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Giuliano Tocci, MD, PhD, ESH Hypertension Specialist

Giuliano Tocci, MD, PhD, ESH Hypertension Specialist Centro per la Diagnosi e la Cura dell ’ Ipertensione Arteriosa, Cattedra di Cardiologia, Dipartimento di Medicina Clinica e Molecolare, Facoltà di Medicina e Psicologia

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Giuliano Tocci, MD, PhD, ESH Hypertension Specialist

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  1. Giuliano Tocci, MD, PhD, ESH Hypertension Specialist Centro per la Diagnosi e la Cura dell’Ipertensione Arteriosa, Cattedra di Cardiologia, Dipartimento di Medicina Clinica e Molecolare, Facoltà di Medicina e Psicologia Università di Roma Sapienza, Azienda Ospedaliera Sant’Andrea, Roma, Italia. E-mail: giuliano.tocci@uniroma1.it E-mail: centro.ipertensione@ospedalesantandrea.it

  2. BP Stratification in Hypertensive Patients enrolled in Hypertension Surveys in Italy 71% N=52.715 22% n=1.831 n=3.739 n=3.374 n=15.904 n=13.297 n=2.081 Volpe M, Tocci G, et al. JHypertens 2007 Jul;25(7):1491-8

  3. Resistant Hypertension Hypertension is usually defined resistant or refractory to treatment when atherapeutic plan that has included attention to lifestyle measures and the prescription of at least three drugs (including a diuretic) in adequate doses has failed to lower systolic and diastolic blood pressure to goal. According to this definition prevalence of resistant hypertension is relatively high (in ALLHAT 8% pts with 4 drugs and 15% with resistant hypertension). In such situations, referral to a specialist or a hypertension center should be considered, because resistant hypertension is recognized to be often associated with subclinical organ damage and a high or very high cardiovascular risk. 2007 ESH/ESC Hypertension Guidelines Mancia G, et al. J Hypertens 2007;25:1105–1187

  4. Epidemiologia dell‘Ipertensione Arteriosa in Italia

  5. Schematic Representation of the Catheter Ablation of Renal Arteries

  6. The Renal Denervation Procedure • 4-6 focal treatments are delivered • 120 seconds per treatment • ≥5 mm between locations • Stable, unique locations • Circumferential coverage • The catheter is pulled, rotated, and new location and prior treatment site are assessed

  7. The blood pressure lowering effects of renal denervation in a real world population of patients with uncontrolled hypertension: Early outcomes from the Global SYMPLICITY Registry Michael Böhm, on behalf of the Global SYMPLICITY Registry Investigators Oral Comunication at ESC 2013 Congress Felix Mahfoud et al. Expert consensus document from the ESC on catheter-based RD, Eur Heart J April 2013 

  8. Global SYMPLICITY Registry Purpose of the Registry To document: • Long-term safety & effectiveness • Real world patient population with: • Hypertension and/or • Other diseases characterized by elevated sympathetic drive • Procedural technique

  9. S-3 Global SYMPLICITY Registry Rationale

  10. Global SYMPLICITY Registry Current Activated Site Locations CA: 5 Korea: 10 C&EEU: 10 WE: 116 MEA: 11 ASEAN: 10 LA: 6 ANZ: 11

  11. Global SYMPLICITY Registry Primary Objective • Safety Parameters • Peri-procedural safety • Long-term safety • Vascular effect • Renal effect • Hemodynamic effect

  12. Global SYMPLICITY Registry Secondary Objectives • Patient characterization • Effect on blood pressure levels • Effects on major cardiovascular endpoints (MACE), including death, stroke, MI, renal function, CHF. • Changes in baseline antihypertensive medication

  13. Global SYMPLICITY Registry Patients’ Allocation and Follow-Up Consecutive patients treated in real world population ~ 5000 patients GREAT Registry N=1000 Korea Registry* N=102 South Africa Registry* N=400 Rest of GSR N~3500 Canada and Mexico* ~ 200 sites International Min. 10% randomly assigned to 100% monitoring Follow-up schedule 4yr 3mo 6mo 12mo 2yr 3yr 5yr *: limited to resistant hypertension only

  14. Global SYMPLICITY Registry Patients’ characteristics at baseline • 1097 patients treated as of June 26, 2013 • 86% with SBP ≥140 mmHg • 66% of patients treated according to ESC Consensus paper on Renal Denervation1 • SBP ≥ 160 mm Hg (≥ 150 mmHg Diabetes II), 3+ meds, including diuretic • 13% with BP ≥180/100 mmHg Co-Morbidities Include: • Diabetes II 38.2% • Renal Disease 30.1% • Sleep Apnea 16.9% • Hx of Cardiac Disease 49% • Heart Failure 9.2% • Atrial Fibrillation 12.6% • LVH 15.9% Mahfoud F et al. Expert consensus document from the ESC on catheter-based RD, Eur Heart J April 2013 

  15. Global SYMPLICITY Registry Patients’ characteristics at baseline

  16. Global SYMPLICITY Registry Blood Pressure levels and Antihypertensive Tx at baseline

  17. Global SYMPLICITY Registry Presence of Comorbidities according to SBP stratification

  18. Global SYMPLICITY Registry Distribution of Patients according to 2013 ESH/ESC Global Cardiovascular Risk Stratification

