Evaluation of Cangrelor Use After Percutaneous Coronary Intervention in Patients With Mechanical Circulatory Support.

OBJECTIVES: To describe cangrelor use in patients on concurrent mechanical circulatory support who underwent postpercutaneous coronary intervention. DESIGN: A single-center, retrospective, cohort study. SETTING: At a quaternary teaching hospital. PARTICIPANTS: Included patients were ≥18 years old, admitted to the intensive care unit, underwent percutaneous coronary intervention with stent placement, initiated on mechanical circulatory support, and received cangrelor in the postpercutaneous coronary intervention period. INTERVENTIONS: Retrospectively analyzed cangrelor use in patients on mechanical circulatory support. MEASUREMENTS AND MAIN RESULTS: The primary outcome was the incidence of thrombosis and bleeding events during cangrelor administration. Additional outcomes included initial cangrelor dose, number of cangrelor dose adjustments per patient, survival from mechanical circulatory support, and mortality within 30 days. Overall, 19 patients were included in this study. In total, 14 patients (74%) experienced a bleeding event; however, 93% were classified as a minor bleed. There was 1 major bleeding event. There were no thrombotic events observed during cangrelor administration. The median initial cangrelor dose was 0.5 µg/kg/min. There were 10 patients who underwent dose adjustment, with the majority being dose reductions based on antiplatelet monitoring (VerifyNow assay). Survival from mechanical circulatory support occurred in 17 patients (89%), and 30-day mortality occurred in 8 patients (42%). CONCLUSIONS: For patients receiving cangrelor as a bridge to oral P2Y12 inhibitor therapy on mechanical circulatory support, the authors observed a low rate of major bleeding and no episodes of thrombosis. Lower starting doses appear feasible with no observed increased risk of thrombotic complications. Future studies are needed to confirm these observations.

Anticoagulation Management for Impella Percutaneous Ventricular Assist Devices: An Analysis of a Single-Center Experience.

BACKGROUND: Impella devices offer temporary mechanical circulatory support for cardiogenic shock. The manufacturer recommends systemic anticoagulation with a target activated clotting time of 160 to 180 s but provides no guidance on how to manage both the heparinized purge solution and the additional intravenous heparin needed to reach this therapeutic range. Previous publications demonstrated a lack of standardization in heparin management for Impella devices. OBJECTIVE: The purpose of this study was to compare the effectiveness and safety of 2 different heparin protocols for long-term Impella support. METHODS: This single-center, retrospective study included adult patients on Impella support for greater than 24 hours. The primary end point was time to therapeutic range measured in hours, from time of implantation to the first of 2 consecutive measurements within the therapeutic range. Secondary end points included percentage of time in therapeutic range, rates of major bleeding, pump thrombosis, hemolysis, and nursing satisfaction. RESULTS: There were 19 patients identified, with 7 using the original protocol and 12 using the revised protocol. Time to therapeutic range was similar between protocols (15.5 vs 12 hours, P = NS). Another 14 patients were managed with patient-specific protocols as a result of bleeding or physician preference. In total, 42% of all patients in this study experienced major bleeding. There were no confirmed thrombosis events. This study was limited by a small sample size. CONCLUSION AND RELEVANCE: Despite using different heparin protocols, outcomes and bleeding events were similar between groups. Future studies are needed to determine the optimal degree of anticoagulation necessary to reduce bleeding risk.

Parent-child relationship quality and family transmission of parent posttraumatic stress disorder symptoms and child externalizing and internalizing symptoms following fathers' exposure to combat trauma.

