Revascularization of occluded renal artery stent grafts after complex endovascular aortic repair and its impact on renal function.

BACKGROUND: Acute occlusion of renal bridging stent grafts after fenestrated/branched endovascular aortic repair (F/B-EVAR) is an acknowledged complication with high morbidity that often results in chronic dialysis dependence. The feasibility and effect of timely or late (≥6 hours of ischemia) renal artery revascularization has not been adequately reported. METHODS: We performed a retrospective, multicenter study across 11 tertiary institutions of all consecutive patients who had undergone revascularization of renal artery stent graft occlusions after complex EVAR. The end points were technical success, association between ischemia time and renal function salvage, interventional complications, mortality, and mid-term outcomes. RESULTS: From 2009 to 2019, 38 patients with 46 target vessels (TVs; eight bilateral occlusions) were treated for renal artery occlusions after complex EVAR (mean age, 63.5 ± 10 years; 63.2% male). Six patients had a solitary kidney (15.8%). Of the 38 patients, 16 (42.1%) had undergone FEVAR and 22 (57.9%) had undergone BEVAR. The technical success rate was 95.7% (44 of 46 TVs). The recanalization technique used was sole aspiration thrombectomy in 5.3%, aspiration thrombectomy and stent graft relining in 52.6%, and sole stent graft relining in 36.8%. The median renal ischemia time was 27.5 hours (range, 4-720 hours; interquartile range, 4-36 hours). Most patients (94.4%) had been treated after ≥6 hours of renal ischemia time, and 55.6% had been treated after 24 hours. In 14 patients (36.8%), renal function had improved after intervention (mean glomerular filtration rate improvement, 14.2 ± 9 mL/min/1.73 m2). However, 24 patients (63.2%) showed no improvement. Improvement of renal function did not correlate with the length of renal ischemia time. Of the 14 patients with bilateral renal artery occlusion or a solitary kidney, 9 experienced partial recovery of renal function and no longer required hemodialysis. In-hospital mortality was 2.6%. The cause of renal stent graft occlusion could not be identified in 50% of the TVs (23 of 46). However, in 19 (41.3%), significant stenosis or a kink of the renal stent graft was found. The median follow-up was 11 months (interquartile range, 0-28 months). The estimated 1-year patient survival and patency rate of the renal stent grafts was 97.4% and 83.8%, respectively. CONCLUSIONS: Revascularization of occluded renal bridging stent grafts after F/B-EVAR is a safe and feasible technique and can lead to significant improvement of renal function, even after long ischemia times (>24 hours) of the renal parenchyma or bilateral occlusion, as long as residual perfusion of the renal parenchyma has been preserved. Also, the long-term patency rates justify aggressive management of renal artery occlusion after F/B-EVAR.

Multicenter Experience With Large Diameter Balloon-Expandable Stent-Grafts for the Treatment of Infrarenal Penetrating Aortic Ulcers.

PURPOSE: To describe the use of large-diameter balloon-expandable stent-grafts (BeGraft aortic stent-graft, Bentley InnoMed GmbH, Hechingen, Germany) in the treatment of infrarenal penetrating aortic ulcer (iPAU). MATERIALS AND METHODS: Retrospective analysis of patients undergoing endovascular treatment with the BeGraft aortic stent-graft in 8 European centers from January 2017 to October 2020. Demographics, perioperative data, and midterm outcomes were collected. Endpoints of the study were technical feasibility, early mortality, and morbidity. RESULTS: A total of 40 patients were included. The mean age was 73.9±7.05 years and 63.2% were male. Indications for treatment included size and morphology (65%), presence of symptoms (29.5%), and contained ruptures (5.5%). Urgent treatment was performed in 5% of cases. Technical success was 97.5%. Median operation time was 58 minutes (19-170 minutes), with 27.5% of patients having additional procedures during the main intervention (1 additional repair with a C-TAG (W.L. Gore & Associates, Inc, Flagstaff, AZ, USA) thoracic endoprosthesis, 5 covered endovascular reconstruction of aortic bifurcation procedures, 3 extensions with proximal cuffs, and 2 percutaneous angioplasties of the common iliac arteries). Percutaneous femoral access was used in 72.5%, while groin cut-down was performed in 27.5%. Repair was successful with only 1 stent in 45% of cases, while 37.5% required 2 stents and nearly 17.5% required 3/4 stent-grafts. The 30-day mortality was 0%, with a 2.5% reintervention rate (1 patient required evacuation of an intra-abdominal hematoma). Median follow-up was 13.9 months (2-39 months), during which no vascular-related reinterventions or deaths were reported. In 4 patients, a type II endoleak was observed. No cases of graft migration, thrombosis, or stent-fracture were observed. CONCLUSIONS: The treatment of iPAU with the BeGraft aortic stent-graft in a selective patient group is feasible with low rate of perioperative morbidity and mortality. Balloon-expandable stent-grafts offer the option to repair iPAUs with a shorter coverage of the aorta using low-profile sheath, that enables treatment in the presence of calcified access vessels and small diameter aortic bifurcations.

