Next-generation transcarotid artery revascularization: TransCarotid flOw Reversal Cerebral Protection And CGUARD MicroNET-Covered Embolic Prevention Stent System To Reduce Strokes - TOPGUARD Study.

BACKGROUND: Stent-assisted carotid artery revascularization employing surgical cutdown for transcervical access and dynamic flow reversal (TCAR) is gaining popularity. TCAR, despite maximized intra-procedural cerebral protection, shows a marked excess of 30-day neurologic complications in symptomatic vs. asymptomatic stenoses. The TCAR conventional single-layer stent (free-cell area 5.89mm2) inability to seal embologenic lesions may be particularly relevant after the flow reversal neuroprotection is terminated. METHODS: We evaluated peri-procedural and 30-day major adverse cerebral and cardiac events (MACCE) of TCAR (ENROUTE, SilkRoad Medical) paired with MicroNET-covered neuroprotective stent (CGuard, InspireMD) in consecutive patients at elevated risk of complications with transfemoral/transradial filter-protected stenting (increased lesion-related and/or access-related risk). CGuard (MicroNET free cell area ≈0.02-0.03 mm2) has level-1 evidence for reducing intra- and abolishing post-procedural lesion-related cerebral embolism. RESULTS: One hundred and six increased-risk patients (age 72 [61-76] years, median [Q1-Q3]; 60.4% symptomatic, 49.1% diabetic, 36.8% women, 61.3% left-sided index lesion) were enrolled in three vascular surgery centers. Angiographic stenosis severity was 81 (75-91)%, lesion length 21 (15-26)mm, increased-risk lesional characteristics 87.7%. Study stent use was 100% (no other stent types). 74.5% lesions were predilated; post-dilatation rate was 90.6%. Flow reversal duration was 8 (5-11)min. One stroke (0.9%) occurred in an asymptomatic patient prior to establishing neuroprotection (index lesion disruption with the sheath insertion wire); there were no other peri-procedural MACCE. No further adverse events occurred by 30-days. 30-day stent patency was 100% with normal velocities and absence of any in-stent material by Duplex Doppler. CONCLUSIONS: Despite a high proportion of increased-risk lesions and clinically symptomatic patients in this study, TCAR employing the MicroNET-covered anti-embolic stent showed 30-day MACCE rate <1%. This suggests a clinical role for combining maximized intra-procedural prevention of cerebral embolism by dynamic flow reversal with anti-embolic stent prevention of peri- and post-procedural cerebral embolism (TOPGUARD NCT04547387).

A multi-center study of the MicroNET-covered stent in consecutive patients with acute carotid-related stroke: SAFEGUARD-STROKE.

Introduction: Acute carotid-related stroke (CRS), with its large thrombo-embolic load and large volume of affected brain tissue, poses significant management challenges. First generation (single-layer) carotid stents fail to insulate the athero-thrombotic material; thus they are often non-optimized (increasing thrombosis risk), yet their use is associated with a significant (20-30%) risk of new cerebral embolism. Aim: To evaluate, in a multi-center multi-specialty investigator-initiated study, outcomes of the MicroNET-covered (cell area ≈ 0.02-0.03 mm2) carotid stent (CGuard, InspireMD) in consecutive CRS patients eligible for emergency recanalization. Treatment, other than study device use, was according to center/operator routine. Material and methods: Seventy-five patients (age 40-89 years, 26.7% women) were enrolled in 7 interventional stroke centers. Results: The median Alberta Stroke Program Early CT Score (ASPECTS) was 9 (6-10). Study stent use was 100% (no other stent types implanted); retrograde strategy predominated (69.2%) in tandem lesions. Technical success was 100%. Post-dilatation balloon diameter was 4.0 to 8.0 mm. 89% of patients achieved final modified Thrombolysis in Cerebral Infarction (mTICI) 2b-c/3. Glycoprotein IIb/IIIa inhibitor use as intraarterial (IA) bolus + intravenous (IV) infusion was an independent predictor of symptomatic intracranial hemorrhage (OR = 13.9, 95% CI: 5.1-84.5, p < 0.001). The mortality rate was 9.4% in-hospital and 12.2% at 90 days. Ninety-day mRS0-2 was 74.3%, mRS3-5 13.5%; stent patency was 93.2%. Heparin-limited-to-flush predicted patency loss on univariate (OR = 14.3, 95% CI: 1.5-53.1, p < 0.007) but not on multivariate analysis. Small-diameter balloon/absent post-dilatation was an independent predictor of stent patency loss (OR = 15.2, 95% CI: 5.7-73.2, p < 0.001). Conclusions: This largest to-date study of the MicroNET-covered stent in consecutive CRS patients demonstrated a high acute angiographic success rate, high 90-day patency and favorable clinical outcomes despite variability in procedural strategies and pharmacotherapy (SAFEGUARD-STROKE NCT05195658).

