consensus documents on catheter-based renal denervation - dr. josep redón i mas

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Consensus Documents on Catheter-based Renal

Denervation

Josep Redon. MD, PhD, FAHA Scientific Director Research Foundation and Research Institute INCLIVA. University of Valencia

Surgical sympathectomy for BP control

However, surgical sympathectomy was associated with significant morbidity

100

90

80

70

60

50

40

30

20

10

0 0 2 3 4 5 6 7 8 9 10 1

Time in Years

% S

urv

ivals

Surgical n=1266

Medical n=467

Group 3

Group 3

Group 1

Group 2

Group 4

Group 1

Group 2

Group 4

Survival rate of normal population

Age 43

• Group 1:

Patients with persistently

elevated BP, minimal/no

eyeground changes nor

abnormalities in cerebral,

cardiac, or renal nerves

• Groups 2-4:

Patients with

increasing amounts of

cardiovascular disease

Adapted from Smithwick RH, Thompson JE. JAMA. 1953;152:1501-1504.

Renal sympathetic-nerve ablation by using radiofrequency waves

M Krum

Consensus documents on catheter-based RDN

Discrepancies?

Final thoughts

How many?

Domains covered

Publications in PubMed about Resistant Hypertension

* Until October 26th

*

Consensus documents

Schmieder RE, Redon J, Grassi G, et al. J Hypertens. 2012;30(5):837-41.

Schmieder RE, Redon J, Grassi G, et al. EuroIntervention. 2013 May;9 Suppl R:R58-66.

Mahfoud F, Lüscher TF, Andersson B, et al; Eur Heart J. 2013 Jul;34(28):2149-57.

Schlaich MP, Schmieder RE, Bakris G, et al. J Am Coll Cardiol. 2013 Dec 3;62(22):2031-45.

Moss J, Vorwerk D, Belli AM, et al. Cardiovasc Intervent Radiol. 2013 Nov 13.

Khan NA, Herman RJ, Quinn RR, et al. Can J Cardiol. 2014 Jan;30(1):16-21.

Tsioufis C, Mahfoud F, Mancia G et al. J Hypertension (in press)

Consensus documents: Scientific Societies and Groups

Schmieder RE, Redon J, Grassi G, et al. J Hypertens. 2012;30(5):837-41.

Schmieder RE, Redon J, Grassi G, et al. EuroIntervention. 2013 May;9 Suppl R:R58-66.

Mahfoud F, Lüscher TF, Andersson B, et al; Eur Heart J. 2013 Jul;34(28):2149-57.

Schlaich MP, Schmieder RE, Bakris G, et al. J Am Coll Cardiol. 2013 Dec 3;62(22):2031-45.

Moss J, Vorwerk D, Belli AM, et al. Cardiovasc Intervent Radiol. 2013 Nov 13.

Khan NA, Herman RJ, Quinn RR, et al. Can J Cardiol. 2014 Jan;30(1):16-21.

Tsioufis C, Mahfoud F, Mancia G et al. J Hypertension (in press)

ESH, ESC, INT-EXPERTS, CIRSE, CANADIAN

Consensus documents: General Guidelines

NICE August 2011

ESH-ESC Guidelines 2013.

J Hypertens 2013:31:1281-1357

AHA

Hypertension 2013:November 15 (epub ahead)

JNC 8

JAMA 2013:December 18 (epub ahead)

ASH-ISH

J Hypertens 2014;32:3-15

2013 ESH/ESC Hypertension Guidelines

Recommendations for treatment of resistant hypertension

Mancia et al. J Hypertens 2013:31:1281-1357

Recommendations Class Level

In resistant hypertensive patients it is recommended that physicians check

whether the drugs included in the

existing multiple drug regimen have any

BP lowering effect, and withdraw them if

their effect is absent or minimal.

IIa C

Mineralocorticoid receptor antagonists,

amiloride, and the alpha-1-blocker

doxazosin should be considered, if no

contraindication exists.

IIa B

2013 ESH/ESC Hypertension Guidelines

Recommendations Class Level

In case of ineffectiveness of drug treatment invasive procedures such as renal denervation and baroreceptor

stimulation may be considered.

IIb C

Until more evidence is available on the long-term efficacy

and safety of renal denervation and baroreceptor

stimulation, it is recommended that these procedures

remain in the hands of experienced operators and

diagnosis and follow-up restricted to hypertension centers.

I C

It is recommended that the invasive approaches are

considered only for truly resistant hypertensive patients, with

clinic values ≥160 mmHg SBP or ≥110 mmHg DBP and with

BP elevation confirmed by ABPM.

