Featured in this issue: Volume 21 Number 1 MORE CHOICE MORE SUSTAINED CONTROL1 UNIQUE SCORED 90 mgMR F O RMU L AT I O N A compelling choice in sulphonylurea treatment: Once daily formulation Improved compliance 2 DYNACAZ 30, 60, 90 mg MR. Each tablet contains 30, 60, 90 mg gliclazide respectively. S3 A42/21.2/0249, A48/21.2/1194, A53/21.2/0083. For full prescribing information, refer to the professional information approved by SAHPRA, 15 June 2021. 1) McGavin JK, et al. Gliclazide modified release. Drugs 2002;62(9):13571364. 2) Crepaldi G and Fioretto P. Gliclazide modified release: Its place in the therapeutic armamentarium. Metabolism 2000;49(10)supplement 2:21-25. DCZC1038/04/2024. www.pharmadynamics.co.za CUSTOMER CARE LINE +27 21 707 7000 MR GLICLAZIDE 60 mg 90 mg Dynacaz 30 mg November 2024 SAJDVD The South African Journal of Diabetes & Vascular Disease The electronic version of the journal is available at www.diabetesjournal.co.za n Carotid intima–media thickness and patient outcomes in CAD in South Africa n Assessment and outcomes after suturemediated femoral vascular closure device n Predictive value of trygliceride–glucose index for MACE in premature CAD n ABC control and cardiovascular risk in patients with type 2 diabetes and depression
For further product information contact PHARMA DYNAMICS Email info@pharmadynamics.co.za CUSTOMER CARE LINE +27 21 707 7000 ALWAYS ON GUARD TESDYN 40/5 mg, 40/10 mg, 80/5 mg, 80/10 mg. Each tablet contains 40, 80 mg telmisartan respectively and 5, 10 mg amlodipine (as amlodipine besylate) respectively. S3 A55/7.1.3/0668, 0669, 0670, 0671. For full prescribing information, refer to the professional information approved by SAHPRA, November 2023. 1) Source: Based on internal analysis by Pharmadynamics (Pty) Ltd using data from the following source: IQVIA TPM MAT April 2024 ATC1 A1A- Brands measured in Units, reflecting estimates of real-world activity. Copyright IQVIA. All rights reserved. 2) Approved professional information. 3) Neldam, S. et al. (2011) “Telmisartan and amlodipine single-pill combinations vs amlodipine monotherapy for superior blood pressure lowering and improved tolerability in patients with uncontrolled hypertension: Results of the TEAMSTA-5 study,” Journal of clinical hypertension (Greenwich, Conn.), 13(7), pp. 459–466. doi: 10.1111/j.1751-7176.2011.00468.x. * Fixed-dose combination. TNA1139/08/2024. TELMISARTAN/ AMLODIPINE FDC* TELMISARTAN/AMLODIPINE FDC* OFFERS 24 HOUR BLOOD PRESSURE CONTROL2 clinically relevant blood pressure reductions with 63 % to 93 % of patients achieving DBP goal. an incidence of peripheral oedema < 4 %. a treatment compliance rate ≥98 %. TELMISARTAN / AMLODIPINE FDC* has shown: 3 According to Neldam, S. et al ., INTRODUCING OUR TELMISARTAN / AMLODIPINE 40/5 mg 40/10 mg 80/5 mg 80/10 mg CONVENIENTLY PACKED IN 30’s
HYPERINSULINAEMIA ISSN 1811-6515 THE SOUTH AFRICAN JOURNAL OF Diabetes & vascular disease Corresponding Editor DR FA MAHOMED Head of Internal Medicine Madadeni Hospital Newcastle KwaZulu-Natal Consulting Editor PROF J-C MBANYA National Editorial Board DR A AMOD Centre for Diabetes, Endocrinology and Metabolic Diseases, Life Healthcare, Chatsmed Gardens Hospital, Durban SR K BECKERT Diabetes Nurse, Paarl PROF F BONNICI Emeritus Professor, Faculty of Health Sciences, University of Cape Town and President of Diabetes South Africa PROF R DELPORT Department of Family Medicine, University of Pretoria DR L DISTILLER Director of the Centre of Diabetes and Endocrinology, Houghton, Johannesburg PROF WF MOLLENTZE Head of Department of Internal Medicine, University of the Free State, Bloemfontein PROF CD POTGIETER Specialist Nephrologist, University of Pretoria and Jakaranda Hospital, Pretoria PROF K SLIWA Associate Professor of Medicine and Cardiology, Baragwanath Hospital, University of the Witwatersrand, Johannesburg PROF YK SEEDAT Emeritus Professor of Medicine and Honorary Research Associate, University of Natal, Durban International Editorial Board PROF IW CAMPBELL Physician, Victoria Hospital, Kircaldy, Scotland, UK PROF PJ GRANT Professor of Medicine and head of Academic Unit of Molecular Vascular Medicine, Faculty of Medicine and Health, University of Leeds; honorary consultant physician, United Leeds Teaching Hospitals NHS Trust, UK PROF J-C MBANYA Professor of Endocrinology, Faculty of Medicine and Biomedical Sciences, University of Yaounde I, Cameroon and President, International Diabetes Federation PROF N POULTER Professor of Preventive Cardiovascular Medicine, Imperial College, School of Medicine, London, UK DR H PURCELL Senior Research Fellow in Cardiology, Royal Brompton National Heart and Lung Hospital, London, UK VOLUME 21 NUMBER 1 • november 2024 www.diabetesjournal.co.za CONTENTS 3 From the Editor’s Desk FA Mahomed Research Articles 4 Correlation between carotid intima–media thickness and patient outcomes in coronary artery disease in central South Africa V Mokoena, L Botes, SC Brown, FE Smit 10 Ultrasonographic assessment and clinical outcomes after deployment of a suture-mediated femoral vascular closure device D Papoutsis, K Mourouzis, N Bozini, K Aznaouridis, E Oikonomou, K Chatzimichael, E Brountzos, M Vavuranakis, C Tsioufis, J Lekakis, G Siasos, D Tousoulis
