PubMed: 26242363
DOI: 10.1245/s10434-015-4739-1 -
Aesthetic Plastic Surgery Apr 2020With advancements in materials engineering, many plastic surgeons have looked to allogeneic tissue and alloplastic materials as a possible source of structure for...
Allogeneic and Alloplastic Augmentation Grafts in Nipple-Areola Complex Reconstruction: A Systematic Review and Pooled Outcomes Analysis of Complications and Aesthetic Outcomes.
BACKGROUND
With advancements in materials engineering, many plastic surgeons have looked to allogeneic tissue and alloplastic materials as a possible source of structure for long-lasting nipple-areola complex reconstruction. Furthermore, in light of the recent mandate from the Food and Drug Administration restricting the marketing and direct indication of acellular dermal matrices (ADMs) in breast reconstruction, we sought to highlight the overall safety and efficacy demonstrated in the existing literature surrounding all alloplastic materials in nipple-areola complex reconstruction. In this study, the authors conduct a systematic review and pooled outcomes analysis on allogenic and alloplastic implant materials utilized to achieve long-lasting nipple projection stratified by specific material used and respective outcomes.
METHODS
A comprehensive systematic review on allogenic and synthetic materials data utilized in nipple reconstruction was conducted utilizing Medline/PubMed database. Articles were stratified by (1) alloplastic material, as well as (2) objective and patient-reported outcomes.
RESULTS
A total of 592 nipple-areola complexes on 482 patients were featured in 15 case series. In all studies, alloplastic or allograft material was utilized to achieve and maintain nipple projection. Subjective measurements revealed a patient satisfaction rate of 93.3% or higher with the majority of patients being very satisfied with their reconstruction. The alloplastic and allograft implants analyzed had an overall complication rate of 5.3% across all materials used. The most common complication reported was flap or graft necrosis with a pooled rate of 2.5%. Overall, the Ceratite implant presented with the highest complication rate (18%) including flap/graft necrosis (13%) and extrusion of the artificial bone (5%). Other rigid implants such as the biodesign nipple reconstruction cylinder reported complications of extrusion (3.6%), projection loss requiring revision (2.5%), wound dehiscence/drainage (1.5%), flap or graft necrosis (1.0%) and excessive bleeding (0.5%). ADM implants had reported complications of both insufficient projection (0.8%) and excessive projection (1.6%), which required surgical revision. Injectable materials had minimal reported complications of pain during injection (0.8%) with Radiesse and a false-positive PET scan result (0.8%) with DermaLive.
CONCLUSIONS
Allogeneic and alloplastic grafts are a reliable means of achieving satisfactory nipple projection, with a relatively low overall complication profile. The use of Ceratite (artificial bone) led to the highest complication rates. Further clinical studies are necessary to better understand the feasibility and longer-term outcomes of the use of allogeneic and synthetic augmentation grafts to improve nipple projection.
LEVEL OF EVIDENCE III
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.
Topics: Breast Neoplasms; Esthetics; Hematopoietic Stem Cell Transplantation; Humans; Mammaplasty; Nipples; Retrospective Studies; Treatment Outcome
PubMed: 31722063
DOI: 10.1007/s00266-019-01539-7 -
Plastic and Reconstructive Surgery Jan 2016Many techniques have been described for nipple reconstruction, with the principal limitation being excessive loss of projection. The ideal reconstructed nipple provides... (Comparative Study)
Comparative Study Review
BACKGROUND
Many techniques have been described for nipple reconstruction, with the principal limitation being excessive loss of projection. The ideal reconstructed nipple provides sustained projection, the fewest complications, and high levels of patient satisfaction. A variety of materials are available for projection augmentation, including autologous, allogeneic, and synthetic materials. To date, there has been no systematic review to study the efficacy, projection, and complication rates of different materials used in nipple reconstruction.
METHODS
MEDLINE, Embase, and PubMed databases were searched, from inception to August of 2014, to identify literature reporting on outcomes of autologous, allogeneic, and synthetic grafts in nipple reconstruction. Retrospective and prospective studies with controlled and uncontrolled conditions were included. Studies reporting the use of autologous flap techniques without grafts and articles lacking postoperative outcomes were excluded. Study quality was assessed using the Newcastle-Ottawa Scale.
