Long-Term Results up to 12 Months After Catheter-Based Alcohol-Mediated Renal Denervation for Treatment of Resistant Hypertension.

"Disclosures Dr Mahfoud is supported by Deutsche Gesellschaft für Kardiologie (DGK), and Deutsche Forschungsgemeinschaft (SFB TRR219) and has received scientific support and speaker honoraria from Bayer, Boehringer Ingelheim, Medtronic, and ReCor Medical. Dr Schmieder reports grants and personal fees from Ablative Solutions Inc, Medtronic, ReCor Medical, and ROX. Dr van der Giet received honoraria from CVRX. Dr Fischell is an employee and shareholder in Ablative Solutions Inc. Dr Pathak received speaker honoraria from Ablative Solutions Inc, Medtronic, and ReCor Medical and is investigator for trials sponsored by Medtronic, ReCor Medical, and Ablative Solutions Inc. Dr Bertog has received travel reimbursement from Ablative Solutions Inc, and Medtronic and is the co-owner of Cardiorenal LLC. The other authors report no conflicts."

"Sources of Funding This work was supported by Ablative Solutions, Inc."

"After a stable antihypertensive medication regimen of at least 4 weeks, 45 eligible patients with mean office BP of 169/99±15/13 mm Hg, corresponding 24-hour mean ambulatory BP of 151/89±14/12 mm Hg, and with suitable renal arterial anatomy evaluated with a preprocedural renal duplex ultrasound (RDUS) and computed tomographic angiography/magnetic resonance angiography, underwent bilateral RDN (of each of the 2 renal arteries). Four patients each had 1 accessory renal artery treated in addition to the 2 main renal arteries, and one patient had 2 procedures staged for unilateral treatment of each renal artery. Therefore, a total of 94 renal arteries were treated using the Peregrine Catheter with 0.6 mL of alcohol infused per renal artery and with a mean (SD) distance from the ostium to the infusion site of 20.2 (6.6) mm. All 46 procedures were technically successful without device deficiencies, with a mean treatment time of 7±3 minute/artery (Table I in the Data Supplement). No general anesthesia and minimal conscious sedation was given. Mild or no pain was reported during alcohol infusion in 50/87 (57%) renal arteries for which periprocedural pain data were obtained. There were 2 vascular access pseudoaneurysms, both without longer-term sequelae. The patients were seen at scheduled visits at 7 days, 1 month, and 3, 6, and 12 months. At the 12-month visit, patients came to the study center to undergo seated office BP measurements (triplicate readings), RDUS, a physical exam and laboratory assessments, and to record adverse events and antihypertensive medications. Seated office BP was measured with the same validated device (Omron 705IT with printer, Omron, Kyoto, Japan) in all patients, as described previously. Sequential 24-hour ambulatory BP measurements were recorded to assess eligibility at baseline, after the 4-week stable regimen of antihypertensive medications and at 1, 3, 6 and 12 months post-procedure (Spacelabs Healthcare Monitor, Spacelabs Healthcare, Snoqualmie, Washington), as described previously. All 24-hour ambulatory BP readings were sent to a core laboratory (ERT, St. Louis, MO). Renal artery imaging by RDUS, computed tomographic angiography or magnetic resonance angiography was performed at baseline, and at 6 and 12 months to detect renal artery stenosis; images were assessed by a core laboratory (Cardiovascular Core Analysis Laboratory, Stanford University, Stanford, California), as described previously. The trial is registered at www.ClinicalTrials.gov, NCT02570113. Registration:: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02570113."