Ambar Mehta

Patient, surgeon, and hospital disparities associated with benign hysterectomy approach and perioperative complications

BACKGROUND: Hysterectomy is among the most common major surgical procedures performed in women. Approximately 450,000 hysterectomy procedures are performed each year in the United States for benign indications. However, little is known regarding contemporary US hysterectomy trends for women with benign disease with respect to operative technique and perioperative complications, and the association between these 2 factors with patient, surgeon, and hospital characteristics. OBJECTIVE: We sought to describe contemporary hysterectomy trends and explore associations between patient, surgeon, and hospital characteristics with surgical approach and perioperative complications. STUDY DESIGN: Hysterectomies performed for benign indications by general gynecologists from July 2012 through September 2014 were analyzed in the all‐payer Maryland Health Services Cost Review Commission database. We excluded hysterectomies performed by gynecologic oncologists, reproductive endocrinologists, and female pelvic medicine and reconstructive surgeons. We included both open hysterectomies and those performed by minimally invasive surgery, which included vaginal hysterectomies. Perioperative complications were defined using the Agency for Healthcare Research and Quality patient safety indicators. Surgeon hysterectomy volume during the 2‐year study period was analyzed (0‐5 cases annually = very low, 6‐10 = low, 11‐20 = medium, and ≥21 = high). We utilized logistic regression and negative binomial regression to identify patient, surgeon, and hospital characteristics associated with minimally invasive surgery utilization and perioperative complications, respectively. RESULTS: A total of 5660 hospitalizations were identified during the study period. Most patients (61.5%) had an open hysterectomy; 38.5% underwent a minimally invasive surgery procedure (25.1% robotic, 46.6% laparoscopic, 28.3% vaginal). Most surgeons (68.2%) were very low– or low‐volume surgeons. Factors associated with a lower likelihood of undergoing minimally invasive surgery included older patient age (reference 45‐64 years; 20‐44 years: adjusted odds ratio, 1.16; 95% confidence interval, 1.05–1.28), black race (reference white; adjusted odds ratio, 0.70; 95% confidence interval, 0.63–0.78), Hispanic ethnicity (adjusted odds ratio, 0.62; 95% confidence interval, 0.48–0.80), smaller hospital (reference large; small: adjusted odds ratio, 0.26; 95% confidence interval, 0.15–0.45; medium: adjusted odds ratio, 0.87; 95% confidence interval, 0.79–0.96), medium hospital hysterectomy volume (reference ≥200 hysterectomies; 100‐200: adjusted odds ratio, 0.78; 95% confidence interval, 0.71–0.87), and medium vs high surgeon volume (reference high; medium: adjusted odds ratio, 0.87; 95% confidence interval, 0.78–0.97). Complications occurred in 25.8% of open and 8.2% of minimally invasive hysterectomies (P < .0001). Minimally invasive hysterectomy (adjusted odds ratio, 0.22; 95% confidence interval, 0.17–0.27) and large hysterectomy volume hospitals (reference ≥200 hysterectomies; 1‐100: adjusted odds ratio, 2.26; 95% confidence interval, 1.60–3.20; 101‐200: adjusted odds ratio, 1.63; 95% confidence interval, 1.23–2.16) were associated with fewer complications, while patient payer, including Medicare (reference private; adjusted odds ratio, 1.86; 95% confidence interval, 1.33–2.61), Medicaid (adjusted odds ratio, 1.63; 95% confidence interval, 1.30–2.04), and self‐pay status (adjusted odds ratio, 2.41; 95% confidence interval, 1.40–4.12), and very‐low and low surgeon hysterectomy volume (reference ≥21 cases; 1‐5 cases: adjusted odds ratio, 1.73; 95% confidence interval, 1.22–2.47; 6‐10 cases: adjusted odds ratio, 1.60; 95% confidence interval, 1.11–2.23) were associated with perioperative complications. CONCLUSION: Use of minimally invasive hysterectomy for benign indications remains variable, with most patients undergoing open, more morbid procedures. Older and black patients and smaller hospitals are associated with open hysterectomy. Patient race and payer status, hysterectomy approach, and surgeon volume were associated with perioperative complications. Hysterectomies performed for benign indications by high‐volume surgeons or by minimally invasive techniques may represent an opportunity to reduce preventable harm.

