Showing papers in "JAMA Surgery in 2017"

Enhanced Recovery After Surgery: A Review

Abstract: Importance Enhanced Recovery After Surgery (ERAS) is a paradigm shift in perioperative care, resulting in substantial improvements in clinical outcomes and cost savings. Observations Enhanced Recovery After Surgery is a multimodal, multidisciplinary approach to the care of the surgical patient. Enhanced Recovery After Surgery process implementation involves a team consisting of surgeons, anesthetists, an ERAS coordinator (often a nurse or a physician assistant), and staff from units that care for the surgical patient. The care protocol is based on published evidence. The ERAS Society, an international nonprofit professional society that promotes, develops, and implements ERAS programs, publishes updated guidelines for many operations, such as evidence-based modern care changes from overnight fasting to carbohydrate drinks 2 hours before surgery, minimally invasive approaches instead of large incisions, management of fluids to seek balance rather than large volumes of intravenous fluids, avoidance of or early removal of drains and tubes, early mobilization, and serving of drinks and food the day of the operation. Enhanced Recovery After Surgery protocols have resulted in shorter length of hospital stay by 30% to 50% and similar reductions in complications, while readmissions and costs are reduced. The elements of the protocol reduce the stress of the operation to retain anabolic homeostasis. The ERAS Society conducts structured implementation programs that are currently in use in more than 20 countries. Local ERAS teams from hospitals are trained to implement ERAS processes. Audit of process compliance and patient outcomes are important features. Enhanced Recovery After Surgery started mainly with colorectal surgery but has been shown to improve outcomes in almost all major surgical specialties. Conclusions and Relevance Enhanced Recovery After Surgery is an evidence-based care improvement process for surgical patients. Implementation of ERAS programs results in major improvements in clinical outcomes and cost, making ERAS an important example of value-based care applied to surgery.

Centers for Disease Control and Prevention Guideline for the Prevention of Surgical Site Infection, 2017

Abstract: Importance The human and financial costs of treating surgical site infections (SSIs) are increasing. The number of surgical procedures performed in the United States continues to rise, and surgical patients are initially seen with increasingly complex comorbidities. It is estimated that approximately half of SSIs are deemed preventable using evidence-based strategies. Objective To provide new and updated evidence-based recommendations for the prevention of SSI. Evidence Review A targeted systematic review of the literature was conducted in MEDLINE, EMBASE, CINAHL, and the Cochrane Library from 1998 through April 2014. A modified Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) approach was used to assess the quality of evidence and the strength of the resulting recommendation and to provide explicit links between them. Of 5759 titles and abstracts screened, 896 underwent full-text review by 2 independent reviewers. After exclusions, 170 studies were extracted into evidence tables, appraised, and synthesized. Findings Before surgery, patients should shower or bathe (full body) with soap (antimicrobial or nonantimicrobial) or an antiseptic agent on at least the night before the operative day. Antimicrobial prophylaxis should be administered only when indicated based on published clinical practice guidelines and timed such that a bactericidal concentration of the agents is established in the serum and tissues when the incision is made. In cesarean section procedures, antimicrobial prophylaxis should be administered before skin incision. Skin preparation in the operating room should be performed using an alcohol-based agent unless contraindicated. For clean and clean-contaminated procedures, additional prophylactic antimicrobial agent doses should not be administered after the surgical incision is closed in the operating room, even in the presence of a drain. Topical antimicrobial agents should not be applied to the surgical incision. During surgery, glycemic control should be implemented using blood glucose target levels less than 200 mg/dL, and normothermia should be maintained in all patients. Increased fraction of inspired oxygen should be administered during surgery and after extubation in the immediate postoperative period for patients with normal pulmonary function undergoing general anesthesia with endotracheal intubation. Transfusion of blood products should not be withheld from surgical patients as a means to prevent SSI. Conclusions and Relevance This guideline is intended to provide new and updated evidence-based recommendations for the prevention of SSI and should be incorporated into comprehensive surgical quality improvement programs to improve patient safety.

New Persistent Opioid Use After Minor and Major Surgical Procedures in US Adults.

Abstract: Importance Despite increased focus on reducing opioid prescribing for long-term pain, little is known regarding the incidence and risk factors for persistent opioid use after surgery. Objective To determine the incidence of new persistent opioid use after minor and major surgical procedures. Design, Setting, and Participants Using a nationwide insurance claims data set from 2013 to 2014, we identified US adults aged 18 to 64 years without opioid use in the year prior to surgery (ie, no opioid prescription fulfillments from 12 months to 1 month prior to the procedure). For patients filling a perioperative opioid prescription, we calculated the incidence of persistent opioid use for more than 90 days among opioid-naive patients after both minor surgical procedures (ie, varicose vein removal, laparoscopic cholecystectomy, laparoscopic appendectomy, hemorrhoidectomy, thyroidectomy, transurethral prostate surgery, parathyroidectomy, and carpal tunnel) and major surgical procedures (ie, ventral incisional hernia repair, colectomy, reflux surgery, bariatric surgery, and hysterectomy). We then assessed data for patient-level predictors of persistent opioid use. Main Outcomes and Measures The primary outcome was defined a priori prior to data extraction. The primary outcome was new persistent opioid use, which was defined as an opioid prescription fulfillment between 90 and 180 days after the surgical procedure. Results A total of 36 177 patients met the inclusion criteria, with 29 068 (80.3%) receiving minor surgical procedures and 7109 (19.7%) receiving major procedures. The cohort had a mean (SD) age of 44.6 (11.9) years and was predominately female (23 913 [66.1%]) and white (26 091 [72.1%]). The rates of new persistent opioid use were similar between the 2 groups, ranging from 5.9% to 6.5%. By comparison, the incidence in the nonoperative control cohort was only 0.4%. Risk factors independently associated with new persistent opioid use included preoperative tobacco use (adjusted odds ratio [aOR], 1.35; 95% CI, 1.21-1.49), alcohol and substance abuse disorders (aOR, 1.34; 95% CI, 1.05-1.72), mood disorders (aOR, 1.15; 95% CI, 1.01-1.30), anxiety (aOR, 1.25; 95% CI, 1.10-1.42), and preoperative pain disorders (back pain: aOR, 1.57; 95% CI, 1.42-1.75; neck pain: aOR, 1.22; 95% CI, 1.07-1.39; arthritis: aOR, 1.56; 95% CI, 1.40-1.73; and centralized pain: aOR, 1.39; 95% CI, 1.26-1.54). Conclusions and Relevance New persistent opioid use after surgery is common and is not significantly different between minor and major surgical procedures but rather associated with behavioral and pain disorders. This suggests its use is not due to surgical pain but addressable patient-level predictors. New persistent opioid use represents a common but previously underappreciated surgical complication that warrants increased awareness.

Prescription Opioid Analgesics Commonly Unused After Surgery: A Systematic Review.

Abstract: Importance Prescription opioid analgesics play an important role in the treatment of postoperative pain; however, unused opioids may be diverted for nonmedical use and contribute to opioid-related injuries and deaths. Objective To quantify how commonly postoperative prescription opioids are unused, why they remain unused, and what practices are followed regarding their storage and disposal. Evidence Review MEDLINE, EMBASE, and Cochrane Central Register of Controlled Trials were searched from database inception to October 18, 2016, for studies describing opioid oversupply for adults after a surgical procedure. The primary outcome—opioid oversupply—was defined as the number of patients with either filled but unused opioid prescriptions or unfilled opioid prescriptions. Two reviewers independently screened studies for inclusion, extracted data, and assessed the study quality. Findings Six eligible studies reported on a total of 810 unique patients (range, 30-250 patients) who underwent 7 different types of surgical procedures. Across the 6 studies, 67% to 92% of patients reported unused opioids. Of all the opioid tablets obtained by surgical patients, 42% to 71% went unused. Most patients stopped or used no opioids owing to adequate pain control, and 16% to 29% of patients reported opioid-induced adverse effects. In 2 studies examining storage safety, 73% to 77% of patients reported that their prescription opioids were not stored in locked containers. All studies reported low rates of anticipated or actual disposal, but no study reported US Food and Drug Administration–recommended disposal methods in more than 9% of patients. Conclusions and Relevance Postoperative prescription opioids often go unused, unlocked, and undisposed, suggesting an important reservoir of opioids contributing to nonmedical use of these products, which could cause injuries or even deaths.

