Improving Rates of Venous Thromboembolism Prophylaxis in Multiple Myeloma Patients on Immunomodulatory Drugs

Abstract BACKGROUND: Multiple myeloma patients who receive immunomodulatory drugs (IMiDs: lenalidomide, thalidomide, and pomalidomide) have an increased risk of developing venous thromboembolism (VTE). Guidelines for thromboprophylaxis are based on additional patient and disease characteristics. We describe our single-institution experience with VTE prophylaxis and an intervention to improve VTE risk assessment and prophylaxis. METHODS: A retrospective review using an internal patient database assessed VTE in multiple myeloma patients being treated with IMiDs from 2000-2016. VTE risk factors for each patient were assessed to determine alignment with thromboprophylaxis guidelines. A Quality Improvement (QI) phase from April 1, 2017 to December 31, 2017 added pharmacy oversight to perform an independent VTE risk assessment. Every patient started on an IMiD during this period underwent a separate VTE risk assessment by a pharmacist or hematologist. Each patient was categorized as high or low VTE risk based on NCCN guidelines. The results and recommendations for VTE prophylaxis were given to the myeloma provider. Results: In the initial retrospective review, 107 patients were identified who developed VTE during treatment of multiple myeloma with an IMiD despite thromboprophylaxis in 91 patients (85% of total; 78% on aspirin). The most common VTE risk factors per NCCN guidelines included cardiac disease (n=70), obesity (n=32), chronic kidney disease (n=27), and prior history of VTE (n=18). Eight patients received anticoagulant-based thromboprophylaxis. In the QI phase, 39 multiple myeloma patients were started on IMiDs. The risk assessment classified 17 as low-risk and 22 as high-risk. Of the high-risk patients, 14 (64%) were placed on an anticoagulant for thromboprophylaxis. Eleven (79%) of the anticoagulants used were direct oral anticoagulants (DOACs), 2 (14%) were a low-molecular weight heparin, one (7%) warfarin. The number of thromboembolic events that occurred were 6 (15%): 4 were high-risk on aspirin and 2 were low-risk on aspirin. The 2 low-risk patients who developed VTE had additional provoking factors (active infection, central line placement, smoking, a long driving trip). Eight high-risk patients were given aspirin. Out of the 8, 3 patients developed VTE and were then switched to anticoagulation. One high-risk patient received aspirin because of moderate thrombocytopenia and subsequently developed a VTE. No patients on anticoagulation developed a VTE. The number of complications attributed to thromboprophylaxis were 2 (5%). Two minor bleeding events occurred in patients who were on DOACs (1 epistaxis and 1 grade 1 GI bleed). Both patients continued DOAC anticoagulation after the event resolved. Conclusions: This two-phase QI study showed that multiple myeloma patients at high risk for VTE benefit from guideline-based thromboprophylaxis facilitated through a pharmacy-based system. DOAC's ease of use offer patients and providers an agreeable option that may improve compliance of VTE guidelines. However, prospective studies with DOACs in multiple myeloma are urgently needed to support this. Figure. Figure. Disclosures No relevant conflicts of interest to declare.

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MELISSE, a large multicentric observational study to determine risk factors of venous thromboembolism in patients with multiple myeloma treated with immunomodulatory drugs

Thrombosis and Haemostasis ◽

10.1160/th13-02-0140 ◽

2013 ◽

Vol 110 (10) ◽

pp. 844-851 ◽

Cited By ~ 33

Author(s):

Philippe Rodon ◽

Cyrille Hulin ◽

Laurent Daley ◽

Charles Dauriac ◽

Maya Hacini ◽

...

Keyword(s):

