Acute kidney injury in patients undergoing endovascular therapy for critical limb ischemia.

BACKGROUND: Similar to coronary angiography and interventions, patients undergoing percutaneous treatment of lower extremity peripheral arterial disease are also at risk of acute kidney injury (AKI). The incidence, risk factors associations, need for dialysis and inhospital mortality related to AKI in patients with critical limb ischemia (CLI) following endovascular therapy is poorly defined. OBJECTIVES: The purpose of this study was to analyze data from the National Inpatient Sample (NIS) to determine the aforementioned outcomes in patients with CLI. METHODS: Using the full NIS admission dataset from 2003 through 2012, ICD-9 codes relevant to comorbid conditions, procedure codes, composite codes for AKI, and inhospital mortality were analyzed using multivariate models. RESULTS: A total of 273,624 patients were included with a mean age of 70.0 ± 27.4 years, 46.0% were female, 57.2% had diabetes, 43.4% had coronary artery disease (CAD), and 29.2% had chronic kidney disease (CKD). The overall rate of AKI was 10.4%, and there was a temporal rise over the analysis period in AKI incidence (p < .001). Age, diabetes, CKD, and heart failure were all associated with AKI (p < .0001). The inhospital mortality rate in the patients with AKI declined over time but was higher than in patients without AKI (6.0% vs. 1.4%), p < .0001. The mortality rate was substantially higher in patients with AKI requiring dialysis as compared to AKI not requiring dialysis (13.4% vs. 5.6%), p < .0001. CONCLUSIONS: AKI is associated with age, CKD, and heart failure. The incidence of AKI following endovascular therapy for CLI is rising and independently associated with inhospital mortality.

Evaluation of patritumab with or without erlotinib in combination with standard cytotoxic agents against pediatric sarcoma xenograft models.

BACKGROUND: Integrating molecularly targeted agents with cytotoxic drugs used in curative treatment of pediatric cancers is complex. An evaluation was undertaken with the ERBB3/Her3-specific antibody patritumab (P) either alone or with the ERBB1/epidermal growth factor receptor inhibitor erlotinib (E) in combination with standard cytotoxic agents, cisplatin, vincristine, and cyclophosphamide, in pediatric sarcoma xenograft models that express receptors and ligands targeted by these agents. PROCEDURES: Tumor models were selected based upon ERBB3 expression and phosphorylation, and ligand (heregulin) expression. Patritumab, E, or these agents combined was evaluated without or with concomitant cytotoxic agents using procedures developed by the Pediatric Preclinical Testing Program. RESULTS: Full doses of cytotoxic agents were tolerated when combined with P, whereas dose reductions of 25% (vincristine, cisplatin) or 50% (cyclophosphamide) were required when combined with P + E. Patritumab, E alone, or in combination did not significantly inhibit growth of any tumor model, except for Rh18 xenografts (E alone). Patritumab had no single-agent activity and marginally enhanced the activity of vincristine and cisplatin only in Ewing sarcoma ES-4. P + E did not increase the antitumor activity of vincristine or cisplatin, whereas dose-reduced cyclophosphamide was significantly less active than cyclophosphamide administered at its maximum tolerated dose when combined with P + E. CONCLUSIONS: P had no single-agent activity, although it marginally potentiated the activity of vincristine and cisplatin in one of three models studied. However, the addition of E necessitated dose reduction of each cytotoxic agent, abrogating the enhancement observed with P alone.

Design of a cluster-randomized minority recruitment trial: RECRUIT.

BACKGROUND: Racial/ethnic minority groups remain underrepresented in clinical trials. Many strategies to increase minority recruitment focus on minority communities and emphasize common diseases such as hypertension. Scant literature focuses on minority recruitment to trials of less common conditions, often conducted in specialty clinics and dependent on physician referrals. We identified trust/mistrust of specialist physician investigators and institutions conducting medical research and consequent participant reluctance to participate in clinical trials as key-shared barriers across racial/ethnic groups. We developed a trust-based continuous quality improvement intervention to build trust between specialist physician investigators and community minority-serving physicians and ultimately potential trial participants. To avoid the inherent biases of non-randomized studies, we evaluated the intervention in the national Randomized Recruitment Intervention Trial (RECRUIT). This report presents the design of RECRUIT. Specialty clinic follow-up continues through April 2017. METHODS: We hypothesized that specialist physician investigators and coordinators trained in the trust-based continuous quality improvement intervention would enroll a greater proportion of minority participants in their specialty clinics than specialist physician investigators in control specialty clinics. Specialty clinic was the unit of randomization. Using continuous quality improvement, the specialist physician investigators and coordinators tailored recruitment approaches to their specialty clinic characteristics and populations. Primary analyses were adjusted for clustering by specialty clinic within parent trial and matching covariates. RESULTS: RECRUIT was implemented in four multi-site clinical trials (parent trials) supported by three National Institutes of Health institutes and included 50 associated specialty clinics from these parent trials. Using current data, we have 88% power or greater to detect a 0.15 or greater difference from the currently observed control proportion adjusting for clustering. We detected no differences in baseline matching criteria between intervention and control specialty clinics (all p values > 0.17). CONCLUSION: RECRUIT was the first multi-site randomized control trial to examine the effectiveness of a trust-based continuous quality improvement intervention to increase minority recruitment into clinical trials. RECRUIT's innovations included its focus on building trust between specialist investigators and minority-serving physicians, the use of continuous quality improvement to tailor the intervention to each specialty clinic's specific racial/ethnic populations and barriers to minority recruitment, and the use of specialty clinics from more than one parent multi-site trial to increase generalizability. The effectiveness of the RECRUIT intervention will be determined after the completion of trial data collection and planned analyses.

