Improved Time in Therapeutic Range with International Normalized Ratio Remote Monitoring for Patients with Left Ventricular Assist Devices.

Despite advances in therapy, bleeding and thromboembolic events are frequent complications in patients with left ventricular assist device (LVAD) support. Maintaining warfarin in therapeutic range has been shown to be more challenging in this patient population compared to other indications. Patients with LVADs on warfarin typically are within goal international normalized ratio (INR) range 36-57% of the time, compared to about 65% for other indications. The goal of this study was to evaluate if an INR remote monitoring system along with the implementation of a standardized warfarin management protocol improves warfarin time in therapeutic range (TTR) for patients with LVADs. This single-center, retrospective, observational study included 78 patients with LVADs that were followed at our academic center from January 2015 to October 2017. In October 2016, we updated our warfarin management protocol and implemented a remote monitoring system with patients' weekly INR results monitored. The primary objective of the study was to determine the difference between TTRs in remote monitoring versus standard monitoring. We found that the average TTR was significantly higher in the remote monitoring group compared to the standard monitoring cohort (61.1% vs. 40.0%, p < 0.005). However, bleeding, thrombotic incidence, and hospital readmission rates were similar between the two patient cohorts. Remote monitoring improved warfarin TTR significantly in this study and may have the potential to improve anticoagulation-related outcomes in patients with LVADs.

Impact of Protocolized Pharmacist Intervention on Critical Activated Partial Thromboplastin Time Values With Heparin Infusions.

Background: Unfractionated heparin (UFH) infusions are commonly managed with nurse-driven nomograms titrated to activated partial thromboplastin time (aPTT). In some patients, anti-Xa values may be more appropriate measures of anticoagulation. At the present institution, an update to the nurse-driven aPTT nomogram requires pharmacist notification and clinical assessment for critically supratherapeutic aPTT results. Objective: The purpose of this study was to evaluate the efficacy and safety of the nomogram update. Methods: A single-center, retrospective, pre-post analysis was conducted in patients treated with UFH who experienced a critical aPTT during the 6 months preceding and following the nomogram update. Patients with erroneous critical aPTT results were excluded. The primary endpoint was the time in therapeutic range (Rosendaal method) from the first critical aPTT until UFH discontinuation. Secondary endpoints included the proportion of patients transitioned to anti-Xa monitoring and the incidence of Bleeding Academic Research Consortium (BARC) 2, 3, 5 bleeding. Data were analyzed by the χ2 test. The study was institutional review board approved. Results: Of 277 UFH infusions, 142 belonged to the pre-implementation group and 135 to the post-implementation group. Baseline aPTTs were similar between the 2 groups. Time in therapeutic range was 58.1% versus 62.4% of between groups (P = .467). UFH was transitioned to pharmacist-driven anti-Xa monitoring in 16.2% versus 40.3% of patients (P < .001). BARC 2, 3, 5 bleeding occurred in 23.2% versus 13.4% of patients (P < .001). Conclusions: Application of these data suggest improved safety and efficacy outcomes with directed pharmacist management of UFH in patients with critically elevated aPTTs.

Derivation and Validation of Age- and Body Mass Index-Adjusted Weight-Based Unfractionated Heparin Dosing.

Unfractionated heparin dosing is unpredictable and subject to numerous pharmacokinetic changes including distribution and metabolic changes associated with obesity and age. Weight-based dosing is commonly used to better predict the dose for a patient when targeting a therapeutic range. A dosing equation that adjusts weight-based doses for age and body mass index may improve therapeutic dose prediction. We conducted a 2-phase observational study with a derivation and validation period to develop an equation to adjust weight-based unfractionated heparin for age and body mass index to target a therapeutic activated partial thromboplastin time of 60 to 80 seconds. The first phase retrospectively identified patients who acheived therapeutic anticoagulation and utilized linear regression to determine a predictive equation for weight-based dosing that adjusts for age and body mass index. The second phase prospectively identified patients in an observational manner and compared the dose of unfractionated heparin on which they became therapeutic against both the weight-based dose and the predicted dose adjusted for age and body mass index. The correlation between predictive age and body mass index adjusted dose and actual therapeutic dose was 0.703 compared to the correlation between the empiric weight-based dose and actual therapeutic dose which was 0.532 ( P = .05). Age and body mass index adjusted weight-based dosing significantly improved therapeutic dose prediction for unfractionated heparin. Further study in a prospective, randomized trial is warranted for validation of this approach in a real world setting.

Evaluation of Compliance with a Weight-based Nurse-driven Heparin Nomogram in a Tertiary Academic Medical Center.

