Nipple-Sparing Mastectomy With Immediate Reconstruction After Breast-Conserving Therapy and Radiation: Complications and Oncologic Safety.

INTRODUCTION: Nipple-sparing mastectomy (NSM) offers improved, patient-centered outcomes with demonstrated oncologic safety ( Ann Surg Oncol 2020;27:344-351). Indications for NSM continue to expand to patients outside of the traditional eligibility criteria, including those with prior breast-conserving therapy (BCT) with radiotherapy. Currently, limited data exist evaluating both short- and long-term outcomes in patients proceeding to NSM after prior BCT. METHODS: All patients undergoing bilateral NSM in a single institution from 2002 through 2017 with history of prior BCT were included in the final cohort, without exclusions. A retrospective chart review was performed to identify patient demographics, operative details, and complications. Outcomes assessed included early complications (<30 days from NSM), late complications (>30 days), rates of prosthetic failure, unplanned reoperations, and reconstructive failures, as well as oncologic safety. Student t , χ 2 , and Fisher exact tests were used to analyze outcomes of paired (BCT vs non-BCT) breasts within each patient. RESULTS: A total of 17 patients undergoing 34 NSMs were included. Each had a history of BCT and either ipsilateral breast recurrence (64.7%), risk-reducing NSM (23.5%), or a new contralateral primary cancer (11.8%). The cohort had a mean age of 51.1 years. With regard to acute complications (ischemia, infection, nipple-areolar complex or flap ischemia or necrosis, and wound dehiscence), there was no significant difference noted between breasts with prior BCT versus no prior BCT overall (41.2% vs 35.3%, respectively; P = 0.724). Complications occurring after 30 days postoperatively (capsular contracture, contour abnormality, animation deformity, bottoming out, rotation, and rippling) in prior BCT breasts versus no prior BCT had no significant differences overall (58.8% vs 41.2% respectively; P = 0.303). The mean follow-up was 5.5 years, during which no patients had a reported locoregional or distant recurrence in either breast. CONCLUSIONS: No significant differences in early or late complications were identified between breasts in patients undergoing bilateral NSM with a history of unilateral BCT and XRT. In the 5.5 years of follow-up, there were no recurrences, lending support to NSM for management of recurrent disease in addition to National Comprehensive Cancer Network-recommended total mastectomy. We propose that NSM should not be contraindicated in patients exposed to radiation with BCT.

Risk of Breast Implant-Associated Anaplastic Large Cell Lymphoma in Patients with Textured Tissue Expanders.

BACKGROUND: The association between textured implants and breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) is well established, but the risk of BIA-ALCL in patients with transient exposure to a textured tissue expander (TE) is not as well documented. The aim of this study was to assess the incidence and risk of BIA-ALCL in patients with temporary exposure to a textured TE with subsequent smooth implant placement. METHODS: This single-institution retrospective cohort study included all female patients who underwent two-stage breast reconstruction with placement of a textured TE from 1995 to 2016 with subsequent exchange to a smooth permanent implant. Primary outcome of interest was development of BIA-ALCL. Patients with exposure to textured implants were excluded. Follow-up was determined by last documented visit. The authors calculated summary statistics for exposure time and follow-up intervals. RESULTS: Overall, 3310 patients had temporary exposure to a textured TE with exchange to a smooth implant, totaling 5201 textured TEs. Average textured TE exposure time was 6.7 months (median, 5.8 months). Average follow-up was 6.8 years (median, 6.3 years), ranging from 3.7 months to 18 years. No cases of BIA-ALCL were identified. CONCLUSIONS: As no cases of BIA-ALCL were identified, the risk of BIA-ALCL with short exposure to textured TEs is likely lower than the risk from exposure to permanent textured implants. Although longer follow-up is needed, these results can help counsel patients with previous exposure to textured TEs who are concerned about their risk of BIA-ALCL and can contribute to discussions on potential continued utility of textured TEs. CLINICAL QUESTION/LEVEL OF EVIDENCE: Risk, IV.

Moving towards patient-reported outcomes in routine clinical practice: implementation lessons from the BREAST-Q.

