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Venous Thromboembolism Prophylaxis in High-Risk General Surgery in Asia

Liew NC, Lee L

World J Surg, 2016 07;40(7):1788-9.
PMID: 26464151 DOI: 10.1007/s00268-015-3273-4
Matched MeSH terms: Venous Thromboembolism/drug therapy*
Fulltext Risk of serious adverse events after the BNT162b2, CoronaVac, and ChAdOx1 vaccines in Malaysia: A self-controlled case series study

Ab Rahman N, Lim MT, Lee FY, Lee SC, Ramli A, Saharudin SN, et al.

Vaccine, 2022 Jul 30;40(32):4394-4402.
PMID: 35667917 DOI: 10.1016/j.vaccine.2022.05.075

BACKGROUND: Rapid deployment of COVID-19 vaccines is challenging for safety surveillance, especially on adverse events of special interest (AESIs) that were not identified during the pre-licensure studies. This study evaluated the risk of hospitalisations for predefined diagnoses among the vaccinated population in Malaysia.
METHODS: Hospital admissions for selected diagnoses between 1 February 2021 and 30 September 2021 were linked to the national COVID-19 immunisation register. We conducted self-controlled case-series study by identifying individuals who received COVID-19 vaccine and diagnosis of thrombocytopenia, venous thromboembolism, myocardial infarction, myocarditis/pericarditis, arrhythmia, stroke, Bell's Palsy, and convulsion/seizure. The incidence of events was assessed in risk period of 21 days postvaccination relative to the control period. We used conditional Poisson regression to calculate the incidence rate ratio (IRR) and 95% confidence interval (CI) with adjustment for calendar period.
RESULTS: There was no increase in the risk for myocarditis/pericarditis, Bell's Palsy, stroke, and myocardial infarction in the 21 days following either dose of BNT162b2, CoronaVac, and ChAdOx1 vaccines. A small increased risk of venous thromboembolism (IRR 1.24; 95% CI 1.02, 1.49), arrhythmia (IRR 1.16, 95% CI 1.07, 1.26), and convulsion/seizure (IRR 1.26; 95% CI 1.07, 1.48) was observed among BNT162b2 recipients. No association between CoronaVac vaccine was found with all events except arrhythmia (IRR 1.15; 95% CI 1.01, 1.30). ChAdOx1 vaccine was associated with an increased risk of thrombocytopenia (IRR 2.67; 95% CI 1.21, 5.89) and venous thromboembolism (IRR 2.22; 95% CI 1.17, 4.21).
CONCLUSION: This study shows acceptable safety profiles of COVID-19 vaccines among recipients of BNT162b2, CoronaVac, and ChAdOx1 vaccines. This information can be used together with effectiveness data for risk-benefit analysis of the vaccination program. Further surveillance with more data is required to assess AESIs following COVID-19 vaccination in short- and long-term.

Matched MeSH terms: Venous Thromboembolism/chemically induced; Venous Thromboembolism/epidemiology
Venous thromboembolism in Asia and worldwide: Emerging insights from GARFIELD-VTE

Angchaisuksiri P, Goto S, Farjat AE, Fryk H, Bang SM, Chiang CE, et al.

Thromb Res, 2021 05;201:63-72.
PMID: 33652328 DOI: 10.1016/j.thromres.2021.02.024

BACKGROUND: Although epidemiological studies report a lower risk of venous thromboembolism (VTE) than in the Western world, VTE rates in Asia may be underestimated. Furthermore, it is uncertain whether VTE outcomes differ in Asia and the rest of the world (ROW).
METHODS: GARFIELD-VTE is a global, prospective, non-interventional study of real-world treatment practices. In this study, we compared baseline characteristics, treatment patterns, and 12-month outcomes in Asia and ROW.
RESULTS: Of the 10,684 enrolled patients, 1822 (17.1%) were Asian (China n = 420, Hong Kong n = 98, Japan n = 148, Malaysia n = 244, South Korea n = 343, Taiwan n = 232, Thailand n = 337). Compared with ROW patients, those from Asia were more often female (57.4% vs. 48.0%), non-smokers (74.0% vs. 58.9%) and had a lower BMI (24.8 kg/m2 vs. 29.1 kg/m2). Asian patients were more likely to be managed in the hospital (86.9% vs. 70.4%) and to have active cancer (19.8% vs. 8.1%) or a history of cancer (19.1% vs. 12.0%). Asian patients received no anticoagulation more frequently than ROW patients (6.5% vs. 2.1%). Over 12-months follow-up, the rate of all-cause mortality (per 100 person-years [95% confidence interval]) was higher in Asians (15.2 [13.4-17.3] vs. 5.9 [5.4-6.5]). Adjusted hazard ratios indicated a higher risk of all-cause mortality in Asian patients than the ROW (1.32 [1.08-1.62]). The frequencies of major bleeding and recurrent VTE were similar.
CONCLUSION: Asian patients have different risk profiles, treatment patterns and a higher risk of mortality compared with the ROW.

