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The New England Journal of Medicine Apr 2014Prior unblinded studies have suggested that catheter-based renal-artery denervation reduces blood pressure in patients with resistant hypertension. (Comparative Study)
Comparative Study Randomized Controlled Trial
BACKGROUND
Prior unblinded studies have suggested that catheter-based renal-artery denervation reduces blood pressure in patients with resistant hypertension.
METHODS
We designed a prospective, single-blind, randomized, sham-controlled trial. Patients with severe resistant hypertension were randomly assigned in a 2:1 ratio to undergo renal denervation or a sham procedure. Before randomization, patients were receiving a stable antihypertensive regimen involving maximally tolerated doses of at least three drugs, including a diuretic. The primary efficacy end point was the change in office systolic blood pressure at 6 months; a secondary efficacy end point was the change in mean 24-hour ambulatory systolic blood pressure. The primary safety end point was a composite of death, end-stage renal disease, embolic events resulting in end-organ damage, renovascular complications, or hypertensive crisis at 1 month or new renal-artery stenosis of more than 70% at 6 months.
RESULTS
A total of 535 patients underwent randomization. The mean (±SD) change in systolic blood pressure at 6 months was -14.13±23.93 mm Hg in the denervation group as compared with -11.74±25.94 mm Hg in the sham-procedure group (P<0.001 for both comparisons of the change from baseline), for a difference of -2.39 mm Hg (95% confidence interval [CI], -6.89 to 2.12; P=0.26 for superiority with a margin of 5 mm Hg). The change in 24-hour ambulatory systolic blood pressure was -6.75±15.11 mm Hg in the denervation group and -4.79±17.25 mm Hg in the sham-procedure group, for a difference of -1.96 mm Hg (95% CI, -4.97 to 1.06; P=0.98 for superiority with a margin of 2 mm Hg). There were no significant differences in safety between the two groups.
CONCLUSIONS
This blinded trial did not show a significant reduction of systolic blood pressure in patients with resistant hypertension 6 months after renal-artery denervation as compared with a sham control. (Funded by Medtronic; SYMPLICITY HTN-3 ClinicalTrials.gov number, NCT01418261.).
Topics: Aged; Blood Pressure; Denervation; Female; Humans; Hypertension; Intention to Treat Analysis; Male; Middle Aged; Placebos; Radiography; Renal Artery; Single-Blind Method; Treatment Failure
PubMed: 24678939
DOI: 10.1056/NEJMoa1402670 -
European Journal of Vascular and... May 2022Kidney autotransplantation (ATx) is a treatment option for distal renal artery aneurysm (RAA). This systematic review evaluated the indications, treatment strategy, and... (Review)
Review
OBJECTIVE
Kidney autotransplantation (ATx) is a treatment option for distal renal artery aneurysm (RAA). This systematic review evaluated the indications, treatment strategy, and outcome of kidney ATx to verify the value of this procedure in treating RAA.
DATA SOURCES
PubMed, Embase, and Web of Science.
REVIEW METHODS
All study types were included, except study protocols and animal studies, without time or language restrictions. Data sources were reviewed until April 2021 to identify relevant articles evaluating operating time, cold and warm ischaemia time, total complications, length of hospital stay, and mortality rate in patients with RAA receiving kidney ATx.
RESULTS
The literature search retrieved 644 articles. Of these, 55 clinical studies (including 37 case reports and 18 case series) investigating 199 patients were eligible for inclusion. Endovascular treatment had failed in 17% of 70 patients with RAA. Heterotopic kidney ATx was performed in 81% of patients, and 19% received orthotopic kidney ATx. Unplanned nephrectomy was reported in only one patient (0.1%). Post-operative complications were reported in 6.9% of patients, including urinary tract infection (2.0%), wound infection (1.3%), acute renal insufficiency (0.6%), graft thrombosis (0.6%), kidney hypoperfusion (0.6%), haematoma (0.6%), lymphocoele (0.6%), pseudoaneurysm (0.6%), and arterial occlusion (0.6%). None of the patients died peri-operatively, and organ loss was reported in only one patient (0.05%). No further organ loss or death was reported during follow up (median follow up duration 12 months).
