Lower extremity deep vein thrombosis (DVT) is a serious medical condition that can lead to life-threatening complications, including pulmonary embolism or long-term disability from post-thrombotic syndrome.¹ Accurate diagnosis of deep vein thrombosis (DVT) is crucial for minimizing the risk of thromboembolic complications and preventing unnecessary exposure of patients without thrombosis to the risks associated with anticoagulant therapy.² Various risk factors predispose individuals to deep vein thrombosis (DVT), including trauma, cancer, and genetic mutations that promote blood hypercoagulability. Venous thrombosis can also develop in people after major surgery, especially when it leads to prolonged periods of immobility.³ Clinical examination and patient history alone are not reliable for diagnosing deep vein thrombosis (DVT). Therefore, highly sensitive and specific diagnostic tests are necessary to ensure accurate diagnosis.⁴ Laboratory testing with D-dimer has a sensitivity exceeding 90% but a specificity of approximately 50%, making it useful for excluding but not confirming deep vein thrombosis (DVT)⁵. The imaging gold standard for DVT diagnosis is contrast venography⁶; however, due to its invasive nature, it is less frequently performed today. The current imaging modality of choice for detecting DVT is venous ultrasonography, a non-invasive method that does not involve ionizing radiation or the administration of radiographic contrast media⁷. While the sensitivity and specificity of venous ultrasonography can vary between studies, it generally has a high discrimination power, especially for DVT in the proximal veins.⁸ The goal of therapy for lower-extremity deep vein thrombosis (DVT) is to prevent thrombus extension and pulmonary embolism in the short term, while also reducing the risk of recurrent events in the long term.⁹ Although anticoagulation therapy is the primary treatment for deep vein thrombosis (DVT), thrombolysis and placement of an inferior vena cava filter are two additional interventions that warrant consideration.⁹ The recently published 9th American College of Chest Physicians/ISTH guidelines recommend the routine use of various new oral anticoagulant drugs, including dabigatran and rivaroxaban, for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE).¹⁰ Although not commonly utilized, thrombolysis and inferior vena cava (IVC) filters have been proposed as adjunctive treatments to anticoagulation⁴. Catheter-directed thrombolysis (CDT) and pharmaco-mechanical catheter-directed thrombolysis (PCDT) are minimally invasive endovascular procedures designed to restore vessel patency in the acute phase of thrombotic illness.¹¹

AIM:

To study risk factors, clinic-radiological evaluation, management, and outcome of lower extremity deep vein thrombosis.

OBJECTIVE:

1. To study risk factors for lower extremity deep vein thrombosis
2. To evaluate the clinic-radiological diagnosis of lower extremity deep vein thrombosis
3. To assess the outcome (morbidity/mortality) of lower extremity deep vein thrombosis

Study design: Retrospective observational study

Study site: SVIMS, SPMC (W), Tirupati.

Sample size: Patients diagnosed with lower extremity deep vein thrombosis and a total of 5 patients were admitted to SVIMS during the period from April 2023 to July 2024.

Inclusion criteria

1. All age group patients diagnosed with lower extremity deep vein thrombosis

Exclusion criteria

1. Patients who were diagnosed with lower extremity deep vein thrombosis and treated on an outpatient basis.
2. Patients who were diagnosed with lower extremity deep vein thrombosis and treated outside SVIMS.

Regulatory clearances: The study will be conducted after approval from the institutional ethics committee, SVIMS.

Methods

All patients diagnosed with lower extremity deep vein thrombosis and admitted to SVIMS, SPMC(W), Tirupati, over a 15-month period, from 1st April 2023 to July 2024, were included in the study. Consents were taken from all respective departments to include their cases in the study. All the required data of the study were taken from the medical records of the SVIMS, SPMC (W) hospital. The data includes demographic details, presenting complaints, comorbidities, general condition, vital parameters, examination findings, investigations (laboratory and radiological), treatment details, complications, and follow-up details. The modified Wells score will be calculated for all the patients. All the obtained data will be entered into a proforma and then into the master sheet. The outcome of the patients will be entered into the proforma for all patients.

Statistical Analysis:

All data were double-checked to exclude any clerical errors. Data will be recorded on a predesigned proforma and managed using a Microsoft Excel worksheet (Microsoft Corp, Redmond, WA).  Descriptive statistics for categorical variables will be performed by computing the frequencies (percentages) in each category. For the quantitative variables, approximate normality of distribution will be assessed. Variables following normal distribution will be summarized by mean ± standard deviation; the remaining variables will be summarized as median [interquartile range (IQR)]. Chi-square test will be used. The Pearson correlation coefficient will be used to correlate the Wells score with the outcome. The statistical software IBM SPSS Statistics Version 26 (IBM Corp Somers NY, USA) will be used for statistical calculations.

A total of 56 subjects were enrolled in our study. The mean age was 47.36 ± 16.39. Table 1 shows the age group distribution of the study subjects, with the fourth decade age group comprising 33.9%, followed by the second- and third-decade age group populations.

Table 1 shows the age-wise distribution.

Table 2 shows the gender-wise distribution.

In our study, Table 3 shows that 57.14% of the study subjects had left lower limb pain (8.9%), swelling (21.4%), and pain and swelling (26%.7%) were signs and symptoms in the left lower limb, and only 3.2% of the study subjects had bilateral lower limb involvement.

Table 3 shows signs and symptoms of Deep Vein Thrombosis.

In our study, 19.65% of the study population had a similar history of DVT in the past, followed by 17.9% who had previous surgical procedures, and 1.8% who had epilepsy on antiepileptics and a family history of thrombotic diseases shown in table 4.

