With an unrestricted educational grant from. The Interventional Treatment of Resistant Hypertension

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1 With an unrestricted educational grant from The Interventional Treatment of Resistant Hypertension

2 Felix Mahfoud Interventional Cardiology University Hospital Homburg/Saar Germany Dr. Mahfoud graduated from the medical school of Frankfurt, Germany With >450 cases performed his institution has the biggest experience with renal denervation worldwide Member of the Working Group Interventional Hypertension Treatment of the European Society of Hypertension He was involved in all SYMPLICITY trials and registries

3 Jean Renkin Interventional Cardiologist Assistant Professor of Cardiology Catheterization Laboratory UCL St Luc University Hospital Brussels Belgium Prof. Renkin is active in interventional cardiology since his fellowship at the Montreal Heart Institute in the 80 Mainly involved in coronary artery disease therapy More focused on TAVI and Renal Denervation procedures during the last years He was co-investigator in the SymplicityHTN2 trial

4 Pierre-Francois Plouin Internist, Professor of Cardiovascular Medicine Hopital Europeen Georges Pompidou, Paris, France Head of the Department of Hypertension and Vascular Medicine Past-President of the French Society of Hypertension Leads COMETE (COrtico and MEdullary adrenal Tumors), French network on adrenal tumors Co-founder of the European Network on Adrenal Tumors Member of European and International Societies of Hypertension & Endocrinology

5 Will McKane Clinical Director of Sheffield Kidney Institute Sheffield Teaching Hospitals NHS Trust UK Dr McKane graduated from University of Cambridge and the Medical School of St Bartholomew s Hospital in London He undertook his nephrology training at St Mary s Hospital, London and completed a PhD in the field of xenotransplantation at Imperial College He was appointed to the Sheffield Kidney Institute in 2001 with specific clinical expertise in transplantation and became head of department in 2007

6 Thomas Zeller Head, Department of Angiology at Universitäts - Herzzentrum Freiburg Bad Krozingen, Bad Krozingen Germany Member Guideline Commission European Society of Cardiology Member of Scientific Board Transcatheter Therapeutics (TCT) Congress Editorial Board Member of the trade magazines VASA, EUROIntervention, Vascular Medicine, Catheterization Cardiovascular Interventions, Journal of Endovascular Therapy, Gefäßmedizin.net

7 Isabelle Durand-Zaleski Head of the evaluation department in the National Health Autority. Head of the Paris Health Economics and Health Services Research Units, Head of the public health department of the Henri Mondor teaching Hospital in Créteil France Medical doctor, Professor in Public Health PhD research in economics and management in Paris IX University, Master in Public Health from Harvard University, diploma from the political study institute of Paris

8 Afferent Efferent Gluconeogenesis Insulin resistance Vasoconstriction Atherosclerosis Renal ischemia Adenosine LVH Ischemia Heart Failure Renin secretion Sodium retention Proteinuria Mahfoud F et al, DMW 2010

9 Renal denervation reduces fasting glucose and insulin Change in fasting glucose (mg/dl) Change in fasting insulin (µiu/ml) 1 month 3 months 1 month 3 months p= p= p= ,6 p=0.006 Mahfoud F et al, Circulation 2011

10 BP changes (mmhg) Blood pressure reduction over 36 months p<0.01 for all changes compared to baseline Systolic BP Diastolic BP M (n=143) 3 M (n=148) 6 M (n=144) 12 M (n=130) 18 M (n=107) 24 M (n=59) 30 M (n=24) 36 M (n=24) Oral presentation ACC 2012, Sobotka PA on behalf of the Symplicity HTN1-Investigators

11 % Patients Blood pressure control after renal denervation 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 180 mmhg mmhg mm Hg < 140 mmhg 0% Baseline 12 Mo 24 Mo 36 Mo (n=150) (n=130) (n=59) (n=24) Oral presentation ACC 2012, Sobotka PA on behalf of the Symplicity HTN1-Investigators

12 Blood pressure reduction in Symplicity Primary Endpoint (6 months post-randomisation) 10 0 RDN (n = 49) Control (n = 51) 1 0 from Baseline to 6 Months (mmhg) Diastolic Systolic Diastolic p <0.01 for difference between RDN and Control Systolic -50 Expanded results presented at the American College of Cardiology Annual Meeting 2012 (Esler, M.)

