Improvement in health-related quality of life after renal sympathetic denervation in real-world hypertensive patients: 12-month outcomes in the Global SYMPLICITY Registry.
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SUBMITTER: Kindermann I
PROVIDER: S-EPMC8031037 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:Hypertension is one of the most prevalent chronic diseases worldwide and the incidence of resistant hypertension is increasing. Catheter-based renal denervation (RDN) offers a new approach to reaching blood pressure goals by targeting the renal nerves. The technique has demonstrated significant and sustained reductions in blood pressure (BP) in the Symplicity HTN-1 and Symplicity HTN-2 clinical trials. The Global SYMPLICITY Registry aims to demonstrate safety and effectiveness in a 'real-world' patient population. Real-world RDN experience has emphasised that patient selection is crucial to successful outcomes; a multidisciplinary referral network is recommended to increase awareness of the procedure and identify patients who are likely to respond best to RDN. Further advances in catheter technology have led to the development of the multi-electrode Symplicity Spyral™ multi-electrode catheter; preliminary data from the feasibility study using the Symplicity Spyral catheter indicate clinical efficacy and procedural safety with reduced procedure times. The Symplicity Spyral catheter is not yet commercially available. The indications of RDN may also expand beyond resistant hypertension - encouraging data have been seen in patients with moderate treatment resistant hypertension. Furthermore, RDN may be beneficial in other clinical states characterised by sympathetic nervous system overactivation including heart failure and chronic kidney disease. Additional data are needed to evaluate the efficacy of RDN in these disease states.
| S-EPMC5808595 | biostudies-other
Project description:After three years of excessive confidence, overoptimistic expectations and performance of 15 to 20,000 renal denervation procedures in Europe, the failure of a single well-designed US trial--Symplicity HTN-3--to meet its primary efficacy endpoint has cast doubt on renal denervation as a whole. The use of a sound methodology, including randomisation and blinded endpoint assessment was enough to see the typical 25-30 mmHg systolic blood pressure decrease observed after renal denervation melt down to less than 3 mmHg, the rest being likely explained by Hawthorne and placebo effects, attenuation of white coat effect, regression to the mean and other physician and patient-related biases. The modest blood pressure benefit directly assignable to renal denervation should be balanced with unresolved safety issues, such as potentially increased risk of renal artery stenosis after the procedure (more than ten cases reported up to now, most of them in 2014), unclear long-term impact on renal function and lack of morbidity-mortality data. Accordingly, there is no doubt that renal denervation is not ready for clinical use. Still, renal denervation is supported by a strong rationale and is occasionally followed by major blood pressure responses in at-risk patients who may otherwise have remained uncontrolled. Upcoming research programmes should focus on identification of those few patients with truly resistant hypertension who may derive a substantial benefit from the technique, within the context of well-designed randomised trials and independent registries. While electrical stimulation of baroreceptors and other interventional treatments of hypertension are already "knocking at the door", the premature and uncontrolled dissemination of renal denervation should remain an example of what should not be done, and trigger radical changes in evaluation processes of new devices by national and European health authorities.
| S-EPMC4122808 | biostudies-literature
Project description:AimsCatheter-based renal artery denervation (RDN) has been shown to lower blood pressure (BP) in certain patients with uncontrolled hypertension. Isolated systolic hypertension (ISH) (systolic BP [SBP] ≥140 mmHg and diastolic BP <90 mmHg), characterized by increased vascular stiffness, is the predominant hypertensive phenotype in elderly patients. This study compared baseline characteristics and SBP change at 6 months between patients with ISH and combined systolic–diastolic hypertension (CH).Methods and resultsThis study pooled data from 1103 patients from SYMPLICITY HTN-3 and the Global SYMPLICITY Registry. A total of 429 patients had ISH, and 674 had CH. Patients with ISH were significantly older than those with CH (66 vs. 55 years), had more type 2 diabetes mellitus (52.9 vs. 34.6%), and a lower estimated glomerular filtration rate (71.8 vs. 78.6 mL/min/1.73 m2); all P < 0.001. At 6 months, the SBP drop for CH patients was −18.7 ± 23.7 mmHg compared with a reduction of −10.9 ± 21.7 mmHg for ISH patients −7.8 mmHg, 95% confidence interval, CI, −10.5, −5.1, P < 0.001). The change in 24-h SBP at 6 months was −8.8 ± 16.2 mmHg in patients with CH vs. −5.8 ± 15.4 mmHg in ISH (−3.0 mmHg, 95% CI −5.4, −0.6, P = 0.015). Presence of ISH at baseline but not age was associated with less pronounced BP changes following the procedure. The strongest predictor of office SBP reduction at 6 months was CH, followed by aldosterone antagonist use and non-use of vasodilators.ConclusionThe reduction in BP among patients with ISH following RDN was less pronounced than the reduction in patients with CH.Clinical.trials.gov identifiersNCT01534299 and NCT01418261.
