scholarly journals Anatomically optimized distal renal denervation — sustained blood pressure lowering efficacy during 3 years after the intervention

2020 ◽  
Vol 24 (3S) ◽  
pp. 98
Author(s):  
S. E. Pekarskiy ◽  
A. E. Baev ◽  
A. Yu. Falkovskaya ◽  
E. S. Sitkova ◽  
I. V. Zyubanova ◽  
...  

<p><strong>Aim</strong>. To test the hypothesis that anatomical optimisation of radiofrequency renal denervation (RDN) by redistribution of treatment to segmental branches of the renal artery causes a durable increase in the efficacy of the intervention.<br /><strong>Methods</strong>. A double-blind randomised control study in parallel groups with a 3-year follow-up was performed in patients with apparent resistant hypertension (office systolic BP ≥160 or diastolic BP ≥100 mmHg despite stable treatment with ≥3 drugs, including a diuretic). Exclusion criteria were secondary hypertension, mean 24-h systolic BP &lt;135 mmHg, eGFR &lt;30 <!-- x-tinymce/html-mce_4595809011604631814436 -->mL/min/m<sup>2</sup> and severe comorbidity increasing procedural risks (investigator’s assessment). Eligible patients were randomised 1:1 into distal RDN or RDN in the main trunk of the renal artery. Treatment assignment was done in the operation room immediately before the procedure. For the duration of the study, the assigned treatment was unknown to patients, physicians and other outcome assessors. Long-term efficacy of the procedure was measured by changes in BP (office and ambulatory), whereas safety was assessed by changes in the 24-h protein excretion, serum creatinine and eGFR 3 years post-procedure.<br /><strong>Results</strong>. Of the 55 randomised patients, 39 (71%) completed a 3-year assessment (21 after distal RDN and 18 after RDN in the main trunk of the renal artery). Compared to baseline, the mean 24-h BP remained significantly lowered in the distal RDN group by −16.9 (95% CI −27.3;−6.5)/−8.5 (95% CI −14.2;−2.9) mmHg, p = 0.002/0.004 (systolic/diastolic, respectively). The lowering of the mean 24-h BP was almost twofold less and non-significant in the group of RDN in the main trunk of the renal artery: −8.7 (95% CI −19.6;2.2)/−5.8 (95% CI −11.8;0.1).<br /><strong>Conclusion</strong>. Anatomical optimisation of endovascular renal denervation produces a powerful and sustained increase in the efficacy of the intervention.</p><p>Received 19 May 2020. Revised 10 July 2020. Accepted 7 September 2020.</p><p><strong>Funding</strong>: The study did not have sponsorship.</p><p><strong>Conflict of interest</strong>: Authors declare no conflict of interest.</p><p><strong>Clin.Trials.gov Identifier</strong>: NCT02667912.</p><p><strong>Author contributions</strong><br />Conception and design: S.E. Pekarskiy<br />Data collection and analysis: S.E. Pekarskiy, A.E. Baev, A.Yu. Falkovskaya, E.S. Sitkova, I.V. Zyubanova, V.A. Lichikaki, V.F. Mordovin<br />Statistical analysis: S.E. Pekarskiy<br />Drafting the article: S.E. Pekarskiy, A.E. Baev<br />Critical revision of the article: S.V. Popov<br />Final approval of the version to be published: S.E. Pekarskiy, A.E. Baev, A.Yu. Falkovskaya, E.S. Sitkova, I.V. Zyubanova, V.A. Lichikaki, V.F. Mordovin, S.V. Popov</p>

2015 ◽  
Vol 9 (4) ◽  
pp. 362
Author(s):  
Aurelio Negro ◽  
Rosaria Santi ◽  
Antonio Manari ◽  
Franco Perazzoli

A 52-year-old Caucasian woman with essential resistant and refractory hypertension despite optimal medical therapy, including 6 different antihypertensive drugs was referred for the catheter-based renal denervation. Due to unfavourable anatomy because of non-critical fibromuscular dysplasia on the right renal artery, renal denervation of only the left renal artery was performed. Before and after the renal denervation, the patient’s blood pressure was monitored by <em>office</em> measurements and ambulatory blood pressure measurements (ABPM). Before the procedure, the mean <em>office</em> blood pressure was 157/98 mmHg; at ABPM, the mean blood pressure values were 145/94 mmHg. At 6 months of follow-up, the mean <em>office</em> blood pressure was 134/90 mmHg and 121/76 mmHg at ABPM. In latest 12 months of follow-up, <em>office</em> and ABPM blood pressure were 125/80 and 127/80 mmHg respectively. This unique case suggests that unilateral renal denervation may be effective in lowering blood pressure in patients with refractory hypertension and unfavorable renal arteries anatomy.