Rare instances of concomitant acute myocardial infarction and stroke.

Cardio-cerebral infarction (CCI) is a term coined to describe concomitant myocardial infarction and acute ischemic stroke. Acute myocardial infarction and stroke, as separate events, constitute some of the most important causes for disability and mortality in aging societies. Stroke can either occur simultaneously with myocardial infarction or become a serious complication of myocardial infarction and/or its treatment. The frequency of CCI has been reported at a 0.009% incidence rate in stroke patients and is associated with an extremely high mortality. Because of the rare occurrence of CCI, there are currently no guidelines for assessing its diagnosis and optimal treatment. Therefore, currently, the management of CCI cases needs to be individualized. Hopefully, in the future, the results of large clinical trials or prospective registries are expected to enhance our understanding of managing concomitant acute MI and stroke. In this review we have focused on the current literacy in the diagnosis and treatment of CCIs. The paper illustrates potential distinct scenarios of CCI through the analysis of three patient cases (Fig. 5, Ref. 65). Text in PDF www.elis.sk Keywords: myocardial infarction, stroke, cardio-cerebral infarction, carotid artery stenting, cardiac surgery.

A Non-Coronary, Peripheral Arterial Atherosclerotic Disease (Carotid, Renal, Lower Limb) in Elderly Patients-A Review: Part I-Epidemiology, Risk Factors, and Atherosclerosis-Related Diversities in Elderly Patients.

Atherosclerosis is a generalized and progressive disease. Ageing is a key risk factor for atherosclerosis progression that is associated with the increased incidence of ischemic events in supplied organs, including stroke, coronary events, limb ischemia, or renal failure. Cardiovascular disease is the leading cause of death and major disability in adults ≥ 75 years of age. Atherosclerotic occlusive disease affects everyday activity and quality of life, and it is associated with reduced life expectancy. Although there is evidence on coronary artery disease management in the elderly, there is insufficient data on the management in older patients presented with atherosclerotic lesions outside the coronary territory. Despite this, trials and observational studies systematically exclude older patients, particularly those with severe comorbidities, physical or cognitive dysfunctions, frailty, or residence in a nursing home. This results in serious critical gaps in knowledge and a lack of guidance on the appropriate medical treatment and referral for endovascular or surgical interventions. Therefore, we attempted to gather data on the prevalence, risk factors, and management strategies in patients with extra-coronary atherosclerotic lesions.

A Non-Coronary, Peripheral Arterial Atherosclerotic Disease (Carotid, Renal, Lower Limb) in Elderly Patients-A Review PART II-Pharmacological Approach for Management of Elderly Patients with Peripheral Atherosclerotic Lesions outside Coronary Territory.

