Preliminary experience with Ardian Symplicity system in renal denervation for the treatment of arterial hypertension resistant to medical therapy

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1 Preliminary experience with Ardian Symplicity system in renal denervation for the treatment of arterial hypertension resistant to medical therapy Poster No.: C-0768 Congress: ECR 2011 Type: Scientific Exhibit Authors: G. Simonetti 1, A. Spinelli 1, R. Gandini 1, V. Da Ros 1, E. Gaspari 1, I. Coco 2, M. De Francesco 1, N. Di Daniele 1, R. Lauro 1 ; 1 Rome/IT, 2 Roma/IT Keywords: DOI: Hypertension, Treatment effects, Diagnostic procedure, Ablation procedures, Image manipulation / Reconstruction, CT- Angiography, Catheter arteriography, Kidney, Interventional vascular /ecr2011/C-0768 Any information contained in this pdf file is automatically generated from digital material submitted to EPOS by third parties in the form of scientific presentations. References to any names, marks, products, or services of third parties or hypertext links to thirdparty sites or information are provided solely as a convenience to you and do not in any way constitute or imply ECR's endorsement, sponsorship or recommendation of the third party, information, product or service. ECR is not responsible for the content of these pages and does not make any representations regarding the content or accuracy of material in this file. As per copyright regulations, any unauthorised use of the material or parts thereof as well as commercial reproduction or multiple distribution by any traditional or electronically based reproduction/publication method ist strictly prohibited. You agree to defend, indemnify, and hold ECR harmless from and against any and all claims, damages, costs, and expenses, including attorneys' fees, arising from or related to your use of these pages. Please note: Links to movies, ppt slideshows and any other multimedia files are not Page 1 of 21

2 available in the pdf version of presentations. Page 2 of 21

3 Purpose The treatment of essential hypertension is currently based on the use of safe and effective drug therapies to reduce sympathetic hyperactivity. Today it is estimated that only 65% of patients treated with medical therapy obtained satisfactory blood pressure levels, as to relate to the inability of doctors to obtain appropriate blood pressure control despite the use of all drug therapies available, and the frequent poor compliance of patients who do not like recruiting medicines for life for treatment of a disease asyntomatic for a long time. This is the context of a subgroup of patients with "uncontrolled hypertension" or patients taking at least 3 antihypertensive drugs, and yet have blood pressure> 160/90 mmhg. The aim of this study was to assess the efficacy and safety of percutaneous treatment with Symplicity Ardian system in the treatment of patients with essential hypertension resistant to conventional drug therapy. Page 3 of 21

4 Methods and Materials In September 2010, 5 patients affected by essential hypertension, treated with at least four anti-hypertensive medications and non responders to the medical treatment, underwent cathter-based procedure for renal denervation of both renal artery. Followup visits were scheduled at 30 and 60 days. Renal Angio-CT was perfomed few days before the procedure for the evaluation of renal anatomy and a correct planning. ECD and resistive index (RI) of both renal artery, estimated glomerular filtration rate (GFR) with Cockroft-Gault and pressure Holter were done before, at 30 days and 60 days after procedure. Primary endpoints were office blood pressure and safety data at 1 and 2 months follow-up after procedure. Blood-pressure lowering effectiveness was assessed by student t test. Inclusion / exclusion criteria Inclusion criteria were as follows : - Essential hypertension not responding to drug therapy with three or more antihypertensive drugs including a diuretic. Systolic blood pressure (SBP) = /> 160 mmhg. - Normal renal function (GFR> 90 ml / min) or chronic renal failure, mild (GFR ml / min) or moderate (GFR ml / min), according to the NKF-KDOQI guidelines, based on the value of the GFR calculated using the Cockroft-Gault formula. - Age > 18 and < 75 years. - Absence of systemic or renal disease with possible renal involvement. - Length of renal artery # 2cm and a minimum diameter at ostium # 4mm. - No evidence of accessory renal arteries - Pathological microalbuminuria (> 300 mg/24 h). - Normoalbuminuria ( mg/24 h). - No abnormalities on fundus examination (variable degrees of hypertensive retinopathy) or echocardiographic examination (left ventricular hypertrophy). Exclusion criteria were: - Clinical evidence of secondary hypertension: Page 4 of 21

