Page 48 - GUIAS ESC ESH 2018

48 ESC/ESH Guidelines

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renal denervation originally reported in the Symplicity HTN-1 and . . . 7.6.4 Other devices
HTN-2 trials. 365 A reduction in sympathetic activity following renal . . . The carotid body is located at the bifurcation of the common carotid.
denervation has also been observed. 366 However, two RCTs with a . . . It is innervated by nerve fibres from the vagus nerve through the cer-
sham procedure control 367,368 failed to document the superiority of . . . vical ganglion and the carotid sinus nerve. 379 Stimulation of the caro-
renal denervation compared with the sham procedure in reducing . . . tid body drives sympathetic tone, resulting in an increase in BP and
BP, but did confirm the safety of the procedure. Another RCT, the . . . minute ventilation. Surgical resection of the carotid body is associated
Renal Denervation for Hypertension (DENERHTN) trial, 369 showed . . . with reductions in BP 380 and sympathetic overactivity in patients with
the superiority of renal denervation in combination with optimized . . . heart failure. 381 Devices for endovascular carotid body modification
pharmacotherapy compared with pharmacotherapy alone. The . . . by ultrasound-guided ablation have been developed and are currently
PRAGUE-15 study 370 documented similar effects between renal . . . under investigation.
denervation and optimized pharmacotherapy (mainly by adding spi- . . . In summary, device-based therapy for hypertension is a fast-
ronolactone) with respect to BP-lowering efficacy; however, the lat- . . . moving field. Further sham-controlled studies are needed before
ter was associated with more side effects and high discontinuation . . . device-based therapies can be recommended for the routine treat-
rates. Beyond resistant hypertension, interim data in the first 80 . . . ment of hypertension outside of the framework of clinical trials.
patients treated with renal denervation but with no background anti- . . .
hypertensive therapy showed a modest effect of renal denervation . . .
vs. sham control on 24 h ambulatory BP after 3 months. 366 This study .
is ongoing. Device-based therapies for hypertension
Evaluating the efficacy of renal denervation has been challenging
because the procedure needs to be applied to a population with a Recommendation Class a Level b
high probability of BP response. This is complicated by (i) the com-
Use of device-based therapies is not recom-
plex pathophysiology of hypertension, (ii) the lack of clinically applica-
mended for the routine treatment of hyperten-
ble measures of sympathetic activity, (iii) the absence of predictors of
sion, unless in the context of clinical studies III B
the long-term BP response following renal denervation, and (iv) the
and RCTs, until further evidence regarding their
absence of reliable markers of procedural success to immediately 367,368
establish whether denervation has been achieved. 371 There is evi- safety and efficacy becomes available.
dence indicating that isolated systolic hypertension, characterized by
increased aortic stiffness, is associated with a limited response to RCT = randomized controlled trial.
a Class of recommendation.
renal denervation 372,373 and baroreceptor stimulation (see above). b Level of evidence.
Except for rare problems related to the catheterization procedure
(access site complications, vessel dissection, etc.), no major complica-
tions or deterioration of renal function have been reported.
Major uncertainties remain as to the clinical role of renal denerva- 8 Hypertension in specific
tion outside of clinical studies, which should be performed in carefully
selected patients at specialist hypertension centres and by experi- circumstances
enced operators.
8.1 Resistant hypertension
7.6.3 Creation of an arteriovenous fistula 8.1.1 Definition of resistant hypertension
The central iliac arteriovenous anastomosis creates a fixed-calibre (4 Hypertension is defined as resistant to treatment when the recom-
mm) conduit between the external iliac artery and vein using a stent- mended treatment strategy fails to lower office SBP and DBP values
like nitinol device (ROX arteriovenous coupler). 374,375 Device to <140 mmHg and/or <90 mmHg, respectively, and the inadequate
deployment can be verified and is reversible, resulting in the diversion control of BP is confirmed by ABPM or HBPM in patients whose
of arterial blood (0.8–1 L/min) into the venous circuit with immedi- adherence to therapy has been confirmed. The recommended treat-
ate, verifiable reductions in BP. 374,375 The BP-lowering effect of arte- ment strategy should include appropriate lifestyle measures and
riovenous anastomosis was first observed in a study of patients with treatment with optimal or best-tolerated doses of three or more
chronic obstructive pulmonary disease (COPD), in whom a moder- drugs, which should include a diuretic, typically an ACE inhibitor or
ate improvement in the 6 min walking test was shown. 376 In the ROX an ARB, and a CCB. Pseudo-resistant hypertension (see below) and
CONTROL HTN trial, patients with resistant hypertension were secondary causes of hypertension should also have been excluded
randomized to receive either standard care or insertion of an arterio- (see section 8.2).
venous coupler in combination with standard care. 377 At 6 months, Prevalence studies of resistant hypertension have been limited by
office and ambulatory BP were significantly reduced in the coupler variation in the definition used, and reported prevalence rates range
group compared with the control group. Some important safety from 5–30% in patients with treated hypertension. After applying a
aspects need to be considered. Ipsilateral venous stenosis, which strict definition (see above) and having excluded causes of pseudo-
needed venoplasty and/or stenting, occurred in 29% of patients. resistant hypertension (see section 8.1.2), the true prevalence of
There were no reports of right heart failure or high-output cardiac resistant hypertension is likely to be <10% of treated patients.
failure after device implantation over the short-term, but longer Patients with resistant hypertension are at higher risk of HMOD,
follow-up is clearly needed. 377,378 CKD, and premature CV events. 382

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