Comparison of trauma-dosed tranexamic acid versus aminocaproic acid in cardiac surgery in the setting of drug shortage.

BACKGROUND: Antifibrinolytic agents, tranexamic acid (TXA) and epsilon-aminocaproic acid (EACA), are often used during cardiac surgery to decrease the number of allogenic blood transfusions and to prevent perioperative bleeding. Weight-based TXA dosing regimens have been compared to fixed-dose regimens of EACA with variable outcomes in perioperative blood product transfusions and chest tube output. Serious adverse events, including seizures, have been reported with higher doses of TXA. Fixed-dose TXA regimens have been evaluated in trauma and orthopedic surgery but there is a paucity of evidence in the cardiac surgery population. AIMS OF THE STUDY: To compare the safety and efficacy of fixed-dose TXA versus EACA in patients undergoing cardiac surgery. METHODS: A single-center, retrospective chart review was conducted at a 793-bed tertiary care academic teaching hospital comparing cardiac surgery patients receiving either fixed-dose TXA 1000 mg followed by a 500-1000 mg infusion or EACA-7.5 g intravenous boluses followed by a 1-1.25 g/h infusion for the duration of the surgery. The major endpoint included chest tube output at 12 h, 24 h, and 7 days postoperatively. Minor endpoints included quantity and incidence of blood product transfusions and reported safety events. RESULTS: There were 1544 patients included. Chest tube output was similar between groups and the TXA group required more intraoperative blood product transfusions (22.7% vs. 18.2%, p = .03). There were no differences in the median quantity of total blood products administered postoperatively at 24 h or at 7 days. Reported safety events were similar between groups. CONCLUSION: Both fixed-dose TXA and EACA may be considered safe and effective options for antifibrinolytic therapy in cardiac surgery patients.

Evaluation of Prescribing Practices and Outcomes Using Direct-acting Oral Anticoagulants After Cardiac Surgery.

PURPOSE: Cardiac surgery patients frequently require anticoagulation. Warfarin remains the preferred agent, and a few trials have reported negative outcomes with the use of direct-acting oral anticoagulants (DOACs) in these patients. Therefore, limited literature exists that supports the dosing, safety, and efficacy of DOACs within the cardiac surgery population. METHODS: This single-center, retrospective analysis was conducted at a tertiary academic medical center. All data were extrapolated from electronic medical records of qualifying patients from August 2017 to August 2019. Adult patients were included if they received at least 1 of 4 DOACs (apixaban, rivaroxaban, edoxaban, or dabigatran) after undergoing one of the following cardiac surgeries: coronary artery bypass graft, bioprosthetic valve replacement, aortic surgery, or valve repair. The composite safety end point included major bleeding and clinically relevant nonmajor bleeding, as defined by the International Society on Thrombosis and Hemostasis. The composite efficacy outcome of thromboembolic events included deep vein thrombosis, pulmonary embolism, ischemic stroke, and intracardiac thrombus. FINDINGS: A total of 305 patient charts were identified for analysis; 229 patients met the inclusion criteria. The composite safety outcome occurred in 12 patients (5.2%) within 90 days after cardiac surgery. One patient (0.4%) experienced a thromboembolic event within 90 days after cardiac surgery. The most commonly prescribed DOAC was apixaban (79.0%). US Food and Drug Administration-approved dosing was used in 91.3% of patients, and DOACs were primarily used for the indication of stroke prevention in atrial fibrillation or atrial flutter (88.2%). IMPLICATIONS: These data provide insight into the prescribing practices, efficacy, and safety of DOACs in cardiac surgery patients.

Evaluation of safety of switching between oral P2Y12 inhibitors: a descriptive study.

PURPOSE: Dual antiplatelet therapy with aspirin and a P2Y12 inhibitor is recommended for patients with acute coronary syndrome and after percutaneous coronary intervention with stenting in stable coronary artery disease to help prevent further thromboembolic events. However, there is limited guidance on appropriate strategies for switching between oral P2Y12 inhibitors. The aim of this study was to evaluate safety of switching modalities at our institution and compare them to the recently published expert consensus recommendations. METHODS: This was a retrospective, descriptive analysis of patients admitted to Brigham and Women's Hospital from January 2015 to December 2018. Patients were included if they were at least 18 years of age and had documented administrations of two or more oral P2Y12 inhibitors during the same admission. The major safety endpoint was incidence of major adverse cardiac events (MACE) (cardiovascular death, myocardial infarction, stroke, and non-coronary artery bypass grafting (CABG)-related bleeding) at seven days or until hospital discharge. Minor endpoints included the incidence of in-stent thrombosis, number of patients who received appropriate loading doses (LD) before and after the recently published recommendations, and documented reason for switching between agents. RESULTS: There were 253 patients included in the final analysis. Of these, 83 patients were on clopidogrel as the first agent prior to switching, 9 patients were on prasugrel, and 161 were on ticagrelor. There was no incidence of the primary safety endpoint observed in any group. However, the number of patients who received a LD when switching between oral P2Y12 inhibitors increased from 80.0% to 87.0% after publication of the expert consensus paper. The most common reasons for switching from one agent to another were cost/insurance coverage (19.0%), need for triple therapy (16.0%), and bleeding risk (11.0%). CONCLUSION: Different switching modalities were not associated with an increase in MACE at our institution; however, larger randomized controlled trials are warranted.

