The document discusses consensus documents on catheter-based renal denervation (RDN) for treatment of resistant hypertension. It summarizes that there are 7 consensus documents from scientific societies and groups published between 2012-2014 that cover domains such as the pathophysiology of hypertension, rationale for RDN, candidate selection criteria, procedural aspects, efficacy assessment, safety data, and recommendations. There are still many unmet needs including randomized blinded studies, long-term data on efficacy and safety, and impact on patient outcomes. Overall the consensus documents provide guidance on RDN but more research is still required.
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Consensus documents on catheter-based renal denervation - Dr. Josep Redón i Mas
1. 1
Consensus Documents on
Catheter-based Renal
Denervation
Josep Redon. MD, PhD, FAHA
Scientific Director
Research Foundation and Research Institute
INCLIVA. University of Valencia
2. 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.
7. 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)
8. 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
10. 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
11. 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
Recommendations for treatment of
resistant hypertension
Mancia et al. J Hypertens 2013:31:1281-1357
13. Consensus documents: Domains (I)
Domain ESH-1 ESH-2 ESH-3 ESC EXP CIRSE CJC
Global burden an Aetiology of Resistant
Hypertension
14. 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)
15. Consensus documents: Domains (I)
Domain ESH-1 ESH-2 ESH-3 ESC EXP CIRSE CJC
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
17. Consensus documents: Domains (I)
Domain ESH-1 ESH-2 ESH-3 ESC EXP CIRSE CJC
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
Anatomy and image of renal arteries
Location of sympathetic fibers in the arterial wall
18. Sympathetic nerves in the renal artery
Atherton DS et al. Clin Anat 2012;25:628-633.
19. Consensus documents: Domains (I)
Domain ESH-1 ESH-2 ESH-3 ESC EXP CIRSE CJC
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
Anatomy and image of renal arteries
Location of sympathetic fibers in the arterial wall
Selection of candidates
21. Consensus documents: Domains (I)
Domain ESH-1 ESH-2 ESH-3 ESC EXP CIRSE CJC
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
Anatomy and image of renal arteries
Location of sympathetic fibers in the arterial wall
Selection of candidates
Available systems
22. Consensus documents: Domains (I)
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)
23. Consensus documents: Domains (I)
Domain ESH-1 ESH-2 ESH-3 ESC EXP CIRSE CJC
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
Anatomy and image of renal arteries
Location of sympathetic fibers in the arterial wall
Selection of candidates
Available systems
Procedure
24. Consensus documents: Domains (I)
Domain ESH-1 ESH-2 ESH-3 ESC EXP CIRSE CJC
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
Anatomy and image of renal arteries
Location of sympathetic fibers in the arterial wall
Selection of candidates
Available systems
Procedure
Assessment of efficacy
BP reduction
Impact in organ damage, diabetes, arrythmias, slleep
apnea, CKD
Patient follow-up
25. Consensus documents: Domains (II)
Domain ESH-1 ESH-2 ESH-3 ESC EXP CIRSE CJC
Areas of limited knowledge
Limitations and open questions
Unmeet needs
26. 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
27. Consensus documents: Domains (II)
Domain ESH-1 ESH-2 ESH-3 ESC EXP CIRSE CJC
Areas of limited knowledge
Limitations and open questions
Unmeet needs
Table of recomendations
28. 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
29. Today Recommendations in Renal
Denervation
Schmider, Redon, Grassi et al. J Hypertens 2012;30:837-841
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
30. Consensus documents: Domains (II)
Domain ESH-1 ESH-2 ESH-3 ESC EXP CIRSE CJC
Areas of limited knowledge
Limitations and open questions
Unmeet needs
Table of recomendations
Safety data
31. Consensus documents: Domains (II)
Domain ESH-1 ESH-2 ESH-3 ESC EXP CIRSE CJC
Areas of limited knowledge
Limitations and open questions
Unmeet needs
Table of recomendations
Safety data
Ambulatory BP after RDN
32. Consensus documents: Domains (II)
Domain ESH-1 ESH-2 ESH-3 ESC EXP CIRSE CJC
Areas of limited knowledge
Limitations and open questions
Unmeet needs
Table of recomendations
Safety data
Ambulatory BP after RDN
Requirements and organization of a RDN team
33. Consensus documents: Domains (II)
Domain ESH-1 ESH-2 ESH-3 ESC EXP CIRSE CJC
Areas of limited knowledge
Limitations and open questions
Unmeet needs
Table of recomendations
Safety data
Ambulatory BP after RDN
Requirements and organization of a RDN team
Future Research
34. Consensus documents: Domains (II)
Domain ESH-1 ESH-2 ESH-3 ESC EXP CIRSE CJC
Areas of limited knowledge
Limitations and open questions
Unmeet needs
Table of recomendations
Safety data
Ambulatory BP after RDN
Requirements and organization of a RDN team
Future Research
Registries
35. Consensus documents: Domains (II)
Domain ESH-1 ESH-2 ESH-3 ESC EXP CIRSE CJC
Areas of limited knowledge
Limitations and open questions
Unmeet needs
Table of recomendations
Safety data
Ambulatory BP after RDN
Requirements and organization of a RDN team
Future Research
Registries
Cost-efectiviness
36. Consensus documents: Domains (II)
Domain ESH-1 ESH-2 ESH-3 ESC EXP CIRSE CJC
Areas of limited knowledge
Limitations and open questions
Unmeet needs
Table of recomendations
Safety data
Ambulatory BP after RDN
Requirements and organization of a RDN team
Future Research
Registries
Cost-efectiviness
Predictors of response
38. Today Recommendations in Renal
Denervation
Schmider, Redon, Grassi et al. J Hypertens 2012;30:837-841
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
39. Today Recommendations in Renal
Denervation
Mahfoud F, Lüscher TF, Andersson B, et al; Eur Heart J. 2013 Jul;34(28):2149-57
41. 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