Heparin, Enoxaparin, and Mechanical Prophylaxis Utilization Evaluation in DVT Prophylaxis in a Major Teaching Hospital in West of Iran

Background: Considering the high prevalence and risk of Deep Vein Thrombosis (DVT) and pulmonary thromboembolism (PTE) in hospitalized patients and the existence of different prophylaxis methods in these patients, the necessity of evaluating the rational administration of heparin or enoxaparin and mechanical prophylaxis is one of the important priorities. The present study aimed to evaluate the consistency of the Heparin/Enoxaparin administration in comparison to guidelines in patients admitted to Imam Reza Hospital. Methods: In this prospective study drug use evaluation (DUE), 300 hospitalized patients receiving venous thrombosis prophylaxis were enrolled, of which 150 patients were selected from surgical wards and 150 patients from internal wards. The demographic and clinical data of patients were collected using clinical records of them. We used the checklists based on the Geneva System for patients admitted to internal wards and the Caprini Questionnaire for patients in surgical wards to evaluate whether patients had received heparin/enoxaparin prophylaxis and mechanical DVT prevention according to guidelines. Results: In the surgical ward, prophylactic treatment for venous thrombosis was administered in 85 (56.6%) patients admitted to surgical wards in accordance with the clinical guideline and in the internal ward, in 42 (28%) patients, with a significant difference between two sections (P: 0.0001). Mechanical prophylaxis, including compressive socks, was performed in 99 (66%) patients in the surgical ward and in the internal ward only in 56 (37.4%) patients, according to the guideline. Drug prophylaxis was administered in surgical wards in 116 (77.3%) patients and in internal wards, in 79 (52.6%) patients according to the guideline. Conclusion: Intravenous thrombosis prophylaxis, according to the guidelines, is more common in patients admitted to surgical wards than in internal wards. But in both sectors, statistics are far from international standards.

A 15-Year Review of Clinical Practice Patterns and Evidence-Based Medicine in Carpometacarpal Joint Arthroplasty

Background: The purpose of this study was to help understand national practice patterns in carpometacarpal (CMC) arthroplasty and how they have evolved with evidence-based recommendations over the past 15 years. Methods: The American Board of Plastic Surgery (ABPS) started collecting practice data on primary CMC joint arthroplasty in 2006 as a portion of its continuous certification (CC) process. Data on primary CMC arthroplasty from May 2006 through December 2013 were reviewed and compared to those from January 2014 to March 2020. National practice trends observed in these data were evaluated. Comprehensive evidence-based medicine reviews published in 2008, 2011, 2013, and 2017 were reviewed alongside the CC data. Results: In all, 570 primary CMC joint arthroplasty cases were included from May 2006 to March 2020. The average age at the time of repair was 62 years and the patient population was predominantly female (79%). Most cases were done under general anesthesia (69%), and there was an increase in the use of regional anesthesia with nerve block when our 2 cohorts were compared (27% vs 37%; P = .020). A trapezium excision with flexor carpi radialis tendon ligament reconstruction was the most popular technique (72%) and an increase in the use of simple trapeziectomy was observed (6% vs 14%; P = .001). One-third of patients did not receive any form of deep vein thrombosis prophylaxis. Conclusions: The ABPS CC data provide a databank that allows for direct observation of national practice trends and sheds light on potential avenues for improvement in patient care.

