MedStar Washington Hospital Center Research Articles

Risk of cesarean in obese nulliparous women with unfavorable cervix: elective induction vs expectant management at term

The objective of the study was to examine maternal and neonatal outcomes in obese nulliparous women with an unfavorable cervix undergoing elective induction of labor compared with expectant management after 39.0 weeks. This was a retrospective analysis of a cohort of nulliparous women with a vertex singleton gestation who delivered at MedStar Washington Hospital Center from 2007 to 2012. Patients with unfavorable cervix between 38.0 and 38.9 weeks (modified Bishop <5) and a body mass index of 30.0 kg/m(2) or greater at the time of delivery were included. Women undergoing elective induction between 39.0 and 40.9 weeks' gestation were compared with those who were expectantly managed beyond 39.0 weeks. Outcomes were analyzed using χ(2), Student t, or Wilcoxon rank sum tests as appropriate with a significance set at P < .05. Sixty patients meeting inclusion criteria underwent elective induction of labor and were compared with 410 patients expectantly managed beyond 39.0 weeks. The rate of cesarean delivery was significantly higher in the electively induced group (40.0% vs 25.9%, respectively, P = .022). Other maternal outcomes, including operative vaginal delivery, rate of third- or fourth-degree lacerations, chorioamnionitis, postpartum hemorrhage, and a need for a blood transfusion were similar. The neonatal intensive care unit admission rate was higher in the electively induced group (18.3% vs 6.3%, P = .001). Birthweight, umbilical artery pH less than 7.0, and Apgar less than 7 at 5 minutes were similar. Elective labor induction at term in obese nulliparous parturients carries an increased risk of cesarean delivery and higher neonatal intensive care unit admission rate as compared with expectant management.

Abstract OT1-1-12: SAFE-HEaRt: A pilot study assessing the cardiac SAFEty of HER2 targeted therapy in patients with HER2 positive breast cancer and reduced left ventricular function

Abstract Background: Substantial benefit of trastuzumab is associated with cardiac side effects, mostly asymptomatic. According to current FDA approved package insert, patients should not receive trastuzumab or newer HER2 targeted therapies if there is evidence of cardiomyopathy. Trial design: SAFE-HEaRt is a pilot study evaluating the cardiac safety of trastuzumab, pertuzumab and ado-trastuzumab emtansine in 30 patients with HER2 positive breast cancer (BC) and mild LV dysfunction (LVEF≥40% and &amp;lt;50%) while on optimized cardiac therapy with B-Blockers and ACE inhibitors. Left ventricular ejection fraction (LVEF) and myocardial strain will be assessed at baseline, week 6,12,18 and then every 12 weeks. Troponin I (cTnI) and high-sensitivity cardiac troponin T (hs-cTnT) will be collected at the same time points. Main Eligibility criteria: Patients diagnosed with stage I-IV HER2 positive BC; LVEF≥40% and &amp;lt;50% prior to or while receiving non-lapatinib HER2 targeted therapy. Specific aims: The primary endpoint is the proportion of patients who complete planned oncologic therapy without the development of a cardiac event (presence of symptoms attributable to heart failure (HF) confirmed by a cardiologist, cardiac arrhythmia requiring pharmacological or electrical treatment, myocardial infarction, sudden cardiac death or death due to myocardial infarct, arrhythmia or HF) or asymptomatic worsening of cardiac function (i.e. asymptomatic decline in LVEF &amp;gt;10% points from baseline and/or LVEF&amp;lt;35% corroborated by a confirmatory echocardiogram in 2-4 weeks). Additional endpoints include: Median time to development of an event; absolute changes in LVEF during HER2 targeted therapy; HER2 therapy holds attributed to cardiotoxicity; correlation of myocardial strain and serum biomarkers with cardiac events and asymptomatic worsening of cardiac function. Statistical methods: A two-stage design is used to test if the completion rate of planned oncologic therapy will be at least 30% versus less than 10% with 80% power at a significance level of 5%. At the first stage, 15 patients will be entered. If one or more patients complete therapy in the absence of a cardiac event, then additional 15 patients will be enrolled in the second stage. Early stopping rules are incorporated for safety based on cardiac death and symptomatic HF. Safety monitoring plan consists of an internal cardiac review panel and a Data Safety Monitoring Board (DSMB) that includes an external cardiologist expert. Present accrual and target accrual: The Institutional Review Board has approved the study. Enrollment of the first patient is expected in July 2013 with a total of 30 patients planned to be recruited. The initial recruitment sites are MedStar Washington Hospital Center and MedStar Georgetown University Hospital. This trial is partially supported by Genentech and funded by a Conquer Cancer Foundation of ASCO Young Investigator Award, supported by The Breast Cancer Research Foundation. Any opinions, findings, and conclusions expressed in this material are those of the author(s) and do not necessarily reflect those of the American Society of Clinical Oncology, the Conquer Cancer Foundation, or The Breast Cancer Research Foundation. Citation Information: Cancer Res 2013;73(24 Suppl): Abstract nr OT1-1-12.

