Evaluation of arteriovenous fistula maturation and early prediction of clinical eligibility, using ultrasound: The Fistula Maturation Evaluation (FAME) Study.

INTRODUCTION: The study of time-related alterations of ultrasound-determined parameters during maturation, and the assessment of time to hemodynamic maturation, enabling early prediction of clinical eligibility, of hemodialysis autologous arteriovenous fistulae (AVF). METHODS: This is an observational, prospective, study of only AVF-eligible patients referred for access creation, from 02/2019 to 02/2022 (ClinicalTrials.gov identifier: NCT0473687). Brachial artery diameter (dBA), access flow volume (FV), non-augmented efferent vein diameter (dEV), resistivity index (RI), and efferent vein total wall thickness (tEV), were assessed by ultrasound. Measurements were conducted daily in the first week and repeated on days 14, 21, 30, 60, and 90, postoperatively. The primary endpoint included the documentation of serial changes of flow and structural parameters related to AVF maturation in the first 90 days of the post-operative period and maturation early prediction. Secondary endpoints included the determination of factors affecting maturation. RESULTS: One hundred one participants (mean age, 67 ± 6 years; 76 males) were enrolled. Average dBA and FV reached maximum on day 60 (5.64 ± 0.85 mm) and 90 (1.172 ± 617 mL/min), respectively. Day 7 values of dBA (5.48 ± 0.73 mm) and FV (1.039 ± 531 mL/min) did not alter significantly during the follow-up period. Parameters indicative of clinical functionality, dEV (5.82 ± 0.90 mm) and tEV (0.493 ± 0.10 mm), reached approximately 90% of maximum (6.66 ± 1.42 mm and 0.526 ± 0.11 mm), by day 14. RI reached minimum on day 30 (0.46 ± 0.09), without significant changes after day 2 (0.48 ± 0.09, p = 0.284). A significant correlation was identified, between day 7 FV and day 60 dEV (r = 0.40, p = 0.0002). A FV cut-off value ⩾657.51 mL/min, on day 7, predicted successful fistula maturation with 85% sensitivity and 100% specificity. Multivariate analysis identified female gender, age >75, diabetes, and wrist access as independent predictors of decreased values of maturation parameters. CONCLUSION: Hemodynamic maturation is completed by the first postoperative week, while AVF is clinically functional, by the second. FV can be used for early prediction of maturation.

Results of a hemodialysis vascular access routine ultrasound surveillance protocol and frequency of surveillance guided pre-emptive access maintenance interventions.

BACKGROUND: To evaluate the implementation of routine surveillance using ultrasound on hemodialysis vascular access (VA) outcomes and determine the number and frequency of corrective, surveillance-guided procedures performed. METHODS: Multicenter, prospective, observational study that includes consecutive hemodialysis patients receiving therapy from native arteriovenous fistulae (AVF) or grafts (AVG). Participants were assigned to a routine VA Color Doppler ultrasound surveillance (DUS) protocol from January 2019 to December 2021. Patients were referred for corrective procedures (endovascular or surgical) based on clinical or DUS findings (pre-emptive procedures; PEP). Primary endpoint was the estimation of primary unassisted (PUP) and secondary patency (SP) rates. Secondary endpoints were the determination of the number and frequency of PEP and VA survival rates. RESULTS: In total, 223 patients with 243 VA (192 AVF and 51 AVG) were included. Access PUP and SP rates were 83% and 93% at 12 months, 75% and 88% at 24 months, and 72% and 83% at 36 months follow-up. Autologous fistulae PUP and SP were 89% and 96% at 12 months, 81% and 93% at 24 months, and 80% and 89% at 36 months, respectively. Graft PUP and SP were 56% and 80% at 12 months, 44% and 65% at 24 months, and 39% and 54% at 36 months, respectively. In total, 56 corrective procedures (38/56 PEP; 65.5%) were performed (0.13 procedures/year), of which 34 were in AVF patients (0.09 procedures/year) and 22 in AVG patients (0.40 procedures/year). Overall, 33 VA losses occurred (0.06 failures/year), 17 in AVF (0.04 failures/year), and 16 in AVG patients (0.20 failures/year). CONCLUSION: The use of DUS resulted in the timely diagnosis of dysfunction, satisfactory overall VA survival, and patency rates, with a low PEP frequency. Randomized controlled trials are required to establish the value of DUS surveillance on access patency and whether DUS-guided interventions could improve VA outcomes.

