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ORIGINAL ARTICLE
Year : 2023 | Volume
: 22
| Issue : 4 | Page : 415-419
Clinical profile, risk factors, and clinical outcomes in patients of venous thromboembolism at a tertiary care center
MA Khan1, Mohammed Mahaboob Pasha1, MN Arjun2, Narayanan Subramanian3
1 Department of Medicine, Command Hospital Air Force, Bengaluru, Karnataka, India
2 Department of Medicine and Rheumatology, Command Hospital Air Force, Bengaluru, Karnataka, India
3 Department of Respiratory Medicine, Command Hospital Air Force, Bengaluru, Karnataka, India
Correspondence Address:
Mohammed Mahaboob Pasha
Department of Medicine, Command Hospital Air Force, Bengaluru - 560 007, Karnataka
India
Source of Support: None, Conflict of Interest: None
CheckDOI: 10.4103/aam.aam_123_22
Abstract
Background: Venous thromboembolism (VTE) commonly presents as either deep-vein thrombosis (DVT) or pulmonary embolism (PE). Despite rapid advances in its diagnostic and therapeutic modalities, it still leads to significant morbidity and mortality. Objectives: Our study predominantly aims at studying the clinical profile, risk factors, and the clinical outcomes in VTE patients presenting to a single tertiary care center to rapidly detect the disease and use appropriate thrombo-prophylaxis. Materials and Methods: This was an prospective observational study involving 40 patients of confirmed cases of VTE who presented to this tertiary care hospital during a period from June 2017 to May 2019. Data collected included the age, sex, clinical presentation, risk factors, diagnostic modalities, and their clinical outcomes. Descriptive analysis was carried out by mean and standard deviation for quantitative variables; frequency and proportion for the categorical variables. Results: Among the study groups, 30 (74%) had DVT, 4 (11%) had PE, and 6 (15%) had both. Major risk factors detected included smoking history (44%), recent surgery (15%), malignancy (11%), history of immobility (10%), and past history of DVT (15%). The clinical presentation mainly included leg pain (62%) and leg swelling (87%).The outcomes were predominantly re-canalization (31%), recurrent DVT (21%), recurrent PE (1%), chronic DVT (27%), chronic venous insufficiency (36%), chronic venous ulcer (7%), pulmonary hypertension (16%), and death (5%). In our study population, the most common pro-thrombotic state was found to be hyperhomocysteinemia. Conclusions: In our study of VTE patients, we have highlighted the possible risk factors, clinical presentation, and clinical outcomes to identify the disease early and help us initiate appropriate thromboprophylaxis to reduce morbidity.
Résumé
Contexte: Thromboembolie veineuse (TEV) se présente généralement comme une thrombose veineuse profonde (TVP) ou embolie pulmonaire (PE). Malgré les progrès rapides de ses modalités diagnostiques et thérapeutiques, il entraîne toujours une morbidité et une mortalité importantes. Objectifs: Notre étude vise principalement à étudier le profil clinique, les facteurs de risque et les résultats cliniques chez les patients TEV se présentant dans un seul centre de soins tertiaires.afin de détecter rapidement la maladie et d'utiliser une thrombo-prophylaxie appropriée. Matériels et méthodes: Il s'agissaitun descriptifd'observationétude impliquant40 patients de cas confirmés de TEV qui se sont présentés àHôpital de commandement de l'armée de l'air de Bangalorependant une période allant de juin 2017 à mai 2019. Les données recueillies comprenaient l'âge, le sexe, la présentation clinique, les facteurs de risque, les modalités de diagnostic et leurs résultats cliniques.L'analyse descriptive a été effectuée par moyenne et écart-type pour les variables quantitatives;fréquence et proportion pour les variables catégorielles. Résultats: Parmi le groupe d'étude30 (74 %) avaient une TVP,4(11 %) avaient une EP et 6 (15 %) avaient les deux. R majeurles facteurs de risque détectés comprenaient les antécédents de tabagisme(44 %), chirurgie récente (15 %), malignité (11 %), antécédents d'immobilité (10 %) et antécédents de TVP (15 %). La présentation clinique comprenait des douleurs aux jambes (62 %) et un gonflement des jambes (87 %). Les critères de jugement étaient principalement la recanalisation (31 %), la TVP récurrente (21 %), l'EP récurrente (1 %), la TVP chronique (27 %) , insuffisance veineuse chronique (36 %), ulcère veineux chronique (7 %), hypertension pulmonaire (16 %) et décès (5 %). Dans notre population d'étude, l'état pro-thrombotique le plus courant était l'hyper-homocystéinémie. Conclusions: Dans notre étude sur les patients atteints de TEV, nous avons mis en évidence les facteurs de risque possibles, la présentation clinique et les résultats cliniques afin d'identifier la maladie de manière précoce et de nous aider à initier une thrombo-prophylaxie appropriée pour réduire la morbidité.