Risk Factors ◽

Risk Assessment ◽

Multiple Myeloma ◽

Venous Thromboembolism ◽

Observational Study ◽

Vitamin K Antagonists ◽

Real Life ◽

Immunomodulatory Drugs ◽

Vte Prophylaxis ◽

Increased Risk

SummaryImmunomodulatory drugs (IMiDs) are associated with an increased risk of venous thromboembolism (VTE) in multiple myeloma (MM) patients. We designed MELISSE, a multicentre prospective observational study, to evaluate VTE incidence and identify risk factors in IMiDstreated MM. Our objective was to determine the real-life practice of VTE prophylaxis strategy. A total of 524 MM patients were included, and we planned to collect information at baseline, at four and at 12 months, on MM therapy, on VTE risk factors and management. VTE incidence was 7% (n=31), including 2.5% pulmonary embolism (PE) (n=11), similar at four or 12 months. VTE was observed at all risk assessment levels, although the increased risk assessment level correlated to a lower rate of VTE, maybe due to the implemented thromboprophylaxis strategy. VTE occurred in 7% on aspirin vs 3% on lowmolecular- weight heparin (LMWH) prophylaxis, and none on vitamin K antagonists (VKA). New risk factors for VTE in IMiDs-treated MM were identified. In conclusion, VTE prophylaxis is compulsory in IMiDstreated MM, based on individualised VTE risk assessment. Anticoagulation prophylaxis with LMWH should clearly be prioritised in MM patients with high VTE risk, along with VKA. Further prospective studies will identify most relevant VTE risk factors in IMiDs-treated MM to select accurately which MM patients should receive LMWH prophylaxis and for which duration to optimise VTE risk reduction.

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Successful Model for Guideline Implementation to Prevent Cancer-Associated Thrombosis: Venous Thromboembolism Prevention in the Ambulatory Cancer Clinic

JCO Oncology Practice ◽

10.1200/jop.19.00697 ◽

2020 ◽

Vol 16 (9) ◽

pp. e868-e874 ◽

Cited By ~ 2

Author(s):

Chris E. Holmes ◽

Steven Ades ◽

Susan Gilchrist ◽

Daniel Douce ◽

Karen Libby ◽

...

Keyword(s):

Risk Assessment ◽

Venous Thromboembolism ◽

High Risk ◽

Assessment Tool ◽

Guideline Implementation ◽

Vte Prophylaxis ◽

Successful Model ◽

Venous Thromboembolism Prevention ◽

Risk Patients ◽

Cancer Associated Thrombosis

PURPOSE: Guidelines recommend venous thromboembolism (VTE) risk assessment in outpatients with cancer and pharmacologic thromboprophylaxis in selected patients at high risk for VTE. Although validated risk stratification tools are available, < 10% of oncologists use a risk assessment tool, and rates of VTE prophylaxis in high-risk patients are low in practice. We hypothesized that implementation of a systems-based program that uses the electronic health record (EHR) and offers personalized VTE prophylaxis recommendations would increase VTE risk assessment rates in patients initiating outpatient chemotherapy. PATIENTS AND METHODS: Venous Thromboembolism Prevention in the Ambulatory Cancer Clinic (VTEPACC) was a multidisciplinary program implemented by nurses, oncologists, pharmacists, hematologists, advanced practice providers, and quality partners. We prospectively identified high-risk patients using the Khorana and Protecht scores (≥ 3 points) via an EHR-based risk assessment tool. Patients with a predicted high risk of VTE during treatment were offered a hematology consultation to consider VTE prophylaxis. Results of the consultation were communicated to the treating oncologist, and clinical outcomes were tracked. RESULTS: A total of 918 outpatients with cancer initiating cancer-directed therapy were evaluated. VTE monthly education rates increased from < 5% before VTEPACC to 81.6% (standard deviation [SD], 11.9; range, 63.6%-97.7%) during the implementation phase and 94.7% (SD, 4.9; range, 82.1%-100%) for the full 2-year postimplementation phase. In the postimplementation phase, 213 patients (23.2%) were identified as being at high risk for developing a VTE. Referrals to hematology were offered to 151 patients (71%), with 141 patients (93%) being assessed and 93.8% receiving VTE prophylaxis. CONCLUSION: VTEPACC is a successful model for guideline implementation to provide VTE risk assessment and prophylaxis to prevent cancer-associated thrombosis in outpatients. Methods applied can readily translate into practice and overcome the current implementation gaps between guidelines and clinical practice.

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Prophylaxis of venous thromboembolism in general surgery: guidelines differ and we still need local policies

Annals of The Royal College of Surgeons of England ◽

10.1308/003588411x580926 ◽

2011 ◽

Vol 93 (5) ◽

pp. 370-374

Author(s):

D Veeramootoo ◽

L Harrower ◽

R Saunders ◽

D Robinson ◽

WB Campbell

Keyword(s):