Matched MeSH terms: Venous Thromboembolism
Fulltext Low-molecular-weight heparin and mortality in acutely ill medical patients

Kakkar AK, Cimminiello C, Goldhaber SZ, Parakh R, Wang C, Bergmann JF, et al.

N Engl J Med, 2011 Dec 29;365(26):2463-72.
PMID: 22204723 DOI: 10.1056/NEJMoa1111288

BACKGROUND: Although thromboprophylaxis reduces the incidence of venous thromboembolism in acutely ill medical patients, an associated reduction in the rate of death from any cause has not been shown.
METHODS: We conducted a double-blind, placebo-controlled, randomized trial to assess the effect of subcutaneous enoxaparin (40 mg daily) as compared with placebo--both administered for 10±4 days in patients who were wearing elastic stockings with graduated compression--on the rate of death from any cause among hospitalized, acutely ill medical patients at participating sites in China, India, Korea, Malaysia, Mexico, the Philippines, and Tunisia. Inclusion criteria were an age of at least 40 years and hospitalization for acute decompensated heart failure, severe systemic infection with at least one risk factor for venous thromboembolism, or active cancer. The primary efficacy outcome was the rate of death from any cause at 30 days after randomization. The primary safety outcome was the rate of major bleeding during and up to 48 hours after the treatment period.
RESULTS: A total of 8307 patients were randomly assigned to receive enoxaparin plus elastic stockings with graduated compression (4171 patients) or placebo plus elastic stockings with graduated compression (4136 patients) and were included in the intention-to-treat population. The rate of death from any cause at day 30 was 4.9% in the enoxaparin group as compared with 4.8% in the placebo group (risk ratio, 1.0; 95% confidence interval [CI], 0.8 to 1.2; P=0.83). The rate of major bleeding was 0.4% in the enoxaparin group and 0.3% in the placebo group (risk ratio, 1.4; 95% CI, 0.7 to 3.1; P=0.35).
CONCLUSIONS: The use of enoxaparin plus elastic stockings with graduated compression, as compared with elastic stockings with graduated compression alone, was not associated with a reduction in the rate of death from any cause among hospitalized, acutely ill medical patients. (Funded by Sanofi; LIFENOX ClinicalTrials.gov number, NCT00622648.).
Note: Malaysia is a study site: participating investigators: Yaw Chong Hwa (WT Ma), Najihah I, SH How, Abdul Razak AM, Law WC (ST Tie), Bharathan T, Monniaty M, Aris Chandran, Ngau Yen Yew, Aziah AM, Irene Wong, CK Chuah, Rosemi S, KK Sia, Jeyaindran S, CY Leong

Matched MeSH terms: Venous Thromboembolism/prevention & control
Fulltext Inherited Anti-Thrombin Deficiency in A Malay-Malaysian Family: A Missense Mutation at Nucleotide g.13267C>A aka anti-thrombin Budapest 5 (p.Pro439Thr) of the SERPINC 1 gene

Norlelawati AT, Rusmawati I, Naznin M, Nur Nadia O, Rizqan Aizzani R, Noraziana AW

Med J Malaysia, 2014 Feb;69(1):27-30.
PMID: 24814625 MyJurnal

OBJECTIVE: Inherited anti-thrombin deficiency is an autosomal dominant disorder which is associated with increased risk for venous thromboembolism (VTE). This condition is very rare in Malaysia and there has been no documented report. Thus, the aim of the present study is to investigate the type of an inherited anti-thrombin deficiency mutation in a 25-year-old Malay woman who presented with deep vein thrombosis in her first pregnancy.

METHODS: DNA was extracted from the patient's blood sample and buccal mucosal swabs from family members. Polymerase chain reaction(PCR) assays were designed to cover all seven exons of the serpin peptidase inhibitor, clade C (antithrombin), member 1 (SERPINC1) gene; and the products were subjected to DNA sequencing. Sequences were referred to NCBI Reference Sequence: NG_012462.1.

RESULTS: A heterozygous substitution mutation at nucleotide position 13267 (CCT->ACT) was identified in the patient and two other family members, giving a possible change of codon 439 (Pro→Thr) also known as anti-thrombin Budapest 5. The genotype was absent in 90 healthy controls.

CONCLUSION: The study revealed a heterozygous antithrombin Budapest 5 mutation in SERPINC 1 giving rise to a possible anti-thrombin deficiency in a Malay-Malaysian family.

