Effect of renal denervation on blood pressure in the presence of antihypertensive drugs: 6-month efficacy and safety results from the SPYRAL HTN-ON MED proof-of-concept randomised trial

AbstractRenal denervation is a potential alternative to antihypertensive drug therapy. However, data on patient preference for this treatment option are limited and there are no data specifically from Asian patients. This study evaluated patient preference for renal denervation in patients with hypertension from Japan. Patients were a subset of those who participated in a March 2020 online electronic survey of patients with hypertension who had regularly visited medical institutions for treatment, were receiving antihypertensive drug therapy and had home blood pressure recordings available. The survey included a question about patient preference for treatment with renal denervation. A total of 2,392 patients were included (66% male, mean age 59.8 ± 11.6 years, mean duration of hypertension 11.4 ± 9.5 years). Preference for renal denervation was expressed by 755 patients (31.6%), and was higher in males than in females, in younger compared with older patients, in those with higher versus lower blood pressure, in patients who were less adherent versus more adherent to antihypertensive drug therapy, and in those who did rather than did not have antihypertensive drug-related side effects. Significant predictors of preference for renal denervation on logistic regression analysis were younger patient age, male sex, higher home or office systolic blood pressure, poor antihypertensive drug adherence, the presence of heart failure, and the presence of side effects during treatment with antihypertensive drugs. Overall, a relevant proportion of Japanese patients with hypertension expressed a preference for renal denervation. This should be taken into account when making shared decisions about antihypertensive drug therapy.

Download Full-text

Resistant Hypertension: A Real Entity Requiring Special Treatment?

European Cardiology Review ◽

10.15420/ecr.2016.11.1 ◽

2016 ◽

Vol 11 (1) ◽

pp. 8

Author(s):

Stefano Taddei ◽

Rosa Maria Bruno ◽

◽

Keyword(s):

Blood Pressure ◽

Resistant Hypertension ◽

Renal Denervation ◽

Antihypertensive Drugs ◽

Pressure Control ◽

Clinical Situation ◽

Special Treatment ◽

Separate Clinical Entity ◽

Real Entity ◽

Definition Of

Resistant hypertension (RH) was defined many years ago as a clinical situation in which blood pressure remains uncontrolled despite concomitant intake of at least three antihypertensive drugs (one of them preferably being a diuretic) at full doses. This operative definition was aimed at identifying a subset of hypertensive patients requiring a more extensive clinical workup in order to achieve an adequate blood pressure control. An oversimplification of this picture led to consider RH as a separate clinical entity requiring special, expensive treatments, such as renal denervation and baroreceptor activating therapy. In this review we will discuss the utility and the shortcomings of the definition of RH and the possible consequences for treatment.

Download Full-text

Unilateral renal sympathetic denervation may reduce blood pressure in patients with refractory hypertension

Italian Journal of Medicine ◽

10.4081/itjm.2015.544 ◽

2015 ◽

Vol 9 (4) ◽

pp. 362

Author(s):

Aurelio Negro ◽

Rosaria Santi ◽

Antonio Manari ◽

Franco Perazzoli

Keyword(s):

Blood Pressure ◽

Renal Artery ◽

Renal Denervation ◽

Antihypertensive Drugs ◽

Renal Sympathetic Denervation ◽

Caucasian Woman ◽

Left Renal Artery ◽

Refractory Hypertension ◽

The Mean

A 52-year-old Caucasian woman with essential resistant and refractory hypertension despite optimal medical therapy, including 6 different antihypertensive drugs was referred for the catheter-based renal denervation. Due to unfavourable anatomy because of non-critical fibromuscular dysplasia on the right renal artery, renal denervation of only the left renal artery was performed. Before and after the renal denervation, the patient’s blood pressure was monitored by office measurements and ambulatory blood pressure measurements (ABPM). Before the procedure, the mean office blood pressure was 157/98 mmHg; at ABPM, the mean blood pressure values were 145/94 mmHg. At 6 months of follow-up, the mean office blood pressure was 134/90 mmHg and 121/76 mmHg at ABPM. In latest 12 months of follow-up, office and ABPM blood pressure were 125/80 and 127/80 mmHg respectively. This unique case suggests that unilateral renal denervation may be effective in lowering blood pressure in patients with refractory hypertension and unfavorable renal arteries anatomy.