CONCLUSION
In patients with distal perihilar RAA, surgical repair with kidney ATx appears to be a suitable alternative when endovascular approaches are not appropriate. In these cases, kidney ATx saves the kidney and provides good clinical outcomes. However, these findings should be interpreted with caution, considering the lack of data regarding the adverse events, potential for favourable publication bias among included studies, and the absence of consecutive series and prospective trials.
Topics: Aneurysm; Humans; Kidney; Kidney Diseases; Prospective Studies; Renal Artery; Retrospective Studies; Transplantation, Autologous; Treatment Outcome
PubMed: 35283006
DOI: 10.1016/j.ejvs.2022.01.015 -
Hellenic Journal of Cardiology : HJC =... 2020Currently, renal denervation (RDN) has proven its overall procedural and renal safety in registries and trials. Available data, suggest that vascular complications are...
Currently, renal denervation (RDN) has proven its overall procedural and renal safety in registries and trials. Available data, suggest that vascular complications are rather scarce in modern studies using established neuromodulation catheters of different technologies and kidney parameters are mainly maintained stable overtime in RDN patients. Identification of the impact of energy delivery at vascular level by means of advanced methodologies such as optical coherence tomography (OCT) is a meaningful research tool. This accumulation of evidence on the acute and late effects of the procedure in the renal artery tissue especially when a new catheter is tested, as in the present work can further enhance our knowledge on the pathophysiology and clinical outcome of RDN.
Topics: Blood Pressure; Catheter Ablation; Denervation; Humans; Hypertension; Kidney; Renal Artery; Sympathectomy; Treatment Outcome
PubMed: 32916295
DOI: 10.1016/j.hjc.2020.09.002 -
Seminars in Cell & Developmental Biology Jul 2019The kidney vasculature has a unique and complex architecture that is central for the kidney to exert its multiple and essential physiological functions with the ultimate... (Review)
Review
The kidney vasculature has a unique and complex architecture that is central for the kidney to exert its multiple and essential physiological functions with the ultimate goal of maintaining homeostasis. An appropriate development and coordinated assembly of the different vascular cell types and their association with the corresponding nephrons is crucial for the generation of a functioning kidney. In this review we provide an overview of the renal vascular anatomy, histology, and current knowledge of the embryological origin and molecular pathways involved in its development. Understanding the cellular and molecular mechanisms involved in renal vascular development is the first step to advance the field of regenerative medicine.
Topics: Animals; Gene Expression Regulation, Developmental; Humans; Kidney; Neovascularization, Physiologic; Nephrons; Regenerative Medicine; Renal Artery; Renal Veins
PubMed: 29879472
DOI: 10.1016/j.semcdb.2018.06.001 -
Langenbeck's Archives of Surgery May 2021Visceral and renal artery aneurysms (VAA, RAA) are very rare pathologies. Both surgical and endovascular therapies are discussed as therapeutic options for ruptured and...
PURPOSE
Visceral and renal artery aneurysms (VAA, RAA) are very rare pathologies. Both surgical and endovascular therapies are discussed as therapeutic options for ruptured and non-ruptured aneurysm repair; we describe our experience in the open and endovascular management of these entities.
METHODS
Retrospective database analysis of 60 treated VAA and RAA in 59 patients between 1994 and 2020. Outcome data was descriptively analyzed.
RESULTS
Thirty-seven aneurysms were surgically treated and 23 interventionally. In the total study cohort, we observed a mortality of 1.7% and a morbidity of 18.6%. One major complication occurred. The morbidity was higher after surgical repair in ruptured and non-ruptured cases. The mean aneurysm diameter was 30.5 ± 15.6 mm. Patients with hepatic or pancreaticoduodenal artery aneurysms presented more often in the stage of rupture, without differences in aneurysm size. The length of hospital stay after endovascular repair was significantly shorter compared to open surgical treatment (7.2 ± 6.9 days versus 11.8 ± 6.7 days, p = 0.014), but only in elective cases. Primary technical success was significantly better in patients that underwent surgical repair in an intention to treat analysis (100% versus 79.3%). The mean follow-up of the cohort was 53.5 months (range 3-207 months).