Matched MeSH terms: Venous Thromboembolism
Fulltext New oral anticoagulants for venous thromboembolism (VTE) prophylaxis

Liew NC, Sim KH, Ng SC, Suhail A, Premchandran N

Med J Malaysia, 2011 Aug;66(3):278-80; quiz 281.
PMID: 22111463 MyJurnal

Venous thromboembolism is a rising concern in Asia especially among patients after surgery where this complication is readily preventable. Despite the availability of several treatment options, the acceptance of prophylaxis and usage of these methods remain low. A possible explanation to this behavior is the limitations attached to the available treatment options: narrow therapeutic window of warfarin and parenteral administration of low molecular weight as well as unfractionated heparins. Newer agents have been researched and introduced to overcome these limitations in the hope of improving the adaptation towards post surgical thromboprophylaxis. Dabigatran and rivaroxaban are two such new agents that are promising in view of efficacy and ease of administration.

Matched MeSH terms: Venous Thromboembolism/prevention & control*
Antithrombotic effects of hydroxychloroquine in a pregnant patient with Antiphospholipid syndrome and recurrent venous thromboembolism

Gan SP, Ong SG

Med J Malaysia, 2017 04;72(2):124-125.
PMID: 28473677 MyJurnal

A pregnant woman with antiphospholipid syndrome presented with repeated venous thromboembolism (VTE) in the first and second trimesters of pregnancy despite receiving combination therapy with low-molecular-weight heparin and aspirin. The addition of hydroxychloroquine prevented further VTE recurrence, thus demonstrating its potential antithrombotic effects.

Matched MeSH terms: Venous Thromboembolism/complications*
Reference ranges for D-dimer levels in Malaysian women in the three trimesters of pregnancy

Mohmad Sallih N, Subbiah I, Ali A, Jackson N

Malays J Pathol, 2019 Apr;41(1):7-13.
PMID: 31025632

INTRODUCTION: Plasma D-dimer levels rise progressively during pregnancy, so one cannot apply normal reference ranges, or the usual cut-off value (500ng/mL), for the exclusion of venous thromboembolism (VTE), in pregnant women. This study was carried out in pregnant Malaysian women in order to build applicable reference ranges for D-dimer.
MATERIALS AND METHODS: A cross-sectional study was conducted to measure D-dimer in healthy pregnant women, and a non-pregnant control group, using the quantitative HaemosIL D-dimer HS500 assay. Reference ranges were derived using CLSI 'Robust' methods, and differences between group medians were tested using the Kruskal-Wallis and Mann-Whitney U tests.
RESULTS: Plasma D-dimer levels were measured in 92 pregnant women (distributed across the three trimesters)and 31 control women. The medians (and reference ranges) in ng/mL were: control 265 (<799); first trimester 481 (<1070); second trimester 1073 (357-1748); 3rd trimester 1533 (771-2410). There were significant differences between the D-dimer levels of each group and each of the other groups (P<0.001).
CONCLUSIONS: Reference ranges for D-dimer in pregnant Malaysian women have been establised by this study. Whether these ranges can be used to determine cut-off levels for the exclusion of VTE at different stages of pregnancy is doubtful, as the levels rise continuously through pregnancy, and some very high outlying values occur in apparently normal near-term pregnancy.

Matched MeSH terms: Venous Thromboembolism
Fulltext Long-term hormone therapy for perimenopausal and postmenopausal women

Marjoribanks J, Farquhar C, Roberts H, Lethaby A, Lee J

Cochrane Database Syst Rev, 2017 Jan 17;1(1):CD004143.
PMID: 28093732 DOI: 10.1002/14651858.CD004143.pub5

