Reduction In Ambulatory Blood Pressure Research Articles

RELEVANCE OF TARGETING THE DISTAL RENAL ARTERY AND BRANCHES WITH RADIOFREQUENCY RENAL DENERVATION–INSIGHTS FROM A POST-HOC ANALYSIS IN HYPERTENSIVE CHRONIC KIDNEY DISEASE PATIENTS

Objective: We previously reported that renal denervation (RDN) approach aimed at chronic kidney (CKD) disease and hypertension management was efficient in reducing blood pressure (BP) in resistant hypertensive patients with chronic kidney disease (CKD) in the long-term. Taking into account recent data obtained from the SPYRAL HTN-OFF and HTN-ON MED trials, we now performed a post hoc analysis in our resistant hypertensive patients with CKD to evaluate whether our (RDN) approach yielded a close association with the magnitude of the BP response. Design and method: We performed a post hoc analysis of a 24-month follow up evaluation of 30 patients who underwent RDN between 2011 and 2012 using a standard irrigated cardiac ablation catheter radiofrequency based approach. We assessed the association between changes from baseline to 12 and 24-months follow-up in mean ambulatory systolic and diastolic BP and the total number of ablation sites. Furthermore, we explored whether or not distal vs proximal treatment may influence this association. Results: The mean change in ambulatory systolic BP compared to baseline was −19.4 ± 12.7 mmHg (95%CI: −24.1 to −14.6) at 12-month (p < 0.0001) and −21.3 ± 14.1 mmHg (95%CI: −26.9 to −15.7) at 24-month follow-up (p < 0.0001). There was no correlation between ambulatory systolic BP-lowering effect and the total number (17.7 ± 6.0) of renal artery ablation sites neither at 12 (Pearson: r = −0.3 (95%CI: −0.6 to 0.1), p = 0.1542) nor at 24 (Pearson: r = −0.2 (95%CI: −0.5 to 0.2), p = 0.4009) months post-procedure. However, correlations between ambulatory systolic BP-lowering effect and the number of treatments performed in the distal segment and branches were significant at the 12 (Pearson: r = −0.7 (95% CI: −0.8 to −0.4), p < 0.0001) and 24-months follow-up (Pearson: r = −0.8 (95%CI: −0.9 to −0.6), p < 0.0001). Conclusions: Our findings confirm that in a cohort of CKD patients with resistant hypertension RDN resulted in a significant and sustained ambulatory BP reduction. Importantly, only the number of ablations performed in the distal segment and branches of renal arteries correlated strongly with the long-term systolic BP-lowering efficacy. Our post-hoc analysis supports the notion that RDN performed distally and in the branches may yield a more favourable long-term BP response.

A randomized controlled trial on the blood pressure-lowering effect of amlodipine and nifedipine-GITS in sustained hypertension.

In a multicenter, randomized trial, we investigated whether the long half-time dihydropyridine calcium channel blocker amlodipine was more efficacious than the gastrointestinal therapeutic system (GITS) formulation of nifedipine in lowering ambulatory blood pressure (BP) in sustained hypertension (clinic systolic/diastolic BP 140-179/90-109mmHg and 24-hour systolic/diastolic BP≥130/80mmHg). Eligible patients were randomly assigned to amlodipine 5-10mg/day or nifedipine-GITS 30-60mg/day. Ambulatory BP monitoring was performed for 24hours at baseline and 4-week treatment and for 48hours at 8-week treatment with a dose of medication missed on the second day. After 8-week treatment, BP was similarly reduced in the amlodipine (n=257) and nifedipine-GITS groups (n=248) for both clinic and ambulatory (24-hour systolic/diastolic BP10.3/6.5 vs 10.9/6.3mmHg, P≥0.24) measurements. However, after missing a dose of medication, ambulatory BP reductions were greater in the amlodipine than nifedipine-GITS group, with a significant (P≤0.04) between-group difference in 24-hour (-1.2mmHg) and daytime diastolic BP (-1.5mmHg). In conclusion, amlodipine and nifedipine-GITS were efficacious in reducing 24-hour BP. When a dose of medication was missed, amlodipine became more efficacious than nifedipine-GITS.