BACKGROUND: Aging is a key risk factor for atherosclerosis progression that is associated with increased incidence of ischemic events in supplied organs, including stroke, coronary events, limb ischemia, or renal failure. Cardiovascular disease is the leading cause of death and major disability in adults ≥ 75 years of age. Atherosclerotic occlusive disease affects everyday activity, quality of life, and it is associated with reduced life expectancy. As most multicenter randomized trials exclude elderly and very elderly patients, particularly those with severe comorbidities, physical or cognitive dysfunctions, frailty, or residence in a nursing home, there is insufficient data on the management of older patients presenting with atherosclerotic lesions outside coronary territory. This results in serious critical gaps in knowledge and a lack of guidance on the appropriate medical treatment. In addition, due to a variety of severe comorbidities in the elderly, the average daily number of pills taken by octogenarians exceeds nine. Polypharmacy frequently results in drug therapy problems related to interactions, drug toxicity, falls with injury, delirium, and non-adherence. Therefore, we have attempted to gather data on the medical treatment in patients with extra-cardiac atherosclerotic lesions indicating where there is some evidence of the management in elderly patients and where there are gaps in evidence-based medicine. Public PubMed databases were searched to review existing evidence on the effectiveness of lipid-lowering, antithrombotic, and new glucose-lowering medications in patients with extra-cardiac atherosclerotic occlusive disease.

Endovascular carotid revascularization under open-chest extracorporeal circulation combined with cardiac surgery in unstable patients at increased risk of carotid-related stroke: SIMultaneous urgent cardiac surgery and MicroNet-covered stent carotid revascularization in extreme-risk patients-SIMGUARD Study.

BACKGROUND: In patients at urgent need for cardiac surgery coexisting with increased-stroke-risk carotid stenosis, any staged intervention increases the risk of complications from the primarily unaddressed pathology. In this challenging cohort, we assessed safety and feasibility of endovascular carotid revascularization under open-chest extracorporeal circulation (ECC) combined with cardiac surgery (hybrid-room true simultaneous treatment). METHODS: Per-protocol (PP), after general anesthesia induction, chest-opening and ECC stand-by installation, carotid stenting (CAS) was performed (femoral/radial or direct carotid access) with ad-hoc/on-hand switch to ECC cardiac surgery. RESULTS: Over 78 months, 60 patients (70.7±6.9years, 85% male, all American Society of Anesthesiology grade IV) were enrolled. All were at increased carotid-related stroke risk (ipsilateral recent stroke/transient ischemick attack, asymptomatic cerebral infarct, increased-risk lesion morphology, bilateral severe stenosis). Majority of study procedures involved CAS+coronary bypass surgery or CAS+valve replacement±coronary bypass. 45 (75%) patients were PP- and 15 (25%) not-PP (NPP-) managed (context therapy). CAS was 100% neuroprotected (transient flow reversal-64.4%, filters-35.6%) and employed micronet-covered plaque-sequestrating stents with routine post-dilatation optimization/embedding. 4 deaths (6.7%) and 7 strokes (11.7%) occurred by 30-days. Despite CAS+surgery performed on aspirin and unfractionated heparin-only (delayed clopidogrel-loading), no thrombosis occurred in the stented arteries, and 30-days stent patency was 100%. NPP-management significantly increased the risk of death/ipsilateral stroke (OR 38.5; P<0.001) and death/any stroke (OR 12.3; P=0.002) by 30-days. CONCLUSIONS: In cardiac unstable patients at increased carotid-related stroke risk who require urgent cardiac surgery, simultaneous cardiac surgery and CAS with micronet-covered stent lesion sequestration is feasible and safe and shows efficacy in minimizing stroke risk. Larger-scale, multicentric evaluation is warranted. (SIMGUARD NCT04973579).

Clinical Characteristics and Outcomes of Aortic Arch Emergencies: Takayasu Disease, Fibromuscular Dysplasia, and Aortic Arch Pathologies: A Retrospective Study and Review of the Literature.