Postoperative Multimodal Analgesia Pain Management With Nonopioid Analgesics and Techniques: A Review.

Abstract: Importance Amid the current opioid epidemic in the United States, the enhanced recovery after surgery pathway (ERAS) has emerged as one of the best strategies to improve the value and quality of surgical care and has been increasingly adopted for a broad range of complex surgical procedures. The goal of this article was to outline important components of opioid-sparing analgesic regimens. Observations Regional analgesia, acetaminophen, nonsteroidal anti-inflammatory agents, gabapentinoids, tramadol, lidocaine, and/or theN-methyl-d-aspartate class of glutamate receptor antagonists have been shown to be effective adjuncts to narcotic analgesia. Nonsteroidal anti-inflammatory agents are not associated with an increase in postoperative bleeding. A meta-analysis of 27 randomized clinical trials found no difference in postoperative bleeding between the groups taking ketorolac tromethamine (33 of 1304 patients [2.5%]) and the control groups (21 of 1010 [2.1%]) (odds ratio [OR], 1.1; 95% CI, 0.61-2.06;P = .72). After adoption of the multimodal analgesia approach for a colorectal ERAS pathway, most patients used less opioids while in the hospital and many did not need opioids after hospital discharge, although approximately 50% of patients received some opioid during their stay. Conclusions and Relevance Multimodal analgesia is readily available and the evidence is strong to support its efficacy. Surgeons should use this effective approach for patients both using and not using the ERAS pathway to reduce opioid consumption.

Seven-Year Weight Trajectories and Health Outcomes in the Longitudinal Assessment of Bariatric Surgery (LABS) Study.

Abstract: Importance More information is needed about the durability of weight loss and health improvements after bariatric surgical procedures. Objective To examine long-term weight change and health status following Roux-en-Y gastric bypass (RYGB) and laparoscopic adjustable gastric banding (LAGB). Design, setting, and participants The Longitudinal Assessment of Bariatric Surgery (LABS) study is a multicenter observational cohort study at 10 US hospitals in 6 geographically diverse clinical centers. Adults undergoing bariatric surgical procedures as part of clinical care between 2006 and 2009 were recruited and followed up until January 31, 2015. Participants completed presurgery, 6-month, and annual research assessments for up to 7 years. Main outcome and measures Percentage of weight change from baseline, diabetes, dyslipidemia, and hypertension, determined by physical measures, laboratory testing, and medication use. Results Of 2348 participants, 1738 underwent RYGB (74%) and 610 underwent LAGB (26%). For RYBG, the median age was 45 years (range, 19-75 years), the median body mass index (calculated as weight in kilograms divided by height in meters squared) was 47 (range, 34-81), 1389 participants (80%) were women, and 257 participants (15%) were nonwhite. For LAGB, the median age was 48 years (range, 18-78), the body mass index was 44 (range, 33-87), 465 participants (76%) were women, and 63 participants (10%) were nonwhite. Follow-up weights were obtained in 1300 of 1569 (83%) eligible for a year-7 visit. Seven years following RYGB, mean weight loss was 38.2 kg (95% CI, 36.9-39.5), or 28.4% (95% CI, 27.6-29.2) of baseline weight; between years 3 and 7 mean weight regain was 3.9% (95% CI, 3.4-4.4) of baseline weight. Seven years after LAGB, mean weight loss was 18.8 kg (95% CI, 16.3-21.3) or 14.9% (95% CI, 13.1-16.7), with 1.4% (95% CI, 0.4-2.4) regain. Six distinct weight change trajectory patterns for RYGB and 7 for LAGB were identified. Most participants followed trajectories in which weight regain from 3 to 7 years was small relative to year-3 weight loss, but patterns were variable. Compared with baseline, dyslipidemia prevalence was lower 7 years following both procedures; diabetes and hypertension prevalence were lower following RYGB only. Among those with diabetes at baseline (488 of 1723 with RYGB [28%]; 175 of 604 with LAGB [29%]), the proportion in remission at 1, 3, 5, and 7 years were 71.2% (95% CI, 67.0-75.4), 69.4% (95% CI, 65.0-73.8), 64.6% (95% CI, 60.0-69.2), and 60.2% (95% CI, 54.7-65.6), respectively, for RYGB and 30.7% (95% CI, 22.8-38.7), 29.3% (95% CI, 21.6-37.1), 29.2% (95% CI, 21.0-37.4), and 20.3% (95% CI, 9.7-30.9) for LAGB. The incidence of diabetes at all follow-up assessments was less than 1.5% for RYGB. Bariatric reoperations occurred in 14 RYGB and 160 LAGB participants. Conclusions and relevance Following bariatric surgery, different weight loss patterns were observed, but most participants maintained much of their weight loss with variable fluctuations over the long term. There was some decline in diabetes remission over time, but the incidence of new cases is low following RYGB. Trial registration clinicaltrials.gov Identifier: NCT00465829.

Postoperative Pulmonary Complications, Early Mortality, and Hospital Stay Following Noncardiothoracic Surgery: A Multicenter Study by the Perioperative Research Network Investigators

Abstract: Importance Postoperative pulmonary complications (PPCs), a leading cause of poor surgical outcomes, are heterogeneous in their pathophysiology, severity, and reporting accuracy. Objective To prospectively study clinical and radiological PPCs and respiratory insufficiency therapies in a high-risk surgical population. Design, Setting, and Participants We performed a multicenter prospective observational study in 7 US academic institutions. American Society of Anesthesiologists physical status 3 patients who presented for noncardiothoracic surgery requiring 2 hours or more of general anesthesia with mechanical ventilation from May to November 2014 were included in the study. We hypothesized that PPCs, even mild, would be associated with early postoperative mortality and use of hospital resources. We analyzed their association with modifiable perioperative variables. Exposure Noncardiothoracic surgery. Main Outcomes and Measures Predefined PPCs occurring within the first 7 postoperative days were prospectively identified. We used bivariable and logistic regression analyses to study the association of PPCs with ventilatory and other perioperative variables. Results This study included 1202 patients who underwent predominantly abdominal, orthopedic, and neurological procedures. The mean (SD) age of patients was 62.1 (13.8) years, and 636 (52.9%) were men. At least 1 PPC occurred in 401 patients (33.4%), mainly the need for prolonged oxygen therapy by nasal cannula (n = 235; 19.6%) and atelectasis (n = 206; 17.1%). Patients with 1 or more PPCs, even mild, had significantly increased early postoperative mortality, intensive care unit (ICU) admission, and ICU/hospital length of stay. Significant PPC risk factors included nonmodifiable (emergency [yes vs no]: odds ratio [OR], 4.47, 95% CI, 1.59-12.56; surgical site [abdominal/pelvic vs nonabdominal/pelvic]: OR, 2.54, 95% CI, 1.67-3.89; and age [in years]: OR, 1.03, 95% CI, 1.02-1.05) and potentially modifiable (colloid administration [yes vs no]: OR, 1.75, 95% CI, 1.03-2.97; preoperative oxygenation: OR, 0.86, 95% CI, 0.80-0.93; blood loss [in milliliters]: OR, 1.17, 95% CI, 1.05-1.30; anesthesia duration [in minutes]: OR, 1.14, 95% CI, 1.05-1.24; and tidal volume [in milliliters per kilogram of predicted body weight]: OR, 1.12, 95% CI, 1.01-1.24) factors. Conclusions and Relevance Postoperative pulmonary complications are common in patients with American Society of Anesthesiologists physical status 3, despite current protective ventilation practices. Even mild PPCs are associated with increased early postoperative mortality, ICU admission, and length of stay (ICU and hospital). Mild frequent PPCs (eg, atelectasis and prolonged oxygen therapy need) deserve increased attention and intervention for improving perioperative outcomes.