Download Full-text

Non-pharmacological methods in the treatment of resistant hypertension

Folia Medica ◽

10.2478/v10153-011-0081-y ◽

2012 ◽

Vol 54 (2) ◽

pp. 5-12 ◽

Cited By ~ 2

Author(s):

Kostadin N. Kichukov ◽

Hristo V. Dimitrov ◽

Lora K. Nikolova ◽

Ivo S. Petrov ◽

Maria P. Tokmakova

Keyword(s):

Blood Pressure ◽

Resistant Hypertension ◽

Renal Denervation ◽

Antihypertensive Drugs ◽

Adult Population ◽

Clinical Problem ◽

Renal Sympathetic Denervation ◽

Great Promise ◽

Long Term Effects ◽

Blood Pressure Targets

ABSTRACT INTRODUCTION: Arterial hypertension is the most common chronic cardiovascular disease affecting about 25% of the adult population. Meta-analyses have demonstrated a linear relationship between blood pressure and the risk of cardiovascular events. Resistant hypertension defined as failure to reach blood pressure targets despite treatment with three antihypertensive drugs including a diuretic represents a serious clinical problem. It has been estimated that it affects between 8.9% and 12.8% of all treated hypertensive subjects. In resistant hypertension the optimal blood pressure is illusive despite very well tailored therapy. OBJECTIVE: Management of resistant hypertension is exactly the fi eld where blood pressurecontrolling non-pharmacological methods fi t best. The present article aims at throwing light on these methods’ principles of action, on who the target patient groups are and the respective results. Two methods are especially reviewed here: the carotid barorefl ex stimulation and the transcatheter renal sympathetic denervation. Current results from the use of renal denervation suggest stable effi ciency of the method, the results becoming signifi cant 6 months after the procedure is applied and sustained for two years in the follow-up. As much as 90% of the treated patients respond to the procedure. The transcatheter renal denervation is associated with only 2.61% of procedural complications. The barorefl ex carotid stimulation, too, is known to produce a stable effect on blood pressure: the effect become obvious at 12 months in 88% of the treated subjects. The neurologic complications associated with the procedure are reported to occur in 4.4% of cases. CONCLUSION: The present review article clearly demonstrates that non-pharmacological methods for treatment of resistant hypertension show great promise despite some open questions concerning their long term effects and procedural safety.

Download Full-text

Predictors of blood pressure response after renal denervation beyond pretreatment blood pressure

European Heart Journal ◽

10.1093/eurheartj/ehab724.2379 ◽

2021 ◽

Vol 42 (Supplement_1) ◽

Author(s):

R Schmieder ◽

C Delles ◽

L Lauder ◽

C Ott ◽

M Boehm ◽

...

Keyword(s):