Non-atherosclerotic aortic arch pathologies (NA-AAPs) and anatomical variants are characterized as rare cardiovascular diseases with a low incidence rate, below 1 case per 2000 population, but enormous heterogeneity in terms of anatomical variants, i.e., Takayasu disease (TAK) and fibromuscular dysplasia (FMD). In specific clinical scenarios, NA-AAPs constitute life-threatening disorders. METHODS: In this study, 82 (1.07%) consecutive patients with NA-AAPs (including 38 TAKs, 26 FMDs, and 18 other AAPs) out of 7645 patients who underwent endovascular treatment (EVT) for the aortic arch and its side-branch diseases at a single institution between 2002 and 2022 were retrospectively reviewed. The recorded demographic, biochemical, diagnostic, operative, and postoperative factors were reviewed, and the functional outcomes were determined during follow-up. A systematic review of the literature was also performed. RESULTS: The study group comprised 65 (79.3%) female and 17 (21.7%) male subjects with a mean age of 46.1 ± 14.9 years. Overall, 62 (75.6%) patients were diagnosed with either cerebral ischemia symptoms or aortic arch dissection on admission. The EVT was feasible in 59 (72%) patients, whereas 23 (28%) patients were referred for medical treatment. In EVT patients, severe periprocedural complications occurred in two (3.39%) patients, including one periprocedural death and one cerebral hyperperfusion syndrome. During a median follow-up period of 64 months, cardiovascular events occurred in 24 (29.6%) patients (5 deaths, 13 ISs, and 6 myocardial infarctions). Repeated EVT for the index lesion was performed in 21/59 (35.6%) patients, including 19/33 (57.6%) in TAK and 2/13 (15.4%) in FMD. In the AAP group, one patient required additional stent-graft implantation for progressing dissection to the iliac arteries at 12 months. A baseline white blood count (odds ratio [HR]: 1.25, 95% confidence interval [CI]: 1.11-1.39; p < 0.001) was the only independent prognostic factor for recurrent stenosis, while a baseline hemoglobin level (HR: 0.73, 95%CI: 0.59-0.89; p = 0.002) and coronary involvement (HR: 4.11, 95%CI: 1.74-9.71; p = 0.001) were independently associated with a risk of major cardiac and cerebral events according to the multivariate Cox proportional hazards regression analysis. CONCLUSIONS: This study showed that AAPs should not be neglected in clinical settings, as it can be a life-threatening condition requiring a multidisciplinary approach. The knowledge of prognostic risk factors for adverse outcomes may improve surveillance in this group of patients.

Diabetes Mellitus and Clinical Outcomes in Carotid Artery Revascularization Using Second-Generation, MicroNet-Covered Stents: Analysis from the PARADIGM Study.

Introduction: Carotid artery stenting (CAS) using conventional (single-layer) stents is associated with worse clinical outcomes in diabetes mellitus (DM) vs. non-DM patients: an effect driven largely by lesion-related adverse events. CAS outcomes with MicroNet-covered stents (MCS) in diabetic patients have not been evaluated. Aim: To compare short- and long-term clinical outcomes and restenosis rate in DM vs. non-DM patients with carotid stenosis treated using MCS. Materials and Methods: In a prospective study in all-comer symptomatic and increased-stroke-risk asymptomatic carotid stenosis, 101 consecutive patients (age 51-86 years, 41% diabetics) underwent 106 MCS-CAS. Clinical outcomes and duplex ultrasound velocities were assessed periprocedurally and at 30 days/12 months. Results: Baseline characteristics of DM vs. non-DM patients were similar except for a higher prevalence of recent cerebral symptoms in DM. Type 1 and type 1+2 plaques were more prevalent in DM patients (26.7% vs. 9.8%, p = 0.02; 62.2% vs. 37.7%, p = 0.01). Proximal embolic protection was more prevalent in DM (60% vs. 36%; p = 0.015). 30-day clinical complications were limited to a single periprocedural minor stroke in DM (2.4% vs. 0%, p = 0.22). 12-month in-stent velocities and clinical outcomes were not different (death rate 4.8% vs. 3.3%; p = 0.69; no new strokes). Restenosis rate was not different (0% vs. 1.7%, p = 0.22). Conclusions: MCS may offset the adverse impact of DM on periprocedural, 30-day, and 12-month clinical complications of CAS and minimize the risk of in-stent restenosis. In this increased-stroke-risk cohort, adverse event rate was low both in DM and non-DM. Further larger-scale clinical datasets including extended follow-ups are warranted.