Safety and Outcomes of the Transoral Endoscopic Thyroidectomy Vestibular Approach

Abstract: Importance Natural orifice transluminal endoscopic surgery thyroidectomy is a novel approach to avoid surgical scars. Objective To compare the safety and outcomes of the transoral endoscopic thyroidectomy vestibular approach (TOETVA) with those of open thyroidectomy (OT). Design, Setting, and Participants This study retrospectively reviewed all TOETVA and OT operations performed from April 1, 2014, through August 31, 2016, at Police General Hospital, Bangkok, Thailand. All patients who underwent TOETVA and patients who underwent OT were included. Exclusion criteria were (1) previous neck surgery, (2) substernal goiter, (3) lymph node or distance metastasis, and (4) suspicious invasion to the adjacent organs. Propensity score matching was conducted to reduce selective bias. Main Outcomes and Measures Operative time, blood loss, and complications related to thyroid surgery. Results Of the 425 patients who underwent transoral endoscopic thyroidectomy (mean age, 35.3 [12.1] years; age range, 16-81 years; 389 [92.2%] female), 422 successfully were treated with the TOETVA; 3 patients were converted to a conventional operation because of bleeding. Twenty-five patients (5.9%) had transient recurrent laryngeal nerve palsy, and 46 (10.9%) had transient hypoparathyroidism. None had permanent recurrent laryngeal nerve palsy or permanent hypoparathyroidism. Three patients (0.7%) had transient mental nerve injury; all cases resolved by 4 months. One patient developed postoperative hematoma treated by OT. Twenty patients (4.7%) had seroma treated by simple aspiration. Operative time was longer for the TOETVA compared with the OT group (100.8 [39.7] vs 79.4 [32.1] minutes,P = 1.61 × 10−10). The mean (SD) visual analog scale score for pain was lower in the TOETVA group (1.1 [1.2] vs 2.8 [1.2],P = 2.52 × 10−38). Estimated mean (SD) blood loss (36.9 [32.4] vs 37.6 [23.1] mL,P = .43) and rate of complications (45 of 216 [20.8%] vs 38 of 216 [17.6%],P = .41) were not significantly different in the TOETVA vs OT group. Conclusions and Relevance The TOETVA was performed as safely as OT, requires only conventional laparoscopic instruments, and avoids incisional scars; thus, the approach may be an option for select patients.

Reduction in Opioid Prescribing Through Evidence-Based Prescribing Guidelines

Abstract: This interrupted time series analysis found significant changes in multiple dimensions of pain medication usage after the implementation of postoperative opioid prescription guidelines in a single hospital.

Development and Initial Validation of the Risk Analysis Index for Measuring Frailty in Surgical Populations.

Abstract: Importance Growing consensus suggests that frailty-associated risks should inform shared surgical decision making. However, it is not clear how best to screen for frailty in preoperative surgical populations. Objective To develop and validate the Risk Analysis Index (RAI), a 14-item instrument used to measure surgical frailty. It can be calculated prospectively (RAI-C), using a clinical questionnaire, or retrospectively (RAI-A), using variables from the surgical quality improvement databases (Veterans Affairs or American College of Surgeons National Surgical Quality Improvement Projects). Design, Setting, and Participants Single-site, prospective cohort from July 2011 to September 2015 at the Veterans Affairs Nebraska–Western Iowa Heath Care System, a Level 1b Veterans Affairs Medical Center. The study included all patients presenting to the medical center for elective surgery. Exposures We assessed the RAI-C for all patients scheduled for surgery, linking these scores to administrative and quality improvement data to calculate the RAI-A and the modified Frailty Index. Main Outcomes and Measures Receiver operator characteristics and C statistics for each measure predicting postoperative mortality and morbidity. Results Of the participants, the mean (SD) age was 60.7 (13.9) years and 249 participants (3.6%) were women. We assessed the RAI-C 10 698 times, from which we linked 6856 unique patients to mortality data. The C statistic predicting 180-day mortality for the RAI-C was 0.772. Of these 6856 unique patients, we linked 2785 to local Veterans Affairs Surgeons National Surgical Quality Improvement Projects data and calculated the C statistic for both the RAI-A (0.823) and RAI-C (0.824), along with the correlation between the 2 scores ( r = 0.478; P P Conclusions and Relevance The RAI-C and RAI-A represent effective tools for measuring frailty in surgical populations with predictive ability on par with other frailty tools. Moderate correlation between the measures suggests convergent validity. The RAI-C offers the advantage of prospective, preoperative assessment that is proved feasible for large-scale screening in clinical practice. However, further efforts should be directed at determining the optimal components of preoperative frailty assessment.

Prevalence of Work-Related Musculoskeletal Disorders Among Surgeons and Interventionalists: A Systematic Review and Meta-analysis.

Abstract: Importance Physicians in procedural specialties are at high risk for work-related musculoskeletal disorders (MSDs). This has been called “an impending epidemic” in the context of the looming workforce shortage; however, prevalence estimates vary by study. Objectives To estimate the prevalence of work-related MSDs among at-risk physicians and to evaluate the scope of preventive efforts. Data Sources and Study Selection Systematic search in MEDLINE (Ovid), Embase (Elsevier), Web of Science, PubMed (National Center for Biotechnology Information), and 2 clinical trial registries, without language restriction, for studies reporting on the prevalence and prevention of work-related MSDs among at-risk physicians published until December 2016. The Meta-analysis of Observational Studies in Epidemiology (MOOSE) guidelines for meta-analyses and systematic reviews of observational studies were used. At-risk physicians were defined as surgeons and medical interventionalists. Studies reporting on specific disorders or pain assessed with validated instruments were included. Data Extraction and Synthesis Study characteristics; disease prevalence for the neck, shoulder, back, and upper extremity; and measures of resulting disability were recorded. Study estimates were pooled using random-effects meta-analytic models. Main Outcomes and Measures Career prevalence of injuries and 12-month prevalence of pain. Results Among 21 articles (5828 physicians [mean age, 46.0 years; 78.5% male; 12.8 years in practice; 14.4 hours performing procedures per week]) included in this systematic review and meta-analysis, pooled crude prevalence estimates of the most common work-related MSDs were degenerative cervical spine disease in 17% (457 of 2406 physicians) (95% CI, 12%-25%), rotator cuff pathology in 18% (300 of 1513 physicians) (95% CI, 13%-25%), degenerative lumbar spine disease in 19% (544 of 2449 physicians) (95% CI, 5%-16%), and carpal tunnel syndrome in 9% (256 of 2449 physicians) (95% CI, 5%-16%). From 1997 to 2015, the prevalence of degenerative cervical spine disease and degenerative lumbar spine disease increased by 18.3% and 27%, respectively. Pooled prevalence estimates for pain ranged from 35% to 60% and differed by assessment instrument. Of those with a work-related MSD, 12% (277 of 2319 physicians) (95% CI, 7%-18%) required a leave of absence, practice restriction or modification, or early retirement. Heterogeneity was considerable for all crude analyses (meanI2 = 93.5%) but was lower for sensitivity analyses (meanI2 = 72.3%). Interventions focused on products and behaviors. Twelve at-risk specialties described a gross lack of awareness and an unmet need for ergonomics education. Conclusions and Relevance Prevalence estimates of work-related MSDs among at-risk physicians appear to be high. Further research is needed to develop and validate an evidence-based applied ergonomics program aimed at preventing these disorders in this population.

Health Disparities and Triple-Negative Breast Cancer in African American Women: A Review

Abstract: Importance Variation in cancer incidence and outcome has well-documented correlations with racial/ethnic identity. In the United States, the possible genetic and ancestral hereditary explanations for these associations are confounded by socioeconomic, cultural, and lifestyle patterns. Differences in the breast cancer burden of African American compared with European/white American women represent one of the most notable examples of disparities in oncology related to racial/ethnic identity. Elucidating the source of these associations is imperative in achieving the promise of the national Precision Medicine Initiative. Observations Population-based breast cancer mortality rates have been higher for African American compared with white American women since the early 1980s, largely reflecting declines in mortality that have been disproportionately experienced among white American patients and at least partly explained by the advent of endocrine therapy that is less effective in African American women because of the higher prevalence of estrogen receptor–negative disease. The increased risk of triple-negative breast cancer in African American women as well as western, sub-Saharan African women compared with white American, European, and east African women furthermore suggests that selected genetic components of geographically defined African ancestry are associated with hereditary susceptibility for specific patterns of mammary carcinogenesis. Disentangling health care access barriers, as well as reproductive, lifestyle, and dietary factors from genetic contributions to breast cancer disparities remains challenging. Epigenetics and experiences of societal inequality (allostatic load) increase the complexity of studying breast cancer risk related to racial/ethnic identity. Conclusions and Relevance Oncologic anthropology represents a transdisciplinary field of research that can combine the expertise of population geneticists, multispecialty oncologists, molecular epidemiologists, and behavioral scientists to eliminate breast cancer disparities related to racial/ethnic identity and advance knowledge related to the pathogenesis of triple-negative breast cancer.

