Long-Term Results up to 12 Months After Catheter-Based Alcohol-Mediated Renal Denervation for Treatment of Resistant Hypertension.
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ABSTRACT:
SUBMITTER: Mahfoud F
PROVIDER: S-EPMC8452324 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:Renal denervation (RDN) has been proposed as a novel interventional antihypertensive technique. However, existing evidence was mainly from patients with severe resistant hypertension. The authors aimed to evaluate the efficacy of RDN in patients with resistant hypertension with mildly elevated blood pressure (BP). Studies of RDN in patients with mild resistant hypertension (systolic office BP 140-160 mm Hg despite treatment with three antihypertensive drugs including one diuretic, or mean systolic BP by 24-hour ambulatory BP measurement [ABPM] 135-150 mm Hg) were included. Two observational and one randomized cohort were identified (109 patients in the RDN group and 36 patients in the control group). Overall, the mean age of patients was 62±10 years, and 69.7% were male. Before-after comparison showed that RDN significantly reduced ABPM as compared with the baseline systolic ABPM, from 146.3±13 mm Hg at baseline to 134.6±14.7 mm Hg at 6-month follow-up and diastolic ABPM from 80.8±9.4 mm Hg at baseline to 75.5±9.8 mm Hg at 6-month follow up (both P<.001). This significant effect was not observed in the control group. Between-group comparison showed a greater change in ABPM in the RDN group as compared with that in the control group (change in systolic ABPM: -11.7±9.9 mm Hg in RDN vs -3.5±9.6 mm Hg in controls [P<.001]; change in diastolic ABPM: -5.3±6.3 mm Hg in RDN vs -2.1±5.5 mm Hg in control [P=.007]). RDN was also associated with a significantly decreased office systolic/diastolic BP and reduced number of antihypertensive medications. No severe adverse events were found during follow-up. RDN seems feasible to treat patients with mild resistant hypertension.
| S-EPMC8031049 | biostudies-literature
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| S-EPMC8607757 | biostudies-literature
Project description: Not available
| S-EPMC6464209 | biostudies-literature
Project description:Catheter-based renal denervation (RDN) has been investigated for hypertension (HTN) treatment with variable success. One of the novel approaches to RDN is the delivery of micro-doses of dehydrated alcohol to the adventitial space of the renal artery to perform perivascular ablation of the sympathetic nerves. We sought to assess the safety and efficiency of transcatheter alcohol-mediated perivascular renal denervation in patients with resistant hypertension. Fifty adult patients who had been referred for resistant HTN were screened. To qualify for the study, the patients had to have a mean 24 h systolic pressure ≥ 135 mmHg based upon ambulatory blood pressure monitoring (ABPM) and acceptable renal artery anatomy confirmed by the contrast computer tomography (AngioCT) and nephrologist consultation. Ten patients were eligible for chemical RND. There were no safety issues throughout the 24 months of follow-ups. The mean decrease in the office BP (OBP) was significant during 24 months of follow-up (p < 0.01). The difference in the BP in the ABPM was statistically significant in the 1st, 3rd and 12th months (p < 0.01), whereas during the 3-month follow-up, a trend was observed. The modifications of anti-hypertension drugs throughout the follow-up period were minimal. This study has shown that transcatheter alcohol-mediated renal denervation in patients with resistant hypertension is feasible and safe. Nevertheless, it is a hypothesis-generating study.