Production Editor SHAUNA GERMISHUIZEN TEL: 021 785 7178 FAX: 086 628 1197 e-mail: shauna@clinicscardive.com Financial & Production Co-ordinator ELSABÉ BURMEISTER TEL: 021 976 8129 CELL: 082 775 6808 FAX: 086 664 4202 e-mail: elsabe@clinicscardive.com Content Manager MICHAEL MEADON (Design Connection) TEL: 021 976 8129 FAX: 086 655 7149 e-mail: michael@clinicscardive.com The South African Journal of Diabetes and Vascular Disease is published twice a year for Clinics Cardive Publishing (Pty) Ltd and printed by Durbanville Commercial Printers/Tandym Print. Online Services: Design Connection. All correspondence to be directed to: THE EDITOR PO BOX 1013 DURBANVILLE 7551 or elsabe@clinicscardive.com TEL: 021 976 8129 FAX: 086 664 4202 INT: +27 (0)21 976-8129 To subscribe to the journal or change address, email elsabe@clinicscardive.com Full text articles available on: www.diabetesjournal.co.za via www.sabinet.co.za The opinions, data and statements that appear in any articles published in this journal are those of the contributors. The publisher, editors and members of the editorial board do not necessarily share the views expressed herein. Although every effort is made to ensure accuracy and avoid mistakes, no liability on the part of the publisher, editors, the editorial board or their agents or employees is accepted for the consequences of any inaccurate or misleading information. 2 VOLUME 21 NUMBER 1 • November 2024 CONTENTS 16 The predictive value of triglyceride–glucose index for assessing the severity and MACE of premature coronary artery disease L Yang, Y Peng, Z Zhang 22 Comprehensive ABC (HbA1c, blood pressure, LDL-C) control and cardiovascular disease risk in patients with type 2 diabetes mellitus and major depressive disorder in a South African managed healthcare organisation L A Naidoo, N Butkow, P Barnard-Ashton, E Libhaber
VOLUME 21 NUMBER 1 • November 2024 3 SA JOURNAL OF DIABETES & VASCULAR DISEASE From the Editor’s Desk From the Editor’s Desk In this issue, the following topics are discussed: carotid intima–media thickness and cardiovascular risk factors and outcomes in coronary artery bypass grafting (CABG) in central South Africa, effectiveness of a femoral vascular closure device with percutaneous angiography, the use of the triglyceride– glucose index in cardiovascular disease in premature coronary artery disease, and cardiovascular disease risk-factor control and outcomes in patients with major depressive disorder and type 2 diabetes. Mokoena et al. (page 4) examined the correlation between intima–media thickness (IMT) and cardiovascular risk factors and outcomes with CABG in the Free State Province of South Africa. The researchers found no correlation with outcomes but some correlation with cardiovascular risk factors. IMT could be a useful marker for cardiovascular disease because it is non-invasive and easy to measure with an ultrasound probe.1 While Mokoena et al. showed no correlation with outcomes, this could have been due to a small sample size. Other studies have shown a correlation with cardiovascular disease outcomes with CABG2 but used different outcomes and definitions of IMT. Measurement of IMT is not clear-cut: a measurement of 1 mm was used by Ham et al.,3 whereas 1.5 mm and another measure, degree of stenosis, was used by Polak et al.4 Variability in operator experience may also be a factor. A more recent study shows that a combined IMT measurement (measuring both the common carotid and internal carotid arteries) may be the best measurement to use.5 Papoutsis et al., from Athens, Greece (page 10) determined vascular changes and complications after use of a femoral vascular closure device, used at the end of percutaneous angiography to seal the femoral artery. The options for sealing the femoral artery include manual compression, use of a collagen sealant and use of a vascular device, among others. Choice depends on a number of factors and availability.6 Papoutsis and colleagues showed that the device they used was safe to use and had minimal complications. Yang et al., from Gansu Province, China (page 16) assessed the use of the triglyceride–glucose index for assessing cardiovascular outcomes in premature coronary artery disease (premature defined as less than 55 years in males and less than 60 years in females). The measurement is cheap and easy to do. It uses fasting levels of triglycerides and glucose in the calculation and is shown to be associated with insulin resistance, type 2 diabetes, hypertension and obesity. It correlates to cardiovascular risk at all ages.7 This study found a correlation in younger patients and may be a useful addition in the clinical arena when assessing cardiovascular risk in these patients. Naidoo et al., from Johannesburg, South Africa (page 22) determined the effect of major depressive disorder (MDD) on cardiovascular risk factors and outcomes in patients with type 2 diabetes. A number of psychiatric conditions are associated with adverse cardiac outcomes. MDD is common in the general population and has clearly been shown to be associated with a number of poor cardiac outcomes and increased overall mortality.8 Naidoo and colleagues found poorer cardiac riskfactor control and more frequent admissions and re-admissions for macrovascular outcomes, even in their managed-care setting. The diagnosis of depression remains an important clinical issue when assessing risk for cardiovascular disease and impact on care. References 1. Øygarden H. Carotid intima–media thickness and prediction of cardiovascular disease. J Am Heart Assoc 2017; 6(1): 1–3. 2. Ham SY, Song JW, Shim JK, Soh S, Kim HJ, Kwak YL. Prognostic role of carotid intima–media thickness in off-pump coronary artery bypass surgery. Sci Rep 2018; 8(1): 1–8. 3. Ham SY, Song JW, Shim JK, Soh S, Kim HJ, Kwak YL. Prognostic role of carotid intima–media thickness in off-pump coronary artery bypass surgery. Sci Rep 2018; 8(1): 1–8. 4. Polak JF, Szklo M, Kronmal RA, Burke GL, Shea S, Zavodni AEH, O’Leary DH. The value of carotid artery plaque and intima–media thickness for incident cardiovascular disease: the multi-ethnic study of atherosclerosis. J Am Heart Assoc 2013; 2(2): 1–10. 5. Ling Y, Wan Y, Barinas-Mitchell E, Fujiyoshi A, Cui H, Maimaiti A, et al. Varying definitions of carotid intima–media thickness and future cardiovascular disease: a systematic review and meta-analysis. J Am Heart Assoc 2023; 12(23). 6. Sartorius B, Behnes M, Ünsal M, Hoffmann U, Lang S, Mashayekhi K, et al. Arterial access-site complications after use of a vascular closure device related to puncture height. BMC Cardiovasc Disord 2017; 17(1): 1–8. 7. Hong S, Han K, Park CY. The triglyceride glucose index is a simple and lowcost marker associated with atherosclerotic cardiovascular disease: a populationbased study. BMC Med 2020; 18(1): 1–8. 8. Krittanawong C, Maitra NS, Qadeer YK, Wang Z, Fogg S, Storch EA, et al. Association of depression and cardiovascular disease. Am J Med 2023; 136(9): 881–895. Correspondence to: FA Mahomed Head of Internal Medicine, Madadeni Hospital Newcastle, KwaZulu-Natal