| S-EPMC5381589 | biostudies-literature
Project description:AIMS:Several 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 RESULTS:The 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. CONCLUSION:Long-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.
| S-EPMC6837160 | 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:Background We have previously reported the feasibility of noninvasive stereotactic body radiotherapy (SBRT) as a novel approach for renal denervation. Methods and Results Herein, from a translational point of view, we assessed the antihypertensive effect and chronological evolution of SBRT-induced renal nerve injury within 6 months in a hypertensive swine model. Hypertension was induced in swine by subcutaneous implantation of deoxycorticosterone acetate pellets in combination with a high-salt diet. A single dose of 25 Gy with SBRT was delivered for renal denervation in 9 swine within 3.4±1.0 minutes. Blood pressure levels at baseline and 1 and 6 months post-SBRT were comparable to control (n=5), whereas renal norepinephrine was significantly lower at 6 months (P<0.05). Abdominal computed tomography, performed before euthanasia and renal function assessment, remained normal. Standard semiquantitative histological assessment showed that compared with control (1.4±0.4), renal nerve injury was greater at 1 month post-SBRT (2.3±0.3) and peaked at 6 months post-SBRT (3.2±0.8) (P<0.05), along with a higher proportion of active caspase-3-positive nerves (P<0.05). Moreover, SBRT resulted in continuous dysfunction of renal sympathetic nerves and low level of nerve regeneration in 6 months by immunohistochemistry analysis. Conclusions SBRT delivering 25 Gy for renal denervation was safe and related to sustained reduction of sympathetic activity by aggravating nerve damage and inhibiting nerve regeneration up to 6 months; however, its translation to clinical trial should be cautious because of the negative blood pressure response in the deoxycorticosterone acetate-salt hypertensive swine model.
| S-EPMC8475062 | biostudies-literature
Project description:Background:Endovascular management of atherosclerotic infrainguinal arteries recently shifted towards drug eluting devices, designed to locally prevent the restenosis process. Numerous clinical studies report an advantage of drug coated balloons over uncoated balloon angioplasty in treating lower extremity peripheral artery disease. However, as coating and balloon platforms are different, each device requires dedicated clinical evaluations. Objective:The aim of the study is to further investigate the safety and effectiveness of a Paclitaxel-Coated Balloon for the treatment of atherosclerotic infrainguinal arteries in a real-world setting. Methods:203 patients out of a final sample of 882 were enrolled in this prospective multicenter, observational, all-comers registry during the first 12 months. The primary endpoints were major adverse events (defined as procedure or device related death within 30 days post index procedure, clinically-driven target lesion revascularization or major target limb amputation) at 6 months and freedom from clinically-driven target lesion revascularization at 12 months. Both endpoints were adjudicated by a Clinical Events Committee. Results:Mean patient age was 70.2±10.4 years (60.1% male). 47.3% of the patients were diabetic and 67.5% had a history of smoking. Severe claudication was reported in 37.4% and 40% had critical limb ischemia. 257 lesions, including 13.2% in the infrapopliteal territory, were treated with Passeo-18 Lux (mean lesion length 75.1 mm±69.4, 20% occlusions, 76.3% calcified). At 6 months, the rate of major adverse events was 5.5% (95%CI 3.1-9.7). Freedom from clinically-driven target lesion revascularization at 12 months was 93.2% (95%CI 89.1-95.8). All causes mortality was 6.5% (95%CI 3.8-11.0) and overall amputation rate was 4.2% (95%CI 2.1-8.3) at 12 months. Conclusion:In a real-world environment, the BIOLUX P-III registry preliminary results confirm the safety and efficacy of the Paclitaxel-Coated Passeo-18 Lux balloon as a stand-alone treatment option for atherosclerotic infrainguinal arteries.
| S-EPMC5944304 | biostudies-literature
Project description:BackgroundIt is unclear whether renal denervation (RDN) can safely result in blood pressure (BP) reductions in Asian hypertensive patients and whether such reductions would be sustainable. The study is to assess the safety and efficacy of RDN achieved by either main renal artery ablation using the Symplicity FlexTM catheter or main plus branch renal artery ablations using the Symplicity SpyralTM catheter in Taiwanese uncontrolled hypertensive patients enrolled in the Global SYMPLICITY Registry (GSR) with 3 years of follow-up.MethodsThe GSR is a prospective, open-label, and all-comer registry to evaluate the safety and effectiveness of RDN in patients with uncontrolled hypertension worldwide.ResultsAmong 26 patients enrolled (mean age, 59.1 ± 13.8 years), 8 were treated with the Symplicity FlexTM catheter, and 18 were treated with the Symplicity SpyralTM catheter. Baseline office systolic BP was 168.2 ± 19.8 mmHg and diastolic BP was 89.0 ± 14.3 mmHg. Office BP reductions following RDN were sustained throughout the follow-up periods of up to 3 years in the Symplicity FlexTM group and 2 years in the Symplicity SpyralTM group. In the Symplicity FlexTM group, the office systolic BP reductions were 14.9 ± 14.7 mmHg and 29.7 ± 25.9 mmHg at 3 months and 3 years, respectively (both p < 0.05 from baseline). In the Symplicity SpyralTM group, the office systolic BP reductions were 21.2 ± 28.7 mmHg and 42.4 ± 10.7 mmHg at 3 months and 2 years, respectively (both p < 0.05 from baseline). There were no significant changes in heart rate or antihypertensive medication classes. Three protocol-defined adverse events occurred in 2 patients, including new-onset end-stage renal disease, stroke, and hospitalization for new-onset heart failure.ConclusionsGiven the susceptibility of Asian populations to hypertension, RDN, as a safe antihypertensive procedure with long-lasting BP-lowering effects, could reliably serve as an alternative or complementary BP-lowering strategy for patients with uncontrolled hypertension in Taiwan and other Asian countries.