RESULTS
Thirty-one studies met the inclusion criteria. After evidence review, one study represented two of nine stars on the Newcastle-Ottawa Scale, two studies represented three stars, six studies represented four stars, seven studies represented five stars, 11 studies represented six stars, and four studies represented seven stars.
CONCLUSIONS
The results of this review revealed heterogeneity in the type of material used within each category and inconsistent methodology used in outcomes assessment in nipple reconstruction. Overall, the quality of evidence is low. Synthetic materials have higher complication rates and allogeneic grafts have nipple projection comparable to that of autologous grafts. Further investigation with high-level evidence is necessary to determine the optimal material for nipple reconstruction.
CLINICAL QUESTION/LEVEL OF EVIDENCE
Therapeutic, IV.
Topics: Esthetics; Female; Graft Rejection; Graft Survival; Humans; Mammaplasty; Nipples; Risk Assessment; Skin, Artificial; Surgical Flaps; Tissue Expansion; Transplantation, Autologous; Transplantation, Homologous; Treatment Outcome
PubMed: 26710046
DOI: 10.1097/PRS.0000000000001861 -
ANZ Journal of Surgery Jan 2023Native skin flap necrosis is a potentially devastating complication following skin-sparing or nipple-sparing mastectomy with a reported incidence of as high as 30%.... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Native skin flap necrosis is a potentially devastating complication following skin-sparing or nipple-sparing mastectomy with a reported incidence of as high as 30%. Treatment depends on the depth and extent of tissue necrosis and can range from dressings to surgical debridement and further reconstruction. This can have implications on patient physical and psychological wellbeing as well as cost of treatment. This study aims to identify and appraise cost-effective non-surgical adjuncts for the prevention of native skin flap necrosis.
METHODS
A systematic review was performed using the preferred reporting items for systematic reviews and meta-analyses (PRISMA) statement and structured around existing recommended guidelines. A search of MEDLINE, EMBASE, Cumulative Index to Nursing and Allied Health Literature and ClinicalTrials.gov was performed with the medical subject headings 'mastectomy' and 'flap necrosis'. After exclusion, 12 articles were selected for review and analysed.
RESULTS
A total of 8439 mastectomies were performed on 7895 patients. Preventative non-surgical adjuncts that demonstrated statistically significant reduction in mastectomy flap necrosis included topical nitroglycerin ointment (P = 0.000), closed-Incision negative pressure wound therapy (P = 0.000), topical dimethylsulfoxide ointment (P = 0.03), oral cilostazol (P = 0.032), and local heat pre-conditioning (P = 0.047).
CONCLUSIONS
This study identifies multiple adjuncts that may aid in preventing mastectomy skin flap necrosis, especially in high-risk patients. Further studies could aim to define standardized protocols and compare the various adjuncts in different circumstances.
Topics: Humans; Female; Ointments; Surgical Flaps; Mastectomy; Mastectomy, Subcutaneous; Postoperative Complications; Vascular Diseases; Skin Diseases; Necrosis; Mammaplasty; Breast Neoplasms; Retrospective Studies; Nipples
PubMed: 36373495
DOI: 10.1111/ans.18146 -
International Journal of Surgery... Jan 2024Emerging remote-access surgical methods are utilized to treat differentiated thyroid cancer. The study aimed to compare the surgical integrity, safety, efficacy, and... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Emerging remote-access surgical methods are utilized to treat differentiated thyroid cancer. The study aimed to compare the surgical integrity, safety, efficacy, and postoperative experience of patients among common surgical methods.
METHODS
The PubMed, Medline, Cochrane Library, Web of Science, and EMBASE databases were searched from their inception until March 2023. Pairwise meta-analysis and Bayesian network meta-analysis were performed. The surface under the cumulative ranking curve (SUCRA) was used to illuminate the probability that each method would be the best for each outcome.