The Maintained Glycemic Target Goal and Renal Function Are Associated with Cardiovascular and Renal Outcomes in Diabetic Patients Following Stent-Supported Angioplasty for Renovascular Atherosclerotic Disease.

Patients with type 2 diabetes mellitus (T2DM) constitute a large proportion of patients with atherosclerotic renal artery stenosis (ARAS). However, the mechanism of impaired renal function and hypertension in this subset of patients is multifactorial. We aimed to investigate whether, in diabetic patients, renal function (RF), systolic (SBP) and diastolic blood pressure (DBP) values following stent-supported angioplasty (PTA) for ARAS have an impact on cardiovascular and renal outcomes. Methods: The study group included 93 patients with T2DM and resistant hypertension who underwent PTA for ARAS. The pre- and post-procedure (6 to 12, and 24 months) values of SBP, DBP, eGFR and glycaemia were obtained. The prospective follow-up of median 44 months was performed for combined outcome: major cardiac and cerebral events (MACCE) and progression to renal replacement therapy (RRT). Results: MACCE-RRT occurred in 46 (49.5%) patients, with higher incidence in patients with higher values of SBP (147.8 ± 25.8 vs. 136.7 ± 15.8 mmHg, p = 0.006), DBP (80.8 ± 13.3 vs. 74.4 ± 12.3 mmHg, p = 0.009), chronic kidney disease in stages 3B to 5 (p = 0.029) and those who have not obtained target glycemic goals compared to well-maintained T2DM (p = 0.007) at 24-months. On multivariate Cox analysis, well-maintained T2DM targets [Hazard Ratio (HR):0.27; 95% Confidence Interval (CI):0.13−0.57; p < 0.001], eGFR below 45 mL/min/m2 (HR: 2.20; 95%CI: 1.20−4.04; p = 0.011), previous stroke (HR:2.52; 95%CI:1.19−5.34; p = 0.015) retained their associations with MACCE-RRT, while BP values were not associated with the outcome. Conclusions: The post-procedural RF, maintained glycemic target goal and previous stroke are vital for the outcome in patients undergoing PTA for renovascular disease in diabetic patients.

Combined intra-arterial and intra-muscular transfer of Wharton's jelly mesenchymal stem/stromal cells in no-option critical limb ischemia - CIRCULATE N-O CLI Pilot Study.

Introduction: Despite progress in pharmacologic and revascularization therapies, no-option critical limb ischemia poses a major clinical and societal problem. Prior cell-based strategies involved mainly autologous (limited) cell sources. Aim: To evaluate the safety and feasibility of a novel ischemic tissue reparation/regeneration strategy using Wharton's jelly mesenchymal stem/stromal cells (WJMSCs) as an "unlimited" cell source in N-O CLI (first-in-man study, FIM). Material and methods: Enrollment criteria included Rutherford-4 to Rutherford-6 in absence of anatomic/technical feasibility for revascularization and adequate inflow via the common femoral artery with patency of at least one below-the-knee artery. 30 × 106 WJMSCs were administered intra-arterially and intra-muscularly (50%/50%) over 3-6-week intervals (3-6 administrations). Safety, feasibility and potential signals of efficacy were assessed at 12 and 48 months. Results: Five patients (age 61-71, 60% male, Rutherford-6 20%, Rutherford-5 60%, Rutherford-4 20%) were enrolled. WJMSCs were administered per protocol in absence of administration technique-related adverse events. Hyperemia, lasting 12-24 h, occurred in 4/5 subjects. Transient edema and pain (reactive to paracetamol) occurred in 3 (60%) patients. Amputation-free survival was 80% after 12 and 48 months. In those who avoided amputation, ischemic ulcerations healed and Rutherford stage improved. 4/5 patients were free of resting pain after 3-6 doses. Conclusions: This FIM study demonstrated the safety and feasibility of WJMSCs use in patients with N-O CLI and suggested treatment efficacy with ≥ 3 doses. Our findings provide a basis for a randomized, double-blind clinical trial to assess the efficacy of WJMSC-based therapeutic strategy in N-O CLI patients.

