76 research outputs found

    Endovascular Abdominal Aortic Aneurysm Repair With Ovation Alto Stent Graft: Protocol for the ALTAIR (ALTo endogrAft Italian Registry) Study

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    Background: Since 2010, the Ovation Abdominal Stent Graft System has offered an innovative sealing option for abdominal aortic aneurysm (AAA) by including a sealing ring filled with polymer 13 mm from the renal arteries. In August 2020, the redesigned Ovation Alto, with a sealing ring 6 mm closer to the top of the fabric, received CE Mark approval. Objective: This registry study aims to evaluate intraoperative, perioperative, and postoperative results in patients treated by the Alto stent graft (Endologix Inc.) for elective AAA repair in a multicentric consecutive experience. Methods: All consecutive eligible patients submitted to endovascular aneurysm repair (EVAR) by Alto Endovascular AAA implantation will be included in this analysis. Patients will be submitted to EVAR procedures based on their own preferences, anatomical features, and operators experience. An estimated number of 300 patients submitted to EVAR with Alto stent graft should be enrolled. It is estimated that the inclusion period will be 24 months. The follow-up period is set to be 5 years. Full data sets and cross-sectional images of contrast-enhanced computed tomography scan performed before EVAR, at the first postoperative month, at 24 or 36 months, and at 5-year follow-up interval will be reported in the central database for a centralized core laboratory review of morphological changes. The primary endpoint of the study is to evaluate the technical and clinical success of EVAR with the Alto stent graft in short- (90-day), mid- (1-year), and long-term (5-year) follow-up periods. The following secondary endpoints will be also addressed: operative time; intraoperative radiation exposure; contrast medium usage; AAA sac shrinkage at 12-month and 5-year follow-up; any potential role of patients' baseline characteristics, valuated on preoperative computed tomography angiographic study, and of device configuration (number of component) in the primary endpoint. Results: The study is currently in the recruitment phase and the final patient is expected to be treated by the end of 2023 and then followed up for 5 years. A total of 300 patients will be recruited. Analyses will focus on primary and secondary endpoints. Updated results will be shared at 1- and 3-5-year follow-ups. Conclusions: The results from this registry study could validate the safety and effectiveness of the new design of the Ovation Alto Stent Graft. The technical modifications to the endograft could allow for accommodation of a more comprehensive range of anatomies on-label

    Acute deep vein thrombosis and pulmonary embolism: is the thromboaspiration device an appropriate choice?

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    Nowadays patients affected by deep vein thrombosis (DVT) and pulmonary embolism (PE) are studied widely but the challenge for physicians is when and how they are to be treated. Most patients present serious comorbidities that can potentially make treatment difficult. An increasing cohort of patients cannot be treated with systemic fibrinolysis but fortunately today, physicians can utilize a number of different instruments to resolve acute DVT and PE

    Serum Albumin Is Inversely Associated With Portal Vein Thrombosis in Cirrhosis

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    We analyzed whether serum albumin is independently associated with portal vein thrombosis (PVT) in liver cirrhosis (LC) and if a biologic plausibility exists. This study was divided into three parts. In part 1 (retrospective analysis), 753 consecutive patients with LC with ultrasound-detected PVT were retrospectively analyzed. In part 2, 112 patients with LC and 56 matched controls were entered in the cross-sectional study. In part 3, 5 patients with cirrhosis were entered in the in vivo study and 4 healthy subjects (HSs) were entered in the in vitro study to explore if albumin may affect platelet activation by modulating oxidative stress. In the 753 patients with LC, the prevalence of PVT was 16.7%; logistic analysis showed that only age (odds ratio [OR], 1.024; P = 0.012) and serum albumin (OR, -0.422; P = 0.0001) significantly predicted patients with PVT. Analyzing the 112 patients with LC and controls, soluble clusters of differentiation (CD)40-ligand (P = 0.0238), soluble Nox2-derived peptide (sNox2-dp; P < 0.0001), and urinary excretion of isoprostanes (P = 0.0078) were higher in patients with LC. In LC, albumin was correlated with sCD4OL (Spearman's rank correlation coefficient [r(s)], -0.33; P < 0.001), sNox2-dp (r(s), -0.57; P < 0.0001), and urinary excretion of isoprostanes (r(s), -0.48; P < 0.0001) levels. The in vivo study showed a progressive decrease in platelet aggregation, sNox2-dp, and urinary 8-iso prostaglandin F2 alpha-III formation 2 hours and 3 days after albumin infusion. Finally, platelet aggregation, sNox2-dp, and isoprostane formation significantly decreased in platelets from HSs incubated with scalar concentrations of albumin. Conclusion: Low serum albumin in LC is associated with PVT, suggesting that albumin could be a modulator of the hemostatic system through interference with mechanisms regulating platelet activation

