Percutaneous Coronary Intervention Mortality, Cost, Complications, and Disparities after Radiation Therapy: Artificial Intelligence-Augmented, Cost Effectiveness, and Computational Ethical Analysis

The optimal cardio-oncology management of radiation therapy and its complications are unknown despite the high patient and societal costs. This study is the first known nationally representative, multi-year, artificial intelligence and propensity score-augmented causal clinical inference and computational ethical and policy analysis of percutaneous coronary intervention (PCI) mortality, cost, and disparities including by primary malignancy following radiation therapy. Bayesian Machine learning-augmented Propensity Score translational (BAM-PS) statistics were conducted in the 2016–2020 National Inpatient Sample. Of the 148,755,036 adult hospitalizations, 2,229,285 (1.50%) had a history of radiation therapy, of whom, 67,450 (3.00%) had an inpatient AMI, and of whom, 18,400 (28.69%) underwent PCI. Post-AMI mortality, costs, and complications were comparable with and without radiation across cancers in general and across the 30 primary malignancies tested, except for breast cancer, in which PCI significantly increased mortality (OR 3.70, 95%CI 1.10–12.43, p = 0.035). In addition to significant sex, race, and insurance disparities, significant regional disparities were associated with nearly 50 extra inpatient deaths and over USD 500 million lost. This large clinical, cost, and pluralistic ethical analysis suggests PCI when clinically indicated should be provided to patients regardless of sex, race, insurance, or region to generate significant improvements in population health, cost savings, and social equity

Global Convergence on the Bioethics of Surgical Implants

The increasing globalization of mankind with pluralistic belief systems necessitates physicians by virtue of their profession to partner with bioethics for soundly applying emerging knowledge and technologies for the best use of the patient. A subfield within medicine in which this need is acutely felt is that of surgical implants. Within this subfield such recent promising ethics and medicine partnerships include the International Tissue Engineering Research Association and UNESCO Chair in Bioethics and Human Rights’ International Code of Ethics. In this paper, we provide an overview of the emerging human rights framework from bioethics and international law, discussion of key framework principles, their application to the current surgical challenge of implantation of surgical mesh for prolapse, and conclusions and recommendations. Such discussions are meant to facilitate true quality improvement in patient care by ensuring the exciting technologies and medical practices emerging new daily are accompanied by an equal commitment of physicians to ethically provide their services for the chief end of the patient’s good

Vitamin D Status and the Risk of Anemia in Community-Dwelling Adults: Results from the National Health and Nutrition Examination Survey 2001–2006

Abstract Low vitamin D status has been implicated in several chronic medical conditions and unfavorable health outcomes. Our goal was to investigate whether serum 25-hydroxyvitamin D (25OHD) levels are a potentially modifiable risk factor for anemia in a nationally representative cohort of community-dwelling individuals in the United States. We performed a cross-sectional study of 5456 individuals (≥17 years) from the National Health and Nutrition Examination Survey from 2001 to 2006. Locally weighted scatterplot smoothing (LOWESS) was used to graphically depict the relationship between serum 25OHD levels and the cumulative frequency of anemia. Multivariable logistic regression models were then used to assess the independent association of 25OHD levels with anemia, while controlling for age, sex, race, body mass index, chronic kidney disease, as well as serum levels of C-reactive protein, ferritin, iron, vitamin B12, and folic acid. The mean (standard error) 25OHD and hemoglobin levels in the analytic group were 23.5 (0.4) ng/mL and 14.4 (0.1) g/dL, respectively. Prevalence of anemia was 3.9%. Locally weighted scatterplot smoothing analysis demonstrated a near-linear relationship between vitamin D status and cumulative frequency of anemia up to 25OHD levels of approximately 20 ng/mL. With increasing 25OHD levels, the curve flattened out progressively. Multivariable regression analysis demonstrated an inverse association of 25OHD levels with the risk of anemia (adjusted odds ratio 0.97; 95% confidence interval 0.95–0.99 per 1 ng/mL change in 25OHD). Compared to individuals with ≥20 ng/mL, individuals with 25OHD levels <20 ng/mL were more likely to be anemic (adjusted odds ratio 1.64; 95% confidence interval 1.08–2.49). In a nationally representative sample of community-dwelling individuals in the United States, low 25OHD levels were associated with increased risk of anemia. Randomized controlled trials are needed to determine whether optimizing vitamin D status can reduce the burden of anemia in the general population