Table 4 shows risk factors for Deep Vein Thrombosis

In our study, the Modified Wells score for Deep vein thrombosis showed that 51.8% of the study population had DVT likely, and 48.2% had DVT not likely.

Table 5 shows the modified Wells score for DVT

In our study, the Modified Wells score for Pulmonary Embolism showed 62.5% of the study population had PE likely, according to the Modified Wells score, and 37.5% of the study population had PE not likely, according to the wells score.

Table 6 shows the modified Wells score for PE

In our study, 58.9% of the 56 subjects had PV thrombus, 57.1% had thrombus in the SFV and CFV, and only 8.9% had Calf veins thrombus, with 7.1% having CIV thrombus. 

Table 7 shows the sites of deep vein thrombosis

In this study, only 46.3% of the study population were on regular follow-up without any complications, followed by 33.9% of the study population who had irregular follow-up, and 3.6 % of the study population had died.

Table 8 shows complications and the outcome of the patient

In the present hospital-based retrospective study, a total of 56 patients were involved after the diagnosis was confirmed clinically and radiologically.

Our study included patients aged 15-85 years, with a mean age of 47.36 ± 16.39 years. Similar age groups were found by Mandiye et al.,¹² with a mean age of 52.8 ± 1.6 years, and by Silverstein et al.,¹³ with a mean age of 51 years. Considering the gender distribution, 66.1% were males, with a 2:1 gender ratio observed amongst the study population. Similar results were reported from Mandiye et al.,¹² where 63.3% were males with a 1:0.57 gender ratio. This finding was a milestone in screening male patients on a larger scale for early detection and treatment of the disease, which may also be suggestive of a reduction in smoking by the males who are at higher risk of the disease.  

In our study, 57.14% of subjects experienced signs and symptoms such as left lower limb pain (8.9%), swelling (21.4%), and both pain and swelling (26.7%). Only 3.2% of subjects had bilateral lower limb involvement. In a study conducted by Mandiye et al.,¹² 54.4% of all patients were affected, with pain and swelling (27.7%), pain alone (5.5%), and pulmonary embolism (3.3%). This aligns well with the study by Glover-Bendick¹³ and Ezeet al¹⁴., where 25 patients with unilateral leg swelling were found to have DVT. In their study, only 5% of patients had DVT without leg swelling. This is well explained by normal venous physiology, which states that when primary venous channels are obstructed, venous pressure and volume increase, leading to edema. This also corresponds with the study by Langsfeldet al¹⁵., which identified edema as the most common sign in patients with DVT.

In our study, 19.65% of the population had a history of DVT in the past, followed by 17.9% who had previous surgical procedures, and 1.8% with epilepsy on antiepileptics and a family history of thrombotic diseases. In a study by Mandiye et al¹²., 27.3% had pregnancy or puerperium, 27.3% had a history of immobilization, and up to 45.5% of patients reported smoking. In the study by Alikhan R et al¹⁷., malignancy and immobilization were linked to an increased risk of the disease. 16.1% and 10.1% of the present study found that diabetes and hypertension were risk factors for lower limb DVTs. A challenging clinical course was more likely to occur in diabetic individuals with venous thromboembolism. Recurrent DVT was predictably associated with diabetes independently.¹⁸ Moreover, hypertension is also a considerable risk factor for DVT. Numerous co-morbidities are frequently present in DVT patients. Studies on the link between DVT and hypertension have been reported during the past few years. However, the findings are conflicting. According to several research studies, hypertension may promote the growth of DVT.^19,20 According to Wang et al.,²¹ and Song et al,²² there was no statistically significant link between DVT and hypertension. As a result, further research is still needed on this controversial issue.

In our study, 58.9% of the 56 subjects had a PV thrombus, 57.1% had thrombus in the SFV and CFV, and only 8.9% had calf vein thrombus, with 7.1% having CIV thrombus. In another study, Mandiye et al¹² identified thrombus primarily in the superficial femoral vein (40%), followed by the common femoral vein (31.1%) of the patients. The findings of the present study were supported by Markel et al²³., and Khaladkar SM²⁴.  One Patient developed pulmonary thromboembolism. Filter placement was done to prevent Pulmonary Embolism. One patient developed post-thrombotic (post-phlebitis) syndrome as a long-term complication of DVT.

In our study, 23.21% of the 56 patients had both anticoagulant therapy and radiological interventions. IVC filters were used, and DVT thrombolysis was done in 8.9% of the study subjects. IVC & CIV Stenting and thrombolysis were done in 3.57% of the study population. Catheter-guided thrombolysis was done in 3.57% of the study subjects. Mechanical thrombectomy and thrombolysis, IVC and CIV Angioplasty, IVC Venogram were done in 1.7% of the study subjects each.

Limitations of the study:

The current study faced some limitations. The sample size is not large enough to represent the population. Since it is a retrospective and single study, its findings are less generalizable and lack some crucial data. For example, the patient’s history did not include inherited factors of thromboembolism. These limitations did not affect the overall results, which are consistent with the findings in the literature.

The direct risk factors for deep vein thrombosis were previous surgeries,  previous episodes of DVT, immobilization, and smoking. Patient needs to have regular follow-up to evaluate the recanalization. The patient needs to be highly motivated and educated about the importance of regular oral medication. Regular checkups of high-risk patients, early detection, and prompt treatment of the disease can reduce the chances of complications and enhance patient recovery.

Funding:

This study has no grant or funding, and no organizations or institutes support it.

Disclosure:

The authors declared no conflicts of interest in this study.

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