The blood pressure lowering effects of renal denervation in a real world population of patients with uncontrolled hypertension: early outcomes from the Global SYMPLICITY registry

Abstract

Purpose: The Global SYMPLICITY Registry was designed to assess the safety and effectiveness of low energy radiofrequency ablation of renal artery nerves using the Symplicity™ renal denervation system to lower blood pressure in a real world population of hypertensive patients. The registry will provide additional data regarding the effects of renal denervation on comorbid conditions that are postulated to be similarly influenced by increased sympathetic tone. Methods: The Global SYMPLICITY Registry is a prospective, open-label, multi-centre study enrolling patients at up to 200 sites worldwide. Adult patients with uncontrolled hypertension who are considered appropriate candidates for renal denervation by their physician are treated with the Symplicity™ catheter according to the approved Instructions for Use. Office-based and ambulatory blood pressure measurements, changes in antihypertensive medications and measures of renal function, vascular complications and other protocol-defined safety events and other tests specific to the patient's clinical condition(s) are collected. Results: There are currently 752 patients enrolled with approximately half being enrolled in Germany. Based on preliminary data from 588 treated patients the mean age of patients is 60.0±12.8 years, 62.% are males, and 36.2% have at least one comorbidity (42.0% have diabetes mellitus, 8.5% have heart failure, 11.9% have a history of atrial fibrillation, 29.5% have chronic kidney disease, and 14.5% have sleep apnea). At baseline, those being treated for hypertension were taking an average of 4.2±1.3 anti-hypertensive medications and had an office systolic BP of 163.8±22.7 mm Hg. Change in office and ambulatory blood pressure at 3 and 6 month follow-up in approximately 200 real world patients treated with the Symplicity catheter will be available for presentation at ESC. Periproce-dural and short-term safety will also be reported. Conclusion: Renal denervation can significantly lower blood pressure in patients with treatment-resistant hypertension. This large real world registry will provide a large body of safety and efficacy data to further guide appropriate use of RDN in diverse patient populations.