scholarly journals Insights on safety and efficacy of renal artery denervation for uncontrolled-resistant hypertension in a high risk population with chronic kidney disease: first Italian real-world experience

Author(s):  
Federico Marin ◽  
Simone Fezzi ◽  
Alessia Gambaro ◽  
Francesco Ederle ◽  
Gianluca Castaldi ◽  
...  

Abstract Aims To evaluate the safety and efficacy of catheter-based radiofrequency renal sympathetic denervation (RSD) in a daily practice population of patients with uncontrolled resistant hypertension, on top of medical therapy. Methods Consecutive unselected patients with uncontrolled resistant hypertension undergoing RSD were enrolled. Office and ambulatory blood pressure (BP) measurements were collected at baseline and 3, 6 and 12 months after RSD. Efficacy was assessed even in patients with an estimated glomerular filtration rate (eGFR) below 45 mL/min/1.73 m2. Patients were defined as responders if systolic BP decreased by at least 5 mmHg at ambulatory BP or by 10 mmHg at office BP at their last follow-up visit. Results Forty patients with multiple comorbidities underwent RSD from 2012 to 2019. Baseline office and ambulatory BP was 159.0/84.9 ± 26.2/14.9 mmHg and 155.2/86.5 ± 20.9/14.0 mmHg, respectively. At 12-month follow up a significant reduction in office and ambulatory systolic BP, respectively by − 19.7 ± 27.1 mmHg and by − 13.9 ± 23.6 mmHg, was observed. BP reduction at 12-month follow-up among patients with eGFR < 45 mL/min was similar to that obtained in patients with higher eGFR. Twenty-nine patients (74.4%) were responders. Combined hypertension, higher ambulatory systolic BP and lower E/E’ at baseline emerged as predictors of successful RSD at univariate analysis. No major complications were observed and renal function (was stable up to 12 months), even in patients with the lowest eGFR values at baseline. Conclusion RSD is safe and feasible in patients with uncontrolled resistant hypertension on top of medical therapy, even in a high-risk CKD population with multiple comorbidities, with a significant reduction in systolic BP and a trend towards a reduction in diastolic BP lasting up to 12 months. Graphic abstract

2021 ◽  
Vol 23 (Supplement_G) ◽  
Author(s):  
Simone Fezzi ◽  
Gianluca Castaldi ◽  
Maddalena Widmann ◽  
Federico Marin ◽  
Alessandro Ruzzarin ◽  
...  

Abstract Aims To evaluate the safety and the efficacy of catheter-based radiofrequency renal sympathetic denervation (RSD) in a daily practice population of patients with uncontrolled resistant hypertension on top of medical therapy. Methods and results Consecutive unselected patients with uncontrolled resistant hypertension undergoing RSD were enrolled. Office and ambulatory blood pressure (BP) monitoring were collected at baseline and 3, 6, and 12 months after RSD. Efficacy was assessed also in patients with an estimated glomerular filtration rate below 45 ml/min/1.73 m2. Patients were defined responders to RSD if systolic BP decreased by at least 5 mmHg at ambulatory BP or by 10 mmHg at office BP at the last follow-up available. Fifty-four patients with multiple comorbidities underwent RSD for uncontrolled-resistant hypertension from 2012 to 2021. Baseline office and ambulatory BP was 161.0/87.2 ± 24.1/15.6 mmHg and 155.4/87.5 ± 19.3/14.6 mmHg, respectively. At 12-month follow-up a significant reduction of office and ambulatory systolic BP, respectively by − 15.66 ± 29.73 mmHg (P &lt; 0.01) and by − 11.3 ± 23.1 mmHg (P &lt; 0.05), was noticed. BP reduction at 12-month follow-up among patients with eGFR &lt;45 ml/min was similar to that obtained in patients with higher eGFR. Among patients treated before July 2020 with available follow-up (45/54) 36 patients (80%) were classified as responders. Combined hypertension, higher ambulatory systolic BP and lower E/E’ at baseline emerged as predictors of success of RSD at univariate analysis. Among responders and non-responders, the average medication number showed no significant difference at baseline and during follow-up. No major complications were observed and renal function was stable up to 12 months, even in patients with lowest eGFR at baseline. Conclusions RSD is safe and feasible in patients with uncontrolled resistant hypertension on top of medical therapy, even in a high-risk CKD population with multiple comorbidities, with a significant reduction of systolic BP and a trend of reduction of the diastolic BP up to 12 months. 775 Figure


2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
K Stepien ◽  
P Furczynska ◽  
M Zalewska ◽  
K Nowak ◽  
A Wlodarczyk ◽  
...  