RESEARCH ARTICLE SA JOURNAL OF DIABETES & VASCULAR DISEASE 4 VOLUME 21 NUMBER 1 • November 2024 Correlation between carotid intima–media thickness and patient outcomes in coronary artery disease in central South Africa Abstract Objectives: Carotid intima–medial thickness (CIMT) is a noninvasive tool used to detect atherosclerosis and diagnose cardiovascular disease. This study aimed to determine whether pre-operative CIMT measurements correlated with intraand postoperative outcomes in patients with acute coronary syndrome (ACS) undergoing coronary artery bypass graft (CABG) surgery. Methods: This retrospective, analytical cohort included 89 patients diagnosed with ACS who received CABG surgery. Patients were divided into two cohorts: group 1: normal CIMT < 0.07 cm and group 2: abnormal CIMT ≥ 0.07 cm. B-mode ultrasound was used to measure the CIMT in all patients. Pre-, intra- and postoperative data and complications were recorded for each patient. Results: The study included 77 (86.5%) males and 12 (13.5%) females. Pre-operative mean body mass index was significantly higher (p = 0.03) in group 2 than in group 1. Group 2 had a significantly increased incidence of diabetes (p = 0.008) and hypertension (p = 0.009), and increased NT-proBNP levels (p = 0.02). Intra- and postoperative outcomes between the groups were comparable, with no significant differences. Conclusion: The study showed no correlation between abnormal CIMT and increased adverse intra- and postoperative patient outcomes. Therefore, the results of this study show CIMT should not be considered a tool to predict adverse events in patients undergoing CABG surgery. Keywords: carotid intima–media thickness, acute coronary syndrome, outcomes, complications, coronary artery bypass graft surgery Global cardiovascular deaths are estimated at 17.9 million annually, representing 31% of all deaths.1 In sub-Saharan Africa (SSA), noncommunicable diseases are the second most common cause of death, accounting for 2.6 million deaths or 35%.2 From the year 2000 to 2016, SSA experienced a 37% increase in coronary heart disease, with a projected increase of 21% by 2030.3 The early detection of high-risk individuals has significant clinical value. Measurement of carotid intima–medial thickness (CIMT) has been used as a marker to establish the presence,4 risk5 and extent6 of cardiovascular disease (CVD). Several studies have validated the application of this imaging technique because it can detect slight changes over time, associated with future cardiovascular events.7,8 The 2010 American Heart Association/American College of Cardiology guidelines recommended measurement of CIMT as a class IIa (reasonable to perform) recommendation for cardiovascular risk assessment in asymptomatic adults with intermediate cardiovascular risk.9 The Mannheim Carotid Intima–Media Thickness and Plaque Consensus update from the advisory board of the Watching the Risk symposium in 2004 stated that CIMT and the measurement of plaque presence are recommended for the initial detection of CVD risk in asymptomatic patients at intermediate risk or if risk factors were present. Several authors10,11 have investigated the correlation between CIMT and an increased risk for the development of coronary artery disease (CAD) and concluded that, with an increase in CIMT, the risk of CAD and myocardial infarction becomes correspondingly higher. Cardiac surgery with cardiopulmonary bypass (CPB) causes the systemic inflammatory response syndrome (SIRS), of which two to 6% of cases are associated with severe morbidity and death.12 Lactate production is a well-established indicator of tissue perfusion and regional brain oxygen saturation13 during CPB.14 Atherosclerosis adversely affects the endothelium and is associated with an abnormal inflammatory response.15-17 Since the mechanism of SIRS is linked to the endothelial response during CPB circulation, changes in endothelial function and tissue oxygenation are negatively affected by SIRS.18 CIMT is a valuable marker to predict the severity of coronary artery atherosclerosis; it may be postulated that CIMT can be used to predict surgical outcomes. Limited data are available on CIMT and its correlation with operative outcomes in coronary artery bypass graft (CABG) patients,19,20 with no data being available for the central South African population. The aim of this study was to investigate whether pre-operative CIMT measurements in acute coronary syndrome (ACS) patients undergoing elective CABG surgery would affect intra- and postoperative surgical outcomes. V Mokoena, L Botes, SC Brown, FE Smit Correspondence to: SC Brown Department of Paediatric Cardiology, University of the Free State, Bloemfontein, South Africa e-mail: Gnpdscb@ufs.ac.za V Mokoena, FE Smit Department of Cardiothoracic Surgery, University of the Free State, Bloemfontein, South Africa L Botes Department of Health Sciences, Central University of Technology, Bloemfontein, South Africa Previously published online in Cardiovasc J Afr November 2023 S Afr J Diabetes Vasc Dis 2024; 21: 4–9