Sham-Controlled Randomized Trials of Catheter-Based Renal Denervation in Patients With Hypertension

BackgroundThere are conflicting data regarding the relative effectiveness of renal sympathetic denervation (RSD) in patients with hypertension. ObjectivesThe purpose of this study was to evaluate the blood pressure (BP) response after RSD in sham-controlled randomized trials. MethodsDatabases were searched through June 30, 2018. Randomized trials (RCTs) with ≥50 patients comparing catheter-based RSD with a sham control were included. The authors calculated summary treatment estimates as weighted mean differences (WMD) with 95% confidence intervals (CIs) using random-effects meta-analysis. ResultsThe analysis included 977 patients from 6 trials. The reduction in 24-h ambulatory systolic blood pressure (ASBP) was significantly greater for patients treated with RSD than sham procedure (WMD −3.65 mm Hg, 95% CI: −5.33 to −1.98; p < 0.001). Compared with sham, RSD was also associated with a significant decrease in daytime ASBP (WMD −4.07 mm Hg, 95% CI: −6.46 to −1.68; p < 0.001), office systolic BP (WMD −5.53 mm Hg, 95% CI: −8.18 to −2.87; p < 0.001), 24-h ambulatory diastolic BP (WMD −1.71 mm Hg, 95% CI: −3.06 to −0.35; p = 0.01), daytime ambulatory diastolic BP (WMD −1.57 mm Hg, 95% CI: −2.73 to −0.42; p = 0.008), and office diastolic BP (WMD −3.37 mm Hg, 95% CI: −4.86 to −1.88; p < 0.001). Compared with first-generation trials, a significantly greater reduction in daytime ASBP was observed with RSD in second-generation trials (6.12 mm Hg vs. 2.14 mm Hg; p interaction = 0.04); however, this interaction was not significant for 24-h ASBP (4.85 mm Hg vs. 2.23 mm Hg; p interaction = 0.13). ConclusionsRSD significantly reduced blood pressure compared with sham control. Results of this meta-analysis should inform the design of larger, pivotal trials to evaluate the long-term efficacy and safety of RSD in patients with hypertension.

RETRACTED ARTICLE: Vasodilatory Properties of Sacubitril/Valsartan Explored in Hypertensives Aged Over 55Years: A Meta-Analysis.

A complete assessment of the efficacy and safety of sacubitril/valsartan for hypertension is not available yet. Therefore, we performed a meta-analysis of randomized controlled trials (RCTs) by incorporating only RCTs including patients aged > 55 years in which the antihypertensive efficacy and safety of sacubitril/valsartan were compared with those of a reference drug (comparator). The mean reductions in systolic blood pressure and diastolic blood pressure in the sitting position (msSBP and msDBP, respectively)were assumed as primary efficacy endpoints. Even mean reduction in ambulatory systolic blood pressure (maSBP) and ambulatory diastolic blood pressure(maDBP), were explored. Adverse events (AEs) were taken as safety outcomes. Five RCTs were included for a total of 1513 patients for analysis. In all studies, the comparator drug was an ARB (valsartan in two cases and olmesartan in the remaining three cases). Compared with ARBs, after 12 weeks there was a significant reduction in msSBP (weight mean difference [WMD] = - 5.41 mmHg, 95% CI - 7.0 to - 3.8; P < 0.01), msDBP (WMD = - 1.22 mmHg, 95% CI : - 2.15 to - 0.3; P < 0.01), maSBP (WMD = - 4.58 mmHg, 95% CI: - 5.62 to - 3.54; P < 0.01) and maDBP (WMD = - 2.17mm Hg, 95% Cl: - 2.78 to - 1.56; P < 0.01). Comparison with ARBs consistently showed superiority of the antihypertensive effect of sacubitril/valsartan. Therefore, based on the preliminary evidence derived from these small trials, sacubitril/valsartan could be proposed as an elective drug for hypertension in patients aged over 55.

Effects of renal denervation on kidney function and long-term outcomes: 3-year follow-up from the Global SYMPLICITY Registry.

