scholarly journals Renal Sympathetic Denervation by Image-Guided Percutaneous Ethanol Injection – Histopathologic Characteristics, Efficacy and Safety

2020 ◽  
Vol 192 (06) ◽  
pp. 549-560
Author(s):  
Patrick Freyhardt ◽  
Patrick Haage ◽  
Anna Walter ◽  
Birgit Aufmesser-Freyhardt ◽  
Rolf W. Guenther ◽  
...  
Keyword(s):  
Renal Denervation ◽  
Percutaneous Ethanol Injection ◽  
Renal Tissue ◽  
Renal Sympathetic Denervation ◽  
Efficacy And Safety ◽  
Ethanol Injection ◽  
Contralateral Kidney ◽  
Image Guided ◽  
Group I ◽  
Group Ii

Purpose Evaluation of the efficacy and safety of chemical renal denervation by image-guided periarterial ethanol injection in pigs with emphasis on histopathological characteristics. Materials and Methods Unilateral renal periarterial ethanol injection under general anesthesia was performed in 16 animals with the contralateral kidney serving as the control. All interventions were performed in an open MRI system under real-time multiplanar guidance. In 10 pigs an ethanol-carbostesin contrast agent mixture was injected with amounts of 5 ml (6 animals, group I) and 10 ml (4 animals, group II). 6 pigs (group III) were treated with 10 ml of an ethanol-polyacrylic (2 %) mixture. Four weeks after treatment, all animals underwent MRI including MRA. After euthanasia, macroscopic and histologic examination of the kidneys, renal arteries and periarterial tissue was performed to assess nerve injury and potential side effects. Furthermore, the norepinephrine concentration (RTNEC) in the renal tissue was determined as a surrogate parameter of efficacy. Results Histologic signs of nerval degeneration with various degrees of severity and circumferential distribution were found in all groups. Injury depths ranged up to 7.6 mm. In groups II and III the nerve count was significantly lower on the treated side. Renal artery stenosis was not observed in any pig. In all pigs of group II treatment resulted in neural degeneration with a mean RTNEC reduction of 53 % (p < 0.02). In groups I and III significant changes in RTNEC were not observed. Conclusion Image-guided percutaneous periarterial ethanol injection was efficient and safe for renal denervation. The detected variations in histologic outcome underlined the importance of the preclinical optimization of the technique in order to maximize treatment effects in humans. Key Points: Citation Format

Renal Denervation Prevents Sodium Retention and Hypertension in Salt-Sensitive Rabbits with Genetic Baroreflex Impairment

1996 ◽  
Vol 90 (4) ◽  
pp. 287-293 ◽  
Author(s):  
Marta Weinstock ◽  
Elena Gorodetsky ◽  
Ronald Kalman
Keyword(s):  
Heart Rate ◽  
Mean Arterial Pressure ◽  
Arterial Pressure ◽  
Plasma Renin Activity ◽  
Renal Denervation ◽  
Plasma Renin ◽  
High Salt ◽  
Renin Activity ◽  
Group I ◽  
Group Ii

1. Rabbits with a genetic impairment in baroreflex control of heart rate become hypertensive on a high salt diet. The present study determined the effect of bilateral renal denervation on blood pressure and sodium balance after salt loading (four times normal intake; 28–36 mEq NaCl/day) in normotensive rabbits with high (Group I) and low (Group II) baroreflex sensitivity, respectively. 2. Eight rabbits in each group were denervated or sham-denervated 1 week before commencement of the high salt diet. Before operation, the two groups differed only in the gain of their cardiac baroreflex (Group I, −6.4 ± 0.4 beats min−1 mmHg−1; Group II, −3.2 ± 0.15 beats min−1 mmHg−1). 3. In Group I sham-denervated rabbits, mean arterial pressure remained unchanged, and plasma renin activity and heart rate fell significantly in response to the high salt. In Group II sham-denervated rabbits, mean arterial pressure increased by 10.6 ± 1.2 mmHg, and heart rate and plasma renin activity remained unchanged. Their cumulative Na+ retention and weight gain was more than twice that of Group I sham-denervated rabbits. 4. Renal denervation decreased plasma renin activity in both groups to <1 pmol Ang I h−1 ml−1, lowered cumulative Na+ retention from 102 ± 4 to 35 ± 5 mEq (P<0.01) and completely prevented the increase in mean arterial pressure in response to high salt in Group II. 5. The results suggest that Group II rabbits retain salt and fluid in response to their diet because of an abnormality in their control of renal nerve activity, possibly via vagal afferents. This results in blood pressure elevation because of an inability to lower peripheral resistance and heart rate in response to the increase in cardiac output. 6. Since they display several of the characteristics of salt-sensitive hypertensive humans, i.e. salt retention, normal plasma renin activity, but abnormal regulation of plasma renin activity and blood flow in response to salt loading, Group II are an appropriate model of human salt-induced hypertension.