Misclassification of carotid stenosis severity with area stenosis-based evaluation by computed tomography angiography: impact on erroneous indication to revascularization or patient (lesion) migration to a higher guideline recommendation class as per ESC/ESVS/ESO/SVS and CMS-FDA thresholds.

Intoduction: Despite a growing understanding of the role played by plaque morphology, the degree of carotid lumen reduction remains the principle parameter in decisions on revascularization in symptomatic and asymptomatic patients. Computed tomography angiography (CTA) is a widely used guideline-approved imaging modality, with "percent stenosis" commonly calculated as %area reduction (area stenosis - AS). Aim: We evaluated the impact of the non-linear relationship between diameter stenosis (DS) and AS (area = π • (diameter/2)2, so that in concentric lesions 51%AS is 30%DS and 75%AS is 50%DS) on stenosis severity misclassification using calculation of area reduction. Material and methods: CTA and catheter quantitative angiography (cQA) were performed in 300 consecutive patients referred to a tertiary vascular centre for potential carotid revascularization (age: 47-83 years, 33.7% symptomatic, 36% female; referral stenosis of ≥ "50%"). CTA-AS was determined by agreement of 2 experienced radiologists; cQA-DS (pivotal trials standard reference, NASCET method) was calculated by agreement of 2 corelab analysts. Results: For symptomatic lesion thresholds, CTA-AS-based calculation reclassified 76% of "< 50%" cQA-DS measurements to the "50-69%" group, and 58% of "50-69%" measurements to the "≥ 70%" group. For asymptomatic lesion thresholds, 78% of "< 60%" cQA-DS measurements were reclassified to the "60-79%" group, whereas 42% of "60-79%" cQA measurements crossed to the "≥ 80%" class. Overall, employing CTA-AS instead of cQA-DS enlarged the "60-79%" and "≥ 80%" lesion severity classes 1.6- and 5.8-fold, respectively, whereas the "≥ 70%" class increased 4.15-fold. Conclusions: Replacing the pivotal carotid trials reference standard cQA-DS "%stenosis" measurement with CTA-AS-based "%stenosis" results in a large-scale lesion/patient erroneous gain of an "indication" to revascularization or migration to a higher revascularization indication class. In consequence, unnecessary carotid procedures may be performed in the absence of cQA verification. Until guidelines rectify the "%stenosis" measurement methods with different guideline-approved imaging modalities (and, where needed, re-adjust decision thresholds), CTA-AS measurement should not be used as a basis for carotid revascularization.

Cellular therapies in no-option critical limb ischemia: present status and future directions.

Critical limb ischemia - an advanced stage of lower extremity arterial disease with presence of rest pain and/or ischemic ulcers - remains an important cause of major amputations and disability in developed societies. Novel treatment strategies are urgently needed to prevent (or delay) amputations in particular for patients in whom effective revascularization is no longer feasible for anatomic and/or technical reasons (no-option critical limb ischemia - N-O CLI). Cellular therapies have been gaining the growing attention of researchers and clinicians in the last two decades. Several cell types have been used in pre-clinical and clinical studies, and a number of mechanisms have been proposed to contribute to vascular reparation and regeneration in N-O CLI. Although early trials suggested clinical improvement with use of cell-based therapies in N-O CLI, meta-analyses that included randomized controlled trials have not provided definitive conclusions. Fundamental limitations have involved poorly defined cell lines/populations, limited numbers of study participants and limited follow-up periods, and enrolling patients "too sick to benefit" (such as those in Rutherford class 6). Recent advances include standardized "unlimited" sources of therapeutic cells and better understanding of mechanisms that may contribute to vascular reparation and regeneration. Furthermore, based on recent pre-clinical and clinical studies, cell-free preparations (such as microvesicle-based) are being increasingly developed along with advanced therapy medical products consisting of engineered cells and pro-angiogenic factors.

