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

2020 ◽  
Vol 54 (11) ◽  
pp. 1073-1082
Author(s):  
Ethan Wood ◽  
Charles Hayes ◽  
Anthony Hart
Keyword(s):  
Therapeutic Range ◽  
Major Bleeding ◽  
Small Sample Size ◽  
Small Sample ◽  
Ventricular Assist Devices ◽  
Patient Specific ◽  
Circulatory Support ◽  
Single Center ◽  
Bleeding Events ◽  
Anticoagulation Management

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.

Clinical Outcomes and Pharmacists' Acceptance of a Community Hospital's Anticoagulation Management Service Utilizing Decentralized Clinical Staff Pharmacists

2009 ◽  
Vol 43 (4) ◽  
pp. 621-628 ◽  
Author(s):  
Anita Airee ◽  
Alexander B Guirguis ◽  
Rima A Mohammad
Keyword(s):  
Patient Safety ◽  
Medical Care ◽  
Therapeutic Range ◽  
Statistical Significance ◽  
Anticoagulation Therapy ◽  
Patient Specific ◽  
Management Service ◽  
Anticoagulation Management ◽  
Major Barrier ◽  
Anticoagulation Management Service

Background: In 2008, the Joint Commission released an updated National Patient Safety Goals document that requires institutions to implement practices that reduce the likelihood of patient harm associated with use of anticoagulation therapy. One of the expectations associated with this goal was that each organization would establish an anticoagulant management program. To our knowledge, few data exist to describe the implementation and assessment of anticoagulation programs in smaller, nonteaching community hospitals using decentralized pharmacists in an integrated practice model. Objective: To compare the performance of a protocol-driven anticoagulation management service led by decentralized pharmacists in a nonteaching community hospital with that of usual medical care provided by hospitalist physicians before this program was implemented. Based on these results, as well as a pharmacist satisfaction survey, evaluate the service and identify barriers to expansion. Methods: We conducted a retrospective cohort study comparing 50 consecutive patients who were starting warfarin for the first time beginning in November 2003 with 50 patients managed by hospitalist physicians prior to November 2002 (the time of program implementation). Results: There were no significant differences between groups with regard to time in therapeutic range once therapeutic, length of stay, international normalized ratios (INRs) greater than 3.5, or INRs less than 2. Patients in the pharmacy management group had significantly fewer drug interactions with antimicrobials than did the usual medical care group. Although time to therapeutic range was longer in the pharmacy protocol group, there were fewer patients with INRs greater than 3.5, although this did not reach statistical significance. Conclusions: The efficacy of the pharmacist-led anticoagulation management service was no different from that of usual medical care. Patient safety appeared improved, in part due to more careful initial dose selection based on patient-specific factors. Although this program was accepted by pharmacists, time limitations were perceived to be a major barrier to quality care and expansion of the service.

scholarly journals P0342A STUDY OF TREATMENT WITH RITUXIMAB IN REFRACTORY LUPUS NEPHRITIS

2020 ◽  
Vol 35 (Supplement_3) ◽  
Author(s):  
Pranab Jyoti Mahanta ◽  
Manjuri Sharma ◽  
Shahzad Alam ◽  
Prodip Kumar Doley ◽  
Gayatri Pegu ◽  
...  
Keyword(s):  
Lupus Nephritis ◽  
Small Sample Size ◽  
Life Time ◽  
Immunosuppressive Drugs ◽  
Small Sample ◽  
Post Treatment ◽  
Urinary Protein ◽  
Single Center ◽  
Renal Response ◽  
Stage Renal Disease