RESULTS
Thirty-two studies comprising 7042 patients were included. Robotic bilateral axillo-breast approach (RBABA) and robotic gasless transaxillary approach (RGAA) retrieved fewer lymph nodes (LNs) than open thyroidectomy (OT). RBABA showed a significantly lower permanent recurrent laryngeal nerve (RLN) palsy rate than OT. According to SUCRA values, endoscopic transoral approach (EOA) ranked the highest in retrieved LNs (0.84), the proportion of stimulated serum thyroglobulin less than 1.0 ng/ml (0.77), and the pain score (0.77). Endoscopic bilateral areola approach (EBAA) ranked the highest in the transient RLN palsy rate (0.72). The endoscopic gasless transaxillary approach (EGAA) ranked the highest in the transient hypoparathyroidism rate (0.78). RBABA ranked the highest in the rate of permanent RLN palsy (0.94) and hypoparathyroidism (0.77). OT ranked the highest in operative time (0.92).
CONCLUSIONS
Each surgical method of total thyroidectomy has benefits and limitations. EOA performed the best in maintaining surgical integrality and reducing the pain score, while taking a long operative time. Generally, RBABA showed the best advantage in protecting parathyroid glands and RLN but with the longest operative time. OT had the best advantage in operative time. Therefore, OT and EOA are ideal methods for patients with a higher risk of central LN metastasis. RBABA and EOA may not be suitable for elderly patients or those with high anesthesia risk.
Topics: Humans; Aged; Thyroidectomy; Bayes Theorem; Network Meta-Analysis; Thyroid Neoplasms; Vocal Cord Paralysis; Hypoparathyroidism; Adenocarcinoma; Pain; Retrospective Studies
PubMed: 37916941
DOI: 10.1097/JS9.0000000000000819 -
Plastic and Reconstructive Surgery May 2019The incidence of nipple-sparing mastectomy is rising, but no single incision type has been proven to be superior. This study systematically evaluated the rate and... (Meta-Analysis)
Meta-Analysis
BACKGROUND
The incidence of nipple-sparing mastectomy is rising, but no single incision type has been proven to be superior. This study systematically evaluated the rate and efficacy of various nipple-sparing mastectomy incision locations, focusing on nipple-areola complex necrosis and reconstructive method.
METHODS
A systematic literature review was performed according to the Preferred Reporting Items for Systematic Review and Meta-Analyses guidelines identifying studies on nipple-sparing mastectomy where incision type was described. Pooled descriptive statistics meta-analysis of overall (nipple-areola complex) necrosis rate and nipple-areola complex necrosis by incision type was performed.
RESULTS
Fifty-one studies (9975 nipple-sparing mastectomies) were included. Thirty-two incision variations were identified and categorized into one of six groups: inframammary fold, radial, periareolar, mastopexy/prior scar/reduction, endoscopic, and other. The most common incision types were inframammary fold [3634 nipple-sparing mastectomies (37.8 percent)] and radial [3575 nipple-sparing mastectomies (37.2 percent)]. Meta-analysis revealed an overall partial nipple-areola complex necrosis rate of 4.62 percent (95 percent CI, 3.14 to 6.37 percent) and a total nipple-areola complex necrosis rate of 2.49 percent (95 percent CI, 1.87 to 3.21 percent). Information on overall nipple-areola complex necrosis rate by incision type was available for 30 of 51 studies (4645 nipple-sparing mastectomies). Periareolar incision had the highest nipple-areola complex necrosis rate (18.10 percent). Endoscopic and mastopexy/prior scar/reduction incisions had the lowest rates of necrosis at 4.90 percent and 5.79 percent, respectively, followed by the inframammary fold incision (6.82 percent). The rate of single-stage implant reconstruction increased during this period.
CONCLUSIONS
For nipple-sparing mastectomy, the periareolar incision maintains the highest necrosis rate because of disruption of the nipple-areola complex blood supply. The inframammary fold incision has become the most popular incision, demonstrating an acceptable complication profile.
