Renal denervation for treatment of uncontrolled hypertension in an Asian population: results from the Global SYMPLICITY Registry in South Korea (GSR Korea)

The Asia Renal Denervation Consortium consensus conference of Asian physicians actively performing renal denervation (RDN) was recently convened to share up-to-date information and regional perspectives, with the goal of consensus on RDN in Asia. First- and second-generation trials of RDN have demonstrated the efficacy and safety of this treatment modality for lowering blood pressure in patients with resistant hypertension. Considering the ethnic differences of the hypertension profile and demographics of cardiovascular disease demonstrated in the SYMPLICITY HTN (Renal Denervation in Patients With Uncontrolled Hypertension)-Japan study and Global SYMPLICITY registry data from Korea and Taiwan, RDN might be an effective hypertension management strategy in Asia. Patient preference for device-based therapy should be considered as part of a shared patient-physician decision process. A practical population for RDN treatment could consist of Asian patients with uncontrolled essential hypertension, including resistant hypertension. Opportunities to refine the procedure, expand the therapy to other sympathetically mediated diseases, and explore the specific effects on nocturnal and morning hypertension offer a promising future for RDN. Based on available evidence, RDN should not be considered a therapy of last resort but as an initial therapy option that may be applied alone or as a complementary therapy to antihypertensive medication.

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Effects of renal denervation on kidney function and long-term outcomes: 3-year follow-up from the Global SYMPLICITY Registry

European Heart Journal ◽

10.1093/eurheartj/ehz118 ◽

2019 ◽

Vol 40 (42) ◽

pp. 3474-3482 ◽

Cited By ~ 45

Author(s):

Felix Mahfoud ◽

Michael Böhm ◽

Roland Schmieder ◽

Krzysztof Narkiewicz ◽

Sebastian Ewen ◽

...

Keyword(s):

Renal Function ◽

Real World ◽

Active Sites ◽

Renal Denervation ◽

Uncontrolled Hypertension ◽

Open Label ◽

Hypertensive Patients ◽

Safety And Efficacy

Abstract Aims Several studies and registries have demonstrated sustained reductions in blood pressure (BP) after renal denervation (RDN). The long-term safety and efficacy after RDN in real-world patients with uncontrolled hypertension, however, remains unknown. The objective of this study was to assess the long-term safety and efficacy of RDN, including its effects on renal function. Methods and results The Global SYMPLICITY Registry is a prospective, open-label registry conducted at 196 active sites worldwide in hypertensive patients receiving RDN treatment. Among 2237 patients enrolled and treated with the SYMPLICITY Flex catheter, 1742 were eligible for follow-up at 3 years. Baseline office and 24-h ambulatory systolic BP (SBP) were 166 ± 25 and 154 ± 18 mmHg, respectively. SBP reduction after RDN was sustained over 3 years, including decreases in both office (−16.5 ± 28.6 mmHg, P < 0.001) and 24-h ambulatory SBP (−8.0 ± 20.0 mmHg; P < 0.001). Twenty-one percent of patients had a baseline estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m2. Between baseline and 3 years, renal function declined by 7.1 mL/min/1.73 m2 in patients without chronic kidney disease (CKD; eGFR ≥60 mL/min/1.73 m2; baseline eGFR 87 ± 17 mL/min/1.73 m2) and by 3.7 mL/min/1.73 m2 in patients with CKD (eGFR <60 mL/min/1.73 m2; baseline eGFR 47 ± 11 mL/min/1.73 m2). No long-term safety concerns were observed following the RDN procedure. Conclusion Long-term data from the Global SYMPLICITY Registry representing the largest available cohort of hypertensive patients receiving RDN in a real-world clinical setting demonstrate both the safety and efficacy of the procedure with significant and sustained office and ambulatory BP reductions out to 3 years.

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Safety and performance of the second generation EnligHTN™ Renal Denervation System in patients with drug-resistant, uncontrolled hypertension

Atherosclerosis ◽

10.1016/j.atherosclerosis.2017.04.022 ◽

2017 ◽

Vol 262 ◽

pp. 94-100 ◽

Cited By ~ 15

Author(s):

Stephen G. Worthley ◽

Gerard T. Wilkins ◽

Mark W. Webster ◽

Joseph K. Montarello ◽

Sinny Delacroix ◽

...

Keyword(s):

Renal Denervation ◽

Second Generation ◽

Uncontrolled Hypertension ◽

Drug Resistant ◽

And Performance

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TCT-761 Long-term (3-year) safety and effectiveness from the Global SYMPLICITY Registry of renal denervation in a real world patient population with uncontrolled hypertension

Journal of the American College of Cardiology ◽

10.1016/j.jacc.2016.09.791 ◽

2016 ◽

Vol 68 (18) ◽

pp. B308 ◽

Cited By ~ 3

Author(s):

Felix Mahfoud ◽

Nicole Brilakis ◽

Michael Böhm ◽

Krzysztof Narkiewicz ◽

Luis Ruilope ◽

...