5 Renal - Endocrine Parenchymal pathology (acute and chronic glomerulonephritis, polycystic kidney disease, diabetic nephropathy, hydronephrosis) Vascular pathology (renal artery stenosis or vasculitis) Renin-secreting tumors Acromegaly, hypothyroidism, hyperthyroidism, primary hyperparathyroidism Pathology of adrenal cortex (Cushing's syndrome, primary iperaldosteronism, congenital adrenal hyperplasia) or medullary (pheochromocytoma) Extrasurrenal Chromaffin Tumors Carcinoid Aortic coartaction Pregnancy Neurological disease Drug (oral contraceptives, nasal decongestants or systemic sympathomimetics, corticosteroids, NSAIDs, cyclosporine, tacrolimus, lithium, licorice or carbenoxolone preparations, tricyclic antidepressants, beta-blockers in the event of abrupt suspension, abuse of alcohol or drugs Kidney disease characterized by lesions different by nephroangiosclerosis documented with previous renal biopsy or with medical history or anatomical abnormalities. - Chronic renal failure (GFR ml / min) and ESRD - End Stage Renal Disease (GFR <15 ml / min) in patients with renal replacement therapy with hemodialysis or peritoneal dialysis. - Heart failure class III-IV - Cardiac ischemic events NHYA in previus 6 months. - Cerebral ischemic events - Significant or symptomatic carotid artery stenosis in patients treated with clonidine, moxonidine, rilmetidina and farfari. - Hemodynamically significant valvular disease - PMK and / or Defibrillators. - History of coagulopathies - Neoplasms Page 5 of 21

6 Images for this section: Fig. 0 Dipartimento di Diagnostica per Immagini, Imaging Molecolare, Radiologia Page 6 of 21

7 Fig. 0 Dipartimento di Diagnostica per Immagini, Imaging Molecolare, Radiologia Page 7 of 21

8 Fig. 0: Digital Subtraction Angiography (DSA): length (>20mm) and diameter (>4mm) measurement of left renal arterial, corresponding to anatomical inclusion criteria for the endovascular treatment. Dipartimento di Diagnostica per Immagini, Imaging Molecolare, Radiologia Page 8 of 21

9 Fig. 0: Angiography Imaging shows the procedural phases in the treatment of right renal arterial. A series of endovascular ablations with retraction interval (5 mm) and torsion angle of 90 by Simplicity catheter on the proximal-superior portion of renal arterial. Dipartimento di Diagnostica per Immagini, Imaging Molecolare, Radiologia Fig. 0: Angiography Imaging shows the procedural phases in the treatment of right renal arterial. A series of endovascular ablations with retraction interval (5 mm) and torsion angle of 90 by Simplicity catheter on the the distal-inferior portion of renal arterial. Page 9 of 21

10 Dipartimento di Diagnostica per Immagini, Imaging Molecolare, Radiologia Fig. 0: Study population. Pt: patients; T0: basal blood-pressure value and pharmacological therapy during the enrollment of patients; GFR: glomerular filtration rate Dipartimento di Diagnostica per Immagini, Imaging Molecolare, Radiologia Page 10 of 21

11 Fig. 0: MSCT of right renal artery with VR Dipartimento di Diagnostica per Immagini, Imaging Molecolare, Radiologia Page 11 of 21

12 Fig. 0: MSCT with AVA, Curved and axial MPR Dipartimento di Diagnostica per Immagini, Imaging Molecolare, Radiologia Page 12 of 21

13 Results In the treated patients, baseline mean office blood pressure was 171/100 mmhg (SD 35/20), (mean 4-7 antihypertensive medications); mean GFR was 91,6 ml/min/1.73 m 2 (SD 15). Office blood pressures after procedure were reduced by -25/-16 and -23/-13 mmhg at 1 and 2 months, respectively. In each patients medical therapy was reduced in both number and drugs dosage. Any intra or periprocedural or renovascular complications were not observed. Page 13 of 21

14 Images for this section: Fig. 0: Study population. Pt: patients; T0: basal blood-pressure value and pharmacological therapy during the enrollment of patients; GFR: glomerular filtration rate Dipartimento di Diagnostica per Immagini, Imaging Molecolare, Radiologia Page 14 of 21

15 Fig. 0: Study population. Follow-up. Pt: patients; T0: basal blood-pressure value and pharmacological therapy during the enrollment of patients; T1: blood-pressure value and pharmacological therapy at 30 days post-procedural. Dipartimento di Diagnostica per Immagini, Imaging Molecolare, Radiologia Page 15 of 21

16 Fig. 0: Study population. Follow-up. Pt: patients; T1: blood-pressure value and pharmacological therapy at 30 days post-procedural. T2: blood-pressure value and pharmacological therapy at 60 days post-procedural. Dipartimento di Diagnostica per Immagini, Imaging Molecolare, Radiologia Page 16 of 21

17 Conclusion The therapeutic sympathetic renal denervation is a innovative, fast, easy and safe percutaneous procedure for the treatment of patients with hypertension refractory to conventional drug therapy. The clinical and procedural efficacy has been demonstrated by the achievement of significant and sustained reductions in blood pressure in the population studied, without significant complications intra / peri-and post-procedure. Despite the results of this study are encouraging, confirmation on prospective randomized studies, cohort of patients more extensive and follow-up longer in order to definitively validate the technique is mandatory. Page 17 of 21

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21 Personal Information Page 21 of 21