Modified Frailty Index Predicts Postoperative Outcomes in Patients Undergoing Radical Pelvic Surgery

Patients undergoing radical pelvic surgery such as proctectomy or radical cystectomy are at risk of experiencing a variety of complications. Frailty renders patients vulnerable to adverse events. We hypothesize that frailty measured preoperatively using a validated scoring system correlates with increased likelihood of experiencing Clavien-Dindo grade IV complications and 30-day mortality and may be used as a predictive model for patients preoperatively. The NSQIP database was queried for patients who underwent proctectomy or radical cystectomy from 2008 to 2012. Preoperative frailty was calculated using the 11-point modified frailty index (MFI). Patients were scored based on the presence of indicators and categorized into two groups (= 3). Major postoperative morbidities and mortality were identified and analyzed in each group. 10,048 proctectomy and cystectomy patients were identified. The MFI was found to be predictive of both 30-day mortality (P = 3 is predictive of postoperative morbidity and mortality. Providers should be encouraged to calculate frailty preoperatively to predict adverse outcomes

Safety and Efficacy of Acute Clopidogrel Load in Patients with Moderate and Severe Ischemic Strokes

Objective. To study the safety and efficacy of a clopidogrel loading dose in patients with moderate and severe acute ischemic strokes. Background. The safety of clopidogrel loading has been extensively investigated in patients with minor strokes and transient ischemic attacks. Methods. Acute ischemic stroke patients presenting consecutively to our center from 07/01/08 to 07/31/13 were screened. Clopidogrel loading was defined as at least 300 mg dose (with or without aspirin) given within 6 hours of admission. We compared outcomes in patients with baseline NIHSS > 3 with and without clopidogrel loading. Results. Inclusion criteria were met for 1011 patients (43.6% females, 69.1% black, median age 63). Patients with clopidogrel loading had lower baseline NIHSS than patients who were not loaded (8 versus 9, p=0.005). The two groups had similar risk for hemorrhagic transformation (p=0.918) and symptomatic hemorrhage (p=0.599). Patients who were loaded had a lower rate of neurological worsening (38.9% versus 48.3%, p=0.031) and less in-hospital mortality (4.3% versus 13.4%, p=0.001) compared to those who were not loaded. The likelihood of having a poor functional outcome did not differ between the two groups after adjusting for NIHSS on admission (OR = 0.71, 95% CI 0.4633–1.0906, p=0.118). Conclusion. Clopidogrel loading dose was not associated with increased risk for hemorrhagic transformation or symptomatic intracranial hemorrhage in our retrospective study and was associated with reduced rates of neuroworsening following moderate and severe stroke

Antiepileptic Drug Management in Acute Ischemic Stroke: Are Vascular Neurologists Utilizing Electroencephalograms? An Observational Cohort Study

Introduction. This study examines the utility of electroencephalography (EEG) in clinical decision making in acute ischemic stroke (AIS) patients in regards to the prescription of antiseizure medications. Methods. Patients were grouped as having positive EEG (+) for epileptiform activity or negative EEG (-). These studies were no more than 30 minutes in length. Patients’ charts were retrospectively reviewed for antiepileptic drug (AED) use before, during, and on discharge from AIS hospitalization. Results. Of the 509 patients meeting inclusion criteria, 24 (4.7%) had a positive EEG. Patients did not significantly differ with respect to any demographic or baseline characteristics with the exception of prior history of seizure. In the EEG- group, AEDs were discontinued in only 3.5% of patients. In the EEG+ group, only 37.5% of patients had an initiation or change to their AED regimen within 36 hours of the study. 62.5% of the EEG+ group had a cortical stroke. Significance. Our results indicate that vascular neurologists are not using spot EEGs to routinely guide inpatient AED management. EEGs may have greater utility in those with a prior history of seizures and cortical strokes. Longer or continuous EEG monitoring may have better utility in the AIS population if there is clinical suspicion of seizure

Vitamin D Status and Acute Respiratory Infection: Cross Sectional Results from the United States National Health and Nutrition Examination Survey, 2001–2006

