CARDIOVASCULAR JOURNAL OF AFRICA • Volume 33, No 3, May/June 2022 AFRICA 129 change in gauge length and, therefore, in its electrical resistance.12 This study researched the convenience and reliability of SGP in the assessment of patients with CVD. Methods This was a descriptive study conducted in the Department of Cardiovascular Surgery, Faculty of Medicine, Kafkas University, between June 2016 and May 2021. The study included 432 patients referred to the vascular clinic owing to symptomatic CVD diagnosed with DUS imaging. The study was approved by the Kafkas University Research Ethics Committee (issue nr. 2016/0071) and conducted according to the Helsinki Declaration. There were 193 (44.7%) men and 239 (55.3%) women, with a mean age of 45.16 ± 12.54 (range 20–78). The inclusion criteria were the presence of a CVD diagnosed with DUS and a signed informed consent form showing the patients were willing to volunteer for participation. The exclusion criteria were unwillingness to participate in the study, lack of or doubtful CVD, and conditions in which the simultaneous SGP measurements failed. The researchers prepared the data-collection form to register the patients’ data and SGP measurements. According to a detailed physical examination, the patients’ data, disease staging, and oedema or pigmentation were noted in this form. Lastly, bilateral lower-extremity measurements were done in each patient with the SGP. In this study, a single SGP device (Venometer® V3, Amtec Medical Ltd, Antrim, UK) and its indium gallium strain gauges were used for the examination of all patients. All measurements were taken following the operating manual.13 According to the manual, the positioning of the patient is critical. The patients should lie down in a supine position and horizontally with minimum back lift. They should also keep stationary in this position during the measurements as the SGP is extremely precise in recording unwanted movements, resulting in diagnostic variables being wrongly measured. During the test, the arms should also be relaxed and lie next to the patient. The foot positioner apparatus supports the feet with an adequate flexion degree of the femur. If the femur’s flexion is not sufficient, and if the patients feel a lack of support underneath, they tend to maintain the leg position with the muscular tonus. This muscle contraction may be impossible for a geriatric patient; however, a young individual unconsciously balances the leg position with maintained muscle tonus. In both cases, muscle tonus leads to vasoconstriction and decreases the venous blood flow as in DVT, causing misdiagnosis. The foot positioner may be supported if it is needed to be more stable. The contralateral extremity may be positioned on or under the foot positioner. Some patients may feel more comfortable if mild analgesia is applied before the procedure. Patient comfort is essential for accurate results. If the patient is nervous, feels chilly, or has pain, the venous system may close itself, leaving a venous disease undiagnosed. Finally, the strain-gauge cuff is wrapped around the calf muscle and tightened with velcro. A cable connection is then made with the plethysmography device to start the measurements. The following five parameters were measured: • venous volume (V): the volume during venous occlusion under 60 mmHg pressure of inflated cuff in the capacitance mode (ml/100 ml) • venous emptying (VE): time of venous outflow (ml/100 ml/ min) • expelled volume ratio in four seconds (EV4/V): the ratio of expelled blood volume in four seconds over the total volume, indicating the venous outflow • half refilling time (t½): filling time of half of the venous volume, indicating the venous reflux (seconds), which alters with exercise • refilling volume (RV): this is another parameter altered with exercise, indicating the muscle pump function (ml/100 ml). The patients were requested to shake their legs 15 times before taking the t½ and RV measurements. Statistical analysis The SPSS 20.0 for Windows (SPSS, Inc; Chicago, USA) statistical software was used for statistical analyses. The descriptive values are defined as number (n), percentage (%), average (Avr), standard deviation (SD) and median. Pearson’s chi-squared test was used for the comparison of categorical variables. Continuous variables were compared with non-parametric Mann–Whitney U- and Kruskal–Wallis tests as they were unsuitable for the normality assessment done with Kolmogorov–Smirnov and Shapiro–Wilk tests. The Spearman correlation test was used for the correlation between continuous variables. Diagnostic features of the measurement values over CVD diagnosis were analysed with receiver operating characteristics (ROC) curves. In the presence of significant limiting values, the sensitivity and specificity values were calculated. Statistical significance was accepted as p < 0.05. Results Four hundred and thirty-two patients, including 239 (55.3%) women and 193 (44.7%) men, were included in the study. The average age was 45.16 ± 12.54 years (median age 46 years; range 20–78 years). The age groups were determined as 20–29 years (56 patients; 13.0%), 30–39 years (114 patients; 26.4%), 40–49 years (102 patients; 23.6%), 50–59 years (101 patients; 23.4%) and above 60 years (59 patients; 13.6%). All participants initially underwent DUS imaging and were diagnosed with DVT (49.8%), CVI (40.0%), thrombophlebitis (5.6%) and DVI (4.6%) (Table 1). The pathological distributions were quantitatively determined in women as DVT (46.9%), CVI (42.2%), thrombophlebitis (6.3%) and DVI (4.6%), and in men as DVT (53.4%), CVI (37.3%), thrombophlebitis (4.6%) and DVI (4.7%). There was no significant difference regarding the diagnostic distribution between the genders (p = 0.559). Localisation and lateralisation statistics of the pathologies revealed that left-sided involvement was slightly more predominant, although the right greater saphenous vein (GSV) was the most affected site (Table 2). The pathologies were located mainly on the left side in both women (53.6%) and men (50.8%). There was no significant difference regarding localisation and lateralisation between the genders (p = 0.316). Among the various risk factors, immobilisation, genetic factors and smoking were the leading causes (Table 3). The three major risk factors in the men were smoking (17.6%), immobilisation (15.0%) and genetic factors (11.9%). However, in women, the three primary risk factors were pregnancy (16.3%), oral contraceptives
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