2020 ◽  
Vol 19 (4) ◽  
pp. 2225
Author(s):  
E. S. Sitkova ◽  
V. F. Mordovin ◽  
S. E. Pekarsky ◽  
T. M. Ripp ◽  
A. Yu. Falkovskaya ◽  
...  

Aim. To study the effectiveness of using the anatomically optimized distal renal denervation (RDN) in comparison with the standard approach for reducing myocardial damage and left ventricular (LV) hypertrophy in patients with resistant hypertension (HTN).Material and methods. The randomized double-blind study of the efficacy and safety of distal RDN compared to conventional main renal artery intervention (ClinicalTrials.gov NCT02667912) for the treatment of resistant HTN included 26 patients. All patients were divided into two groups: group 1 (n=16) — distal RDN, group 2 (n=10) — conventional RDN. In addition to 24-hour blood pressure (BP) monitoring, initially and 12 months after the intervention, contrast- enhanced cardiac magnetic resonance imaging was performed to determine the left ventricular mass and non-coronary myocardial damage area. All patients signed informed consent. Twenty-four patients completed the present study.Results. After 12 months, the mean 24-hour BP significantly decreased after both distal RDN (from 167,2±28,5/93,2±19,3 to 147,0±13,7/81,5±9,3 mm Hg (p<0,05)) and conventional RDN (from 157,5±22,5/90,6±23,9 to 139,9±17,7/80,0±16,7 (p<0,05)). Also in both cases, a trend to LV mass decrease was revealed: from 252,6±85,2 to 221,0±60,3 gm (p=0,096) after the distal RDN; from 214,3±54,1 to 186,4±48,1 gm (p=0,071) after the conventional RDN. In contrast, the myocardial damage area decreased only after distal RDN (from 2,33±1,33 to 1,35±0,67 cm3 (p=0,02)) and did not change after conventional RDN.Conclusion. In comparison with the conventional main renal artery intervention, distal RDN in patients with resistant HTN has an additional cardioprotective effect — a decrease in LV myocardial damage area.


2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
T Ripp ◽  
T Ryabova ◽  
S Pekarskiy ◽  
V Mordovin ◽  
E Buharova ◽  
...  

Abstract Background/Introduction Distal renal denervation (RD) of the segmental branches beyond the bifurcation of the main renal artery is considered more effective treatment than conventional RD of the trunk renal artery. Evidence accumulated over the last decade has shown that global longitudinal strain (GLS) from speckle-tracking analysis of 2-dimensional echocardiography may represent a sensitive parameter of the left ventricular (LV) dysfunction. Purpose We compared cardiac function, structure, and GLS parameters after distal and conventional RD in the double-blind randomized prospective study. Methods The study (NCT01499810) compromised 55 patients who met criteria for resistant hypertension and signed informed consent. Patients were randomized to either endovascular conventional RD of the main renal artery (group 1, n=27) or to distal treatment applied to the segmental branches after the bifurcation of the main renal artery (group 2, n=28). Parameters of GLS from speckle-tracking echocardiography, ejection fraction, thickness of the interventricular septum (IVS) and LV posterior wall (PW), as well as the parameters of the diastolic function of the heart were assessed at baseline and at 12-months follow-up. Reference echocardiographic values were adapted from the ASE/ESC guidelines. Baseline parameters of heart and drug intake did not significantly differ between patients at the time of randomization. Results Drug treatment consisted in combination therapy in the maximum tolerated doses. Patients used different types of drugs, but the number of drug classes did not significantly differ between groups (4.1 in group 1 vs. 4.2 in group 2). Reduction of systolic blood pressure was significantly greater after distal RD vs. conventional RD: −22.1 vs. −11.5 mm Hg, respectively (p<0.05). Decrease in the LV wall thickness was significantly greater after distal RD then after conventional RD, namely: changes in the IVS thickness were −0.21 (−0.39; 1.2) mm after distal RD vs. 1.21 (−0.44; −2.64) mm after conventional RD, p=0.023; changes in the PW thickness were −0.87 (−2.6; −0.62) mm after distal RD vs. 0.07 (−0.45; 1.25) mm after conventional RD, p=0.021. Normalization of diastolic function was found in 13% ((group 1) and 26% ((group 2) in patients with first and second degrees of LV diastolic dysfunction. Speckle-tracking parameters of the left ventricle and some parameters of the left atrium (reduced size by 18% vs 27% of patients) also improved after DRD. Conclusion(s) Compared to conventional RD, distal RD treatment applied to the segmental branches beyond the bifurcation of the main renal artery significantly greater attenuated the LV wall thickness and the number of patients with diastolic dysfunction. At 12-month follow up, the global longitudinal LV function also improved in distal RD patients.