Abstract P2-12-03: BRCA1/2 testing in an urban population of black women (BW)

Abstract Background: Current indications for BRCA1/2 testing do not vary by race or ethnicity except for Ashkenazi Jewish individuals. Uptake of BRCA1/2 testing is low in BW, despite the presence of risk factors for BRCA1/2 mutations such as diagnosis of breast cancer (BC) at a young age and triple negative breast cancer (TNBC). The prevalence of BRCA1/2 mutations in BW is not well defined. Aims: To determine the prevalence and predictors of deleterious BRCA1/2 mutations and variants of uncertain significance (VUS) in an urban population of BW, to describe preventive measures taken by BW with deleterious BRCA1/2 mutations and to describe the timing of genetic testing in BW with BC. Methods: We performed a retrospective study of all BW, defined as women who self-identified as black, African or African-American, who underwent genetic risk evaluation at two hospitals in Washington DC from 2006-2012. We collected data on age, insurance, BRCA1/2 test results, preventive measures taken after receipt of test results, oncologic history and family history (FH), defined as a first or second degree relative with BC diagnosed at age ≤ 50 and/or a first or second degree relative with ovarian cancer (OC) diagnosed at any age. Results: 211 BW received genetic counseling during this time period, 85.8% at MedStar Washington Hospital Center, and 14.2% at MedStar Georgetown University Hospital. 73% were affected (148 BC, 6 OC). Among those with BC, 14.2% had TNBC. Median age was 48 years (range 24-83). BRCA1/2 testing was performed in 70.1% (119 BC, 6 OC, 23 unaffected). Deleterious BRCA1/2 mutations were identified in 12.2% (18/148) of BW (10 BRCA1, 8 BRCA2). VUS were identified in 9.5% (14/148) of BW (3 BRCA1, 11 BRCA2). 15.2% of BW tested in 2006-2009 had VUS compared to 4.9% of BW tested in 2010-2012. 64% of VUS have been reclassified, all as benign polymorphisms except for one. BRACAnalysis Large Rearrangement Test (BART) was performed in 20.9% but did not identify any mutations. Deleterious BRCA1/2 mutations were identified in 28.5% of BW with TNBC who underwent BRCA1/2 testing, with higher prevalence among those diagnosed at younger ages (≤ age 50: 45.5%, ≤ age 60: 40%). Deleterious BRCA1/2 mutations were identified in 75% of BW with TNBC diagnosed ≤ age 50 and a positive FH. Following receipt of test results, 28% of BW found to have deleterious BRCA1/2 mutations underwent prophylactic oophorectomy and 33% underwent prophylactic mastectomy within the study time period. BRCA1/2 counseling was performed prior to definitive breast surgery in 40.5% of BW affected with BC. 11.1% of BW with BRCA1/2 mutations were underinsured and received testing under grant support. Conclusions: In this retrospective study of a large population of BW who underwent genetic risk evaluation, the prevalence of deleterious BRCA1/2 mutations was 12.2%. A very high prevalence was seen in BW with TNBC, particularly in the presence of a FH. As expected, identification of VUS decreased over time. Inadequate insurance coverage remains a barrier to genetic testing among BW. (Supported by the Familial Cancer Registry at LCCC P30 CA51008-17). Citation Information: Cancer Res 2013;73(24 Suppl): Abstract nr P2-12-03.

Crowdsourcing in Healthcare

Patricia Robin McCartney is the Director of Nursing Research at MedStar Washington Hospital Center, Washington, DC, Professor Emerita, State University of New York University at Buffalo, and an Editorial Board Member of MCN. She can be reached via email at [email protected] The author declares no conflict of interest.

