Ultrasound Renal Denervation Research Articles

Abstract 4118611: Blood Pressure Lowering Effectiveness of Ultrasound Renal Denervation: A Systematic Review and Meta-analysis.

Background: Ultrasound Renal Denervation (uRDN) has emerged as an innovative therapeutic modality for resistant hypertension. However, there is uncertainty regarding the effectiveness of this procedure compared to other renal denervation techniques. We aimed to evaluate the effectiveness of uRDN especially on ambulatory and daytime blood pressure. Objectives: given the need for clarity in treatment approaches, our study aimed to evaluate the impact of ultrasound renal denervation particularly on ambulatory and daytime blood pressure in patients with hypertension. Methods: we conducted a systematic search of Embase, PubMed, and Cochrane Library databases up to March 2024 to identify randomized controlled trials (RCT) evaluating the effectiveness of uRDN. Statistical analyses were performed using RevMan 6.3 software, utilizing the mean and standard deviation method to calculate mean differences (MD) with a 95% confidence interval (CI). Results: four studies were included in the final analysis, involving 648 patients. Ultrasound renal denervation reduced daytime ambulatory SBP (5.12 mmHg; 95% CI -6.07 to -4.16, p = < 0.00001), 24 hours SBP (-4.87 mmHg; 95% CI 6.53 to -3.20, p = < 0.00001), office SBP (-5.03 mmHg; 95% CI -6.27 to -3.79, p = < 0.00001) at 2 months after the procedure and showed a decrease in patient medication at 6 months after the procedure. Conclusions: the use of uRND decreases the blood pressure among patients within 2-3 months following the procedure. However, after 6-months of procedure, there is no further significant reduction in blood pressure, although there is a notable decrease in medication. With this data, it is reassuring to conclude that endovascular uRDN using upgraded catheter technologies with the refinement of contemporary procedural techniques has improved the BP-lowering efficacy and safety of RDN during a 3 to 6-month follow-up, with decrease short-term need in medications. The impact of uRDN on the long term deserves further investigation.

Efficacy and Safety of Ultrasound Renal Denervation on Office Blood Pressure of Patients with Resistant Arterial Hypertension: A Systematic Review and Meta-analysis.

Resistant arterial hypertension (RAH) is one of the main causes of increased cardiovascular risk around the world. The benefits of ultrasound renal denervation (uRDN) as a non-invasive treatment are still not fully clear. We aim to demonstrate the efficacy of uRDN in reducing office blood pressure of patients in treatment for RAH. PubMed, Embase, and Cochrane were searched for randomized trials comparing uRDN to sham or medical control groups in RAH patients undergoing renal denervation. Mean Differences (MD) with 95% confidence intervals (CIs) were calculated, and I2 statistics assessed heterogeneity. Statistical significance was set at p < 0.05. Statistical analysis was performed using R software version 4.2.3. It was included 5 studies with 709 patients, of which 395 (55.71%) received uRDN treatment and 314 (44.29%) in the sham group. Mean follow-up time ranged from 2 to 48 months and mean age ranged from 52.3 to 62 years. The uRDN decreased systolic blood pressure (SBP) and diastolic blood pressure (DBP) in all measures significantly, including reductions in Office SBP (MD -4.459 mmHg; 95% CI -7.710 to -1.208; p = 0.007; I2 = 47%) and Office DBP (MD -2.039 mmHg; 95% CI -3.975 to -0.102; p = 0.039; I2 = 27%). This meta-analysis highlights uRDN's superiority over the sham group in controlling SBP and DBP in RAH. However, further studies are needed to fully understand the efficacy of uRDN procedure in the management of RAH.

Long-term safety and efficacy of endovascular ultrasound renal denervation in resistant hypertension: 8-year results from the ACHIEVE study.