Thrombocytagátló és antikoagulációs terápia a szívsebészetben napjainkban

Összefoglaló. Egy szívműtét tervezésekor és a perioperatív időszakban egyaránt kiemelkedő jelentősége van a megfelelő thrombocytagátló és antikoaguláns kezelés alkalmazásának. Írásunk célja összefoglalni és ismertetni a jelenleg érvényes nemzetközi ajánlásokat és a jelentős tanulmányok eredményeit, összpontosítva a Magyarországon alkalmazásban lévő gyakorlatra. A bizonyítékokon alapuló iránymutatások alábbi, legújabb adatai döntően a European Association for Cardio-Thoracic Surgery és a European Society of Cardiology ajánlásaira épülnek, ezeket kiegészítettük az American College of Cardiology, az American Heart Association és a Society of Thoracic Surgeons útmutatásaival, végül egyes témákban hozzáfűztük az elmúlt időszak meghatározó tanulmányainak főbb eredményeit. Cikkünkben érintjük a mono- és kettős thrombocytagátló, továbbá az oralis antikoaguláns kezelés szerepkörét, beleértve az új típusú thrombocytagátló és oralis antikoaguláns gyógyszereket, valamint az áthidaló terápia fontosságát az antikoagulálásban, a különböző típusú beültetett szívbillentyűk esetén betartandó antikoagulálási ajánlásokat, valamint kitérünk a perioperatív pitvarfibrilláció, a posztoperatív thrombosisprofilaxis és a vérzésveszély esetén történő gyógyszeres kezelés témájára. Figyelembe veendő, hogy a jelen információk folyamatos frissítésen mennek keresztül, a lenti javaslatok csupán a jelen helyzetet mutatják be. Orv Hetil. 2021; 162(48): 1910–1919. Summary. The use of appropriate antiplatelet and anticoagulant therapy has got an outstanding role both in the planning of cardiac surgery and also during the perioperative period. The aim of our paper is to summarize and present the current international recommendations and the results of significant studies, focusing on the current practice in Hungary. The following informations are based on the evidence-based guidelines and recommendations of the European Association for Cardio-Thoracic Surgery and the European Society of Cardiology, supplemented by guidelines from the American College of Cardiology, the American Heart Association and the Society of Thoracic Surgeons, finally we added some topics from the main results of major studies of the last years. In this paper, we discuss the role of mono- and dual anti-platelet and oral anticoagulant therapy, including the mechanism of novel antiplatelet and oral anticoagulant drugs, the importance of bridging therapy in anticoagulation, postoperative thrombosis prophylaxis and the medication practice in the case of bleeding risk. It should be noted that though the present information has been recently updated, the suggestions below only illustrate the current state of evidence. Orv Hetil. 2021; 162(48): 1910–1919.