Abstract Background Recently heart failure (HF) has been found to be a new dementia risk factor, nevertheless their relations in patients following HF decompensation remain unknown. Purpose We sought to investigate whether a screening diagnosis for dementia (SDD) in this high-risk population may predict unfavorable long-term clinical outcomes. Methods 142 patients following HF decompensation requiring hospitalization were enrolled. Within a median time of 55 months all patients were screened for dementia with ALFI-MMSE scale whereas their compliance was assessed with the Morisky Medication Adherence Scale. Any incidents of myocardial infarction, coronary revascularization, stroke or transient ischemic attack (TIA), revascularization, HF hospitalization and bleedings during follow-up were collected. Results SDD was established in 37 patients (26%) based on the result of an ALFI-MMSE score of &lt;17 points. By multivariate analysis the lower results of the ALFI-MMSE score were associated with a history of stroke/TIA (β=−0.29, P&lt;0.001), peripheral arterial disease (PAD) (β=−0.20, P=0.011) and lower glomerular filtration rate (β=0.24, P=0.009). During the follow-up, patients with SDD were more often rehospitalized following HF decompensation (48.7% vs 28.6%, P=0.014) than patients without SDD, despite a similar level of compliance (P=0.25). Irrespective of stroke/TIA history, SDD independently increased the risk of rehospitalization due to HF decompensation (HR 2.22, 95% CI 1.23–4.01, P=0.007). Conclusions As shown for the first time in literature patients following decompensated HF, a history of stroke/TIA, PAD and impaired renal function independently influenced SDD. In this high-risk population, SDD was not associated with patients' compliance but irrespective of the stroke/TIA history it increased the risk of recurrent HF hospitalization. The survival free of rehospitalization Funding Acknowledgement Type of funding source: None


Stroke ◽  
2014 ◽  
Vol 45 (suppl_1) ◽  
Author(s):  
Michael F Waters ◽  
Brian L Hoh ◽  
Michael J Lynn ◽  
Tanya N Turan ◽  
Colin P Derdeyn ◽  
...  

Background: The SAMMPRIS trial showed that aggressive medical therapy was more effective than stenting for preventing stroke in high-risk patients with symptomatic intracranial stenosis. However, 15% of patients in the medical group still had a primary endpoint (any stroke or death within 30 days of enrollment or stroke in the territory beyond 30 days) during a median follow-up of 32.7 months. We sought to determine baseline risk factors that were associated with a primary endpoint in the medical arm of SAMMPRIS. Methods: Data on 227 patients randomized to the medical group in SAMMPRIS were analyzed. Baseline demographic features, vascular risk factors, qualifying event, brain imaging and angiographic features were analyzed. The hazard ratio and p-value from a Cox proportional hazard regression model relating time until a primary endpoint to each factor were calculated. Results: Female gender, diabetes, stroke as the qualifying event (especially non-penetrator stroke), old infarct in the territory of the stenotic artery, and > 80% stenosis were associated (p < 0.10) with a higher risk of the primary endpoint on univariate analysis (see accompanying table) (multivariate analysis will be available by the time of ISC). Variables not associated with a higher risk of a primary endpoint in the medical arm included: age, race, antithrombotic therapy at the time of a qualifying event, time from qualifying event to enrollment (< 7 days vs. > 7 days), and location of stenosis. Conclusions: Several features were associated with an increased risk of the primary endpoint in the medical group in SAMMPRIS. On univariate analysis, the most important risk factors were an old infarct in the territory of the stenotic artery and stroke (especially non-penetrator stroke) as the qualifying event. These features will be useful for identifying particularly high-risk patients who should be targeted for future clinical trials testing alternative therapies to aggressive medical management.