Transactional cascades among child internalizing and externalizing symptoms, and fathers' and mothers' posttraumatic stress disorder (PTSD) symptoms were examined in a sample of families with a male parent who had been deployed to recent military conflicts in the Middle East. The role of parents' positive engagement and coercive interaction with their child, and family members' emotion regulation were tested as processes linking cascades of parent and child symptoms. A subsample of 183 families with deployed fathers and nondeployed mothers and their 4- to 13-year-old children who participated in a randomized control trial intervention (After Deployment: Adaptive Parenting Tools) were assessed at baseline prior to intervention, and at 12 and 24 months after baseline, using parent reports of their own and their child's symptoms. Parents' observed behavior during interaction with their children was coded using a multimethod approach at each assessment point. Reciprocal cascades among fathers' and mothers' PTSD symptoms, and child internalizing and externalizing symptoms, were observed. Fathers' and mothers' positive engagement during parent-child interaction linked their PTSD symptoms and their child's internalizing symptoms. Fathers' and mothers' coercive behavior toward their child linked their PTSD symptoms and their child's externalizing symptoms. Each family member's capacity for emotion regulation was associated with his or her adjustment problems at baseline. Implications for intervention, and for research using longitudinal models and a family-systems perspective of co-occurrence and cascades of symptoms across family members are described.

Bleeding outcomes associated with coronary artery bypass graft surgery and recent clopidogrel exposure.

BACKGROUND: Guidelines recommend discontinuing clopidogrel for at least 5 days before elective coronary artery bypass graft surgery (CABG) to limit blood transfusions and for at least 24 hours before urgent CABG to reduce major bleeding complications. Studies have produced conflicting results regarding whether recent exposure to clopidogrel increases bleeding, the need for intraoperative and postoperative blood products, postoperative complications, and hospital length of stay. We evaluated the effect of clopidogrel exposure on major bleeding at our institution within 5 days of CABG. METHODS: We conducted a retrospective review of patients who underwent CABG at a tertiary academic medical center. The primary outcome was major bleeding, defined as transfusion of 4 units of packed red blood cells (PRBCs) and/or a need for reexploration. Secondary outcomes included non-life-threatening bleeding, defined as transfusion of 2 units but <4 units of PRBCs; postoperative complications; hospital length of stay; readmission within 30 days of the procedure; and hospital mortality. Major bleeding events were analyzed with a logistic regression model that adjusted for covariates of bleeding risk factors. RESULTS: Of the 715 patients we reviewed, 169 patients received clopidogrel within 5 days before CABG, and 546 patients did not. A significantly higher incidence of major bleeding was observed in the clopidogrel group compared with the group not exposed to clopidogrel (32% versus 17%, P = .002). After adjusting for covariates, patients exposed to clopidogrel had significantly higher odds of major bleeding (odds ratio, 2.1; 95% confidence interval, 1.3-3.4; P = .003). The groups were similar with respect to postoperative complications, except for infection. The clopidogrel-exposed group had a significantly higher rate of leg site infections (3% versus 0.2%, P = .003). CONCLUSIONS: Clopidogrel exposure within 5 days of CABG is associated with an increased risk of major bleeding.

Drug-related problems and hospital admissions in cardiac transplant recipients.

BACKGROUND: Drug-related problems (DRPs) in the general population account for 15% of all hospital admissions, of which approximately 30% are preventable. Cardiac transplant patients may be at increased risk for DRPs because of their complicated medication regimens that include drugs with a narrow therapeutic index. OBJECTIVE: To determine the incidence and preventability of DRPs causing hospital admission in cardiac transplant patients at a single institution. METHODS: Between November 2009 and January 2010, a prospective longitudinal study investigated the incidence and preventability of DRPs in a single cardiac transplant center. Three independent reviewers used validated scoring systems to determine the incidence and preventability of drug-related hospital admissions. DRPs were classified by type, pharmacologic class, and impact on length of stay. RESULTS: During the 3-month study period, 48 cardiac transplant patients were hospitalized. DRPs accounted for 40% (19/48) of these admissions and 58% (11/19) were adjudicated to be preventable. Common DRPs included supratherapeutic (32%) and subtherapeutic (16%) dosage, adverse drug reaction (32%), drug interaction (5%), and nonadherence (5%). Pharmacologic classes implicated included immunosuppressant (63%), antimicrobial (11%), electrolyte/fluid (11%), and anticoagulant (5%). Average length of stay in drug-related compared to non-drug-related admissions was 11.4 versus 8.5 days (p = 0.458). When annualized, 44 hospitalizations or 500 hospital days may have been prevented. CONCLUSIONS: Hospital admissions following cardiac transplantation are often drug related (40%) and preventable (58%). Incorporating this insight into the multidisciplinary transplant team may improve outcomes, assist in meeting national quality mandates by the United Network for Organ Sharing and Centers for Medicare Services, and lead to new benchmarks for transplant centers.