Ultrasound renal sympathetic denervation (uRDN) reduces blood pressure (BP) in the absence and presence of antihypertensive treatment at 2months. Beyond 3years, there is a lack of follow-up data. This study investigated the long-term safety and efficacy of uRDN. This prospective observational study recruited patients previously included in the international multicenter ACHIEVE study, with office systolic blood pressure (SBP) ≥160 mmHg, 24h ambulatory SBP ≥130mmHg, ≥3 antihypertensive drugs and estimated Glomerular Filtration Rate (eGFR) ≥45 ml/min/1.73m2 undergoing uRDN. The primary efficacy outcome was 24h ambulatory SBP, adjusted for the number of defined daily dosages (DDD) of antihypertensive drugs. Statistical analyses were performed using linear mixed-effects models and inverse probability weighting. A total of 27 out of the initially enrolled 96 patients underwent prospective follow-up at a median of 8.2 [7.6-8.9]years. Mean age was 62.6±9.3years (37.0% female). Preprocedural 24h ambulatory BP was 151.9/84.1±11.5/11.1 mmHg and the median number of DDDs was 5.0 [4.3-7.0]. At 8years after uRDN, the change in 24h ambulatory SBP was -19.5 [95%CI -26.7,-12.4] mmHg (p<0.001). The 8-year change in the number of DDDs was -1.7 [-2.8,-0.6] (p = 0.003). The 8-year decline in eGFR was -8.9 [-13.2,-4.7] ml/min/1.73m2 (p<0.001). Clinical event data were available for all 96 patients (median follow-up 3.5 [1.0-8.0]years). Renal failure occurred in one patient and no cases of renal artery stenosis were detected. A significant BP reduction was observed up until 8years following uRDN in parallel to a decrease in drug burden over time, in the absence of procedure-related adverse events.

Renal denervation - radiofrequency vs. ultrasound: insights from a mixed treatment comparison meta-analysis of randomized sham controlled trials.

Multiple randomized trials have shown that renal denervation (RDN) reduces blood pressure (BP) when compared with sham control but the antihypertensive efficacy of radiofrequency vs. ultrasound-based RDN is uncertain. We aimed to compare the outcomes of radiofrequency RDN (rRDN) and ultrasound RDN (uRDN), when compared with sham in patients with hypertension. PubMed, EMBASE, and clinicaltrials.gov databases were searched for randomized sham-controlled trials (RCTs) of rRDN or uRDN or for trials of rRDN vs. uRDN. Primary efficacy outcome was 24-h ambulatory SBP. A mixed treatment comparison meta-analysis was performed comparing the efficacy and safety against sham and against each other. Among 13 RCTs that enrolled 2285 hypertensive patients, rRDN reduced 24-h ambulatory SBP [(MD = 2.34 mmHg; 95% confidence interval (95% CI): 0.72-3.95], office SBP (MD = 5.04 mmHg; 95% CI: 2.68-7.40)], and office DBP (MD = 2.95 mmHg; 95% CI: 1.68-4.22) when compared with sham. Similarly, uRDN reduced 24-h ambulatory SBP (MD = 4.74 mmHg; 95% CI: 2.80-6.67), day-time ambulatory SBP (MD = 5.40 mmHg; 95% CI: 3.68-7.13), night-time ambulatory SBP (MD = 3.84 mmHg; 95% CI: 0.02-7.67), and office SBP (3.98 mmHg; 95% CI: 0.78-7.19) when compared with sham. There was significantly greater reduction in 24-h ambulatory SBP (MD = 2.40 mmHg; 95% CI: 0.09-4.71), day-time ambulatory SBP (MD = 4.09 mmHg; 95% CI: 1.61-6.56), and night-time ambulatory SBP (MD = 5.76 mmHg; 95% CI: 0.48-11.0) with uRDN when compared with rRDN. For primary efficacy outcome, uRDN ranked #1, followed by rRDN (#2), and sham (#3). In hypertensive patients, rRDN and uRDN significantly reduced 24-h ambulatory and office SBP when compared with sham control with significantly greater reduction in ambulatory BP with uRDN than with rRDN at 4 months (mean) of follow-up. A large-scale randomized head-to-head trial of rRDN or uRDN is warranted to evaluate if there are differences in efficacy.