Blood Pressure ◽

Resistant Hypertension ◽

Renal Denervation ◽

Antihypertensive Drugs ◽

Blood Pressure Response ◽

Methodological Approach ◽

Large Degree ◽

Initial Value ◽

Study Population ◽

Pre Treatment

Abstract Background The principle of initial value (Wilder's law of initial value) proposes that the “direction of response of body function to any agent depends to a large degree on the initial value of that function”. Indeed, in several trials on renal denervation (RDN), pre-treatment blood pressure (BP) has been consistently and repeatedly found to predict the decrease in BP after RDN. Efforts to discover further statistically significant and clinically meaningful predictors of BP response to RDN failed. Objective By use of a new methodological approach, we aimed to determine predictors of BP response after RDN in patients with resistant hypertension. Methods The study population comprised 266 patients with resistant hypertension (mean age 62 years, 34% females, mean BMI 30.5 kg/m2, 27% had coronary heart disease, 42% had diabetes mellitus and 61% had hypercholesterolaemia) who underwent radiofrequency RDN with the Symplicity catheter at the Universities of Homburg and Erlangen. Clinical data including 24h ambulatory BP (ABP) were obtained prior to, and 3, 6 and 12 months after RDN. The primary parameter of response was defined as change in 24-hour systolic ABP after 6 months from pre-treatment values. As expected, change in 24h systolic ABP correlated with pre-treatment 24h systolic ABP (r2 linear = 0.225, p<0.001), with change in 24h systolic ABP = 73.82 + 0.55 x pre-treatment 24h systolic ABP. To overcome the predominant role of the pre-treatment BP that may mask other factors, we calculated for each individual patient the “expected systolic ABP decrease” by applying this regression equation and the “excessive systolic ABP decrease” by subtracting the measured from expected change in 24h systolic ABP. We divided the study population into 2 groups (above [responders] and below [non-responders] of the median change in excessive 24h systolic ABP. Results Neither pre-treatment 24h systolic or diastolic ABP, nor office systolic or diastolic BP differed between the two groups (all p>0.20). Following RDN, 24h systolic ABP decreased in the responders by −23.3±16 vs non-responders +1.4±11 mmHg at 6 month, and 24h systolic ABP values were also significantly lower in responders at 3 and 12 months (all p<0.001), without difference in number of antihypertensive drugs between the groups. Of all clinical variables at baseline, office heart rate (65.6 vs 68.7±12 bpm, p=0.024) and HbA1c (6.07±0.88 vs. 6.37±1.23%, p=0.035) were lower in responders compared with non-responders. Finally, a multiple regression analysis confirmed that pre-treatment 24h systolic ABP (beta +0.565, p<0001), HbA1c (beta −0.167, p=0.004) and office HR (beta +0.106, p=0.057) were independent predictors of decrease in 24h systolic ABP. Conclusion In patients with resistant hypertension, lower HbA1c and office HR were identified as predictors of BP response in addition to pre-treatment BP. This finding may help to identify hypertensive patients who benefit most from RDN. FUNDunding Acknowledgement Type of funding sources: Other. Main funding source(s): Extramural grant provided vy Medtronic INc

Download Full-text

Efficacy and safety of renal denervation for Chinese patients with resistant hypertension using a microirrigated catheter: study design and protocol for a prospective multicentre randomised controlled trial

BMJ Open ◽

10.1136/bmjopen-2016-015672 ◽

2017 ◽

Vol 7 (9) ◽

pp. e015672 ◽

Cited By ~ 1

Author(s):

Zongjun Liu ◽

Li Shen ◽

Weijian Huang ◽

Xianxian Zhao ◽

Weiyi Fang ◽

...

Keyword(s):

Blood Pressure ◽

Resistant Hypertension ◽

Antihypertensive Medication ◽

Renal Denervation ◽

Controlled Trial ◽

Academic Community ◽

Chinese Patients ◽

Efficacy And Safety ◽

Primary Analysis ◽

Randomised Controlled

IntroductionAvailable data show that approximately 8%–18% of patients with primary hypertension will develop resistant hypertension. In recent years, catheter-based renal denervation (RDN) has emerged as a potential treatment option for resistant hypertension. A number of observational studies and randomised controlled trials among non-Chinese patients have demonstrated its potential safety and efficacy.Methods and analysisThis is a multicentre, randomised, open-label, parallel-group, active controlled trial that will investigate the efficacy and safety of a 5F saline-irrigated radiofrequency ablation (RFA) used for RDN in the treatment of Chinese patients with resistant hypertension. A total of 254 patients who have failed pharmacological therapy will be enrolled. Eligible subjects will be randomised in a 1:1 ratio to undergo RDN using the RFA plus antihypertensive medication or to receive treatment with antihypertensive medication alone. The primary outcome measure is the change in 24 hours average ambulatory systolic blood pressure from baseline to 3 months, comparing the RDN-plus-medication group with the medication-alone group. Important secondary endpoints include the change in office blood pressure from baseline to 6 months after randomisation. Safety endpoints such as changes in renal function will also be evaluated. The full analysis set, according to the intent-to-treat principle, will be established as the primary analysis population.Ethics and disseminationAll participants will provide informed consent; the study protocol has been approved by the Independent Ethics Committee for each site. This study is designed to investigate the efficacy and safety of RDN using a 5F saline microirrigated RFA. Findings will be shared with participating hospitals, policymakers and the academic community to promote the clinical management of resistant hypertension in China.Trial registrationClinicalTrials.gov ID:NCT02900729; pre-results.