At Risk ◽

Venous Thromboembolism ◽

High Risk ◽

Risk Groups ◽

Low Risk ◽

Vte Prophylaxis ◽

Risk Patients ◽

Local Policies ◽

One Year ◽

The Uk

INTRODUCTION Venous thromboembolism (VTE) prophylaxis has become a major issue for surgeons both in the UK and worldwide. Sev-eral different sources of guidance on VTE prophylaxis are available but these differ in design and detail. METHODS Two similar audits were performed, one year apart, on the VTE prophylaxis prescribed for all general surgical inpatients during a single week (90 patients and 101 patients). Classification of patients into different risk groups and compliance in prescribing prophylaxis were examined using different international, national and local guidelines. RESULTS There were significant differences between the numbers of patients in high, moderate and low-risk groups according to the different guidelines. When groups were combined to indicate simply ‘at risk’ or ‘not at risk’ (in the manner of one of the guidelines), then differences were not significant. Our compliance improved from the first audit to the second. Patients at high risk received VTE prophylaxis according to guidance more consistently than those at low risk. CONCLUSIONS Differences in guidance on VTE prophylaxis can affect compliance significantly when auditing practice, depending on the choice of ‘gold standard’. National guidance does not remove the need for clear and detailed local policies. Making decisions about policies for lower-risk patients can be more difficult than for those at high risk.

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Final Analysis of MELISSE, a Large Multicentric Observational Study to Determine Risk Factors of Venous Thromboembolism in Patients with Multiple Myeloma Treated with Immunomodulator Drugs

Blood ◽

10.1182/blood.v118.21.1235.1235 ◽

2011 ◽

Vol 118 (21) ◽

pp. 1235-1235 ◽

Cited By ~ 1

Author(s):

Xavier Leleu ◽

Laurent Daley ◽

Philippe Rodon ◽

Cyrille Hulin ◽

Charles Dauriac ◽

...

Keyword(s):

Risk Factors ◽

Multiple Myeloma ◽

High Risk ◽

Incidence Rate ◽

Research Funding ◽

Final Analysis ◽

Vte Prophylaxis ◽

High Risk Patients ◽

Increased Risk ◽

Risk Patients

Abstract Abstract 1235 Background. Immunomodulator drugs (IMiDs) are associated with an increased risk of thromboembolic events (TE). Multiple Myeloma patients (MM) that can not benefit from novel agents, including IMiDs, only have 9 months survival. IMiDs must be stopped when TE occurs with the consequence of potential shortened life expectancy. MELISSE was designed to prospectively evaluate the incidence and risk factors of venous TE (VTE) associated with IMiDs in MM. We have presented the interim analysis of MELISSE at ASH 2010. A reduced incidence rate of early VTE was observed when a prophylaxis for VTE was started as compared to patients that had no prophylaxis. Interestingly, we also reported that most of the patients had received aspirin, while aspirin is not considered to exert any venous prophylactic effect. LMWH was primarily proposed to patients with high risk of TE according to physician's evaluation. We present the final analysis of MELISSE with updated results at 1 year. Method. A total of 524 MM treated with IMiDs-based therapy were included in 52 IFM centers. VTE prophylaxis was recommended prior to start IMiDs, the choice of which was left at the discretion of the investigator. Patients gave written informed consent according to the declaration of Helsinki. The physicians were to record the risk of VTE occurrence, categorized as low, moderate and high, based on guidelines and their own appreciation of the risk. Occurrence of any VTE was to be recorded along with the management of the event and the patient's outcome. The data were collected at entry in the study, and then after 4 and 12 months. Results. The median age was 70 years old, with 64.67% of patients >65 years old. Overall 36.0% had thalidomide-based and 64.0% had lenalidomide-based therapy, with 180 patients in first line and the remaining patients in 2nd and 3rd lines of therapy. The observed repartition of TE risk factors was as expected in a European population with myeloma. The risk of VTE was assessed as high in 14.2% patient and small or intermediate otherwise. Interestingly, approximately 70% of patients rated as low and intermediate risk received aspirin as a routine prophylaxis for VTE as compared to 20% in high risk patients. LMWH was primarily given to high risk patients, 45.8%. Surprisingly, 16.0% of patients had no VTE prophylaxis. Investigators recorded 29 (5.5% annual incidence rate) TE at 12 months, including 12 associated with PE. The incidence rate of TE was similar within the first 4 months (early occurrence, 3.5%) versus after 4 months (late, 2.5%). We have not identified any risk factor that would explain early versus late occurrence of VTE. Interestingly, the incidence of VTE was higher in patients that had no prophylaxis treatment, 8.5%, as compared to 4.4% and 5.9% in the LMWH and aspirin groups, respectively. There was no PE recorded in patients that were on LMWH prophylaxis. The VTE was equally breakdown across the 3 groups of risk factors. The bleeding adverse events were reported for 27 patients, mainly patients with aspirin. We isolated a model with 3 variables that independently predicted a higher risk to develop VTE in the multivariate model, and that comprised the male gender [OR 4.31 (95% CI 1.60 – 13.90)], the smoking habit [6.76 (1.73–22.42)] and the association to EPO [2.66 (1.04–6.58)]. Aspirin showed no significance, but with a p value at 0.55. The multivariate analysis is limited as certain subgroups with high risk factors might have received the optimal VTE prophylaxis, such as patients with bed rest and patients with prior history of VTE. These 2 groups rarely had aspirin. Survival data will be updated and presented at ASH 2011. Conclusion. This study further demonstrates that TE prophylaxis is required for MM treated with IMiDs-based therapy. There is a slight increase risk of VTE/PE with the use of aspirin as compared to LMWH, but a significant increase in bleeding events. Although we have identified risk factors of VTE in MM treated with IMiDs, for the first time, we could not identified VTE risk factors to guide investigators between LMWH and aspirin-based prophylaxis. The optimal dose and duration of LMWH remains to be determined. Disclosures: Leleu: LeoPharma: Honoraria, Research Funding; Celgene: Honoraria, Research Funding; Janssen Cilag: Honoraria, Research Funding; Roche: Research Funding; Amgen: Honoraria; Novartis: Research Funding. Daley:LeoPharma: Employment. Hulin:Janssen: Honoraria; Celgene: Honoraria. Lamblin:LeoPharma: Employment. Natta:LeoPharma: Employment.

