Reduced Effect of Percutaneous Renal Denervation on Blood Pressure in Patients With Isolated Systolic Hypertension

Ewen, Sebastian; Ukena, Christian; Linz, Dominik; Kindermann, Ingrid; Cremers, Bodo; Laufs, Ulrich; Wagenpfeil, Stefan; Schmieder, Roland E.; Böhm, Michael; Mahfoud, Felix

doi:10.1161/hypertensionaha.114.04336

Cited by 112 publications

(58 citation statements)

References 34 publications

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Section: Figurementioning

confidence: 78%

“…Isolated systolic hypertension defined by office BP measurements (SBP ≥140 mm Hg and DBP <90 mm Hg) has been reported to be associated with a poor BP response to RD in an observational study. 27 We did not find such significant association when we used ambulatory BP levels to define isolated systolic hypertension, but the number of patients with isolated systolic hypertension was small.The main result of our study is that both baseline average nighttime ambulatory SBP and its variability (SD SBP ) measured after 4 weeks of standardized triple combination therapy were significant and independent predictors of the 24-hour ambulatory SBP response to RD at 6 months and not to that of the SSAHT given alone. Nighttime BP levels have been shown to better predict cardiovascular morbidity and mortality than daytime BP levels, 28 and nighttime BP variability seems to bring an added predictive value.…”

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confidence: 78%

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Twenty-Four-Hour Blood Pressure Monitoring to Predict and Assess Impact of Renal Denervation

et al. 2017

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T he DENERHTN1 trial (Renal Denervation for Hypertension) showed that renal denervation (RD) with the Symplicity flex catheter added to a standardized stepped-care antihypertensive treatment (SSAHT) recommended by UK guidelines 2 significantly reduced daytime (primary end point), nighttime, and 24-hour ambulatory systolic blood pressure (SBP) by ≈6 mm Hg more than the SSAHT alone after 6-month follow-up in patients with well-defined resistant hypertension (RH) to Abstract-The DENERHTN trial (Renal Denervation for Hypertension) confirmed the blood pressure (BP) lowering efficacy of renal denervation added to a standardized stepped-care antihypertensive treatment for resistant hypertension at 6 months. We report here the effect of denervation on 24-hour BP and its variability and look for parameters that predicted the BP response. Patients with resistant hypertension were randomly assigned to denervation plus stepped-care treatment or treatment alone (control). Average and standard deviation of 24-hour, daytime, and nighttime BP and the smoothness index were calculated on recordings performed at randomization and 6 months. Responders were defined as a 6-month 24-hour systolic BP reduction ≥20 mm Hg. Analyses were performed on the per-protocol population. The significantly greater BP reduction in the denervation group was associated with a higher smoothness index (P=0.02). Variability of 24-hour, daytime, and nighttime BP did not change significantly from baseline to 6 months in both groups. The number of responders was greater in the denervation (20/44, 44.5%) than in the control group (11/53, 20.8%; P=0.01). In the discriminant analysis, baseline average nighttime systolic BP and standard deviation were significant predictors of the systolic BP response in the denervation group only, allowing adequate responder classification of 70% of the patients. Our results show that denervation lowers ambulatory BP homogeneously over 24 hours in patients with resistant hypertension and suggest that nighttime systolic BP and variability are predictors of the BP response to denervation. Clinical Trial Registration-URL: https://www.clinicaltrials.gov. Unique identifier: NCT01570777. Gosse et al ABPM to Predict Renal Denervation BP Lowering 4954-week standardized triple therapy confirmed by ambulatory blood pressure monitoring (ABPM). We also observed a large between-patient variability in the daytime SBP response to RD, greater than that observed in the SSHAT group, suggesting that some patients could be true responders to RD. Male sex, baseline daytime ambulatory SBP, changes in daytime ambulatory heart rate (HR), low treatment score, and high adherence to study medication, but not ethnic origin, were the independent contributors to the blood pressure (BP) response. In a PROBE trial (Prospective Randomized Open-Blind End Point), such as DENERHTN, the use of ABPM to assess the BP effect of RD has the advantage of eliminating observer bias and placebo effect.3 Moreover, ABPM allows investigating the effects of RD on the whole ...