BACKGROUND: Hormone therapy (HT) is widely provided for control of menopausal symptoms and has been used for the management and prevention of cardiovascular disease, osteoporosis and dementia in older women. This is an updated version of a Cochrane review first published in 2005. OBJECTIVES: To assess effects of long-term HT (at least 1 year's duration) on mortality, cardiovascular outcomes, cancer, gallbladder disease, fracture and cognition in perimenopausal and postmenopausal women during and after cessation of treatment. SEARCH METHODS: We searched the following databases to September 2016: Cochrane Gynaecology and Fertility Group Trials Register, Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase and PsycINFO. We searched the registers of ongoing trials and reference lists provided in previous studies and systematic reviews. SELECTION CRITERIA: We included randomised double-blinded studies of HT versus placebo, taken for at least 1 year by perimenopausal or postmenopausal women. HT included oestrogens, with or without progestogens, via the oral, transdermal, subcutaneous or intranasal route. DATA COLLECTION AND ANALYSIS: Two review authors independently selected studies, assessed risk of bias and extracted data. We calculated risk ratios (RRs) for dichotomous data and mean differences (MDs) for continuous data, along with 95% confidence intervals (CIs). We assessed the quality of the evidence by using GRADE methods. MAIN RESULTS: We included 22 studies involving 43,637 women. We derived nearly 70% of the data from two well-conducted studies (HERS 1998; WHI 1998). Most participants were postmenopausal American women with at least some degree of comorbidity, and mean participant age in most studies was over 60 years. None of the studies focused on perimenopausal women.In relatively healthy postmenopausal women (i.e. generally fit, without overt disease), combined continuous HT increased the risk of a coronary event (after 1 year's use: from 2 per 1000 to between 3 and 7 per 1000), venous thromboembolism (after 1 year's use: from 2 per 1000 to between 4 and 11 per 1000), stroke (after 3 years' use: from 6 per 1000 to between 6 and 12 per 1000), breast cancer (after 5.6 years' use: from 19 per 1000 to between 20 and 30 per 1000), gallbladder disease (after 5.6 years' use: from 27 per 1000 to between 38 and 60 per 1000) and death from lung cancer (after 5.6 years' use plus 2.4 years' additional follow-up: from 5 per 1000 to between 6 and 13 per 1000).Oestrogen-only HT increased the risk of venous thromboembolism (after 1 to 2 years' use: from 2 per 1000 to 2 to 10 per 1000; after 7 years' use: from 16 per 1000 to 16 to 28 per 1000), stroke (after 7 years' use: from 24 per 1000 to between 25 and 40 per 1000) and gallbladder disease (after 7 years' use: from 27 per 1000 to between 38 and 60 per 1000) but reduced the risk of breast cancer (after 7 years' use: from 25 per 1000 to between 15 and 25 per 1000) and clinical fracture (after 7 years' use: from 141 per 1000 to between 92 and 113 per 1000) and did not increase the risk of coronary events at any follow-up time.Women over 65 years of age who were relatively healthy and taking continuous combined HT showed an increase in the incidence of dementia (after 4 years' use: from 9 per 1000 to 11 to 30 per 1000). Among women with cardiovascular disease, use of combined continuous HT significantly increased the risk of venous thromboembolism (at 1 year's use: from 3 per 1000 to between 3 and 29 per 1000). Women taking HT had a significantly decreased incidence of fracture with long-term use.Risk of fracture was the only outcome for which strong evidence showed clinical benefit derived from HT (after 5.6 years' use of combined HT: from 111 per 1000 to between 79 and 96 per 1000; after 7.1 years' use of oestrogen-only HT: from 141 per 1000 to between 92 and 113 per 1000). Researchers found no strong evidence that HT has a clinically meaningful impact on the incidence of colorectal cancer.One trial analysed subgroups of 2839 relatively healthy women 50 to 59 years of age who were taking combined continuous HT and 1637 who were taking oestrogen-only HT versus similar-sized placebo groups. The only significantly increased risk reported was for venous thromboembolism in women taking combined continuous HT: Their absolute risk remained low, at less than 1/500. However, other differences in risk cannot be excluded, as this study was not designed to have the power to detect differences between groups of women within 10 years of menopause.For most studies, risk of bias was low in most domains. The overall quality of evidence for the main comparisons was moderate. The main limitation in the quality of evidence was that only about 30% of women were 50 to 59 years old at baseline, which is the age at which women are most likely to consider HT for vasomotor symptoms. AUTHORS' CONCLUSIONS: Women with intolerable menopausal symptoms may wish to weigh the benefits of symptom relief against the small absolute risk of harm arising from short-term use of low-dose HT, provided they do not have specific contraindications. HT may be unsuitable for some women, including those at increased risk of cardiovascular disease, increased risk of thromboembolic disease (such as those with obesity or a history of venous thrombosis) or increased risk of some types of cancer (such as breast cancer, in women with a uterus). The risk of endometrial cancer among women with a uterus taking oestrogen-only HT is well documented.HT is not indicated for primary or secondary prevention of cardiovascular disease or dementia, nor for prevention of deterioration of cognitive function in postmenopausal women. Although HT is considered effective for the prevention of postmenopausal osteoporosis, it is generally recommended as an option only for women at significant risk for whom non-oestrogen therapies are unsuitable. Data are insufficient for assessment of the risk of long-term HT use in perimenopausal women and in postmenopausal women younger than 50 years of age.

Matched MeSH terms: Venous Thromboembolism/chemically induced
Profile of Patients Diagnosed With Acute Venous Thromboembolism in Routine Clinical Practice: The RE-COVERY DVT/PE™ Study

Goldhaber SZ, Ageno W, Casella IB, Chee KH, Schellong S, Singer DE, et al.