Normal cognitive test scores cannot be interpreted as accurate measures of ability in the context of failed performance validity testing: A symptom- and detection-coached simulation study.

Introduction: While use of performance validity tests (PVTs) has become a standard of practice in neuropsychology, there are differing opinions regarding whether to interpret cognitive test data when standard scores fall within normal limits despite PVTs being failed. This study is the first to empirically determine whether normal cognitive test scores underrepresent functioning when PVTs are failed.Method: Participants, randomly assigned to either a simulated malingering group (n = 50) instructed to mildly suppress test performances or a best-effort/control group (n = 50), completed neuropsychological tests which included the North American Adult Reading Test (NAART), California Verbal Learning Test - 2nd Edition (CVLT-II), and Test of Memory Malingering (TOMM).Results: Groups were not significantly different in age, sex, education, or NAART predicted intellectual ability, but simulators performed significantly worse than controls on the TOMM, CVLT-II Forced Choice Recognition, and CVLT-II Short Delay Free Recall. The groups did not significantly differ on other examined CVLT-II measures. Of simulators who failed validity testing, 36% scored no worse than average and 73% scored no worse than low average on any of the examined CVLT-II indices.Conclusions: Of simulated malingerers who failed validity testing, nearly three-fourths were able to produce cognitive test scores that were within normal limits, which indicates that normal cognitive performances cannot be interpreted as accurately reflecting an individual's capabilities when obtained in the presence of validity test failure. At the same time, only 2 of 50 simulators were successful in passing validity testing while scoring within an impaired range on cognitive testing. This latter finding indicates that successfully feigning cognitive deficits is difficult when PVTs are utilized within the examination.

COVID-19 pandemic: Challenges and solutions from the cardiology pharmacist's perspective.

The recent coronavirus disease 2019 (COVID-19) pandemic caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) challenges pharmacists worldwide. Alongside other specialized pharmacists, we re-evaluated daily processes and therapies used to treat COVID-19 patients within our institutions from a cardiovascular perspective and share what we have learned. To develop a collaborative approach for cardiology issues and concerns in the care of confirmed or suspected COVID-19 patients by drawing on the experiences of cardiology pharmacists across the country. On March 26, 2020, a conference call was convened composed of 24 cardiology residency-trained pharmacists (23 actively practicing in cardiology and 1 in critical care) from 16 institutions across the United States to discuss cardiology issues each have encountered with COVID-19 patients. Discussion centered around providing optimal pharmaceutical care while limiting staff exposure. The collaborative of pharmacists found for the ST-elevation myocardial infarction patient, many institutions were diverting COVID-19 rule-out patients to their Emergency Department (ED). Thrombolytics are an alternative to percutaneous coronary intervention (PCI) allowing for timely treatment of patients and decreased staff exposure. An emergency response grab and go kit includes initial drugs and airway equipment so the patient can be treated and the cart can be left outside the room. Cardiology pharmacists have developed policies and procedures to address monitoring of QT prolonging medications, the use of inhaled prostacyclins, and national drug shortages. Technology has allowed us to practice social distancing, while staying in close contact with our teams, patients, and colleagues and continuing to teach. Residents are engaged in unique decision-making processes with their preceptors and assist as pharmacist extenders. Cardiology pharmacists are in a unique position to work with other pharmacists and health care professionals to implement safe and effective practice changes during the COVID-19 pandemic. Ongoing monitoring and adjustments are necessary in rapidly changing times.

Efficacy of Direct Acting Oral Anticoagulant Drugs in Treatment of Left Atrial Appendage Thrombus in Patients With Atrial Fibrillation.