| S-EPMC7356226 | biostudies-literature
Project description:AIM:The purpose of this pilot study was to assess whether renal sympathetic denervation (RDN) decreases atrial fibrillation (AF) burden in hypertensive patients with symptomatic AF at 6- and 12-month follow-up, as measured using an implantable cardiac monitor (ICM). METHODS AND RESULTS:A total of 20 patients with symptomatic paroxysmal or persistent AF (EHRA???II) and primary hypertension with a mean office systolic blood pressure (BP) of >?140 mmHg were enrolled. After enrolment, an ICM was implanted 3 months pre-RDN to monitor AF burden. Quality of life (QOL) was assessed using the Atrial Fibrillation Effect on QualiTy-of-life (AFEQT) questionnaire. Mean age was 64?±?7 years and 55% were females. AF burden in min/day decreased from a median (IQR) of 1.39 (0-11) pre-RDN to 0.67 (0-31.6) at 6 months (p?=?0.64) and to 0.94 (0-6.0) at 12 months (pre-RDN vs. 12 months; p?=?0.03). QOL improved significantly at both 6 months (+?11?±?15 points, p?=?0.006) and 12 months (+?10?±?19, p?=?0.04) as compared to pre-RDN. Office BP decreased significantly at 12-month follow-up (-?20?±?19/-?7?±?10 mmHg), p?<?0.01) as compared to pre-RDN. Ambulatory BP decreased -?7?±?16/-?3?±?9 mmHg (p?>?0.05) at 12-month follow-up as compared to pre-RDN. CONCLUSION:This pilot study suggests that RDN might be able to decrease AF burden in min/day as measured using an ICM, with a positive effect on QOL. Large-scale randomized trials are needed to prove the definite value of RDN in hypertensive patients with atrial fibrillation.
| S-EPMC6529371 | biostudies-literature
Project description:Renal denervation is a promising new non-pharmacological treatment for resistant hypertension. However, there is a lack of data from Asian patients. The REQUIRE trial investigated the blood pressure-lowering efficacy of renal denervation in treated patients with resistant hypertension from Japan and South Korea. Adults with resistant hypertension (seated office blood pressure ≥150/90 mmHg and 24-hour ambulatory systolic blood pressure ≥140 mmHg) with suitable renal artery anatomy were randomized to ultrasound renal denervation or a sham procedure. The primary endpoint was change from baseline in 24-hour ambulatory systolic blood pressure at 3 months. A total of 143 patients were included (72 renal denervation, 71 sham control). Reduction from baseline in 24-hour ambulatory systolic blood pressure at 3 months was not significantly different between the renal denervation (-6.6 mmHg) and sham control (-6.5 mmHg) groups (difference: -0.1, 95% confidence interval -5.5, 5.3; p = 0.971). Reductions from baseline in home and office systolic blood pressure (differences: -1.8 mmHg [p = 0.488] and -2.0 mmHg [p = 0.511], respectively), and medication load, did not differ significantly between the two groups. The procedure-/device-related major adverse events was not seen. This study did not show a significant difference in ambulatory blood pressure reductions between renal denervation and a sham procedure in treated patients with resistant hypertension. Although blood pressure reduction after renal denervation was similar to other sham-controlled studies, the sham group in this study showed much greater reduction. This unexpected blood pressure reduction in the sham control group highlights study design issues that will be addressed in a new trial. CLINICAL TRIAL REGISTRATION: NCT02918305 ( http://www.clinicaltrials.gov ).
| S-EPMC8766280 | biostudies-literature
Project description:The year 2014 was a turning point for the field of renal denervation (RDN) and its potential use to treat resistant hypertension. Tremendous enthusiasm shifted to sober reflection on the efficacy of a technology once touted as the cure to resistant hypertension. The following review highlights 2 major questions: First, does catheter-based RDN lower blood pressure and, second, will RDN using catheter-directed therapy for the treatment of resistant hypertension ever become more than an investigational technology.
| S-EPMC6279104 | biostudies-literature
Project description:Hypertension represents a significant global public health concern, contributing to vascular and renal morbidity, cardiovascular mortality, and economic burden. The opportunity to influence clinical outcomes through hypertension management is therefore paramount. Despite adherence to multiple available medical therapies, a significant proportion of patients have persistent blood pressure elevation, a condition termed resistant hypertension. Recent recognition of the importance of the renal sympathetic and somatic nerves in modulating blood pressure and the development of a novel procedure that selectively removes these contributors to resistant hypertension represents an opportunity to provide clinically meaningful benefit across wide and varied patient populations. Early clinical evaluation with catheter-based, selective renal sympathetic denervation in patients with resistant hypertension has mechanistically correlated sympathetic efferent denervation with decreased renal norepinephrine spillover and renin activity, increased renal plasma flow, and has demonstrated clinically significant, sustained reductions in blood pressure. The SYMPLICITY HTN-3 Trial is a pivotal study designed as a prospective, randomized, masked procedure, single-blind trial evaluating the safety and effectiveness of catheter-based bilateral renal denervation for the treatment of uncontrolled hypertension despite compliance with at least 3 antihypertensive medications of different classes (at least one of which is a diuretic) at maximal tolerable doses. The primary effectiveness endpoint is measured as the change in office-based systolic blood pressure from baseline to 6 months. This manuscript describes the design and methodology of a regulatory trial of selective renal denervation for the treatment of hypertension among patients who have failed pharmacologic therapy.