Effect of Surgeon and Hospital Volume on Emergency General Surgery Outcomes

BACKGROUND Emergency general surgery (EGS) contributes to half of all surgical mortality nationwide, is associated with a 50% complication rate, and has a 15% readmission rate within 30 days. We assessed associations between surgeon and hospital EGS volume with these outcomes. STUDY DESIGN Using Marylands Health Services Cost Review Commission database, we identified nontrauma EGS procedures performed by general surgeons among patients 20 years or older, who were admitted urgently or emergently, from July 2012 to September 2014. We created surgeon and hospital volume categories, stratified EGS procedures into simple (mortality ≤ 0.5%) and complex (>0.5%) procedures, and assessed postoperative mortality, complications, and 30-day readmissions. Multivariable logistic regressions both adjusted for clinical factors and accounted for clustering by individual surgeons. RESULTS We identified 14,753 procedures (61.5% simple EGS, 38.5% complex EGS) by 252 (73.3%) low-volume surgeons (≤25 total EGS procedures/year), 63 (18.3%) medium-volume surgeons (26 to 50/year), and 29 (8.4%) high-volume surgeons (>50/year). Low-volume surgeons operated on one-third (33.1%) of all patients. For simple procedures, the very low rate of death (0.2%) prevented a meaningful regression with mortality; however, there were no associations between low-volume surgeons and complications (adjusted odds ratio [aOR] 1.07; 95% CI 0.81 to 1.41) or 30-day readmissions (aOR 0.80; 95% CI 0.64 to 1.01) relative to high-volume surgeons. Among complex procedures, low-volume surgeons were associated with greater mortality (aOR 1.64; 95% CI 1.12 to 2.41) relative to high-volume surgeons, but not complications (aOR 1.06; 95% CI 0.85 to 1.32) or 30-day readmission (aOR 0.99; 95% CI 0.80 to 1.22). Low-volume hospitals (≤125 total EGS procedures/year) relative to high-volume hospitals (>250/year) were not associated with mortality, complications, or 30-day readmissions for simple or complex procedures. CONCLUSIONS We found evidence that surgeon EGS volume was associated with outcomes. Developing EGS-specific services, mentorship opportunities, and clinical pathways for less-experienced surgeons may improve outcomes.

Emergency department utilization and predictors of mortality for inpatient inguinal hernia repairs

BACKGROUND Although inguinal hernias are common surgical diagnoses, minimally symptomatic patients are often not scheduled for repairs and are asked to seek medical attention if they develop symptoms. We investigated factors associated with emergency department (ED) utilization for inguinal hernia repairs and determined whether ED utilization affected mortality for this otherwise electively treated condition. METHODS We performed a retrospective analysis of the 2009-2013 Nationwide Inpatient Sample to identify patients who presented through the ED and were then admitted for unilateral inguinal hernia repairs. Multivariable logistic regressions that adjusted for several patient and hospital characteristics determined predictors of both ED admission and postoperative mortality. RESULTS There were 116,357 inpatient hospitalizations. The majority (57%) resulted from ED admissions, of which most (85%) had a diagnosis of obstruction or gangrene. Notable predictors of ED admission from the multivariable analysis included obstruction (odds ratio, 9.77 [95% confidence interval: 9.05-10.55]), gangrene (18.24 [13.00-25.59]), Black race (1.47 [1.29-1.69]), Hispanic ethnicity (1.35 [1.18-1.54]), self-pay (2.29 [1.97-2.66]) and Medicaid insurance (1.76 [1.50-2.06]). While overall mortality decreased from 2.03% in 2009 to 1.36% in 2013, admission through the ED was independently associated with higher mortality compared with elective repair (1.67 [1.21-2.29]), even after adjusting for the diagnosis of obstruction and gangrene. Other predictors of mortality included patient age and comorbidities. CONCLUSIONS In our study, Black, Hispanic, and self-pay patients were more likely to present through the ED. After adjusting for obstruction or gangrene, simply presenting through the ED was independently associated with a 67% higher postoperative mortality rate compared with that of an elective operation. Our findings suggest both a difference in ED utilization and subsequent difference in mortality by patient race and ethnicity and insurance for this common surgical condition.