  19. Global SYMPLICITY Registry Procedural Details • 98% anatomically eligible • Mean length: 42 ± 14 mm • Mean diameter: 5.8 ± 3.4 mm • Mean Symplicity procedure time: 50 min • Mean # bilateral ablations: 13.5 • Mean contrast volume used: 128 ± 80 cc

  20. Global SYMPLICITY Registry Procedural Safety(safety population N=1,162) • Renal artery re-intervention due to dissection 0.09% (n=1) • Vascular complication • Vascular complication, pseudoaneurysm 0.34% (n=4) • Vascular complication, hematoma 0.09% (n=1)

  21. Global SYMPLICITY Registry Change in Office BP levels according to baseline BP ≥ 140 ≥ 180† ≥ 140 ≥ 160* ≥ 180† ≥ 160* ≥ 180† ≥ 160* ≥ 140 6 months 12 months 3 months -37 n=612 n=468 n=391 n=78 n=313 n=91 n=51 n=79 n=9 * ≥ 150 mm Hg in Diabetes † ≥ 100 mm Hg DBP p < 0.001 for all values except; P = 0.001 SBP ≥ 180, 12m; p = 0.0005 DBP ≥ 180, 12m

  22. Global SYMPLICITY Registry Change in 24-hour ABP levels according to baseline BP ≥ 140 ≥ 180† ≥ 140 ≥ 160* ≥ 180† ≥ 160* ≥ 180† ≥ 160* ≥ 140 ** 6 months 12 months 3 months n=288 n=196 n=181 n=35 n=132 n=24 n=25 n=18 p < 0.0001 for all time points except; p=0.0456 SBP ≥ 140 mm Hg, p=0.7611 DBP ≥ 140 mm Hg (12m); p=0.0677 SBP ≥ 160/150 mm Hg, p=0.7838 DBP ≥ 160/150 mm Hg (12m); p=0.0001 and p=0.0036 SBP ≥ 180/100 mm Hg (3m + 6m) and p=0.0007 and p=0.0017 DBP ≥ 180/100 mm Hg (3m + 6m) ** Sample size for >180/100 at 12 months too small to be shown (n=2) * ≥ 150 mm Hg in Diabetes † ≥ 100 mm Hg DBP

  23. Global SYMPLICITY Registry Renal Function 100 Stage I Stage II eGFR (mL/min/1.73m2) Stage III Stage IV ESRD Stage V

  24. Global SYMPLICITY Registry Antihypertensive Medications Analysis

  25. Global SYMPLICITY Registry Antihypertensive Medications Analysis * Indicates a significant change from baseline

  26. Global SYMPLICITY Registry Chronic Safety Data Event Patients (num) Incidence (patient/year) • Major CV Events • Hospitalization for hypertensive crisis 6 1.46% • Death, deemed unrelated to device or procedure 5 1.22% • Stroke 6 1.46% • MI 4 0.97% • Hospitalization for Afib 6 1.46% • Hospitalization for new onset HF 5 1.22% • Renal Events: • Serum creatinine elevations 4 0.97% • New onset of end-stage renal disease 1 0.24% • (Nephrotoxic overdose) • Post-Procedural Events: • Renal artery re-intervention 1 0.24% • Hematoma 1 0.24% Data on patients reaching 3 or 6 or 12 month follow up

  27. Global SYMPLICITY Registry Conclusions • Excellent procedural and clinical safety profile in real world • Treatment resembles current consensus • Significant reduction in both Office and ambulatory BP • Enrolment and analyses continue

  28. Take-Home Message • Il trattamento dell’ipertensione arteriosa non controllata (o resistente) richiede l’impiego di terapie di combinazione con diverse classi di farmaci. • Tali terapie di combinazione dovrebbero essere: • Semplici • Razionali • A dosaggio “adeguato” (pieno) • Studi clinici disponibili dimostrano come l’impiego di terapie di combinazione duplici o triplici (farmaco bloccante RAS, diuretico tiazidico e CCB diidropiridinico a dosaggio pieno) consentono di ottenere il controllo dei valori di PAS/PAD in oltre 70-80% dei pazienti trattati. • Nel rimanente 20-30% l’impiego di farmaci di 4 scelta (antialdosteronici o inibitori diretti della renina) può consentire di ridurre ulteriormente i valori pressori e raggiungere il controllo dei valori pressori. • Nei casi non responsivi alla terapia (o con documentate allergie o intolleranze), l’impiego della denervazione delle arterie renali rappresenta una opzione efficace, sicura e ben tollerata per ridurre i valori pressori e contribuire a raggiungere il controllo della pressione arteriosa.

  29. How to improve BP control in daily clinical practice of hypertension? Volpe M, et al. G Ital Cardiol (Rome) 2012 Dec;13(12):853-60 Ipertensione Prev Cardiovasc 2013; in press High Blood Press Cardiovasc Prev 2013 March: in press

  30. How to manage difficult-to-treat patients with resistant hypertension? Volpe M, et al. G Ital Cardiol (Rome) 2012 Dec;13(12):846-5 Ipertensione Prev Cardiovasc 2013; in press High Blood Press Cardiovasc Prev 2012 Dec;19(4):237-44

  31. Grazie per la Vostra Attenzione! E: giuliano.tocci@uniroma1.it E: centro.ipertensione@ospedalesantandrea.it

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