Efficacy and safety of sofosbuvir plus daclatasvir with or without ribavirin in treatment of Egyptian patients infected with chronic HCV (Single Centre Study)

QJM ◽  
2021 ◽  
Vol 114 (Supplement_1) ◽  
Author(s):  
Mohammed Shaker ◽  
Heba Abdella ◽  
Zeinab hefny
Keyword(s):  
General Hospital ◽  
Cross Sectional Study ◽  
World Health ◽  
Combination Regimen ◽  
Efficacy And Safety ◽  
Cross Sectional ◽  
Group I ◽  
Egyptian Patients ◽  
Group Ii ◽  
Chronic Hcv

Abstract Background and aim As indicated by the World Health Organization (WHO), Egypt is positioned as the country with the world’s highest prevalence of Hepatitis C virus (HCV). The current study was designed to describe the efficacy and safety of Sofosbuvir plus Daclatasvir with or without Ribavirin in treatment of chronic HCV in a cohort of Egyptian patients who were referred to the viral hepatitis unit in El -Fayoum general hospital. Methods This is a prospective descriptive cross sectional study that describes the effect of 12 weeks of daily Sofosbuvir (SOF) 400 mg plus Daclatasvir (DCV) 60 mg with or without ribavirin (RBV) with dose adjustment if indicated. It included 200 patients that fulfilled the inclusion and exclusion criteria and treated in El -Fayoum general hospital, El-Fayoum, Egypt. Results In the current study, concerning viral response, SVR12 rate was achieved by 92.5% in the overall patients (185/200); by 98% (98/100) in group I, and by 87% (87/100) in group II. Concerning safety and tolerability, The main adverse effects recorded during and after 12 weeks of treatments were fatigue (46%), (66%); headache (24%), (40%); gastrointestinal upset (15%), (43%); and nausea (10%), (15%) in group 1 and group 2, respectively. Only one female patient in group II developed HCC. All patients completed treatment till the end of course. Conclusion The current study suggested that treatment of SOF plus DCV with/without RBV for chronic HCV patients in Egypt was generally safe, well tolerated, and of high efficacy, reflecting the antiviral potency and high resistance barrier of the combination regimen.

scholarly journals A COMPARATIVE STUDY OF EFFICACY AND SAFETY AMONG METFORMIN WITH SITAGLIPTIN, METFORMIN WITH VOGLIBOSE, AND METFORMIN WITH GLIMEPIRIDE IN PATIENTS WITH TYPE 2 DIABETES MELLITUS

2017 ◽  
Vol 10 (12) ◽  
pp. 313
Author(s):  
Kala P ◽  
Jamuna Rani R ◽  
Kumar Js
Keyword(s):  
Diabetes Mellitus ◽  
Type 2 Diabetes ◽  
Type 2 Diabetes Mellitus ◽  
Plasma Glucose ◽  
P Value ◽  
Efficacy And Safety ◽  
Group Iii ◽  
Group I ◽  
Group Ii