Correction: The impact of tackle football injuries on the American healthcare system with a neurological focus.

[This corrects the article DOI: 10.1371/journal.pone.0195827.].

The impact of tackle football injuries on the American healthcare system with a neurological focus.

BACKGROUND: Recent interest in the study of concussion and other neurological injuries has heightened awareness of the medical implications of American tackle football injuries amongst the public. OBJECTIVE: Using the National Emergency Department Sample (NEDS) and the National Inpatient Sample (NIS), the largest publicly available all-payer emergency department and inpatient healthcare databases in the United States, we sought to describe the impact of tackle football injuries on the American healthcare system by delineating injuries, specifically neurological in nature, suffered as a consequence of tackle football between 2010 and 2013. METHODS: The NEDS and NIS databases were queried to collect data on all patients presented to the emergency department (ED) and/or were admitted to hospitals with an ICD code for injuries related to American tackle football between the years 2010 and 2013. Subsequently those with football-related neurological injuries were abstracted using ICD codes for concussion, skull/face injury, intracranial injury, spine injury, and spinal cord injury (SCI). Patient demographics, length of hospital stay (LOS), cost and charge data, neurosurgical interventions, hospital type, and disposition were collected and analyzed. RESULTS: A total of 819,000 patients presented to EDs for evaluation of injuries secondary to American tackle football between 2010 and 2013, with 1.13% having injuries requiring inpatient admission (average length of stay 2.4 days). 80.4% of the ED visits were from the pediatric population. Of note, a statistically significant increase in the number of pediatric concussions over time was demonstrated (OR = 1.1, 95% CI 1.1 to 1.2). Patients were more likely to be admitted to trauma centers, teaching hospitals, the south or west regions, or with private insurance. There were 471 spinal cord injuries and 1,908 total spine injuries. Ten patients died during the study time period. The combined ED and inpatient charges were $1.35 billion. CONCLUSION: Injuries related to tackle football are a frequent cause of emergency room visits, specifically in the pediatric population, but severe acute trauma requiring inpatient admission or operative interventions are rare. Continued investigation in the long-term health impact of football related concussion and other repetitive lower impact trauma is warranted.

Trajectory of systolic blood pressure in a low-income, racial-ethnic minority cohort with diabetes and baseline uncontrolled hypertension.

In two primary care clinics in Texas serving low-income patients, systolic blood pressure (SBP) trajectory was examined during 2 years in patients with diabetes mellitus (mean SBP ≥140 mm Hg: 152 mm Hg±11.2 in the baseline year). Among 860 eligible patients, 62.0% were women, 78.8% were Hispanic, and 41.2% were uninsured. Overall, SBP dropped 0.56 mm Hg per month or 13.4 mm Hg by 24 months. For patients with mean glycated hemoglobin ≥9% in year 1, SBP declined 4.8 mm Hg less by 24 months vs those with glycated hemoglobin <7% (P=.03). Compared with white women, SPB declined 7.2 mm Hg less by 24 months in Hispanic women (P=.03) and 9.6 mm Hg less by 24 months in black men (P=.04). SBP also declined 9.1 mm Hg less by 24 months for patients taking four or more blood pressure drug classes at baseline vs one drug class. In this low-income cohort, clinically complex patients and racial-ethnic minorities had clinically significantly smaller declines in SBP.

Validation of a defibrillation lead ventricular volume measurement compared to three-dimensional echocardiography.

BACKGROUND: There is increasing evidence that using frequent invasive measures of pressure in patients with heart failure results in improved outcomes compared to traditional measures. Admittance, a measure of volume derived from preexisting defibrillation leads, is proposed as a new technique to monitor cardiac hemodynamics in patients with an implantable defibrillator. OBJECTIVE: The purpose of this study was to evaluate the accuracy of a new ventricular volume sensor (VVS, CardioVol) compared with 3-dimenssional echocardiography (echo) in patients with an implantable defibrillator. METHODS: Twenty-two patients referred for generator replacement had their defibrillation lead attached to VVS to determine the level of agreement to a volume measurement standard (echo). Two opposite hemodynamic challenges were sequentially applied to the heart (overdrive pacing and dobutamine administration) to determine whether real changes in hemodynamics could be reliably and repeatedly assessed with VVS. Equivalence of end-diastolic volume (EDV) and stroke volume (SV) determined by both methods was also assessed. RESULTS: EDV and SV were compared using VVS and echo. VVS tracked expected physiologic trends. EDV was modulated -10% by overdrive pacing (14 mL). SV was modulated -13.7% during overdrive pacing (-6 mL) and increased over baseline +14.6% (+8 mL) with dobutamine. VVS and echo mean EDVs were found statistically equivalent, with margin of equivalence 13.8 mL (P <.05). Likewise, mean SVs were found statistically equivalent with margin of equivalence 15.8 mL (P <.05). CONCLUSION: VVS provides an accurate method for ventricular volume assessment using chronically implanted defibrillator leads and is statistically equivalent to echo determination of mean EDV and SV.