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Section: Figurementioning

confidence: 78%

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confidence: 78%

Twenty-Four-Hour Blood Pressure Monitoring to Predict and Assess Impact of Renal Denervation

et al. 2017

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“…One somewhat more tangible suggestion has been that older patients have not responded as well as younger patients, supposedly because the isolated systolic hyper-tension associated with aging is more likely to depend on intrinsic arterial stiffness and is thus less amenable to sympathetic denervation. 9 This argument, however, may not be entirely valid. We know from pivotal studies in older people with predominant systolic hypertension that differing pharmacologic agents, including diuretics, calcium channel blockers, and angiotensinconverting enzyme inhibitors, have very effectively reduced BP and prevented major cardiovas-cular outcomes in people aged well into their 80s.…”

Section: Heterogeneity Of Resultsmentioning

confidence: 99%

Renal Denervation for the Treatment of Hypertension: Making a New Start, Getting It Right

Weber

Kirtane

Mauri

et al. 2015

Clinical Cardiology

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The renal nerves contribute to hypertension through effects in the kidney that enhance sodium retention and renin secretion, and by effects in the central nervous system that increase systemic sympathetic activity. Therefore, targeting the renal nerves provides a logical basis for treating hypertension. Several trials of renal denervation-achieved by applying radiofrequency energy through catheters placed in the renal arteries-have been completed. Clinical results have been incon-sistent, however, partly because of factors related to the ablation technique and partly because these studies have been performed in patients with the inadequately defined clinical condition of ''treatmentresistant hyper-tension.'' This statement now explains our conclusion that future studies of renal denervation should be guided by the established randomized, controlled clinical trial designs used for studying antihypertensive drugs and other treatments for hypertension. BackgroundEven before the treatment of hypertension became routine, it was understood that high levels of blood pressure (BP) were associated with premature death, stroke, cardiovascular events, and renal failure. One of the early and effective interventions for severe or symptomatic hypertension was the use of surgical sympathectomy. 1 Although this technique was useful in reducing BP and improving survival, major side effects such as disabling postural hypotension and sexual dysfunction were important limiting factors. Later, many of the early drugs developed for treating hypertension were also based on interrupting the sym-pathetic nervous system, but, again, their side effects-although not as severe as those associated with surgical intervention-made these drugs difficult to use.

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“…A very common finding across RDN studies is that higher baseline SBP predicts a blood pressure lowering response [6, 11, 13-18]. A study focusing more specifically on this question provides support: RDN did not significantly lower BP in patients with mild hypertension [19].…”

Section: Introductionmentioning

confidence: 99%

“…Although interesting if confirmed, neither of these would likely be a practical approach to screening patients for RDN treatment. Several other variables, including sex, BMI, eGFR, and number of attempted ablations have demonstrated a positive predictive role in at least one study [6, 11, 14, 16, 18, 24]; however the importance of these factors remains disputed as other studies have not supported similar predictive power [13, 15, 17, 25]. Other baseline patient characteristics, such as age, comorbidities, isolated systolic HTN, baseline DBP, and race, have been consistently shown not to predict the magnitude of BP response to RDN [6, 11, 13, 15, 16, 24, 25].…”

Section: Introductionmentioning

confidence: 99%

Can we predict the blood pressure response to renal denervation?

Fink

Phelps

2017

Autonomic Neuroscience

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Renal denervation (RDN) is a new therapy used to treat drug-resistant hypertension in the clinical setting. Published human trials show substantial inter-individual variability in the blood pressure (BP) response to RDN, even when technical aspects of the treatment are standardized as much as possible between patients. Widespread acceptance of RDN for treating hypertension will require accurate identification of patients likely to respond to RDN with a fall in BP that is clinically significant in magnitude, well-maintained over time and does not cause adverse consequences. In this paper we review and evaluate clinical studies that address possible predictors of the BP response to RDN. We conclude that only one generally reliable predictor has been identified to date, namely pre-RDN BP level, although there is some evidence for a few other factors. Experimental interventions in laboratory animals provide the opportunity to explore potential predictors that are difficult to investigate in human patients. Therefore we also describe results (from our lab and others) with RDN in spontaneously hypertensive rats. Since virtually all patients receiving RDN are taking three or more antihypertensive drugs, a particular focus of our work was on how ongoing antihypertensive drug treatment might alter the BP response to RDN. We conclude that patient age (or duration of hypertension) and concomitant treatment with certain drugs can affect the blood pressure response to RDN and that this information could help predict a favorable clinical response.

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Reduced Effect of Percutaneous Renal Denervation on Blood Pressure in Patients With Isolated Systolic Hypertension

Cited by 112 publications

References 34 publications

Twenty-Four-Hour Blood Pressure Monitoring to Predict and Assess Impact of Renal Denervation

Twenty-Four-Hour Blood Pressure Monitoring to Predict and Assess Impact of Renal Denervation

Renal Denervation for the Treatment of Hypertension: Making a New Start, Getting It Right

Can we predict the blood pressure response to renal denervation?

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