Thrombosis Prophylaxis with Apixaban in Patients Treated with Asparaginase

Background: Acute Lymphoblastic Leukemia (ALL) outcomes have significantly improved over time with multi-agent chemotherapy, and the addition of asparaginase (ASP) has demonstrated the ability to prolong overall survival. ASP has multiple toxicities, and it remains a challenge to manage them safely, particularly coagulopathy and thrombosis (30-40% based on historical studies). The best prophylactic anticoagulation strategy in patients with acute leukemias, particularly ALL with asparaginase use, remains unclear due to severe coexisting thrombocytopenia and coagulopathy. Though the current guidelines recommend using Antithrombin (AT) replacement or low molecular weight heparin (LMWH) for thrombosis prophylaxis, the evidence is weak with concerns of thrombosis (Blood (2020) 136 (3): 328-338) with the use of fibrinogen concentrates(cryoprecipitate) and limited efficacy data with AT replacement and unfractionated heparin (UFH) for thrombosis prophylaxis. Due to potential "resistance" to LMWH and UFH from acquired AT deficiency with ASP use, our institution in 2017 has adopted the use of the direct Xa inhibitor, Apixaban for thrombosis prophyalxis. We report the safety and effectiveness of Apixaban for thrombosis prophylaxis with ASP. Methods: In this retrospective study, we reviewed the data on 20 patients treated with ASP between 2017-2020. Thrombosis prophylaxis was instituted with Apixaban 2.5 mg PO Q 12 hourly for three weeks along with cryoprecipitate as needed for bleeding or fibrinogen levels <100 mg/dL (normal 160-450 mg/dL) to balance the risk of bleeding. Apixaban was held if platelet count <20,000/µL and for invasive procedures or clinically significant bleeding events. We evaluated demographic data, ALL risk category, type of ASP use, laboratory data (Table 1 & 2) for four weeks following ASP, amount of cryoprecipitate used, major bleeding, clinically relevant non-major bleeding (CRNMB), and thrombosis incidence. The medians of pertinent laboratory data were plotted on a graph. Descriptive statistics with medians, quartiles, frequencies, and percentages are reported. Results: Among the 20 patients treated during this period, 18 (90%) had ALL, and 2(10%) had NK/T cell lymphoma. Of the patients with ALL, 67% had high risk and 33% with standard-risk ALL. The median age of this cohort was 29.5 years (range: 19-63 years), 80% were males, 70% white, 30% were Latino or Hispanic, median body mass index-BMI of 30.2 kg/m 2(19.4-40.7 kg/m 2) and 65% were non-smokers. The median baseline AT activity was 107% (79-221%), 95% used concurrent corticosteroids (65%- Prednisone, and 30% used Dexamethasone). The most common induction treatment was CALGB 10403 (55%). Of the total, 95% received pegylated ASP, and only one patient received Erwinia ASP due to prior history of anaphylaxis. The major toxicities attributed to ASP included 5% grade II and 15% grade III-IV aspartate aminotransferase (AST) or alanine aminotransferase (ALT) elevation, 20% had bilirubin elevation, 10% developed grade III-IV acute pancreatitis, and 5% developed severe hypertriglyceridemia needing aphaeresis. Two patients (10%) developed thrombosis [catheter associated deep venous thrombosis (DVT) and one patient with lower extremity proximal DVT] within 4 weeks of use of ASP, with one of the two patients (5%) developing (lower extremity proximal DVT) while on being off anticoagulation due to bleeding. Major bleeding or CRNMB developed in 5% (spontaneous splenic rupture from ALL leading to hemorrhagic shock). The median number of cryoprecipitate units used per patient during weeks 1,2,3, and 4 was 5(0-35), 5(0-40), 5(0-15), 7.5(0-15), respectively; No patients received fresh frozen plasma or AT concentrates. Conclusions: With the use of Apixaban prophylaxis, the incidence of thrombosis was 10% within four weeks from ASP and 5% while on anticoagulation. The incidence of major bleeding or CRNMB was 5%. Hypofibrinogenemia, acquired AT deficiency due to ASP, was seen between days 7-21 after using ASP (figure 1 & 2) and recovered subsequently. This study demonstrates initial evidence of the safety and efficacy of Apixaban for thrombosis prophylaxis and cryoprecipitate infusions in patients treated with ASP. Figure 1 Figure 1. Disclosures Gundabolu: Samus Therapeutics: Research Funding; Pfizer: Research Funding; BioMarin Pharmaceuticals: Consultancy; Bristol-Myers Squibb Company: Consultancy; Blueprint Medicines: Consultancy. Bhatt: Jazz: Research Funding; Incyte: Consultancy, Research Funding; Pfizer: Research Funding; Tolero Pharmaceuticals, Inc: Research Funding; National Marrow Donor Program: Research Funding; Abbvie: Consultancy, Research Funding; Genentech: Consultancy; Abbvie: Consultancy, Research Funding; Partnership for health analytic research, LLC: Consultancy; Servier Pharmaceuticals LLC: Consultancy; Rigel: Consultancy. Vose: Kite, a Gilead Company: Honoraria, Research Funding. Lunning: Myeloid Therapeutics: Consultancy; Janssen: Consultancy; Kyowa Kirin: Consultancy; AstraZeneca: Consultancy; ADC Therapeutics: Consultancy; Novartis: Consultancy; Celgene, a Bristol Myers Squibb Co.: Consultancy; AbbVie: Consultancy; TG Therapeutics: Consultancy; Daiichi-Sankyo: Consultancy; Legend: Consultancy; Kite, a Gilead Company: Consultancy; Verastem: Consultancy; Acrotech: Consultancy; Karyopharm: Consultancy; Spectrum: Consultancy; Beigene: Consultancy; Morphosys: Consultancy. Baljevic: BMS/Celgene: Consultancy; Oncopeptides: Other: Advisory Board; Janssen Research: Other: Advisory Board; Karyopharm: Other: Advisory Board; BMS/Celgene: Other: Advisory Board; Amgen: Research Funding; Exelixis: Research Funding. Ganti: Merck: Research Funding; Apexigen: Research Funding; Nektar: Research Funding; Top Alliance Biosceinces: Research Funding; Lovance: Research Funding; Novartis: Research Funding; WindMil Therapeitucs: Research Funding; Takeda: Research Funding; Flagship Biosciences: Consultancy; AstraZeneca: Consultancy, Other: Advisory Board; Mirati Therapeutics: Consultancy, Other: Advisory Board; G1 Therapeutics: Consultancy, Other: Advisory Board; Blueprint Medicines: Consultancy, Other: Advisory Board; Cardinal Health: Consultancy, Other: Advisory Board; Roche: Consultancy, Other: Advisory Board; YMabS Therapeutics: Other: DSMC Chair.