BACKGROUND: Recently, our institution adopted a weight-based nurse-driven heparin titration protocol that relies on nurses ordering laboratories, adjusting doses, and initiating boluses. Numerous institutions have implemented similar protocols with reported success. METHODS: A single-center retrospective analysis was conducted at the Brigham and Women's Hospital in Boston, Massachusetts that included all patients who were initiated on the weight-based nurse-driven heparin nomogram during a 30-day period. Nomogram compliance was defined as the rate of correct titrations per nomogram encounter and further separated into laboratory, titration, or dosing compliance. Spearman's coefficient was utilized to determine the correlation between noncompliance and percentage of activated partial thromboplastin time (aPTT) values in range. RESULTS: Overall, 211 patients were evaluated for inclusion, of which 95 patients were determined to meet criteria for evaluation. The total nomogram compliance rate was 84.6% ± 10.5%. Laboratory, titration, and dosing compliances were 77.6% ± 19.2%, 87.2% ± 14.5%, and 91.8% ± 10.6%, respectively. The percent of aPTT values in therapeutic range was 39.6% ± 24.6%. A moderate negative correlation between the percentage of aPTT values in range and the nomogram error rate was observed (r = -0.452, P < 0.001). This relationship was found to be driven by the rate of dosing error, which showed the strongest correlation with percentage of aPTT values out of range (r = -0.465, P = 0.001). CONCLUSIONS: Implementation of a nurse-driven heparin titration nomogram relies on compliance with the prescribed protocol. Dosing compliance had the lowest error rate, whereas dosing noncompliance had the strongest impact on percentage of aPTT values in range.

Description and Evaluation of the Implementation of a Weight-Based, Nurse-Driven Heparin Nomogram in a Tertiary Academic Medical Center.

Weight-based, nurse-driven heparin nomograms are reported in the medical literature to improve the time it takes to reach a minimum threshold for anticoagulation without compromising patient safety in specific indications or patient populations. This is the first report in the literature of an institution-wide protocol implementation and evaluation of effectiveness with simultaneous transition to an electronic health record. The purpose of implementing this practice change at our institution was to standardize practice, improve time to reach therapeutic anticoagulation, and improve patient safety. We conducted a retrospective analysis utilizing a pre/postimplementation design to compare outcomes. The primary end point evaluated was the time to reach minimum threshold value for therapeutic anticoagulation. Additionally, we assessed the percentage of patients who reached minimum threshold therapeutic anticoagulation within 24 hours, the percentage of patients with a critically supratherapeutic activated partial thromboplastin time (aPTT) value (≥120 seconds) during therapy, and a description of heparin titration for the first 4 aPTT results with nomogram use. Overall time to therapeutic anticoagulation decreased from a mean 18.7 to 11.7 hours (hazard ratio [HR] 1.59; 95% confidence interval 1.22-2.08; P < .0005). Percentage of patients receiving therapeutic anticoagulation within 24 hours increased from 74.4 to 88.5 (odds ratio [OR 2.97, P = .002) and the percentage of patients with an aPTT ≥120 seconds remained constant at 49.9 versus 46.8 (OR 0.92, P = .73). This practice change reduced time to therapeutic anticoagulation without an increase in the proportion of patients with a critically supratherapeutic aPTT at our institution.

Risk factors for acute kidney injury associated with the treatment of bacterial endocarditis at a tertiary academic medical center.

BACKGROUND: Acute kidney injury (AKI) is a common complication of endocarditis. OBJECTIVE: To determine risk factors for the development of AKI in patients treated for endocarditis. METHODS: This single centre, retrospective univariate and multivariate analysis to determine risk factors for the development of AKI included patients diagnosed with endocarditis between January 2009 and October 2013. RESULTS: Of 211 included patients, a total of 84 (39.8%) patients developed AKI. We identified multiple independent variables associated with the development of AKI, including: age ≥ 65 years, presence of hardware, chronic kidney disease, AKI on admission, infection with Staphylococcus spp, receipt of nafcillin or oxacillin or aminoglycoside and nafcillin or oxacillin or aminoglycoside and vancomycin, vancomycin trough level ≥ 20.0 mcg/ml, aminoglycoside total daily dose reduction, duration of vancomycin exceeding three days, receipt of loop diuretic or more than three concomitant nephrotoxins and duration of loop diuretic or non-steroidal anti-inflammatory drug therapy exceeding seven days. CONCLUSIONS: In patients treated for endocarditis, multiple risk factors for AKI were identified. Prospective studies are needed to evaluate these variables for causation of AKI in patients treated for endocarditis.

Assessment of Drug Therapy-Related Issues in an Outpatient Heart Failure Population and the Potential Impact of Pharmacist-Driven Intervention.

