Mechanical thrombectomy in acute limb ischemia: ad Interim results of the INDIAN UP Trial.

BACKGROUND: Penumbra/Indigo aspiration thrombectomy Systems (Penumbra Inc.) in patients with acute lower limb ischemia (ALLI) is becoming a fundamental alternative to surgical and intra-arterial thrombolysis. The INDIAN UP trial represents the second phase of the Italian national multicenter trial evaluating the safety and effectiveness of the device in the treatment of ALLI. METHODS: To assess vessel patency, the TIPI (Thrombo-aspiration In Peripheral Ischemia), is used. The TIPI flow in three different moments: at presentation, immediately after thromboaspiration, and after all adjuvant procedures. The primary outcome is the technical success of the thrombo-aspiration with the investigative system, defined as near complete or complete revascularization TIPI 2 - 3. Safety and clinical success rate were collected at one month follow-up. RESULTS: A total of 250 patients were enrolled. The mean age was 72.2±13.1 years and 72.1% were male. Rutherford grade on enrolment was I in 10.8%, IIa in 34.9%, and IIb in 54.4%. Primary technical success (TIPI 2-3 flow) was achieved in 90.8% of patients. Adjunctive procedures were needed in 158 cases. After all interventions, assisted primary technical success was 96.4%. No systemic bleeding complications or device related serious adverse events were reported. At one month follow up, survival rate was 97.2%, limb salvage was 97.6%. Primary patency was 89.6% and 13 (5.4%) reinterventions were registered. CONCLUSIONS: The updated results of the INDIAN UP trial have confirmed the high value of the mechanical thromboaspiration device Indigo Penumbra in the treatment of ALLI in a large variety of clinical and anatomical settings.

Expanded Polytetrafluoroethylene Membranes for Vascular Stent Coating: Manufacturing, Biomedical and Surgical Applications, Innovations and Case Reports.

Coated stents are defined as innovative stents surrounded by a thin polymer membrane based on polytetrafluoroethylene (PTFE)useful in the treatment of numerous vascular pathologies. Endovascular methodology involves the use of such devices to restore blood flow in small-, medium- and large-calibre arteries, both centrally and peripherally. These membranes cross the stent struts and act as a physical barrier to block the growth of intimal tissue in the lumen, preventing so-called intimal hyperplasia and late stent thrombosis. PTFE for vascular applications is known as expanded polytetrafluoroethylene (e-PTFE) and it can be rolled up to form a thin multilayer membrane expandable by 4 to 5 times its original diameter. This membrane plays an important role in initiating the restenotic process because wrapped graft stent could be used as the treatment option for trauma devices during emergency situations and to treat a number of pathological vascular disease. In this review, we will investigate the multidisciplinary techniques used for the production of e-PTFE membranes, the advantages and disadvantages of their use, the innovations and the results in biomedical and surgery field when used to cover graft stents.

How the First Year of the COVID-19 Pandemic Impacted Patients' Hospital Admission and Care in the Vascular Surgery Divisions of the Southern Regions of the Italian Peninsula.

Background: To investigate the effects of the COVID-19 lockdowns on the vasculopathic population. Methods: The Divisions of Vascular Surgery of the southern Italian peninsula joined this multicenter retrospective study. Each received a 13-point questionnaire investigating the hospitalization rate of vascular patients in the first 11 months of the COVID-19 pandemic and in the preceding 11 months. Results: 27 out of 29 Centers were enrolled. April-December 2020 (7092 patients) vs. 2019 (9161 patients): post-EVAR surveillance, hospitalization for Rutherford category 3 peripheral arterial disease, and asymptomatic carotid stenosis revascularization significantly decreased (1484 (16.2%) vs. 1014 (14.3%), p = 0.0009; 1401 (15.29%) vs. 959 (13.52%), p = 0.0006; and 1558 (17.01%) vs. 934 (13.17%), p < 0.0001, respectively), while admissions for revascularization or major amputations for chronic limb-threatening ischemia and urgent revascularization for symptomatic carotid stenosis significantly increased (1204 (16.98%) vs. 1245 (13.59%), p < 0.0001; 355 (5.01%) vs. 358 (3.91%), p = 0.0007; and 153 (2.16%) vs. 140 (1.53%), p = 0.0009, respectively). Conclusions: The suspension of elective procedures during the COVID-19 pandemic caused a significant reduction in post-EVAR surveillance, and in the hospitalization of asymptomatic carotid stenosis revascularization and Rutherford 3 peripheral arterial disease. Consequentially, we observed a significant increase in admissions for urgent revascularization for symptomatic carotid stenosis, as well as for revascularization or major amputations for chronic limb-threatening ischemia.