Hospital variation in mortality after emergent bowel resections: The role of failure-to-rescue

BACKGROUND Hospital variation in failure-to-rescue (FTR) rates has partially explained nationwide differences in mortality after elective surgeries. To examine the role of FTR among emergency general surgery, we compared nationwide risk-adjusted mortality, complications, and FTR rates after emergent bowel resections. METHODS We identified patients who underwent emergent small or large bowel resections in the 2010 to 2011 Nationwide Inpatient Sample using the American Association for the Surgery of Trauma criteria. We then calculated risk-adjusted mortality rates for each hospital using multivariable logistic regressions and postestimation, which adjusted for patient age, sex, race and ethnicity, payer status, comorbidities, and hospital clustering. After excluding hospitals with fewer than 10 resections per year, we ranked the remaining hospitals by their risk-adjusted mortality rates and divided them into five quintiles. We compared both risk-adjusted complication rates and FTR rates between the top (lowest mortality) and bottom (highest mortality) quintiles. RESULTS We identified 21,564 emergent bowel resections, weighted to 105,925 procedures nationwide. The bottom quintile of hospitals had an overall risk-adjusted mortality rate that was 10.9 times higher than that of the top quintile of hospitals (15.3% vs. 1.4%). While risk-adjusted complication rates were similarly high for both the bottom and the top quintiles of hospitals (22.5% vs. 15.7%), the risk-adjusted FTR rates were 10.8 times higher in the bottom quintile of hospitals relative to the top quintile of hospitals (33.4% vs. 3.1%). Using larger hospital volume thresholds yielded similar findings. Furthermore, large variations existed in complication-specific FTR rates (surgical site infection [6.6%] to myocardial infarction [29.4%]). CONCLUSION Nationwide hospital variation in risk-adjusted mortality rates exist after emergent bowel resections. As complication rates were similar across hospitals, the significantly higher FTR rates at higher-mortality hospitals may drive this variation in mortality. System-level initiatives addressing the management of postoperative complications may improve patient care and reduce variation in outcomes. LEVEL OF EVIDENCE Prognostic and epidemiological study, level IV.

Outcomes of Partnered Individuals Undergoing Bariatric Surgery Together: A Single Institution Case Series

Abstract There exists marked variation in weight loss among the 200,000 annual bariatric patients, and many of these patients struggle with weight regain. Several studies have suggested that positive social support may significantly impact bariatric surgery outcomes, leading to more excess weight loss and maintenance of this weight loss through appropriate lifestyle changes. We sought to understand this by assessing clinical and behavioral outcomes among married couples whereby both spouses underwent bariatric surgery at our institution. In our case series, we found evidence that married couples meet or exceed postoperative weight loss milestones at 12, 18, and 24 months and did not show signs of weight regain as a group at 18 or 24 months. Among partners who underwent the same clinical pathway at our single institution, women tended to lose more weight than men at 12 months. Additionally, while there was significant variation in postoperative follow-up among patients, we found that partners within couples typically exhibited the same behavior with respect to postoperative visits when they had their surgeries within a year of each other. This case series suggests that partnered patients undergoing bariatric surgery can meet or exceed weight loss outcomes and may practice similar follow-up adherence.

Emergency general surgery in geriatric patients: A statewide analysis of surgeon and hospital volume with outcomes