PURPOSE: Longitudinal, routine utilization of patient-reported outcome measures (PROMs) in clinical care has been challenging. The purpose of this study is to describe a quality improvement initiative to improve patient engagement with the BREAST-Q, a gold-standard PROM for breast reconstruction. METHODS: In 2011, we implemented the BREAST-Q as part of routine care. In 2018, we began a quality improvement initiative to increase BREAST-Q patient participation. The BREAST-Q was administered at every clinic visit via an institutional patient portal or an in-clinic tablet; digital dashboard technologies were used to improve workflow integration, real-time accountability, and immediate data availability at clinic visits. High clinical staff engagement was encouraged by assigning "BREAST-Q Champions." BREAST-Q completion data and patient characteristics were examined to understand non-response to the assessment. RESULTS: Following quality improvement, the average annual BREAST-Q completion rate increased from 42.8% in 2011-2017 to 87.6% in 2019, the last full year of our study period. High completion rates were maintained January-July 2020; however, a significantly larger proportion of BREAST-Qs were completed at home in 2020 versus the same period in 2019 (49.7 vs. 38.8%, p < 0.001), potentially due to the COVID-19 pandemic. Compared with non-responders, responders were younger (49.7 vs. 52.2 years, p < 0.001), more likely to be white (76.9 vs. 73.6%, p < 0.001), and had private insurance (79.4 vs. 69.8%, p < 0.001). CONCLUSION: Our quality improvement initiative successfully increased routine completion of the BREAST-Q. Similar implementation techniques may prove beneficial at other institutions interested in incorporating PROMs into routine care.

Rare complications of pessary use: A systematic review of case reports.

Introduction: Pessaries are desirable for its overall safety profiles. Serious complications have been reported; however, there is little summative evidence. This systematic review aimed to consolidate all reported serious outcomes from pessaries usage to better identify and counsel patients who might be at higher risk of developing these adverse events. Methods: We performed a systematic literature review using search terms such as 'prolapse', 'stress urinary incontinence' and 'pessary or pessaries or pessarium' on PubMed, Embase and CINAHL. A total of 36 articles were identified. Patient-level data were extracted from case reports to further describe complications on an individual level. Results: Overall median age of the patients was 82 years (range 62-98). The most frequent complications were vesicovaginal fistula (25%, n = 9/36), rectovaginal fistula (19%, n = 7/36), vaginal impaction (11%, n = 4/36) and vaginal evisceration of small bowel through vaginal vault (8%, n = 3/36). In the vesicovaginal fistula cohort, none of the patients had a history of radiation, and two had histories of total abdominal hysterectomy (22%). In the rectovaginal fistula cohort, one patient had a history of pelvic radiation for rectal squamous cell carcinoma, and another had a history of chronic steroid use for rheumatoid arthritis. No other risk factors were reported in the other groups. Ring and Gellhorn were the most represented pessary types among the studies, 16 (44%) and 12 (33%), respectively. No complications were reported with surgical and non-surgical treatment of the complications. Conclusion: Pessaries are a reasonable and durable treatment for POP with exceedingly rare reports of severe adverse complications. The ideal candidate for pessary should have a good self-care index. Studies to determine causative factors of the more serious adverse events are needed; however, this may be difficult given the long follow-up that is required.

Smooth versus Textured Implant Breast Reconstruction: Patient-Reported Outcomes and Complications.

BACKGROUND: The association between textured surface breast implants and breast implant-associated anaplastic large cell lymphoma has led to an increase in surgical procedures to exchange textured devices to smooth surface implants. Because patient satisfaction is an integral part of breast reconstruction, the purpose of this study was to compare patient-reported outcomes between smooth and textured implant recipients. METHODS: Patients aged 18 years or older who underwent implant-based postmastectomy breast reconstruction with either smooth or textured devices from 2009 to 2017 and completed the BREAST-Q patient-reported outcome measure following reconstruction were included in this analysis. The primary outcomes of interest were mean and median BREAST-Q scores and postoperative complications. RESULTS: Overall, 1077 patients were included-785 who underwent breast reconstruction with smooth implants and 292 who underwent breast reconstruction with textured implants. No statistical differences were observed between the textured and smooth implant groups for any of the BREAST-Q domain scores at any of the early (3-month) to late (2-year) postoperative time points. Smooth implant recipients reported significantly more rippling (p = 0.003) than textured implant recipients. In contrast, textured implant recipients had a higher rate of cellulitis than smooth implant recipients (p = 0.016). CONCLUSIONS: These data suggest that postoperative satisfaction with breasts or health-related quality of life following immediate postmastectomy implant-based breast reconstruction is likely independent of implant surface type. However, smooth breast implants may result in more rippling. The authors' findings represent an important aid in counseling patients who have questions about the risks and benefits of replacing their textured implants with smooth surface devices. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, III.

BIA-ALCL and Textured Breast Implants: A Systematic Review of Evidence Supporting Surgical Risk Management Strategies.