Intraoperative Infusion of Dexmedetomidine for Prevention of Postoperative Delirium and Cognitive Dysfunction in Elderly Patients Undergoing Major Elective Noncardiac Surgery: A Randomized Clinical Trial.

Abstract: Importance Postoperative delirium occurs in 10% to 60% of elderly patients having major surgery and is associated with longer hospital stays, increased hospital costs, and 1-year mortality. Emerging literature suggests that dexmedetomidine sedation in critical care units is associated with reduced incidence of delirium. However, intraoperative use of dexmedetomidine for prevention of delirium has not been well studied. Objective To evaluate whether an intraoperative infusion of dexmedetomidine reduces postoperative delirium. Design, Setting, and Participants This study was a multicenter, double-blind, randomized, placebo-controlled trial that randomly assigned patients to dexmedetomidine or saline placebo infused during surgery and for 2 hours in the recovery room. Patients were assessed daily for postoperative delirium (primary outcome) and secondarily for postoperative cognitive decline. Participants were elderly (>68 years) patients undergoing major elective noncardiac surgery. The study dates were February 2008 to May 2014. Interventions Dexmedetomidine infusion (0.5 µg/kg/h) during surgery and up to 2 hours in the recovery room. Main Outcomes and Measures The primary hypothesis tested was that intraoperative dexmedetomidine administration would reduce postoperative delirium. Secondarily, the study examined the correlation between dexmedetomidine use and postoperative cognitive change. Results In total, 404 patients were randomized; 390 completed in-hospital delirium assessments (median [interquartile range] age, 74.0 [71.0-78.0] years; 51.3% [200 of 390] female). There was no difference in postoperative delirium between the dexmedetomidine and placebo groups (12.2% [23 of 189] vs 11.4% [23 of 201],P = .94). After adjustment for age and educational level, there was no difference in the postoperative cognitive performance between treatment groups at 3 months and 6 months. Adverse events were comparably distributed in the treatment groups. Conclusions and Relevance Intraoperative dexmedetomidine does not prevent postoperative delirium. The reduction in delirium previously demonstrated in numerous surgical intensive care unit studies was not observed, which underscores the importance of timing when administering the drug to prevent delirium. Trial Registration clinicaltrials.gov IdentifierNCT00561678

A Framework to Improve Surgeon Communication in High-Stakes Surgical Decisions: Best Case/Worst Case.

Abstract: Importance Although many older adults prefer to avoid burdensome interventions with limited ability to preserve their functional status, aggressive treatments, including surgery, are common near the end of life. Shared decision making is critical to achieve value-concordant treatment decisions and minimize unwanted care. However, communication in the acute inpatient setting is challenging. Objective To evaluate the proof of concept of an intervention to teach surgeons to use the Best Case/Worst Case framework as a strategy to change surgeon communication and promote shared decision making during high-stakes surgical decisions. Design, Setting, and Participants Our prospective pre-post study was conducted from June 2014 to August 2015, and data were analyzed using a mixed methods approach. The data were drawn from decision-making conversations between 32 older inpatients with an acute nonemergent surgical problem, 30 family members, and 25 surgeons at 1 tertiary care hospital in Madison, Wisconsin. Interventions A 2-hour training session to teach each study-enrolled surgeon to use the Best Case/Worst Case communication framework. Main Outcomes and Measures We scored conversation transcripts using OPTION 5, an observer measure of shared decision making, and used qualitative content analysis to characterize patterns in conversation structure, description of outcomes, and deliberation over treatment alternatives. Results The study participants were patients aged 68 to 95 years (n = 32), 44% of whom had 5 or more comorbid conditions; family members of patients (n = 30); and surgeons (n = 17). The median OPTION 5 score improved from 41 preintervention (interquartile range, 26-66) to 74 after Best Case/Worst Case training (interquartile range, 60-81). Before training, surgeons described the patient’s problem in conjunction with an operative solution, directed deliberation over options, listed discrete procedural risks, and did not integrate preferences into a treatment recommendation. After training, surgeons using Best Case/Worst Case clearly presented a choice between treatments, described a range of postoperative trajectories including functional decline, and involved patients and families in deliberation. Conclusions and Relevance Using the Best Case/Worst Case framework changed surgeon communication by shifting the focus of decision-making conversations from an isolated surgical problem to a discussion about treatment alternatives and outcomes. This intervention can help surgeons structure challenging conversations to promote shared decision making in the acute setting.

Breast Implant-Associated Anaplastic Large Cell Lymphoma: A Systematic Review.

Abstract: Importance Breast implant–associated anaplastic large cell lymphoma (BIA-ALCL), a rare peripheral T-cell lymphoma, is increasing in incidence. However, many practitioners who treat patients with breast cancer are not aware of this disease. Objectives To assess how BIA-ALCL develops, its risk factors, diagnosis, and subsequent treatment and to disseminate information about this entity to the medical field. Evidence Review A literature review was performed in an academic medical setting. All review articles, case reports, original research articles, and any other articles relevant to BIA-ALCL were included. Data on BIA-ALCL, such as pathophysiology, patient demographics, presentation, diagnosis, treatment, and outcomes, were extracted. Particular focus was paid to age, time to onset, implant type, initial symptoms, treatment, and survival. The search was conducted in January 2017 for studies published in any year. Findings After duplicates were excluded, 304 relevant articles were assessed, and 115 were included from the first documented case in August 1997 through January 2017. Thirty review articles, 44 case reports or series, 15 original research articles, and 26 “other” articles (eg, techniques, special topics, letters) were reviewed. A total of 93 cases have been reported in the literature, and with the addition of 2 unreported cases from the Penn State Health Milton S. Hershey Medical Center, 95 patients were included in this systematic review. Almost all documented BIA-ALCL cases have been associated with a textured device. The underlying mechanism is thought to be due to chronic inflammation from indolent infections, leading to malignant transformation of T cells that are anaplastic lymphoma kinase (ALK) negative and CD30 positive. The mean time to presentation is approximately 10 years after implant placement, with 55 of 83 (66%) patients initially seen with an isolated late-onset seroma and 7 of 83 (8%) with an isolated new breast mass. Ultrasonography with fluid aspiration can be used for diagnosis. Treatment must include removal of the implant and surrounding capsule. More advanced disease may require chemotherapy, radiotherapy, and lymph node dissection. Conclusions and Relevance Breast implant–associated anaplastic large cell lymphoma is a rare cancer in patients with breast implants but is increasing in incidence. It is important for all physicians involved in the care of patients with breast implants to be aware of this entity and be able to recognize initial symptoms.

Risk Associated With Complications and Mortality After Urgent Surgery vs Elective and Emergency Surgery: Implications for Defining "Quality" and Reporting Outcomes for Urgent Surgery.

Abstract: Importance Given the current climate of outcomes-driven quality reporting, it is critical to appropriately risk stratify patients using standardized metrics. Objective To elucidate the risk associated with urgent surgery on complications and mortality after general surgical procedures. Design, Setting, and Participants This retrospective review used the American College of Surgeons National Surgery Quality Improvement Program database to capture all general surgery cases performed at 435 hospitals nationwide between January 1, 2013, and December 31, 2013. Data analysis was performed from November 11, 2015, to February 16, 2017. Exposures Any operations coded as both nonelective and nonemergency were designated into a novel category titled urgent . Main Outcomes and Measures The primary outcome was 30-day mortality; secondary outcomes included 30-day rates of complications, reoperation, and readmission in urgent cases compared with both elective and emergency cases. Results Of 173 643 patients undergoing general surgery (101 632 females and 72 011 males), 130 235 (75.0%) were categorized as elective, 22 592 (13.0%) as emergency, and 20 816 (12.0%) as nonelective and nonemergency. When controlling for standard American College of Surgeons National Surgery Quality Improvement Program preoperative risk factors, with elective surgery as the reference value, the 3 groups had significantly distinct odds ratios (ORs) of experiencing any complication (urgent surgery: OR, 1.38; 95% CI, 1.30-1.45; P P P P Conclusions and Relevance This study highlights the need for improved risk stratification on the basis of urgency because operations performed urgently have distinct rates of morbidity and mortality compared with procedures performed either electively or emergently. Because we tie quality outcomes to reimbursement, such a category should improve predictive models and more accurately reflect the quality and value of care provided by surgeons who do not have traditional elective practices.