Objective: Type 2 diabetes mellitus (DM) is a most common metabolic disorder. The present study aimed to compare the efficacy and safety among metformin with sitagliptin, metformin with voglibose, and metformin with glimepiride in patients with type 2 DM. Methods: This study was a prospective, randomized clinical trial study, conducted in patients attending the diabetology outpatient department of SRM Medical College Hospital and Research Center, Potheri, Kancheepuram, Tamil Nadu, from January 2013 to January 2014. The patients were randomized into three groups with 40 patients in each group. Fasting plasma glucose (FPG), 2 hrs postprandial plasma glucose (PPG), and hemoglobin A1c (HbA1c) level were assessed in all the patients before starting the treatment. In Group I, patients were prescribed metformin 500 mg with sitagliptin 50 mg, in Group II, patients were given metformin 500 mg with voglibose 0.2 mg, and in Group III, patients were put on metformin 500 mg with glimepiride 1 mg in the fixed combination. The outcome of the therapy was based on the level of improvement in the blood parameters. Results: There was a significant reduction of FPG level seen in all three groups (p value - Group I <0.0001, Group II < 0.005, and Group III <0.0001). Group I and III showed significant reduction of PPG with p value <0.0001. There was a significant reduction of HbA1c seen in all the three groups (p<0.0001). Conclusion: From the results of this study, it could be concluded that all the three groups were comparable in their efficacy.

P4564Sympathetic renal denervation in patients with refractory arterial hypertension: 2-years follow-up

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
Z Shugushev ◽  
D A Maximkin ◽  
A Chepurnoy ◽  
O Safonova ◽  
A Faibushevich
Keyword(s):  
Heart Failure ◽  
Arterial Hypertension ◽  
Renal Denervation ◽  
Renal Arteries ◽  
Walk Test ◽  
Main Trunk ◽  
Group I ◽  
Group Ii ◽  
6 Minute Walk Test ◽  
Minute Walk

Abstract Aim To evaluate the efficacy of the sympathetic renal denervation procedure in patients with refractory arterial hypertension and heart failure. Methods The study included 72 patients with refractory arterial hypertension. We used randomization in 2 main groups: the Group I (n=36) included patients, who underwent denervation procedure of the main trunk of the renal artery and the Group 2 (n=36) - included patients who underwent denervation procedure in main trunk and also in second-order renal arteries. Additionally, patients were divided into 2 subgroups: the subgroup A (n=30) included patients, who underwent denervation procedure with a SYMPLICITY catheter, and the subgroup B (n=42) - included patients who underwent denervation procedure with a VESSIX catheter. Also, the renal denervation procedure efficacy, in patients with chronic heart failure (CHF) was analyzed. In all groups, 24-hour blood pressure monitoring, echocardiography and a 6-minute walk test were monitored. Inclusion criteria: refractory hypertension, age of patients 18–85 years, systolic blood pressure (SBP) ≥140/90 mmHg and ≥130/90 mmHg in patients with diabetes mellitus, functioning kidneys, renal arteries ≥40 mm in diameter and the length of the site up to the first bifurcation of at least 20 mm, absence of stenoses in the renal arteries, GFR≥40 ml/min/1.73m2, suitable anatomy of the renal arteries for endovascular procedure. Results 24 months result after the denervation procedure was demonstrated significantly decreased SBP in patients of both groups. In group I, it was, compared with pre-operative data (174.9±1.6 vs. 151.7±2.3 mmHg, respectively; p<0.05), and in group II - 181.9±2.1 vs. 140.4±3.8 mmHg, respectively; p<0.05). However, when comparing SBP values between groups, SBP in group I was significantly higher, than in group II (151.7±2.3 vs. 140.4±3.8 mmHg, respectively; p<0.05). In addition, the average number of drugs in group I was decreased to 2.1±0.8 after 24th month, and in group II - to 1.4±0.6 (p<0.05). When comparing SBP value in subgroup A and subgroup B, the average daily SBP also significantly difference and amounted to 147.8±1.8 vs. 138.4±3.2 mmHg, respectively; p<0.05). Among the all patients included in the study, 38 patients were with CHF. The 6-minute walk test results, compared with pre-operative data, showed a significant improvement and amounted to 321.24±83.22 vs. 212.42±54.72m, respectively; p<0.05. Conclusions The sympathetic renal denervation may be regarded as an effective method of treatment of patients with resistant hypertension, as well as patients with concomitant chronic heart failure. Performing denervation in the arteries of the second order, significantly improves the prognosis of patients, and in patients with concomitant heart failure significantly increases the quality of life and exercise tolerance. Acknowledgement/Funding Russian Academic Excellence Project 5-100

scholarly journals Hemodynamic and neural responses to renal denervation of the nerve to the clipped kidney by cryoablation in two-kidney, one-clip hypertensive rats