13 The CVRx Rheos System Programming System Baroreflex Activation Leads Implantable Pulse Generator Established mechanism of action Targeted and specific Personalized and programmable Ensures compliance CE Marked for the treatment of resistant hypertension

14 Resistance to 3 drugs Perform ABPM Side effects Non-compliance Sub-optimal Rx Pressor agents Low GFR no BP <135/85 yes yes Pay attention, inform, adapt drug regimen, use loop diuretics, refer to nephrologist

15 Resistance to 3 drugs Perform ABPM Side effects Non-compliance Sub-optimal Rx Pressor agents Low GFR no BP <135/85 yes no Aldo/renin ratio metanephrines CT- or MR-angio yes Pay attention, inform, adapt drug regimen, use loop diuretics, refer to nephrologist 4-drug medication Renal denervation no Consider etiologic treatment Curable HTN? yes

16 Prevalence of resistant hypertension in US 245 million adults 51 million treated hypertension 6.5 million resistant hypertension Persell SD Hypertension 2011;57:

17 Summary of antihypertensive drug treatment Aged under 55 years Aged over 55 years or black person of African or Caribbean family origin of any age ACE or ARB Calcium Channel Blocker Step 1 ACE/ARB + CCB Step 2 ACE/ARB + CCB + Diuretic Step 3 Resistant hypertension ACE/ARB + CCB+ Diuretic Consider spironolactone, alpha- or beta-blocker Seek expert advice Step 4

18 Systolic BP and cardiovascular mortality Stroke Ischemic Heart Disease Age at risk: years years years Age at risk: years years years years years years Usual systolic blood pressure (mm Hg) Usual systolic blood pressure (mm Hg)

19 Definition of resistant hypertension Office BP > 140/90 mmhg, despite lifestyle measures and the treatment with 3 drug classes including a diuretic in adequate doses Prevalence of resistant in the ALLHAT cohort 8% of the patients were prescribed 4 or more drugs It has been calculated that a minimum of 15% would have been classified as having resistant hypertension 2007 Guidelines for the management of arterial hypertension: The Task Force for the Management of Arterial Hypertension of the European Society of Hypertension (ESH) and of the European Society of Cardiology (ESC). Eur Heart J 2007;28(12):

20 Acute & 6 months Safety HTN-1 & HTN-2 n = 259 Acute Safety Minor complications 5/259 2 renal artery dissections (stent) 3 access site complications, treated conservatively Safety at 6 months No vascular abnormalities at any site of RF delivery One progression of a pre-existing stenosis unrelated to RF treatment (stented) No electrolyte disturbances 1 episode of hypotension resulting in hospitalisation No significant change in renal function at one year Symplicity HTN-1 Investigators. Hypertension. 2011;57: & oral presentation Esler M HTN-2 at ACC March 2012

21 Medication Changes HTN 2 Despite protocol guidance to maintain medications, some medication changes were required RDN (n=49) Control (n=51) P-value # Med Dose Decrease (%) 10 (20%) 3 (6%) 0.04 # Med Dose Increase (%) 4 (8%) 6 (12%) 0.74 Symplicity HTN-2 Investigators. Lancet. 2010;376:

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23 Office

24 Ambulatory

25 Ambulatory Blood Pressure Measurement (ABPM) 24h

26 Home

27 Ambulatory Blood Pressure Measurement (ABPM) 24h

28 Ambulatory Blood Pressure Measurement (ABPM) 24h

29 The Interventional Treatment of Resistant Hypertension Made possible by an unrestricted educational grant from Medtronic

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31 Device Set-Up 6F sheath and guiding catheter Foot switch Symplicity 2 radiofrequency catheter Proprietary RF Generator Automated Low-power Built-in safety algorithms 31

32 Drug Management Anxiolytic and Amnesic Midazolam (Dormicum) or similar Pain Management Fentanyl or Morphine or similar Anticoagulation Heparin: target ACT >250 sec Vasodilatation IA nitroglycerine ( mg) through renal guide before treating each artery

33 Dedicated Guide Catheter Configuration Typical: RDC-1 Alternate: LIMA

34 What you should know about the catheter tip features Tip of Guiding catheter 5mm 12mm Flexible Tip (self-orienting) Deflectable Shaft

35 Catheter Tip Features

36 36 Catheter Manipulation

37 Treatment Site Superior Posterior Renal artery Anterior Inferior Ablations are separated both longitudinally and rotationally (spacing >5 mm)

38 Example Treatment Sites Distal locations in straight vessels may require more deflection to achieve vessel wall contact Because of added guide catheter support, proximal locations may require less deflection to achieve vessel wall contact