    Beta-Blocker Use in Older Hospitalized Patients Affected by Heart Failure and Chronic Obstructive Pulmonary Disease: An Italian Survey From the REPOSI Register

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    Beta (β)-blockers (BB) are useful in reducing morbidity and mortality in patients with heart failure (HF) and concomitant chronic obstructive pulmonary disease (COPD). Nevertheless, the use of BBs could induce bronchoconstriction due to β2-blockade. For this reason, both the ESC and GOLD guidelines strongly suggest the use of selective β1-BB in patients with HF and COPD. However, low adherence to guidelines was observed in multiple clinical settings. The aim of the study was to investigate the BBs use in older patients affected by HF and COPD, recorded in the REPOSI register. Of 942 patients affected by HF, 47.1% were treated with BBs. The use of BBs was significantly lower in patients with HF and COPD than in patients affected by HF alone, both at admission and at discharge (admission, 36.9% vs. 51.3%; discharge, 38.0% vs. 51.7%). In addition, no further BB users were found at discharge. The probability to being treated with a BB was significantly lower in patients with HF also affected by COPD (adj. OR, 95% CI: 0.50, 0.37-0.67), while the diagnosis of COPD was not associated with the choice of selective β1-BB (adj. OR, 95% CI: 1.33, 0.76-2.34). Despite clear recommendations by clinical guidelines, a significant underuse of BBs was also observed after hospital discharge. In COPD affected patients, physicians unreasonably reject BBs use, rather than choosing a β1-BB. The expected improvement of the BB prescriptions after hospitalization was not observed. A multidisciplinary approach among hospital physicians, general practitioners, and pharmacologists should be carried out for better drug management and adherence to guideline recommendations

    Advential cystic disease of the popliteal artery, experience of a single vascular and endovascular center.

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    Adventitial cystic disease (ACD) is an uncommon condition with only around 300 cases reported in the literature. ACD consists of a collection of gelatinous material within a cyst, that is adjacent or surrounding a vessel. In the last five years three cases of ACD have been observed: the first case was a 48-year-old man, ex nicotine abuser, with a four-month history of progressive claudication; the second case was a 55-year-old man, ex nicotine abuser, with ischemic heart failure and a one-year history of progressive claudication; the third case was a 70-year-old man, with diabetes, dislipidemia and current nicotine abuser with a few-day history of acute pain in the right leg. In two cases the cysts were incised and the contents evacuated. The adventitia was repaired and the wound closed. The first patient is currently asymptomatic after four years from surgery. The second one, at 21 months, follow-up, presented newly severe claudication. Duplex ultrasound scan and computed tomography angiography demonstrated a cranial progression of the lesions. This lesion was treated with bare stent, with complete regression of the symptoms. The third patient was treated with interposition of an autogenous saphenous vein. The patient is asymptomatic at the three-month follow-up. Even if ACD is quite rare, it should be taken in consideration in young patients with severe claudication and no- or poor comorbidities. The best treatment is the incision of the cysts and the advential reconstruction. Short lesions can be treated with endovascular therapy

    Renal aneurysms: surgical vs. endovascular treatment.

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    Renal artery aneurysms (RAA) are rare (general population incidence is 0.09%). At this time, the appropriateness of the type of intervention ‑ surgical or endovascular ‑ is based on single center experiences rather than large randomized trials. Endovascular therapy offers less morbidity but surgery has excellent long-term results. In reality, the choice of the treatment relies on the operative risk. A patient with a RAA and good surgical risk should be offered open surgery. If the patient is deemed to be at high risk from surgery then the choice of the type of endovascular treatment (stent grafting, coil/glue embolization, multilayer stenting) should be based on the location and shape of the RAA. RAA should be treated by surgeons/interventionalists who have demonstrated expertise in renal artery procedures