SA JOURNAL OF DIABETES & VASCULAR DISEASE RESEARCH ARTICLE VOLUME 21 NUMBER 1 • November 2024 5 Methods This retrospective, analytical cohort included ACS patients who received elective CABG surgery as the mode of treatment between 2008 and 2014. During this period, 200 patients received CIMT evaluations, of whom 89 patients met the inclusion criteria and had complete data sets. The study was performed at the Cardiothoracic Surgery Department at Universitas Academic Hospital, Bloemfontein, the only public tertiary referral hospital in the central South African region. It mainly services patients from the Free State and Northern Cape provinces and Lesotho. Ethical clearance was obtained from the Health Science Research Ethics Committee (HSREC) of the University of the Free State (UFSHSD 2020/1708/2601) and the Free State Department of Health. This study was a sub-study of a prospective investigation conducted on all ACS patients (ETVOS NR 51/07). Eighty-nine patients were included in the study and divided into two cohorts as per genderspecific CIMT reference ranges. Group 1 included patients with normal CIMT values (CIMT < 0.07 cm) and group 2 patients had abnormal CIMT values (CIMT ≥ 0.07 cm). Patient demographics, clinical history, pre-operative risk factors, EuroSCORE II, CPB, near-infrared spectroscopy (NIRS) and postoperative outcomes and complications were recorded from the patients’ medical records and the departmental database. Ethnicity was self-identified and cross-referenced using the hospital identification system. Pre-operative results for levels of cholesterol, creatine, total creatine kinase, glucose, insulin, N-terminal-pro-B-type natriuretic peptide (NT-proBNP) and the creatinine kinase-MB (CK-MB) isoform were captured. Blood analysis was performed by the National Health Laboratory Service according to the laboratory standard operating procedures, applying local laboratory reference ranges for each parameter. Body mass index (BMI) was calculated using the Du Bois formula21 and categorised as underweight (> 18.5 kg/m2), normal or healthy weight (18.5–24.9 kg/m2), overweight (25.0–29.9 kg/m2) and obese (> 30 kg/m2).22 Hypertension was defined as isolated systolic hypertension (> 140/90 mmHg), according to the definition of Mancia et al.23 Patients with normal (120–129/80–89 mmHg) and/or high normal (130–139/85–89 mmHg) blood pressures were classified as not having hypertension. The CIMTmeasurements were performed pre-operatively one day prior to surgery. Patient positioning and the examination procedure were done according to standardised methods published in the Mannheim CIMT and plaque consensus.24 Standard equipment included a high-resolution B-mode system operating in black-andwhite mode, with linear ultrasound transducers at frequencies > 7 MHz. A Phillips EnVisor sonar machine and phased/sector array 2–8 MHz L12-3 sonar probe was used to obtain the CIMT images. Three CIMT measurements were recorded and averaged. For our study, a normal CIMT cut-off was set at < 0.07 cm for males and < 0.065 cm for females. For an abnormal CIMT the cutoff was ≥ 0.07 cm for males and ≥ 0.065 cm for females. Since there are no consistent reference guidelines for CIMT cut-off in the literature, the groups were divided based on the primary cut-off values per gender, as Youn et al. recommended.25 Due to the lack of standard reference guidelines in the literature, a second limited sub-analysis was done using a cut-off CIMT value of ≥ 0.09 cm as abnormal, irrespective of gender or age.26 However, only the intra- and postoperative outcomes and complications were compared between groups. Lactate levels were analysed at specified time intervals: (1) after the insertion of an intra-arterial catheter (T1 or baseline), (2) after intubation (T2), and (3) at approximately 15-minute intervals for the duration of surgery (T3, T4, etc). Postoperatively, lactate values were recorded at one, two, four, eight, 12, 24, 48 and 72 hours after the patient was admitted to the intensive care unit (ICU). Only peak lactate values were used for intra- and postoperative analysis. This study defines peak lactate as > 4 mmol/dl during and after surgery. Two NIRS electrodes were placed on the patient’s forehead before the patient was induced, and baseline values were set. Results were interpreted as either satisfactory (NIRS values > 50% or < 20% drop from baseline) or as compromised cerebral blood flow (NIRS values ≤ 50% or > 20% drop from baseline). It should be noted that not all patients received NIRS measurements because not all theatres were equipped with a NIRS monitor. Only 32 of the 89 patients had recorded NIRS measurements. Standard transthoracic echocardiograms (TTE) were performed on all patients in line with the British Society of Echocardiography protocol for comprehensive adult TTE studies.27 A Phillips EnVisor echocardiography machine was used and the patient’s left ventricular ejection fraction (LVEF) was calculated peri-operatively using Simpson’s method. The American Society of Echocardiography defines LVEF as the percentage of blood ejected during a left ventricular contraction of the heart, using quantitative measures. LVEF was calculated using the formula: LVEF = EDV – ESV EDV × 100 Where EDV is the end-diastolic volume and ESV is the end-systolic volume. The cut-off value for normal LVEF for our study was determined at > 55%. Statistical analysis Statistical analyses were done using R Software version 3.2.2 (2015/08/14). XLSTAT version 2016.03.30846 was used for t-tests and the calculation of confidence intervals. Data were compared using the Student’s t-test for normally distributed continuous variables, the Mann–Whitney test for continuous data that were not normally distributed, and the chi-squared or Fisher’s exact test (where cell counts were less than five) for categorical variables. Statistical significance was noted if the p-value was less than 0.05. Results Eighty-nine ACS patients received CIMT measurements prior to elective CABG surgery. Twenty-eight patients (31%) presented with a normal CIMT and 61 (69%) with an abnormal CIMT. Seventyseven (86.5%) were male and 12 (13.5%) were female patients. The mean age of the groups was comparable, and both groups presented with a preponderance of Caucasian males (80%). The mean BMI was significantly higher in group 2 compared to group 1 (29.2 vs 26.6 kg/m2) (p < 0.05). The demographic and anthropometric data are summarised in Table 1. Significantly more patients in group 2 with an abnormal CIMT presented with hypertension (p = 0.009), diabetes (p = 0.008) and an increased NT-proBNP level (p = 0.017). Low-density lipoprotein