2013 ◽  
Vol 34 (28) ◽  
pp. 2132-2140 ◽  
Author(s):  
Stephen G. Worthley ◽  
Costas P. Tsioufis ◽  
Matthew I. Worthley ◽  
Ajay Sinhal ◽  
Derek P. Chew ◽  
...  

2011 ◽  
Vol 70 (6) ◽  
pp. 1083-1086 ◽  
Author(s):  
Amelia Ruffatti ◽  
Teresa Del Ross ◽  
Manuela Ciprian ◽  
Maria T Bertero ◽  
Sciascia Salvatore ◽  
...  

ObjectivesTo assess risk factors for a first thrombotic event in confirmed antiphospholipid (aPL) antibody carriers and to evaluate the efficacy of prophylactic treatments.MethodsInclusion criteria were age 18–65 years, no history of thrombosis and two consecutive positive aPL results. Demographic, laboratory and clinical parameters were collected at enrolment, once a year during the follow-up and at the time of the thrombotic event, whenever that occurred.Results258 subjects were prospectively observed between October 2004 and October 2008. The mean±SD follow-up was 35.0±11.9 months (range 1–48). A first thrombotic event (9 venous, 4 arterial and 1 transient ischaemic attack) occurred in 14 subjects (5.4%, annual incidence rate 1.86%). Hypertension and lupus anticoagulant (LA) were significantly predictive of thrombosis (both at p<0.05) and thromboprophylaxis was significantly protective during high-risk periods (p<0.05) according to univariate analysis. Hypertension and LA were identified by multivariate logistic regression analysis as independent risk factors for thrombosis (HR 3.8, 95% CI 1.3 to 11.1, p<0.05, and HR 3.9, 95% CI 1.1 to 14, p<0.05, respectively).ConclusionsHypertension and LA are independent risk factors for thrombosis in aPL carriers. Thromboprophylaxis in these subjects should probably be limited to high-risk situations.


2009 ◽  
Vol 27 (1) ◽  
pp. 38-44 ◽  
Author(s):  
Ahmad A. Tarhini ◽  
Joseph Stuckert ◽  
Sandra Lee ◽  
Cindy Sander ◽  
John M. Kirkwood

PurposeWe evaluated adjuvant trial E1694 to more precisely define the prognostic significance of serum S100B in patients with high-risk resected melanoma.Patients and MethodsSera from 670 E1694 patients banked at baseline and three additional time points were tested for S100B protein using chemiluminescence.ResultsS100B testing results showed that the higher the S100B level is, the higher the risk of relapse and death, regardless of the cutoff value. Univariate analysis showed that baseline S100B ≥ 0.15 μg/L is significantly correlated with overall survival (OS; P = .01). Multivariate analysis was performed adjusting for significant prognostic factors (ulceration and lymph node status) and treatment. Baseline S100B was a significant prognostic factor for survival (hazard ratio = 1.39; 95% CI, 1.01 to 1.92; P = .043). S100B values measured at later time points over 1 year were also demonstrated to be significant prognostic factors for relapse-free survival (RFS) and OS. Lower S100B values at baseline and during follow-up were associated with longer survival. A changing S100B from low at baseline to high on follow-up seemed to be associated with the worst RFS and OS.ConclusionFor patients with high-risk surgically resected melanoma, a high baseline or increasing serum S100B is an independent prognostic marker of risk for mortality that may allow us to refine the application of adjuvant therapy in the future.


2014 ◽  
Vol 4 ◽  
pp. 258-263 ◽  
Author(s):  
Michał Kosowski ◽  
Wojciech Zimoch ◽  
Tomasz Gwizdek ◽  
Radosław Konieczny ◽  
Piotr Kübler ◽  
...  

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
F Mantovani ◽  
M A Clavel ◽  
F Jayme ◽  
L Valli ◽  
R M De Mola ◽  
...  