Carotid Stent Restenosis and Thrombosis in Rabbits: The Effect of Antiplatelet Agents.

BACKGROUND: The purpose of the study was the comparative assessment of ticagrelor and clopidogrel effects on carotid post-balloon injury (PBI) and on post carotid artery stenting (CAS) rate of in-stent restenosis (ISR) and in-stent thrombosis in atherosclerotic rabbits. METHODS: Forty-eight New Zealand white rabbits on high-fat diet were randomized into 4 groups: A1: PBI and clopidogrel (30 mg/kg/d), A2: PBI and ticagrelor (21 mg/kg twice daily), B1: PBI, CAS, and clopidogrel (30 mg/kg/d), B2: PBI, CAS, and ticagrelor (21 mg/kg twice daily). All rabbits received orally aspirin (10 mg/kg/d) and interventions were performed in their right carotid arteries (RCAs). Optical coherence tomography (OCT) and carotid angiography were performed at end point, while platelet aggregation and lipid profile were measured. After euthanasia both carotids were obtained for histological examination. RESULTS: In B1 group, 3 rabbits presented thrombotic total occlusion of the stents, while none such episode was observed in B2 group. The neointimal areas in RCAs, calculated by OCT, did not differ between A1 and A2 groups, and between B1 and B2 groups (P > .05). From the histological findings, the intima/(media + intima) percentage (%) in RCAs of balloon-injured rabbits did not present any difference between groups (P = .812). Similarly, the immunohistochemically determined accumulation of endothelial cells and macrophages on vascular walls was equivalent between groups (P > .05). CONCLUSION: Following carotid balloon injury and stenting, clopidogrel and ticagrelor did not show any differential effects on the extent of neointimal formation and ISR in atherosclerotic rabbits receiving aspirin. Three thrombotic stent occlusions were noted in the clopidogrel treatment group, but this finding was not statistically significant.

The relationship of novel adipokines, RBP4 and omentin-1, with carotid atherosclerosis severity and vulnerability.

OBJECTIVE: We investigated the relationship of circulating novel adipokines, retinol-binding protein 4 (RBP4) and omentin-1, with advanced carotid atherosclerosis and ultrasound indexes of severity (total plaque area-TPA) and plaque echogenicity and vulnerability (Gray-Scale median - GSM score). METHODS: We enrolled 225 patients with high-grade carotid stenosis (HGCS) who underwent carotid revascularization (73 Symptomatic patients, 152 asymptomatic patients) and 75 age- and sex-matched, asymptomatic individuals with low-grade (<50%) carotid stenosis (LGCS). Seventy-three individuals without current manifestations of atherosclerotic disease served as control group (COG). All participants underwent carotid ultrasound with TPA and GSM score assessment. Moreover, clinical parameters, metabolic profile, and circulating levels of hsCRP and adipokines were assessed. RESULTS: RBP4 was significantly elevated in HGCS (51.44 ± 16.23 mg/L) compared to LGCS (38.39 ± 8.85 mg/L), independent of symptoms existence, whereas RBP4 levels in COG were even lower (25.74 ± 10.72 mg/L, p < 0.001 compared to either HGCS or LGCS). Inversely, serum omentin-1 levels were significantly lower across HGCS (490.41 ± 172 ng/ml) and LGCS (603.20 ± 202.43 ng/ml) than COG (815.3 ± 185.32, p < 0.001). Moreover, the considerable difference between HGCS and LGCS (p < 0.001) was exclusively attributed to the excessive suppression of omentin-1 concentrations in symptomatic versus asymptomatic (p = 0.004) patients. HGCS and LGCS did not differ in the rest of clinical and biochemical parameters. In multiple regression analysis, RBP4 (beta = 0.232, p = 0.025) and hsCRP (beta = 0.300, p = 0.004) emerged as independent determinants of TPA in patients with carotid atherosclerosis. Low serum levels of omentin-1 correlated with GSM score and symptoms but that association was lost in multivariate analysis.. CONCLUSION: RBP4 serum levels were significantly elevated in patients with established carotid atherosclerosis and were positively associated with atherosclerosis severity. The association of low serum omentin-1 with carotid plaque echolucency requires further investigation.. ClinicalTrials.gov Identifier: NCT00636766.

Flow-diverting stents for the treatment of arterial aneurysms.