Effect of Ultrasound Renal Denervation in Patients with CKD: A Matched-Controlled Analysis of the RADIANCE Clinical Trial Program

Effect of Ultrasound Renal Denervation in Patients with CKD: A Matched-Controlled Analysis of the RADIANCE Clinical Trial Program

36-month durability of ultrasound renal denervation for hypertension resistant to combination therapy in RADIANCE-HTN TRIO.

Endovascular ultrasound renal denervation (uRDN) reduced blood pressure (BP) compared to sham at 2 months in patients with resistant hypertension in the multicenter, blinded, randomized, sham-controlled RADIANCE-HTN TRIO trial. This analysis evaluates longer-term outcomes of patients randomized to uRDN. Patients with resistant hypertension to a 3-drug combination pill were randomized to uRDN (n = 69) or sham (n = 67). From 2-5 months, patients followed a standardized anti-hypertensive medication (AHM) titration protocol. At 6 months, patients were unblinded and received AHM per standard of care. In the uRDN group, 71% (49/69) completed 36-month follow-up. Screening office BP was 159/103 on 3.9 AHM. Baseline office BP on the single-pill combination was 153/99 mmHg. At 36 months, office BP changed by -14.5 ± 26.1/-9.0 ± 14.8 mmHg from screening (p < 0.001 for both) and -8.0 ± 24.5/-5.0 ± 14.6 mmHg from baseline (p = 0.007; p = 0.022) on 3.7 AHM. The efficacy of uRDN was durable to 36 months in patients with resistant hypertension with no safety concerns.

Abstract MP09: Characteristics of Antihypertension Medication Adherence Among Patients with Resistant Hypertension in the RADIANCE HTN-TRIO Ultrasound Renal Denervation Trial

Background: About 50% of patients are nonadherent to antihypertensive medications (AHM), impairing blood pressure (BP) management. The RADIANCE-HTN TRIO trial screened patients with resistant hypertension by first placing them on a fixed-dose combination triple pill (ARB+amlodipine+HCTZ). Ambulatory BP measurement 4 weeks later found 43% had controlled BP and were thus ineligible for enrollment. A total of 136 patients with uncontrolled BP were randomized to ultrasound renal denervation (uRDN) or sham-control. This analysis assessed adherence characteristics among patients in the trial. Method: TRIO patients consented to have chemical adherence testing that detected AHM or their metabolites in spot urine samples at baseline, 2 and 6 months. Full adherence (FA) was defined by all prescribed drugs detected in the sample. Results: Adherence data were available at any timepoint for 129 and all timepoints for 91 patients. Among patients with data at all timepoints, 66% (60/91) were FA and 34% (31/91) were partially- or fully nonadherent (PA/NA) to any of their prescribed medications. Adherence rates did not differ between treatment groups or geographies. Women were less likely to be FA (p&lt;0.001) (Table). PA/NA patients had higher rates of peripheral and cerebrovascular disease, and higher BP before and after triple pill. Adherence to triple pill was 81% at baseline, 85% at 2-months, and 83% at 6-months. Medications were titrated after 2-months. At 6-months, adherence to additional medication classes prescribed was: aldosterone antagonist 71%, beta blockers 62%, and centrally-acting alpha-2 agonists 60%. Conclusions: The stringent TRIO study design uncovered significant medication nonadherence that translated into a high rate of apparent resistant HTN. It also showed high adherence to a fixed-dose triple pill. One third of enrolled patients were not fully adherent to medications, and these patients had higher BP and higher rates of vascular disease. Understanding clinical features associated with medication adherence may improve hypertension management.