AimsSeveral studies and registries have demonstrated sustained reductions in blood pressure (BP) after renal denervation (RDN). The long-term safety and efficacy after RDN in real-world patients with uncontrolled hypertension, however, remains unknown. The objective of this study was to assess the long-term safety and efficacy of RDN, including its effects on renal function.Methods and resultsThe Global SYMPLICITY Registry is a prospective, open-label registry conducted at 196 active sites worldwide in hypertensive patients receiving RDN treatment. Among 2237 patients enrolled and treated with the SYMPLICITY Flex catheter, 1742 were eligible for follow-up at 3 years. Baseline office and 24-h ambulatory systolic BP (SBP) were 166 ± 25 and 154 ± 18 mmHg, respectively. SBP reduction after RDN was sustained over 3 years, including decreases in both office (−16.5 ± 28.6 mmHg, P < 0.001) and 24-h ambulatory SBP (−8.0 ± 20.0 mmHg; P < 0.001). Twenty-one percent of patients had a baseline estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m2. Between baseline and 3 years, renal function declined by 7.1 mL/min/1.73 m2 in patients without chronic kidney disease (CKD; eGFR ≥60 mL/min/1.73 m2; baseline eGFR 87 ± 17 mL/min/1.73 m2) and by 3.7 mL/min/1.73 m2 in patients with CKD (eGFR <60 mL/min/1.73 m2; baseline eGFR 47 ± 11 mL/min/1.73 m2). No long-term safety concerns were observed following the RDN procedure.ConclusionLong-term data from the Global SYMPLICITY Registry representing the largest available cohort of hypertensive patients receiving RDN in a real-world clinical setting demonstrate both the safety and efficacy of the procedure with significant and sustained office and ambulatory BP reductions out to 3 years.

Antihypertensive effect of sacubitril/valsartan: a meta-analysis.

The efficacy and safety of sacubitril/valsartan used as an antihypertensive agent has not yet been completely assessed. Thus, to investigate them in elderly hypertensive patients, a meta-analysis has been performed. The meta-analysis incorporated only randomized controlled trials (RCTs) in which sacubitril/valsartan was compared with a reference drug. The mean reductions in systolic blood pressure (msSBP) and diastolic blood pressure (msDBP) in the sitting position as well as the mean reductions in ambulatory systolic blood pressure (maSBP) and ambulatory diastolic blood pressure (maDBP), were assumed as efficacy endpoints. Adverse events were taken as safety outcomes. Five RCTs were included for a total of 1513 patients for analysis. In all studies, the comparator drug was an angiotensin receptor blocker (ARB) - valsartan in two cases and olmesartan in the remaining three cases. Compared with ARBs, there was a significant reduction in msSBP (weight mean difference [WMD] -5.41 mmHg, 95% CI: -7.0 to -3.8; P<0.01), msDBP (WMD=-1.22 mmHg, 95% CI: -2.15 to -0.3; P<0.01), maSBP (WMD=-4.58 mmHg, 95% CI: -5.62 to -3.54; P<0.01) and maDBP (WMD=-2.17 mmHg, 95% CI: - 2.78 to -1.56; P<0.01) in elderly hypertensive patients at 12 weeks. Sacubitril/valsartan may reduce arterial pressure more efficaciously than ARBs in elderly hypertensive patients.

Six-Month Results of Treatment-Blinded Medication Titration for Hypertension Control After Randomization to Endovascular Ultrasound Renal Denervation or a Sham Procedure in the RADIANCE-HTN SOLO Trial.

The multicenter, international, randomized, blinded, sham-controlled RADIANCE-HTN SOLO trial (A Study of the ReCor Medical Paradise System in Clinical Hypertension) demonstrated a 6.3 mm Hg greater reduction in daytime ambulatory systolic blood pressure (BP) at 2 months by endovascular ultrasound renal denervation (RDN) compared with a sham procedure among patients not treated with antihypertensive medications. We report 6-month results after the addition of a recommended standardized stepped-care antihypertensive treatment to the randomized endovascular procedure under continued blinding to initial treatment. Patients with a daytime ambulatory BP ≥135/85 mm Hg and <170/105 mm Hg after a 4-week discontinuation of up to 2 antihypertensive medications, and a suitable renal artery anatomy, were randomized to RDN (n=74) or sham (n=72). Patients were to remain off antihypertensive medications throughout the first 2 months of follow-up unless safety BP criteria were exceeded. Between 2 and 5 months, if monthly measured home BP was ≥135/85 mm Hg, a standardized stepped-care antihypertensive treatment was recommended consisting of the sequential addition of amlodipine (5 mg/d), a standard dose of an angiotensin-converting enzyme inhibitor/angiotensin receptor blocker, and hydrochlorothiazide (12.5 mg/d), followed by the sequential uptitration of hydrochlorothiazide (25 mg/d) and amlodipine (10 mg/d). Outcomes included the 6-month (1) change in daytime ambulatory systolic BP adjusted for medications and baseline systolic BP, (2) medication burden, and (3) safety. A total of 69/74 RDN patients and 71/72 sham patients completed the 6-month ambulatory BP measurement. At 6 months, 65.2% of patients in the RDN group were treated with the standardized stepped-care antihypertensive treatment versus 84.5% in the sham group (P=0.008), and the average number of antihypertensive medications and defined daily dose were less in the RDN group than in the sham group (0.9±0.9 versus 1.3±0.9, P=0.010 and 1.4±1.5 versus 2.0±1.8, P=0.018; respectively). Despite less intensive standardized stepped-care antihypertensive treatment, RDN reduced daytime ambulatory systolic BP to a greater extent than sham (-18.1±12.2 versus -15.6±13.2 mm Hg, respectively; difference adjusted for baseline BP and number of medications: -4.3 mm Hg, 95% confidence interval, -7.9 to -0.6, P=0.024). There were no major adverse events in either group through 6 months. The BP-lowering effect of endovascular ultrasound RDN was maintained at 6 months with less prescribed antihypertensive medications compared with a sham control. URL: https://www. gov. Unique identifier: NCT02649426.