RESEARCH ARTICLE SA JOURNAL OF DIABETES & VASCULAR DISEASE 6 VOLUME 21 NUMBER 1 • November 2024 cholesterol could not be analysed due to incomplete data sets. All other clinical parameters were comparable between groups (p > 0.05). The pre-operative CK-MB isoform, total cholesterol and NT-proBNP values exceeded the upper reference limit in group 2 (Table 2). The mean EuroSCORE II of both groups was high, but patients were evenly distributed in the three severity classifications with no differences between groups. The intra-operative clinical variables were similar between groups and no significant differences were detected (Table 3). The post-operative outcomes between groups were similar with no significant differences (Table 4). Most patients in both groups had an ICU stay of less than three days, with only 21.43% in group 1 and 14.75% in group 2 exceeding a three-day ICU stay. The mortality rate was low, with only one (2%) fatality in the abnormal CIMT group due to sepsis. Postoperative complications in both groups were limited. Patients with an abnormal CIMT tended to have more postoperative complications than those with a normal CIMT (34.4 vs 21.4%) (Fig. 1). The prevalence of postoperative complications was too low to analyse statistically. When a higher CIMT cut-off value was used as an abnormal indicator for CIMT (0.09 cm), the pre-, intra- and postoperative limited sub-analysis demonstrated similar results between groups with no statistically significant differences (Table 5). Postoperative complications did not show any significant differences. Table 1. Demographic and anthropometric data of normal and abnormal CIMT groups Group 1 Group 2 normal CIMT abnormal CIMT Variables (n = 28, 31%) (n = 61, 69%) p-value Age (years), mean ± SD 58.9 ± 8.88 59.6 ± 9.15 0.72 Gender, n (%) Male 23 (82.1) 54 (88.5) Female 5 (17.9) 7 (11.5) Ethnicity, n (%) Caucasian (n = 69) 22 (78.57) 47 (77.05) > 0.99 Mixed race (n = 9) 2 (7.14) 7 (11.48) 0.71 Black African (n = 9) 4 (14.29) 5 (8.20) 0.45 Asian (n = 2) 0 2 (3.28) – BMI (kg/m2), mean ± SD 26.6 ± 4.88 29.2 ± 5.85 0.03* Overweight, n (%) 12 (42.9) 19 (31.2) Obese, n (%) 13 (46.4) 16 (26.2) Severely obese, n (%) 0 4 (6.6) Normal CIMT males < 0.07 cm; abnormal CIMT males ≥ 0.07 cm; normal CIMT females < 0.065 cm; abnormal CIMT females ≥ 0.065 cm. CIMT, carotid intima–media thickness; SD, standard deviation. *Statistically significant p-value < 0.05 Table 2. Pre-operative clinical data of normal and abnormal CIMT groups Group 1 Group 2 normal CIMT abnormal CIMT Variables (n = 28, 31%) (n = 61, 69%) p-value CIMT (mm), mean ± SD 0.06 ± 0.01 0.095 ± 0.03 < 0.0001* Hypertension, n (%) 16 (57.14) 52 (85.25) 0.009* Diabetes, n (%) 2 (7.14) 21 (34.43) 0.008* Cholesterol (LDL) > 3 mmol, No analysis, n (%) 24 (85.71) 28 (45.90) incomplete mean ± SD 4.4 ± 0.07) 4.09 ± 0.94 data sets Statin use, n (%) 22 (78.57) 44 (67.21) – Hypercholesterolaemia, n (%) 14 (50.0) 24 (39.34) 0.57 NT-proBNP (ng/l), mean ± SD 562.9 ± 591.2 1344.4 ± 1646.7 0.017* Current/ex-smoker, n (%) 12 (42.86) 31 (50.82) 0.64 CK-MB isoform (ng/ml), mean ± SD 32.8 ± 96.39 20.8 ± 49.28 0.58 Glucose (mmol/l), mean ± SD 6.05 ± 2.053 6.37 ± 2.70 0.58 Insulin (mU/l), mean ± SD 24.8 ± 39.49 28.06 ± 30.71 0.74 LVEF, mean ± SD 54.4 ± 14.39 52.2 ± 15.07 0.52 EuroSCORE II, n (%) 6 (21.4) 16 (26.2) – 0–2, low risk, n (%) 11 (39.3) 20 (32.8) – 3–5, medium risk, n (%) 7 (25.0) 20 (32.8) – > 5, high risk, mean ± SD 6.18 ± 9.60 7.53 ± 13.85 0.61 Normal CIMT males < 0.70 mm; abnormal CIMT males ≥ 0.07 cm; normal CIMT females < 0.065 cm; abnormal CIMT females ≥ 0.065 cm. CIMT, carotid intima–media thickness; SD, standard deviation; LVEF, left ventricular ejection fraction. *Statistically significant p-value < 0.05. Table 3. Intra-operative clinical data of normal and abnormal CIMT groups Group 1 Group 2 normal CIMT abnormal CIMT Variables (n = 28, 31%) (n = 61, 69%) p-value Peak lactate (mmol/dl), mean ± SD 4.7 ± 1.6 4.02 ± 1.8 0.085 Cumulative bypass time (min), mean ± SD 112 ± 22.7 111.4 ± 31.5 0.92 Cumulative cross-clamp time (min), mean ± SD 60.5 ± 14.3 59.3 ± 18.5 0.75 Total number of grafts ≥ 3, n (%) 21 (75.00) 43 (70.5) 0.85 Intra-aortic balloon pump, n (%) 15 (53.6) 21 (34.4) 0.14 NIRS > 50%; drop of < 20%, n (%) 3 (10.7) 17 (27.9) 0.13 NIRS < 50%; drop of > 20%, n (%) 13 (46.5) 24 (39.3) Phenylephrine bolus at 100 μg/ml during bypass, n (%) 23 (82.1) 49 (80.3) > 0.99 mean ± SD 15.07 ± 22.04 20.7 ± 17.8 0.30 Adrenaline during anaesthesia at more than 20 μg/kg/min, n (%) 6 (21.4) 9 (14.8) 0.63 mean ± SD 0.07 ± 0.04 0.3 ± 0.4 0.16 Adrenaline bolus during bypass 1:1 000 000 mg/ml, n (%) 4 (14.3) 17 (27.9) 0.20 mean ± SD 3 ± 1.8 7 ± 9.4 0.13 Effortil bolus during bypass (mg), n (%) 2 (7.1) 5 (8.2) > 0.99 mean ± SD 14.5 ± 7.8 11.6 ± 5.4 0.69 Normal CIMT males < 0.07 cm; abnormal CIMT males ≥ 0.07cm; normal CIMT females < 0.065 cm; abnormal CIMT females ≥ 0.065 cm. CIMT, carotid intima–media thickness; SD, standard deviation. *Statistically significant p-value < 0.05.
