CARDIOVASCULAR JOURNAL OF AFRICA • Volume 35, No 2, May – August 2024 AFRICA 111 Changes in blood pressure after catheter-based renal denervation in South Africa Iftikhar O Ebrahim, Mpiko Ntsekhe, Brian Rayner, Martin Fahy, Giuseppe Mancia, Michael Böhm; on behalf of the Global SYMPLICITY Registry investigators Abstract Background: Renal denervation (RDN) is an interventional treatment for patients with uncontrolled hypertension. The Global SYMPLICITY Registry (GSR) is a prospective, all-comer, world-wide registry designed to assess the safety and efficacy of RDN. We evaluated the outcomes in South African patients in the GSR over 12 months. Methods: Eligible patients with hypertension had a daytime mean blood pressure (BP) > 135/85 mmHg or night-time mean BP > 120/70 mmHg. Office and 24-hour ambulatory systolic BP reduction and adverse events over 12 months were evaluated. Results: South African patients (n = 36) in the GSR had a mean age of 54.4 ± 9.9 years with a median of four prescribed antihypertensive medication classes. At 12 months, mean changes in office and 24-hour ambulatory systolic BP were –16.9 ± 24.2 and –15.3 ± 18.5 mmHg, respectively, with only one adverse event recorded. Conclusion: RDN safety and efficacy in South African patients were consistent with world-wide GSR results. Keywords: renal denervation, hypertension, Global SYMPLICITY Registry Submitted 7/3/22; accepted 12/4/23 Published online 27/6/23 Cardiovasc J Afr 2024; 35: 111–114 www.cvja.co.za DOI: 10.5830/CVJA-2023-021 Hypertension is a global public health concern, affecting one in three adults in the developed world, and it contributes to increased vascular and renal morbidity, as well as cardiovascular mortality.1-3 The risk of cardiovascular death doubles for every 20 and 10 mmHg increase in systolic and diastolic blood pressures (BP), respectively, above 115/75 mmHg (systolic/diastolic BP).4 Multidisciplinary treatments, including dietary restrictions, lifestyle changes and pharmacological antihypertensive therapies, have proved inadequate in reducing BP to recommended levels for at least one-third of individuals with hypertension.5,6 Non-adherence to the prescribed antihypertensive medication regimen is thought to contribute to inadequate control of BP.7-9 Catheter-based renal denervation (RDN) of the sympathetic nerves using radio-frequency energy has emerged as a novel, safe and effective treatment option to reduce BP in patients with uncontrolled hypertension.10 Several randomised, shamcontrolled clinical trials have demonstrated BP reduction in patients after RDN.11-13 However, follow-up data after RDN in real-world patients is needed.14 The Global SYMPLICITY Registry (GSR) is an ongoing, prospective clinical study that has enrolled patients since 2012 to evaluate the impact of RDN on BP reduction in an all-comers population. In a study of more than 10 000 patients from the sub-Saharan African countries of Ghana, Kenya, Burkina Faso and South Africa, South Africa had the highest prevalence of hypertension, highlighting the need for alternative treatment options for South African patients.15 This analysis specifically examined the safety of RDN and changes in BP up to 12 months post-RDN in GSR patients enrolled and followed up in South Africa. Methods The GSR is a prospective, multi-centre, open-label registry to document the safety and efficacy of RDN treatment in an all-comers population in real-world clinical settings. The design of the GSR and interim results and analyses in other subpopulations have been published previously.16-19 National regulatory authorities, ethics committees and review boards of the participating centres approved the registry. The GSR is registered (NCT01534299) at ClinicalTrials.gov. Enrolment eligibility for the GSR South Africa was similar to other SYMPLICITY studies.17-19 Patients ≥ 18 years of age or as required by local regulations, with uncontrolled hypertension as described by the South African Hypertension Guidelines of 2011, with a daytime mean BP > 135/85 mmHg (systolic/ diastolic) or a night-time mean BP > 120/70 mmHg, were eligible. Exclusion criteria were pregnancy, estimated glomerular filtration rate < 30 ml/min, significant aortic stenosis, secondary causes of hypertension or complex renal vascular anatomy making RDN technically difficult. The GSR recommended three BP measurements be taken at each office visit and 24-hour ambulatory BP measured as per published guidelines.20 The most recent office and ambulatory Raslouw Private Hospital, Pretoria, South Africa Iftikhar O Ebrahim, MB BCh, MMed, drioebrahim@gmail.com Groote Schuur Hospital and University of Cape Town, Cape Town, South Africa Mpiko Ntsekhe, MD Brian Rayner, MD Medtronic, Santa Rosa, California, USA Martin Fahy, MS University of Milano-Bicocca and Policlinico di Monza, Monza, Italy Giuseppe Mancia, MD, PhD Clinic of Internal Medicine III, Saarland University, Saarland University Hospital, Homburg/Saar, Germany Michael Böhm, MD
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