Impact of continued clopidogrel use on outcomes of patients undergoing carotid endarterectomy.

OBJECTIVE: The aim of this study was to evaluate the use of clopidogrel at the time of carotid endarterectomy (CEA) and its association with postoperative complications. METHODS: Single-institution, retrospective review of a prospective database. RESULTS: From 2010 to 2017, CEA was performed in 1066 consecutive patients (median age, 73 years; 66% men). The indications for operation included ≥70% asymptomatic stenosis (458; 43%), prior stroke (314; 29%), and transient cerebral or retinal ischemia (294; 28%). At the time of operation, 509 (48%) patients were taking aspirin alone, 441 (41%) were taking clopidogrel (374 in combination with aspirin, 67 as sole therapy), 83 (8%) were on no documented antiplatelet medication, and 33 (3%) were taking warfarin (with therapeutic international normalized ratio). The likelihood of clopidogrel use at the time of operation was higher for patients with a history of symptomatic carotid disease (P = .002). Over the study period, clopidogrel use increased from 31.9% in 2010 to 56.8% in 2017, which corresponds to an 11% (95% confidence interval, 6%-15%) increase annually. Postoperative strokes occurred in 15 patients (overall incidence, 1.4%), the majority of which were minor (12/15; 80%). Six strokes occurred in patients taking aspirin alone (6/509; 1.2%), two in patients on clopidogrel and aspirin (2/441; 0.5%), two in patients taking clopidogrel alone (2/67; 2.9%), three in patients on no documented antiplatelet medication (3/83; 3.6%), and two in those taking warfarin (one of which was secondary to a fatal intracranial hemorrhage within 30 days of discharge [2/33; 6.1%]). The 30-day mortality rate was 0.03% (3/1066); the risk for the combined endpoint of any stroke, death, or myocardial infarction (MI) was 2.3% (25/1066), and the risk for major stroke, death, or MI was 1.2%. There was no apparent association between clopidogrel use and the incidence of postoperative bleeding (P = .59) or any other postoperative complication (stroke, death, MI, cranial nerve injury; P = .15). CONCLUSIONS: Clopidogrel use in our CEA practice has increased over time and has not been associated with an increased risk of postoperative complications, including bleeding. These data suggest that clopidogrel should not be discontinued prior to CEA and should be considered as part of 'optimal medical therapy' in patients undergoing CEA.

Leveraging Clerkship Experiences to Address Segregated Care: A Survey-Based Approach to Student-Led Advocacy.

Phenomenon: Many academic medical centers (AMCs) have a history of separating patients on the basis of insurance status. In New York State, where Black and Latino patients are more than twice as likely to have Medicaid as white patients, this practice leads to de facto racial segregation in healthcare. Emerging evidence suggests that this segregation of care is detrimental to both patient care and medical education. Medical students are uniquely positioned to be change makers in this space but face significant barriers to speaking out about these disparities and successfully advocating for institutional change. Approach: The authors designed, piloted, and distributed a 16-item survey on segregated care to third-year medical students at a large academic medical center in New York City. Students were asked both open- and close-ended questions about witnessing separation and differences in patient care on the basis of insurance during their clinical rotations. The survey was shared with 140 students in March 2019 with a response rate of 46.4% (n = 65). Preliminary findings were presented to school and hospital administrators. Findings: More than half of survey respondents reported witnessing separation of patient care or differences in patient care on the basis of insurance (56.3%, n = 36 and 51.6%, n = 33 respectively). Many students reported that these experiences contributed to cynicism and burnout. The authors leveraged these results to advocate for quality improvement measures. In Ob-Gyn, department leadership launched a clinical transformation taskforce and recruited a new Vice Chair of Clinical Transformation/Chief Patient Experience Officer, whose role includes addressing segregated care and disparities in health outcomes. The hospital committed to establishing integrated practices in new clinical spaces and launching a similar survey among house staff. Insights: Many medical students experience and participate in segregated care during their clerkships and this has the potential to impact their education. Medical students are well-positioned to recognize segregated care across health systems and leverage their experiences for advocacy. A survey-based approach can be a powerful tool enabling students to collect these experiences to address segregated care and other health equity issues.