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VTE Incidence in RRMM Patients Treated with NOVEL Agents: A Monocentric Real Life Experience

Blood ◽

10.1182/blood-2019-131015 ◽

2019 ◽

Vol 134 (Supplement_1) ◽

pp. 4972-4972

Author(s):

Gaetano Giuffrida ◽

Concetta Conticello ◽

Valeria Calafiore ◽

Enrica Antonia Martino ◽

Silvia Giamporcaro ◽

...

Keyword(s):

Risk Factors ◽

High Risk ◽

Research Funding ◽

Real Life ◽

Low Risk ◽

Novel Agents ◽

Vte Prophylaxis ◽

High Risk Patients ◽

Risk Patients ◽

Low Incidence

INTRODUCTION: Venous thromboembolism (VTE) is very common in patients with malignancies. Compared to the general population, patients with multiple myeloma (MM) have a 9-fold increased risk of developing VTE. In patients treated with thalidomide or lenalidomide, current guidelines recommend systematic VTE prophylaxis with ASA in low risk patients while vitamin K antagonists (VKA) or low weight molecular heparin (LWMH) or unfractionated heparin (UFH) in high-risk patients, based on the type of anti-MM treatment that patients receive and patient-related individual risk factors (e. g. history of VTE). However, little is known on VTE prophylaxis in patients treated with next generation anti-myeloma drugs, such as pomalidomide, carfilzomib and monoclonal antibodies daratumumab and elotuzumab. Here, we describe the incidence of VTE in MM patients treated with third generation novel agents in real life. In addition, we stratify patients on drugs category-based regimens to evaluate strategy of VTE prophylaxis between different groups of patients. MATERIALS AND METHODS: A retrospective cohort of 137 patients affected by relapsed and/ or refractory multiple myeloma treated with novel agents was analyzed. Patients were followed at the Division of Hematology of Catania from April 2013 to June2019. Our series includes 75 patients exposed to Pomalidomide and Dexametasone (PomaD), 46 patients receiving Carfilzomib, Lenalidomide and desamethasone regimen (KRd), 14 patients exposed to Daratumumab(Dara), 27 patients to Daratumumab, Bortezomib and desamethasone (DaraVD), 4 patients to Daratumumab lenalidomide and desamethasone (DaraRd), and12 patients exposed to Elotuzumab and Lenalidomide (EloRd). Several patients were exposed to multiple lines of treatment with novel agents: the total number of analyzed treatments are 178. Patients were stratified to high or low risk for VTE: risk factors taken into account were obesity, history of VTE, central venous catheter, inhered thrombophilia, surgical procedures and comorbidities such as infections, immobilization, cardiac disease, chronic renal disease. Low risk patients had no or one risk factor; in case of two or more risk factors, the patients were classified as high risk. Low-dose aspirin (ASA 100 mg per os once daily) or equivalent was prescribed in low risk patients, low-molecular-weight heparin (LMWH) or equivalent was given to high risk patients. Only Dara treatment did not include standard prophylaxis in patients without risk factors. RESULTS: Real life observation revealed a low incidence of VTE (6 VTE-4,3%) in patients exposed to novel agents together with a standard prophylaxis in case of risk of thromboembolic complications. Forty patients were at high risk of VTE, while 97 patients were classified as low risk; VTE/PE occurred in 2 high risk patients who refused to make correct LMWH prophylaxis due to the discomfort of the subcutaneous administration, developing distal DVT respectively after cycle 1 and 2 of KRd. Two low risk patients treated with PomaD developed DVT of lower extremities during cycle 2 and 4; 2 low risk patients had pulmonary embolism during PomaD cycle 8. CONCLUSIONS: Low incidence of VTE in patients with RRMM receiving PomaD, KRd, EloRd, DaraVD, DaraRd, Dara or EloRd treatment is probably due to a correct risk assessment and subsequent prophylaxis in case of therapies including immunomodulators or in case of patients with high risk for thromboembolic complications. These data support the use of VTE risk stratification-based prophylactic strategies in myeloma patients treated with new drugs. Disclosures Conticello: Celgene: Consultancy, Honoraria, Research Funding; Amgen: Consultancy, Honoraria, Research Funding. Di Raimondo:Takeda: Consultancy; Amgen: Consultancy, Honoraria, Research Funding.