BACKGROUND: The Ambulatory Cardiac Triage, Intervention, and Education (ACTIVE) infusion unit is an outpatient center that aims to provide heart failure (HF) patients with comprehensive multidisciplinary interventions. OBJECTIVE: To describe the patient population served in ACTIVE and to document the prevalence of comorbidities and drug therapy-related issues (DRIs) in order to define the most effective role of a pharmacist in the unit. METHODS: Patients who have been interviewed by a pharmacist in ACTIVE were included. Comprehensive medical and medication profile reviews were performed. Patient comorbidities were documented, and DRIs were classified. RESULTS: Sixty patients were included. Most prevalent cardiac comorbidities included hypertension (73%) and hyperlipidemia (62%). Top 3 noncardiac comorbidities included chronic kidney disease (60%), diabetes (50%), and obesity (35%). The prevalence of DRI was reported as follows: (1) needs additional/alternative therapy (untreated indication [37] or suboptimal therapeutic choice [46]), (2) wrong drug (major drug-drug interaction [90], contraindication [11], or duplicate therapy [1]), (3) suboptimal dosing (17), (4) dose exceeds recommended maximum (9), and (5) adverse drug reaction (93). In 63 (22%) of the DRIs, a pharmacist made recommendations to modify the regimen. CONCLUSION: The prevalence of DRI is high even among HF patients managed in a subspecialty cardiovascular practice. Pharmacists in this setting play a vital role in more effectively resolving DRI.

Implementation of a dexmedetomidine stewardship program at a tertiary academic medical center.

BACKGROUND: Brigham and Women's Hospital implemented a dexmedetomidine stewardship program in October 2010 beginning with an institution-specific prescribing guideline. To ensure continued adherence to the prescribing guideline, a pharmacist-driven quality assurance program was implemented in November 2011. OBJECTIVE: The primary objective of this study is to describe the role and impact of a dexmedetomidine stewardship program on dexmedetomidine use at a tertiary academic medical center. METHODS: This is a prospective descriptive analysis of a dexmedetomidine stewardship program. Dexmedetomidine stewardship data were collected prospectively from January 2012 through June 2012, in all intensive care units (ICUs) at a single academic medical center. Adult patients (>18 years old) receiving dexmedetomidine therapy continuously for sedation and in the ICU were included in the analysis. RESULTS: A total of 99 patients were identified during the study time frame, during which 71 (71.7%) were identified as compliant with the institutional guideline. The total number of patients receiving dexmedetomidine for greater than 24 hours was 13 (13.1%), of whom 10 (76.9%) received targeted interventions; 15 (15.2%) targeted interventions were made on all patients receiving dexmedetomidine during the study time frame. The total use of dexmedetomidine during the study period was 1310 vials, compared with 5404 vials during the equivalent time frame in 2010-a 76% reduction. CONCLUSIONS: A dexmedetomidine stewardship program, including an institution-specific prescribing guideline and a pharmacist-driven quality assurance program may ensure guideline compliance and decreased use of dexmedetomidine at an academic medical center.

A pilot study evaluating the effect of mindfulness-based stress reduction on psychological status, physical status, salivary cortisol, and interleukin-6 among advanced-stage cancer patients and their caregivers.

PURPOSE: To investigate whether a mindfulness-based stress reduction program for cancer (MBSR-C) improved psychological and physical symptoms, quality of life (QOL), and stress markers among advanced-stage cancer patients and caregivers. DESIGN: A pilot within-subject design was used. METHOD: Patients previously diagnosed with advanced-stage breast, colon, lung, or prostate cancer and on treatment were recruited from the Moffitt Cancer Center and Research Institute. Twenty-six patient-caregiver dyads completed a modified 6-week, self-study MBSR-C program based on the Kabat-Zinn model. Psychological and physical symptoms and QOL were compared pre- and post-MBSR-C sessions. Salivary cortisol and interleukin-6 were assessed pre- and post-MBSR-C session at 1, 3, and 6 weeks. FINDINGS: Following the 6-week MBSR program, patients showed improvements in stress and anxiety (p < .05); caregivers' psychological and QOL also improved but were not statistically significant. Both patients and caregivers had decreases in cortisol at Weeks 1 and 3 (p < .05) but not at Week 6. Similar to cortisol levels at Week 6, salivary interleukin-6 levels were lower overall (before/after an MBSR-C session), compared with Week 1 for patients and caregivers. CONCLUSIONS: MBSR-C may be a beneficial intervention for reducing stress, anxiety, cortisol levels, and symptoms in advanced-stage cancer patients and may also benefit caregivers.