Keyword(s):

Real World ◽

Patient Population ◽

Renal Denervation ◽

Uncontrolled Hypertension

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Intravascular Renal Denervation in Renal Dialysis Patients with Uncontrolled Hypertension: A Case Series of Four Patients

American Journal of Case Reports ◽

10.12659/ajcr.909820 ◽

2018 ◽

Vol 19 ◽

pp. 985-991 ◽

Cited By ~ 1

Author(s):

Päivi M. Pietilä-Effati ◽

Anna K. Salmela ◽

M. Juhani Koistinen

Keyword(s):

Renal Denervation ◽

Case Series ◽

Renal Dialysis ◽

Uncontrolled Hypertension ◽

Dialysis Patients

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Radiofrequency renal denervation with mono-electrode and multi-electrode device for treatment in patient with uncontrolled hypertension: results of a 6-month follow-up

Systemic Hypertension ◽

10.26442/2075082x.2020.1.200077 ◽

2020 ◽

Vol 17 (1) ◽

pp. 46-50 ◽

Cited By ~ 1

Author(s):

Regina A. Agaeva ◽

Nikolai M. Danilov ◽

Galina V. Shchcelkova ◽

Yuri G. Matchin ◽

Irina E. Chazova

Keyword(s):

Blood Pressure ◽

Arterial Hypertension ◽

Renal Denervation ◽

Blood Pressure Monitoring ◽

Hypotensive Effect ◽

Uncontrolled Hypertension ◽

Pressure Monitoring ◽

Group A ◽

Group B

Aim. To study the efficacy and safety of radiofrequency renal denervation with mono-electrode and multi-electrode devices in patients with uncontrolled arterial hypertension during а 6-month follow-up period. Materials and methods. The study included 52 patients with uncontrolled arterial hypertension, while receiving multicomponent antihypertensive therapy, including diuretic. Patients underwent radiofrequency renal denervation with a mono-electrode (group A; n=27) and multi-electrode devices (group B; n=25). The effectiveness of the procedure was study according to office blood pressure (BP) and ambulatory blood pressure monitoring (ABPM). Results. In group A and B, according to office BP after 6 months, there decreased in SBP/DBP by 32/14 and 30/10 mmHg (р=0.00001/р=0.00001 and p=0.00001/0.0004) respectively. According to ABPM, in group A there was a decrease in the average daily SBP and DBP by 7 and 4 mmHg (р=0.01 and р=0.03) respectively. According to ABPM, after 6 months in group B, there was a decrease in the average daily SBP and DBP by 12 and 6 mmHg (р=0.0003 and р=0.0007) respectively. Conclusions. The results confirm the safety and effectiveness of radiofrequency renal denervation. RDN of the distal branches of the renal arteries leads to a greater hypotensive effect.

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Confounding Factors in Renal Denervation Trials

Hypertension ◽

10.1161/hypertensionaha.120.15745 ◽

2020 ◽

Vol 76 (5) ◽

pp. 1410-1417

Author(s):

David E. Kandzari ◽

Felix Mahfoud ◽

Deepak L. Bhatt ◽

Michael Böhm ◽

Michael A. Weber ◽

...

Keyword(s):

Blood Pressure ◽

Clinical Trial ◽

Trial Design ◽

Renal Denervation ◽

Controlled Trial ◽

Clinical Trial Design ◽

Uncontrolled Hypertension ◽

Clinical Equipoise ◽

Confounding Factors ◽

Adherence Behavior

Recent randomized sham-controlled trials have demonstrated significant blood pressure reductions following renal denervation (RDN) in patients with hypertension, both in the presence and absence of antihypertensive therapy. These new data encouraged us to revisit previously published insights into potential clinical trial confounding factors that informed the design and conduct of forthcoming trials. Initially identified confounders related to procedural technique, medication variability, and selected patient subgroups have been addressed in contemporary trial design. Regarding procedural method and technology, blood pressure reductions may be improved by ensuring circumferential lesion creation in the distal renal arteries and branch vessels. Safety of the RDN procedure has been demonstrated in multiple independent meta-analyses including thousands of treated patients with low reported rates of renal vessel complications and maintenance of renal function. However, a newer generation of RDN trials has also introduced insights related to medication adherence, patient selection, and the definition of treatment response. Evolving evidence indicates that RDN therapy may be considered in higher risk populations of uncontrolled hypertension regardless of ethnicity and in patients expressing a strong preference for a nondrug therapy option. Despite advances in procedural technique and clinical trial conduct, inconsistent antihypertensive-drug adherence behavior remains perhaps the most critical clinical trial design issue for device-based hypertension therapies. As the balance in clinical equipoise increasingly favors RDN, justification of sham-controlled trial designs will be revisited, and novel study designs may be required to evaluate the safety and efficacy of novel devices and procedures intended to address the escalating prevalence of poorly controlled hypertension.

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