EVALUATION OF GUIDELINE DIRECTED MEDICAL THERAPY IN A PHARMACIST-LED HEART FAILURE CLINIC

Background: Guideline directed medical therapy (GDMT) for the treatment of heart failure with reduced ejection fraction (HFrEF) improves morbidity and mortality. According to the CHAMP-HF registry, only 15% of patients with HFrEF achieve target dosing. Published literature reports increased achievement of GDMT by 25-40% through a multidisciplinary approach. However, the pharmacists’ role on the impact of GDMT is not well described. The purpose of this study is to evaluate the impact that the CVD Ambulatory Care Pharmacy Clinic has on achievement of GDMT for patients with HFrEF. Methods: This is the interim analysis of an IRB approved retrospective cohort study. This study compares achievement of GDMT in HFrEF patients managed by the pharmacy clinic versus the control group. GDMT is defined as achievement of target dosing or maximum tolerated doses. Control group represents those not seen by CVD Pharmacy clinic. Inclusion criteria includes adult patients with EF ≤ 45%, hospitalization in the previous 12 months, followed by a cardiologist within the health system, and not on maximum tolerated doses of GDMT. The primary outcome is the number of patients on GDMT 12 months after the initial visit. Secondary outcomes include days from initial visit until GDMT, number of patients on moderate dosing of GDMT and change in EF after GDMT. Patients were enrolled from October 1, 2019 through September 30, 2020. Results: Achievement of GDMT at 12 months was 67.2% (39/58) in the intervention group compared to 16.2% (7/43) in the control (P \u3c0.001). Days to GDMT was a median of 95.5 [57-175.5] days and 143 [64-214] days for the intervention and control group respectively (P = 0.493). In the intervention group, 50% (29/58) of patients achieved moderate dosing at 12 months compared to 11.6% (5/43) in the control group (P\u3c0.001). Patients in the intervention group who had an echo after achieving GDMT had a median increase in EF of 12% [5-20] after GDMT achievement. For all patients who achieved GDMT, 32.6% (15/46) achieved target dosing of medications. Conclusion: The CVD Ambulatory Care Pharmacy Clinic was associated with higher rates of GDMT achievement compared to the control and a shorter time to GDMT achievement

Project #37: Management Guidelines for Patients with COVID-19: Rapid Cycle Improvement

Project’s purpose is to rapidly devise, continually improve, educate, and implement a live and changing COVID-19 management guideline based upon emerging best available evidence. This project also aims to optimize the care of patients with COVID-19 and improve patient outcomes.https://scholarlycommons.henryford.com/qualityexpo2022/1004/thumbnail.jp

Safety and efficacy of target-specific anticoagulants in patients with venous thromboembolism

OBJECTIVE: To review the role of target-specific anticoagulants (TSACs) for the treatment of venous thromboembolism (VTE) and their associated efficacy and safety. DATA SOURCES: Peer-reviewed clinical trials, review articles, and relevant treatment guidelines were identified from MEDLINE (1966 to November 2014) using the following search terms: venous thromboembolism, vitamin K antagonist (VKA), target-specific anticoagulant, deep-vein thrombosis, pulmonary embolism. Results were limited to human trials published in English. Citations from articles were reviewed for additional references. STUDY SELECTION AND DATA EXTRACTION: Clinical trials evaluating VTE treatment were included. Trials that evaluated alternative end points were excluded. DATA SYNTHESIS: Patients with VTE have a high risk of developing recurrent events and subsequent death if not treated in an appropriate manner. TSACs have been evaluated in several large clinical trials in patients with acute VTE. These trials have shown positive outcomes when compared with VKAs for treatment of VTE in the general population. Paralleled with these results, TSACs had similar or lower rates of bleeding compared with VKAs. CONCLUSIONS: Taken together, available evidence suggests that TSACs produce similar clinical benefits with less bleeding incidence when compared with VKAs in the treatment of VTE. There are significant differences between each study investigating this class of medication for VTE treatment. Each TSAC has potential advantages, and to date, there has been no head-to-head trial comparing them