Cost-effectiveness frameworks for comparing genome and exome sequencing versus conventional diagnostic pathways: A scoping review and recommended methods.

PURPOSE: Methodological challenges have limited economic evaluations of genome sequencing (GS) and exome sequencing (ES). Our objective was to develop conceptual frameworks for model-based cost-effectiveness analyses (CEAs) of diagnostic GS/ES. METHODS: We conducted a scoping review of economic analyses to develop and iterate with experts a set of conceptual CEA frameworks for GS/ES for prenatal testing, early diagnosis in pediatrics, diagnosis of delayed-onset disorders in pediatrics, genetic testing in cancer, screening of newborns, and general population screening. RESULTS: Reflecting on 57 studies meeting inclusion criteria, we recommend the following considerations for each clinical scenario. For prenatal testing, performing comparative analyses of costs of ES strategies and postpartum care, as well as genetic diagnoses and pregnancy outcomes. For early diagnosis in pediatrics, modeling quality-adjusted life years (QALYs) and costs over ≥20 years for rapid turnaround GS/ES. For hereditary cancer syndrome testing, modeling cumulative costs and QALYs for the individual tested and first/second/third-degree relatives. For tumor profiling, not restricting to treatment uptake or response and including QALYs and costs of downstream outcomes. For screening, modeling lifetime costs and QALYs and considering consequences of low penetrance and GS/ES reanalysis. CONCLUSION: Our frameworks can guide the design of model-based CEAs and ultimately foster robust evidence for the economic value of GS/ES.

Surgical outcomes in patients with endoscopic versus transcranial approach for skull base malignancies: a 10-year institutional experience.

OBJECT: The authors performed an extensive comparison between patients treated with open versus an endoscopic approach for skull base malignancy with emphasis on surgical outcomes. METHODS: A single-institution retrospective review of 60 patients who underwent surgery for skull base malignancy between 2009 and 2018 was performed. Disease features, surgical resection, post-operative morbidities, adjuvant treatment, recurrence, and survival rates were compared between 30 patients who received purely open surgery and 30 patients who underwent purely endoscopic resection for a skull base malignancy. RESULTS: Of the 60 patients with skull base malignancy, 30 underwent open resection and 30 underwent endoscopic resection. The most common hisotype for endoscopic resection was squamous cell carcinoma (26.7%), olfactory neuroblastoma (16.7%), and sarcoma (10.0%), and 43.3%, 13.3%, and 10.0% for the open resection cohort, respectively. There were no statistical differences in gross total resection, surgical-associated cranial neuropathy, or ability to achieve negative margins between the groups (p > 0.1, all comparisons). Patients who underwent endoscopic resection had shorter surgeries (320.3 ± 158.5 minutes vs. 495.3 ± 187.6 minutes (p = 0.0003), less intraoperative blood loss (282.2 ± 333.6 ml vs. 696.7 ± 500.2 ml (p < 0.0001), and shorter length of stay (3.5 ± 3.7 days vs. 8.8 ± 6.0 days (p < 0.0001). Additionally, patients treated endoscopically initiated adjuvant radiation treatment more quickly (48.0 ± 20.3 days vs. 72.0 ± 20.5 days (p = 0.01). CONCLUSIONS: An endoscopic endonasal approach facilitates a clinically meaningful improvement in surgical outcomes for skull base malignancies.

Detection of Hippocampal Subfield Asymmetry at 7T With Automated Segmentation in Epilepsy Patients With Normal Clinical Strength MRIs.