Defining Optimal Length of Opioid Pain Medication Prescription After Common Surgical Procedures.

Abstract: Importance The overprescription of pain medications has been implicated as a driver of the burgeoning opioid epidemic; however, few guidelines exist regarding the appropriateness of opioid pain medication prescriptions after surgery. Objectives To describe patterns of opioid pain medication prescriptions after common surgical procedures and determine the appropriateness of the prescription as indicated by the rate of refills. Design, Setting, and Participants The Department of Defense Military Health System Data Repository was used to identify opioid-naive individuals 18 to 64 years of age who had undergone 1 of 8 common surgical procedures between January 1, 2005, and September 30, 2014. The adjusted risk of refilling an opioid prescription based on the number of days of initial prescription was modeled using a generalized additive model with spline smoothing. Exposures Length of initial prescription for opioid pain medication. Main Outcomes and Measures Need for an additional subsequent prescription for opioid pain medication, or a refill. Results Of the 215 140 individuals (107 588 women and 107 552 men; mean [SD] age, 40.1 [12.8] years) who underwent a procedure within the study time frame and received and filled at least 1 prescription for opioid pain medication within 14 days of their index procedure, 41 107 (19.1%) received at least 1 refill prescription. The median prescription lengths were 4 days (interquartile range [IQR], 3-5 days) for appendectomy and cholecystectomy, 5 days (IQR, 3-6 days) for inguinal hernia repair, 4 days (IQR, 3-5 days) for hysterectomy, 5 days (IQR, 3-6 days) for mastectomy, 5 days (IQR, 4-8 days) for anterior cruciate ligament repair and rotator cuff repair, and 7 days (IQR, 5-10 days) for discectomy. The early nadir in the probability of refill was at an initial prescription of 9 days for general surgery procedures (probability of refill, 10.7%), 13 days for women’s health procedures (probability of refill, 16.8%), and 15 days for musculoskeletal procedures (probability of refill, 32.5%). Conclusions and Relevance Ideally, opioid prescriptions after surgery should balance adequate pain management against the duration of treatment. In practice, the optimal length of opioid prescriptions lies between the observed median prescription length and the early nadir, or 4 to 9 days for general surgery procedures, 4 to 13 days for women’s health procedures, and 6 to 15 days for musculoskeletal procedures.

Effect of Perioperative Gabapentin on Postoperative Pain Resolution and Opioid Cessation in a Mixed Surgical Cohort: A Randomized Clinical Trial.

Abstract: Importance Guidelines recommend using gabapentin to decrease postoperative pain and opioid use, but significant variation exists in clinical practice. Objective To determine the effect of perioperative gabapentin on remote postoperative time to pain resolution and opioid cessation. Design, Setting, and Participants A randomized, double-blind, placebo-controlled trial of perioperative gabapentin was conducted at a single-center, tertiary referral teaching hospital. A total of 1805 patients aged 18 to 75 years scheduled for surgery (thoracotomy, video-assisted thoracoscopic surgery, total hip replacement, total knee replacement, mastectomy, breast lumpectomy, hand surgery, carpal tunnel surgery, knee arthroscopy, shoulder arthroplasty, and shoulder arthroscopy) were screened. Participants were enrolled from May 25, 2010, to July 25, 2014, and followed up for 2 years postoperatively. Intention-to-treat analysis was used in evaluation of the findings. Interventions Gabapentin, 1200 mg, preoperatively and 600 mg, 3 times a day postoperatively or active placebo (lorazepam, 0.5 mg) preoperatively followed by inactive placebo postoperatively for 72 hours. Main Outcomes and Measures Primary outcome was time to pain resolution (5 consecutive reports of 0 of 10 possible levels of average pain at the surgical site on the numeric rating scale of pain). Secondary outcomes were time to opioid cessation (5 consecutive reports of no opioid use) and the proportion of participants with continued pain or opioid use at 6 months and 1 year. Results Of 1805 patients screened for enrollment, 1383 were excluded, including 926 who did not meet inclusion criteria and 273 who declined to participate. Overall, 8% of patients randomized were lost to follow-up. A total of 202 patients were randomized to active placebo and 208 patients were randomized to gabapentin in the intention-to-treat analysis (mean [SD] age, 56.7 [11.7] years; 256 (62.4%) women and 154 (37.6%) men). Baseline characteristics of the groups were similar. Perioperative gabapentin did not affect time to pain cessation (hazard ratio [HR], 1.04; 95% CI, 0.82-1.33; P = .73) in the intention-to-treat analysis. However, participants receiving gabapentin had a 24% increase in the rate of opioid cessation after surgery (HR, 1.24; 95% CI, 1.00-1.54; P = .05). No significant differences were noted in the number of adverse events as well as the rate of medication discontinuation due to sedation or dizziness (placebo, 42 of 202 [20.8%]; gabapentin, 52 of 208 [25.0%]). Conclusions and Relevance Perioperative administration of gabapentin had no effect on postoperative pain resolution, but it had a modest effect on promoting opioid cessation after surgery. The routine use of perioperative gabapentin may be warranted to promote opioid cessation and prevent chronic opioid use. Optimal dosing and timing of perioperative gabapentin in the context of specific operations to decrease opioid use should be addressed in further research. Trial Registration clinicaltrials.gov Identifier:NCT01067144

Association of the Modified Frailty Index With 30-Day Surgical Readmission.

Abstract: Importance Frail patients are known to have poor perioperative outcomes. There is a paucity of literature investigating how the Modified Frailty Index (mFI), a validated measure of frailty, is associated with unplanned readmission among military veterans following surgery. Objective To understand the association between frailty and 30-day postoperative unplanned readmission. Design, Setting, and Participants A retrospective cohort study was conducted among adult patients who underwent surgery and were discharged alive from Veterans Affairs hospitals for orthopedic, general, and vascular conditions between October 1, 2007, and September 30, 2014, with a postoperative length of stay between 2 and 30 days. Exposure Frailty, as calculated by the 11 variables on the mFI. Main Outcomes and Measures The primary outcome of interest is 30-day unplanned readmission. Secondary outcomes included any 30-day predischarge or postdischarge complication, 30-day postdischarge mortality, and 30-day emergency department visit. Results The study sample included 236 957 surgical procedures (among 223 877 men and 13 080 women; mean [SD] age, 64.0 [11.3] years) from high-volume surgical specialties: 101 348 procedures (42.8%) in orthopedic surgery, 92 808 procedures (39.2%) in general surgery, and 42 801 procedures (18.1%) in vascular surgery. The mFI was associated with readmission (odds ratio [OR], 1.11; 95% CI, 1.10-1.12;R2 = 10.3%; C statistic, 0.71). Unadjusted rates of overall 30-day readmission (26 262 [11.1%]), postdischarge emergency department visit (34 204 [14.4%]), any predischarge (13 855 [5.9%]) or postdischarge (14 836 [6.3%]) complication, and postdischarge mortality (1985 [0.8%]) varied by frailty in a dose-dependent fashion. In analysis by individual mFI components using Harrell ranking, impaired functional status, identified as nonindependent functional status (OR, 1.16; 95% CI, 1.11-1.21;P Conclusions and Relevance The mFI is associated with poor surgical outcomes, including readmission, primarily due to impaired functional status. Targeting potentially modifiable aspects of frailty preoperatively, such as improving functional status, may improve perioperative outcomes and decrease readmissions.

Drug-Free Interventions to Reduce Pain or Opioid Consumption After Total Knee Arthroplasty: A Systematic Review and Meta-analysis.