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Genomic classifier (ColoPrint) to predict outcome and chemotherapy benefit in stage II and III colon cancer patients.

Journal of Clinical Oncology ◽

10.1200/jco.2013.31.15_suppl.3612 ◽

2013 ◽

Vol 31 (15_suppl) ◽

pp. 3612-3612

Author(s):

Scott Kopetz ◽

Zhi-Qin Jiang ◽

Michael J. Overman ◽

Robert Rosenberg ◽

Ramon Salazar ◽

...

Keyword(s):

Risk Factors ◽

High Risk ◽

Adjuvant Chemotherapy ◽

Additional Treatment ◽

Low Risk ◽

Stage Ii ◽

Nccn Guidelines ◽

High Risk Patients ◽

Risk Patients

3612 Background: Although benefit of chemotherapy in stage II and III colorectal cancer patients is significant, many patients might not need adjuvant chemotherapy because they have a good prognosis even without additional treatment. ColoPrint is a gene expression classifier that distinguish patients with low or high risk of disease relapse. It was developed using whole genome expression data and validated in independent validation studies (JCO 2011, Ann Surg 2013). Methods: In this study, ColoPrint was validated in stage II (n=96) and III patients (n=95) treated at the MD Anderson Cancer Center. Frozen tissue specimen, clinical parameters and follow-up data (median follow-up 64 months) were available. Stage II patients from this study were pooled with patients from previous studies (n=416) and ColoPrint performance was compared to clinical risk factors described in the NCCN Guidelines 2013. Results: In the MDACC patient cohort, ColoPrint classified 56% of stage II and III patients as being at Low Risk. The 3-year Relapse-Free-Survival (RFS) was 90.5% for Low Risk and 78.1% for High Risk patients with a HR of 2.42 (p=0.025). In uni-and multivariate analysis, ColoPrint and stage were the only significant factors to predict outcome. Low Risk ColoPrint patients had a good outcome independent of stage or chemotherapy treatment (91% 3-year RFS for treated patients, 90% for untreated patients) while ColoPrint High Risk patients treated with adjuvant chemotherapy had 3-year RFS of 84%, compared to 70% 3-year RFS in untreated patients (p=0.037). In the pooled stage II dataset, ColoPrint identified 63% of patients as Low Risk with a 3-year RFS of 93% while High Risk patients had a 3-year RFS of 82.3% with a HR of 2.7 (p=0.001). In the univariate analysis, no clinical factor reached statistical significance. Using clinical high risk factors as described in the NCCN guidelines as classification, 56% of patients were classified as low risk with a 3-year RFS of 90.3% while high risk patients had a 3-year RFS of 87.7% with a HR of 0.6 (p=0.63). Conclusions: ColoPrint significantly improves prognostic accuracy, thereby facilitating the identification of patients at higher risk who might be considered for additional treatment.

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Whom Should We Test for COVID-19? Performance of a Symptom and Risk Factor Questionnaire on COVID-19 Test Results and Patient Outcomes in an Immediate Care Setting

Journal of Primary Care & Community Health ◽

10.1177/2150132720981297 ◽

2020 ◽

Vol 11 ◽

pp. 215013272098129

Author(s):

Lauren Oshman ◽

Amanda Caplan ◽

Raabiah Ali ◽

Lavisha Singh ◽

Rabeeya Khalid ◽

...