Effects of renal denervation on blood pressure in hypertensive patients with end-stage renal disease: a single centre experience.

Sympathetic nerve activity is a hallmark of hypertension in end-stage renal disease (ESRD). An initial proof-of-concept study implies that renal denervation (RDN) is feasible and safe in RDN, but overall data are limited. In this single-centre prospective pilot study six patients with ESRD and treatment resistant hypertension were consecutively included. Ambulatory blood pressure (ABP) was measured before and 6 months after RDN (Symplictiy Flex™, Medtronic Inc., Santa Rosa, CA). Moreover, haemodialysis parameters which may affect BP reduction were monitored closely. In all patients bilateral RDN was successful done, without documentation of peri- or postprocedural complications. There was a significant reduction in 24-h ABP by 20 ± 17/15 ± 12mmHg 6 months after RDN (systolic: 163 ± 16 versus 143 ± 9mmHg, p = 0.043; diastolic: 96 ± 9 versus 81 ± 15mmHg, p = 0.043), with similar results for day-, and nighttime values, respectively. Antihypertensive medication was kept stable as well as there was no change in haemodialysis parameters during follow-up. In addition, ultrafiltration/week (1.4 ± 1.4 versus 2.2 ± 1.4l, p = 0.08) as well as hematocrit (measured at baseline and 6 months after RDN) (33.7 ± 4.3 versus 33.1 ± 3.9%, p = 0.715) revealed no change in volume status. Our single-centre pilot study not only supports current data on renal safety of RDN even in small arteries of patients with ESRD, but also enhances the knowledge towards an effective ABP reduction in this type of hypertensive patients.

Anti-Hypertensive Effect of Sacubitril/Valsartan: A Meta-Analysis of Randomized Controlled Trials.

BackgroundFor elderly patients suffering from arterial hypertension, a complete assessment of the efficacy and safety of sacubitril/valsartan used as an anti-hypertensive agent is not available yet. Therefore, we decided to perform a meta-analysis of randomized controlled trials (RCTs) to explore some endpoints concerning anti-hypertensive efficacy as well as safety of sacubitril/valsartan in elderly hypertensive patients.MethodsPubMed and Scopus have been extensively investigated with the help of some key words until June 15, 2018. The meta-analysis incorporated exclusively RCTs in which the anti-hypertensive efficacy and safety of sacubitril/valsartan were compared with those of a reference drug (comparator) that could be an angiotensin-converting enzyme inhibitor (ACEi), an angiotensin receptor blocker (ARB), a calcium channel blocker (CCB) or a beta-blocker. Continuous ambulatory blood pressure monitoring was required as an inclusion criterion in the studies to be included in the meta-analysis. The mean reductions in systolic blood pressure and diastolic blood pressure in the sitting position (msSBP and msDBP, respectively), as well as the mean reductions in ambulatory systolic blood pressure (maSBP) and ambulatory diastolic blood pressure (maDBP), were assumed as efficacy endpoints. Adverse events (AEs) were taken as safety outcomes.ResultsFive RCTs were included with a total of 1,513 patients for analysis. In all studies, the comparator drug was an ARB (valsartan in two cases and olmesartan in the remaining three cases). Compared with ARBs, after 12 weeks there was a significant reduction in msSBP (weight mean difference (WMD) = - 5.41 mm Hg, 95% confidence interval (CI): -7.0 to -3.8; P < 0.01), msDBP (WMD = -1.22 mm Hg, 95% CI : -2.15 to -0.3; P < 0.01), maSBP (WMD = -4.58 mm Hg, 95% CI: -5.62 to -3.54; P < 0.01) and maDBP (WMD = -2.17 mm Hg, 95% CI: - 2.78 to -1.56; P < 0.01) in elderly hypertensive patients at 12 weeks.ConclusionsSacubitril/valsartan may reduce arterial pressure more efficaciously than ARBs in elderly hypertensive patients. These results have to be confirmed by further RCTs with a good methodological quality, possibly with a greater sample size.