Mots-clés: Thromboembolie veineuse, Profil clinique, Facteurs de risque, Résultats cliniques
Keywords: Clinical outcomes, clinical profile, risk factors, venous thromboembolism
Introduction 
Thrombosis is defined as the formation of a blood clot inside the blood vessel, which obstructs the blood flow through the circulatory system. The most common presentations of venous thrombosis include deep-vein thrombosis (DVT) of the lower extremity and pulmonary embolism (PE). A major theory delineating the pathogenesis of venous thromboembolism (VTE), often called Virchow's triad,[1],[2] proposes that VTE occurs as a result of:
Alterations in blood flow (i.e., stasis)Vascular endothelial injuryAlterations in the constituents of the blood (i.e., inherited or acquired hypercoagulable state).A risk factor for thrombosis can now be identified in over 80% of patients with venous thrombosis. The causes of venous thrombosis can be divided into two groups: hereditary and acquired and are often multiple in a given patient.[3],[4] The common inherited risk factors include Factor V Leiden mutation, prothrombin gene mutation, Protein C and S deficiency, antithrombin deficiency, and rarely dysfibrinogenemia.[5],[6] Acquired risk factors or predisposing conditions for thrombosis include a prior thrombotic event, recent major surgery, presence of a central venous catheter, trauma, immobilization, malignancy, chemotherapy, pregnancy, the use of oral contraceptives, myeloproliferative disorders, antiphospholipid syndrome (APS), nephrotic syndrome, renal transplant, obesity, smoking, and inflammatory bowel disease. Hyperhomocytenemia can be both inherited and acquired prothrombotic state.
DVT is a condition in which a blood clot forms in the deep veins of the leg, groin or arm whereas PE takes place when a DVT clot breaks free from the vein and reaches the lungs blocking the blood supply. DVT is potentially asymptomatic and shows symptoms such as leg pain, swelling, and complications occur only in severe cases. The postphlebitic syndrome, PE, venous ulcers, and death are the complications involved in DVT. The common symptoms in PE include severe dyspnea, chest pain, and hypotension. PE has a high mortality rate when compared with DVT.
Need for the study
In many of the published studies, there is a lacunae regarding the identification of risk factors associated with VTE and proper utilization of thromboprophylaxis. Patient characteristics and treatment modalities which may lead to high risk in developing the chances of recurrent VTE are not highlightened in studies. The main objective of the present study is to analyze the profile of VTE patients in a tertiary care hospital and to identify the risk factors of VTE along with the clinical outcomes. Through the proper identification of risk factors, utilization of thromboprophylaxis can be carried out in patients at high risk, thereby mortality and morbidity can be reduced in patients with VET.
Materials and Methods This was a prospective observational study involving 40 inpatients of confirmed cases of VTE, both male and female patients above the age of 18 years, who presented to the department of medicine of a single tertiary care hospital during a period from June 2017 to May 2019. The patients were followed up for 1 year for clinical outcomes. The sample size was calculated assuming the proportion of VTE as 19% as per the study by Heit.[7] Study was approved by the institutional human ethics committee. Informed written consent was obtained from all the study participants before enrolment.