Topics: Breast Implantation; Breast Neoplasms; Female; Humans; Mastectomy, Subcutaneous; Necrosis; Nipples; Organ Sparing Treatments; Postoperative Complications; Retrospective Studies; Surgical Wound
PubMed: 30789474
DOI: 10.1097/PRS.0000000000005502 -
Journal of Robotic Surgery Apr 2022Breast cancer is worldwide the most common cause of cancer in women and causes the second most common cancer-related death. Nipple-sparing mastectomy (NSM) is commonly... (Meta-Analysis)
Meta-Analysis Review
Breast cancer is worldwide the most common cause of cancer in women and causes the second most common cancer-related death. Nipple-sparing mastectomy (NSM) is commonly used in therapeutic and prophylactic settings. Furthermore, (preventive) mastectomies are, besides complications, also associated with psychological and cosmetic consequences. Robotic NSM (RNSM) allows for better visualization of the planes and reducing the invasiveness. The aim of this study was to compare the postoperative complication rate of RNSM to NSM. A systematic search was performed on all (R)NSM articles. The primary outcome was determining the overall postoperative complication rate of traditional NSM and RNSM. Secondary outcomes were comparing the specific postoperative complication rates: implant loss, hematoma, (flap)necrosis, infection, and seroma. Forty-nine studies containing 13,886 cases of (R)NSM were included. No statistically significant differences were found regarding postoperative complications (RNSM 3.9%, NSM 7.0%, p = 0.070), postoperative implant loss (RNSM 4.1%, NSM 3.2%, p = 0.523), hematomas (RNSM 4.3%, NSM 2.0%, p = 0.059), necrosis (RNSM 4.3%, NSM 7.4%, p = 0.230), infection (RNSM 8.3%, NSM 4.0%, p = 0.054) or seromas (RNSM 3.0%, NSM 2.0%, p = 0.421). Overall, there are no statistically significant differences in complication rates between NSM and RNSM.
Topics: Breast Neoplasms; Female; Humans; Mastectomy; Nipples; Retrospective Studies; Robotic Surgical Procedures
PubMed: 34128142
DOI: 10.1007/s11701-021-01265-w -
Korean Journal of Radiology Aug 2023This systematic review and meta-analysis evaluated the accuracy of preoperative breast magnetic resonance imaging (MRI) features and tumor-to-nipple distance (TND) for... (Meta-Analysis)
Meta-Analysis
Diagnostic Accuracy of Magnetic Resonance Imaging Features and Tumor-to-Nipple Distance for the Nipple-Areolar Complex Involvement of Breast Cancer: A Systematic Review and Meta-Analysis.
OBJECTIVE
This systematic review and meta-analysis evaluated the accuracy of preoperative breast magnetic resonance imaging (MRI) features and tumor-to-nipple distance (TND) for diagnosing occult nipple-areolar complex (NAC) involvement in breast cancer.
MATERIALS AND METHODS
The MEDLINE, Embase, and Cochrane databases were searched for articles published until March 20, 2022, excluding studies of patients with clinically evident NAC involvement or those treated with neoadjuvant chemotherapy. Study quality was assessed using the Quality Assessment of Diagnostic Accuracy Studies 2 tool. Two reviewers independently evaluated studies that reported the diagnostic performance of MRI imaging features such as continuity to the NAC, unilateral NAC enhancement, non-mass enhancement (NME) type, mass size (> 20 mm), and TND. Summary estimates of the sensitivity and specificity curves and the summary receiver operating characteristic (SROC) curve of the MRI features for NAC involvement were calculated using random-effects models. We also calculated the TND cutoffs required to achieve predetermined specificity values.
RESULTS
Fifteen studies (n = 4002 breast lesions) were analyzed. The pooled sensitivity and specificity (with 95% confidence intervals) for NAC involvement diagnosis were 71% (58-81) and 94% (91-96), respectively, for continuity to the NAC; 58% (45-70) and 97% (95-99), respectively, for unilateral NAC enhancement; 55% (46-64) and 83% (75-88), respectively, for NME type; and 88% (68-96) and 58% (40-75), respectively, for mass size (> 20 mm). TND had an area under the SROC curve of 0.799 for NAC involvement. A TND of 11.5 mm achieved a predetermined specificity of 85% with a sensitivity of 64%, and a TND of 12.3 mm yielded a predetermined specificity of 83% with a sensitivity of 65%.
CONCLUSION
Continuity to the NAC and unilateral NAC enhancement may help predict occult NAC involvement in breast cancer. To achieve the desired diagnostic performance with TND, a suitable cutoff value should be considered.