Abstract P386: Predictors of Home Blood Pressure Response to Ultrasound Renal Denervation

Background: Out-of-office blood pressure measurements are recommended for hypertension (HTN) management. The RADIANCE clinical trial program showed that ultrasound renal denervation (uRDN) significantly reduces daytime ambulatory systolic blood pressure (SBP) in patients with mild-to-moderate HTN (RADIANCE-HTN SOLO, RADIANCE II) and resistant HTN (RADIANCE-HTN TRIO). Previous analyses have assessed predictors of daytime ambulatory SBP response at 2-months. This analysis assessed predictors of home SBP (HSBP) at 2-months. Method: This analysis included 250 patients who were randomized to and received uRDN and were treated per-protocol. Separate linear regression models were used to assess predictors of the change in HSBP at 2-months. Multivariable regression analysis was conducted including variables with p-value&lt;0.20. Backward selection with a stay criterion of 0.20 was used to select the predictors for the final multivariable analysis. Study was pre-defined as a covariate in the final model. Results: Patients were 69% male and 76% white; average age was 53.9 years and baseline office BP 155.5/101.5 mmHg. The only significant predictor (p&lt; 0.05) resulting from the separate linear regression models adjusting for cohort was baseline HSBP. Other predictors included in the multivariable analyses (p&lt;0.20) were sex, black race, screening medications(Y/N), orthostatic HTN, and right renal artery diameter. In the multivariable analyses, baseline HSBP was the only significant predictor of change in HSBP at 2-months (p=0.009, See Table). Conclusions: In this analysis of response to treatment with uRDN using home BPs, baseline HSBP was the only consistent significant predictor of response. Baseline BP value as a predictor of RDN response is consistent with prior analyses.

Overview of the 2023 FDA Circulatory System Devices Advisory Panel meeting on the Recor Paradise Ultrasound-Based Renal Denervation System.

Hypertension continues to be a prominent, avoidable factor contributing to major vascular issues on a global scale. Even with lifestyle adjustments and more aggressive medical treatments, maintaining optimal blood pressure levels remains challenging. This challenge has driven the emergence of device-oriented approaches to address hypertension. To assess the safety and efficacy of the Recor Paradise Ultrasound Renal Denervation System, the Circulatory System Devices Panel was convened by the US Food and Drug Administration (FDA).This manuscript provides a condensed overview of the information put forth by the sponsor and the FDA, along with an account of the considerations and conversations that took place during the meeting.

Cost Effectiveness of Endovascular Ultrasound Renal Denervation in Patients with Resistant Hypertension.

Resistant hypertension (rHTN) is defined as blood pressure (BP) of ≥ 140/90mmHg despite treatment with at least three antihypertensive medications, including a diuretic. Endovascular ultrasound renal denervation (uRDN) aims to control BP alongside conventional BP treatment with antihypertensive medication. This analysis assesses the cost effectiveness of the addition of the Paradise uRDN System compared with standard of care alone in patients with rHTN from the perspective of the United Kingdom (UK) health care system. Using RADIANCE-HTN TRIO trial data, we developed a state-transition model. Baseline risk was calculated using Framingham and Prospective Cardiovascular Münster (PROCAM) risk equations to estimate the long-term cardiovascular risks in patients treated with the Paradise uRDN System, based on the observed systolic BP (SBP) reduction following uRDN. Relative risks sourced from a meta-analysis of randomised controlled trials were then used to project cardiovascular events in patients with baseline SBP ('control' patients); utility and mortality inputs and costs were derived from UK data. Costs and outcomes were discounted at 3.5% per annum. Modelled outcomes were validated against trial meta-analyses and the QRISK3 algorithm and real-world evidence of RDN effectiveness. One-way and probabilistic sensitivity analyses were conducted to assess the uncertainty surrounding the model inputs and sensitivity of the model results to changes in parameter inputs. Results were reported as incremental cost-effectiveness ratios (ICERs). A mean reduction in office SBP of 8.5mmHg with uRDN resulted in an average improvement in both absolute life-years (LYs) and quality-adjusted life-years (QALYs) gained compared with standard of care alone (0.73 LYs and 0.67 QALYs). The overall base-case ICER with uRDN was estimated at £5600 (€6500) per QALY gained (95% confidence interval £5463-£5739 [€6341-€6661]); modelling demonstrated > 99% probability that the ICER is below the £20,000-£30,000 (€23,214-€34,821) per QALYs gained willingness-to-pay threshold in the UK. Results were consistent across sensitivity analyses and validation checks. Endovascular ultrasound RDN with the Paradise system offers patients with rHTN, clinicians, and healthcare systems a cost-effective treatment option alongside antihypertensive medication.