1-Year Results From a Prospective Experience on CAS Using the CGuard Stent System: The IRONGUARD 2 Study.

OBJECTIVES: The aim of this study was to evaluate the 1-year safety and efficacy of a dual-layered stent (DLS) for carotid artery stenting (CAS) in a multicenter registry. BACKGROUND: DLS have been proved to be safe and efficient during short-term follow-up. Recent data have raised the concern that the benefit of CAS performed with using a DLS may be hampered by a higher restenosis rate at 1 year. METHODS: From January 2017 to June 2019, a physician-initiated, prospective, multispecialty registry enrolled 733 consecutive patients undergoing CAS using the CGuard embolic prevention system at 20 centers. The primary endpoint was the occurrence of death and stroke at 1 year. Secondary endpoints were 1-year rates of transient ischemic attack, acute myocardial infarction, internal carotid artery (ICA) restenosis, in-stent thrombosis, and external carotid artery occlusion. RESULTS: At 1 year, follow-up was available in 726 patients (99.04%). Beyond 30 days postprocedure, 1 minor stroke (0.13%), four transient ischemic attacks (0.55%), 2 fatal acute myocardial infarctions (0.27%), and 6 noncardiac deaths (1.10%) occurred. On duplex ultrasound examination, ICA restenosis was found in 6 patients (0.82%): 2 total occlusions and 4 in-stent restenoses. No predictors of target ICA restenosis and/or occlusion could be detected, and dual-antiplatelet therapy duration (90 days vs 30 days) was not found to be related to major adverse cardiovascular event or restenosis occurrence. CONCLUSIONS: This real-world registry suggests that DLS use in clinical practice is safe and associated with minimal occurrence of adverse neurologic events up to 12-month follow-up.

Safety and Efficacy of Vacuum Assisted Thrombo-Aspiration in Patients with Acute Lower Limb Ischaemia: The INDIAN Trial.

OBJECTIVE: The aim was to evaluate the short term safety and effectiveness of the Penumbra/Indigo aspiration thrombectomy Systems (Penumbra Inc.) in patients with acute lower limb ischaemia. (ALLI). Recently, endovascular vacuum assisted thrombectomy devices, similar to those used in the management of acute ischaemic stroke, have become available for peripheral arteries, but data are still scarce. METHODS: To assess vessel patency, a modified Thrombolysis in Myocardial Infarction (TIMI) classification, called TIPI (Thrombo-aspiration In Peripheral Ischaemia), is proposed. The TIPI flow is assessed at presentation, immediately after treatment with the study device, and after all adjuvant procedures. The primary outcome is the technical success of the thrombo-aspiration with the investigative system, defined as near complete or complete revascularisation TIPI 2 - 3. Safety and clinical success rate were collected at one month. RESULTS: One hundred and fifty patients were enrolled. The mean age was 72.4 years and 73.3% were male. Rutherford grade on enrolment was I in 16%, IIa in 40.7%, and IIb in 43.3% with a mean ankle brachial index of 0.19. Primary technical success (TIPI 2 - 3 flow) was achieved in 88.7% of patients. Adjunctive procedures included angioplasty/stenting of chronic atherosclerotic lesions (n = 39), thrombolysis (n = 31), covered stenting (n = 15), and supplementary Fogarty embolectomy (n = 6). After all interventions, assisted primary technical success was 95.3% (TIPI 2 - 3 in 143/150). No systemic bleeding complications or device related serious adverse events were reported. At one month follow up, one death, and one below the knee amputation were recorded. Primary patency was 92% (138/150), and the re-intervention rate was 7.33%, resulting in an assisted primary and secondary patency of 94% and 99.33%, respectively. CONCLUSION: Results from the INDIAN registry reveal that mechanical thrombectomy using the Indigo system is safe and effective for revascularisation of ALLI as a primary therapy.

1-Month Results From a Prospective Experience on CAS Using CGuard Stent System: The IRONGUARD 2 Study.

OBJECTIVES: This study sought to evaluate 30-day safety and efficacy of dual-layer mesh-covered carotid stent systems for carotid artery stenting (CAS) in the clinical practice. BACKGROUND: When compared with carotid endarterectomy, CAS has been associated with a higher rate of post procedural neurologic events; these could be related to plaque's debris prolapsing through stent's mesh. Consequently, the need for increased plaque coverage has resulted in the development of dual-layer mesh-covered carotid stent systems. METHODS: From January 2017 to June 2019, a physician-initiated, prospective, multispecialty registry enrolled 733 consecutive patients undergoing CAS using the CGuard embolic prevention system in 20 centers. The primary endpoint was stroke up to 30 days; secondary endpoints were technical and procedural success; external carotid artery occlusion; and in-hospital and 30-day transient ischemic attack (TIA), acute myocardial infarction (AMI), and death rates. RESULTS: Symptoms were present in 131 (17.87%) patients. An embolic protection device was used in 731 (99.72%) patients. Procedural success was 100%, technical success was obtained in all but 1 (99.86%) patient, who died in hospital due to a hemorrhagic stroke. Six TIAs, 2 minor strokes, and 1 AMI occurred during in-hospital stay, and external carotid artery occlusion was evident in 8 (1.09%) patients. Between hospital discharge and 30-day follow-up, 2 TIAs, 1 minor stroke, and 3 AMIs occurred. Therefore, the cumulative stroke rate was 0.54%. CONCLUSIONS: This real-world registry suggests that use of CGuard embolic prevention system in clinical practice is safe and associated with a minimal occurrence of adverse neurological events up to 30-day follow-up.