Prognostic implications of percutaneous coronary interventions performed according to the appropriate use criteria for coronary revascularization

To assess the prognostic implication of the ACCF/AHA/SCAI appropriate use criteria (AUC) for coronary revascularization in a cohort of non-acute coronary syndrome patients. The AUC for coronary revascularization were developed in order to deliver high-quality care; however, the prognostic impact of these criteria remains undefined. Consecutive patients (n=3817) undergoing elective percutaneous coronary intervention (PCI) at MedStar Washington Hospital Center since the 2009 AUC publication were retrospectively grouped according to AUC as an "Appropriate," "Inappropriate," or "Undetermined" indication for PCI. Outcomes to 1 year were compared. PCI was categorized as "Appropriate" in 47%, "Inappropriate" in 1.8% and as "Uncertain" in 51% of patients. "Appropriate" PCI patients had a higher prevalence of hypertension and diabetes but a lower prevalence of smoking. "Inappropriate" PCI involved the treatment of more complicated lesions, with lower rates of drug-eluting stent utilization. While there were no differences in procedural complications among the 3 groups, in-hospital major complications and outcomes were worse for "Inappropriate" PCI patients. The 30-day (3.2% vs. 7% vs. 4.1%, p=0.32) and 1-year (13.1% vs. 11.8% vs. 15.3%, p=0.43) major adverse cardiac event rates of the "Appropriate," "Inappropriate," and "Uncertain" PCI patients, respectively, were comparable. In multivariable analysis, the procedural appropriateness was not associated with either in-hospital or 1-year outcome. At large, physicians practicing in tertiary centers adhere to the AUC when subjecting patients with non-acute coronary syndrome to revascularization. The present analysis did not demonstrate association between long-term outcome and procedure appropriateness according to the AUC.

Chronic Hypertension in Pregnancy

Dr. Clark-Ganheart is Maternal-Fetal Medicine Fellow, Department of Obstetrics and Gynecology, MedStar Washington Hospital Center, 110 Irving St, NW, St 5B-39, Washington, DC 20010; E-mail: [email protected]; and Dr. Timofeev is Assistant Professor of Gynecology and Obstetrics, Division of Maternal-Fetal Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland. All faculty and staff in a position to control the content of this CME activity and their spouses/life partners (if any) have disclosed that they have no financial relationships with, or financial interests in, any commercial organizations pertaining to this educational activity. Lippincott Continuing Medical Education Institute, Inc., is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians. Lippincott Continuing Medical Education Institute, Inc., designates this enduring material for a maximum of 1.5 AMA PRA Category 1 Credits™. Physicians should only claim credit commensurate with the extent of their participation in the activity. To earn CME credit, you must read the CME article and complete the quiz and evaluation on the enclosed answer form, answering at least seven of the 10 quiz questions correctly. This activity expires on August 30, 2014.

Intensive CT scan surveillance for patients who have undergone curative intent treatment for colorectal cancer: The Medstar Washington Hospital Center experience.

e14675 Background: The current ASCO guideline for surveillance after curative intent treatment of colorectal cancer is yearly CT scan of the chest, abdomen and pelvis with every 3-6 months history and physical exam and serial measurement of Carcinoembryonic antigen (CEA). The benefit of doing more intensive CT scan surveillance has not been adequately substantiated. Methods: Data of patients with resectable stage I-III colorectal cancer treated at Medstar Washington Hospital Center from January 2000-June 2012 were retrospectively reviewed. Epidemiologic, histopathologic , surveillance schedule (CT scan and CEA), and survival data were analyzed. Our institutional standard was to obtain CT scans every 3 months for the first year, every 6 months for the second year and then yearly for years 3-5. Results: Thirty-three patients with adequate documentation were included. The mean age of the patients was 59.6 years at diagnosis, 55% were female and 78% ethnically African American. 6% were in stage I, 37% were in stage II and 57% in stage III. CT scan was used in 100% of the patients done with a median interval of 7 months. At follow up, 28 (85%) patients had recurrence at a median of 21.6 months from surgery. 67% had recurrence in the liver. 96% of these recurrences were diagnosed primarily by CT scan and only 1 patient (3%) was diagnosed with MRI of the liver following an elevated CEA with a negative CT scan. Only 50% of patients with recurrence had an elevated CEA. 54% of patients with recurrence were able to undergo curative treatment (resection and/or chemotherapy). Conclusions: In this single institution, retrospective review, CT scan surveillance was utilized more frequently than specified in current ASCO guidelines. CEA screening alone would have missed 50% of patients with potentially curable recurrent cancer. Our data shows that more intensive CT scan surveillance led to earlier detection of recurrences that allowed patients to undergo curative intent treatment. A prospective study is warranted to further support this finding.