Direct acting oral anticoagulants (DOACs) are increasingly used for thromboembolic prophylaxis in patients with atrial fibrillation (AF). However, there is limited data to evaluate the use of DOACs for the treatment of pre-existing left atrial appendage thrombus. We aimed to determine the efficacy of DOACs in treatment of left atrial appendage (LAA) thrombus utilizing transesophageal echocardiographic (TEE) and clinical outcomes. In this single-center study, we identified 33 patients that were treated for LAA thrombus with DOAC. Eighteen were treated with apixaban, 10 with dabigatran, and 5 with rivaroxaban. The primary endpoint was defined as resolution of LAA thrombus (in patients undergoing TEE), or death, major bleeding requiring transfusion, intracranial hemorrhage, ischemic stroke, or peripheral embolization. In this study, 15 of the 16 patients treated with DOACs who underwent follow-up TEE had resolution of LAA thrombus, with a mean duration of 112 days. Of the 15 patients who achieved resolution of the LAA thrombus, 14 had resolution by their first follow-up TEE. In the 17 patients without a follow-up TEE, 1 died of a retroperitoneal bleed (28 days after DOAC initiation), and 1 suffered an ischemic stroke (484 days after DOAC initiation). In general, patients without a follow-up TEE were older and had more co-morbidities. Although these results are descriptive and limited in number of patients, we believe this is ample evidence that DOACs are relatively safe and efficacious in treatment of patients with AF and concomitant LAA thrombus.

Efficacy of Direct Acting Oral Anticoagulants in Treatment of Left Ventricular Thrombus.

Direct acting oral anticoagulants (DOACs) are increasingly used as off-label alternatives to vitamin K antagonists for the treatment of left ventricular (LV) thrombus. However, efficacy data is limited to small case series and one meta-analysis of case reports. We aimed to determine the efficacy and safety of DOACs in treatment of LV thrombus utilizing transthoracic echocardiography (TTE) and clinical outcomes. We identified 52 patients (mean age = 64 years, 71% men) treated with a DOAC for LV thrombus (n = 26 apixaban, n = 24 rivaroxaban, and n = 2 dabigatran). Thirty-five of the 52 patients had a follow-up TTE after DOAC initiation. The primary end point was defined as resolution of LV thrombus (in patients with a subsequent TTE), or death, major bleeding requiring transfusion, intracranial hemorrhage, ischemic stroke, or peripheral embolization. An experienced echocardiographer (M.L.M.) reviewed all TTEs for presence or absence of LV thrombus without knowledge of time point or clinical data. Twenty-nine of the 35 (83%) patients who underwent follow-up TTE had resolution of LV thrombus, with a mean duration of 264 days. Of the total study population, there was 1 cardioembolic event (transient ischemic attack) 52 days after initiating DOAC, 3 gastrointestinal bleeds requiring transfusion, and 1 patient with epistaxis requiring transfusion. All patients with a hemorrhagic complication were receiving concomitant antiplatelet therapy. DOAC therapy appears promising for the treatment of LV thrombus. A larger, prospective study is warranted to confirm these results.

Drug Recognition Expert (DRE) examination characteristics of cannabis impairment.

