First Report of the Global SYMPLICITY Registry on the Effect of Renal Artery Denervation in Patients With Uncontrolled Hypertension

Abstract

Abstract-This study aimed to assess the safety and effectiveness of renal denervation using the Symplicity system in realworld patients with uncontrolled hypertension (NCT01534299). The Global SYMPLICITY Registry is a prospective, open-label, multicenter registry. Office and 24-hour ambulatory blood pressures (BPs) were measured. Change from baseline to 6 months was analyzed for all patients and for subgroups based on baseline office systolic BP, diabetic status, and renal function; a cohort with severe hypertension (office systolic pressure, ≥160 mm Hg; 24-hour systolic pressure, ≥135 mm Hg; and ≥3 antihypertensive medication classes) was also included. The analysis included protocol-defined safety events. Six-month outcomes for 998 patients, including 323 in the severe hypertension cohort, are reported. Mean baseline office systolic BP was 163.5±24.0 mm Hg for all patients and 179.3±16.5 mm Hg for the severe cohort; the corresponding baseline 24-hour mean systolic BPs were 151.5±17.0 and 159.0±15.6 mm Hg. At 6 months, the changes in office and 24-hour systolic BPs were −11.6±25.3 and −6.6±18.0 mm Hg for all patients (P<0.001 for both) and −20.3±22.8 and −8.9±16.9 mm Hg for those with severe hypertension (P<0.001 for both). Renal denervation was associated with low rates of adverse events. After the procedure through 6 months, there was 1 new renal artery stenosis >70% and 5 cases of hospitalization for a hypertensive emergency. In clinical practice, renal denervation resulted in significant reductions in office and 24-hour BPs with a favorable safety profile. Greater BP-lowering effects occurred in patients with higher baseline pressures. Clinical Trial Registration-URL: www.clinicaltrials.gov. Unique identifier: NCT01534299 ) in which sympathetic hyperactivity may play a role in addition to and independently of the BP increase. 5Because RDN is an interventional procedure that may expose patients to some risks and could increase costs, large databases on safety and efficacy in clinical practice settings, without the strict inclusion and exclusion criteria and site selection used in clinical trials, are needed. The Global SYMPLICITY registry (GSR) 19 will provide data on periprocedural and renal safety as well as the effectiveness of BP reduction in such a real-world population of patients undergoing RDN. Herein, the GSR investigators report on the 6-month follow-up of the largest group of hypertensive patients to undergo RDN in an uncontrolled global clinical setting. Methods DesignThis analysis is based on 998 patients with complete safety and office BP data at baseline and 6 months of follow-up, who underwent RDN from February 1, 2012, to September 9, 2013. One-hundred thirtyfour centers in Canada, Western Europe, Latin America, Eastern Europe, South Africa, Middle East, Asia, Australia, and New Zealand were involved (see online-only Data Supplement).The study design of the prospective, open-label, multicenter GSR has been published previously. 19 In brief, the registry will include ≤5000 patients with hy...

Impact of Renal Denervation on Atrial Arrhythmogenic Substrate in Ischemic Model of Heart Failure

“…The beneficial myocardial effects of RDN were shown in the present study, whereas off‐target effects of RDN (eg, postprocedural blood pressure reduction, worsening renal function, and vascular complication) were also reported previously 35, 36. Therefore, careful patient selection should be clinically considered in the application of RDN.…”

Impact of Renal Denervation on Patients With Obstructive Sleep Apnea and Resistant Hypertension – Insights From the SYMPLICITY HTN-3 Trial –

“…37, 38 The reduction in 24-h ambulatory SBP after RDN was less pronounced than the reduction in office SBP, in both OSA and non-OSA subjects, a phenomenon observed not only in the SYMPLICITY HTN-3 trial but in other studies of RDN. 38, 39 This difference in office and ambulatory BP reductions appears to be greater with increasing baseline BP. 40 Compared with 24-h ambulatory BP, office BP is more susceptible to white coat hypertension, Hawthorne effect, measurement bias, and measurement variability.…”

Pharmacological Monotherapy versus Renal Artery Denervation in Controlled Hypertensive Patients

“…Greater BP-lowering effects occurred in patients with higher baseline pressures. [34] The recent results of the SYMPLICITY HTN-3 trial have challenged preclinical science, clinical anecdote, and the consistency observed across early phase trials. Although the trial demonstrated the safety of RSD, among 535 patients identified with treatment-resistant hypertension the difference in 6-month BP decline between RSD and sham-treatment groups was not significantly different for office or ambulatory measures.…”