Download Full-text

SAFETY OF THE COMBINED EMERGENCY ANTIHYPERTENSIVE THERAPY

EMERGENCY MEDICAL CARE ◽

10.24884/2072-6716-2021-22-1-32-39 ◽

2021 ◽

Vol 22 (1) ◽

pp. 32-39

Author(s):

О. V. Grishsin

Keyword(s):

Blood Pressure ◽

Medical Care ◽

Therapeutic Effect ◽

Antihypertensive Therapy ◽

Antihypertensive Drugs ◽

Efficacy And Safety ◽

Emergency Medical Care ◽

Emergency Therapy ◽

Emergency Medical ◽

Objective Control

In 91 patients with increased blood pressure, the efficacy and safety of three combinations of antihypertensive drugs was clarified. It was proved that the use of hourly monitoring of changes in blood pressure immediately after the provision of emergency therapy with the help of sublingual use of combinations of antihypertensive drugs allows for objective control of the time of onset and duration of the preservation of the therapeutic effect and to assess the likelihood and severity of repeated increase and excessive decrease in blood pressure. It has been shown that combinations of antihypertensive drugs: captopril with furosemide, moxonidine with furosemide and moxonidine with nifedipine are not only highly effective, but also safe, and therefore can be used by a doctor or paramedic of emergency medical care to provide emergency therapy, even in elderly and senile patients with comorbid pathology.

Download Full-text

Renal Denervation Therapy (RDT) in Resistant Hypertension

BIRDEM Medical Journal ◽

10.3329/birdem.v2i2.12325 ◽

2012 ◽

Vol 2 (2) ◽

pp. 104-112

Author(s):

Mohammad Gaffar Amin ◽

Hasna Fahmima Haque

Keyword(s):

Blood Pressure ◽

Nervous System ◽

Sympathetic Nervous System ◽

Renal Artery ◽

Resistant Hypertension ◽

Renal Denervation ◽

Antihypertensive Drugs ◽

Antihypertensive Agents ◽

Radiofrequency Energy ◽

Sympathetic Nervous

Resistant hypertension is defined as blood pressure that remains above therapeutic goal despite the use of three antihypertensive drugs including a diuretic. As much as one third of patients with arterial hypertension are treatmentrefractory as they do not reach sufficient blood pressure control despite combination antihypertensive therapy of significant duration. The hyperactivity of sympathetic nervous system (SNS) in the occurrence of treatment-resistant long standing hypertension has been established both in animal models and in clinical practice. In these patients, the kidneys play a central role as an activator of the sympathetic nervous system. The failure of purely pharmacological approaches to treat resistant hypertension has stimulated interest in invasive device-based treatments based on old concepts. In the absence of orally active antihypertensive agents, patients with severe and complicated hypertension were widely treated by surgical denervation of the kidneys until the 1960s, but this approach was associated with a high incidence of severe adverse events and a high mortality rate. A new catheter system using radiofrequency energy has been developed, allowing an endovascular approach to renal denervation and providing patients, with resistant hypertension, with a new therapeutic option that is minimally invasive and can be performed rapidly under local anaesthesia. With this method the afferent and efferent sympathetic nervous fibers surrounding the renal artery are ablated precisely keeping the renal artery intact. To date, this technique has been evaluated only in open-label trials including small numbers of highly selected resistant hypertensive patients with suitable renal artery anatomy. The available evidence suggests a significant and persistent blood pressure-lowering effect and a very low incidence of short & long term complications with no deleterious effects on renal function. These data, although promising, need confirmation in larger randomized controlled clinical trials with longerterm follow-up.DOI: http://dx.doi.org/10.3329/birdem.v2i2.12325(Birdem Med J 2012; 2(2): 104-112)

Download Full-text

Perspektivy klinicheskogo primeneniyanovoy fiksirovannoy kombinatsii -preparata Ko-Eksforzh v lecheniiarterial'noy gipertonii

Cardiosomatics ◽

10.26442/cs44978 ◽

2011 ◽

Vol 2 (1) ◽

pp. 64-71

Author(s):

Marina Gennad'evna Bubnova

Keyword(s):

Blood Pressure ◽

Arterial Hypertension ◽

Antihypertensive Therapy ◽

Fixed Combination ◽

Antihypertensive Drugs ◽

Treatment Compliance ◽

Efficacy And Safety ◽

High Efficacy

Summary. This review is concerned with improving of blood pressure (BP) control in patients with arterial hypertension (AH). The reasons for the low treatment compliance and combined antihypertensive therapy benefits are analyzed. Data for futility of an extended use of antihypertensive drugs (AHD) fixed combinations are given. Studies demonstrating high efficacy and safety of a new triple fixed combination of amlodipine, valsartan and hydrochlorothiazide (HCT) are presented as well. Patients with hypertension, which should more actively use this combination of drugs, are signified.

Download Full-text