1. 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 .

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

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

4. 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

5. The procedure is simple

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

7. The procedure is effective in resistant hypertension

8. 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 ;376:

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

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

11. The effect is durable

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

13. Acceptance is growing

14. Frankfurt Experience

15. Patient referrals c c v

16. Patient referrals

17. Patient referrals v

18. Indications are expanding

19. Potential Benefits
Heart failure
Sleep apnea

20. RD improves glucose tolerance
Glucose tolerance test, 75 g glucose per os
Renal denervation
+10
3 months *
-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

21. 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

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

23. New techniques and devices are upcoming

24. 16: :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