Overview of betrixaban and its role in clinical practice

PURPOSE: The role of betrixaban in the prevention of venous thromboembolism (VTE) in acutely medically ill patients and its efficacy and safety profiles are reviewed. SUMMARY: Acutely medically ill patients have a high risk of developing VTE during hospitalization, and this risk continues into the postdischarge phase. Extended-duration betrixaban therapy has been evaluated in a large clinical trial (the APEX trial) and in a meta-analysis of pooled data on acutely medically ill patients. These studies have shown positive outcomes when betrixaban was compared with conventional-duration subcutaneous enoxaparin therapy for prevention of VTE in acutely medically ill patients. In parallel with these results, oral betrixaban therapy was found to be associated with a rate of major bleeding comparable to that associated with subcutaneous enoxaparin therapy; however, betrixaban use was associated with a higher cumulative rate of major and clinically relevant nonmajor bleeding. In the APEX trial, the primary endpoint was not met in 1 of the prespecified cohorts, but betrixaban appeared to confer benefit in another cohort and in the overall study population. Certain populations of patients, including the elderly, are at high risk for bleeding (mainly attributable to altered pharmacokinetics and polypharmacy); such patients are not appropriate candidates for extended-duration betrixaban therapy. Betrixaban can be a potential option for VTE prevention in medical patients; however, drug interaction potential and third-party coverage should be evaluated prior to prescribing. CONCLUSION: Betrixaban is an oral option for VTE prevention in medical patients

Incidence of heparin-induced thrombocytopenia in patients with temporary mechanical circulatory support devices.

Introduction: Temporary mechanical circulatory support (MCS) devices are used for hemodynamic support in patients with cardiogenic shock. MCS devices are prone to thrombosis and require anticoagulation, often with unfractionated heparin. Heparin exposure and device related thrombocytopenia complicate the diagnosis of heparin-induced thrombocytopenia (HIT) and may lead to unnecessary treatment with direct thrombin inhibitors (DTI). To provide safe and effective care for patients with newly implanted MCS devices, the incidence of laboratory confirmed HIT needs to be further characterized. Objective: To determine the incidence of HIT in patients with newlyimplanted temporary MCS devices Study Design: Retrospective, cohort study Methods: This study included patients admitted to the cardiovascular intensive care unit with a newly-implanted temporary MCS device at Henry Ford Hospital from January 2014 to January 2017. MCS devices included in this study were extra-corporeal membrane oxygenation (ECMO) and Impella®. The primary endpoint was the incidence of laboratory confirmed HIT. Definite HIT was defined as a positive serotonin release assay (SRA) or heparin-induced platelet antibody assay (HIPA) with an optical density (OD) greater than or equal to 2. Probable HIT was defined as an OD between 1.01 and 1.99 +/-SRA intermediate, while possible HIT was defined as an OD between 0.41 and 1 +/-SRA intermediate. HIT negative was defined as an OD less than 0.4 or a negative SRA. Non-HIT related thrombocytopenia was defined as an absence of HIPA or SRA order. In cases where SRA and OD were both ordered but SRA interpretation conflicted with OD interpretation, HIT category was determined based on SRA due to this assay\u27s greater sensitivity and specificity compared to HIPA. However, if SRA result was intermediate, then the likelihood of HIT was determined based on OD instead. Secondary endpoints include use of DTI such as argatroban in patients with unconfirmed HIT, incidence of HIT amongst each of the MCS devices, and utility of the 4T score, HIT Expert Probability (HEP) score, and Lillo-Le Louët model in predicting the presence of HIT. Categorical variables are presented as n (%). Continuous variables are presented as mean (standard deviation (SD)) or median (interquartile range), as appropriate. Results: A total of 182 cases with newly-implanted temporary MCS devices met inclusion criteria: 122 Impella® (67%) and 60 ECMO (33%). Diagnostic HIT assays were ordered in 43 of 182 cases (23.6%). In this population, 43 HIPA and 16 SRA assays were ordered. The median OD was 0.19 (0.11-0.52); two SRAs were positive and 14 were negative. Of the 182 cases, two had definite HIT (1.1%), zero had probable HIT, two had possible HIT (1.1%), and 39 were HIT negative (21.4%). The incidence of definite HIT was 1.7% (1/60) in the ECMO group and 0.82% (1/122) in the Impella® group. For patients with diagnostic HIT assays ordered, the 4T score sensitivity was 0.25 (0.01-0.78) and specificity was 0.79 (0.63-0.90). By comparison, the sensitivity of the HEP score was 0.50 (0.09-0.91) and specificity was 0.62 (0.45-0.76). Argatroban was administered to 16 patients with suspected HIT (37.21%) and was continued for an average of 6.25 days (SD 8.25); two of these patients were later determined to be HIT negative. Conclusion: Definite or probable HIT occurs infrequently with ECMO and Impella devices, yet over one-third of patients receive alternative anticoagulation despite being negative for HIT. Current HIT scoring systems failed to accurately screen for HIT in temporary support MCS devices and a modified MCS HIT scoring model is needed. Further analysis is needed to assess the implications of over-diagnosing HIT and the subsequent initiation of alternative anticoagulants

