Comparison of two individualized antithrombotic protocols in HeartWare HVAD recipients.

We previously reported low rates of pump thrombosis and hemorrhagic stroke, but increased bleeding, under our original antithrombosis protocol (P1) in HeartWare recipients. We designed and implemented a revised protocol (P2) to reduce complexity and bleeding. Thrombelastography and PFA-100 guide antiplatelet titration. Goals for P2 were altered to decrease antiplatelet use and anticoagulation intensity. We compared the incidence and rates of gastrointestinal bleeding (GIB), embolic (eCVA) and hemorrhagic (hCVA) stroke, pump thrombosis (PT), and total bleeding (GIB+hCVA), total thrombosis (eCVA+PT), and total events between P1 and P2. Laboratory and medication data were assessed. Patients with and without hemocompatibility-related adverse events (HRAEs) were compared. The study included 123 patients (P1: 65; P2: 58). GIB rate decreased (P1: 0.66; P2 0.30 EPPY, P = .003). CVA rates and incidence were statistically similar, although hCVA incidence increased (P1: 3%; P2: 12%, P = .06). Incidence (P1: 3%; P2: 16%, P = .02) and rate (P1: 0.03; P2: 0.12 EPPY, P = .08) of PT increased. Incidence and rate of overall HRAEs and thrombotic events were similar, while bleeding rate decreased (P1: 0.69; P2: 0.40 EPPY, P = .02). Twelve-month medication burden decreased. Compared to non-HRAE patients, patients with bleeding HRAEs had more antiplatelet and pentoxifylline use, but less statin use; and lower PFAs. Patients with thrombotic HRAEs had less dual antiplatelet use, lower INRs, R-times, and PFA-ADP values. A revised antithrombotic protocol decreased GIB and overall hemorrhagic HRAE rate and medication burden. Unfortunately, PT increased. Non-HRAE and HRAE patients differed in anticoagulation and antiplatelet intensity. These differences will guide the revision of P2.

Determinants of external ventricular drain placement and associated outcomes in patients with spontaneous intraventricular hemorrhage.

BACKGROUND: External ventricular drain (EVD) usage in patients with intraventricular hemorrhage (IVH) is variable in current practice and in clinical trials, and its impact on outcome remains controversial. The objective of this study was to identify the clinical predictors of EVD utilization, and associated outcome in adults with spontaneous IVH with or without intracerebral hemorrhage (ICH). METHODS: Retrospective review of 183 consecutive IVH patients admitted to a University Hospital between 2003 and 2010. Clinical and radiographic data were analyzed for associations between EVD placement and mortality, poor outcome, and improvement in Glasgow Coma Scale score (GCS) using multivariate logistic regression models. RESULTS: Average age was 62 ± 15.6 years, and average ICH and IVH volumes were 35.8 ± 40.9 cc and 19.7 ± 25.3 cc, respectively. Independent predictors of EVD placement within first 5 days of admission were GCS ≤ 8 (OR 11.5; P < 0.001), Graeb score >5 (OR 4.6; P = 0.001), and non-lobar ICH ≤ 30 cc (OR 9.7; P < 0.001). Median GCS increased from 5 (IQR 3-7) 48 h post-EVD (P < 0.001). EVD placement was an independent predictor of reduced mortality (OR 0.31; P = 0.04) and modified Rankin score 0-3 (OR 15.7; P = 0.01) at hospital discharge. In patients with hydrocephalus on presentation, EVD was associated with reduced mortality for patients with GCS > 3 after controlling for ICH and IVH severity (OR 0.02; P = 0.01). CONCLUSIONS: Patients with lower GCS, higher IVH severity, and lower ICH volume are more likely to have an EVD placed. EVD placement is associated with reduced mortality and improved short-term outcomes in patients with IVH after adjusting for known severity factors. EVD use should be protocolized in clinical trials of ICH management where IVH is included.

Validity and reliability of The Johns Hopkins Adapted Cognitive Exam for critically ill patients.

OBJECTIVE: To validate The Johns Hopkins Adapted Cognitive Exam designed to assess and quantify cognition in critically ill patients. DESIGN: Prospective cohort study. SETTING: Neurosciences, surgical, and medical intensive care units at The Johns Hopkins Hospital. PATIENTS: One hundred six adult critically ill patients. INTERVENTIONS: One expert neurologic assessment and four measurements of the Adapted Cognitive Exam (all patients). Four measurements of the Folstein Mini-Mental State Examination in nonintubated patients only. Adapted Cognitive Exam and Mini-Mental State Examination were performed by 76 different raters. MEASUREMENTS AND MAIN RESULTS: One hundred six patients were assessed, 46 intubated and 60 nonintubated, resulting in 424 Adapted Cognitive Exam and 240 Mini-Mental State Examination measurements. Criterion validity was assessed by comparing Adapted Cognitive Exam with a neurointensivist's assessment of cognitive status (ρ = 0.83, p < .001). Ordinal logistic regression established optimal predicted cut points for cognitive status classification (≤ 28 = severely impaired, 29-55 = moderately impaired, ≥ 56 = mildly impaired or normal). Using these cut points, the Adapted Cognitive Exam appropriately classified cognitive status 90% of the time. Construct validity was assessed by comparing Adapted Cognitive Exam with Mini-Mental State Examination in nonintubated patients (ρ = 0.81, p < .001). Face validity was assessed by surveying raters who used both the Adapted Cognitive Exam and Mini-Mental State Examination and indicated the Adapted Cognitive Exam was an accurate reflection of the patient's cognitive status, more sensitive a marker of cognition than the Mini-Mental State Examination, and easy to use. The Adapted Cognitive Exam demonstrated excellent interrater reliability (intraclass correlation coefficient = 0.997; 95% confidence interval 0.997-0.998) and interitem reliability of each of the five subscales of the Adapted Cognitive Exam and Mini-Mental State Examination (Cronbach's α: range for Adapted Cognitive Exam = 0.83-0.88; range for Mini-Mental State Examination = 0.72-0.81). CONCLUSION: The Adapted Cognitive Exam is the first valid and reliable examination for the assessment and quantification of cognition in critically ill patients. It provides a useful, objective tool that can be used by any member of the interdisciplinary critical care team to support clinical assessment and research efforts.