524. Assessing the Safety of an Outpatient Remdesivir Infusion Program for Patients with Severe COVID-19 in the Setting of a Pandemic Surge

Background (i) Remdesivir (RDV) shortens recovery time among COVID-19 patients in an inpatient setting. (ii) Treatments for outpatients diagnosed with COVID-19 are limited. (iii) In early 2021, there was a national surge in COVID-19 hospitalizations, which resulted in hospital bed and staff shortages. (iv) In the face of this pandemic surge, we piloted a program to expand our RDV treatment capacity by establishing an off-label, outpatient infusion tent (OIT) for patients with severe COVID-19. (v) This is a retrospective, descriptive report examining the safety and efficacy of this program, with outcomes of interest being 30-day mortality and hospital admission within the subsequent 30 days Methods (i) The OIT, consisting of 11 chairs capable of treating 35 patients per day, was operational from January 1 to February 19, 2021. (ii) Patients were referred to the outpatient RDV program primarily from urgent care (UC) and the emergency department (ED), and from the inpatient setting to complete therapy. Patients received at least one dose prior to referral. (iii) Eligibility criteria included a confirmed COVID-19 diagnosis, radiographic evidence of viral pneumonia, and an oxygen saturation less than or equal to 94 on room air. (iv) Exclusion criteria included pregnancy, sepsis, end-stage renal disease or GFR < 30, hepatitis with transaminases 10 times the limit of normal. Patients with BMI > 40, age > 75, chronic lung disease, dementia, were considered on a case by case basis. (v) Patients received dexamethasone and deep vein thrombosis prophylaxis Results (i) A total of 88 patients received 258 infusions. The average number of outpatient infusions per participant was 2.9. (ii) Four out of 88 patients died (4.5%) within 30 days of first dose in the infusion tent. No deaths occurred in the outpatient setting. (iii) Fourteen out of 88 patients were admitted to the hospital within the subsequent 30 days (15.9%). (iv) 11/14 admissions (78.6%) were due to progression of COVID-19. There were no admissions due to adverse drug reactions Table 1. Patient Characteristics Table 2. Admissions Within Subsequent 30 Days Conclusion Mortality rate in outpatients with severe COVID-19 treated with RDV was similar to that reported in inpatients. In this cohort of patients with severe COVID, a majority (84.1%) avoided hospitalization while still receiving appropriate treatment. Results suggest RDV can be safely delivered to outpatients with severe COVID-19. Disclosures All Authors: No reported disclosures

Low Prevalence of Thrombosis Prophylaxis Dose Adjustments Highlights Implications for Patient Safety

Background: Pharmacologic thromboprophylaxis (PTP) is the mainstay prevention strategy for venous thromboembolism (VTE). PTP agents traditionally dosed, like unfractionated heparin (UFH) and enoxaparin (ENOX), are associated with failure and bleeding in obese and underweight patients, respectively. Objectives: This study aimed to describe the prevalence of unadjusted ENOX and UFH dosing for PTP based on anthropometric measures. Patients/Methods: This was a post-hoc, multicenter, cross–sectional analysis of critically ill adults receiving PTP with ENOX or UFH. The primary outcome was the prevalence of unadjusted PTP based on body mass index (BMI) and total body weight (TBW). Definitions for dose adjustments were developed based on existing literature. A secondary outcome was to identify factors associated with unadjusted dosing per BMI and TBW using multivariable generalized linear mixed-effect models. Results: The nested cohort included 172 patients (ENOX=46, UFH=126). Unadjusted PTP was observed in 118 patients (68.6%) based on BMI and 74 (43%) per TBW. When comparing UFH to ENOX, more patients who received UFH had doses unadjusted by BMI (78.6% vs. 41.3%, p<0.05) but not TBW (43.7% vs. 41.3%). Factors independently associated with unadjusted PTP per BMI were receipt of UFH (OR 6.93, 95% CI 1.06-8.77) or a BMI underweight or overweight/obese (OR 10.45, 95% CI 4.38-24.92). Having a TBW <50kg or >100kg (OR 4.85, 95% CI 2.15-10.96) were independently associated with unadjusted PTP based on TBW. Conclusions: Unadjusted dosing of PTP occurs frequently in critically ill adults receiving ENOX or UFH. This was seen in body size extremes by both BMI and TBW.

Rare complication of nadroparin injections: skin necrosis and heparin-induced thrombocytopenia syndrome

We described a rare case of nadroparin-induced skin necrosis with thrombocytopenia.LMWH therapy is used in thrombosis prophylaxis, it is important to recognize that skin necrosis can be a part of HIT early in its course and change heparin or LMWH to non-heparin anticoagulants such as director thrombin III inhibitors.