Am J Med, 2020 08;133(8):936-945.
PMID: 32325043 DOI: 10.1016/j.amjmed.2020.03.036

BACKGROUND: The safety and efficacy of nonvitamin K antagonist oral anticoagulants (NOACs) for the treatment of venous thromboembolism (VTE) have been established in randomized controlled trials, but limited data are available on their use in clinical practice across geographical regions.
METHODS: In the international RE-COVERY DVT/PE observational study (enrollment January 2016 to May 2017), we sought to characterize the patient population and describe the prescribed anticoagulant. Patient characteristics and anticoagulants administered after objective diagnosis of VTE were recorded at the baseline visit and again at hospital discharge or at 14 days after the diagnosis, whichever was later.
RESULTS: A total of 6095 patients were included, 50.2% were male, and the mean age was 61.5 years. The most common comorbidities were hypertension (35%), diabetes mellitus (11%), cancer (11%), prior VTE(11%), and trauma/surgery (7%). Overall, 77% of patients received oral anticoagulants, with 54% on NOACs and 23% on vitamin K antagonists (VKAs); 20% received parenteral anticoagulation only. NOACs comprised about 60% of anticoagulant treatment in Europe and Asia but substantially less in Latin America (29%) and the Middle East (21%). For NOAC therapies, the distribution (as a percentage of the total cohort) was rivaroxaban 25.6%, dabigatran 15.5%, apixaban 11.3%, and edoxaban 1.7%. Treatment with NOACs was less frequent in patients who had cancer, chronic renal disease, heart failure, or stroke.
CONCLUSIONS: These findings enhance our understanding of baseline characteristics and the initial management of patients with VTE in routine practice.

Matched MeSH terms: Venous Thromboembolism/drug therapy*; Venous Thromboembolism/epidemiology
Adjustments to warfarin dosing after gastric bypass and sleeve gastrectomy

Strong AT, Sharma G, Nor Hanipah Z, Tu C, Brethauer SA, Schauer PR, et al.

Surg Obes Relat Dis, 2018 05;14(5):700-706.
PMID: 29496441 DOI: 10.1016/j.soard.2017.12.021

BACKGROUND: Warfarin dosing after bariatric surgery may be influenced by alterations in gastrointestinal pH, transit time, absorptive surface area, gut microbiota, food intake, and adipose tissue.
OBJECTIVES: The aim of this study was to describe trends in warfarin dosing after Roux-en-Y gastric bypass (RYGB) and sleeve gastrectomy (SG).
SETTING: Single academic center.
METHODS: All patients chronically on warfarin anticoagulation before RYGB or SG were retrospectively identified. Indications for anticoagulation, history of bleeding or thrombotic events, perioperative complications, and warfarin dosing were collected.
RESULTS: Fifty-three patients (RYGB n = 31, SG n = 22) on chronic warfarin therapy were identified (56.6% female, mean 54.4 ± 11.7 yr of age). Of this cohort, 34.0% had prior venous thromboembolic events, 43.4% had atrial fibrillation, and 5.7% had mechanical cardiac valves. Preoperatively, the average daily dose of warfarin was similar in the RYGB group (8.3 ± 4.1 mg) and SG group (6.9 ± 2.8 mg). One month after surgery, mean daily dose of warfarin was reduced 24.1% in the RYGB group (P

Matched MeSH terms: Venous Thromboembolism/complications
Profile of Patients with Isolated Distal Deep Vein Thrombosis versus Proximal Deep Vein Thrombosis or Pulmonary Embolism: RE-COVERY DVT/PE Study

Schellong S, Ageno W, Casella IB, Chee KH, Schulman S, Singer DE, et al.

Semin Thromb Hemost, 2021 May 10.
PMID: 33971682 DOI: 10.1055/s-0041-1729169

Isolated distal deep vein thrombosis (IDDVT) is presumed to be more benign than proximal DVT (PDVT) or pulmonary embolism (PE), suggesting a need for different management approaches. This subgroup analysis of the RE-COVERY DVT/PE global, observational study investigated patient characteristics, hospitalization details, and anticoagulant therapy in patients with IDDVT in real-world settings in 34 countries enrolled from January 2016 to May 2017. Data were analyzed descriptively according to the type and location of the index venous thromboembolism (VTE): IDDVT, PDVT ± distal DVT (DDVT), and PE ± DVT. Of the 6,095 eligible patients, 323 with DVT located outside the lower limb and no PE were excluded. Of the remaining 5,772 patients, 17.6% had IDDVT, 39.9% had PDVT ± DDVT, and 42.5% had PE ± DVT. IDDVT patients were younger and had fewer risk factors for VTE than the other groups. Other comorbidities were less frequent in the IDDVT group, except for varicose veins, superficial thrombophlebitis, and venous insufficiency. IDDVT patients were less likely to be diagnosed in an emergency department (22.3 vs. 29.7% for PDVT ± DDVT and 45.4% for PE ± DVT) or hospitalized for VTE (29.2 vs. 48.5% for PDVT ± DDVT and 75.0% for PE ± DVT). At hospital discharge or 14 days after diagnosis (whichever was later), non-vitamin K antagonist oral anticoagulants were the most commonly used anticoagulants (55.6% for IDDVT, 54.7% for PDVT ± DDVT, and 52.8% for PE ± DVT). Although differences in patient characteristics, risk factors, and clinical management were identified, anticoagulant treatment of IDDVT was almost equal to that of PDVT or PE. Prospective studies should investigate whether, in a global perspective, this is an appropriate use of anticoagulants. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov NCT02596230.