Diffusion as a Natural Contrast in MR Imaging of Peripheral Artery Disease (PAD) Tissue Changes. A Case Study of the Clinical Application of DTI for a Patient with Chronic Calf Muscles Ischemia.

This paper reports a first application of diffusion tensor imaging with corrections by using the B-matrix spatial distribution method (BSD-DTI) for peripheral artery disease (PAD) detected in the changes of diffusion tensor parameters (DTPs). A 76-year-old male was diagnosed as having PAD, since he demonstrated in angiographic images of lower legs severe arterial stenosis and the presence of lateral and peripheral circulation and assigned to the double-blind RCT using mesenchymal stem cells (MSCs) or placebo for the regenerative treatment of implications of ischemic diseases. In order to indicate changes in diffusivity in calf muscles in comparison to a healthy control, a DTI methodology was developed. The main advantage of the applied protocol was decreased scanning time, which was achieved by reducing b-value and number of scans (to 1), while maintaining minimal number of diffusion gradient directions and high resolution. This was possible due to calibration via the BSD method, which reduced systematic errors and allowed quantitative analysis. In the course of PAD, diffusivities were elevated across the calf muscles in posterior compartment and lost their anisotropy. Different character was noticed for anterior compartment, in which diffusivities along and across muscles were decreased without a significant loss of anisotropy. After the intervention involving a series of injections, the improvement of DTPs and tractography was visible, but can be assigned neither to MSCs nor placebo before unblinding.

Simple clinical scores to predict blood pressure and renal function response to renal artery stenting for atherosclerotic renal artery stenosis.

INTRODUCTION: There are no systematic tools to predict blood pressure (BP) or renal function (RF) improvement after stent­assisted percutaneous transluminal angioplasty (PTA) for atherosclerotic renal artery stenosis (ARAS). OBJECTIVE: This study aimed to develop simple, clinically applicable scores based on preprocedural clinical and renal ultrasonography parameters in order to predict BP and RF improvement following ARAS­PTA. PATIENTS AND METHODS: A total of 202 patients who underwent ARAS­PTA were categorized as RF responders (eGFR increase ≥11 ml/min/1.73 m2) or BP responders (systolic and diastolic BP decrease ≥20 mm Hg and ≥5 mm Hg, respectively) at 12 months following ARAS­PTA. The variables associated with the RF or BP response in univariable analysis were included in a multivariable logistic regression model. Point­based response scales were developed proportionally to odds ratios in each of the 2 models to embrace the maximum score of 10. RESULTS: The BP response to ARAS­PTA was 93.3% in the high­probability category (6-10 points), 66.7% in the medium­probability category (3-5 points), and 25.3% in the low­probability category (0-2 points), with the preprocedural variables of systolic BP ≥145 mm Hg (3 points), diastolic BP ≥83 mm Hg (4 points), PTA of a single functioning kidney (2 points), and bilateral PTA (1 point). The RF response was 77.3% in the high­probability category (8-10 points), 33% in the medium­probability category (4-7 points), and 10.9% in the low­probability category (0-3 points) for serum creatinine levels >122 µmol/l and eGFR >30 ml/min/1.73 m2 (3 points), index kidney length >98 mm (3 points), renal artery end­diastolic velocity >1.1 m/s (2 points), and arterial resistive index <0.74 (2 points). CONCLUSIONS: Models of favorable BP and RF response may improve patient selection for ARAS­PTA. Further insights are expected from prospective validation.

Long-term outcomes and determinants of stenosis recurrence after renal artery angioplasty in hypertensive patients with renovascular disease.