Abstract: Importance There is increased interest in nonpharmacological treatments to reduce pain after total knee arthroplasty. Yet, little consensus supports the effectiveness of these interventions. Objective To systematically review and meta-analyze evidence of nonpharmacological interventions for postoperative pain management after total knee arthroplasty. Data Sources Database searches of MEDLINE (PubMed), EMBASE (OVID), Cochrane Central Register of Controlled Trials (CENTRAL), Cochrane Database of Systematic Reviews, Web of Science (ISI database), Physiotherapy Evidence (PEDRO) database, and ClinicalTrials.gov for the period between January 1946 and April 2016. Study Selection Randomized clinical trials comparing nonpharmacological interventions with other interventions in combination with standard care were included. Data Extraction and Synthesis Two reviewers independently extracted the data from selected articles using a standardized form and assessed the risk of bias. A random-effects model was used for the analyses. Main Outcomes and Measures Postoperative pain and consumption of opioids and analgesics. Results Of 5509 studies, 39 randomized clinical trials were included in the meta-analysis (2391 patients). The most commonly performed interventions included continuous passive motion, preoperative exercise, cryotherapy, electrotherapy, and acupuncture. Moderate-certainty evidence showed that electrotherapy reduced the use of opioids (mean difference, −3.50; 95% CI, −5.90 to −1.10 morphine equivalents in milligrams per kilogram per 48 hours; P = .004; I2 = 17%) and that acupuncture delayed opioid use (mean difference, 46.17; 95% CI, 20.84 to 71.50 minutes to the first patient-controlled analgesia; P I2 = 19%). There was low-certainty evidence that acupuncture improved pain (mean difference, −1.14; 95% CI, −1.90 to −0.38 on a visual analog scale at 2 days; P = .003; I2 = 0%). Very low-certainty evidence showed that cryotherapy was associated with a reduction in opioid consumption (mean difference, −0.13; 95% CI, −0.26 to −0.01 morphine equivalents in milligrams per kilogram per 48 hours; P = .03; I2 = 86%) and in pain improvement (mean difference, −0.51; 95% CI, −1.00 to −0.02 on the visual analog scale; P I2 = 62%). Low-certainty or very low-certainty evidence showed that continuous passive motion and preoperative exercise had no pain improvement and reduction in opioid consumption: for continuous passive motion, the mean differences were −0.05 (95% CI, −0.35 to 0.25) on the visual analog scale ( P = .74; I2 = 52%) and 6.58 (95% CI, −6.33 to 19.49) opioid consumption at 1 and 2 weeks ( P = .32, I2 = 87%), and for preoperative exercise, the mean difference was −0.14 (95% CI, −1.11 to 0.84) on the Western Ontario and McMaster Universities Arthritis Index Scale ( P = .78, I2 = 65%). Conclusions and Relevance In this meta-analysis, electrotherapy and acupuncture after total knee arthroplasty were associated with reduced and delayed opioid consumption.

Effect of a Modified Hospital Elder Life Program on Delirium and Length of Hospital Stay in Patients Undergoing Abdominal Surgery: A Cluster Randomized Clinical Trial.

Abstract: Importance Older patients undergoing abdominal surgery commonly experience preventable delirium, which extends their hospital length of stay (LOS). Objective To examine whether a modified Hospital Elder Life Program (mHELP) reduces incident delirium and LOS in older patients undergoing abdominal surgery. Design, Setting, and Participants This cluster randomized clinical trial of 577 eligible patients enrolled 377 older patients (≥65 years of age) undergoing gastrectomy, pancreaticoduodenectomy, and colectomy at a 2000-bed urban medical center in Taipei, Taiwan, from August 1, 2009, through October 31, 2012. Consecutive older patients scheduled for elective abdominal surgery with expected LOS longer than 6 days were enrolled, with a recruitment rate of 65.3%. Participants were cluster randomized by room to receive the mHELP or usual care. Interventions The intervention (implemented by an mHELP nurse) consisted of 3 protocols administered daily: orienting communication, oral and nutritional assistance, and early mobilization. Intervention group participants received all 3 mHELP protocols postoperatively, in addition to usual care, as soon as they arrived in the inpatient ward and until hospital discharge. Adherence to protocols was tracked daily. Main Outcomes and Measures Presence of delirium was assessed daily by 2 trained nurses who were masked to intervention status by using the Confusion Assessment Method. Data on LOS were abstracted from the medical record. Results Of 577 eligible patients, 377 (65.3%) were enrolled and randomly assigned to the mHELP (n = 197; mean [SD] age, 74.3 [5.8] years; 111 [56.4%] male) or control (n = 180; mean [SD] age, 74.8 [6.0] years; 103 [57.2%] male) group. Postoperative delirium occurred in 13 of 196 (6.6%) mHELP participants vs 27 of 179 (15.1%) control individuals, representing a relative risk of 0.44 in the mHELP group (95% CI, 0.23–0.83;P = .008). Intervention group participants received the mHELP for a median of 7 days (interquartile range, 6–10 days) and had a shorter median LOS (12.0 days) than control participants (14.0 days) (P = .04). Conclusions and Relevance For older patients undergoing abdominal surgery who received the mHELP, the odds of delirium were reduced by 56% and LOS was reduced by 2 days. Our findings support using the mHELP to advance postoperative care for older patients undergoing major abdominal surgery. Trial Registration clinicaltrials.gov Identifier:NCT01045330.

Enhanced Recovery After Surgery Program Implementation in 2 Surgical Populations in an Integrated Health Care Delivery System.

Abstract: Importance Novel approaches to perioperative surgical care focus on optimizing nutrition, mobility, and pain management to minimize adverse events after surgical procedures. Objective To evaluate the outcomes of an enhanced recovery after surgery (ERAS) program among 2 target populations: patients undergoing elective colorectal resection and patients undergoing emergency hip fracture repair. Design, Setting, and Participants A pre-post difference-in-differences study before and after ERAS implementation in the target populations compared with contemporaneous surgical comparator groups (patients undergoing elective gastrointestinal surgery and emergency orthopedic surgery). Implementation began in February and March 2014 and concluded by the end of 2014 at 20 medical centers within the Kaiser Permanente Northern California integrated health care delivery system. Exposures A multifaceted ERAS program designed with a particular focus on perioperative pain management, mobility, nutrition, and patient engagement. Main Outcomes and Measures The primary outcome was hospital length of stay. Secondary outcomes included hospital mortality, home discharge, 30-day readmission rates, and complication rates. Results The study included a total of 3768 patients undergoing elective colorectal resection (mean [SD] age, 62.7 [14.1] years; 1812 [48.1%] male) and 5002 patients undergoing emergency hip fracture repair (mean [SD] age, 79.5 [11.8] years; 1586 [31.7%] male). Comparator surgical patients included 5556 patients undergoing elective gastrointestinal surgery and 1523 patients undergoing emergency orthopedic surgery. Most process metrics had significantly greater changes in the ERAS target populations after implementation compared with comparator surgical populations, including those for ambulation, nutrition, and opioid use. Hospital length of stay and postoperative complication rates were also significantly lower among ERAS target populations after implementation. The rate ratios for postoperative complications were 0.68 (95% CI, 0.46-0.99; P = .04) for patients undergoing colorectal resection and 0.67 (95% CI, 0.45-0.99, P = .05) for patients with hip fracture. Among patients undergoing colorectal resection, ERAS implementation was associated with decreased rates of hospital mortality (0.17; 95% CI, 0.03-0.86; P = .03), whereas among patients with hip fracture, implementation was associated with increased rates of home discharge (1.24; 95% CI, 1.06-1.44; P = .007). Conclusions and Relevance Multicenter implementation of an ERAS program among patients undergoing elective colorectal resection and patients undergoing emergency hip fracture repair successfully altered processes of care and was associated with significant absolute and relative decreases in hospital length of stay and postoperative complication rates. Rapid, large-scale implementation of a multidisciplinary ERAS program is feasible and effective in improving surgical outcomes.

Identification of Patients With Documented Pathologic Complete Response in the Breast After Neoadjuvant Chemotherapy for Omission of Axillary Surgery

Abstract: Importance A pathologic complete response (pCR; no invasive or in situ cancer) occurs in 40% to 50% of patients with HER2 -positive ( HER2 +) and triple-negative (TN) breast cancer. The need for surgery if percutaneous biopsy of the breast after neoadjuvant chemotherapy (NCT) indicates pCR in the breast (hereinafter referred to as breast pCR) has been questioned, and appropriate management of the axilla in such patients is unknown. Objective To identify patients among exceptional responders to NCT with a low risk for axillary metastases when breast pCR is documented who may be eligible for an omission of surgery clinical trial design. Design, Setting, and Participants This prospective cohort study at a single-institution academic national comprehensive cancer center included 527 consecutive patients with HER2 +/TN (T1/T2 and N0/N1) cancer treated with NCT followed by standard breast and nodal surgery from January 1, 2010, through December 31, 2014. Main Outcomes and Measures Patients who achieved a breast pCR were compared with patients who did not based on subtype, initial ultrasonographic findings, and documented pathologic nodal status. Incidence of positive findings for nodal disease on final pathologic review was calculated for patients with and without pCR and compared using relative risk ratios with 95% CIs. Results The analysis included 527 patients (median age, 51 [range, 23-84] years). Among 290 patients with initial nodal ultrasonography showing N0 disease, 116 (40.4%) had a breast pCR and 100% had no evidence of axillary lymph node metastases after NCT. Among 237 patients with initial biopsy-proved N1 disease, 69 of 77 (89.6%) with and 68 of 160 (42.5%) without a breast pCR had no evidence of residual nodal disease ( P P Conclusions and Relevance Breast pCR is highly correlated with nodal status after NCT, and the risk for missing nodal metastases without axillary surgery in this cohort is extremely low. These data provide the fundamental basis and rationale for management of the axilla in clinical trials of omission of cancer surgery when image-guided biopsy indicates a breast pCR.