Keyword(s):

Risk Factors ◽

Risk Assessment ◽

Risk Factor ◽

High Risk ◽

Effect Size ◽

Care Setting ◽

Risk Group ◽

Low Risk ◽

Risk Patients ◽

Assessment Questionnaire

Introduction: The CDC and Illinois Department of Public Health disseminated risk factor criteria for COVID-19 testing early in the pandemic. The objective of this study is to assess the effectiveness of risk stratifying patients for COVID-19 testing and to identify which risk factors and which other clinical variables were associated with SARS-CoV-2 PCR test positivity. Methods: We conducted an observational cohort study on a sample of symptomatic patients evaluated at an immediate care setting. A risk assessment questionnaire was administered to every patient before clinician evaluation. High-risk patients received SARS-CoV-2 test and low-risk patients were evaluated by a clinician and selectively tested based on clinician judgment. Multivariate analyses tested whether risk factors and additional variables were associated with test positivity. Results: The adjusted odds ratio of testing positive was associated with COVID-19-positive or suspect close contact (aOR 1.56, 95% CI 1.15-2.10), large gathering attendance with a COVID-19-positive individual (aOR 1.92, 95% CI 1.10-3.34), and, with the largest effect size, decreased taste/smell (aOR 2.83, 95% CI 2.01-3.99). Testing positive was associated with ages 45-64 and ≥65 (aOR 1.75, 95% CI 1.25-2.44, and aOR 2.78, 95% CI 1.49-5.16), systolic blood pressures ≤120 (aOR 1.64, 95% CI 1.20-2.24), and, with the largest effect size, temperatures ≥99.0°F (aOR 3.06, 95% CI 2.23-4.20). The rate of positive SARS-CoV-2 test was similar between high-risk and low risk patients (225 [22.2%] vs 50 [19.8%]; P = .41). Discussion: The risk assessment questionnaire was not effective at stratifying patients for testing. Although individual risk factors were associated with SARS-CoV-2 test positivity, the low-risk group had similar positivity rates to the high-risk group. Our observations underscore the need for clinicians to develop clinical experience and share best practices and for systems and payors to support policies, funding, and resources to test all symptomatic patients.

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Venous Thromboembolism (VTE) Risk Assessment & Prophylaxis In Irish Hospitalized Obstetric Patients: A Nationwide Cross-Sectional Study

Blood ◽

10.1182/blood.v122.21.1151.1151 ◽

2013 ◽

Vol 122 (21) ◽

pp. 1151-1151

Author(s):

Caroline M Noone ◽

Susan O'Shea ◽

Maeve P Crowley ◽

John Higgins

Keyword(s):

Risk Factors ◽

Risk Assessment ◽

High Risk ◽

Conflicts Of Interest ◽

Mode Of Delivery ◽

Low Risk ◽

Average Weight ◽

Intermediate Risk ◽

Cross Sectional ◽

Risk Patients

Abstract Background Pulmonary embolism continues to be the second leading cause of mortality in pregnancy and the puerperium. VTE complicates 1 - 2/1000 pregnancies, and the risk increases with age, mode of delivery, and presence of co-morbidities. Literature has shown that the use of low molecular weight heparin (LMWH) is safe in this patient cohort. Aims Assessment of the prevalence of VTE risk in hospitalised women in both the antenatal and postnatal groups to determine the proportion of at-risk patients who receive LMWH prophylaxis appropriately. Methods The study period was September 2011 to November 2012. All inpatients in the participating hospitals on the day of investigation were assessed for risk of VTE on the basis of hospital chart review. Risk profile was assessed in accordance with the 2009 Royal College of Obstetricians and Gynaecologist Guidelines. Patients undergoing procedures or on the labour ward at the time of review were excluded. Ethical approval was obtained from the ethics committees governing all centres. Results 610 pregnancies were reviewed across 19 centres. The average age of was 31+/- 5.65yrs (Range 16-47), with 21.87% aged over 35. 22% had a parity of 3 or more. The average weight was 71.51kg (Range 42-134kg, SD 14.482kg). Data on BMI was available for 77% - 34% were overweight and 21% were obese. 1% had a BMI>40. 31% were antenatal and 69% were postnatal. 63% of antenatal patients were low risk (<2 risk factors), 35% were intermediate risk (2 or more risk factors, prophylaxis should be considered) and 2% were high risk. All the high risk patients were on prophylaxis at an appropriate dose. 4% of the low risk patients were on prophylaxis unnecessarily. Only 7% of the intermediate risk patients were on correctly dosed prophylaxis. Among postnatal patients, 41% were low risk (<2 risk factors), 58% were intermediate risk (2 or more risk factors, require prophylaxis) and <1% were high risk. 80% were appropriately risk stratified and put on LMWH if necessary. 59% of patients should have been on LMWH but only 42% were (92% Tinzaparin and 8% Enoxoparin). This included 8 patients who were on LMWH unnecessarily. 38% were on too low a dose. Conclusion VTE prophylaxis remains a central issue in obstetric care given its prominent role in maternal morbidity and mortality and the increasing prevalence of risk factors such as obesity and increasing maternal age. It is clear that while there is good awareness of the risk in the postnatal period, there is less emphasis on risk assessment in antenatal patients where prophylaxis is rarely used. Those on prophylaxis are also likely to be on an incorrect dose. There is a clear role for a national guideline to standardize care for all pregnant women. On the basis of these findings, we have authored a guideline and this is now in use as a reference in all Irish maternity units. Disclosures: No relevant conflicts of interest to declare.