Abstract Background and Aims SLE patients have 40% to 70% life time risk of developing lupus nephritis (LN). In LN patients rate of end-stage renal disease is 10%, remaining constant in the last 30 years, even after the emergence of various immunosuppressive therapy. SLE is an example of classical antibody-mediated disease and hence treatment with B cell depleting agent (like the use of Rituximab ) appears to be a promising approach for this unwinnable disease from the Roman era. The aim of this study was to analyze the outcome in terms of - no renal response (NRR), complete renal response (CRR) or partial renal response (PRR) at week 24 after rituximab treatment initiation in refractory LN. CRR considered, if serum creatinine (S Cr) level returned to baseline, with a decline in the 24 hour urinary protein to < 500 mg/day. PRR defined as stabilization (+/-25%), or improvement of S Cr, plus a 50% decrease in 24 hour urinary protein (which was < 3.5 gm/day). NRR considered, if participant did not achieve either a CRR or PRR. Method It is a single center prospective observational study, comparing short term (24 week) outcomes in resistant lupus nephritis patients of >18 year age group with weekly (total 4) dose of rituximab therapy. The study was conducted on 25 refractory lupus nephritis patients admitted in Nephrology Department (not responding to conventional immunosuppressive drugs like cyclophosphamide, MMF). Repeat renal biopsy was performed, all baseline investigations were done. Injection Rituximab 375 mg/m2 weekly 0,1,2,3 week along with premedication treatment were given to every patient. The clinical outcome was assessed monthly post-treatment. Results In the study maximum patients were of class IV, n=21 (84 %). Sustained (6 months post treatment) CRR was achieved in n=6 (24%) patients, n=7 (28%) patients achieved PRR, rest n=12 (48%) patients had NRR. Mean blood absolute CD-19 count was significantly negatively correlated with response to rituximab treatment ( p< 0.001) .Mean absolute CD-19 count was 2.33/microliter in CRR, 2.14/microliter in PRR group and 21.25 / microliter in NRR group . No significant side effects of rituximab were observed. Limitations –Small sample size, single center study, long term follow up not considered. Conclusion In refractory LN patients, 24 weeks after Rituximab treatment

Evaluation of fosaprepitant-associated hypersensitivity reactions at a National Cancer Center

2020 ◽  
Vol 26 (6) ◽  
pp. 1369-1373 ◽  
Author(s):  
Catherine Michelle Laird ◽  
Ashley E Glode ◽  
Kerry Schwarz ◽  
Elaine T Lam ◽  
Cindy L O'Bryant
Keyword(s):  
Small Sample Size ◽  
Medication Administration ◽  
Small Sample ◽  
Patient Specific ◽  
Cancer Center ◽  
Hypersensitivity Reactions ◽  
University Of Colorado ◽  
Time Period ◽  
Systemic Hypersensitivity ◽  
The University

Introduction At our institution, an increased incidence of hypersensitivity reactions was reported following standardization of fosaprepitant as the preferred agent for the prophylaxis of chemotherapy induced nausea and vomiting (CINV) caused by highly emetogenic therapies. The purpose of this evaluation was to assess the incidence of systemic hypersensitivity reactions (HSRs) to fosaprepitant infusions compared to available literature. Methods This evaluation is a retrospective review of electronic health records of adult patients who received their first dose of fosaprepitant for CINV prophylaxis beginning January 1, 2017 through June 30, 2017 at the University of Colorado Cancer Center outpatient infusion center. Subjects were identified using medication administration reports. Individual chart reviews were performed for all patients who received fosaprepitant during the specified timeframe and had a reaction reported on the same date. Results A total of 868 patients received fosaprepitant in the outpatient infusion center during the study time period. Four patients (0.461%) had a systemic HSR attributed to fosaprepitant. Two of the reactions were reported as HSRs in the adverse reaction reporting system and two were found in provider notes during chart review. Due to the small sample size, risk factors for HSRs to fosaprepitant were not able to be determined. Conclusion The incidence of HSRs to fosaprepitant at our institution was found to be consistent with the <1% incidence currently noted in literature. Based on these findings, opportunities have been identified for education on fosaprepitant-associated HSRs, proper documentation and patient-specific precautions.

scholarly journals Time in Therapeutic Range Using a Nomogram for Dose Adjustment of Warfarin in Patients on Hemodialysis With Atrial Fibrillation

2021 ◽  
Vol 8 ◽  
pp. 205435812110460
Author(s):  
Kimberly Defoe ◽  
Jenny Wichart ◽  
Kelvin Leung
Keyword(s):  
Atrial Fibrillation ◽  
Therapeutic Range ◽  
Chart Review ◽  
Warfarin Therapy ◽  
Small Sample Size ◽  
Retrospective Chart Review ◽  
Small Sample ◽  
Time In Therapeutic Range ◽  
Increased Risk ◽  
Chi Square Analysis