| S-EPMC6652693 | biostudies-literature
Project description:Arterial hypertension is the most prevalent risk factor associated with increased cardiovascular morbidity and mortality. Although pharmacological treatment is generally well tolerated, 5%-20% of patients with hypertension are resistant to medical therapy, which is defined as blood pressure above goal (>140/90 mmHg in general; >130-139/80-85 mmHg in patients with diabetes mellitus; >130/80 mmHg in patients with chronic kidney disease) despite treatment with ?3 antihypertensive drugs of different classes, including a diuretic, at optimal doses. These patients are at significantly higher risk for cardiovascular events, in particular stroke, myocardial infarction, and heart failure, as compared with patients with nonresistant hypertension. The etiology of resistant hypertension is multifactorial and a number of risk factors have been identified. In addition, resistant hypertension might be due to secondary causes such as primary aldosteronism, chronic kidney disease, renal artery stenosis, or obstructive sleep apnea. To identify patients with resistant hypertension, the following must be excluded: pseudo-resistance, which might be due to nonadherence to medical treatment; white-coat effect; and inaccurate measurement technique. Activation of the sympathetic nervous system contributes to the development and maintenance of hypertension by increasing renal renin release, decreasing renal blood flow, and enhancing tubular sodium retention. Catheter-based renal denervation (RDN) is a novel technique specifically targeting renal sympathetic nerves. Clinical trials have demonstrated that RDN significantly reduces blood pressure in patients with resistant hypertension. Experimental studies and small clinical studies indicate that RDN might also have beneficial effects in other diseases and comorbidities, characterized by increased sympathetic activity, such as left ventricular hypertrophy, heart failure, metabolic syndrome and hyperinsulinemia, atrial fibrillation, obstructive sleep apnea, and chronic kidney disease. Further controlled studies are required to investigate the role of RDN beyond blood pressure control.
| S-EPMC3791632 | biostudies-other
Project description:Catheter-based renal denervation (RDN) is a novel treatment for resistant hypertension (RH). A recent meta-analysis reported that RDN did not significantly reduce blood pressure (BP) based on the pooled effects with mild to severe heterogeneity. The aim of the present study was to identify and reduce clinical sources of heterogeneity and reassess the safety and efficacy of RDN within the identified homogeneous subpopulations.This was a meta-analysis of 9 randomized clinical trials (RCTs) among patients with RH up to June 2016. Sensitivity analyses and subgroup analyses were extensively conducted by baseline systolic blood pressure (SBP) level, antihypertensive medication change rates, and coronary heart disease (CHD).In all patients with RH, no statistical differences were found in mortality, severe cardiovascular events rate, and changes in 24-h SBP and office SBP at 6 and 12 months. However, subgroup analyses showed significant differences between the RDN and control groups. In the subpopulations with baseline 24-h SBP ?155 mmHg (1 mmHg = 0.133 kPa) and the infrequently changed medication, the use of RDN resulted in a significant reduction in 24-h SBP level at 6 months (P = 0.100 and P= 0.009, respectively). Subgrouping RCTs with a higher prevalent CHD in control showed that the control treatment was significantly better than RDN in office SBP reduction at 6 months (P < 0.001).In all patients with RH, the catheter-based RDN is not more effective in lowering ambulatory or office BP than an optimized antihypertensive drug treatment at 6 and 12 months. However, among RH patients with higher baseline SBP, RDN might be more effective in reducing SBP.
| S-EPMC5494923 | biostudies-literature