Oncologic Safety of Prophylactic Nipple-Sparing Mastectomy in a Population With BRCA Mutations: A Multi-institutional Study.

Abstract: Importance Nipple-sparing mastectomy (NSM) offers superior cosmetic outcomes and has been gaining wide acceptance; however, its role among patients withBRCAmutations remains controversial. Objective To report on the oncologic safety of NSM and provide evidence-based data to patients and health care professionals regarding preservation of the nipple-areolar complex during a risk-reducing mastectomy in a population withBRCAmutations. Design, Setting, and Participants We retrospectively reviewed the outcomes of 9 institutions’ experience with prophylactic NSM from 1968 to 2013 in a cohort of patients withBRCAmutations. Patients with breast cancer were included if they underwent contralateral risk-reducing mastectomy; however, only the prophylactic side was considered in the analysis. Patients found to have an occult primary breast cancer at the time of risk-reducing mastectomy, those having variant(s) of unknown significance, and those undergoing free nipple grafts were excluded. Main Outcomes and Measures The primary outcome measure was development of a new breast cancer after risk-reducing NSM. Three reference data sources were used to model the expected number of events, and this was compared with our observed number of events. Results A total of 548 risk-reducing NSMs in 346 patients were performed at 9 institutions. The median age at NSM was 41 years (interquartile range, 34.5-47.5 years). Bilateral prophylactic NSMs were performed in 202 patients (58.4%), and 144 patients (41.6%) underwent a unilateral risk-reducing NSM secondary to cancer in the contralateral breast. Overall, 201 patients withBRCA1mutations and 145 withBRCA2mutations were included. With median and mean follow-up of 34 and 56 months, respectively, no ipsilateral breast cancers occurred after prophylactic NSM. Breast cancer did not develop in any patients undergoing bilateral risk-reducing NSMs. Using risk models forBRCA1/2mutation carriers, approximately 22 new primary breast cancers were expected without prophylactic NSM. Prophylactic NSM resulted in a significant reduction in breast cancer events (test of observed vs expected events,P Conclusions and Relevance Nipple-sparing mastectomies are highly preventive against breast cancer in aBRCApopulation. Although the follow-up remains relatively short, NSM should be offered as a breast cancer risk–reducing strategy to appropriate patients withBRCAmutations.

Use of Resuscitative Endovascular Balloon Occlusion of the Aorta for Proximal Aortic Control in Patients With Severe Hemorrhage and Arrest.

Abstract: Importance Resuscitative endovascular balloon occlusion of the aorta (REBOA) is a percutaneous transfemoral balloon technique used in select centers for resuscitation and temporary hemostasis, often instead of emergency department thoracotomy. The ability to perform aortic occlusion (AO) with an intravascular device allows focused occlusion at the most distal level to perfuse proximal regions while slowing hemorrhage to injured areas. Objective To describe what is to date the largest single-institution experience with REBOA in the United States. Design, Setting, and Participants Use of REBOA at an urban tertiary care facility for severe traumatic hemorrhage, traumatic arrest (AR), or nontraumatic hemorrhage (NTH) was investigated from February 1, 2013, to January 31, 2017, among 90 patients who were not responsive or were transiently responsive to resuscitation measures, or were in arrest, from presumed hemorrhage below the diaphragm. Possible causes were trauma or nontrauma-related hemorrhage. Patients with ruptured aortic aneurysms were excluded. Main Outcomes and Measures In-hospital mortality. Results Of the 90 patients in the study (15 women and 75 men; mean [SD] age, 41.5 [17.4] years), 29 underwent REBOA for severe traumatic hemorrhage, 50 for AR, and 11 for NTH. For the patients with severe traumatic hemorrhage and AR, the median age was 36.2 years (interquartile range, 25.3-55.5 years), mean (SD) admission Glasgow Coma Scale score was 6 (5), and median Injury Severity Score was 39 (interquartile range, 10-75). The distal thoracic aorta was occluded in 73 patients (81%), and in all patients with AR. A total of 17 patients (19%) had distal abdominal AO. Mean (SD) systolic blood pressure improved in patients with severe traumatic hemorrhage, from 68 (28) mm Hg prior to AO, to 131 (12) mm Hg after AO ( P Conclusions and Relevance REBOA is a minimally invasive alternative to emergency department thoracotomy with aortic cross-clamp to temporize noncompressible torso hemorrhage and obtain proximal control in both traumatic and nontraumatic causes of hemorrhage. REBOA can also be used for more targeted AO in the distal aorta for pelvic, junctional, or extremity hemorrhage.

Association of Patient Frailty With Increased Morbidity After Common Ambulatory General Surgery Operations

Abstract: Importance Frailty is a measure of decreased physiological reserve that is associated with morbidity and mortality in major elective and emergency general surgery operations, independent of chronological age. To date, the association of frailty with outcomes in ambulatory general surgery has not been established. Objective To determine the association between frailty and perioperative morbidity in patients undergoing ambulatory general surgery operations. Design, Setting, and Participants A retrospective cohort study was conducted of 140 828 patients older than 40 years of age from the 2007-2010 American College of Surgeons National Surgical Quality Improvement Program Participant Use File who underwent ambulatory and 23-hour-stay hernia, breast, thyroid, or parathyroid surgery. Data analysis was performed from August 18, 2016, to June 21, 2017. Main Outcomes and Measures The association between the National Surgical Quality Improvement Program modified frailty index and perioperative morbidity was determined via multivariable logistic regression with random-effects modeling to control for clustering within Current Procedural Terminology codes. Results A total of 140 828 patients (80 147 women and 60 681 men; mean [SD] age, 59.3 [12.0] years) underwent ambulatory hernia (n = 71 455), breast (n = 51 267), thyroid, or parathyroid surgery (n = 18 106). Of these patients, 2457 (1.7%) experienced any type of perioperative complication and 971 (0.7%) experienced serious perioperative complications. An increasing modified frailty index was associated with a stepwise increase in the incidence of complications. In multivariable analysis adjusting for age, sex, race/ethnicity, anesthesia type, tobacco use, renal failure, corticosteroid use, and clustering by Current Procedural Terminology codes, an intermediate modified frailty index score (0.18-0.35, corresponding to 2-3 frailty traits) was associated with statistically significant odds ratios of 1.70 (95% CI, 1.54-1.88; P P P P P Conclusions and Relevance Frailty is associated with increased perioperative morbidity in common ambulatory general surgery operations, independent of age, type of anesthesia, and other comorbidities. Surgeons should consider frailty rather than chronological age when counseling and selecting patients for elective ambulatory surgery.

What Surgeons Need to Know About Gender Confirmation Surgery When Providing Care for Transgender Individuals: A Review.

Abstract: Importance In 2014, the US Department of Health and Human Services decided that its 1981 exclusion of transsexual surgical treatments from Medicare coverage was based on outdated, incomplete, and biased science and did not reflect current evidence or standards of care, and the exclusion was therefore lifted. As a direct result of this decision, surgeons nationwide are seeing an increase in consultations for surgical therapy to help transgender and gender-nonconforming individuals. Although some clinicians may have the technical training for such surgical procedures, in many cases, they may not have a full understanding of the complex and comprehensive care required to provide optimal health care for transgender individuals. Observations Gender confirmation surgery is a developing field in the United States and other areas of the world. The World Professional Association for Transgender Health started a global education initiative intended to provide surgeons and other health care professionals with the necessary background knowledge to understand and treat this patient population. This article provides an overview of best practices as set forth in the seventh edition of the Standards of Care for the Health of Transsexual, Transgender, and Gender Nonconforming People by the World Professional Association for Transgender Health, including mental health, endocrinology, and surgery for trans women and trans men. Conclusions and Relevance Experts in each aspect of transgender health have summarized the content of the global education initiative in this article. It provides valuable information to surgeons of all disciplines and other health care professionals to help guide the treatment and management of transgender individuals.