CONCLUSION
Elective endovascular therapy and open surgery of VAA and RAA are safe procedures with a good periprocedural and long-term outcome. Surgical revascularization showed a better primary technical success but was associated with longer length of hospital stays.
Topics: Aneurysm; Blood Vessel Prosthesis Implantation; Endovascular Procedures; Humans; Renal Artery; Retrospective Studies; Treatment Outcome; Viscera
PubMed: 33755764
DOI: 10.1007/s00423-021-02149-1 -
European Journal of Vascular and... Aug 2020Treatment of renal artery aneurysms (RAA) remains controversial. Endovascular treatment has increased for main trunk and for very distal aneurysms, whereas for lesions...
OBJECTIVE
Treatment of renal artery aneurysms (RAA) remains controversial. Endovascular treatment has increased for main trunk and for very distal aneurysms, whereas for lesions located at the bifurcation surgical treatment seems to be a valid option. The goal of this study was to describe the technique of direct reconstruction of RAA and to report on outcomes.
METHODS
This study comprised single centre prospective collection of data with retrospective analysis (January 2015 to August 2018) of patients operated on for distal RAA using direct reconstruction.
RESULTS
A total of 24 RAA in 21 patients (seven men and 14 women, mean age 59 ± 13 years) was included. History of hypertension was found in 15 patients and renal insufficiency was present in one. Mean pre-operative systolic and diastolic blood pressures were 134 ± 21 mmHg and 74 ± 10 mmHg, and mean pre-operative rates of creatinine and glomerular filtration rate were 67 ± 13 μmol/L and 93 ± 49 mL/min/1.73 m, respectively. Indications for repair were a diameter >20 mm in seven cases (mean diameter = 25 ± 2 mm) or rapid growth in one case, symptomatic aneurysm in 12 cases (hypertension, haematuria, pain), and a concomitant lesion in four cases (splenic aneurysm, abdominal aortic aneurysm, occlusive visceral artery lesions). All lesions were distal, main artery bifurcation in 22 cases and hilar in two cases. The main aetiology was fibromuscular dysplasia (16 cases) followed by atherosclerosis (seven cases) and one case of Ehlers Danlos Syndrome. In situ reconstruction was possible for 22 RAA, while two cases required kidney autotransplantation. The mean renal ischaemia time was 18 ± 5 min. At two years, the patency rate was 100%, and mean systolic blood pressure decreased (134 mmHg-122 mmHg, p = .047). Renal function was stable from 93 ± 49 pre-operatively to 95 ± 35 mL/min/1.73 m in the post-operative course (p = .56).
CONCLUSION
Direct reconstruction appears to be efficient for most RAA. This technique is complementary to ex vivo autotransplantation and endovascular treatment.
Topics: Aged; Anastomosis, Surgical; Aneurysm; Databases, Factual; Female; Humans; Kidney Transplantation; Ligation; Male; Middle Aged; Postoperative Complications; Renal Artery; Retrospective Studies; Risk Factors; Time Factors; Transplantation, Autologous; Treatment Outcome; Vascular Surgical Procedures
PubMed: 32402807
DOI: 10.1016/j.ejvs.2020.04.016 -
Heart, Lung & Circulation Jan 2020Early studies of renal artery denervation (RAD) demonstrated efficacy in treating resistant hypertension patients with significant reduction in office blood pressure... (Review)
Review
Early studies of renal artery denervation (RAD) demonstrated efficacy in treating resistant hypertension patients with significant reduction in office blood pressure (BP). This resulted in a growing enthusiasm in the field and a rapid evolution of technology with expanding procedural indications. However, the first randomised sham-controlled trial, Symplicity HTN-3, failed to demonstrate a significant difference in BP reduction between the RAD and the sham control arm, which subsequently led to a major reduction in the clinical application of this procedure. Additionally, the results generated further interest into understanding the mechanism and factors affecting procedural success and identifying the limitations within the field. Many lessons were learned from Symplicity HTN-3 trial, and with recent evidence emerging for RAD in hypertension treatment, the field continues to be refined.
