Renal Sympathetic Denervation View From the EU CRT 2012 Washington, DC, USA, Feb 4-7, 2012 5min NEW FRONTIERS IN DEVICES TO TREAT REFRACTORY HYPERTENSION 3:59PM 4:55PM Kenneth J. Cavanaugh, PhD (Moderator) Mitchell W. Krucoff, MD (Moderator) Robert S. Schwartz, MD (Moderator) Empire Ballroom Scope of the Problem: The Pharma Approach 4:00PM 4:10PM John C. Somberg, MD Implantable Carotid Sinus Modulation Systems 4:15PM Robert S. Schwartz, MD Renal Sympathetic Denervation - View From the EU 4:20PM Horst Sievert, MD Renal Sympathetic Denervation - Industry View 4:25PM Sean M. Salmon, Other Renal Sympathetic Denervation - FDA View 4:30PM Todd Courtney, MS Clinical Trial Design to Assess Devices for the Treatment of Refractory Hypertension 4:35PM Panel Discussion Todd Courtney, MS (Panelist) Sean M. Salmon, Other (Panelist) Robert S. Schwartz, MD (Moderator) Horst Sievert, MD (Panelist) John C. Somberg, MD (Panelist) Yunling Xu, PhD (Panelist) Closing Comments 5:05PM Mitchell W. Krucoff, MD Ron Waksman, MD Renal Sympathetic Denervation View From the EU Horst Sievert, Ilona Hofmann, Ann-Kathrin Ziegler CardioVascular Center Frankfurt, Frankfurt, Germany .

Horst Sievert, MD Consulting Fees: CSI Epitek Gore HLT Lifetech NDC Recor

Consulting Fees: Trireme Veryan Trivascular My presentation will include off label discussions: Not yet decided

Renal Denervation Interruption of renal nerves Reduces central sympathetic drive This results in blood pressure reduction It may have other beneficial effects in heart failure and diabetes

The procedure is simple

Simplicity, Ardian, Medtronic Radiofrequency Treatment #1 Treatment #2 Treatment #3 CE mark, not FDA approved 6

The procedure is effective in resistant hypertension

Primary Endpoint: 6-Month Office BP ∆ from Baseline to 6 Months (mmHg) Systolic Diastolic Systolic Diastolic difference between RDN and Control highly significant (p<0.0001) 84% of RDN patients had ≥ 10 mmHg reduction in SBP Only 10% of RDN patients had no reduction in SBP Symplicity HTN-2 Investigators. Lancet. 2010;376:1903-1909

Randomized Trials in Resistant Hypertension Mean Reduction in Systolic BP Spironolactone3 Renal Denervation1 Darusentan2 ISMN + Sildenafil4 - 12mmHg - 16mmHg - 22mmHg - 32mmHg 1Lancet. 2010 2Curr Hypertens Rep. 2008 Dec;10(6):429-31. 3Hypertension. 2010 Jan;55(1):147-52 4Hypertension. 2010 Jul;56(1):22-3.

The procedure is very safe No procedural SAE in >> 1000 patients No late complications

The effect is durable

Results for 18 Patients with 2-year Follow-up BP change (mmHg) Symplicity HTN-1 Investigators. Hypertension. 2011;57:911-917. 12 12

Acceptance is growing

Frankfurt Experience

Patient referrals c c v

Patient referrals

Patient referrals v

Indications are expanding

Potential Benefits Heart failure Sleep apnea

RD improves glucose tolerance Glucose tolerance test, 75 g glucose per os Renal denervation +10 3 months -9 -27* -10 Reduction in glucose level (mg/dl) -20 -30 60-min glucose level 120-min glucose level -40 *significant reduction (p<0.05) compared to baseline Mahfoud F et al., Circulation 2011 F. Mahfoud et al, Trend Asia Pacific, 2011

Renal Denervation in Borderline Hypertension - Mean Office BP 148.4 142.7 135.3 83.0 82.4 78.0 Mean Office blood pressure at baseline, 3M FU and 6M FU after denervation

The device is too expensive Hospitals are loosing money We all know why that is

New techniques and devices are upcoming

16:00 - 18:00 Session 4 - What is on the Horizon? Moderator: Joachim Weil, MD / Ilona Hofman, MD / James Margolis, MD Renal Denervation - Mercator Med Systems Kirk Seward Renal Denervation - Vessix Vascular James Margolis, MD Renal Denervation - Maya Medical John Ormiston, MD Renal Denervation - Recor Medical Tom Mabin, MD Renal Denervation - CardioSonic Yvonne Bausback Renal Denervation - Sound Interventions Vivek Reddy, MD Other Innovative Technologies: Vascular Dynamics Ann-Kathrin Ziegler Renal Denervation Percutaneous Renal Denervation Eberhard Grube, MD Other Innovative Technologies - CVRx Rolf Wachter, MD Other Innovative Technologies - Rox Medical Dany Schoors, MD