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Title: | Renal denervation with a percutaneous bipolar radiofrequency balloon catheter in patients with resistant hypertension: 6-month results from the REDUCE-HTN clinical study. | Authors: | Meredith I.T. ;Cohen-Mazor M.;Hoppe U.C.;Walters D.L.;Diaz-Cartelle J.;Azizi M.;Sievert H.;Schofer J.;Ormiston J. | Institution: | (Sievert) CardioVascular Center Frankfurt CVC, Seckbacher Landstrasse 65, Frankfurt 60389, Germany (Schofer) Universitares Herz- und Gefaszentrum, Hamburg, Germany (Ormiston) Mercy Angiography, Auckland, New Zealand (Hoppe) Paracelsus Medical University, Salzburg, Austria (Meredith) MonashHEART, Monash Health, Melbourne, Australia (Walters) Prince Charles Hospital, Brisbane, Australia (Azizi) APHP, Hopital Europeen Georges Pompidou, Hypertension Unit, Paris, France (Azizi) Paris Descartes University, Paris, France (Diaz-Cartelle, Cohen-Mazor) Boston Scientific Corporation, Marlborough, MA, United States (Cohen-Mazor) Vessix Vascular, Laguna Hills, CA, United States | Issue Date: | 17-Mar-2015 | Copyright year: | 2015 | Publisher: | EuroPCR | Place of publication: | France | Publication information: | EuroIntervention. 10 (10) (pp 1213-1220), 2015. Date of Publication: 01 Feb 2015. | Journal: | EuroIntervention | Abstract: | Aims: To evaluate the safety and efficacy of the balloon-based bipolar Vessix Renal Denervation System in treating patients with resistant hypertension. Methods and Results: In this prospective, multicentre, single-arm study, 146 patients (age 58.6+/-10.5 years; 61% men) with office systolic blood pressure (BP) >=160 mmHg despite >=3 antihypertensive medications at maximally tolerated doses were treated with the Vessix System. Efficacy endpoints were reductions in office and 24-hour ambulatory systolic and diastolic BPs at six months. Acute and long-term safety, with a focus on the renal artery and estimated glomerular filtration rate (eGFR), were assessed. Baseline office and ambulatory BPs were 182.4+/-18.4/100.2+/-14.0 mmHg and 153.0+/-15.1/87.5+/-13.2 mmHg, respectively. No acute renal artery injury requiring intervention or serious periprocedural cardiovascular events occurred. At six months, office BP was reduced by 24.7+/-22.1/10.3+/-12.7 mmHg (p<0.0001) and ambulatory BP was reduced by 8.4+/-14.4/5.9+/-9.1 mmHg (N=69; p<0.0001). Twenty-six patients (18%) achieved an office systolic BP <140 mmHg. One patient had renal artery stenosis which required stenting. Mean eGFR remained stable. Conclusion(s): Renal artery denervation with the Vessix System reduced both office and ambulatory BP at six months in patients with resistant hypertension. Renal artery safety and renal function results are favourable.Copyright © Europa Digital & Publishing 2015. All rights reserved. | DOI: | http://monash.idm.oclc.org/login?url=http://dx.doi.org/10.4244/EIJY14M12-01 | PubMed URL: | 25452197 [http://www.ncbi.nlm.nih.gov/pubmed/?term=25452197] | ISSN: | 1774-024X | URI: | https://repository.monashhealth.org/monashhealthjspui/handle/1/40650 | Type: | Article | Subjects: | *balloon catheter artery thrombosis/co [Complication] article blood pressure measurement blood pressure monitoring clinical effectiveness controlled study diastolic blood pressure false aneurysm/co [Complication] female flank pain/co [Complication] *generator glomerulus filtration rate hematoma/co [Complication] human infection/co [Complication] kidney artery stenosis/co [Complication] kidney artery stenosis/di [Diagnosis] kidney artery stenosis/su [Surgery] *kidney denervation *kidney denervation system major clinical study male multicenter study prospective study *radiofrequency ablation renal artery *resistant hypertension/dt [Drug Therapy] *resistant hypertension/su [Surgery] resistant hypertension/dt [Drug Therapy] safety stent systolic blood pressure vomiting/co [Complication] adrenergic receptor blocking agent/dt [Drug Therapy] aldosterone antagonist/dt [Drug Therapy] alpha 1 adrenergic receptor blocking agent/dt [Drug Therapy] angiotensin receptor antagonist/dt [Drug Therapy] beta adrenergic receptor blocking agent/dt [Drug Therapy] calcium channel blocking agent/dt [Drug Therapy] dipeptidyl carboxypeptidase inhibitor/ae [Adverse Drug Reaction] dipeptidyl carboxypeptidase inhibitor/dt [Drug Therapy] diuretic agent/ae [Adverse Drug Reaction] diuretic agent/dt [Drug Therapy] hydroxymethylglutaryl coenzyme A reductase inhibitor/ae [Adverse Drug Reaction] hydroxymethylglutaryl coenzyme A reductase inhibitor/dt [Drug Therapy] nitrate/dt [Drug Therapy] renin inhibitor/dt [Drug Therapy] vasodilator agent/dt [Drug Therapy] estimated glomerular filtration rate femoral artery thrombus/co [Complication] acute kidney failure/si [Side Effect] adult angioplasty antihypertensive therapy artery injury glomerulus filtration rate systolic blood pressure vomiting / complication infection / complication human hematoma / complication acute kidney failure / side effect adult angioplasty antihypertensive therapy artery injury artery thrombosis / complication Article *balloon catheter blood pressure measurement blood pressure monitoring clinical effectiveness controlled study diastolic blood pressure false aneurysm / complication female flank pain / complication *generator kidney artery stenosis / complication / diagnosis / surgery *kidney denervation *kidney denervation system major clinical study male multicenter study prospective study *radiofrequency ablation renal artery *resistant hypertension / *drug therapy / *surgery resistant hypertension / drug therapy safety stent |
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