While the etiology of hippocampal sclerosis (HS) in epilepsy patients remains unknown, distinct phenotypes of hippocampal subfield atrophy have been associated with different clinical presentations and surgical outcomes. The advent of novel techniques including ultra-high field 7T magnetic resonance imaging (MRI) and automated subfield volumetry have further enabled detection of hippocampal pathology in patients with epilepsy, however, studies combining both 7T MRI and automated segmentation in epilepsy patients with normal-appearing clinical MRI are limited. In this study, we present a novel application of the automated segmentation of hippocampal subfields (ASHS) software to determine subfield volumes of the CA1, CA2/3, CA4/DG, and the subiculum using ultra high-field 7T MRI scans, including T1-weighted MP2RAGE and T2-TSE sequences, in 27 patients with either mesial temporal lobe epilepsy (mTLE) or neocortical epilepsy (NE) compared to age and gender matched healthy controls. We found that 7T improved visualization of structural abnormalities not otherwise seen on clinical strength MRIs in patients with unilateral mTLE. Additionally, our automated segmentation algorithm was able to detect structural differences in volume and asymmetry across hippocampal subfields in unilateral mTLE patients compared to controls. Specifically, amongst unilateral mTLE patients with longer disease durations, volume loss was observed in the ipsilateral CA1 and CA2/3 subfields and contralateral CA1. There were no differences in subfield volumes in patients with NE compared to controls. We report the first application of 7T with automated segmentation to characterize the relationship between disease duration burden and asymmetry across specific hippocampal subfields in this population. Disease duration was found to have a statistically significant positive relationship with subfield asymmetry within the unilateral mTLE cohort. These findings highlight the ability of 7T MRI and automated segmentation to provide novel qualitative and quantitative information in epilepsy patients who are otherwise MRI-negative at clinical field strengths.

Pre-hospital antiplatelet medication use on COVID-19 disease severity.

OBJECTIVE: To evaluate the association between pre-hospitalization antiplatelet medication use and COVID-19 disease severity. DESIGN: Retrospective cohort study. SETTING: Inpatient units at The Mount Sinai Hospital. PATIENTS: Adults age ≥18 admitted between March 1, 2020 and April 9, 2020 with confirmed COVID-19 infection with at least 28 days follow-up. MEASUREMENTS: We captured baseline demographic, pre-hospitalization antiplatelet medication use, and clinical encounter data for all patients who met inclusion criteria. The primary endpoint was peak score on a 6-point modified ordinal scale (MOS), which is based on World Health Organization blueprint R&S groups, used to grade severity of illness through clinical outcomes of interest. Scores indicate the following: 1 - COVID-19 infection not requiring hospitalization, 2 - requiring hospitalization but not supplemental oxygen, 3 - hospitalization requiring supplemental oxygen, 4 - hospitalization requiring high-flow nasal cannula (HFNC) or non-invasive positive pressure ventilation (NIPPV), 5 - hospitalization requiring intubation or extracorporeal membrane oxygenation (ECMO), 6 - death. Multivariable adjusted partial proportional odds model (PPOM) was performed to examine the association between pre-hospitalization antiplatelet medication use and likelihood of each MOS score. MAIN RESULTS: Of 762 people admitted with COVID-19, 239 (31.4%) used antiplatelet medications pre-hospitalization while 523 (68.6%) did not. Antiplatelet users were older and had more co-morbidities at baseline. Before adjusting for covariates, patients who used antiplatelet medications pre-hospitalization were more likely than non-users to have peak MOS score 6 (death, OR 1.75, 95% CI 1.21-2.52), peak MOS score ≥5 (intubation/ECMO or death, OR 1.4, 95% CI 1.00-1.98) and peak MOS score ≥4 (HFNC, NIPPV, intubation/ECMO or death, OR 1.40, 95% CI 1.01-1.94). On multivariable adjusted PPOM analysis controlling for 13 covariates, there were no longer any significant differences in peak MOS scores between users and non-users. CONCLUSIONS: After adjusting for covariates, pre-hospital antiplatelet use was not associated with COVID-19 severity in hospitalized patients.

Estimated Health Care Utilization and Expenditures in Individuals With Heart Failure From the Medical Expenditure Panel Survey.