Vitamin D is a promising, though under-explored, potential modifiable risk factor for acute respiratory infections (ARIs). We sought to investigate the association of vitamin D status with ARI in a large, nationally-representative sample of non-institutionalized individuals from the United States. We analyzed 14,108 individuals over 16 years of age in the National Health and Nutrition Survey (NHANES) 2001–2006 in this cross-sectional study. We used locally weighted scatterplot smoothing (LOWESS) to depict the relationship between increasing 25-hydroxyvitamin D (25OHD) levels and ARI. We then performed a multivariable regression analysis to investigate the association of 25OHD levels with ARI, while adjusting for known confounders. The median serum 25OHD level was 21 (IQR 15–27) ng/mL. Overall, 4.8% (95% CI: 4.5–5.2) of participants reported an ARI within 30 days before their participation in the national survey. LOWESS analysis revealed a near-linear relationship between vitamin D status and the cumulative frequency of ARI up to 25OHD levels around 30 ng/mL. After adjusting for season, demographic factors, and clinical data, 25OHD levels <30 ng/mL were associated with 58% higher odds of ARI (OR 1.58; 95% CI: 1.07–2.33) compared to levels ≥30 ng/mL. Among the 14,108 participants in NHANES 2001–2006, 25OHD levels were inversely associated with ARI. Carefully designed, randomized, controlled trials are warranted to determine the effect of optimizing vitamin D status on the risk of ARI

The role of cardio-protective agents in cardio-preservation in breast cancer patients receiving Anthracyclines ± Trastuzumab: a Meta-analysis of clinical studies

BACKGROUND: Breast cancer patients often receive cardiotoxic drugs such as anthracyclines (ANT) and Trastuzumab. Numerous trials have tested angiotensin converting enzyme inhibitors (ACEi), angiotensin receptor blockers (ARB), and beta-blockers (BB) as monotherapy or in combination to reprogram cardiac function dynamics in these patients, but no clear conclusions have been reached thus far, due to evident heterogeneity in the design of clinical studies. METHODS: This PRISMA-guided systematic review and meta-analysis assessed a pooled effect estimate of the potential benefit/harm of ACEi/ARB/BB in breast cancer patients treated with ANT ± Trastuzumab. The protocol was registered on the PROSPERO database. Electronic databases (PubMed, Cochrane Central, Scopus, Web of Science) were searched from inception until February 2019. RESULTS: Twenty-two prospective studies comprising of 2,302 participants were included in the meta-analysis. The 16 studies testing the protective effects of ACEi/ARB/BB after immediate completion of chemotherapy showed a significant lower difference in the mean change of left ventricular ejection fraction (LVEF) in patiens receiving cardio-protective drugs as compared to controls, with a standardized mean difference [SMD = -2.36 (95% CI: -3.23 to -1.49), p \u3c 0.00001] favoring the protective role of these drugs. LVEF was evaluated after 6 months after completion of chemotherapy in 3 studies, where ACEi/ARB/BB persistently showed cardio-protective effects as compared to controls [SMD = -6.54 (95% CI: -10.74 to -2.34), p = 0.002]. After 1 year from completion of chemotherapy, ACEi/ARB/BB preserved beneficial effects on LVEF vs control [SMD = -5.37 (95% CI: -9.31 to -1.43), p = 0.008]. The effect of ACEi/ARB/BB on end-systolic volume (ESV) and end-diastolic volume (EDV) were evaluated immediately after chemotherapy completion and after 1 year. No significant protective effect was apparent. On the other hand, end-diastolic diameter (EDD) was significantly spared in the ACEi/ARB/BB group vs control after chemotherapy completion [SMD = -1.11 (95% CI: -1.88 to -0.35), p = 0.004]. Heart failure as a clinical endpoint was assessed in 11 trials. The incidence of heart failure was significantly lower in the ACEi/ARB/BB group as compared to control [Odds ratio = 0.12 (95% CI: 0.03 to 0.45), p = 0.002]. CONCLUSION: ACEi/ARB/BB may act as cardioprotective agents in breast cancer patients who undergo ANT ± Trastuzumab. More studies are required to better assess the magnitude of the cardiotoxicity hazards of ANT ± Trastuzumab, with more precise assessment of the effect of ACEi/ARB/BB on cardio-protection