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

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Presentation transcript:

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

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

PULMONARY HYPERTENSION Normal pulmonary vessels Pulmonary hypertension

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;110:13081312.

Muscle sympathetic nerve activity (MSNA) in patients with pulmonary hypertension 90 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;110:13081312. Контроль Легочная гипертензия

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. 2015;8:e002837 (n – 66, пациенты с легочной гипертензией различной этиологии)

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Through the Femoral Vein and Adva nced to the MPA

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

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

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

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

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

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