BACKGROUND: Heart failure (HF) constitutes a growing burden for public health and the US health care system. While the prevalence of HF is increasing, differences in health care utilization and expenditures within various sociodemographic groups remain poorly defined. METHODS: We used the Medical Expenditure Panel Survey to assess annual health care utilization and expenditures from 2012 to 2017. Health care utilization was based on the annual frequency of various health care encounters. Annual total and out-of-pocket expenditures were evaluated for hospital inpatient stays, emergency room visits, outpatient visits, office-based medical provider visits, prescribed medicines, dental visits, home health aid visits, and other medical expenses. We performed univariable and multivariable regression analysis based on patient characteristics including sociodemographic and comorbidity variables. RESULTS: Our results showed that total health care expenditures among patients with HF were $21 177 (95% CI, $18 819-$24 736) per year as compared with $5652 (95% CI, $5469-$5837) in those without HF (P<0.001). Total expenditures within the population with HF were primarily being driven by expenditures associated with inpatient hospitalizations. Increasing number of comorbid conditions was associated with significant increases in total health care expenditures. Older age, female sex, earlier study years, number of comorbidities, higher level of education, and increasing family income brackets independently raised out-of-pocket expenditures. CONCLUSIONS: Our findings of increased health care utilization and expenditures based on sex, age, increasing number of comorbidities, wealthier income status, and increased education attainment level may be used for efforts aimed at better distributing health care resources to improve health outcomes in HF.

Temporal Bone Encephaloceles: Utility of Preoperative Imaging.

OBJECTIVE: To determine the diagnostic efficacy and clinical value of preoperative computed tomography (CT) and magnetic resonance imaging (MRI) among patients with suspected temporal bone encephaloceles (TBE). STUDY DESIGN: Retrospective chart review from 2006 to 2018. SETTING: Tertiary referral center. SUBJECTS AND METHODS: The subjects underwent surgery for a clinically suspected TBE or cerebrospinal fluid (CSF) leak. Preoperative imaging test characteristics of CT and MRI, including sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV), were calculated for TBE scans and compared with intraoperative findings. RESULTS: Fifty-seven subjects with otorrhea, middle ear effusion, hearing loss, and/or meningitis with suspected TBE or CSF leak were identified. All had preoperative CT scans, and 61% (35/57) had preoperative MRI scans. Intraoperatively, 37 of 57 patients (65%) were found to have a TBE. CT scans (17% sensitivity, 100% specificity, 100% PPV, 46% NPV) were less sensitive than MRI (58% sensitivity, 100% specificity, 100% PPV, 24% NPV) for detecting TBEs. Furthermore, the time from initial scan to operative repair was significantly longer in those who had a CT followed by MRI scan compared with CT alone or a fused CT-MRI scan (mean = 68 vs 15 days, respectively; P = .004). CONCLUSION: CT and MRI provide complementary information that may aid surgical planning. However, imaging cannot always rule out TBE. In cases with high clinical suspicion, surgical confirmation is often required for definitive diagnosis and treatment. The cost of an additional preoperative study should be considered before its use.

Measuring degeneration of the lateral geniculate nuclei from pituitary adenoma compression detected by 7T ultra-high field MRI: a method for predicting vision recovery following surgical decompression of the optic chiasm.

OBJECTIVE: Predicting vision recovery following surgical decompression of the optic chiasm in pituitary adenoma patients remains a clinical challenge, as there is significant variability in postoperative visual function that remains unreliably explained by current prognostic factors. Available literature inadequately characterizes alterations in adenoma patients involving the lateral geniculate nucleus (LGN). This study examined the association of LGN degeneration with chiasmatic compression as well as with the retinal nerve fiber layer (RNFL), pattern standard deviation (PSD), mean deviation (MD), and postoperative vision recovery. PSD is the degree of difference between the measured visual field pattern and the normal pattern ("hill") of vision, and MD is the average of the difference from the age-adjusted normal value. METHODS: A prospective study of 27 pituitary adenoma patients and 27 matched healthy controls was conducted. Participants were scanned on a 7T ultra-high field MRI scanner, and 3 independent readers measured the LGN at its maximum cross-sectional area on coronal T1-weighted MPRAGE imaging. Readers were blinded to diagnosis and to each other's measurements. Neuro-ophthalmological data, including RNFL thickness, MD, and PSD, were acquired for 12 patients, and postoperative visual function data were collected on patients who underwent surgical chiasmal decompression. LGN areas were compared using two-tailed t-tests. RESULTS: The average LGN cross-sectional area of adenoma patients was significantly smaller than that of controls (13.8 vs 19.2 mm2, p < 0.0001). The average LGN cross-sectional area correlated with MD (r = 0.67, p = 0.04), PSD (r = -0.62, p = 0.02), and RNFL thickness (r = 0.75, p = 0.02). The LGN cross-sectional area in adenoma patients with chiasm compression was 26.6% smaller than in patients without compression (p = 0.009). The average tumor volume was 7902.7 mm3. Patients with preoperative vision impairment showed 29.4% smaller LGN cross-sectional areas than patients without deficits (p = 0.003). Patients who experienced improved postoperative vision had LGN cross-sectional areas that were 40.8% larger than those of patients without postoperative improvement (p = 0.007). CONCLUSIONS: The authors demonstrate novel in vivo evidence of LGN volume loss in pituitary adenoma patients and correlate imaging results with neuro-ophthalmology findings and postoperative vision recovery. Morphometric changes to the LGN may reflect anterograde transsynaptic degeneration. These findings indicate that LGN degeneration may be a marker of optic apparatus injury from chiasm compression, and measurement of LGN volume loss may be useful in predicting vision recovery following adenoma resection.