BACKGROUND Geriatric patients undergoing emergency general surgery (EGS) face significant morbidity and mortality. We assessed how surgeon and hospital volumes affected these outcomes. METHODS We identified patients at least 65 years old in Maryland’s Health Services Cost Review Commission database from 2012 to 2014 who underwent one of 12 EGS procedures, as defined by the American Association for the Surgery of Trauma, and then calculated four outcomes: mortality rate, the incidence of at least one of eight common in-hospital EGS complications, failure-to-rescue (death after experiencing a postoperative complication), and the 30-day readmission rate. Median annual volumes of geriatric-EGS procedures divided both surgeons and hospitals into two groups (low volume and high volume). Multivariable logistic regressions calculated associations between the volume groups and outcomes after adjusting for patient, surgeon, and hospital factors, and hospital clusters. RESULTS We identified 3,832 patients who had an EGS procedure by 302 surgeons (median: 8 geriatric-EGS/year, IQR: 3–18) at 44 hospitals (median: 82 geriatric-EGS/year, IQR: 35–132). While operating on 16.5% of all geriatric-EGS patients, low-volume surgeons had higher risk-adjusted adverse outcomes: mortality (7.0% vs. 4.0%, p = 0.005), in-hospital complications (22.1% vs. 19.7%, p = 0.13), failure-to-rescue (17.3% vs. 12.1%, p = 0.021), and 30-day readmissions (11.2% vs. 10.0%, p = 0.55). After adjustment, low-volume surgeons were associated with higher mortality (adjusted odds ratio [aOR] 1.86, 95% CI [1.21–2.86]) and failure-to-rescue rates (aOR 1.74 [1.09–2.80]) but not in-hospital complications (aOR 1.20 [0.95–1.51]) or 30-day readmissions (aOR 1.07 [0.85–1.34]). In contrast, low-volume hospitals relative to high-volume hospitals, and hospitals serving lower proportions of geriatric-EGS patients, were not associated with adverse outcomes. CONCLUSION Relative to their higher-volume counterparts, surgeons performing eight or fewer geriatric-EGS procedures annually were associated with an 86% higher odds of death and 74% higher odds of failure-to-rescue in this elderly EGS patient population. These findings underscore the need for focused care of elderly surgical patients. LEVEL OF EVIDENCE Prognostic and epidemiological, level IV.

A survey of the practice and attitudes of surgeons regarding the treatment of appendicitis

BACKGROUND We surveyed surgeons to document their attitudes, practice, and risk tolerance regarding the treatment of appendicitis. METHODS A web-based survey was sent to the EAST membership. The primary composite endpoint was defined as 1-year incidence of perioperative complications, antibiotic failure, infections, ED visits, and readmissions. RESULTS A total of 563 of 1645 surveys were completed (34% response). Mean age was 47 ± 10 years and 98% were from the United States. Most (72%) were employed at academic teaching hospitals and 66% practiced in an urban setting. There were significant differences in treatment recommendations for different presentations of appendicitis. Regarding the primary composite endpoint, surgeons would tolerate a median 17% [10%-25%] excess morbidity in order to avoid an operation (i.e. non-inferiority) and would require a median 24% [10%-50% lower morbidity for the surgical approach in order to declare it a superior treatment (i.e. superiority). CONCLUSIONS To be considered non-inferior, antibiotic therapy of appendicitis cannot have >17% excess morbidity and appendectomy must have at least 24% lower morbidity to be considered superior.

Is there evidence of a July effect among patients undergoing hysterectomy surgery

BACKGROUND: It is hypothesized that the quality of health care decreases during trainee turnovers at the beginning of the academic year. The influx of new gynecology and surgery residents into hospitals in this setting may be associated with poorer surgical outcomes, known as the July effect. OBJECTIVE: We sought to systematically study hysterectomy outcomes in the state of Maryland during the 3‐month period July through September as compared to all other months of the academic year, in order to assess for the presence of a July effect in hysterectomy surgery. STUDY DESIGN: This is a retrospective study of the Maryland Health Services Cost Review Commission Database from July 2012 through September 2015 focused on women undergoing hysterectomies for benign or malignant disease, either by obstetricians and gynecologists or gynecologic oncologists, during July through September vs October through June. Multivariable logistic regressions accounted for clustering by hospitals and adjusted for several cofactors. The primary outcome includes at least 1 of 11 major perioperative in‐hospital complications; the secondary outcomes were extended postoperative length of stay (defined as >2 days) and 30‐day inpatient readmission rates. RESULTS: We identified 6311 hysterectomies (78.2% benign) performed by 424 surgeons at 20 academic hospitals. Patients were primarily white (42.8%), 45–64 years old (54.4%), and had private insurance (66.3%). The unadjusted rate of in‐hospital complications was 16.8%, extended length of stay was 30.3%, and 30‐day readmissions was 6.6%. After adjustment, patients undergoing hysterectomies during July through September did not have more adverse outcomes relative to those undergoing surgery at other times of the year: complications (adjusted odds ratio, 0.87; 95% confidence interval, 0.75–1.01), length of stay >2 days (adjusted odds ratio, 1.03; 95% confidence interval, 0.90–1.19), and 30‐day readmissions (adjusted odds ratio, 0.99; 95% confidence interval, 0.80–1.23). Sensitivity analyses assessing individual complications, hysterectomy outcomes at nonacademic hospitals, and benign vs malignant indications for hysterectomies yielded similar findings. CONCLUSION: Women in Maryland undergoing hysterectomy surgery at academic hospitals during July through September of the academic year did not experience worse outcomes relative to women having surgery in other months. Additional studies are necessary to further assess the possibility of a July effect in hysterectomy on a national basis. Institutions should continue to provide effective surgical training environments for new interns and residents transitioning to more senior roles, while maintaining optimal patient safety.