SA JOURNAL OF DIABETES & VASCULAR DISEASE RESEARCH ARTICLE VOLUME 21 NUMBER 1 • November 2024 7 Discussion This study aimed to assess the impact of an abnormal CIMT on intra- and postoperative variables in ACS patients receiving CABG surgery. It was hypothesised that patients with pronounced/thickened CIMTs would present with worse intra- and postoperative measurable abnormalities, outcomes and complications. The study results showed that patients with abnormal CIMTs had more pre-operative risk factors than patients with normal CIMTs. However, no significant differences were observed between intra- and postoperative variables when comparing the normal and abnormal CIMT groups, even at a higher abnormal CIMT cut-off value of ≥ 0.09 cm. The anthropometric analysis showed that patients with an abnormal CIMT had a significantly higher BMI and were significantly more overweight than patients with a normal CIMT. This finding is in agreement with studies conducted by Rashid and Mahmud28 and El Jalbout et al.,29 who reported an increased CIMT in adolescents with an increased BMI. In this cohort, 69% of ACS patients who required CPB surgery due to severe CAD had an abnormal CIMT. This finding concurs with several other studies that concluded that CIMT is elevated with advanced CAD.6,30 In our study, in patients with an abnormal CIMT, risk factors such as hypertension, diabetes and increased NT-proBNP levels were significantly more frequent than in those with a normal CIMT. Diabetes directly impacts on CIMT due to vascular endothelial dysfunction.31 Baba et al. reported that patients presenting with diabetes had higher CIMT values than healthy Table 4. Post-operative outcomes of normal and abnormal CIMT groups Group 1 Group 2 normal CIMT abnormal CIMT Variables (n = 28, 31%) (n = 61, 69%) p-value Peak lactate (> 4 mmol/dl), mean ± SD 5.3 ± 3.4 5.8 ±3.2 0.52 Length of stay in ICU > 3 days, mean ± SD 3.1 ± 0.7 3.13 ± 2.2 0.63 n (%) 6 (21.4) 9 (14.8) Length of stay in ICU > 3 days, mean ± SD 2.94 ± 0.1 3.54 ± 0.6 0.33 Mortality, n (%) 0 (0) 1 (2) – Normal CIMT males < 0.07 cm; abnormal CIMT males ≥ 0.07 cm; normal CIMT females < 0.065 cm; abnormal CIMT females ≥ 0.065 cm. CIMT, carotid intima–media thickness; SD, standard deviation. *Statistically significant p-value < 0.05. Table 5. Pre-, intra- and postoperative outcomes compared to normal (< 0.09 cm) and abnormal (≥ 0.09 cm) CIMT values regardless of gender Group 1 Group 2 normal CIMT abnormal CIMT Variables (n = 61, 68.5%) (n = 28, 31.5%) p-value Pre-operative clinical data, mean ± SD NT-proBNP (ng/l), 936.1 ± 165.7 1391 ± 650.5 0.51 LVEF 53.6 ± 1.7 52.1 ± 3.3 0.69 CK-MB isoform (ng/ml) 21.8 ± 10.3 36.10 ± 27.9 0.62 Intra-operative clinical data, mean ± SD Peak lactate (mmol/dl) 4.3 ± 0.2 3.9 ± 0.4 0.29 Cumulative bypass time (min) 112.9 ± 3.8 109.6 ± 6.6 0.66 Postoperative outcomes, mean ± SD Peak lactate (> 4 mmol/dl) 5.8 ± 0.4 5.69 ± 0.70 0.93 Normal CIMT < 0.09 cm; abnormal CIMT ≥ 0.09 cm. CIMT, carotid intima–media thickness; SD, standard deviation. *Statistically significant p-value < 0.05. Fig. 1. Post-operative complications of normal and abnormal CIMT groups.
RESEARCH ARTICLE SA JOURNAL OF DIABETES & VASCULAR DISEASE 8 VOLUME 21 NUMBER 1 • November 2024 controls and that the prevalence of increased CIMT was very high (82.8%) in the Nigerian population.31 In our study, 34% of patients with diabetes had abnormal CIMTs, significantly more than patients with normal CIMTs. Hypertension is multifactorial in cause, including but not limited to, high sodium intake, cigarette smoking, unhealthy diet, low potassium intake, lack of physical activity32 and family history of hypertension.33 Evidence suggests that hypertension is strongly associated with increased CIMT thickening.34 The carotid artery has a relatively small media compared with muscular arteries. Therefore an increased CIMT is thought to primarily represent intimal rather than medial thickening, supporting atherosclerosisrelated cardiovascular events rather than hypertrophy of the medial layer of the carotid artery.35 Our results (Table 2) showed an association between hypertension and an increased CIMT, with significantly more patients presenting with hypertension in the abnormal CIMT group (85.25%) compared to the normal CIMT group (57.14%). Similar observations were reported by Rashid and Mahmud, Magnussen, and Chen et al.28,35,36 The MONICA Risk, Genetics, Archiving, and Monograph (MORGAM) biomarker project demonstrated that adding NT-proBNP to a conventional risk model can improve a 10-year risk estimation for cardiovascular events.37 This study showed that NT-proBNP was significantly higher pre-operatively in patients with an abnormal CIMT. A response to left ventricular strain or ischaemia causes a release of NT-proBNP, which has been found to be an important biomarker for left ventricular systolic dysfunction and left ventricular stress in the general population.38 There was no correlation between CIMT and intra-operative factors, even when a higher abnormal CIMT cut-off value was used. A possible reason is that the study population was too small and that subtle differences may not have been detected. Interestingly, no difference in lactate values was found between the groups. Insufficient oxygen delivery and hypoperfusion during CPB contribute to hyperlactataemia.39 CIMT is a marker of subclinical atherosclerosis and endothelial dysfunction,40 which is a factor that would increase lactate production intraoperatively due to the systemic inflammatory response caused by CPB.41 An increase in lactate is associated with poor outcomes and increased mortality rates in cardiac surgery patients.42 The post-operative complications were comparable between the groups with no statistically significant differences. Our study’s overall post-operative complication rate was low but corresponds with the overall rate of complications reported after CABG surgery (1–3%).43 Data on the accepted normative values are unavailable because there is no widely accepted cut-off value for what constitutes an adverse/abnormal CIMT value. Many variables affect the thickening of the carotid intima in different populations, whether it be age, ethnicity or diet.35 Even when using