Consensus documents on catheter-based renal denervation - Dr. Josep Redón i Mas

1
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 9 101
Time in Years
%Survivals
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

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)

Global burden an Aetiology of Resistant Hypertension
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

Hypertension
Role of renal nerves in Hypertension and CV
diseases
Sympathetic activity in other diseases: diabetes,
sleep apnea
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.

apnea
Selection of candidates

Schlaich et al. JACC 2013 (Epub ahead)

apnea
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)

Hypertension
Role of renal nerves in Hypertension and CV
diseases
Sympathetic activity in other diseases: diabetes,
sleep apnea
Available systems
Procedure

apnea
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

Unmeet needs
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

Denervation
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

Unmeet needs
Safety data

Unmeet needs
Safety data
Ambulatory BP after RDN

Unmeet needs
Safety data
Requirements and organization of a RDN team

Unmeet needs
Safety data
Future Research

Unmeet needs
Safety data
Future Research
Registries

Unmeet needs
Safety data
Future Research
Registries
Cost-efectiviness

Unmeet needs
Safety data
Future Research
Registries
Cost-efectiviness
Predictors of response

Denervation
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

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

Consensus documents on catheter-based renal denervation - Dr. Josep Redón i Mas

Consensus documents on catheter-based renal denervation - Dr. Josep Redón i Mas

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