Jean Marco about the French consensus (7 comments)

I’m going to share with you some of my thoughts on the French consensus paper:

Expert consensus: Renal denervation for the treatment of hypertension published in Archives of cardiovascular Disease 2012; 105, 386-393

“When confirmed, resistant hypertension requires specific management as indicated in the international guidelines – anti-hypertensive treatment dosage increase or adaption (use of maximum tolerance dose of anti-hypertensive agents, selection of another diuretic such as a low dose of spirolactone (25-50mg/d) addition of other pharmacological agents e.g, alpha blockers, beta blockers centrally acting anti-hypertensive agents, direct vasodilators, use of fixed combinations of hypertensive agents; use of home blood pressure to monitor treatment efficacy; and reinforcement of a salt-restricted diet.”


“In patients with resistant hypertension, blood pressure control may be improved via the implementation of device-based therapies that target the sympathetic or parasympathetic regulation of blood pressure including baro-reflex activation therapy and catheder-based renal denervation.”


My comments:

One of the different reasons to explain uncontrolled blood pressure in hypertensive patients is a reluctance or poor adherence to lifelong multiple pills treatment or “poorly selected antihypertensive agents, inappropriate drug dosages or drugs not prescribed in the correct order, taking into account the patients particularities.”

So what?  Why do we need “to increase until we reach the patients maximum tolerance” and then add more than 3 different drugs, creating a sort of ‘millefeuille’ or multi layered effect, before proposing device-based therapies particularly, but not only, in relatively young patients? 

Perhaps it is time to investigate or extend device-based therapies to a less severe form of hypertension or earlier, without this escalation from the aforementioned ‘millefeuille’ effect?

Even if the number of patients is limited, the one-year follow up data of cross over patients in Simplicity HTN-2 trials “Esler MD et al.  Circulation 2012:126:2976-2982” is in favour to extend the indications of RDN by using this Simplicity system. 




Tue, 2013-02-05 18:31

We need to increase and follow this step by step approach because this management has been shown to be efficient in reducing morbidity and mortality in hypertensive patients included in randomized clinical trial. To date, the level of evidence for device based therapies is only a simple reduction in blood pressure and blood pressure is a poor surrogate marker. Finally while the drug -related risk is well known, long term safety data are still missing with device based therapy.

I agree that there is a need to investigate device based therapies sooner but with the right standards of randomized clinical trial or new methodological approach dedicated to device development. Why could a device be marketed with limited patient data, no long follow up and without morbidity and mortality data while all this is required for drug labelling ?

Hypertension specialist who are drug minded are facing a new world driven by device and interventional approach. There is an urgent need to share our vision , promote device and drug development together in order to better control our patients.

Tue, 2013-02-05 18:34

In other fields the "millefeuille" is doing well. If you look at patient with heart failure (combination of beta blockers, RAS blockers etc) or after an ACS, why is it not working with hypertensive patients....Probably the perception of hypertension by patient and doctor is not the same?

Wed, 2013-02-06 16:27
Jean Marco

Prof. Pathak, more questions on the Consensus paper as above - Page 391:

“According to the 2012 expert consensus (JM comments : only C on guidelines rules) indication for catheter-based renal denervation should be restricted to patients with resistant hypertension despite the use of four or more anti-hypertensive drugs that includes at least a diuretic (thiazide or loop diuretic if needed) past or present exposure to spirolactone (and a dose of >25mg/d) office systolic blood pressure >160mmhg confirmed by day time ARP or HBP with SBP>135mm hg and DBP >85mmhg.”

“Past or present exposure to spirolactone (and a dose of >25mg/d)”: The systematic use of spirolactone remains a controversial matter in the various published papers!

Q - Can you comment on why it is a condition for RDN and in which patients?

Same section as above:

"office systolic blood pressure greater than 160mHg and/or diastolic BP greater than 100mmHg confirmed by day time ambulatory monitoring blood pressure or home blood pressure with systolic blood pressure of greater than 135 mmHg and diastolic blood pressure greater than 85mmHg."

This is confusing for me! Please press the experts for clarity!

Q - Do we find the same ambiguity in other consensus papers across Europe – ESH, British, German?

Wed, 2013-02-06 16:45
Atul Pathak

The expert consensus is based on the fact that to date no randomized clinical trial with hard ouctome are available in the field. I agree that the level of evidence is "C" however in the current setting still of help for clinicians. Basically this paper answer major questions about renal denervation: why? in whom? what about follow up etc...

Wed, 2013-02-06 16:54
Atul Pathak

There are still some tips and tricks in the management of hypertensive patients! One of them is spironolactone. If your aim is to control BP and you are facing resistance despite appropriate triple therapy, adding spironolactone is a good way to win the match against elevated BP! Sometimes, spironolactone has some side effects (gynecomastia, hyperkaliemia) and cannot be pursued. In this case renal denervation could be an alternative according to this consensus paper.

Wed, 2013-02-06 16:59
Atul Pathak

No ambiguity about the last point!
In the management of hypertension it is well known that office BP values have very poor diagnostic , therapeutic and prognostic value. Ambulatory blood pressure measurement has allowed to identify new subtypes of hypertensive patient (masked hypertension, white coat hypertension..) and diagnostic , therapeutic and prognostic value of ambulatory BP measurement are far better than office BP.
So when a patient is having office BP above 160/100 mm Hg, it could be real hypertension but also false or pseudo resistant hypertension. Ambulatory blodd pressure will definitively assess the right diagnostic and thus appropriate therapy.

Wed, 2013-02-06 17:16

No ambiguity in other consensus paper but for various reasons ( local market, regulatory affairs, reimbursement plan) the conditions required for RDN are slightly different.
For example the ESH paper only refers to the level of systolic blood pressure and do not take into account diastolic blood pressure. Moreover diabetic patient are eligible for RDN if they have treatment-resistant hypertension defined by office SBP at least 150mmHg (hence treshold different from non diabetic patient). In the UK document the threshhold is above 150 mm Hg on daytime average ambulatory BP.
I agree that these differences are quite equivocal. Maybe that a "real " consensus paper could help.

Thu, 2013-02-07 15:46
j Marco

our colleague raised this crucial point
'Maybe that a "real " consensus paper could help'
I fully agree: it is time to have a 'commun' consensus document, with clear commun definitions
In the field of valve this was acheived with the VARC consensus definition paper
Joining the forces would be more efficient and would open the door for a more open vivion of the future