Author + information
- Received February 9, 2016
- Revision received March 23, 2016
- Accepted April 7, 2016
- Published online June 27, 2016.
- Petr Neuzil, MDa,
- John Ormiston, MDb,
- Todd J. Brinton, MDc,
- Zdenek Starek, MDd,
- Murray Esler, MDe,
- Omar Dawood, MDf,
- Thomas L. Anderson, PhDf,
- Michael Gertner, MDf,
- Rob Whitbourne, MD, PhDg and
- Roland E. Schmieder, MDh,∗ ()
- aDepartment of Cardiology, Homolce Hospital, Prague, Czech Republic
- bMercy Hospital, Mercy Angiography, Auckland, New Zealand
- cDivision of Cardiovascular Medicine, Stanford University, Stanford, California
- dI. International Clinical Research Center, St. Anne’s University Hospital, 1st Department of Internal Medicine/Cardioangiology, Brno, Czech Republic
- eBaker IDI Heart and Diabetes Institute, Melbourne, Victoria, Australia
- fKona Medical, Bellevue, Washington
- gCardiac Investigation Unit, St. Vincents Hospital, Fitzroy, Australia
- hDepartment of Nephrology and Hypertension, University Hospital Erlangen, University Erlangen-Nürnberg, Erlangen, Germany
- ↵∗Reprint requests and correspondence:
Prof. Dr. Roland E. Schmieder, University Hospital Erlangen, Nephrology und Hypertension, Ulmenweg 18, Erlangen 91054, Germany.
Objectives The aim of this study was to assess clinical safety and efficacy outcomes of renal denervation executed by an externally delivered, completely noninvasive focused therapeutic ultrasound device.
Background Renal denervation has emerged as a potential treatment approach for resistant hypertension.
Methods Sixty-nine subjects received renal denervation with externally delivered focused ultrasound via the Kona Medical Surround Sound System. This approach was investigated across 3 consecutive studies to optimize targeting, tracking, and dosing. In the third study, treatments were performed in a completely noninvasive way using duplex ultrasound image guidance to target the therapy. Short- and long-term safety and efficacy were evaluated through use of clinical assessments, magnetic resonance imaging scans prior to and 3 and 24 weeks after renal denervation, and, in cases in which a targeting catheter was used to facilitate targeting, fluoroscopic angiography with contrast.
Results All patients tolerated renal denervation using externally delivered focused ultrasound. Office blood pressure (BP) decreased by 24.6 ± 27.6/9.0 ± 15.0 mm Hg (from baseline BP of 180.0 ± 18.5/97.7 ± 13.7 mm Hg) in 69 patients after 6 months and 23.8 ± 24.1/10.3 ± 13.1 mm Hg in 64 patients with complete 1-year follow-up. The response rate (BP decrease >10 mm Hg) was 75% after 6 months and 77% after 1 year. The most common adverse event was post-treatment back pain, which was reported in 32 of 69 patients and resolved within 72 h in most cases. No intervention-related adverse events involving motor or sensory deficits were reported. Renal function was not altered, and vascular safety was established by magnetic resonance imaging (all patients), fluoroscopic angiography (n = 48), and optical coherence tomography (n = 5).
Conclusions Using externally delivered focused ultrasound and noninvasive duplex ultrasound, image-guided targeting was associated with substantial BP reduction without any major safety signals. Further randomized, sham-controlled trials will be needed to validate this unique approach.
Dr. Brinton received personal fees from Kona Medical during the conduct of the study; and personal fees from Kona Medical outside the submitted work. Dr. Esler received grants from Kona Medical during the conduct of the study and grants; and personal fees from Medtronic outside the submitted work. Dr. Dawood received personal fees from Kona Medical during the conduct of the study. Dr. Anderson is an employee of Kona Medical. Dr. Gertner is the chief executive officer and founder of Kona Medical. Dr. Whitbourne received grants and personal fees from Kona Medical during the conduct of the study. Dr. Schmieder received grants and personal fees from Kona Medical during the conduct of the study. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose. Drs. Neuzil and Ormiston contributed equally to this work.
- Received February 9, 2016.
- Revision received March 23, 2016.
- Accepted April 7, 2016.
- American College of Cardiology Foundation