After clearance from the ethical committee, various clinical, laboratory, and radiological parameters of the study population were collected and compiled. An observational analysis of different risk factors (immobility, malignancy, surgery, pregnancy, etc.) and outcomes (pulmonary hypertention, postphlebitic syndrome, recurrent DVT, death, etc.) were carried out. Descriptive analysis was carried out by mean and standard deviation for quantitative variables; frequency and proportion for categorical variables. IBM SPSS Statistics for Windows, Version 22.0, Armonk, NY,USA:IBM Corp was used for the statistical analysis.[8]
Approach to diagnosis and management of VTE patients was as per the following flowchart [Figure 1]. Wells score[9] was used in predicting PE [Figure 2] and DVT [Figure 3].
Figure 1: Approach to a suspected case of VTE. VTE = Venous thromboembolism Results Out of the total 40 patients enrolled in the study, the mean age was 48.59 ± 17.01 years in the study population, the minimum was 22 and the maximum was 78 years. 26 (64%) were male and 14 (36%) were female in our study group. Descriptive analysis of risk factors in the study population was as depicted below [Table 1]. VTE is a great masquerader and its various clinical presentations are depicted in [Table 2].
Among the diagnostic modalities, 11 (28%) had tachycardia, 37 (94%) elevated D-Dimer, 9 (21%) had elevated BNP, 30 (77%) evidence of Deep Vein Thrombosis (DVT) in color Doppler flow imaging (CDFI), 7 (18%) had cardiac chamber/valvular abnormality in 2D echo, and 10 (26%) had evidence of pulmonary venous cutoff in computed tomography pulmonary angiography. Descriptive analysis of diagnosis of the study population revealed that 30 (74%) had DVT, 5 (11%) had PE, and 6 (15%) had both. Descriptive analysis of clinical outcome and complications is depicted in [Table 3].
Procoagulant workup for inherited causes revealed that 7 (16%) had hyperhomocysteinemia, 2 (4%) had APLA syndrome, 1 (2%) had MTHFR mutation, 1 (2%) had Protein C deficiency, 2 (4%) had Factor V Leiden mutation, 1 (2%) had hyperhomocysteinemia + MTHFR mutation, 1 (2%) had Protein C deficiency + Protein S deficiency, and 1 (2%) had raised Beta 2 Microglobulin + Hyperhomocysteinemia + MTHFR mutation. Management analysis depicted 33 (82%) were managed with low-molecular-weight heparin (LMWH)+WARFARIN followed by WARFARIN, 3 (6%) with LMWH, 1 (2%) with only newer oral anti-coagulants, and 3 (7%) with LMWH followed by novel oral anticoagulants (NOAC) treatment. Three patients were managed with surgical removal of clot, one received temporary inferior vena cava (IVC) filter, and two patients were thrombolysed with reteplace.
Discussion VTE is one of the most common vascular diseases associated with high morbidity rate,[10] which is an acute event complicating 2–3/1000 hospital admissions followed by principal diagnosis. The risk factors associated with VTE can be acquired or hereditary.[3],[4] Acquired factors include fracture in the leg or hip, replacement of knees, recent history of major surgery, trauma, cancer, oral contraceptive therapy whereas the inherited factors may include deficiency of natural coagulant factor, lack of anticoagulant pathway, and high level of factor III. The current study examined the profile of VTE, its risk factors and clinical outcomes among patients admitted to a tertiary care.
For our study, we chose a study population with a mean age of 48.59 ± 17.01 ranging from 22 to 78 years. A total of 40 subjects were included in the study, 64% of them being male and 36% female. Khalafallah, et al.,[11] had almost equal proportions of gender in their study population with 50.5% male and 49.5% female with the mean age of patients being 68 years. In contrast, Gangireddy, et al.,[12] had a predominantly male population in their study group with a whopping 99.6% males with a mean age of 65 years.
The risk factors for VTE in the study population included smoking habit among 44% of the study group, 4% had a history of chemotherapy, 11% were with malignancy, 3% were pregnant, 10% had a history of immobility, and 8% had a history of ongoing surgery. A study by Koonarat, et al.[13] revealed the following risk factors, 2.4% were with prolonged immobilization, 1.2% were with a history of prior surgery, and 3.5% with a history of chemotherapy.