BACKGROUND: The Drug Evaluation and Classification Program (DECP) is commonly utilized in driving under the influence (DUI) cases to help determine category(ies) of impairing drug(s) present in drivers. Cannabis, one of the categories, is associated with approximately doubled crash risk. Our objective was to determine the most reliable DECP metrics for identifying cannabis-driving impairment. METHODS: We evaluated 302 toxicologically-confirmed (blood Δ(9)-tetrahydrocannabinol [THC] ≥1µg/L) cannabis-only DECP cases, wherein examiners successfully identified cannabis, compared to normative data (302 non-impaired individuals). Physiological measures, pupil size/light reaction, and performance on psychophysical tests (one leg stand [OLS], walk and turn [WAT], finger to nose [FTN], Modified Romberg Balance [MRB]) were included. RESULTS: Cases significantly differed from controls (p<0.05) in pulse (increased), systolic blood pressure (elevated), and pupil size (dilated). Blood collection time after arrest significantly decreased THC concentrations; no significant differences were detected between cases with blood THC <5µg/L versus ≥5µg/L. The FTN best predicted cannabis impairment (sensitivity, specificity, positive/negative predictive value, and efficiency ≥87.1%) utilizing ≥3 misses as the deciding criterion; MRB eyelid tremors produced ≥86.1% for all diagnostic characteristics. Other strong indicators included OLS sway, ≥2 WAT clues, and pupil rebound dilation. Requiring ≥2/4 of: ≥3 FTN misses, MRB eyelid tremors, ≥2 OLS clues, and/or ≥2 WAT clues produced the best results (all characteristics ≥96.7%). CONCLUSIONS: Blood specimens should be collected as early as possible. The frequently-debated 5µg/L blood THC per se cutoff showed limited relevance. Combined observations on psychophysical and eye exams produced the best cannabis-impairment indicators.

Relationship of service members' deployment trauma, PTSD symptoms, and experiential avoidance to postdeployment family reengagement.

This research examined whether military service members' deployment-related trauma exposure, posttraumatic stress disorder (PTSD) symptoms, and experiential avoidance are associated with their observed levels of positive social engagement, social withdrawal, reactivity-coercion, and distress avoidance during postdeployment family interaction. Self reports of deployment related trauma, postdeployment PTSD symptoms, and experiential avoidance were collected from 184 men who were deployed to the Middle East conflicts, were partnered, and had a child between 4 and 13 years of age. Video samples of parent-child and partner problem solving and conversations about deployment issues were collected, and were rated by trained observers to assess service members' positive engagement, social withdrawal, reactivity-coercion, and distress avoidance, as well as spouse and child negative affect and behavior. Service members' experiential avoidance was reliably associated with less observed positive engagement and more observed withdrawal and distress avoidance after controlling for spouse and child negative affect and behavior during ongoing interaction. Service members' experiential avoidance also diminished significant associations between service members' PTSD symptoms and their observed behavior. The results are discussed in terms of how service members' psychological acceptance promotes family resilience and adaption to the multiple contextual challenges and role transitions associated with military deployment. Implications for parenting and marital interventions are described.

Drug recognition expert evaluations made using limited data.

The Drug Evaluation Classification (DEC) Program is used by Drug Recognition Expert (DRE) officers to determine whether a suspect is under the influence of a drug or drugs at the time of arrest, and, if so, what category of drug(s). The goal of this project was to investigate the relative importance of face-to-face interactions with the suspect, physical evidence (drugs or paraphernalia found), and confessions/statements made by the suspect (or others) in making these determinations. Seventy records of DRE evaluations were selected from a database containing information from all evaluations conducted in Oregon between 1996 and 1998. Each of the 70 records represented a suspect who had either taken a drug from one of four categories (CNS depressant, CNS stimulant, narcotic analgesic, or cannabis) or who had not taken a drug. To be included, the original DRE evaluation and the subsequent toxicology analysis had to agree that the suspect was under the influence of a drug from one of the four categories or not under the influence of a drug. Records from the 70 cases were submitted in written form to 18 Oregon DREs with statements made by suspects or arresting officers, confessions, toxicology results, and descriptions of drugs or paraphernalia found on the suspect omitted. Based only on the written reports of direct observations, and with physiological and psychophysical test results, the DREs attempted to determine whether each of the 70 suspects was under the influence of a drug or drugs, and, if so, what category of drug(s). If the officers determined that a suspect was under the influence of a drug, their accuracy in specifying the drug category was 81% for cannabis, 94% for narcotic analgesics, 78% for CNS stimulants, and 69% for CNS depressants. Overall accuracy in recognizing drug intoxication was 95%. These percentages indicate that although face-to-face interactions, physical evidence, and confessions/statements can be useful adjuncts to DRE decision-making, the majority of drug category decisions can be made solely on the basis of recorded suspect observations and DRE evaluation results.