I C


Mancia et al. J Hypertens 2013:31:1281-1357


Discrepancies?

Final thoughts

How many?

Domains covered

Consensus documents: Domains (I)

Domain ESH-1 ESH-2 ESH-3 ESC EXP CIRSE CJC

Global burden an Aetiology of Resistant Hypertension

Cumulative hazard curves for the primary endpoint of cardiovascular death/myocardial infarction/stroke in resistant hypertension (REACH registry)

Kumbhani DJ et al. Eur Heart J 2013;34:1204-1215

Time until CVD/MI/Stroke (months) Time until non-fatal stroke (months)




Sympathetic Nevous System and BP control

Role of renal nerves in Hypertension and CV diseases

Sympathetic activity in other diseases: diabetes, sleep apnea

Raional for renal denervation

Undesired effects of sympathetic overactivity








Anatomy and image of renal arteries

Location of sympathetic fibers in the arterial wall

Sympathetic nerves in the renal artery

Atherton DS et al. Clin Anat 2012;25:628-633.










Selection of candidates


Schlaich et al. JACC 2013 (Epub ahead)











Available systems


Available systems in the market

The Symplicity Spyral TM (Medtronic)

The EnligHTN TM (St Jude Medical)

The Iberis TM (Terumo)

The OneShot TM (Covidien)

The Vessix V2 TM (Boston Scientific)

The PARADISE TM (Recor)











Available systems

Procedure











Available systems

Procedure

Assessment of efficacy BP reduction Impact in organ damage, diabetes, arrythmias, slleep apnea, CKD Patient follow-up

Consensus documents: Domains (II)


Areas of limited knowledge Limitations and open questions Unmeet needs

Randomized blinded studies

Use of 24-hour ABPM to enroll patients and to assess BP reduction

Comparison of RDN efficacy and safety when using different procedures

Long-term maintenance of efficacy and safety

Impact in morbidity and mortality reduction

Cost-benefit balance studies

Standardized Certification of RDN Centres

Unmet needs in Renal Denervation

Schmieder, Redon, Grassi et al. J Hypertens 2012;30:837-841




Table of recomendations

Today Recommendations in Renal Denervation

Schmider, Redon, Grassi et al. J Hypertens 2012;30:837-841

First step: Exclude

False resistant hypertension (peudoresistance) by using 24 hour ambulatory blood pressure monitoring (ABPM) and home BP monitoring.

Secondary arterial hypertension

Causes which maintain high BP values and might be removed (obstructive sleep-apnea, high salt intake, BP raising drugs, severe obesity)

Second step: Optimize

Antihypertensive treatment with at least 3 (or better 4) tolerated drugs including a diuretic and an antialdosterone drug (if clinically possible, e.g after re-evaluating renal function and the potential risk of hyperkaliemia)

Check for effective BP control using ABPM before giving indication for RND



Third step: Contraindications

Anatomic contraindications due to unresolved safety issues (avoid RDN in case of multiple renal arteries, main renal artery diameter of less than 4 mm or main renal artery length less than 20 mm, significant renal artery stenosis, previous angioplasty or stenting of renal artery)

eGFR should be > 45 ml/min/1.73m²

Overall

Perform the procedure in very experienced hospital centers, such as hypertension excellence centers

Use devices which have demonstrate efficacy and safety in clinical studies





Safety data





Safety data

Ambulatory BP after RDN





Safety data


Requirements and organization of a RDN team





Safety data



Future Research





Safety data



Future Research

Registries





Safety data



Future Research

Registries

Cost-efectiviness





Safety data



Future Research

Registries

Cost-efectiviness

Predictors of response


Discrepancies?

Final thoughts

How many?

Domains covered



Second step: Optimize

Antihypertensive treatment with at least 3 (or better 4) tolerated drugs including a diuretic and an antialdosterone drug (if clinically possible, e.g after re-evaluating renal function and the potential risk of hyperkaliemia)

Check for effective BP control using ABPM before giving indication for RND


Mahfoud F, Lüscher TF, Andersson B, et al; Eur Heart J. 2013 Jul;34(28):2149-57


Discrepancies?

Final thoughts

How many?

Domains covered

Randomized blinded studies

Use of 24-hour ABPM to enroll patients and to assess BP reduction

Comparison of RDN efficacy and safety when using different procedures

Long-term maintenance of efficacy and safety

Impact in morbidity and mortality reduction

Cost-benefit balance studies

Standardized Certification of RDN Centres

Unmet needs in Renal Denervation

Schmieder, Redon, Grassi et al. J Hypertens 2012;30:837-841

consensus documents on catheter-based renal denervation - dr. josep redón i mas

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