| S-EPMC6859098 | biostudies-literature
Project description:IntroductionThis study was conducted to observe patterns of use of the interleukin-6 receptor-alpha inhibitor tocilizumab in routine clinical practice in patients with rheumatoid arthritis (RA).MethodsThis was a 12-month noninterventional, observational study in adult patients with RA who initiated tocilizumab in routine practice in Canada according to the local product monograph. The primary end point was the proportion of patients receiving tocilizumab at 6 months. Secondary end points were treatment patterns, effectiveness, and safety of tocilizumab over 12 months.ResultsOf 200 patients who initiated tocilizumab (91.0% at 8 mg/kg), 67 (33.5%) received tocilizumab monotherapy and 133 (66.5%) received tocilizumab combined with conventional synthetic disease-modifying antirheumatic drugs (csDMARDs). Kaplan-Meier analysis estimated that 85% (95% CI 74-92%) of monotherapy and 89% (95% CI 82-93%) of combination therapy patients continued to receive tocilizumab at 6 months (log-rank p = 0.0888). During the observation period, 12 (17.9%) monotherapy and 27 (20.3%) combination therapy patients withdrew from the study. At month 12, 58.5% in the monotherapy group and 59.3% in the combination therapy group achieved Disease Activity Score at 28 joints remission (≤ 2.6), 25.6% and 24.7% achieved Simplified Disease Activity Index remission (≤ 3.3), and 18.2% and 22.3% achieved Clinical Disease Activity Index remission (≤ 2.8), respectively. Rates of serious adverse events and serious infections were found in 29.6/100 patient-years (PY) and 3.1/100 PY, respectively, for monotherapy and 19.2/100 PY and 4.8/100 PY, respectively, for combination therapy.ConclusionsPatients initiating tocilizumab in routine practice had comparable effectiveness and safety outcomes regardless of whether they received tocilizumab as monotherapy or as combination therapy with csDMARDs.Trial registrationClinicalTrials.gov identifier, NCT01613378 FUNDING: F. Hoffmann-La Roche (Roche) Canada.
| S-EPMC6251854 | biostudies-literature
Project description:ObjectivesThe efficacy and safety of certolizumab pegol (CZP), an Fc-free, PEGylated anti-TNF, in axial spondyloarthritis (axSpA) has been established in clinical trial settings. We report CZP effectiveness and safety in European clinical practice in patients with axSpA, including radiographic (r-) and non-radiographic (nr-) axSpA.MethodsCIMAX (NCT02354105), a European non-interventional multicentre prospective study, observed CZP treatment response and safety over 12 months in a real-world axSpA cohort. The primary outcome was change from baseline in BASDAI to week 52, with additional outcomes pertaining to effectiveness and safety. Patients who received ≥1 dose CZP were followed up for adverse events, and those with baseline and ≥1 post-baseline BASDAI assessment were included in effectiveness analyses.ResultsA total of 672 patients (r-axSpA: 469; nr-axSpA: 201; unconfirmed diagnosis: 2) from 101 sites received ≥1 dose of CZP, of whom 564 (r-axSpA: 384; nr-axSpA: 179; unconfirmed: 1) were included in the effectiveness analyses. The mean baseline BASDAI was 6.1 in the overall axSpA population and r-axSpA and nr-axSpA subpopulations. At week 52, the mean (s.d.) change in BASDAI was -2.9 (2.3; n = 439); for r-axSpA and nr-axSpA, it was -2.9 (2.2; n = 301) and -2.8 (2.4; n = 137), respectively (P <0.0001 for all). Similar improvements were seen across other axSpA disease measures. In total, 37.9% (255/672) patients experienced adverse events, and 1.8% (12/672) experienced ≥1 serious adverse events.ConclusionImprovements observed in signs and symptoms of axSpA following one year of CZP treatment in real-world clinical practice were similar to those from previous randomized clinical trials, with no new safety concerns.
| S-EPMC7785316 | biostudies-literature