Abstract Background Improved technology together with greater operator experience has led to refinement of balloon aortic valve valvuloplasty (BAV) in recent years. It may provide a palliative treatment option in high-risk patients, highly symptomatic, for whom no other invasive therapy is available. However, there has not been universal adoption of BAV as a standalone therapy. Methods A retrospective analysis of ten years of practice of BAV as palliative strategy in patient with symptomatic aortic stenosis between March 2008 and June 2018 was performed. Demographic, clinical, procedural, and follow-up data on all patients were collected. Results A total of 152 patients (95 women, 63%) with a mean age of 85±6 years underwent BAV. All patients had severe aortic stenosis, were considered not suitable to aortic valve replacement nor Trans-catheter aortic valve implantation (TAVI) for appreciable comorbidity (STS score 9±5) and had severe symptoms mainly of heart failure which required medical attention. A statistically significant decrease in trans-valvular gradient was observed (peak to peak gradient before BAV 52±22 mmHg, after BAV 29±16 mmHg, delta gradient 24±14 mmHg; p<0.0001). Only one patient, who undergone BAV because of cardiogenic shock, died during the procedure. Considering the high-risk population, intra-hospital mortality was low (7 patients died, 4%). Mortality at 1-year follow-up was 43% and survival free from new hospitalization for heart failure was 63% at 1-year follow-up and 53% at 2 years follow-up. 19 patients (13%) required repeated BAV during follow-up. Conclusion BAV as a palliative procedure in high-risk patients who are highly symptomatic, has a low operative mortality in our experience. BAV is associated with a significant reduction in aortic valve gradient and is valuable since half of the patients were alive without re-hospitalizations for heart failure at 2 years follow-up. Acknowledgement/Funding None


Blood ◽  
2006 ◽  
Vol 108 (11) ◽  
pp. 3599-3599
Author(s):  
Naseema Gangat ◽  
Alexandra Wolanskyj ◽  
Rebecca F. McClure ◽  
Chin Y. Li ◽  
Susan M. Schwager ◽  
...  

Abstract Background It is widely recognized that advanced age and prior thrombosis predict recurrent thrombosis in essential thrombocythemia (ET) and are used to risk-stratify patients. However, the paucity of large sample size and long-term follow-up has limited the development of similar prognostic models for survival and leukemic transformation (LT). Methods Data was abstracted from the medical records of a consecutive cohort of patients with WHO-defined ET seen at the Mayo Clinic. Cox proportional hazards was used to determine the impact of clinical and laboratory variables on survival and LT. Overall survival and leukemia-free survival was estimated by Kaplan-Meier plots. Results i. Patient characteristics and outcome The study cohort included 605 patients of which 399 (66%) were females (median age, 57 years; range 5–91). Median follow-up was 84 months (range; 0–424). During this period, 155 patients (26%) have died and LT was documented in 20 patients (3.3%) occurring at a median of 138 months (range; 23–422) from ET diagnosis. ii. Prognostic variables for overall survival Univariate analysis of parameters at diagnosis identified age ≥ 60 years, hemoglobin less than normal (defined as < 12 g/dL in females and < 13.5 g/dL in males), leukocyte count ≥ 15 x 109/L, tobacco use, diabetes mellitus, thrombosis, male sex, and the absence of microvascular symptoms as independent predictors of inferior survival. All of the above except the last two (i.e. male sex and the absence of microvascular symptoms) sustained their prognostic significance on multivariate analysis. Based on the first three prognostic variables: age, hemoglobin level, and leukocyte count, we constructed a prognostic model for survival: low-risk (none of the risk factors), intermediate-risk (1of 3 risk factors), and high-risk (≥ 2 risk factors). The respective median survivals were 278, 200, and 111 months (p<0.0001; Figure 1) iii. Prognostic variables for leukemic transformation On univariate analysis of parameters at ET diagnosis, LT was significantly associated with platelet count ≥ 1000 x 109/L, hemoglobin less than normal, and exposure to P-32. However, on multivariate analysis, only hemoglobin less than normal and platelet count ≥ 1000 x 109/L maintained independent prognostic value. Accordingly, we utilized these two variables, to construct a prognostic model for LT: low-risk (none of the risk factors), intermediate-risk (1 risk factor), and high-risk (both risk factors). Only 1 of the 239 patients (0.4%) in the low-risk group vs. 14 of the 289 (4.8%) in the intermediate-risk and 5 of the 77 (6.5%) in the high-risk group underwent LT (p=0.0009; Figure 2). Conclusion The current study provides clinician-friendly prognostic models for both survival and LT in ET. Figure 1 Figure 1. Figure 2 Figure 2.


Sign in / Sign up

Export Citation Format

Share Document