Virtual optimization of guideline-directed medical therapy in hospitalized patients with heart failure with reduced ejection fraction: the IMPLEMENT-HF pilot study.

AIMS: Implementation of guideline-directed medical therapy (GDMT) for heart failure with reduced ejection fraction (HFrEF) remains incomplete. Non-cardiovascular hospitalization may present opportunities for GDMT optimization. We assessed the efficacy and durability of a virtual, multidisciplinary 'GDMT Team' on medical therapy prescription for HFrEF. METHODS AND RESULTS: Consecutive hospitalizations in patients with HFrEF (ejection fraction ≤40%) were prospectively identified from 3 February to 1 March 2020 (usual care group) and 2 March to 28 August 2020 (intervention group). Patients with critical illness, de novo heart failure, and systolic blood pressure <90 mmHg in the preceeding 24 hs prior to enrollment were excluded. In the intervention group, a pharmacist-physician GDMT Team provided optimization suggestions to treating teams based on an evidence-based algorithm. The primary outcome was a GDMT optimization score, the sum of positive (+1 for new initiations or up-titrations) and negative therapeutic changes (-1 for discontinuations or down-titrations) at hospital discharge. Serious in-hospital safety events were assessed. Among 278 consecutive encounters with HFrEF, 118 met eligibility criteria; 29 (25%) received usual care and 89 (75%) received the GDMT Team intervention. Among usual care encounters, there were no changes in GDMT prescription during hospitalization. In the intervention group, ß-blocker (72% to 88%; P = 0.01), angiotensin receptor-neprilysin inhibitor (6% to 17%; P = 0.03), mineralocorticoid receptor antagonist (16% to 29%; P = 0.05), and triple therapy (9% to 26%; P < 0.01) prescriptions increased during hospitalization. After adjustment for clinically relevant covariates, the GDMT Team was associated with an increase in GDMT optimization score (+0.58; 95% confidence interval +0.09 to +1.07; P = 0.02). There were no serious in-hospital adverse events. CONCLUSIONS: Non-cardiovascular hospitalizations are a potentially safe and effective setting for GDMT optimization. A virtual GDMT Team was associated with improved heart failure therapeutic optimization. This implementation strategy warrants testing in a prospective randomized controlled trial.

Potassium Chloride Sustained Release Dosing Pathway in an Academic Medical Center.

Potassium supplementation can be administered intravenously or orally with either immediate release or sustained release formulations. Sustained release potassium chloride allows for delayed absorption and peak effects. In the inpatient setting, it is important to monitor and prevent both hypokalemia and hyperkalemia. Our tertiary-care academic hospital created a clinical pathway for sustained release potassium chloride supplementation in the inpatient population. Our clinical pathway for sustained release potassium chloride creates dosing restrictions designed to prevent hyperkalemia, while allowing exceptions for patients with high requirements.

Safety and Tolerability of Transitioning from Cangrelor to Ticagrelor in Patients Who Underwent Percutaneous Coronary Intervention.

The 3 phase 3 CHAMPION (Cangrelor vs Standard Therapy to Achieve Optimal Management of Platelet Inhibition) trials collectively demonstrated the safety of transitioning from cangrelor, a potent, parenteral rapidly-acting P2Y12 inhibitor, to clopidogrel in patients who underwent percutaneous coronary intervention (PCI). However, variation in timing of therapy, site-specific binding, and drug half-lives may theoretically complicate switching to other oral P2Y12 inhibitors. Since regulatory approval, limited data are available regarding the "real-world" safety and tolerability of transitioning to these more potent oral P2Y12 antagonists. From November 2015 to January 2017, we evaluated the clinical profiles and efficacy and safety outcomes in cangrelor-treated patients who underwent PCI transitioned to clopidogrel (n = 42) or ticagrelor (n = 82) at a large, tertiary care center. Most patients receiving cangrelor underwent PCI with a drug-eluting stent for acute coronary syndrome via a radial approach in the background of unfractionated heparin. Stent thrombosis within 48 hours was rare and occurred in 1 patient treated with ticagrelor. Global Use of Strategies to Open Occluded Coronary Arteries-defined bleeding occurred in 20% of patients switched to ticagrelor and 29% of patients switched to clopidogrel, but none were severe or life-threatening. In conclusion, rates of stent thrombosis and severe/life-threatening bleeding were low and comparable with those identified in the CHAMPION program, despite use of more potent oral P2Y12 inhibition.

Implementation of an Automated Dispensing Cabinet Stewardship Program at a Tertiary Academic Medical Center.

Automated dispensing cabinet (ADC) use within hospitals is designed to replace or partially replace medication cabinets or carts to allow for a more decentralized model of medication distribution. This project was designed to improve medication delivery by decreasing the burden of dispensing patient-specific medications from a centralized inpatient pharmacy while decreasing overall inventory cost. This single-center pilot analysis evaluated ADC inventory optimization in a mixed medical population. Data collected included inventory cost on ADC, medications removed from or added to ADC, patient-specific medications sent from central pharmacy, and the rate of medication stock outs on ADC.