Real-world experience with ultrasound renal denervation utilizing home blood pressure monitoring: the Global Paradise System registry study design

BackgroundHypertension is a major public health issue due to its association with cardiovascular disease risk. Despite the availability of effective antihypertensive drugs, rates of blood pressure (BP) control remain suboptimal. Renal denervation (RDN) has emerged as an effective non-pharmacological, device-based treatment option for patients with hypertension. The multicenter, single-arm, observational Global Paradise™ System (GPS) registry has been designed to examine the long-term safety and effectiveness of ultrasound RDN (uRDN) with the Paradise System in a large population of patients with hypertension.MethodsThe study aims to enroll up to 3000 patients undergoing uRDN in routine clinical practice. Patients will be recruited over a 4-year period and followed for 5 years (at 3, 6, and 12 months after the uRDN procedure and annually thereafter). Standardized home BP measurements will be taken every 3 months with automatic upload to the cloud. Office and ambulatory BP and adverse events will be collected as per routine clinical practice. Quality-of-Life questionnaires will be used to capture patient-reported outcomes.ConclusionsThis observational registry will provide real-world information on the safety and effectiveness of uRDN in a large population of patients treated during routine clinical practice, and also allow for a better understanding of responses in prespecified subgroups. The focus on home BP in this registry is expected to improve completeness of long-term follow-up and provide unique insights into BP over time.Graphical abstractGlobal Paradise System registry study design. ABP, ambulatory blood pressure; BP, blood pressure; FU, follow-up; M, month; OBP, office blood pressure.

Abstract 13660: Endovascular Ultrasound Renal Denervation for Resistant Hypertension: A Systematic Review and Meta-Analysis of Randomized Sham-Controlled Trials

Background: Radiofrequency renal denervation (RDN) is used as a treatment for resistant hypertension, although its efficacy is still under evaluation. Similarly, ultrasound RDN, a less invasive technique, has yielded inconsistent results in this population. Hypothesis: Ultrasound RDN may lower blood pressure in patients with resistant hypertension. Aims: To compare the efficacy of ultrasound RDN versus a sham procedure in treating resistant hypertension. Methods: We systematically searched PubMed, Cochrane Library, and Embase in May 2023 to include randomized sham-controlled trials assessing the efficacy of ultrasound RDN. Statistical analyses were performed using Review Manager 5.4.1 using generic inverse variance weighting to pool mean ± standard deviation and least square mean ± standard error. Results: We included three studies comprising 323 patients with resistant hypertension on ≥ three antihypertensive medications, of whom 51.7% were randomized to RDN. Follow-up at analysis ranged from 8 to 24 weeks. There were no significant differences between groups in terms of change from baseline in 24-hour ambulatory systolic blood pressure (SBP; MD -2.15 mmHg; 95% -5.07, 0.76; p=0.15; Fig. 1A), 24-hour ambulatory diastolic blood pressure (DBP; MD -1.19 mmHg; 95% CI -2.91, 0.53; p=0.18; Fig. 1B) or office SBP (MD -1.71 mmHg; 95% CI -9.62, 6.20; p=0.67; Fig. 1C). Conclusion: In this meta-analysis, ultrasound RDN did not significantly reduce blood pressure in patients with resistant hypertension as compared with a sham procedure.