Comparing the efficacies of neoadjuvant non-cisplatin-based and cisplatin-based chemotherapies in obtaining pathologic complete remissions in muscle-invasive bladder cancer.

e15577 Background: Muscle-invasive bladder cancer (MIBC) is an aggressive disease and cisplatin-based neoadjvuant chemotherapy is standard therapy. Because of renal insufficiency, many patients are unfit to receive cisplatin and, instead receive carboplatin-based chemotherapy. The efficacy of carboplatin-based chemotherapy has not been studied in this setting. We performed a study comparing the efficacies of neoadjuvant carboplatin-containing and cisplatin-containing chemotherapies in achieving pathologic complete responses (pCR) in MIBC. Overall survival (OS) was also calculated. Methods: Medical records for all patients who underwent cystectomy at MedStar Washington Hospital Center between January 1, 2002 and December 31, 2011 were reviewed to determine which neoadjuvant chemotherapy was given and whether a pCR was reached at the time of cystectomy. OS was also calculated. Results: 232 patients qualified for study. 13 received neoadjuvant cisplatin-based treatment (Group 1) and 12 received neoadjuvant carboplatin-based treatment (Group 2). pCR rates were 53.8% and 41.7% in Groups 1 and 2, respectively. 5-year OS for Groups 1 and 2 were 69% and 75%, respectively. Conclusions: Given the limitations of this small retrospective analysis, carboplatin-based neoadjuvant chemotherapy prior to cystectomy for MIBC appears to be comparable in efficacy to cisplatin-based neoadjuvant chemotherapy.

Clinical Databases

Patricia Robin McCartney is the Director of Nursing Research and faculty for Georgetown Scholars, MedStar Washington Hospital Center, Washington, DC, Professor Emerita, State University of New York University at Buffalo, and an Editorial Board Member of MCN. She can be reached via e-mail at [email protected] The author declares no conflict of interest.

Evidence on Electronic Health Record Documentation Time

Patricia Robin McCartney is the Director of Nursing Research and faculty for Georgetown Scholars, MedStar Washington Hospital Center, Washington, DC, Professor Emerita, State University of New York University at Buffalo, and an Editorial Board Member of MCN. She can be reached via e-mail at [email protected]. The author declares no conflict of interest.

Meaningful Use Stages 1 and 2

Patricia Robin McCartney is the Director of Nursing Research and faculty for Georgetown Scholars, MedStar Washington Hospital Center, Washington, DC, Professor Emerita, State University of New York University at Buffalo, and an Editorial Board Member of MCN. She can be reached via email at [email protected]. The author declares no conflict of interest.

140: Effects of low pre-pregnancy body mass index and gestational weight gain on neonatal outcomes

140 Effects of low pre-pregnancy body mass index and gestational weight gain on neonatal outcomes Milana Berguig, Julia Timofeev, Helain Landy MedStar Georgetown University Hospital, Obstetrics and Gynecology, Washington, DC, MedStar Washington Hospital Center, Obstetrics and Gynecology, Washington, DC OBJECTIVE: To evaluate the effect of low pre-pregnancy body mass index (BMI) and low gestational weight gain on neonatal outcomes as compared to parturients with normal BMI and normal or excessive weight gain. STUDY DESIGN: A retrospective review of a multicenter cohort of deidentified data in the Consortium on Safe Labor (NICHD). This database includes information on 233,844 births from 228,668 deliveries from 2002-2008. Maternal factors and neonatal outcomes were analyzed by BMI (low BMI 18.5 kg/m, normal 18.5-24.9 kg/m) and weight gain during gestation as recommended by the Institute of Medicine 2009 guidelines (normal weight gain of 28-40lbs for women with low BMI, and 25-35lbs for women with normal BMI). Chi square and Fisher’s exact tests were used for statistical analysis, with significance determined at two-tailed 0.05. RESULTS: Low pre-pregnancy BMI showed statistically significant increases in the risk of small for gestational age (SGA) infants (OR 1.96, CI 1.93 2.00), NICU admission (OR 1.24, CI 1.21 1.26), and neonatal death (OR 1.62, CI 1.47 1.79). No statistically significant differences were seen in gestational age at delivery or need for newborn resuscitation. When considering recommended weight gain, women who gained less weight ( 28 lbs for low BMI, and 25 lbs for normal BMI) had higher risks of poor pregnancy outcomes (SGA, 5-minute Apgar score 7, NICU admission, antepartum and intrapartum stillbirth (Table). CONCLUSION: Pregnancy outcomes are influenced by both pre-pregnancy BMI and weight gain during pregnancy. These findings suggest that women can minimize their risk of neonatal morbidity and mortality by optimizing their weight prior to conception and gaining the recommended weight amount throughout the pregnancy.