Protein S-100B as biochemical marker of brain ischemic damage after treatment of carotid stenosis.

BACKGROUND: S-100 protein is a family of low molecular weight proteins found in vertebrates characterized by two calcium binding sites of the helix-loop-helix ("EF-hand type") conformation. There are at least 21 different types of S-100 proteins. The name is derived from the fact that the protein is 100% soluble in ammonium sulfate at neutral pH. Protein S-100B was investigated as a marker of brain ischemic damage after treatment of carotid stenoses. METHODS: Between December 1, 2009 and December 1, 2010, S-100B protein was monitored in 76 patients after carotid artery stenting (CAS) and in 24 patients after carotid endarterectomy (CEA). In each patient, multiple samples were taken: before the procedure (basal sample), immediately after CAS or CEA, 60 minutes after CAS or CEA, and daily during the hospital stay. Evaluation of S-100B was carried out by blind assessment. Patients underwent pre- and postoperative diffusion-weighted magnetic resonance imaging or computed tomographic scan. RESULTS: An S-100B coefficient of variation higher than the established cut-off was detected in 16 patients: three affected by postoperative stroke, two patients with minor stroke, and one patient with fatal stroke; 12 patients presented with uneventful neurological outcome and positive brain imaging; and there was one false positive case. No false negative cases occurred. The postoperative protein S-100B level lowered to basal level in 15 patients: within 24 hours in the 12 patients with the uneventful outcome (and positive brain imaging) and in the false positive case; and after 120 and 144 hours, respectively, in the two patients with minor stroke. In the patient with fatal stroke, protein S-100B never returned to the preoperative level. CONCLUSIONS: In patients with an increased S-100B coefficient of variation, the diffusion-weighted magnetic resonance imaging was positive for ischemic brain lesions, except for one patient who was reported as a false positive case. The postoperative S-100B protein level decreased within 24 hours in the uneventful neurological cases and in the false positive case, whereas long-lasting postoperative increased values of the S-100B protein were observed in patients with poor neurological outcomes.

Contrast-enhanced US in the assessment of the ilio-caval axis in deep venous thrombosis.

PURPOSE: To assess the feasibility and the accuracy of a new technique in the evaluation of deep venous thrombosis (DVT) in the ilio-caval axis. MATERIALS AND METHODS: Thirty-eight patients with suspected DVT were prospectively examined with unenhanced and enhanced colour-Doppler ultrasonography, and ascending contrast venography. Thirty-five out of 38 patients underwent US phlebography, consisting in manual injection of Levovist (Schering Ag, Berlin, Germany) through a 21-G cannula in a suitable dorsal vein of the foot ipsilateral to the suspected DVT. Three patients in whom it was not possible to cannulate a dorsal vein of foot underwent contrast-enhanced US after injection of Levovist through an antecubital vein, but where excluded from the present study. A contrast venogram was nonetheless carried out in all out three patients for comparison with the US-phlebography findings. RESULTS: US-phlebography allowed better definition of the presence and extension of deep vein thrombosis in all patients, when compared to conventional color-Doppler US. In the evaluation of suspected acute thrombosis, the comparative efficacy of Doppler-US and US phlebography compared with ascending phlebography as the gold standard, was as follows: sensitivity of 85.7% and 90%, specificity of 71.4 and 100%, accuracy of 80.9 and 95.2%, PPV of 85.7, and 100%, and NPV of 71.4, and 75%, respectively. In the assessment of chronic thrombosis, US and US phlebography achieved a sensitivity of 90% and 100%, a specificity of 75% and 100%, an accuracy of 85.7% and 100%, a PPV of 100, 100%, a NPV of 87.5, 100%, respectively. No complications related to US phlebography were observed. CONCLUSIONS: US-phlebography is a promising tool in the assessment of deep vein thrombosis, being highly accurate and feasible. However, further studies based on larger series are mandatory to confirm our promising results and establish a standardised role for this new technique.