The Effectiveness of Home Blood Pressure on 24-Hour Blood Pressure Control: A Randomized Controlled Trial.

Home blood pressure monitoring (HBPM) is cited as an effective approach for improving blood pressure control. The objective of this study was to determine the effectiveness of HBPM combined with a health education session in reducing blood pressure and improving medication adherence among adults with hypertension. Two hundred thirteen participants were enrolled in a 3-month study and randomized to receive HBPM or usual care. Participants were also randomized to receive an educational session delivered using a pamphlet or a computer-based program. Topics of the educational session included preventing hypertension, managing weight, staying active, and cutting down on salt and fat. At the 3-month follow-up, there was a reduction in ambulatory blood pressure among the HBPM group. However, the differences found within the HBPM group were no greater than those found among the control group. We did not detect a statistically significant difference in adherence to medication when comparing the HBPM to the usual care group. HBPM and educational session did not lower blood pressure or improve medication adherence in our sample. A greater effect may have been seen if coupled with an enhanced educational intervention and if blood pressure measures were shared with the provided. The findings of this study provide useful insights for future HBPM studies.

A14860 Differential Effects of Aliskiren/Amlodipine Combination and High-dose Amlodipine Monotherapy on Ambulatory Blood Pressure and Target Organ Protection in Hypertensives and its Inadequate Blood Pressure Response in those who with Diabetes

Objectives: The first aim was to compare an aliskiren/amlodipine (ALI/AML) combination with high-dose amlodipine monotherapy on ambulatory blood pressure (ABP) reduction and target organ protection. The second aim was to compare the BP lowering effect of antihypertensive medication on ABP and clinic BP (CBP) between diabetes mellitus (DM) and non-DM patients. Methods: We performed a prospective, randomized, open-label trial in essential hypertensives: 105 patients (mean age: 77.1; male: 41.0%) with CBP over 140/90 mmHg with AML 5 mg were randomly allocated to ALI (150–300 mg) /AML (5 mg) (ALI/AML, n = 53) or high-dose amlodipine (10 mg) (h-dAML, n = 52), and were treated for 16 wks. To the next, we performed a subanalysis, dividing the 86 patients who completed the treatment period into the Non-DM (n = 75) and DM (n = 11), and compared reductions on ABP and CBP. Results: The ALI/AML and h-dAML group showed similarly reduced 24-h SBP, daytime SBP, nighttime SBP, and brachial-ankle pulse wave velocity. The urine albumin-to-creatinine ratio reduction was significantly greater in the ALI/AML (p = 0.02). However, ALI/AML was significantly less effective in reducing early-morning BP (4.0 ± 21.2 vs. − 10.8 ± 22.1 mmHg, p = 0.002) and morning BP surge (10.0 ± 23.2 vs. − 5.4 ± 20.3 mmHg, p = 0.001) compared to h-dAML. The Non-DM and DM group's CBP reduction was similar. However, 24-h SBP reduction (p = 0.01) and daytime SBP reduction (p = 0.01) were significantly smaller in DM compared to Non-DM patients. Conclusion: ALI/AML provided better renal protection than h-dAML. Although ALI/AML and h-dAML showed almost equal reduction on ABP, ALI/AML was significantly less effective in reducing early-morning BP and morning BP surge compared to h-dAML. The ABP reduction was weakened in DM patients.

European Society of Hypertension position paper on renal denervation 2018.