a higher abnormal CIMT cut-off value of 0.09 cm, there was no relationship between higher CIMT values and increased post-operative outcomes and complications. Our results agree with Aboyans et al.,19 who also found little value in pre-operative CIMT. By contrast, some value was reported in off-pump CABG where increased CIMT (0.9 mm) was associated with increased 30-day morbidity rates.20 However, based on our results, CIMT should not be considered a predictor for surgical outcomes in ACS patients undergoing CABG surgery using CPB. Before criteria for abnormal CIMT can be set, there is a need for measurement consensus and population reference values. There are currently no set CIMT population values for South Africa. This study is limited by its retrospective design and the sample size was small. For this reason, only assumptions can be made. A larger patient population may reveal more definite answers on whether increased CIMT values can predict surgical outcomes. Conclusion Our study demonstrated an association between abnormal CIMT and pre-operative risk factors such as BMI, diabetes, hypertension and NT-proBNP level. However, there was no correlation between abnormal CIMT and an increased rate of adverse intra- and postoperative patient outcomes. Therefore, our study does not support the use of CIMT to predict adverse events in patients undergoing CABG surgery. Further studies that include larger patient numbers are needed to confirm our observations. Acknowledgement The authors thank the Robert WM Frater Cardiovascular Centre for their contribution towards this research study. References 1. Mc Namara K, Alzubaidi H, Jackson JK. Cardiovascular disease as a leading cause of death: how are pharmacists getting involved? Integr Pharm Res Pract 2019; 8: 1–11. 2. Yuyun MF, Sliwa K, Kengne AP, Mocumbi AO, Bukhman G. 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Nutr Today 2015; 50(3): 117–128. 23. Mancia G, Backer G De, Uk AD, et al. 2007 Guidelines for the management of arterial hypertension. The Task Force for the Management of Arterial Hypertension of the European Society of Hypertension (ESH) and of the European Society of Cardiology (ESC). Eur Heart J 2007; 28(12): 1462–1536. 24. Touboul P, Hannerici M, Meairs S, Adams H. Mannheim Carotid Intima–Media Thickness and Plaque Consensus (2004–2006–2011): An update on behalf of the advisory board of the 3rd and 4th Watching the Risk Symposium 13th and 15th European Stroke Conferences, Mannheim, Germany, 2004, and Brussels, Belgium. Cerebrovasc Dis 2013; 34(4): 290–296. 25. Youn YJ, Lee NS, Kim JY, et al. Normative values and correlates of mean common carotid intima–media thickness in the Korean rural middle-aged population: The atherosclerosis RIsk of rural areas iN Korea general population (ARIRANG) study. J Korean Med Sci 2011; 26(3): 365–371. 26. Hennerici MG, Neuerburg-Heusler D. Vascular Diagnosis with Ultrasound: Clinical Reference with Case Studies. Stuttgart, New York: Thieme, 1998. 27. Wharton G, Steeds R, Allen J, et al. A minimum dataset for a standard adult transthoracic echocardiogram: a guideline protocol from the British Society of Echocardiography. Echo Res Pract 2015; 2(1): G9–G24. 28. Rashid SA, Mahmud SA. Correlation between carotid artery intima–media thickness and luminal diameter with body mass index and other cardiovascular risk factors in adults. Sultan Qaboos Univ Med J 2015; 15(3): e344–e350. 29. El Jalbout R, Cloutier G, Cardinal MHR, et al. Correction to: Carotid artery intima–media thickness measurement in children with normal and increased body mass index: a comparison of three techniques. Pediatr Radiol 2018; 48(8): 1080. 30. Zhang Y, Guallar E, Qiao Y, Wasserman BA. Is carotid intima–media thickness as predictive as other noninvasive techniques for the detection of coronary artery disease? Arterioscler Thromb Vasc Biol 2014; 34(7): 1341–1345. 31. Baba MM, Abdullahi Talle M, Ibinaiye PO, Abdul H, Buba F. Carotid Intima– media thickness in patients with diabetes mellitus attending tertiary care hospital in Nigeria. Angiol Open Access 2018; 6(2): 1–5. 32. Mills KT, Stefanescu A, He J. The global epidemiology of hypertension. Physiol Behav 2016; 176(1): 139–148. 33. Li A le, Peng Q, Shao Y qin, Fang X, Zhang Y ying. The interaction on hypertension between family history and diabetes and other risk factors. Sci Rep 2021; 11(1): 1–7. 34. Zhang L, Fan F, Qi L, et al. The association between carotid intima–media thickness and new-onset hypertension in a Chinese communitybased population. BMC Cardiovasc Disord 2019; 19(269): 1–6. 35. Magnussen CG. Carotid artery intima–media thickness and hypertensive heart disease: a short review. Clin Hypertens 2017; 23(1): 1–4. 36. Chen Y, Xiong H, Wu D, et al. Relationship of short-term blood pressure variability with carotid intima–media thickness in hypertensive patients. Biomed Eng Online 2015; 14(1): 1–15. 37. Blankenberg S, Zeller T, Saarela O, et al. Contribution of 30 biomarkers to 10-year cardiovascular risk estimation in 2 population cohorts: The MONICA, risk, genetics, archiving, and monograph (MORGAM) biomarker project. Circulation 2010; 121(22): 2388–2397. 38. Mirjafari H, Welsh P, Verstappen SMM, et al. N-terminal pro-brain-type natriuretic peptide (NT-pro-BNP) and mortality risk in early inflammatory polyarthritis: Results from the Norfolk Arthritis Registry (NOAR). Ann Rheum Dis 2014; 73(4): 684–690. 39. Ranucci M, Isgrò G, Ranucci M, et al. Hyperlactatemia during cardiopulmonary bypass: Determinants and impact on postoperative outcome. Crit Care 2006; 10(6): 1–9. 40. Yang CW, Guo YC, Li CI, et al. Subclinical atherosclerosis markers of carotid intima-media thickness, carotid plaques, carotid stenosis, and mortality in community-dwelling adults. Int J Environ Res Public Health 2020; 17(13): 1–14. 41. Laffey JG, Boylan JF, Cheng DCH. The systemic inflammatory response to cardiac surgery. Anesthesiology 2002; 97(1): 215–252. 42. Minton J, Sidebotham DA. Hyperlactatemia and cardiac surgery. J Extra Corpor Technol 2017; 49(1): 7–15. 43. Safaie N, Montazerghaem H, Jodati A, Maghamipour N. In-hospital complications of coronary artery bypass graft surgery in patients older than 70 years. J Cardiovasc Thorac Res 2015; 7(2): 60–62. TELMISARTAN/ AMLODIPINE FDC* INTRODUCING OUR TELMISARTAN/ AMLODIPINE FDC* OFFERS 24 HOUR BLOOD PRESSURE CONTROL2 TELMISARTAN / AMLODIPINE 40/5 mg 40/10 mg 80/5 mg 80/10 mg CONVENIENTLY PACKED IN 30’s TESDYN 40/5 mg, 40/10 mg, 80/5 mg, 80/10 mg. Each tablet contains 40, 80 mg telmisartan respectively and 5, 10 mg amlodipine (as amlodipine besylate) respectively. S3 A55/7.1.3/0668, 0669, 0670, 0671. For full prescribing information, refer to the professional information approved by SAHPRA, November 2023. 1) Source: Based on internal analysis by Pharmadynamics (Pty) Ltd using data from the following source: IQVIA TPM MAT April 2024 ATC1 A1A- Brands measured in Units, reflecting estimates of real-world activity. Copyright IQVIA. All rights reserved 2) Approved professional information. * Fixed-dose combination. TNB1169/10/2024. CUSTOMER CARE LINE +27 21 707 7000 www.pharmadynamics.co.za ALWAYS ON GUARD