2016 ◽  
Vol 310 (2) ◽  
pp. R197-R208 ◽  
Author(s):  
Noreen F. Rossi ◽  
Russell Pajewski ◽  
Haiping Chen ◽  
Peter J. Littrup ◽  
Maria Maliszewska-Scislo
Keyword(s):  
Renal Artery ◽  
Renal Denervation ◽  
Renal Tissue ◽  
Reflex Response ◽  
Ang Ii ◽  
Neural Responses ◽  
Sprague Dawley ◽  
Renal Nerve ◽  
Contralateral Kidney ◽  
Sprague Dawley Rats

Renal artery stenosis is increasing in prevalence. Angioplasty plus stenting has not proven to be better than medical management. There has been a reluctance to use available denervation methodologies in this condition. We studied conscious, chronically instrumented, two-kidney, one-clip (2K-1C) Goldblatt rats, a model of renovascular hypertension, to test the hypothesis that renal denervation by cryoablation (cryo-DNX) of the renal nerve to the clipped kidney decreases mean arterial pressure (MAP), plasma and tissue ANG II, and contralateral renal sympathetic nerve activity (RSNA). Five-week-old male Sprague-Dawley rats underwent sham (ShC) or right renal artery clipping (2K-1C), placement of telemetry transmitters, and pair-feeding with a 0.4% NaCl diet. After 6 wk, rats were randomly assigned to cryo-DNX or sham cryotreatment (sham DNX) of the renal nerve to the clipped kidney. MAP was elevated in 2K-1C and decreased significantly in both ShC cryo-DNX and 2K-1C cryo-DNX. Tissue norepinephrine was ∼85% lower in cryo-DNX kidneys. Plasma ANG II was higher in 2K-1C sham DNX but not in 2K-1C cryo-DNX vs ShC. Renal tissue ANG II in the clipped kidney decreased after cryo-DNX. Baseline integrated RSNA of the unclipped kidney was threefold higher in 2K-1C versus ShC and decreased in 2K-1C cryo-DNX to values similar to ShC. Maximum reflex response of RSNA to baroreceptor unloading in 2K-1C was lower after cryo-DNX. Thus, denervation by cryoablation of the renal nerve to the clipped kidney decreases not only MAP but also plasma and renal tissue ANG II levels and RSNA to the contralateral kidney in conscious, freely moving 2K-1C rats.

Efficacy and safety of vitamin supplements with resveratrol in diabetic macular edema: Long-term results of a comparative study

2021 ◽  
pp. 112067212110576
Author(s):  
Irini Chatziralli ◽  
Eleni Dimitriou ◽  
Alexandros Chatzirallis ◽  
Evaggelia Aissopou ◽  
Dimitrios Kazantzis ◽  
...  
Keyword(s):  
Visual Acuity ◽  
Macular Edema ◽  
Diabetic Macular Edema ◽  
Retinal Thickness ◽  
Efficacy And Safety ◽  
Vitamin Supplements ◽  
Anti Vegf ◽  
Group I ◽  
The Mean ◽  
Group Ii

Purpose To investigate the adjunct efficacy and safety of vitamin supplements, including resveratrol, in patients with diabetic macular edema (DME) treated with intravitreal anti-vascular endothelial factor (anti-VEGF) agents. Methods Participants in this prospective study were 45 patients with DME, who were treated with either intravitreal anti-VEGF injections (n = 23, Group I) or with combination of intravitreal anti-VEGF injections and vitamin supplements, including resveratrol (n = 22, Group II). All patients underwent visual acuity measurement, slit-lamp examination and spectral domain-optical coherence tomography (SD-OCT) at baseline and monthly after the loading phase of three-monthly anti-VEGF injections, following a PRN protocol. Results There was a statistically significant improvement in visual acuity in both groups at month 12 compared to baseline, although the mean change in visual acuity did not differ between the two groups (p = 0.183). Accordingly, there was a statistically significant decrease in central retinal thickness in both groups at month 12 compared to baseline, while the mean difference in central retinal thickness was significantly greater in the “combination” group. The mean number of intravitreal anti-VEGF injection was less in Group II (6.45 ± 1.12 in Group II vs. 7.39 ± 1.31 in Group I, p = 0.018). Conclusions Vitamin supplements with resveratrol was found to be an effective adjunct to intravitreal anti-VEGF injections in patients with DME, offering better anatomic restoration with less injections at the 12-month follow-up.