: This ESH update was deemed necessary with the publication of new results of sham-controlled randomized blinded prospective trials with renal denervation (RDN). Proof of concept studies and first randomized trials (some were sham-controlled) displayed discrepant results about the efficacy of RDN. Three sham-controlled randomized trials of the 2.0 generation yielded now similarity in the average blood pressure decrease following RDN. Reduction of ambulatory blood pressure was approximately 5 to 7 mmHg and of office blood pressure 10 mmHg. Such a decrease in blood pressure by pharmacologic therapy has been found to be associated with lower incidence of cardiovascular events in particular with respect to heart failure and stroke by roughly 25%. Nevertheless, some questions about renal denervation are unanswered. The heterogeneity of the blood pressure-lowering response point to the clinical need to identify predictors for efficacy, and questions on long-term safety could not have been answered due to the short duration of the sham-controlled randomized clinical trials.

A17651 Renal denervation for resistant hypertension in patients less than 65-year-old

Objectives: To investigate the safety and mid-term efficacy of renal denervation (RDN) in less than 65-year-old Chinese patients with resistant hypertension. Methods: In the prospective cohort study, the patients with resistant hypertension were continuously enrolled to undergo RDN between November 2012 and November 2014 using LEPU single-electrode ablation catheter. The primary effectiveness endpoints were reductions in office blood pressure and 24-hour ambulatory blood pressure (24h-ABP) at six months. The primary safety endpoint was the incidence of major adverse event through 6 months. Results: A total of 50 consecutive patients, aged between 26 and 62 (41.9 ± 10.6) years old, were enrolled, in which 18 (36.0%) were female. At six months after surgery, the office BP and 24-h ABP were separately reduced by 23.7 ± 14.5/11.5 ± 7.9 mmHg and 11.1 ± 8.5/7.1 ± 6.2 mmHg, with the reduction of the number of antihypertensive agents from 4.0 (4.0∼4.0) at baseline to 4.0 (3.0∼4.0) (all P < 0.01). There is no significant change of renal function (P > 0.05) and no major adverse events occurred. Only one patient suffered from femoral artery pseudoaneurysm with no sequelae. Conclusion: RDN seems to be safe and effective in lowering BP in the less than 65-year-old Chinese cohort with resistant hypertension.

Renal Denervation in Resistant Hypertension and Obstructive Sleep Apnea

It has been postulated that catheter-based renal denervation (RDN) may lower blood pressure (BP) and improve severity of obstructive sleep apnea (OSA) in resistant hypertensive patients. The aim of our study (NCT01366625) was to investigate in a prospective randomized trial the effect of RDN on BP and clinical course of OSA. Sixty patients with true resistant hypertension coexisting with moderate-to-severe OSA (apnea/hypopnea index, ≥15) were randomly allocated to RDN group (30 patients) and to control group (30 patients). The primary end point was reduction in office systolic BP at 3 months. Secondary end points included reduction in diastolic office and ambulatory BP, change in apnea/hypopnea index and biochemical measurements at 3 months, and change in echocardiographic measurements at 6 months. There were no differences in clinical characteristics between the groups. At 3 months in the RDN group, both office and ambulatory BP were significantly reduced, and a significant decrease in OSA severity (apnea/hypopnea index, 39.4 versus 31.2 events per hour; P =0.015) was observed. Between-group difference in apnea/hypopnea index change was significant at 0.05. At 6 months in the RDN group, reductions in office and ambulatory BP were sustained and were accompanied by significant improvement in echocardiographic measures of global longitudinal strain. There were no differences in metabolic variables in follow-up in both groups. In a randomized controlled trial, RDN lowered both office and ambulatory BP in patients with resistant hypertension and OSA. This was accompanied by improvement of the clinical severity of OSA. Clinical Trial Registration— URL: http://www.clinicaltrials.gov . Unique identifier: NCT01366625.

IMMEDIATE, SIGNIFICANT DECLINE IN CENTRAL AND PERIPHERAL BLOOD PRESSURE WITH CENTRAL ARTERIAL VENOUS ANASTOMOSIS

Objective: Clinical trials have reported the intermediate and long term reductions of blood pressure (BP) following formation of a central iliac arteriovenous anastomosis (cAVA). We present for the first time, the immediate and day one BP changes after the procedure Design and method: This open-label, multicentre, European registry is enrolling patients with a baseline office systolic BP > 140 mmHg, average daytime ambulatory systolic BP > 135 mmHg, and resistant or uncontrolled hypertension due to multidrug intolerances. Subjects underwent arteriovenous (AV) coupler implantation whilst continuing usual medical management. Results: Creation of a cAVA causes immediate, substantial on table reduction of office and ambulatory BP that persists the following day (Table 1). Furthermore, central systolic BP reduced by 23 ± 22 mm Hg (p < 0.0001), central diastolic BP reduced by 13 ± 13 mm Hg (p < 0.0001), and augmentation index (AI) reduced by 39% (p = 0.0006) 1 day after coupler implantation.Conclusions: A significant, instantaneous and day 1 reduction of peripheral and central BP with profound reduction of AI occurs following creation of a cAVA. This magnitude of BP reduction offers the potential to immediately reduce cardiovascular risk associated with hypertension in contrast to alternative therapies for hypertension in which BP reduction takes places over days to weeks.