Matched MeSH terms: Venous Thromboembolism
Fulltext The use of antiplatelet agents for arterial thromboprophylaxis in COVID-19

Kow CS, Hasan SS

Rev Esp Cardiol (Engl Ed), 2021 01;74(1):114-115.
PMID: 32933883 DOI: 10.1016/j.rec.2020.08.009
Matched MeSH terms: Venous Thromboembolism/blood; Venous Thromboembolism/etiology; Venous Thromboembolism/prevention & control*
Fulltext Venous thromboembolism prevention protocol for adapting prophylaxis recommendations to the potential risk post total knee replacement: a randomized controlled trial

Alameri MA, Syed Sulaiman SA, Ashour AM, Al-Saati MF

Pharm Pract (Granada), 2020 09 22;18(3):2025.
PMID: 33029262 DOI: 10.18549/PharmPract.2020.3.2025

Background: Total knee replacement (TKR) is a major orthopedic surgery that is considered high risk for the development of venous thromboembolism (VTE).
Objective: The aim of this study is to evaluate the clinical outcomes that resulted from the use of a new proposed VTE risk stratification protocol for selecting a suitable extended VTE prophylaxis for post TKR surgery patients administered in conjunction with patient education programs.
Method: A randomized controlled trial was conducted in two medical centers in Saudi Arabia. A total of 242 patients were enrolled in the study, 121 patients in each group. The experimental group (A) was assessed by using the proposed VTE risk stratification protocol and also took part in patient education programs about TKR and its complications. The control group (B) was assessed by using the 2005 Caprini risk assessment tool and no education programs were given to this group. Both groups were followed for 35 days post operation.
Results: The mean age of the participants was 65.86 (SD 8.67) and the majority of them were female 137 (56.6%). The mean body mass index of the study sample was 32.46 (SD 5.51). There were no significant differences between the two groups except for surgery type; the proportion of bilateral TKR in group A was higher than in group B (69/121 (28.5%) vs. 40/121(16.5%), p<0.05). There were no confirmed pulmonary embolism cases in the study sample and diagnosis of deep-vein thrombosis was confirmed in 12/242 (5.0%) of patients: 1/121 (0.8%) in group A and 11/121 (9.1%) in group B (p<0.05). The readmission rate for all patients was 2.5% (6/242), all of whom were in group B (p<0.05).
Conclusion: The proposed VTE risk stratification protocol that was applied in conjunction with patient education programs reduced VTE complications and readmission events, post TKR surgery. Trial Registration: ClinicalTrials.gov: Identifier: NCT04031859.

Matched MeSH terms: Venous Thromboembolism
Fulltext Comparing quality of life and treatment satisfaction between patients on warfarin and direct oral anticoagulants: a cross-sectional study

Ng DL, Gan GG, Chai CS, Chee KH, Tan KL, Tan SB, et al.

Patient Prefer Adherence, 2019;13:1363-1373.
PMID: 31616136 DOI: 10.2147/PPA.S204246

Introduction and aim: Patient quality of life (QOL) while on long-term oral anticoagulant therapy has been receiving greater attention in recent years due to the increase in life expectancy brought about by advances in medical care. This study aimed to compare the QOL, treatment satisfaction, hospitalization and bleeding rate in patients on long-term warfarin versus direct oral anticoagulants (DOAC).
Methods: This was a cross-sectional study of patients with non-valvular atrial fibrillation (NVAF) or venous thromboembolism (VTE) on long-term anticoagulant therapy attending the cardiology clinic and anticoagulation clinic of the University Malaya Medical Centre from July 1, 2016, to June 30, 2018. Patient QOL was assessed by using the Short Form 12 Health Survey (SF12), while treatment satisfaction was assessed by using the Perception of Anticoagulation Treatment Questionnaire 2 (PACT-Q2).
Results: A total of 208 patients were recruited; 52.4% received warfarin and 47.6% received DOAC. There was no significant difference in QOL between warfarin and DOAC based on SF12 (physical QOL, P=0.083; mental QOL, P=0.665). Nevertheless, patients in the DOAC group were significantly more satisfied with their treatment compared to the warfarin group based on PACT-Q2 (P=0.004). The hospitalisation rate was significantly higher in the warfarin group than the DOAC group (15.6% versus 3.0%, P=0.002). Clinically relevant minor bleeds and severe bleeding events were non-significantly higher in the warfarin group than the DOAC group (66.7% versus 40.0%, P=0.069).
Conclusion: Compared to warfarin, treatment of NVAF and VTE with DOAC showed comparable QOL, higher treatment satisfaction, lesser hospitalization, and a non-significant trend toward fewer bleeding episodes.