    Device selection for carotid stenting: reviewing the evidence

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    Introduction: Carotid artery stenting (CAS) has recently changed the status in the treatment of the extracranial carotid atheromasic disease. In recent years, evolution in both stents and protection devices as well as in carotid stenting techniques, has resulted in an important reduction in the rate of stroke in patients undergoing CAS procedures. Areas covered: The purpose of this article is reviewing the literature and summarizing the current evidence of the new available materials to underline the importance of the correct choice of the devices during the procedure. Expert commentary: Certainly a key issue in order to limit the periprocedural events to the lowest possible, is to select the appropriate device for the appropriate patient anatomy and clinical syndrome, the so called â\u80\u98tailored approachâ\u80\u99

    High Neutrophil-to-Lymphocyte and Platelet-to-Lymphocyte Ratios Are Associated with a Higher Risk of Hemodialysis Vascular Access Failure

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    Our aim was to determine the predictive role of the preoperative neutrophil-to-lymphocyte ratio (NLR) and platelet-to-lymphocyte ratio (PLR) in vascular access malfunctioning in patients who had undergone their first native arterio-venous fistula (AVF) for hemodialysis. Methods: This was a single-center retrospective observational study. All patients who underwent the procedure of the creation of a first native AVF for hemodialysis from January 2019 to December 2020 were considered eligible to be part of this study. Reinterventions for AVF malfunctioning were registered and the population was subdivided into two groups with respect to AVF malfunctioning. ROC curves were obtained to find the appropriate cut-off values for the NLR and PLR. A multivariate analysis was used to identify the independent predictors for an AVF malfunction. Kaplan–Meier curves were used to evaluate the AVF patency rates. A total of 178 patients were enrolled in the study, of them 70% (n = 121) were male. The mean age was 67.5 ± 12 years. Reinterventions for AVF malfunctioning were performed on 102 patients (57.3%). An NLR > 4.21 and a PLR > 208.8 was selected as the cut-off for AVF malfunctioning. The study population was divided into two groups depending on the NLR and PLR values of the individual. For the NLR < 4.21 group, the AVF patency rates were 90.7%, 85.3%, and 84% at the 3-, 6-, and 12-month follow-up, respectively, and 77.5%, 65.8%, and 39.3% at 3, 6, and 12 months for the NLR > 4.21 group, respectively (p < 0.0001). For the PLR < 208.8 group, the patency rates were 85.6%, 76.7%, and 67.7% at the 3-, 6-, and 12-month follow-up. For the PLR > 208.28 group, the patency rates were 80.8%, 71.2%, and 50.7% for the 3-, 6-, and 12-month follow-up, respectively (p = 0.014). The multivariate analysis highlighted that diabetes mellitus, the neutrophil count, the lymphocyte count, and the NLR were independent risk factors for an AVF failure. In our experience, the NLR and PLR are useful markers for the stratification of vascular access failure in hemodialysis patients. The inexpensive nature and ready availability of the values of these biomarkers are two points of strength for everyday clinical practice

    Safety and feasibility of intravascular optical coherence tomography using a nonocclusive technique to evaluate carotid plaques before and after stent deployment.

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    Abstract Purpose: To evaluate the safety and feasibility of optical coherence tomography (OCT) in patients with carotid stenosis undergoing carotid artery stenting (CAS). Methods: In a prospective study, 25 consecutive patients (15 men; mean age 74±4 years) undergoing protected CAS were enrolled and underwent high-definition (homoaxial resolution 10 µm) OCT image acquisition before stent deployment, immediately after stent placement, and following postdilation of the stent (3 scans/patient). Pullbacks were started during a nonocclusive flush, mechanically injecting 24 mL of 50% diluted contrast at 6 mL/s to displace blood from the artery. Two independent physicians judged the quality of images on a predefined 1-10 scale. The proportions of specific agreement and kappa values (κ) were calculated. Results: No procedural or in-hospital neurological complications occurred (any stroke/death 0%). The technical success of OCT pullbacks was 97.3% (73/75). The total amount of contrast was 86±18 mL/patient. No significant alteration in glomerular filtration rate or any other significant adverse event occurred. The images obtained were of high quality (mean value 8.1 out of 10), with good inter- and intraobserver agreement (κ = 0.81-0.87 and κ = 0.95, respectively). OCT images revealed innovative features such as rupture of the fibrous cap, plaque prolapse, and stent malapposition in a high percentage of the patients (range 24%-100%). Conclusion: Intravascular OCT during a nonocclusive flush appears to be feasible and safe in carotid arteries. Since some original and unexpected information after CAS has been made available for the first time at such a high definition, future studies with OCT should focus on the interaction between carotid plaque and stent design, which might revolutionize our understanding of the mechanisms of carotid stenting, as well as influence our clinical policies
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