Global trends in center accreditation by the Joint Commission International: growing patient implications for international medical and surgical care

Millions of patients travel internationally for medical and surgical care. We found that the annual number of centers accredited by the Joint Commission International increased from one center in 1999 to 132 centers in 2016; there are currently 939 accredited centers across 66 countries. Public health and medicolegal implications related to medical travel deserve attention.

Abstract OT1-1-17: LUX-Breast 2: Phase II, open-label study of oral afatinib in HER2-overexpressing metastatic breast cancer (MBC) patients (pts) who progressed on prior trastuzumab and/or lapatinib*

Background: Management of HER2-overexpressing MBC has improved over the past decade. However, pts still develop resistance to currently available HER2-targeted therapies and novel effective treatments are increasingly required as dual targeted combinations are given in early treatment lines already. Current therapies focus on targeting HER2 and do not inhibit all relevant ErbB Family dimers. Afatinib is an oral, irreversible ErbB Family Blocker that inhibits signaling through activated EGFR (ErbB1), HER2 (ErbB2) and ErbB4 receptors and transphosphorylation of ErbB3. Preclinical studies have demonstrated efficacy in trastuzumab-sensitive, and trastuzumab-resistant human BC xenograft models dependent on ErbB signaling. Efficacy of afatinib in a trastuzumab-resistant SUM190 xenograft model has been shown to be increased by addition of intravenous (i.v.) vinorelbine. Afatinib monotherapy has shown promising clinical benefit in 46% of HER2-overexpressing MBC pts who progressed on prior trastuzumab, with 10% of pts achieving a partial response. 1 Methods: This open-label Phase II trial (NCT01271725) investigates efficacy and safety of afatinib alone (40 mg/day) followed by afatinib ‘beyond progression’ in combination with chemotherapy in 120 pts with HER2-overexpressing MBC, who progressed on prior neoadjuvant and/or adjuvant trastuzumab and/or lapatinib. Pts who progress on afatinib monotherapy receive afatinib + either weekly paclitaxel 80 mg/m 2 or vinorelbine i.v. 25 mg/m 2 . Eligible pts have confirmed HER2-overexpressing BC, Stage IV disease measurable by RECIST 1.1, progressed on trastuzumab and/or lapatinib therapy in either neoadjuvant and/or adjuvant setting, are eligible for retreatment with paclitaxel (i.e. should not have been pretreated with paclitaxel within the past 12 months), or are eligible for treatment with vinorelbine (i.e. should not have been pretreated with vinorelbine). Exclusion criteria include inadequate cardiac, renal, hepatic and hematological function, pre-existing gastrointestinal dysfunction, rapidly progressing visceral MBC, interstitial lung disease, and active brain metastases. The primary endpoint is objective response (OR) and secondary endpoints include best overall response, duration of OR, progression-free survival (PFS) and safety. PFS and safety will be assessed separately for afatinib mono- and combination therapy. An early stopping rule was deployed to minimize the number of pts treated should afatinib be ineffective; once 20 evaluable pts (according to RECIST 1.1) completed at least two courses of afatinib (or progressed during the first course), a meeting was held to evaluate the objective tumor response rate and to decide whether to proceed with the trial or stop due to futility. If at least one unconfirmed OR had been witnessed from all available information at the time, then the trial was to continue to full accrual. This early stopping rule for futility has been passed and the trial will continue to full accrual. Pt enrollment began in May 2011 in ∼40 sites and five countries. 1. Lin NU, et al. Breast Cancer Res Treat 2012. DOI: 10.1007/s10549-012-2003-y. *Updated abstract from ASCO 2012. Citation Information: Cancer Res 2012;72(24 Suppl):Abstract nr OT1-1-17.