2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Peijiang Wang ◽  
Jindong Wan ◽  
Jixin Hou ◽  
Sen Liu ◽  
Fei Ran

Abstract Background Catheter-based renal denervation (RDN) has been introduced to treat resistant hypertension. Although the technology of RDN has been largely improved, denervation of tortuous renal arteries remains challenging. Case presentation This is a case report of a 49-year-old man with drug resistant hypertension. The patient was selected for RDN after ruling out possible causes of secondary hypertension. Computed tomography angiography showed a highly tortuous left renal artery. An Iberis multielectrode ablation catheter failed to reach the target vessel with a regular guiding catheter. A 5-French extension catheter was introduced into the proximal segment of the main left renal artery to provide extra support force, which enabled successful ablation of the highly tortuous left renal artery. His ambulatory blood pressure was significantly decreased at 1 month follow-up. Conclusions It is feasible and effective to use a guide extension catheter for denervation of highly tortuous renal arteries. The present study provides a useful method to ablate tortuous and angled renal arteries and branches.


2000 ◽  
Vol 5 (4) ◽  
pp. 312-325 ◽  
Author(s):  
Gadi Maoz ◽  
Daniel Stein ◽  
Sorin Meged ◽  
Larisa Kurzman ◽  
Joseph Levine ◽  
...  

Psychopharmacological interventions for managing aggression in schizophrenia have thus far yielded inconsistent results. This study evaluates the antiaggressive efficacy of combined haloperidol-propranolol treatment. Thirty-four newly admitted schizophrenic patients were studied in a controlled double-blind trial. Following a 3-day drug-free period and 7 days of haloperidol treatment, patients were randomly assigned to receive either haloperidol-propranolol or haloperidol-placebo for eight consecutive weeks. Doses of medications were adjusted as necessary; biperiden was administered if required. Rating scales were applied to assess aggression, anger, psychosis, depression, anxiety and extrapyramidal symptoms. The mean daily dose of haloperidol was 21 mg (SD = 6.4) in the research group and 29 mg (SD = 6.9) in the controls. Mean and maximal daily doses of propranolol were 159 mg (SD = 61) and 192 mg (SD = 83), and of placebo, 145 mg (SD = 50) and 180 mg (SD = 70), respectively. Compared with the controls, the scores for the research patients decreased significantly from baseline, particularly after 4 weeks of treatment, for some dimensions of anger, psychosis, anxiety, and neuroleptic-induced parkinsonism. A tendency for reduced aggression was shown in the combined haloperidol-propranolol group for some dimensions but not others. These patients also required significantly less biperiden. The tendency toward elevated antiaggressive effect of combined haloperidol-propranolol treatment compared to haloperidol alone may be explained by a simultaneous decrease in aggression, psychotic symptomatology, and anxiety.