Abstract 14132: Thirty-Six Month Results in Patients With Resistant Hypertension After Endovascular Ultrasound Renal Denervation in the RADIANCE-HTN TRIO Trial

Background: Endovascular ultrasound renal denervation (uRDN) has been shown to reduce blood pressure (BP) and medication burden in patients with resistant hypertension in the multicenter, blinded, randomized, sham-controlled RADIANCE-HTN TRIO trial through 6 months. We report the 36-month safety and durability of treatment effect on office BP (OBP) in the patients treated with uRDN. Methods: Patients with hypertension resistant to a 3-drug single-pill confirmed by daytime ambulatory BP ≥135/85 mmHg were randomized to uRDN (n=69) or sham procedure (n=67). From 2-5 months, if monthly home BP was ≥135/85 mmHg, prespecified standardized stepped-care antihypertensive treatment including an aldosterone antagonist (AA) was started under blinding to treatment assignment. After 6 months, patients were unblinded and received antihypertensive medications (AHM) at treating physicians’ discretion. We assessed changes in OBP of the uRDN group at 36 months vs. baseline and screening. Results: Forty-nine of 69 (71%) patients (age: 53.0 ± 7.4 years; 18% female) originally randomized to uRDN completed their 36-month follow-up. OBP at screening in those patients was 159/103 ± 15/10 mmHg on a mean of 3.9 AHM with 33% of patients on AA. Baseline OBP after starting the single-pill combination was 153/99 mmHg. At 36 months OBP changed by -14.5/-9.0 mmHg from screening (p&lt;0.001 for both) and -8.0/-5.0 mmHg from baseline (p=0.007; p=0.02) on a mean of 3.7 AHM with 41% of patients on AA. At 36 months, OBP change from baseline was irrespective of whether or not patients were taking AA. Given ambulatory BP was used to qualify patients at baseline, some patients had OBP &lt;140/90 mmHg. For those with baseline OBP ≥140/90 (n=39), change in OBP at 36 months from baseline was -12.9/-7.4 mmHg (p&lt;0.001 for both) on mean 3.6 AHM. No new uRDN-related long-term safety concerns were identified. Conclusion: In patients with resistant hypertension, the effectiveness and safety of uRDN were durable to 36 months.

Catheter-Based Ultrasound Renal Denervation in Patients with Resistant Hypertension: A Systematic Review

Background: The maintenance and development of hypertension are fundamentally dependent on renal sympathetic hyperactivity. Through regulation of the renal sympathetic nerves, catheter-based renal sympathetic denervation has been demonstrated to dramatically lower blood pressure (BP) in patients with resistant hypertension (systolic blood pressure 160 mm Hg on three or more antihypertensive medicines, including a diuretic). This study assessed a catheter-based ultrasound device of the next generation intended to maximize nerve coverage using circumferential ultrasound energy. This study's objective is to describe the results of renal denervation (RDN) in patients with resistant hypertension using a catheter-based ultrasonography device to measure blood pressure and safety. A potential new non-pharmacological therapy for resistant hypertension is renal denervation. Method: PubMed, Web of Science, Science Direct, Cochrane Library, and Google Scholar were thoroughly searched for relevant material. Throughout this meticulous process, the Rayyan QRCI was used. Results: our review included 10 studies with parameters including the period of study, age range of patients, office blood pressure, ambulatory blood pressure and the used approach. Clinical studies are required to determine whether this method is effective in treating this resistant hypertension. Conclusion: In individuals with resistant hypertension, catheter-based ultrasound renal denervation significantly and persistently lowers blood pressure and has no negative effects on renal function or renal artery anatomy.