BACKGROUND: Anatomic factors may limit the application of stent grafts for the treatment of arterial aneurysms. Flow- diverting stents (FDSs) are specially designed to reduce flow velocity in the aneurysm sac and promote thrombosis while maintaining flow in the main artery and branch vessels. FDSs include the Pipeline Embolization Device (ev3, Plymouth, Minn), the SILK Arterial Reconstruction Device (Balt Extrusion, Montmorency, France), and the Cardiatis Multilayer Stent (Cardiatis, Isnes, Belgium). The first two have been mainly used for the treatment of intracranial aneurysms. The aim of this study was to review the current role of FDSs in the treatment of extracranial arterial aneurysms. METHODS: A systematic electronic health database search was conducted using PubMed, Ovid, Medline, and the Cochrane Database on all accessible published articles through March 2012. An additional search for abstracts presented in international congresses for vascular surgery was also performed. Full-text articles and abstracts were analyzed separately due to the heterogeneity of the data. RESULTS: Results of the use of FDSs in arterial aneurysms were reported in 12 full-text articles including 35 patients (26 men, age 65.4) with 38 aneurysms. The aneurysms were located in the hepatic (n = 12), splenic (n = 6), renal (n = 5), celiac (n = 4), superior mesenteric (n = 3), subclavian (n = 2), gastroduodenal (n = 1), and popliteal arteries (n = 1) and in the descending thoracic (n = 1), suprarenal (n = 1) and infrarenal aorta (n = 2). The 30-day mortality was 5.7% (2 of 35 patients). Three stent thromboses occurred (8.3%), none of them with clinical consequences. Thirty patients with 33 aneurysms and patent FDSs were monitored for an average of 9.2 months. Thrombosis occurred in 90.6%, and volume reduction was observed in 81% of the aneurysms. No branch vessel occlusion occurred. Twelve abstracts were identified, including 133 patients (mean age, 64.7 years). They included 62 peripheral, 28 visceral, and 43 abdominal and thoracoabdominal aneurysms. The Cardiatis Multilayer Stent was used in all cases. Thrombosis was achieved in all but two peripheral and visceral aneurysms. Volume reduction was observed in 82.7%, and no branch vessel occlusion occurred. In aortic aneurysms, better results regarding aneurysm thrombosis, reduction of the volume, and patency of collateral branches were reported at 12 months rather than at 6 months postoperatively. No aneurysm rupture has yet been described. CONCLUSIONS: Initial clinical experience with the use of FDSs in the treatment of visceral and peripheral aneurysms yielded satisfactory results in technical success, aneurysm thrombosis and shrinkage, and in patency of branch vessels. The results in aortic aneurysms are still under investigation. No aneurysm rupture has yet been described. There is a significant incidence of FDS thrombosis. Volume reduction of the aneurysm is a clearer evidence of the clinical success after treatment with FDSs than aneurysm thrombosis.

Balloon angioplasty vs nitinol stent placement in the treatment of venous anastomotic stenoses of hemodialysis grafts after surgical thrombectomy.

OBJECTIVE: Most arteriovenous hemodialysis grafts fail ≤18 months after implantation, most commonly due to intimal hyperplasia at the venous anastomosis. This open prospective study compared balloon angioplasty vs nitinol stent placement in the treatment of venous anastomotic stenosis after thrombectomy of prosthetic brachial-axillary accesses. METHODS: Between February 2007 and December 2010, 61 patients with an initial thrombosis of a prosthetic brachial-axillary access were admitted to our hospital. Of these patients, 28 (46%), treated before June 2008, underwent thrombectomy plus balloon angioplasty of the venous anastomosis (group A), whereas the remaining 33 (54%) patients, who were treated after July 2008, underwent graft thrombectomy plus angioplasty with self-expanding nitinol stent placement (group B). Primary, primary-assisted, and secondary patency rates were calculated using Kaplan-Meier analysis and compared between the two groups with the log-rank test. RESULTS: Primary patency was 32% at 3 months, 24% at 6 months, and 14% at 12 months in group A, and the respective values were 85%, 63% and 49% in group B. Primary patency was significantly better in group B than in group A (P < .001; log-rank test). Cumulative median patency was 60 days in group A and 260 days in group B. Patient age, sex, comorbidities, graft material, and graft age did not have prognostic significance. Primary-assisted and secondary patency rates were significantly higher in group B. CONCLUSIONS: Graft thrombectomy plus angioplasty with self-expanding nitinol stent placement provides significantly higher patency rates compared with thrombectomy plus plain balloon angioplasty of the venous anastomosis.