1. Simplicity Denervation System for Pulmonary Artery Denervation in Patients with Residual Pulmonary Hypertension after Pulmonary Thromboembolism and Surgical Thrombectomy

2. RENAL DENERVATION Obstructive sleep apnea
Heart failure Atrial fibrillation
Metabolic syndrom
Mahfoud F, Circulation Schlaich M, J Hypertens Witkowski A, Hypertension 2011
Hypertension
Brandt MC, Mahfoud F, JACC Ukena C, Mahfoud F, Int J Card Linz D, Mahfoud F, Hypertension Linz D, Mahfoud F, Hypertension Linz D, Mahfoud F, Heart Rhythm Davis J, Int J Card 2012
Pokushalov E, JACC 2012
SIMPLICITY I SIMPLICITY II SIMPLICITY III
Renal failure
Hering D, Mahfoud F, JASN Mahfoud F, Hypertension Schlaich M, Int J Card 2013

3. PULMONARY HYPERTENSION
Normal pulmonary vessels
Pulmonary hypertension

4. Enhanced sympathetic activity and pulmonary hypertension
- Circulating catecholamines
- Muscle sympathetic nerve activity (MSNA)
Nootens M., et al. J Am Coll Cardiol. 1995;26:1581–1585.
Velez-Roa S., et al. Circulation. 2004;110:

5. Muscle sympathetic nerve activity (MSNA) in patients with pulmonary hypertension90 80
P < 0.001 70
P < 0.01 60 50 40 30 20 10
Heart rate
ЧСС
MSNA
Pulmonary hypertension Control group
Velez-Roa S., et al. Circulation. 2004;110:
Контроль
Легочная гипертензия

6. CLINICAL STUDY Mean PAP, Systolic PAP and PVR before and one year after the Denervation
100 90
P < 0.01 80 70 60 50
P < 0.01 40 30 20 10
P < 0.01
До процедуры денервации После процедуры денервации
Before denervation
Среднее давление легочной артерии Сопротивление сосудов малого круга
Систолическое давление легочной артерии
Mean PAP PVR
Systolic PAP
Chen S-L. et al. Circ Cardiovasc Interv ;8:e (n – 66, пациенты с легочной гипертензией различной этиологии)

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9. Through the Femoral Vein and Adva
nced to the MPA

11. Simplicity – 3 (n – 513)
Renal Denervation
N-364
Sham procedure
N-175

12. on renal arteries, myocardial infarction, stroke)
Safety end point: complication rate during 30-day’s (mortality, increase of creatinine level > 50%, intervention
on renal arteries, myocardial infarction, stroke)
6 months
Denervation N - 364
Sham N - 171 P
Complication rate
1.4
0.6
0.67
Mortality
1.00
Myocardial infarction
1.7
1.8
Increase of creatinine level > 50%
Renal artery intervention -
Stroke
1.1
1.2
1.0

13. Patients with CTEPH (n=12) Age 42 ± 13 Male, n(%) 6 (50)
Time from thrombectomy to denervation
procedure
8,5 ± 2.4
Symptoms, n (%)
Syncope Fatige Chest pain Dyspnea
Peripheral edema
1 (8.3)
12 (100)
2 (16.7)
Medication, n (%)
Calcium channel blockers
Sildenafil Diuretics Digoxin
Combination of drugs
Oxygen
8 (66.7)
4 (33.3)
Class of CHF according to NYHA, n (%)
I II III IV
3 (25)
Mean PAP
58 ± 6
6 MWD
321 ± 19

14. Complication rate during hospital stay
Осложнения N
Complication
Mortality
Bleeding
Arrhythmias
Progression of CHF

15. Clinical results after 3 months
Before denervation
After denervation P
Mean PAP
58 ± 6
33 ± 4
< 0.01
6 MWD
321 ± 19
487 ± 29

16. Pulmonary hypertension is associated with
enhanced sympathetic activity
The Simplicity denervation system is proven to be safe and effective for pulmonary artery denervation. Further randomized study is needed to confirm the clinical benefit of this procedures in patients with pulmonary hypertension