SPYRAL HTN-OFF MED TRIAL

Objective: Heart rate (HR) is associated with cardiovascular outcomes in hypertensive high-risk vascular patients and heart failure. Recently, the randomized, sham-controlled SPYRAL HTN-OFF MED trial showed reduction of office and ambulatory blood pressure (BP) at 3 months post-renal denervation. The objective of the current analysis is to evaluate the effect of renal denervation on HR in an uncontrolled hypertensive population without medication. Design and method: The SPYRAL HTN-OFF MED trial enrolled uncontrolled hypertensive patients who were drug naïve or removed from their antihypertensive medications. Patients were randomized 1:1 to renal denervation or sham control procedure. BP and HR were measured at baseline and 3 months post-procedure using ambulatory BP monitoring and in the office. For office BP and HR, each data point was an average of 3 measurements. Post-hoc analyses compared changes at 3 months in BP and HR for patients with baseline office HR above and below the median. Results: At 3 months, average office, 24-hour, daytime and night-time HR were significantly reduced in the renal denervation group but not in the sham control group (Table 1). Also, the change in 24-hour HR at 3 months was significantly different between groups. Three-month changes in 24-hour systolic BP, diastolic BP and HR were significantly lower for renal denervation patients with higher baseline HR compared to those with lower baseline HR (Table 2). Similar trends were not seen in the sham control group.Conclusions: In the SPYRAL HTN-OFF MED trial, significant reductions in HR were seen at 3 months in the renal denervation group but not in the sham control group. Post-hoc analyses suggest patients with higher baseline HR could experience greater reductions in ambulatory HR and BP post-renal denervation.

Endovascular ultrasound renal denervation to treat hypertension (RADIANCE-HTN SOLO): a multicentre, international, single-blind, randomised, sham-controlled trial

Early studies suggest that radiofrequency-based renal denervation reduces blood pressure in patients with moderate hypertension. We investigated whether an alternative technology using endovascular ultrasound renal denervation reduces ambulatory blood pressure in patients with hypertension in the absence of antihypertensive medications. RADIANCE-HTN SOLO was a multicentre, international, single-blind, randomised, sham-controlled trial done at 21 centres in the USA and 18 in Europe. Patients with combined systolic-diastolic hypertension aged 18-75 years were eligible if they had ambulatory blood pressure greater than or equal to 135/85 mm Hg and less than 170/105 mm Hg after a 4-week discontinuation of up to two antihypertensive medications and had suitable renal artery anatomy. Patients were randomised (1:1) to undergo renal denervation with the Paradise system (ReCor Medical, Palo Alto, CA, USA) or a sham procedure consisting of renal angiography only. The randomisation sequence was computer generated and stratified by centres with randomised blocks of four or six and permutation of treatments within each block. Patients and outcome assessors were blinded to randomisation. The primary effectiveness endpoint was the change in daytime ambulatory systolic blood pressure at 2 months in the intention-to-treat population. Patients were to remain off antihypertensive medications throughout the 2 months of follow-up unless specified blood pressure criteria were exceeded. Major adverse events included all-cause mortality, renal failure, an embolic event with end-organ damage, renal artery or other major vascular complications requiring intervention, or admission to hospital for hypertensive crisis within 30 days and new renal artery stenosis within 6 months. This study is registered with ClinicalTrials.gov, number NCT02649426. Between March 28, 2016, and Dec 28, 2017, 803 patients were screened for eligibility and 146 were randomised to undergo renal denervation (n=74) or a sham procedure (n=72). The reduction in daytime ambulatory systolic blood pressure was greater with renal denervation (-8·5 mm Hg, SD 9·3) than with the sham procedure (-2·2 mm Hg, SD 10·0; baseline-adjusted difference between groups: -6·3 mm Hg, 95% CI -9·4 to -3·1, p=0·0001). No major adverse events were reported in either group. Compared with a sham procedure, endovascular ultrasound renal denervation reduced ambulatory blood pressure at 2 months in patients with combined systolic-diastolic hypertension in the absence of medications. ReCor Medical.