scholarly journals AB0378 UPGRADING THERAPY STRATEGY IMPROVES PREGNANCY OUTCOME IN ANTIPHOSPHOLIPID SYNDROME: A COHORT MANAGEMENT STUDY

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1489.1-1489
Author(s):  
A. Hoxha ◽  
M. Favaro ◽  
A. Calligaro ◽  
T. Del Ross ◽  
A. T. Ruffatti ◽  
...  
Keyword(s):  
Pregnancy Complications ◽  
Treatment Strategies ◽  
Evidence Based ◽  
Efficacy And Safety ◽  
Live Births ◽  
Pregnancy Morbidity ◽  
Group I ◽  
History Of ◽  
Group Ii ◽  
Evidence Based Guidelines

Background:While it is generally agreed that pregnant APS patients should receive personalized treatment, evidence-based guidelines for these patients continue to be lacking.Objectives:The current study was designed as a management cohort study aiming to evaluate the efficacy and safety of different treatment strategies for pregnant APS patients in the attempt to provide some practical suggestions for attending physicians.Methods:One-hundred-twenty-seven consecutive pregnancies were assessed; 87 (68.5%) with a history of pregnancy morbidity alone were treated with prophylactic low molecular weight heparin (LMWH)+low-dose aspirin (LDA, 100 mg) [Group I] and 40 (31.5%) with a history of thrombosis and/or severe pregnancy complications with therapeutic LMWH+LDA [Group II]. LMWH doses were increased throughout the pregnancies depending on the patients’ weight gain, and treatment was switched to a more intensive one at the first sign of maternal/fetal complications. The study’s primary outcome was live births.Results:There were no significant differences in live birth rate between Group I (95.4%) and Group II (87.5%). Even, fetal complication rate was similar in the two groups; the Group II nevertheless had a higher prevalence of maternal and neonatal complications (p=0.0005 and p=0.01, respectively) and registered a significantly lower gestational age at delivery and birth weight (p=0.0001 and p=0.0005, respectively). Two patients in Group I switched to Group II therapy, six patients in Group II switched to a more intensive treatment strategy (weekly plasma exchange+ fortnightly intravenous immunoglobulins in addition to therapeutic LMWH+LDA). Comparison of the clinical and laboratory characteristics between patients who had shifted to a more intensive therapy and those who did not showed a significant prevalence of history of thrombosis ± pregnancy morbidity (p=0.02, OR 5.96, 95% CI 1.33-26.62) previous pregnancy complications (p=0.02, OR 8.32, 95% CI 1.67-41.3), triple aPL positivity (p <0.0001, OR 97.13, 95% CI 10.6-890) and pregnancy complications (p<0.0001, OR 197,7, 95% CI 10.57-3699) in upgrading group, instead single aPL positivity significantly prevailed (p=0.003, OR 0.06, 95% CI 0.008-0.58) in non-upgrading group. Logistic regression analysis demonstrated that triple aPL positivity was an independent factor for switching to a more effective therapy protocol (p <0.0001, OR 98, 95% CI 10.7-897.54). All eight switched patients achieved a live birth.Conclusion:Using adjusted LMWH doses and upgrading therapy at the first signs of pregnancy complications led to a high rate of live births in a relatively large group of APS patients. The study outlines the criteria for prescribing appropriate therapy for various subsets of these patients and for switching/upgrading the treatment protocol when it is no longer sufficient. Unfortunately, for the moment there are no evidence-based guidelines on the ideal additional treatment in refractory to conventional therapy APS patients. The present results will hopefully help point the direction of future clinical trials investigating the efficacy and safety of the different therapies on large numbers of APS pregnant patients in order to identify the benefits and limits of different treatment strategies administered from the beginning of pregnancy.Disclosure of Interests:Ariela Hoxha Speakers bureau: Celgene, UCB, Novartis, Sanofi, Werfen, Maria Favaro: None declared, Antonia Calligaro: None declared, Teresa Del Ross: None declared, Alessandra Teresa Ruffatti: None declared, Chiara Infantolino: None declared, Marta Tonello: None declared, Elena Mattia: None declared, Amelia Ruffatti: None declared

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