Pathologic Outcomes of Laparoscopic vs Open Mesorectal Excision for Rectal Cancer: A Systematic Review and Meta-analysis

Abstract: Importance Rectal resection with mesorectal excision is the mainstay treatment for rectal cancer. Objective To review and analyze the evidence concerning the pathologic outcomes of laparoscopic (LRR) vs open (ORR) rectal resection for rectal cancer. Data Sources The Cochrane Central Register of Controlled Trials, MEDLINE (through PubMed), EMBASE, Scopus databases, and clinicaltrials.gov were searched for randomized clinical trials (RCTs) comparing LRR vs ORR. Study Selection Only RCTs published in English from January 1, 1995, to June 30, 2016, that compared LRR with ORR for histologically proven rectal cancer in adult patients and reported pathologic outcomes (eg, positive circumferential resection margin, and complete mesorectal excision) were eligible for inclusion. Of 369 records screened, 14 RCTs were selected for the qualitative and quantitative analyses. Data Extraction and Synthesis Two independent reviewers performed the study selection and quality assessment. Random-effects models were used to summarize the risk ratio (RR) and mean differences. Main Outcomes and Measures The rate of positive circumferential resection margin (CRM), defined as 1 mm or less from the closest tumor to the cut edge of the tissue, and the quality of mesorectal excision (complete, nearly complete, or incomplete). Results The meta-analysis included 14 unique RCTs with 4034 unique patients. Of 2989 patients undergoing rectal resection, a positive CRM was found in 135 (7.9%) of 1697 patients undergoing LRR and 79 (6.1%) of 1292 patients undergoing ORR (RR, 1.17; 95% CI, 0.89-1.53; P = .26; I 2 = 0%) in 9 studies. A noncomplete (nearly complete and incomplete) mesorectal excision was reported in 179 (13.2%) of 1354 patients undergoing LRR and 104 (10.4%) of 998 patients undergoing ORR (RR, 1.31; 95% CI, 1.05-1.64; P = .02; I 2 = 0%) in 5 studies. The distal resection margin involvement (RR, 1.12; 95% CI, 0.34-3.67; P = .86), the mean number of lymph nodes retrieved (mean difference, 0.05; 95% CI, −0.77 to 0.86; P = .91), the mean distance to the distal margin (mean difference, 0.01 cm; 95% CI, −0.12 to 0.15 cm; P = .87), and the mean distance to radial margins (mean difference, −0.67 mm; 95% CI, −2.16 to 0.83 mm; P = .38) were not significantly different between LRR and ORR. The risk for bias was assessed as low in 10 studies, high in 3, and unknown in 1. The overall quality of the evidence emerging from the literature was rated as high. Conclusions and Relevance Based on the available evidence, the risk for achieving a noncomplete mesorectal excision is significantly higher in patients undergoing LRR compared with ORR. These findings question the oncologic safety of laparoscopy for the treatment of rectal cancer. However, long-term results of the ongoing RCTs are awaited to assess whether these pathologic results have an effect on disease-free and overall patient survival.

Mortality and Prehospital Blood Pressure in Patients With Major Traumatic Brain Injury: Implications for the Hypotension Threshold

Abstract: Importance Current prehospital traumatic brain injury guidelines use a systolic blood pressure threshold of less than 90 mm Hg for treating hypotension for individuals 10 years and older based on studies showing higher mortality when blood pressure drops below this level. However, the guidelines also acknowledge the weakness of the supporting evidence. Objective To evaluate whether any statistically supportable threshold between systolic pressure and mortality emerges from the data a priori, without assuming that a cut point exists. Design, Setting, and Participants Observational evaluation of a large prehospital database established as a part of the Excellence in Prehospital Injury Care Traumatic Brain Injury Study. Patients from the preimplementation cohort (January 2007 to March 2014) 10 years and older with moderate or severe traumatic brain injury (Barell Matrix Type 1 classification, International Classification of Diseases, Ninth Revision head region severity score of 3 or greater, and/or Abbreviated Injury Scale head-region severity score of 3 or greater) and a prehospital systolic pressure between 40 and 119 mm Hg were included. The generalized additive model and logistic regression were used to determine the association between systolic pressure and probability of death, adjusting for significant/important confounders. Main Outcomes and Measures The main outcome measure was in-hospital mortality. Results Among the 3844 included patients, 2565 (66.7%) were male, and the median (range) age was 35 (10-99) years. The model revealed a monotonically decreasing association between systolic pressure and adjusted probability of death across the entire range (ie, from 40 to 119 mm Hg). Each 10-point increase of systolic pressure was associated with a decrease in the adjusted odds of death of 18.8% (adjusted odds ratio, 0.812; 95% CI, 0.748-0.883). Thus, the adjusted odds of mortality increased as much for a drop from 110 to 100 mm Hg as for a drop from 90 to 80 mm Hg, and so on throughout the range. Conclusions and Relevance We found a linear association between lowest prehospital systolic blood pressure and severity-adjusted probability of mortality across an exceptionally wide range. There is no identifiable threshold or inflection point between 40 and 119 mm Hg. Thus, in patients with traumatic brain injury, the concept that 90 mm Hg represents a unique or important physiological cut point may be wrong. Furthermore, clinically meaningful hypotension may not be as low as current guidelines suggest. Randomized trials evaluating treatment levels significantly above 90 mm Hg are needed.

Correlation Between 24-Hour Predischarge Opioid Use and Amount of Opioids Prescribed at Hospital Discharge.

Abstract: Importance The United States is experiencing an opioid abuse epidemic. Opioid overprescription by physicians may contribute to this epidemic. Objectives To determine if there was a correlation between a postoperative patient’s 24-hour predischarge opioid use and the amount of opioids prescribed at hospital discharge and to determine the number of patients who used no opioids prior to discharge but were still prescribed opioids after hospital discharge. Design, Setting, and Participants This cross-sectional study performed a retrospective record review of 18 343 postoperative patients at Boston Medical Center and Lahey Hospital and Medical Center–Burlington Campus who were discharged home after a postoperative inpatient admission of at least 24 hours. Data collection spanned from May 22, 2014, to June 30, 2016, in the Boston Medical Center data set and from March 23, 2015, to September 7, 2016, in the Lahey Hospital and Medical Center–Burlington Campus data set. Exposures Surgery requiring a postoperative inpatient hospital stay longer than 24 hours. Main Outcomes and Measures The main outcome measures were the patient’s 24-hour predischarge opioid use and the total quantity of opioids prescribed at hospital discharge. Potential overprescription was defined as the number of patients who used no opioids in the 24 hours prior to hospital discharge but were still prescribed opioids after hospital discharge. Results Among the 18 343 patients (10 069 women and 8274 men; mean age, 52.2 years) who underwent 21 452 surgical procedures, there was wide variation in the amount of opioids prescribed at hospital discharge given a postoperative patient’s 24-hour predischarge opioid use. A total of 6548 patients (35.7%) used no opioids in the 24 hours prior to hospital discharge; however, 2988 of these patients (45.6%) were prescribed opioids at hospital discharge, suggesting potential overprescription. Services that had the highest rates of potential overprescription (obstetrics [adjusted odds ratio (AOR), 3.146; 95% CI, 2.094-4.765] and gynecology [AOR, 2.355; 95% CI, 1.663-3.390], orthopedics [AOR, 0.943; 95% CI, 0.719-1.242], and plastic surgery [AOR, 0.733; 95% CI, 0.334-1.682]) generally had the highest rates of patients still using opioids at hospital discharge. Pediatric surgery was the only service that did not have any cases of potential overprescription (AOR, 2.09 × 10−7; 95% CI, 0.000-0.016). Conclusions and Relevance Opioids are not regularly prescribed in a patient-specific manner to postoperative patients. Potential opioid overprescription occurs regularly after surgery among almost all surgical specialties.