A randomized controlled trial comparing home-based isometric handgrip exercise versus endurance training for blood pressure management

Aerobic endurance exercise (AEX) is an effective treatment in the prevention and management of high blood pressure (BP). Growing evidence suggests potential benefits from isometric handgrip (IHG) exercise, which may promote similar or even larger reductions in BP than AEX. We compared the effects of home-based AEX and home-based IHG on BP. Sixty healthy individuals (31 men; mean age, 33.1 years; mean BP, 126.9 ± 1.6/84.7 ± 1.1 mm Hg) were randomized to IHG, AEX, or a control group. Both exercise interventions were performed in the home environment. The IHG group performed daily 4 × 2 minutes sustained grips at 30% of maximal volitional contraction. Participants in the AEX group were advised to perform at least 150 min/wk of aerobic exercise at moderate intensity. Outcome measurements were assessed at baseline and 8 weeks of follow-up. Compared with the control group, AEX resulted in a larger reduction in ambulatory BP; both AEX and IHG exercise tended to induce larger reductions in office systolic BP, and office diastolic BP was significantly more reduced after AEX but not IHG exercise. Responses to training were not significantly different between both the exercise interventions. Eight weeks of home-based AEX results in significant reductions in both ambulatory BP and office BP in healthy adults, whereas IHG reduces only office BP.

Efficacy and safety of sacubitril/valsartan in patients with essential hypertension uncontrolled by olmesartan: A randomized, double-blind, 8-week study.

A majority of patients with hypertension fail to achieve blood pressure (BP) control despite treatment with commonly prescribed drugs. This randomized, double-blind phase III trial assessed the superiority of sacubitril/valsartan 200mg (97/103mg) to continued olmesartan 20mg in reducing ambulatory systolic BP after 8-week treatment in patients with mild to moderate essential hypertension uncontrolled with olmesartan 20mg alone. A total of 376 patients were randomized to receive either sacubitril/valsartan (n=188) or olmesartan (n=188). Superior reductions in 24-hour mean ambulatory systolic BP were observed in the sacubitril/valsartan group vs the olmesartan group (-4.3mmHg vs -1.1mmHg, P<.001). Reductions in 24-hour mean ambulatory diastolic BP and pulse pressure and office systolic BP and diastolic BP were significantly greater with sacubitril/valsartan vs olmesartan (P<.014). A greater proportion of patients achieved BP control with sacubitril/valsartan vs olmesartan. The overall incidence of adverse events was comparable between the groups. Compared with continued olmesartan, sacubitril/valsartan was more effective and generally safe in patients with hypertension uncontrolled with olmesartan 20mg.

Renal sympathetic denervation in Sweden: a report from the Swedish registry for renal denervation.

Renal denervation (RDN) is a catheter-based intervention to treat patients with resistant hypertension. The biological effects of RDN are not fully understood, and randomized controlled trials have generated conflicting evidence. This report presents data from the Swedish Registry for Renal Denervation, an investigator-driven nationwide registry. To assess the safety and efficacy of RDN on patients with resistant hypertension in a real-world clinical setting. This nationwide database contains patient characteristics, procedural details, and follow-up data on all RDN procedures performed in Sweden. Consecutive procedures between 2011 and 2015 were included. The data analysis consists of 252 patients (mean age 61 ± 10 years, 38% women; mean 4.5 ± 1.5 antihypertensive drugs). Office SBP and DBP and 24-h ambulatory blood pressure (BP) decreased 6 months after RDN (176 ± 23/97 ± 17 to 161 ± 26/91 ± 16 mmHg, both P < 0.001; and 155 ± 17/89 ± 14 to 147 ± 18/82 ± 12 mmHg, both P < 0.001). Significant office and ambulatory BP reductions persisted throughout the observation period of 36 months. Major procedure-related vascular complications occurred in four patients. Renal function and number of antihypertensive drugs were unchanged during follow-up. In this complete national cohort, RDN was associated with a sustained reduction in office and ambulatory BP in patients with resistant hypertension. The procedure proved to be feasible and associated with a low-complication rate, including long-term adverse events.