Deterioration free discharge comparison of andexanet-alfa and prothrombin complex concentrates (PCC) for reversal of factor Xa inhibitor associated bleeds

Given the paucity of comparative efficacy data and the difference in cost between andexanet-alfa and prothrombin complex concentrates (PCC), debates continue regarding optimal cost-effective therapy for patients who present with major bleeding associated with oral factor Xa inhibitors. Available literature comparing the cost-effectiveness of the reversal agents is limited, and the large difference in price between therapy options has led many health systems to exclude andexanet-alfa from their formularies. To evaluate the clinical outcomes and cost of PCC compared to andexanet-alfa for patients with factor Xa inhibitor associated bleeds. We performed a quasi-experimental, single health system study of patients treated with PCC or andexanet-alfa from March 2014 to April 2021. Deterioration-free discharge, thrombotic events, length of stay, discharge disposition, and cost were reported. 170 patients were included in the PCC group and 170 patients were included in the andexanet-alfa group. Deterioration-free discharge was achieved in 66.5% of PCC-treated patients compared to 69.4% in the andexanet alfa-treated patients. 31.8% of PCC-treated patients were discharged home compared to 30.6% in the andexanet alfa-treated patients. The cost per deterioration-free discharge was $20,773.62 versus$5230.32 in the andexanet alfa and 4 F-PCC group, respectively. Among patients that experienced a bleed while taking a factor Xa inhibitor, there was no difference in clinical outcomes for patients treated with andexanet-alfa compared to PCC. Although there was no difference in the clinical outcomes, there was a significant difference in cost with andexanet-alfa costing approximately four times as much as PCC per deterioration-free discharge

Incidence of Heparin-Induced Thrombocytopenia in Patients With Newly Implanted Mechanical Circulatory Support Devices

BACKGROUND: Heparin exposure and device-related thrombocytopenia complicate the diagnosis of heparin-induced thrombocytopenia (HIT) in patients receiving mechanical circulatory support (MCS). To improve anticoagulation management for patients with newly implanted MCS devices, incidence of confirmed HIT needs to be further characterized. OBJECTIVES: The purpose of this study is to describe the incidence of HIT and clinical utility of the 4Ts score in patients with newly implanted MCS devices. METHODS: This is a retrospective analysis of MCS patients receiving unfractionated heparin from 2014 to 2017. The primary end point was incidence of laboratory-confirmed HIT. Strong positive, likely positive, low probability, and negative HIT categories were established based on heparin-induced platelet antibody (HIPA) and serotonin release assay (SRA). Secondary end points include characterization of platelet trends, argatroban use, incidence of HIT among each of the MCS devices, and utility of 4Ts score. RESULTS: A total of 342 patient encounters met inclusion criteria, of which 68 HIPA tests and 25 SRAs were ordered. The incidence of HIT was 0.88% (3/342) and 4.4% (3/68) in patients with suspected HIT. Of the 68 HIPA tests, 3 (4.4%) were considered strong positive and 3 of the 25 SRAs were positive. Median 4Ts score was 4 [2.5-4] and optical density 0.19 [0.11-0.54]. The positive predictive value for the 4Ts score was 0.15 (CI = 0.03-0.46) and negative predictive value, 0.93 (CI = 0.82-0.98). CONCLUSION AND RELEVANCE: HIT occurs infrequently with newly implanted MCS devices. The 4Ts score appears to have a high negative predictive value for ruling out HIT