RESEARCH ARTICLE SA JOURNAL OF DIABETES & VASCULAR DISEASE 10 VOLUME 21 NUMBER 1 • November 2024 Ultrasonographic assessment and clinical outcomes after deployment of a suture-mediated femoral vascular closure device Abstract Introduction: Data regarding changes in the arterial vascular wall after the deployment of suture-mediated vascular closure devices (VCD) at the femoral site in patients undergoing percutaneous coronary angiography (CAG) or percutaneous coronary intervention (PCI) are sparse. This study investigated the occurrence of structural vascular changes or adverse vascular complications at the access site in the short term after the deployment of a suture-mediated intravascular VCD. Methods: Ninety-three patients (72% males) with a mean age of 62 ± 11 years were enrolled. Duplex sonography was conducted at the access site at baseline, 24 hours and 30 days after femoral puncture in patients with successful VCD deployment. Vessel diameter, flow velocities, the severity of atherosclerosis, and the intravascular or perivascular tissue alterations in both the right common femoral artery (RCFA) and right external iliac artery (REILA) were assessed. Vascular complications were documented. Results: There were no significant changes regarding the diameter of the RCFA in the transverse and longitudinal view, peak systolic velocity (PSV) of the RCFA, PSV ratio of the RCFA to REILA, the resistive index of the RFCA and the severity of arterial wall abnormalities before femoral puncture, the day following VCD deployment and 30 days after (p = NS for all) in the general population and in patients with diabetes mellitus, on oral anticoagulants or with mild peripheral artery disease (p = NS for all markers). Device failure was observed in four cases. Few (4.4%) patients had vascular complications, which included exclusively major or minor haematomas, most of which did not persist at the 30-day follow up. Conclusion: The use of a suture-mediated VCD was safe and was not associated with adverse vascular wall changes at the femoral access site 30 days after deployment in patients undergoing CAG and/or PCI. Keywords: vascular closure device, suture-mediated, duplex ultrasound, complications, femoral artery The performance of percutaneous coronary angiography (CAG) and percutaneous coronary intervention (PCI) requires artery cannulation. Although transradial cardiac catheterisation is increasingly being adopted due to lower vascular and bleeding complications,1,2 many interventional cardiologists persist in using the femoral approach. This preference may be partly attributed to the greater familiarity that many interventional cardiologists have with the method.3 Importantly, observational studies show that the use of femoral vascular closure devices (VCDs) allows for comparable major bleeding rates between transradial and transfemoral arterial access in patients who underwent CAG or PCI.4 VCDs enable arteriotomy closure, reducing the time to achieve haemostasis, and assuring early remobilisation, ambulation and patient comfort in a safe and cost-efficient manner.5-7 On the other hand, there is a lack of evidence regarding the superiority of VCD implementation over manual compression in terms of adverse vascular complications, such as arteriovenous fistula, pseudoaneurysms, haematomas, occlusion, thrombosis and the incidence of major bleedings, in an all-comers population. However, VCD implementation may particularly benefit selected patient groups who receive CAG.5,8 The effect of VCD deployment on the properties of the vasculature at the femoral access site has been investigated by only a few researchers, who demonstrated that there was no association between VCD implantation and severe adverse vascular complications in a one- and 10-year term.9,10 The use of Perclose Proglide™, a suture-mediated VCD, resulted in better sonographic findings than the Angio-Seal™, a VCD that delivers a suturetethered extravascular collagen plug. However, the lack of baseline measurements prevented the precise evaluation of the VCD effect on the vascular wall, accompanied by the paradoxical observation of an increased vessel lumen on the access site compared to the non-accessed femoral artery.9,10 Dimitrios Papoutsis, Konstantinos Mourouzis, Nikoleta Bozini, Konstantinos Aznaouridis, Evangelos Oikonomou, Katerina Chatzimichael, Elias Brountzos, Manolis Vavuranakis, Costas Tsioufis, John Lekakis, Gerasimos Siasos, Dimitris Tousoulis Correspondence to: Konstantinos Mourouzis Dimitrios Papoutsis, Nikoleta Bozini, Konstantinos Aznaouridis, Evangelos Oikonomou, Manolis Vavuranakis, Costas Tsioufis, Gerasimos Siasos, Dimitris Tousoulis First Department of Cardiology, Medical School, National and Kapodistrian University of Athens, Hippokration Hospital, Athens, Greece e-mail: konstantinos.mourouzis@med.uni-muenchen.de John Lekakis Second Department of Cardiology, Medical School, Attikon Hospital, National and Kapodistrian University of Athens, Athens, Greece Katerina Chatzimichael, Elias Brountzos Second Department of Radiology, Medical School, University General Hospital, ATTIKON, National and Kapodistrian University of Athens, Athens, Greece Previously published online in Cardiovasc J Afr November 2023 S Afr J Diabetes Vasc Dis 2024; 21: 10–15
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