Topics: Blood Pressure; Humans; Hypertension; Randomized Controlled Trials as Topic; Renal Artery; Sympathectomy
PubMed: 31327701
DOI: 10.1016/j.hlc.2019.06.723 -
EuroIntervention : Journal of EuroPCR... May 2020We aimed to estimate the rate of renal artery adverse events following renal denervation with the most commonly applied radiofrequency catheter system based on a... (Meta-Analysis)
Meta-Analysis Review
AIMS
We aimed to estimate the rate of renal artery adverse events following renal denervation with the most commonly applied radiofrequency catheter system based on a comprehensive review of published reports.
METHODS AND RESULTS
We reviewed 50 published renal denervation (RDN) trials reporting on procedural safety including 5,769 subjects with 10,249 patient-years of follow-up. Twenty-six patients with renal artery stenosis or dissection (0.45%) were identified of whom 24 (0.41%) required renal artery stenting. The primary meta-analysis of all reports indicated a 0.20% pooled annual incidence rate of stent implantation (95% CI: 0.12 to 0.29% per year). Additional sensitivity analyses yielded consistent pooled estimates (range: 0.17 to 0.42% per year). Median time from RDN procedure to all renal intervention was 5.5 months (range: 0 to 33 months); 79% of all events occurred within one year of the procedure. A separate review of 14 clinical trials reporting on prospective follow-up imaging using either magnetic resonance imaging, computed tomography or angiography following RDN in 511 total subjects identified just 1 new significant stenosis (0.20%) after a median of 11 months post procedure (one to 36 months).
CONCLUSIONS
Renal artery reintervention following renal denervation with the most commonly applied RF renal denervation system (Symplicity) is rare. Most events were identified within one year.
Topics: Antihypertensive Agents; Blood Pressure; Catheter Ablation; Denervation; Humans; Hypertension; Kidney; Renal Artery; Sympathectomy; Treatment Outcome
PubMed: 32038027
DOI: 10.4244/EIJ-D-19-00902 -
BioMed Research International 2015Hypertension is a globally prevalent condition, with a heavy clinical and economic burden. It is the predominant risk factor for premature cardiovascular and... (Review)
Review
Hypertension is a globally prevalent condition, with a heavy clinical and economic burden. It is the predominant risk factor for premature cardiovascular and cerebrovascular disease, and is associated with a variety of clinical disorders including stroke, congestive cardiac failure, ischaemic heart disease, chronic renal failure, and peripheral arterial disease. A significant subset of hypertensive patients have resistant hypertensive disease. In this group of patients, catheter-based renal artery denervation has emerged as a potential therapy, with favourable clinical efficacy and safety in early trials. Additional benefits of this therapy are also being identified and include effects on left ventricular remodeling, cardiac performance, and symptom status in congestive cardiac failure. Utility of renal denervation for the management of resistant hypertension, however, has become controversial since the release of the Symplicity HTN-3 trial, the first large-scale blinded randomised study investigating the efficacy and safety of renal artery denervation. The aim of this paper is to evaluate the history, utility, and clinical efficacy of renal artery denervation technology, including an in-depth appraisal of the current literature and principal trials.
Topics: Evidence-Based Medicine; Humans; Hypertension, Renal; Renal Artery; Sympathectomy; Treatment Outcome
PubMed: 26495305
DOI: 10.1155/2015/607079 -
Journal of Vascular Surgery Jul 2014
Topics: Aneurysm; Angioplasty; Female; Humans; Male; Renal Artery
PubMed: 24594446
DOI: 10.1016/j.jvs.2014.01.074