NHLBI-Sponsored Randomized Trial of Postconditioning During Primary Percutaneous Coronary Intervention for ST-Elevation Myocardial Infarction.

RATIONALE: Postconditioning at the time of primary percutaneous coronary intervention (PCI) for ST-segment-elevation myocardial infarction may reduce infarct size and improve myocardial salvage. However, clinical trials have shown inconsistent benefit. OBJECTIVE: We performed the first National Heart, Lung, and Blood Institute-sponsored trial of postconditioning in the United States using strict enrollment criteria to optimize the early benefits of postconditioning and assess its long-term effects on left ventricular (LV) function. METHODS AND RESULTS: We randomized 122 ST-segment-elevation myocardial infarction patients to postconditioning (4, 30 seconds PTCA [percutaneous transluminal coronary angioplasty] inflations/deflations)+PCI (n=65) versus routine PCI (n=57). All subjects had an occluded major epicardial artery (thrombolysis in myocardial infarction=0) with ischemic times between 1 and 6 hours with no evidence of preinfarction angina or collateral blood flow. Cardiac magnetic resonance imaging measured at 2 days post-PCI showed no difference between the postconditioning group and control in regards to infarct size (22.5±14.5 versus 24.0±18.5 g), myocardial salvage index (30.3±15.6% versus 31.5±23.6%), or mean LV ejection fraction. Magnetic resonance imaging at 12 months showed a significant recovery of LV ejection fraction in both groups (61.0±11.4% and 61.4±9.1%; P<0.01). Subjects randomized to postconditioning experienced more favorable remodeling over 1 year (LV end-diastolic volume =157±34 to 150±38 mL) compared with the control group (157±40 to 165±45 mL; P<0.03) and reduced microvascular obstruction ( P=0.05) on baseline magnetic resonance imaging and significantly less adverse LV remodeling compared with control subjects with microvascular obstruction ( P<0.05). No significant adverse events were associated with the postconditioning protocol and all patients but one (hemorrhagic stroke) survived through 1 year of follow-up. CONCLUSIONS: We found no early benefit of postconditioning on infarct size, myocardial salvage index, and LV function compared with routine PCI. However, postconditioning was associated with improved LV remodeling at 1 year of follow-up, especially in subjects with microvascular obstruction. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov . Unique identifier: NCT01324453.

Initial presentation of human papillomavirus-related head and neck cancer: A retrospective review.

OBJECTIVE: Human papillomavirus (HPV) has been identified as a risk factor for oropharyngeal squamous cell carcinoma (OPSCC) and a cause of the recent dramatic rise in the incidence of this disease. HPV-positive OPSCC typically affects a younger population and has no validated screening test. This study aims to outline the common presenting signs of HPV-positive OPSCC. METHODS: We conducted a retrospective single-institution review on 370 patients who were treated at the Icahn School of Medicine at Mount Sinai, New York City, between April 2007 and November 2015 for OPSCC. We included patients with newly diagnosed OPSCC and sufficient history and physical data in the final analysis. Univariate analysis was used to compare HPV-positive and HPV-negative cohorts for demographics, tumor location, tumor staging, initial presentation and symptoms, and physical exam findings. RESULTS: Two hundred and seven patients met the inclusion criteria. The most common initial symptoms for OPSCC were neck mass (51.7%) and sore throat (13.0%). The HPV-positive cohort was more likely to present with a chief complaint of neck mass compared to the HPV-negative cohort (56.1% vs. 22.2%; P = 0.0015). A positive neck exam was associated with HPV-positive status (73.9% vs. 40.7%; P = 0.0012). CONCLUSION: HPV-positive OPSCC is an incipient epidemic, poised to surpass cervical cancer as the most common HPV-related cancer by 2020. Initial presenting signs may often be mistaken for benign processes. This study provides physicians with a better understanding of initial presentation of patients with HPV-positive OPSCC, leading to earlier diagnosis and improved outcomes. LEVEL OF EVIDENCE: 4 Laryngoscope, 129:877-882, 2019.