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Incidence, Management and Outcomes of Arterial and Venous Thromboembolism after Chimeric Antigen Receptor Modified T Cells for B-Cell Lymphoma and Multiple Myeloma

Blood ◽

10.1182/blood-2020-136782 ◽

2020 ◽

Vol 136 (Supplement 1) ◽

pp. 7-7

Author(s):

Anna L. Parks ◽

Swetha Kambhampati ◽

Bita Fakhri ◽

Charalambos Andreadis ◽

Lissa Gray ◽

...

Keyword(s):

Risk Factors ◽

Multiple Myeloma ◽

T Cells ◽

Venous Thromboembolism ◽

B Cell ◽

Research Funding ◽

Vte Prophylaxis ◽

Therapeutic Anticoagulation ◽

Car T ◽

History Of

Introduction: Chimeric antigen receptor modified T Cell (CAR-T) therapy is a rapidly developing treatment for patients with relapsed/refractory (R/R) B-cell non-Hodgkin lymphoma (NHL) or multiple myeloma (MM). Although this population is at high risk for thrombosis, there are few data about rates of venous thromboembolism (VTE) and arterial thromboembolism (ATE) with CAR-T. Additionally, treatment with anticoagulation is complicated because of the prevalence of thrombocytopenia following CAR-T. Our goal was to determine the incidence, associated risk factors, management and outcomes of VTE and ATE in the 60 days following CAR-T therapy. Methods: We performed a single-center, retrospective cohort study of all patients who received inpatient CAR-T cells at UCSF Medical Center between January 2018 and May 2020 for R/R NHL or MM as standard-of-care or on a clinical trial. The outcomes of incident VTE and ATE were identified by ICD-10 codes and medical record review. Patient characteristics, pre-existing thrombosis risk factors, laboratory results, medications, and major or clinically relevant non-major bleeding or recurrent thrombotic complications were obtained through chart review. We used descriptive statistics to delineate risk factors, incidence, management and outcomes of thrombotic events. Results: Ninety-one patients who underwent CAR-T therapy were included in the analysis, 37 with NHL and 54 with MM. For NHL, mean age was 63 (range 38-82), and 41% were women. For MM, mean age was 62 (range 33-77), and 50% were women. Patients with NHL were treated with either investigational or Federal Drug Administration-approved CD19-directed therapies, and patients with MM were treated with a variety of investigational B-cell maturation antigen-directed (BCMA) therapies. For thrombotic risk factors, 13% of patients with NHL had a history of VTE, 3% had a history of ATE, 27% had a BMI ≥30, 59% had a recent procedure including central venous catheter (CVC) placement, 14% had an intensive care unit (ICU) stay, and 22% had an infectious complication in the 30 days pre- or post-CAR-T. Forty-one percent of patients with NHL had neurotoxicity of any grade, and 59% had CRS of any grade. At 30 days, 57% had a complete response, 41% had a partial response, 3% had stable disease. For MM, 6% of patients had a pre-existing history of VTE, 2% had a history of ATE, 19% had a BMI ≥30, 96% had a recent procedure, 11% had an ICU stay and 19% had an infection. Seventeen percent had neurotoxicity, and 85% had CRS. Thirty-two percent of patients with NHL and 48% with MM received pharmacologic VTE prophylaxis while undergoing CAR-T. For those who did not receive VTE prophylaxis, thrombocytopenia was the reason for holding prophylaxis, which occurred in 51% and 50% of NHL and MM patients, respectively. In the 60 days post-CAR-T, 4 (11%) patients with NHL were diagnosed with VTE-3 pulmonary embolism (PE) and 1 lower extremity deep vein thrombosis (DVT) associated with a previously placed inferior vena cava filter. Four (7%) patients with MM were diagnosed with VTE-1 PE and 3 upper extremity DVTs associated with CVCs. Five out of these 8 (63%) patients had symptomatic VTE, while the remainder were incidental on PETCT. Mean time from CAR-T infusion to VTE diagnosis was 20 days (range 6-39 days). There were no documented ATEs. Six out of 8 (75%) were treated with therapeutic anticoagulation. Of those who were anticoagulated, 4 patients received direct oral anticoagulants and 2 received low-molecular-weight-heparin. Duration was 3 months in 3 patients, 11 days in 1, 150 days in 1, and indefinitely in 1 with atrial fibrillation. Among all 8 patients with VTE, there were no bleeding events or recurrent thromboses regardless of whether or not they received anticoagulation. Discussion: In this cohort of patients with R/R NHL or MM who received either CD19- or BCMA-directed therapies, almost 1 in 10 developed VTE in the 60 days post-CAR-T. This occurred in the context of a high prevalence of risk factors for thrombosis and low rates of pharmacologic prophylaxis. Among those who developed VTE, the majority were treated with therapeutic anticoagulation for at least 3 months, without documented bleeding or recurrent VTE. Our findings provide crucial information on a common complication that can inform patients, clinicians and researchers and should be expanded upon in larger, prospective studies to identify optimal preventive and therapeutic strategies. Disclosures Fakhri: University of California San Francisco: Current Employment. Andreadis:Jazz Pharmaceuticals: Honoraria; Karyopharm: Honoraria; Incyte: Consultancy; Merck: Research Funding; Gilead/Kite: Consultancy; Novartis: Research Funding; BMS/Celgene/Juno: Honoraria, Research Funding; Genentech: Consultancy, Current equity holder in publicly-traded company. Wong:Janssen: Research Funding; Amgen: Consultancy; Roche: Research Funding; Fortis: Research Funding; Sanofi: Membership on an entity's Board of Directors or advisory committees; Bristol Myers Squibb: Research Funding; GSK: Research Funding. Shah:BMS, Janssen, Bluebird Bio, Sutro Biopharma, Teneobio, Poseida, Nektar: Research Funding; GSK, Amgen, Indapta Therapeutics, Sanofi, BMS, CareDx, Kite, Karyopharm: Consultancy.