BACKGROUND: Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) is a significant public health concern for women with breast implants. The increase in incidence rates underscores the need for improved methods for risk reduction and risk management. The purpose of this study was to perform a systematic review to assess surgical risk reduction techniques and analyze communication/informed consent practices in patients with textured implants. METHODS: A systematic review of the literature was conducted in PubMed (legacy), Embase (Embase.com), and Scopus with four search strategies including key terms centered around breast reconstruction and BIA-ALCL. RESULTS: A total of 571 articles were identified, of which 276 were included in the final review after duplicates were removed. After review, no articles were determined to fit the inclusion criteria of demonstrating data-driven evidence of BIA-ALCL risk reduction through surgical measures, demonstrating a significant lack of data on risk reduction for BIA-ALCL. CONCLUSIONS: Risk management for BIA-ALCL is an evolving area requiring additional investigation. Although removal of textured devices in asymptomatic patients is not currently recommended by the Food and Drug Administration, variability in estimates of risk has led many patients to electively replace these implants in an effort to decrease their risk of developing BIA-ALCL. To date, however, there is no evidence supporting the concept that replacing textured implants with smooth implants reduces risk for this disease. This information should be used to aid in the informed consent process for patients presenting to discuss management of textured breast implants.

Breast Implant-associated Anaplastic Large Cell Lymphoma Incidence: Determining an Accurate Risk.

OBJECTIVE: This study sought to estimate the incidence and incidence rate of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) at a high-volume single institution, which enables vigorous long-term follow-up and implant tracking for more accurate estimates. SUMMARY BACKGROUND DATA: The reported incidence of BIA-ALCL is highly variable, ranging from 1 in 355 to 1 in 30,000 patients, demonstrating a need for more accurate estimates. METHODS: All patients who underwent implant-based breast reconstruction from 1991 to 2017 were retrospectively identified. The incidence and incidence rate of BIA-ALCL were estimated per patient and per implant. A time-to-event analysis was performed using the Kaplan-Meier estimator and life table. RESULTS: During the 26-year study period, 9373 patients underwent reconstruction with 16,065 implants, of which 9589 (59.7%) were textured. Eleven patients were diagnosed with BIA-ALCL, all of whom had a history of textured implants. The overall incidence of BIA-ALCL was 1.79 per 1000 patients (1 in 559) with textured implants and 1.15 per 1000 textured implants (1 in 871), with a median time to diagnosis of 10.3 years (range, 6.4-15.5 yrs). Time-to-event analysis demonstrated a BIA-ALCL cumulative incidence of 0 at up to 6 years, increasing to 4.4 per 1000 patients at 10 to 12 years and 9.4 per 1000 patients at 14 to 16 years, although a sensitivity analysis showed loss to follow-up may have skewed these estimates. CONCLUSIONS: BIA-ALCL incidence and incidence rates may be higher than previous epidemiological estimates, with incidence increasing over time, particularly in patients exposed to textured implants for longer than 10 years.

Development of an Integrated Platform Using Multidisciplinary Real-World Data to Facilitate Biomarker Discovery for Medical Products.

Translational multidisciplinary research is important for the Center for Devices and Radiological Health's efforts for utilizing real-world data (RWD) to enhance predictive evaluation of medical device performance in patient subpopulations. As part of our efforts for developing new RWD-based evidentiary approaches, including in silico discovery of device-related risk predictors and biomarkers, this study aims to characterize the sex/race-related trends in hip replacement outcomes and identify corresponding candidate single nucleotide polymorphisms (SNPs). Adverse outcomes were assessed by deriving RWD from a retrospective analysis of hip replacement hospital discharge data from the National Inpatient Sample (NIS). Candidate SNPs were explored using pre-existing data from the Personalized Medicine Research Project (PMRP). High-Performance Integrated Virtual Environment was used for analyzing and visualizing putative associations between SNPs and adverse outcomes. Ingenuity Pathway Analysis (IPA) was used for exploring plausibility of the sex-related candidate SNPs and characterizing gene networks associated with the variants of interest. The NIS-based epidemiologic evidence showed that periprosthetic osteolysis (PO) was most prevalent among white men. The PMRP-based genetic evidence associated the PO-related male predominance with rs7121 (odds ratio = 4.89; 95% confidence interval = 1.41-17.05) and other candidate SNPs. SNP-based IPA analysis of the expected gene expression alterations and corresponding signaling pathways suggested possible role of sex-related metabolic factors in development of PO, which was substantiated by ad hoc epidemiologic analysis identifying the sex-related differences in metabolic comorbidities in men vs. women with hip replacement-related PO. Thus, our in silico study illustrates RWD-based evidentiary approaches that may facilitate cost/time-efficient discovery of biomarkers for informing use of medical products.

Non-narcotic Perioperative Pain Management in Prosthetic Breast Reconstruction During an Opioid Crisis: A Systematic Review of Paravertebral Blocks.