Variability in Clinical Presentation and Pathologic Implications of Ectopic Pituitary Tumors: Critical Review of Literature.

OBJECTIVE: Pituitary tumors are common, well-described skull base tumors of sellar origin. However, there are reports of rare ectopic pituitary tumors that are found exclusively outside of the sella turcica. Ectopic pituitary tumors have not been holistically analyzed. This study describes presentation and clinical patterns found among patients with ectopic pituitary tumors. METHODS: A comprehensive review of the literature was performed for clinical descriptions of ectopic pituitary tumors. Reports of 85 applicable cases were evaluated. RESULTS: The most common locations of ectopic pituitary tumors were the sphenoid sinus, clivus, suprasellar space, nasopharynx, and cavernous sinus. The majority of ectopic pituitary tumors were reported as being functional secretory tumors; they were statistically significantly more likely to be functional tumors than sellar pituitary tumors. Adrenocorticotrophic hormone, prolactin, growth hormone, and thyroid-stimulating hormone-secreting tumors were most commonly found. Bone invasion was reported in more than one third of the cases, and malignant transformations were reported in 6 cases. A large majority of patients presented with hormonal, neurologic, or physiologic symptoms. CONCLUSIONS: Ectopic pituitary tumors are a rare entity of pituitary tumors with a presentation that can mimic those of other skull base tumors. Clinical presentation often correlates to location of the tumor. Ectopic pituitary tumors were significantly more likely to be functional secretory tumors. They may also exhibit more aggressive behavior than sellar-located tumors. Ectopic pituitary tumors may be part of a spectrum of presenting pathologies. Further genetic or genomic analysis is necessary to better understand their pathogenesis and clinical presentations.

A Dedicated Surveillance Program Improves Compliance with Endovascular Aortic Aneurysm Repair Follow-up.

BACKGROUND: Current recommendations suggest lifetime follow-up for endovascular aortic aneurysm repair (EVAR) patients to avoid consequences associated with endoleak and aneurysm enlargement. Follow-up compliance has been reported between 43% and 92%, with most single-center studies citing successful follow-up surveillance at less than 60%. We investigated follow-up completeness with a defined surveillance program and subsequent secondary intervention prevalence from a single center. METHODS: Our surveillance program notified patients of the need for follow-up imaging and surgeon review. Data were obtained from retrospective review of a prospective database, including operative and follow-up details, follow-up imaging completeness, endoleak incidence, and secondary intervention prevalence. RESULTS: Five hundred seventeen patients received elective EVAR from 2005 to 2015. Surveillance was achieved in 425 (82.3%). Mean number of follow-up studies was 4.2 ± 2.9 and median time to first follow-up was 36 days. Four hundred forty-eight patients (86.7%) had freedom from intervention. Sixty-nine unique patients (13.3%) had 107 secondary interventions. Median time to first secondary intervention in 69 patients was 476 days. Mean number of imaging studies for secondary intervention patients was 6.1 ± 3.9, compared with mean 3.4 ± 2.3 for patients without (P < 0.001). Overall mortality was 24.6% (n = 127), including 32 deaths of unknown cause (6.2% overall) and 95 of non-EVAR-related causes (18.3%). No aneurysm-related deaths were reported. CONCLUSIONS: Regular post-EVAR surveillance through a dedicated program resulted in a high rate of follow-up compliance, 13.3% rate of secondary intervention, and low aneurysm-related mortality. Careful lifetime surveillance remains important in long-term care following elective EVAR.