Abstract 485: An Urologic-nephrologic Based Approach to Resistant Hypertension: Early Clinical Experience with a Non-vascular Treatment
The Symplicity HTN-3 recently failed to meet its primary efficacy endpoint in blood pressure reduction. The natural orifice denervation system developed by Verve Medical directs radiofrequency energy to the renal pelvic space where the preponderance of afferent nerves originate. We have previously demonstrated the feasibility of the Verve Medical NephroBlate to ablate these nerves. We developed a protocol to treat a small number of patients (n=3, 4 kidneys) undergoing elective nephrectomy at Muljibhai Patel Urological Hospital on Nadiad, India. We treated three patients with end stage kidney disease prior to explants of the affected diseased kidney. One patient was pre-renal transplant and had both kidneys treated. One week after fluoroscopically aided transurethral treatment with the NephroBlate™ device, the previously planned nephrectomy was performed. Procedure time was between 9 to 15 minutes and no adverse effects were recorded. The histopathological results in all cases showed a significant destruction of the peri-pelvic nerves from the renal pelvic space to the serosa (1.75mm). With a significant elimination of most of the afferent and efferent nerves in the treated area(approximately 1cm), and no change to the adjacent nerves in the control segments in the histopathologic specimens, as well as a safe and painless procedure for the patients, we proceeded with our clinical studies on resistant hypertensive patients. As in the diseased kidney study, the procedures were done under general anesthesia. Within 30 seconds of treatment of the first kidney, a blood pressure response was noted (reduction of mean systolic blood pressure 44mmHg, reduction of mean diastolic blood pressure 13mmHg). Following the procedure, none of the patients had significant pain or bleeding. At one month follow-up, the patients continue to be normotensive with no renal issues. This very small series did not exclude any patients with renal disease and no patients received any anticoagulants. The blood pressure response was immediate and occurred while the patients were under general anesthesia. In this small series of humans treated with limited follow-up, we see a promising nonvascular alternative for renal denervation for treatment for resistant hypertension.
Author Disclosures: R. Heuser: F. Ownership Interest (includes any stock, stock option, partnership, membership or other equity position in an entity regardless of the form of the entity, or any option or right to acquire such position, and any rights in any patent or other intellectu; Significant; Verve Medical. T. Buena: F. Ownership Interest (includes any stock, stock option, partnership, membership or other equity position in an entity regardless of the form of the entity, or any option or right to acquire such position, and any rights in any patent or other intellectu; Modest; Verve Medical. H. Other; Modest; President & CEO. R. Cooper: H. Other; Modest; Verve Medical. A. Gold: A. Employment; Modest; Verve Medical, Director R&D. R. Rao: A. Employment; Modest; Verve Medical, Sr. Project Engineer. W. Van Alstine: G. Consultant/Advisory Board; Modest; Verve Medical. M. Desai: G. Consultant/Advisory Board; Modest; Verve Medical.
- © 2014 by American Heart Association, Inc.