Matched MeSH terms: Venous Thromboembolism
Bariatric Surgery in Patients on Chronic Anticoagulation Therapy

Sharma G, Hanipah ZN, Aminian A, Punchai S, Bucak E, Schauer PR, et al.

Obes Surg, 2018 08;28(8):2225-2232.
PMID: 29455405 DOI: 10.1007/s11695-018-3120-4

BACKGROUND: Perioperative management of chronically anti-coagulated patients undergoing bariatric surgery requires a balance of managing hemorrhagic and thromboembolic risks. The aim of this study is to evaluate the incidence of hemorrhagic complications and their management in chronically anticoagulated (CAT) patients undergoing bariatric surgery.
METHODS: A retrospective review of CAT patients undergoing bariatric surgery at an academic center from 2008 to 2015 was studied.
RESULTS: A total of 153 patients on CAT underwent surgery [Roux-en-Y gastric bypass (n = 79), sleeve gastrectomy (n = 63), and adjustable gastric banding (n = 11)] during the study period: 85 patients (55%) were females; median age was 56 years (interquartile range [IQR] 49-64), and median BMI was 49 kg/m2 (IQR 43-56). The most common indications for CAT were venous thromboembolism (n = 87) and atrial fibrillation (n = 83). Median duration of procedure and estimated intraoperative blood loss was 150 min (IQR 118-177) and 50 ml (IQR 25-75), respectively. Thirty-day postoperative complications were reported in 33 patients (21.6%) including postoperative bleeding (n = 19), anastomotic leak (n = 3), and pulmonary embolism (n = 1). Nineteen patients (12%) with early postoperative bleeding were further categorized to intra-abdominal (n = 10), intraluminal (n = 6), and at the port site or abdominal wall (n = 3). All-cause readmissions within 30 days of surgery occurred in 19 patients (12%). There was no 30-day mortality.
CONCLUSION: In our experience, patients who require chronic anticoagulation medication are higher than average risk for postoperative complications and all-cause readmission rates. Careful surgical technique and close attention to postoperative anticoagulation protocols are essential to decrease perioperative risk in this high-risk cohort.

Matched MeSH terms: Venous Thromboembolism/etiology
Fulltext COVID-19 as a viral functional ACE2 deficiency disorder with ACE2 related multi-organ disease

Gan R, Rosoman NP, Henshaw DJE, Noble EP, Georgius P, Sommerfeld N

Med Hypotheses, 2020 Nov;144:110024.
PMID: 32758871 DOI: 10.1016/j.mehy.2020.110024

SARS-CoV-2, the agent of COVID-19, shares a lineage with SARS-CoV-1, and a common fatal pulmonary profile but with striking differences in presentation, clinical course, and response to treatment. In contrast to SARS-CoV-1 (SARS), COVID-19 has presented as an often bi-phasic, multi-organ pathology, with a proclivity for severe disease in the elderly and those with hypertension, diabetes and cardiovascular disease. Whilst death is usually related to respiratory collapse, autopsy reveals multi-organ pathology. Chronic pulmonary disease is underrepresented in the group with severe COVID-19. A commonality of aberrant renin angiotensin system (RAS) is suggested in the at-risk group. The identification of angiotensin-converting-enzyme 2 (ACE2) as the receptor allowing viral entry to cells precipitated our interest in the role of ACE2 in COVID-19 pathogenesis. We propose that COVID-19 is a viral multisystem disease, with dominant vascular pathology, mediated by global reduction in ACE2 function, pronounced in disease conditions with RAS bias toward angiotensin-converting-enzyme (ACE) over ACE2. It is further complicated by organ specific pathology related to loss of ACE2 expressing cells particularly affecting the endothelium, alveolus, glomerulus and cardiac microvasculature. The possible upregulation in ACE2 receptor expression may predispose individuals with aberrant RAS status to higher viral load on infection and relatively more cell loss. Relative ACE2 deficiency leads to enhanced and protracted tissue, and vessel exposure to angiotensin II, characterised by vasoconstriction, enhanced thrombosis, cell proliferation and recruitment, increased tissue permeability, and cytokine production (including IL-6) resulting in inflammation. Additionally, there is a profound loss of the "protective" angiotensin (1-7), a vasodilator with anti-inflammatory, anti-thrombotic, antiproliferative, antifibrotic, anti-arrhythmic, and antioxidant activity. Our model predicts global vascular insult related to direct endothelial cell damage, vasoconstriction and thrombosis with a disease specific cytokine profile related to angiotensin II rather than "cytokine storm". Our proposed mechanism of lung injury provides an explanation for early hypoxia without reduction in lung compliance and suggests a need for revision of treatment protocols to address vasoconstriction, thromboprophylaxis, and to minimize additional small airways and alveolar trauma via ventilation choice. Our model predicts long term sequelae of scarring/fibrosis in vessels, lungs, renal and cardiac tissue with protracted illness in at-risk individuals. It is hoped that our model stimulates review of current diagnostic and therapeutic intervention protocols, particularly with respect to early anticoagulation, vasodilatation and revision of ventilatory support choices.

