Extravascular Renal Denervation for Resistant Hypertension: First-in-Human Study

BACKGROUND: Catheter-based intravascular renal denervation produces modest, variable blood pressure reductions, partly because renal sympathetic nerves lie at variable depths within the periarterial adventitia and because accessory or early branching arteries are inaccessible to intraluminal catheters. We developed an extravascular renal denervation system (HyperQure) delivering circumferential radiofrequency energy from outside the artery and assessed its safety and efficacy. Here, we report the primary 3-month outcomes. METHODS: This prospective, multicenter, single-arm, first-in-human pilot trial enrolled 10 patients with resistant hypertension (office blood pressure ≥140/90 mm Hg and daytime ambulatory systolic blood pressure [SBP] ≥135 mm Hg despite ≥3 antihypertensive agents) across 7 Korean centers. All underwent bilateral extravascular renal denervation on stable antihypertensive regimens. The primary end point was 3-month change in 24-hour ambulatory SBP; safety outcomes were assessed through 3 months. RESULTS: All 10 patients (median age, 52.5 years; 7 men) completed follow-up. Seven patients (70%) had accessory or early branching arteries <3 mm typically ineligible for intravascular renal denervation; all were successfully ablated. Median 24-hour ambulatory SBP decreased by 25.0 mm Hg ( P =0.008) and median office SBP by 39.5 mm Hg ( P =0.002). Seven of 10 (70%) achieved office SBP <140 mm Hg despite a reduction in median antihypertensive burden from 6.0 to 4.5 agents. No major or procedure-related adverse events occurred; follow-up computed tomography angiography showed no vascular complications and renal function was preserved. CONCLUSIONS: Extravascular renal denervation using the HyperQure renal denervation System warrants evaluation in a larger controlled trial, particularly in patients with complex renal arterial anatomy.