BACKGROUND: Alternatives to postoperative, narcotic pain management following implant-based, postmastectomy breast reconstruction (IBR) must be a focus for plastic surgeons and anesthesiologists, especially with the current opioid epidemic. Paravertebral blocks (PVBs) are a regional technique that has demonstrated efficacy in patients undergoing a variety of breast cancer-related surgeries. However, a specific understanding of PVB's efficacy in pain management in patients who undergo IBR is lacking. METHODS: A systematic search of PubMed, EMBASE, and Cochrane Library electronic database was conducted to examine PVB administration in mastectomy patients undergoing IBR. Data were abstracted regarding: authors, publication year, study design, patient demographics, tumor laterality, tumor stage, type, and timing of reconstruction. The primary outcome was PVB efficacy, represented as patient-reported pain scores. Secondary outcomes of interest include narcotic consumption, postoperative nausea and vomiting, antiemetic use, and length of stay. RESULTS: The search resulted in 1,516 unique articles. After title and abstract screening, 29 articles met the inclusion criteria for full-text review. Only 7 studies were included. Of those, 2 studies were randomized control trials and 5 were retrospective cohort studies. Heterogeneity of included studies precluded a meta-analysis. Overall, PVB patients had improved pain control, and less opioid consumption. CONCLUSION: PVBs are a regional anesthesia technique which may aid in pain management in the breast reconstructive setting. Evidence suggests that PVBs aid in controlling acute postoperative pain, reduce opioid consumption, and improve patient length of stay. However, some conflicting findings demonstrate a need for continued research in this area of pain control.

Racial/Ethnic Specific Trends in Pediatric Firearm-Related Hospitalizations in the United States, 1998-2011.

OBJECTIVES: To determine the temporal patterns and the difference in trends by race/ethnicity of pediatric firearm hospitalizations (FH) among those aged 15 years or younger in the United States. METHODS: Data on pediatric FH was retrieved from the Nationwide Inpatient Sample between 1998 and 2011 (n = 16,998,470) using external cause of injury codes (E-codes) of the International Classification of Diseases, Ninth Revision, Clinical modification, (assault: E9650-E9654, unintentional: E9220-E9224, E9228, and E9229, suicide: E9550-E9554, E9556, and E9559, undetermined: E9850-E9854, and E9856 and legal: E970). Meta-regression was used to determine the significance of temporal trends. Survey logistic regression adjusted for survey year was used to examine association of pediatric FH with social and demographic characteristics. RESULTS: An annual reduction of 1.07 per 100,000 hospitalizations (p-trend = 0.011) was observed between 1998 and 2011. There was reduction in rate of unintentional-FH (p-trend = 0.013), suicide-FH (p-trend = 0.029), and undetermined-FH (p-trend = 0.002), but not assault-FH (p-trend = 0.18). A decline in rates of FH was observed among whites (p-trend = 0.021) and Hispanics (p-trend = 0.03) while an increase in rates of assault-FH was observed among black children. All other intents and all other racial/ethnic groups showed declining rates during this interval. CONCLUSIONS: There was an overall decline in rates of pediatric FHs in this time period driven by a decline in unintentional-FHs. However there was an increase in assault FH among black children during this same time period.

Comparative assessment of implantable hip devices with different bearing surfaces: systematic appraisal of evidence.

OBJECTIVE: To determine comparative safety and effectiveness of combinations of bearing surfaces of hip implants. DESIGN: Systematic review of clinical trials, observational studies, and registries. DATA SOURCES: Medline, Embase, Cochrane Controlled Trials Register, reference lists of articles, annual reports of major registries, summaries of safety and effectiveness for pre-market application and mandated post-market studies at the United States Food and Drug Administration. STUDY SELECTION: Criteria for inclusion were comparative studies in adults reporting information for various combinations of bearings (such as metal on metal and ceramic on ceramic). Data search, abstraction, and analyses were independently performed and confirmed by at least two authors. Qualitative data syntheses were performed. RESULTS: There were 3139 patients and 3404 hips enrolled in 18 comparative studies and over 830 000 operations in national registries. The mean age range in the trials was 42-71, and 26-88% were women. Disease specific functional outcomes and general quality of life scores were no different or they favoured patients receiving metal on polyethylene rather than metal on metal in the trials. While one clinical study reported fewer dislocations associated with metal on metal implants, in the three largest national registries there was evidence of higher rates of implant revision associated with metal on metal implants compared with metal on polyethylene. One trial reported fewer revisions with ceramic on ceramic compared with metal on polyethylene implants, but data from national registries did not support this finding. CONCLUSIONS: There is limited evidence regarding comparative effectiveness of various hip implant bearings. Results do not indicate any advantage for metal on metal or ceramic on ceramic implants compared with traditional metal on polyethylene or ceramic on polyethylene bearings.