INTRODUCTION: Restenosis (RS) following percutaneous angioplasty (PTA) of renal artery stenosis (RAS) might have an unfavourable impact on renal function and blood pressure (BP) outcomes. AIM: To evaluate the prevalence and predictors of RS in patients treated with PTA for RAS, and the relationship between BP and renal function (RF) changes with RS. MATERIAL AND METHODS: We analysed freedom from RS in 210 patients (age 64.6 ±12.8 years; range: 20-85), who underwent 248 successful stent-assisted PTAs in RAS. The change in levels of serum creatinine (SCC), estimated glomerular filtration rate (eGFR), systolic/diastolic BPs (SBP/DBP) were analysed prior to PTA, at 6-, 12-month, and final follow-up visits, and whenever RS was diagnosed. RESULTS: RS was identified in 30 (14.3%) patients, and there were 36 (14.5%) lesions. The Kaplan-Meier RS-free survival curves in fibromuscular dysplasia, atherosclerosis, and vasculitis at 1 and 7 years were: 100% and 100%; 95.6 and 83.9%; and 71.4 and 39.7%, respectively. Patients with RS, as compared to RS-free patients, presented with less pronounced changes in respect with: SBP (1.4 ±17.6 vs. -15.8 ±25.8 mm Hg; p = 0.01), DBP (2.64 ±10.1 vs. -6.5 ±14.1 mm Hg; p = 0.002), SCC (22.4 ±55.2 vs. -3.6 ±43.9 µmol/l; p = 0.002), and eGFR (-1.85 ±18 vs. -5.34 ±19.5 mm Hg; p = 0.045). In multivariate Cox regression analysis, independent predictors of RS occurred: lack of BP decrease (HR = 4.19, 95% CI: 1.67-10.3; p = 0.002), eGFR increase < 0.17 ml/min/1.73 m2 (HR = 2.93, 95% CI: 1.08-7.91; p = 0.033), stent diameter ≤ 5 mm (HR = 2.76, 95% CI: 1.09-6.97; p = 0.031), and vasculitis (HR = 5.61, 95% CI: 1.83-17.2; p = 0.003). RS was treated in 24 patients with RS recurrence in 20%. CONCLUSIONS: The RS rate differs depending on RAS aetiology. Lack of SBP/DBP and eGFR improvement, vasculitis, and stent diameter are associated with RS risk. Repeated PTA is effective, but recurrent RS occurs in 20% of cases.

Recanalization of Embolized Endovascular Intracranial Aneurysms and Changes in the Blood Viscosity: A Pilot Study.

BACKGROUND The purpose of our research was to evaluate the relationships between blood viscosity and recanalization of coiled intracranial aneurysms. MATERIAL AND METHODS The study included consecutives patients treated endovascularly by a team of experienced neurosurgeons and neuroradiologists due to brain aneurysm. A total of 50 patients (the average age was 57.48 years, SD=13.71) were assigned to 2 groups: group A with recanalization (4 male and 8 female patients) and group B without recanalization (10 male and 28 female patients) were examined. All patients underwent a 6-month follow-up of the whole-blood viscosity test with a Brookfield DV III+pro cone-plate viscometer using the Rheocalc program. Differences between groups were assessed using the Statistica 12 computer program (StatSoft Inc., Tulsa, OK, USA). RESULTS Studies have shown no significant difference in the age range between group A and B (P=0.31). In group A, higher viscosity values were found for whole blood [median: 4.14 dyn×sec/cm² (mPa×sec) quartile range 0.42], compared to group B [median: 3.92 dyn×sec/cm² (mPa×sec); quartile range 0.40; (P=0.04)]. This difference was significant (P=0.04). Additionally, the level of hematocrit was positively related with recanalization, the higher the hematocrit, the more frequent recanalization. A very strong and statistically significant relationship occurred between the frequency of recanalization and smoking (P<0.001). CONCLUSIONS The occurrence of higher values of whole blood viscosity which increase turbulent flow through the vessels may be a risk for recanalization of the coiled intracranial aneurysm.