The main clinical symptoms were leg pain (62%) and leg swelling (87%). The other presentations were acute breathlessness (28%), chest pain (12%), syncope (2%), hematemesis/hemoptysis (1%), tachycardia (28%), cyanosis (2%), hypotension (11%), and acute infarct (1%). The results obtained showed that major comorbidities among the study population included 10% with hypertension (HTN), 1% with HTN + diabetes mellitus (DM), and 2% with HTN + DM + hypothyroidism. Among the study population, 25% had tachycardia, 94% had elevated D-Dimer, 21% had elevated BNP, 77% had evidence of DVT in CDFI, 18% had evidence of cardiac chamber/valvular abnormality in 2D Echo, and 26% had evidence of pulmonary venous cut off in CTPA. Majority of our study population (74%) were diagnosed with DVT, 11% with PE and 15% with DVT + PE. On follow-up of these patients, the following outcomes were noticed complete/partial re-canalization (30%/31%), recurrent DVT (20%), recurrent PE (2%), chronic DVT (27%), chronic venous insufficiency (36%), chronic venous ulcer (7%), and pulmonary HTN (16%) and death (5%).
In comparison, the incidence of mortality caused by VTE was estimated to be 0.3% in a study by Li, et al.[14]
In Lee et al.,[15] study group of patients with upper extremity DVT, 16% had concomitant LE DVT, and 9% had concurrent PE and 6.4% died. Bleeding being one of the major complications of VTE while on anticoagulant therapy, Nieto, et al.[16] found 2.3% had major bleeding, 5.9% patients re-bled, 4.9% had recurrent VTE and 33% died. In Mahan et al.[17] study of VTE patients, re-hospitalization and mortality rates were 17.2% and 6.2%, respectively.
Increased homocysteine levels have toxic effects on the vascular structure.[18] In our study, the most common prothrombotic state was found to be hyperhomocysteinemia (16%), 81.25% of them had DVT, 6.25% had PE, and 12.5% had DVT + PE. In their study, Ekim et al.[19] concluded that hyperhomocysteinemia in women older than 40 years may be a risk factor for DVT. Patients with the APS in our study population were all diagnosed with DVT. Several studies have determined that the frequency of APS in patients presenting with a venous thromboembolic event is between 4% and 14%.[20] Among patients with Factor V Leiden mutation, 75% had DVT and 25% had DVT + PE. The most commonly inherited thrombophilia is Factor V Leiden, which accounts for approximately 30% of cases of VTE.[21] Among the study population, 82% were managed with LMWH + WARFARIN followed by WARFARIN, 6% were given only LMWH treatment, 2% were given only NOAC treatment, and 7% were given LMWH followed by NOAC treatment. This is in accordance with the guidelines for VTE treatment prescribed by Kearon, et al.[22] Apart from anticoagulation, 3% were managed with surgery, 1% with temporary IVC filter placement, 1% was thrombolysed with RTPA therapy, and 1% was thrombolysed with Streptokinase.
Conclusions VTE is one of the most common vascular diseases and associated with a high morbidity rate. It is a multifactorial disease with both environmental and genetic risk factors. In the present study, 81.25%were diagnosed with DVT, 6.25% were diagnosed with PE, and 12.5% were diagnosed with DVT + PE. Smoking and history of past VTE were the main risk factors detected. The main clinical symptoms were leg pain and leg swelling. Hyperhomocystenemia was the most common procoagulant state detected. Major clinical outcomes on follow-up were chronic venous insufficiency and complete or partial re-canalization of the affected veins.
Early detection of the risk factors and clinical settings in case of VTE helps in the early initiation of appropriate thromboprophylaxis measures and thereby prevent the morbidity and mortality attributable to VTE.
Ethical clearance
The study was approved by the Institutional Ethical Committee.
Acknowledgments
We are indebted to the patients who participated in the study. We are also grateful to the Dept of Radiology, Pathology and the Statistician at Command Hospital Air Force Bangalore, India.
Financial support and sponsorship
Nil.
Conflicts of interest
There are no conflicts of interest.
References 
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