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Validation of Postpartum Hemorrhage Admission Risk Factor Stratification in a Large Obstetrics Population

American Journal of Perinatology ◽

10.1055/s-0040-1712166 ◽

2020 ◽

Author(s):

Halley Ruppel ◽

Vincent X. Liu ◽

Neeru R. Gupta ◽

Lauren Soltesz ◽

Gabriel J. Escobar

Keyword(s):

Risk Factors ◽

Risk Assessment ◽

High Risk ◽

Blood Loss ◽

Postpartum Hemorrhage ◽

Risk Group ◽

Risk Groups ◽

Low Risk ◽

Hemorrhage Risk ◽

Present On Admission

Abstract Objective This study aimed to evaluate the performance of the California Maternal Quality Care Collaborative (CMQCC) admission risk criteria for stratifying postpartum hemorrhage risk in a large obstetrics population. Study Design Using detailed electronic health record data, we classified 261,964 delivery hospitalizations from Kaiser Permanente Northern California hospitals between 2010 and 2017 into high-, medium-, and low-risk groups based on CMQCC criteria. We used logistic regression to assess associations between CMQCC risk groups and postpartum hemorrhage using two different postpartum hemorrhage definitions, standard postpartum hemorrhage (blood loss ≥1,000 mL) and severe postpartum hemorrhage (based on transfusion, laboratory, and blood loss data). Among the low-risk group, we also evaluated associations between additional present-on-admission factors and severe postpartum hemorrhage. Results Using the standard definition, postpartum hemorrhage occurred in approximately 5% of hospitalizations (n = 13,479), with a rate of 3.2, 10.5, and 10.2% in the low-, medium-, and high-risk groups. Severe postpartum hemorrhage occurred in 824 hospitalizations (0.3%), with a rate of 0.2, 0.5, and 1.3% in the low-, medium-, and high-risk groups. For either definition, the odds of postpartum hemorrhage were significantly higher in medium- and high-risk groups compared with the low-risk group. Over 40% of postpartum hemorrhages occurred in hospitalizations that were classified as low risk. Among the low-risk group, risk factors including hypertension and diabetes were associated with higher odds of severe postpartum hemorrhage. Conclusion We found that the CMQCC admission risk assessment criteria stratified women by increasing rates of severe postpartum hemorrhage in our sample, which enables early preparation for many postpartum hemorrhages. However, the CMQCC risk factors missed a substantial proportion of postpartum hemorrhages. Efforts to improve postpartum hemorrhage risk assessment using present-on-admission risk factors should consider inclusion of other nonobstetrical factors.

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