Background: Patients treated with hemodialysis and prescribed warfarin typically have lower time in therapeutic range (TTR) compared to the general population. This may result in less benefit or increased risk of over anticoagulation in these patients. Objective: To assess effectiveness of use of an electronic nomogram for the management of warfarin therapy in patients treated with hemodialysis. Design: Retrospective chart review. Setting: Adult patients treated with hemodialysis. Patients: Patients on hemodialysis receiving warfarin for the management of atrial fibrillation (AF) with therapy managed by nursing led electronic nomogram. Measurements: Time in therapeutic range (as fraction and Rosendaal). Methods: Retrospective chart review over 1 year of international normalized ratio (INR) results was completed, and TTR was calculated. Comparison of patients with TTR greater than 60% to those less than 60% was completed using chi-square analysis. Results: Of 43 patients with warfarin therapy managed by the nomogram, the mean TTR was 55.2% (calculated by fraction method) or 61.2% (calculated by Rosendaal method). More than half of the patients (63.5%) had moderate to good control, defined as TTR greater than 60%. Female sex, liver disease, or history of substance use and more medication holds were associated with lower TTR. Limitations: Small sample size and retrospective nature of review. Conclusions: The results of this review supports the use of an electronic, nursing-led nomogram for the maintenance management of warfarin therapy in stable patients treated with hemodialysis, as use results in TTR greater than 60% for more than half of patients.

In-Vitro Thrombogenicity Assessment of Mechanical Circulatory Support Devices and Prosthetic Heart Valves

2010 ◽  
Author(s):  
Thomas E. Claiborne ◽  
Gaurav Girdhar ◽  
Jawaad Sheriff ◽  
Jolyon Jesty ◽  
Marvin J. Slepian ◽  
...  
Keyword(s):  
Platelet Activation ◽  
Mechanical Circulatory Support ◽  
Heart Valves ◽  
Anticoagulation Therapy ◽  
Ventricular Assist Devices ◽  
Patient Specific ◽  
Circulatory Support ◽  
Prosthetic Heart Valves ◽  
Bridge To Transplant ◽  
Uncontrolled Bleeding

Mechanical circulatory support (MCS) devices developed for end-stage heart failure or as a bridge-to-transplant include total artificial hearts (TAH) and ventricular assist devices (VAD) and utilize prosthetic heart valves (PHV) or rotary impellers to control blood recirculation [1]. These devices are currently not optimized to reduce the incidence of pathological flow patterns that cause elevated stresses leading to platelet activation and thrombosis. Although the latter is partially mitigated by lifelong anticoagulation therapy, it dramatically increases the risk of uncontrolled bleeding. For instance thromboembolic stroke-related complications (∼2%) were relatively less with the TAH-t compared to uncontrolled bleeding due to anticoagulation use (∼20%) [2]. Platelet activation should therefore be quantified and optimized based on patient-specific cardiac outputs in device prototypes before clinical use.

scholarly journals PROGNOSTIC FACTORS IN MYELODYSPLASTIC SYNDROMES: SINGLE-CENTER EXPERIENCE

2019 ◽  
Vol 141 (7-8) ◽  
pp. 238-246
Keyword(s):  
Prognostic Factors ◽  
Small Sample Size ◽  
Risk Groups ◽  
Small Sample ◽  
World Health ◽  
Single Center ◽  
Single Center Experience ◽  
Age Of Diagnosis ◽  
Transfusion Dependency ◽  
Health Organization

Introduction: Myelodysplastic syndrome (MDS) is one of the most common myeloid neoplasms of elderly characterized by cytopenias and limited therapeutic options. The main aim of this retrospective single-center study was to examine the value of classical prognostic factors. The main outcome of the study was overall survival (OS) defined as death from MDS or any other reason. Methods: We analyzed the medical records of patients diagnosed with MDS at single centre in the period from beginning of 2013 to the end of 2016. Results: Total of 58 patients (median age of diagnosis being 69 years) were included in the study. After median of follow-up of 12 months, median OS was 17 months and estimated 3-year OS rate 25%. Classical prognostic systems such as IPSS, WPSS and R-IPSS were statistically significant prognostic factors discriminating adequately between low and high risk groups in terms of outcome. However, due to small sample size, we were not able to distinguish the most appropriate scoring system. The cytogenetics subgroups according to IPPS and R-IPSS were significant predictors of outcomes underlying its crucial role in MDS diagnosis. Despite the statistical tendency morphological features of MDS (2008 World Health Organization subtype and number of blasts in bone marrow) were not significant predictors of OS. Among clinical features, only presence and degree of anemia and transfusion dependency were significant predictors of inferior survival. Conclusion: The majority of traditional prognostic factors were significant in our cohort in concordance with literature review.

scholarly journals 213. Assessment of Compliance with Order Set and Bundle for Management of Staphylococcus aureus Bacteremia