TCT-210 Long-Term Safety and Efficacy of Endovascular Ultrasound Renal Denervation in Resistant Hypertension: 8-Year Results From the ACHIEVE Study

TCT-210 Long-Term Safety and Efficacy of Endovascular Ultrasound Renal Denervation in Resistant Hypertension: 8-Year Results From the ACHIEVE Study

TCT-398 Endovascular Ultrasound Renal Denervation to Treat Uncontrolled Hypertension: 6-Month Results Following Blinded Medication Titration in the Randomized, Sham-Controlled RADIANCE II Pivotal Trial

TCT-398 Endovascular Ultrasound Renal Denervation to Treat Uncontrolled Hypertension: 6-Month Results Following Blinded Medication Titration in the Randomized, Sham-Controlled RADIANCE II Pivotal Trial

Renal denervation for the treatment of hypertension and kidney disease.

Hypertension is a condition characterized by increased sympathetic activity and the autonomic nervous system. Resistant hypertension, a condition with a prevalence of 10% to 20% in the general hypertensive population, is more likely to experience poor outcomes and adverse cardiovascular events. Renal sympathetic denervation (RDN), a minimally invasive, catheter-based percutaneous intervention, has been considered for treating this condition. Clinical trials have used various catheters, such as the Symplicity Spyral catheter, Vessix Renal Denervation system, and Paradise endovascular ultrasound renal denervation system. After the first randomized clinical trials examining the effectiveness and safety of RDN for lowering blood pressure in hypertensive patients, new clinical trials have used various catheters based on radiofrequency, such as the Spyral catheter, Vessix Renal Denervation system, or based on radiofrequency as the Paradise endovascular ultrasound renal denervation system. Positive results on this trials have shown that endovascular RDN (radiofrequency energy or high focused ultrasound energy) could be considered as a treatment option for uncontrolled resistant hypertension. Therefore, endovascular RDN (radiofrequency energy or high focused ultrasound energy) could be considered as a treatment option for uncontrolled resistant hypertension, which can be considered as an alternative to increasing medication. Nevertheless more data are needed, mainly in cardiovascular outcomes. RDN should be performed in experienced and specialized centers with a multidisciplinary team, and the benefits and risks of RDN should be addressed in a shared-decision-making process.

Endovascular ultrasound renal denervation to lower blood pressure in young hypertensive women planning pregnancy: study protocol for a multicentre randomised, blinded and sham controlled proof of concept study

IntroductionA major issue confronting clinicians treating hypertension in pregnancy is the limited number of pharmacological options. Endovascular catheter-based renal denervation (RDN) is a new method to lower blood pressure (BP)...

Changes in Systolic Blood Pressure after Endovascular Ultrasound Renal Denervation in Patients with Resistant Hypertension

Changes in Systolic Blood Pressure after Endovascular Ultrasound Renal Denervation in Patients with Resistant Hypertension

Renal denervation in hypertension: An updated meta-analysis of the randomized controlled trials.

Radiofrequency or ultrasound renal denervation (RDN) has shown conflicting results when used as an adjunctive option for hypertension management in randomized controlled trials (RCTs). We searched Pubmed, MEDLINE, and other online databases for RCTs comparing RDN versus sham-control procedures in patients with uncontrolled or resistant hypertension. The endpoints of interest were 24-h ambulatory (AMB) blood pressure (BP), daytime AMB BP, and office BP. We performed a random-effects meta-analysis using the inverse variance method to estimate mean difference (MD) with a 95% confidence interval (CI). Nine studies with 1643 patients were included in the final analysis. The mean follow-up was 5 months. As compared with the sham-controlled group, RDN was associated with a significant decrease in 24-h AMB BP (systolic [MD -4.20; 95% CI -5.36 to -3.03; p < 0.00001], diastolic [-2.38; -3.42 to -1.35]), and daytime AMB BP (systolic: -5.11; -6.75 to -3.47, diastolic: -2.88; -3.91 to -1.85). Similarly, office BP was reduced with RDN (systolic: -5.46; -7.12 to -3.81; diastolic: -3.17; -4.23 to -2.12) when compared with placebo. Our meta-analysis shows that RDN is associated with a significant reduction in the 24-h AMB BP, daytime AMB BP, and office BP.