GW26-e2233 Noninvasive Renal Denervation for Resistant Hypertension Using High-intensity Focused Ultrasound

Renal denervation (RDN) has emerged as a promising therapy for patients with resistant hypertension and other diseases related to sympathetic overactivation.1 High-intensity focused ultrasound (HIFU) has been demonstrated to be a novel strategy for effective noninvasive deep tissue ablation in clinical practice.2 The exploration of HIFU has expanded to cardiovascular research, such as noninvasive septal and electrophysiological ablations.3,4 We previously reported that efficient RDN can be achieved using the HIFU procedure with an excellent safety profile in a canine model.5 Thus, the clinical use of HIFU-based RDN to treat resistant hypertension should be investigated. This clinical study was approved by the Institutional Ethical Review Committee at The Second Affiliated Hospital of Chongqing Medical University and was registered with the Chinese Clinical Trial Registry (Registration No. ChiCTR-ONC-13003231). The primary efficacy objective was the change in average 24-hour ambulatory systolic blood pressure at 6 months. The primary safety objective was all adverse events during the study. Eligible patients were treated with HIFU-based RDN from August 2013 to May 2014 with 6 months of follow-up. Written informed consent was obtained from all of the enrolled patients. The enrollment criteria included adult patients with resistant hypertension or patients who could not tolerate antihypertensive medications. The participating patients received stable antihypertensive drug regimen for at least 4 weeks before enrollment and were evaluated by ambulatory blood pressure monitoring to exclude the white coat hypertension and pseudohypertension. A complete listing of the key inclusion and exclusion criteria is shown in Table 1. View this table: Table 1. Key Eligibility Criteria Baseline data collection included the medical history, physical examination, review of medications, ambulatory blood pressure monitoring, office blood pressure (BP), Holter monitoring (including heart rate variability [HRV] analysis), renal artery computed tomography angiography, echocardiography, plasma noradrenaline level, and blood chemistries test (including serum creatinine, …