Topics: Humans; Female; Breast Neoplasms; Nipples; Carcinoma, Ductal, Breast; Sensitivity and Specificity; Magnetic Resonance Imaging; Retrospective Studies
PubMed: 37500575
DOI: 10.3348/kjr.2022.0846 -
Treatment of the benign inverted nipple: A systematic review and recommendations for future therapy.Breast (Edinburgh, Scotland) Oct 2016The inverted nipple is a frequently encountered problem which can cause difficulties with breastfeeding, sexuality, and aesthetic dissatisfaction. Up to now, no... (Review)
Review
The inverted nipple is a frequently encountered problem which can cause difficulties with breastfeeding, sexuality, and aesthetic dissatisfaction. Up to now, no consensus exists on a preferred treatment method. We performed a systematic review to identify the best treatment method for correction of benign inverted nipples. Treatment techniques were subdivided in the categories lactiferous duct preserving and lactiferous duct damaging. A systematic review was performed using the PRISMA statement. Inclusion criteria were: female patients with congenital or acquired inverted nipples, a minimum sample size of 10 nipples, and studies reporting recurrence of inversion with a minimum follow-up of six months. Exclusion criteria were nipple inversion caused by malignancy. Thirteen studies met the inclusion criteria which all had a level of evidence IV. No non-invasive treatment techniques were identified. In the duct preserving category eight studies were included with a recurrence rate of 0.6% (2/350) versus 9.9% (16/161) in the duct damaging category (n = 5). Other outcome parameters were not systematically reported in all studies. Because of a small number of low quality studies with heterogeneous interventions and outcomes a meta-analysis could not be performed and no preferred treatment method was identified. Based on the available data there is no statistical evidence that duct damaging treatment is superior to duct preserving treatment. We recommend that the first method of choice should be a duct preserving treatment method. In the future, more studies of better methodological quality are required and recommendations were made on how these could be conducted.
Topics: Adolescent; Adult; Female; Forecasting; Humans; Middle Aged; Nipples; Plastic Surgery Procedures; Young Adult
PubMed: 27476082
DOI: 10.1016/j.breast.2016.07.011 -
Journal of Obstetric, Gynecologic, and... 2005To review the literature on nipple pain and to delineate effective strategies for the prevention and treatment of nipple pain in breastfeeding mothers. (Review)
Review
OBJECTIVE
To review the literature on nipple pain and to delineate effective strategies for the prevention and treatment of nipple pain in breastfeeding mothers.
DATA SOURCES
Computerized searches on MEDLINE, Pre-MEDLINE, CINAHL, and the Cochrane Library.
STUDY SELECTION
Articles from indexed journals relevant to the objective were reviewed from January 1983 to April 2004. Preference was given to research-based studies in English.
DATA EXTRACTION
Data were extracted and organized under two headings: prevention of nipple pain or trauma and treatment of nipple pain or trauma. The Critical Appraisal Form by J. Briggs was used to extract the data from research-based articles.
DATA SYNTHESIS
The health benefits of breastfeeding for mother and infant are well documented; however, nipple pain is a common reason reported by women for the early termination of breastfeeding. Several studies have compared various treatments for either the prevention of or treatment for nipple pain. These treatments include warm water compresses, tea bag compresses, heat, application of expressed mother's milk, lanolin, vitamin A, collagenase, dexpanthenol, hydrogel therapy, glycerin gel therapy, moist occlusive dressing, education regarding proper latch-on and positioning, and no treatment.
CONCLUSIONS
No one topical agent showed superior results in the relief of nipple discomfort. The most important factor in decreasing the incidence of nipple pain is the provision of education in relation to proper breastfeeding technique and latch-on as well as anticipatory guidance regarding the high incidence of early postpartum nipple pain.
Topics: Administration, Cutaneous; Bandages; Breast Feeding; Clinical Nursing Research; Collagenases; Glycerol; Humans; Lanolin; Maternal-Child Nursing; Nipples; Nursing Evaluation Research; Ointments; Pain; Pain Management; Pantothenic Acid; Patient Education as Topic; Posture; Prenatal Care; Primary Prevention; Puerperal Disorders; Research Design; Skin Care; Time Factors; Vitamin A
PubMed: 16020410
DOI: 10.1177/0884217505276056