1995 ◽  
Vol 74 (04) ◽  
pp. 1064-1070 ◽  
Author(s):  
Marco Cattaneo ◽  
Alan S Harris ◽  
Ulf Strömberg ◽  
Pier Mannuccio Mannucci

SummaryThe effect of desmopressin (DDAVP) on reducing postoperative blood loss after cardiac surgery has been studied in several randomized clinical trials, with conflicting outcomes. Since most trials had insufficient statistical power to detect true differences in blood loss, we performed a meta-analysis of data from relevant studies. Seventeen randomized, double-blind, placebo-controlled trials were analyzed, which included 1171 patients undergoing cardiac surgery for various indications; 579 of them were treated with desmopressin and 592 with placebo. Efficacy parameters were blood loss volumes and transfusion requirements. Desmopressin significantly reduced postoperative blood loss by 9%, but had no statistically significant effect on transfusion requirements. A subanalysis revealed that desmopressin had no protective effects in trials in which the mean blood loss in placebo-treated patients fell in the lower and middle thirds of distribution of blood losses (687-1108 ml/24 h). In contrast, in trials in which the mean blood loss in placebo-treated patients fell in the upper third of distribution (>1109 ml/24 h), desmopressin significantly decreased postoperative blood loss by 34%. Insufficient data were available to perform a sub-analysis on transfusion requirements. Therefore, desmopressin significantly reduces blood loss only in cardiac operations which induce excessive blood loss. Further studies are called to validate the results of this meta-analysis and to identify predictors of excessive blood loss after cardiac surgery.


1995 ◽  
Vol 74 (02) ◽  
pp. 622-625 ◽  
Author(s):  
H H Brackmann ◽  
R Egbring ◽  
A Ferster ◽  
P Fondu ◽  
J M Girardel ◽  
...  

SummaryThe pharmacokinetics and tolerability of factor XIII (FXIII) from plasma were compared with those of FXIII from placenta in a randomised, double-blind, crossover study involving 13 patients with congenital FXIII deficiency. Both FXIII activity and FXIII antigen were monitored. No difference was seen in the mean half-lives of the two preparations (9.3 days and 9.1 days for plasma and placenta FXIII activity, respectively). Response was similar for both preparations, but was slightly greater for FXIII from plasma.Similar results were found for recovery (65% vs 60%). The area under the data completed by extrapolation was significantly higher for FXIII from plasma. No differences between preparations in terms of efficacy or tolerability were observed. It can be concluded that treatment with FXIII concentrate from plasma is as efficient as with FXIII concentrate from placenta in terms of recovery and half-life. Both preparations were equivalent in terms of safety during the observation period. With the administration of monthly injections of approximately 30 U/kg serious bleeding events were prevented and no other serious adverse events occurred.


Author(s):  
Shivananda B Nayak ◽  
Dharindra Sawh ◽  
Brandon Scott ◽  
Vestra Sears ◽  
Kareshma Seebalack ◽  
...  

Purpose: i) To determine the relationship between the cardiac biomarkers ST2 and NT-proBNP with ejection fraction (EF) in heart failure (HF) patients. ii) Assess whether a superiority existed between the aforementioned cardiac markers in diagnosing the HF with reduced EF. iii) Determine the efficacy of both biomarkers in predicting a 30-day cardiovascular event and rehospitalization in patients with HF with reduced EF iv) To assess the influence of age, gender, BMI, anaemia and renal failure on the ST2 and NT-proBNP levels. Design and Methods: A prospective double-blind study was conducted to obtain data from a sample of 64 cardiology patients. A blood sample was collected to test for ST2 and NT-proBNP. An echocardiogram (to obtain EF value), electrocardiogram and questionnaire were also obtained. Results: Of the 64 patients enrolled, 59.4% of the population had an EF less than 40%. At the end of the 30- day period, 7 patients were warded, 37 were not warded, one died and 17 were non respondent. Both biomarkers were efficacious at diagnosing HF with a reduced EF. However, neither of them were efficacious in predicting 30-day rehospitalization. The mean NT-proBNP values being: not rehospitalized (2114.7486) and 30 day rehospitalization (1008.42860) and the mean ST2 values being: not rehospitalized (336.1975), and 30-day rehospitalization. (281.9657). Conclusion: Neither ST2 or NT-proBNP was efficacious in predicting the short- term prognosis in HF with reduced EF. Both however were successful at confirming the diagnosis of HF in HF patients with reduced EF.


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