2021 ◽  
Vol 8 (Supplement_1) ◽  
pp. S214-S215
Author(s):  
Ryan R Flynn ◽  
Marilee Obritsch ◽  
Veronica Lesselyoung ◽  
Joe Strain ◽  
John Kappes
Keyword(s):  
Staphylococcus Aureus ◽  
Statistical Difference ◽  
Small Sample Size ◽  
Small Sample ◽  
Single Center ◽  
Recurrence Rates ◽  
Adequate Treatment ◽  
Single Center Study ◽  
Center Study ◽  
Order Set

Abstract Background Staphylococcus aureus (S. aureus) is an aerobic gram-positive coccus that causes a variety of infections. S. aureus bloodstream infections, also known as bacteremias, have significant morbidity and mortality and are difficult to eradicate. A single-center study showed a 9.4% recurrence rate for S. aureus bacteremia, despite adequate treatment. The Infectious Disease Society of America (IDSA) recognizes the seriousness of S. aureus infections, particularly methicillin-resistant S. aureus (MRSA), and has released guidance for treatment of these infections. Guidance for S. aureus bacteremias include identification and removal of the source and early optimization of antibiotics. Serial imaging and laboratory monitoring, including repeat blood cultures, are also necessary to establish the duration of therapy, ensure microbiologic eradication, and reduce the risk of long-term complications. Due to the complexity of S. aureus bacteremia, early involvement of infectious diseases (ID) specialists is strongly recommended. Methods This retrospective, single-center study was designed to evaluate the current management of S. aureus bacteremias, including compliance to the elements of the S. aureus order set and bundle. Patients 18 years and older who had a positive blood culture for S. aureus were included in this study. Recurrence of S. aureus infection was assessed at 6 months. Data was analyzed to compare patients with and without ID consults. Results Eighty-four patients met inclusion criteria. ID consultation resulted in a higher percentage of patients achieving 100% compliance with the bundle elements compared to patients without ID consults (73% vs 25%, respectively; p=0.009). For further breakdown of compliance see Table 1. No statistical difference was detected in recurrence rates (11% vs 33%, respectively; p=0.18) or mortality (8% vs 25%, respectively; p= 0.17) possibly due to the small sample size. Table 1. Outcomes Conclusion ID specialist involvement for the treatment of S. aureus bacteremia resulted in greater compliance with the S. aureus bacteremia bundle. No statistical difference in recurrence or mortality rates was detected. Disclosures All Authors: No reported disclosures

scholarly journals Clopidogrel Loading Dose 300 vs. 600 mg in Patients Undergoing One-Stop Hybrid Coronary Revascularization: A Prospective Single-Center Randomized Pilot Study

2021 ◽  
Vol 8 ◽  
Author(s):  
Yulin Guo ◽  
Dongjie Li ◽  
Yingdi Gao ◽  
Jing Zhao ◽  
Xiangguang An ◽  
...  
Keyword(s):  
Pilot Study ◽  
Major Bleeding ◽  
Coronary Revascularization ◽  
Artery Bypass ◽  
Loading Dose ◽  
Single Center ◽  
Bleeding Events ◽  
One Stop ◽  
Hybrid Coronary Revascularization ◽  
Major Bleeding Events

Background: The optimal loading dose of clopidogrel in one-stop hybrid coronary revascularization (HCR) remains an “evidence-free” zone. This study aimed to compare the major bleeding and ischemic thrombotic events between different clopidogrel loading doses (300 vs. 600 mg) in one-stop HCR.Methods: In this prospective, single-center, randomized, and parallel pilot study, 100 patients receiving one-stop HCR were randomly assigned to the clopidogrel loading dose 300-mg group or 600-mg group in a 1:1 ratio. Major bleeding events and composite in-hospital ischemic thrombotic and adverse complications were evaluated after the procedure.Results: The results showed that postoperative mean chest drainage of the first 4 days and total drainage were comparable between the two groups. No differences were found in Bleeding Academic Research Consortium (BARC) coronary artery bypass grafting (CABG) related bleeding (4 vs. 2%, P = 1), PLATelet inhibition and patient Outcomes (PLATO) life-threatening bleeding (20 vs. 26%, P = 0.48), and PLATO major bleeding (70 vs. 76%, P = 0.5) in the two groups. The composite ischemic thrombotic and adverse events were also similar.Conclusions: In patients receiving one-stop HCR, clopidogrel 600 mg loading dose did not increase major bleeding events compared with 300 mg. More sufficient data is necessary to evaluate the potential benefits of 600 mg loading dose in one-stop HCR.

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