Iatrogenic pulmonary artery rupture: The realities of management

Catheterization and Cardiovascular InterventionsVolume 81, Issue 1 p. 60-61 Coronary Artery Disease Iatrogenic pulmonary artery rupture: The realities of management† Lowell F. Satler MD, Corresponding Author Lowell F. Satler MD [email protected] Division of Cardiology, MedStar Washington Hospital Center, Washington, DCDivision of Cardiology, MedStar Washington Hospital Center, Washington, DCSearch for more papers by this author Lowell F. Satler MD, Corresponding Author Lowell F. Satler MD [email protected] Division of Cardiology, MedStar Washington Hospital Center, Washington, DCDivision of Cardiology, MedStar Washington Hospital Center, Washington, DCSearch for more papers by this author First published: 26 December 2012 https://doi.org/10.1002/ccd.24745Citations: 3 † Conflict of interest: Nothing to report. Read the full textAboutPDF ToolsRequest permissionExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL No abstract is available for this article.Citing Literature Volume81, Issue11 January 2013Pages 60-61 SCAI Member Sign in RelatedInformation

Sandra M. Swain: follow your passion at work.

Sandra M. Swain, MD, is the current president of American Society of Clinical Oncology (ASCO). Honored as America’s Leading Experts on Adjuvant Chemotherapy & Breast Cancer (Breast Neoplasm), Dr. Swain has an international reputation as a leading authority both in the emergent field of inflammatory breast cancer treatment and in the treatment of early breast cancer with 28 years of medical experience and practice in Medical Oncology. Her research interests include Adjuvant Chemotherapy for, Breast Cancer and development of targeted novel agents for advanced breast cancer. She is now the Medical Director of the Washington Cancer Institute of the Medstar Washington Hospital Center and Professor of Medicine at Georgetown University.

The Ultimate Difficult Airway: Minimizing Emergency Surgical Access

Quentin A. Fisher, MD As a sage observer once noted, the more treatments there are available for a condition, the less likely any of them are ideal. The same principle might hold for assessing and managing airway difficulties. Readers well know how our literature is replete with tests, scoring systems, and devices aimed at anticipating and dealing with these vexing problems. However, a small but persistent number of unanticipated airway catastrophes and near-catastrophes seem to occur. No method of examination can identify the variety of pathologies connoted by the term “difficult airway,” and certainly no single piece of equipment can resolve all of these difficulties. Other components include lack of equipment or facility in its use and even failure to identify previously discovered difficulties. Thus, it requires a combination of best practices in preoperative evaluation, communication about prior experiences, availability of airway equipment, and training to deal with the small but important population occupying the very end layers of the American Society of Anesthesiologists’ algorithm for management of the difficult airway. In this issue of Anesthesia & Analgesia, Dr. Berkow et al. document how a multifaceted program instituted in 1996 contributed to a sharp reduction in, but not complete elimination of, emergency surgical airways in a large teaching hospital. There were 5 components: 1) Information: Patients were reported to a centralized database; they were given special hospital identification bands and written information for future reference by medical personnel; and they were encouraged to enroll in the MedicAlert difficult intubation registry. 2) Evaluation: The anesthesia preoperative evaluation form was redesigned to target more specific issues in airway assessment; patients with possibly difficult airways were noted on the operating room (OR) schedule. 3) Equipment: Standardized difficult airway carts were placed to be readily accessible in the ORs, obstetric unit, and intensive care units. 4) Training: Regularly scheduled training sessions were developed for staff and residents, including a “difficult airway” rotation for residents and twice yearly interdisciplinary grand rounds. 5) Oversight: An interdisciplinary team was formed to serve as expert resources, trainers, and supervisors of the program. The effort paid dividends. In the 4 yr before 1996, there were 6–7 emergency surgical airways required per year because an anesthesiologist was unable to intubate the trachea or ventilate the patient’s lungs. For the 11 yr after instituting the program, the range of emergency surgical airways was 0–3 per year, even though the patient population had increased by more than 50%. No single component of the program can be identified as responsible for the improvement. Surely, many things were happening during the years the program was underway. There was rapid growth in recognizing the problem of difficult airways. Hundreds of articles have appeared in the anesthesia literature, documenting new observations, assessment tools, intubation devices, and in many cases, revisiting the old (e.g., the reintroduction of lighted stylets in the 1990s subsequent to their first introduction in the 1950s). Fiberoptic devices proliferated in the 1990s, and, in the 2000s, we have witnessed the introduction of camera-based videolaryngoscopes. Computers have become accessible in or near most ORs, and software to From the Georgetown University School of Medicine, MedStar–Washington Hospital Center, Washington, DC. Accepted for publication July 2, 2009. Supported by MedStar–Washington Hospital Center. Address correspondence and reprint requests to Quentin A. Fisher, MD, MedStar– Washington Hospital Center, 110 Irving St., NW, Washington, DC 20010. Address e-mail to quentin.fisher@medstar.net. Copyright © 2009 International Anesthesia Research Society