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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

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: [email protected]

E-mail: [email protected]


Bp stratification in hypertensive patients enrolled in hypertension surveys in italy

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


Resistant hypertension

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


Epidemiologia dell ipertensione arteriosa in italia

Epidemiologia dell‘Ipertensione Arteriosa in Italia


Schematic representation of the catheter ablation of renal arteries

Schematic Representation of the Catheter Ablation of Renal Arteries


The renal denervation procedure

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


Giuliano tocci md phd esh hypertension specialist

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 


Purpose of the registry

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


Giuliano tocci md phd esh hypertension specialist

S-3

Global SYMPLICITY Registry

Rationale


Current activated site locations

Global SYMPLICITY Registry

Current Activated Site Locations

CA: 5

Korea: 10

C&EEU: 10

WE: 116

MEA: 11

ASEAN: 10

LA: 6

ANZ: 11


Primary objective

Global SYMPLICITY Registry

Primary Objective

  • Safety Parameters

    • Peri-procedural safety

    • Long-term safety

      • Vascular effect

      • Renal effect

      • Hemodynamic effect


Secondary objectives

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


Patients allocation and follow up

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


Patients characteristics at baseline

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 


Patients characteristics at baseline1

Global SYMPLICITY Registry

Patients’ characteristics at baseline


Blood pressure levels and antihypertensive tx at baseline

Global SYMPLICITY Registry

Blood Pressure levels and Antihypertensive Tx at baseline


Presence of comorbidities according to sbp stratification

Global SYMPLICITY Registry

Presence of Comorbidities according to SBP stratification


Distribution of patients according to 2013 esh esc global cardiovascular risk stratification

Global SYMPLICITY Registry

Distribution of Patients according to 2013 ESH/ESC Global Cardiovascular Risk Stratification


Procedural details

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


Procedural safety safety population n 1 162

Global SYMPLICITY Registry

Procedural Safety(safety population N=1,162)

  • Renal artery re-intervention due to dissection0.09% (n=1)

  • Vascular complication

    • Vascular complication, pseudoaneurysm 0.34% (n=4)

    • Vascular complication, hematoma0.09% (n=1)


Change in office bp levels according to baseline bp

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


Change in 24 hour abp levels according to baseline bp

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


Renal function

Global SYMPLICITY Registry

Renal Function

100

Stage I

Stage II

eGFR (mL/min/1.73m2)

Stage III

Stage IV

ESRD

Stage V


Antihypertensive medications analysis

Global SYMPLICITY Registry

Antihypertensive Medications Analysis


Antihypertensive medications analysis1

Global SYMPLICITY Registry

Antihypertensive Medications Analysis

* Indicates a significant change from baseline


Chronic safety data

Global SYMPLICITY Registry

Chronic Safety Data

EventPatients (num)Incidence (patient/year)

  • Major CV Events

  • Hospitalization for hypertensive crisis61.46%

  • Death, deemed unrelated to device or procedure51.22%

  • Stroke61.46%

  • MI40.97%

  • Hospitalization for Afib61.46%

  • Hospitalization for new onset HF51.22%

  • Renal Events:

  • Serum creatinine elevations40.97%

  • New onset of end-stage renal disease10.24%

  • (Nephrotoxic overdose)

  • Post-Procedural Events:

  • Renal artery re-intervention10.24%

  • Hematoma10.24%

Data on patients reaching 3 or 6 or 12 month follow up


Conclusions

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


Take home message

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.


How to improve bp control in daily clinical practice of hypertension

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


How to manage difficult to treat patients with resistant hypertension

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


Grazie per la vostra attenzione

Grazie per la Vostra Attenzione!

E: [email protected]

E: [email protected]


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