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International Expert Consensus Statement: Percutaneous Transluminal Renal Denervation for the Treatment of Resistant Hypertension

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Catheter-based radiofrequency ablation technology to disrupt both efferent and afferent renal nerves has recently been introduced to clinical medicine after the demonstration of significant systolic and diastolic blood pressure reductions. Clinical trial data available thus far have been obtained primarily in patients with resistant hypertension, defined as standardized systolic clinic blood pressure ≥160 mm Hg (or ≥150 mm Hg in patients with type 2 diabetes) despite appropriate pharmacologic treatment with at least 3 antihypertensive drugs, including a diuretic agent. Accordingly, these criteria and blood pressure thresholds should be borne in mind when selecting patients for renal nerve ablation. Secondary forms of hypertension and pseudoresistance, such as nonadherence to medication, intolerance of medication, and white coat hypertension, should have been ruled out, and 24-h ambulatory blood pressure monitoring is mandatory in this context. Because there are theoretical concerns with regard to renal safety, selected patients should have preserved renal function, with an estimated glomerular filtration rate ≥45 ml/min/1.73 m2. Optimal periprocedural management of volume status and medication regimens at specialized and experienced centers equipped with adequate infrastructure to cope with potential procedural complications will minimize potential patient risks. Long-term safety and efficacy data are limited to 3 years of follow-up in small patient cohorts, so efforts to monitor treated patients are crucial to define the long-term performance of the procedure. Although renal nerve ablation could have beneficial effects in other conditions characterized by elevated renal sympathetic nerve activity, its potential use for such indications should currently be limited to formal research studies of its safety and efficacy.

Key Words

renal denervation
resistant hypertension
sympathetic

Abbreviations and Acronyms

ABPM
ambulatory blood pressure monitoring
AF
atrial fibrillation
BP
blood pressure
eGFR
estimated glomerular filtration rate
MSNA
muscle sympathetic nerve activity
NE
norepinephrine
PVI
pulmonary vein isolation
RDN
renal denervation
RF
radiofrequency

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This international expert consensus statement was the direct work product of members of the Global Medical Education Committee on Renal Denervation, convened and supported by Medtronic. The concept for this position paper was conceived and promoted solely by members of this education committee; at no time were members of the writing group directly compensated for their involvement in the manuscript concept development or its writing, editing, or submission. Medtronic was not involved in the choice of journal for review or its actual submission and response to the editors. The Writing Committee members were reimbursed for travel expenses and provided fair market value for their time in other committee activities unrelated to the writing and submission of this report. This report has not been endorsed by any international or national medical society, and no such endorsement was sought. Dr. Schlaich is supported by National Health and Medical Research Council research fellowships; and has received consulting fees and research support from Medtronic Ardian, Abbott, Novartis, Servier, and Boehringer Ingelheim. Dr. Schmieder has received lecture and consulting fees from Medtronic Ardian. Dr. Bakris has received investigator-initiated grant and research support (direct funding to The University of Chicago) from Forest Labs and Takeda; is a consultant for Takeda, Abbott, CVRx, Johnson & Johnson, Eli Lilly, the U.S. Food and Drug Administration, REATA, Medtronic, and Relapsya; serves on the boards of the National Kidney Foundation and the American Society of Hypertension; and is editor-in-chief of the American Journal of Nephrology and hypertension editor for UpToDate. Dr. Blankestijn has received consultancy and speaker’s fees from Medtronic and St. Jude Medical. Dr. Böhm has received fees for lectures and consultancy from Medtronic, Cordis, and Biosense Webster. Dr. Francis has received honoraria from Medtronic. Dr. Grassi has received grants for lectures and presentations at international scientific meetings from Medtronic. Dr. Hering has been supported by a research fellowship from the Foundation for Polish Science (KOLUMB/2010-1). Dr. Katholi provides consulting services to Medtronic. Dr. Kjeldsen has consulted and lectured for Bayer, Medtronic, Boehringer Ingelheim, Takeda, AZ, Leo, Nycomed, sanofi-aventis, and Sankyo. Dr. Krum is an investigator in studies sponsored by Medtronic and has received honoraria and lecture fees. Dr. Mahfoud is supported by Deutsche Hochdruckliga and Deutsche Forschungsgemeinschaft; and has received fees for lectures and consultancy from Medtronic Ardian, Cordis, St. Jude, and Covidien. Dr. Mancia has received consulting and lecture fees from Medtronic. Dr. Messerli has received consulting and lecture fees from Medtronic. Dr. Narkiewicz has received honoraria (board membership, consultancy, and payment for lectures) from Medtronic. Dr. Parati has received consulting and lecture fees from Medtronic. Dr. Rocha-Singh is a consultant for Medtronic Ardian. Dr. Ruilope has served as adviser and speaker for Medtronic Ardian. Dr. Rump has received speaker’s honoraria and travel support from Medtronic Ardian. Dr. Sobotka is a former employee of Medtronic Ardian. Dr. Tsioufis has received research grants and lecture and consulting fees from St. Jude Medical; and travel support from Medtronic. Dr. Vonend has received speaker’s honoraria and travel support from Medtronic Ardian. Dr. Weber provides consulting services to Medtronic and Boston Scientific. Dr. Williams is a National Institute for Health Research senior investigator; and a member of the Global Scientific Steering Committee for Renal Denervation of Medtronic. Dr. Zeller has received fees for lectures and consultancy from Medtronic Ardian. Dr. Esler is supported by National Health and Medical Research Council research fellowships; and has received consulting fees and research support from Medtronic Ardian and Kona Medical. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.