Matched MeSH terms: Venous Thromboembolism/complications
Fulltext An older woman with pain and swelling of left leg

Das Gupta E

Malays Fam Physician, 2010;5(1):47-8.
PMID: 25606188
Matched MeSH terms: Venous Thromboembolism
Fulltext Venous thromboembolism in critically ill COVID-19 patients receiving prophylactic or therapeutic anticoagulation: a systematic review and meta-analysis

Hasan SS, Radford S, Kow CS, Zaidi STR

J Thromb Thrombolysis, 2020 Nov;50(4):814-821.
PMID: 32748122 DOI: 10.1007/s11239-020-02235-z

Many aspects of care such as management of hypercoagulable state in COVID-19 patients, especially those admitted to intensive care units is challenging in the rapidly evolving pandemic of novel coronavirus disease 2019 (COVID-19). We seek to systematically review the available evidence regarding the anticoagulation approach to prevent venous thromboembolism (VTE) among COVID-19 patients admitted to intensive care units. Electronic databases were searched for studies reporting venous thromboembolic events in patients admitted to the intensive care unit receiving any type of anticoagulation (prophylactic or therapeutic). The pooled prevalence (and 95% confidence interval [CI]) of VTE among patients receiving anticoagulant were calculated using the random-effects model. Subgroup pooled analyses were performed with studies reported prophylactic anticoagulation alone and with studies reported mixed prophylactic and therapeutic anticoagulation. We included twelve studies (8 Europe; 2 UK; 1 each from the US and China) in our systematic review and meta-analysis. All studies utilized LMWH or unfractionated heparin as their pharmacologic thromboprophylaxis, either prophylactic doses or therapeutic doses. Seven studies reported on the proportion of patients with the previous history of VTE (range 0-10%). The pooled prevalence of VTE among ICU patients receiving prophylactic or therapeutic anticoagulation across all studies was 31% (95% CI 20-43%). Subgroup pooled analysis limited to studies reported prophylactic anticoagulation alone and mixed (therapeutic and prophylactic anticoagulation) reported pooled prevalences of VTE of 38% (95% CI 10-70%) and 27% (95% CI 17-40%) respectively. With a high prevalence of thromboprophylaxis failure among COVID-19 patients admitted to intensive care units, individualised rather than protocolised VTE thromboprophylaxis would appear prudent at interim.

Matched MeSH terms: Venous Thromboembolism/blood; Venous Thromboembolism/epidemiology; Venous Thromboembolism/prevention & control*; Venous Thromboembolism/virology
A cost-utility analysis of dabigatran, enoxaparin, and usual care for venous thromboprophylaxis after hip or knee replacement surgery in Thailand

Kotirum S, Chongmelaxme B, Chaiyakunapruk N

J Thromb Thrombolysis, 2017 Feb;43(2):252-262.
PMID: 27704332 DOI: 10.1007/s11239-016-1433-5

To analyze the cost-utility of oral dabigatran etexilate, enoxaparin sodium injection, and no intervention for venous thromboembolism (VTE) prophylaxis after total hip or knee replacement (THR/TKR) surgery among Thai patients. A cost-utility analysis using a decision tree model was conducted using societal and healthcare payers' perspectives to simulate relevant costs and health outcomes covering a 3-month time horizon. Costs were adjusted to year 2014. The willingness-to-pay threshold of THB 160,000 (USD 4926) was used. One-way sensitivity and probabilistic sensitivity analyses using a Monte Carlo simulation were performed. Compared with no VTE prophylaxis, dabigatran and enoxaparin after THR and TKR surgery incurred higher costs and increased quality adjusted life years (QALYs). However, their incremental cost-effectiveness ratios were high above the willingness to pay. Compared with enoxaparin, dabigatran for THR/TKR lowered VTE complications but increased bleeding cases; dabigatran was cost-saving by reducing the costs [by THB 3809.96 (USD 117.30) for THR] and producing more QALYs gained (by 0.00013 for THR). Dabigatran (vs. enoxaparin) had a 98 % likelihood of being cost effective. Dabigatran is cost-saving compared to enoxaparin for VTE prophylaxis after THR or TKR under the Thai context. However, both medications are not cost-effective compared to no thromboprophylaxis.

Matched MeSH terms: Venous Thromboembolism/economics; Venous Thromboembolism/prevention & control*

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