Validity and reliability of an intuitive conscious sedation scoring tool: the nursing instrument for the communication of sedation.

OBJECTIVE: To develop a symmetrical 7-level scale (+3, "dangerously agitated" to -3, "deeply sedated") that is both intuitive and easy to use, the Nursing Instrument for the Communication of Sedation (NICS). DESIGN: Prospective cohort study. SETTING: University medical center. PATIENTS: Mixed surgical, medical intensive care unit (ICU) population. INTERVENTIONS: Patient assessment. MEASUREMENTS AND MAIN RESULTS: Criterion, construct, face validity, and interrater reliability of NICS over time and comparison of ease of use and nursing preference between NICS and four common intensive care unit sedation scales. A total of 395 observations were performed in 104 patients (20 intubated [INT], 84 non intubated) by 59 intensive care unit providers. Criterion validity was tested comparing NICS WITH the 8-point level of arousal scale, demonstrating excellent correlation (rs = .96 overall, .95 non intubated, 0.85 intubated, all p < .001). Construct validity was confirmed by comparing NICS with the Richmond Agitation-Sedation Scale, demonstrating excellent correlation (rs = .98, p < .001). Face validity was determined in a blinded survey of 53 intensive care unit nurses evaluating NICS and four other sedation scales. NICS was highly rated as easy to score, intuitive, and a clinically relevant measure of sedation, and agitation and was preferred overall (74% NICS, 17% Richmond Agitation-Sedation Scale, 11% Other, p < .001 NICS vs. Richmond Agitation-Sedation Scale). Interrater reliability was assessed, using the five scales at three timed intervals, during which 37% of patients received sedative medication. The mean NICS score consistently correlated with each of the other scales over time with an rs of >.9. Using the intraclass correlation coefficient as a measure of Interrater reliability, NICS scored as high, or higher than Richmond Agitation-Sedation Scale, Riker Sedation-Agitation Scale, Motor Activity Assessment Scale, or Ramsay over the three time periods. CONCLUSION: NICS is a valid and reliable sedation scale for use in a mixed population of intensive care unit patients. NICS ranked highest in nursing preference and ease of communication and may thus permit more effective and interactive management of sedation.

Cognitive improvement during continuous sedation in critically ill, awake and responsive patients: the Acute Neurological ICU Sedation Trial (ANIST).

INTRODUCTION: Most anxiolytics and sedative regimens in the intensive care unit (ICU) impair intellectual function, reducing patient autonomy, and often add to patient morbidity. Using an ICU-validated cognitive assessment tool Adapted Cognitive Exam (ACE), we performed a comparison between dexmedetomidine (DEX) and propofol (PRO) to evaluate which sedative regimen offered the least decrement in intellectual capacity. METHODS: This was a prospective, randomized, double-blinded study of 30 awake and intubated brain-injured (BI, n = 18) and non-BI (12) ICU patients. Each patient received fentanyl/PRO and fentanyl/DEX titrated to a calm, awake state using a crossover design. Cognitive testing was performed at each study period using the validated 100-point Hopkins ACE cognitive battery. FINDINGS: Sedation with PRO diminished adjusted ACE scores (100-point exam) by a mean of -12.4 (95% CI -8.3 to -16.5, p < 0.001) while DEX, in contrast, improved ACE scores (6.8, 95% CI 1.2-12.4, p < 0.018). The difference in the change of ACE score between DEX versus PRO, our primary endpoint, was 19.2 (95% CI 12.3-26.1 p < 0.001) in favor of an improved ACE score on DEX. Patients with BI required less sedative, but effects of PRO and DEX on cognition were not changed. No serious adverse events occurred. Modest bradycardia was noted post hoc with DEX (-7.7 bpm, p < 0.01). INTERPRETATION: ICU patients may be offered sedation without necessarily compromising arousal or cognition. Alleviation of anxiety and agitation can singly and effectively improve mental engagement and performance if overt forebrain dysfunction is avoided. Higher ACE scores with DEX may be a consequence of the intellect-sparing yet calming effect of this drug.

Thrombolytics in intraventricular hemorrhage.

Intraventricular hemorrhage (IVH) may occur as an isolated event from primary ventricular bleeding or as a complication of brain hemorrhage from another etiology. It is associated with high mortality and morbidity. Recent translational and clinical studies demonstrate that thrombolytic drugs administered intraventricularly through an external ventricular drain to lyse an IVH clot are safe and may reduce morbidity and mortality. The ongoing, prospective, randomized clinical trial known as Clot Lysis: Evaluating Accelerated Resolution of Intraventricular Hemorrhage (CLEAR IVH) offers new hope for patients with this devastating disease. Preliminary data show marked reduction in time to clot lysis as well as a potential reduction in mortality associated with IVH lysis. A large, phase III, randomized prospective trial to ascertain the true clinical efficacy of this treatment is currently in the planning stages. A review of the use of thrombolytics for treatment of IVH related to other secondary causes is also provided.