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.

Prognostic risk factors for loss of patency after femoropopliteal bailout stenting with dual-component stent: results from the TIGRIS Italian Multicenter Registry.

PURPOSE: To identify the risk factors associated with patency loss after bailout stenting with third-generation hybrid heparin-bonded nitinol stent of the femoropopliteal segment. METHODS: Prospective, multicenter, single-arm registry including 156 patients (50 females, mean age 72 ± 11 years) subjected, from February 2017 to December 2018, to provisional stenting with Gore Tigris vascular stent of the distal superficial femoral artery, with or without involvement of the popliteal artery, in 9 different centers. The 194 lesions, with Rutherford score ≥ 3, were stented in case of recoil, dissection or residual stenosis not responding to percutaneous trans-luminal angioplasty (PTA). The follow-up (FU) was performed with clinical evaluation and duplex ultrasound (DUS) at 1, 6 and 12 months. RESULTS: The primary patency rate was 99(95%CI 98-100)% at 1 month, 86(80-92)% at 6 months and 81(74-88)% at-12 months. After patency loss, 13/23 (56.5%) patients were re-treated, yielding a primary assisted patency of 91(86-96)% at 6 months and 88(82-94)% at 12 months and a secondary patency of 94(90-98)% at 6 months and 90(84-95)% at 12 months. Rutherford score ≥ 4 (p = 0.03) and previous severe treatments (p = 0.01) were identified as risk factors for early patency loss during FU. The involvement of the popliteal artery was not an independent risk factor for loss of patency. CONCLUSIONS: The bailout stenting of the femoropopliteal segment with third-generation nitinol stents is a safe and effective option in case of recoil, dissection or residual stenosis not responding to PTA. Critical limb ischemia and history of previous major treatment at the same level are significant prognostic factors for patency loss during FU.

Long Term Outcomes of Endovascular Aortic Repair in Patients With Abdominal Aortic Aneurysm and Ectatic Common Iliac Arteries.

OBJECTIVE: The purpose of this study was to evaluate the long term results of endovascular aneurysm repair (EVAR) in patients with abdominal aortic aneurysm (AAA) and ectatic common iliac arteries (CIAs). METHODS: In a retrospective analysis of a prospectively collected database in two high volume centres, patients with AAAs undergoing elective standard EVAR were divided into two groups: those with both CIA diameters <18 mm, and those with at least one ectatic iliac artery (CIA ≥ 18 mm). Patients with an intentional external iliac artery landing zone were excluded. Primary outcomes were survival and freedom from re-intervention. Secondary end points were EVAR failure and iliac related endoleak and iliac re-intervention. RESULTS: From 2000 to 2015, 648 patients were included in the study, 277 (43%) had at least one CIA ≥ 18 mm. Pre-operative risk factors were similar between the two groups, with the exception of chronic renal insufficiency (p = .010) and cerebrovascular events (p = .040), which were higher in the ectatic CIA group. At 30 days from primary procedure, there was a higher rate of type Ib endoleak in patients with ectatic iliacs (p = .020). A statistically significant increase in the incidence of late type Ib endoleak in patients with ectatic iliac arteries was confirmed at a mean follow up of 74.8 months (p = .01). The need for iliac related re-intervention was higher in patients with CIAs ≥18 mm (odds ratio 1.94; 95% confidence interval 1.1-3.2). CONCLUSION: Ectatic iliac arteries are considered suitable landing zones for EVAR, although there is an increased risk of secondary interventions in time mainly due to late CIA dilation and secondary type Ib endoleak. Patients receiving EVAR with flared iliac limbs may benefit a more intensive surveillance to avoid late failures.

Radiation dose during endovascular aneurysm repair (EVAR): upgrade of an angiographic system from standard to Eco mode.

PURPOSE: To evaluate the radiation dose reduction during endovascular aneurysm repair (EVAR) after the reconfiguration of a Philips AlluraXper FD20 X-ray system. METHODS: Between 2013 and 2015, we implemented a low-dose protocol (Eco dose) increasing the filtration with 1 mm of Al and 0.1 of Cu on both fluoroscopy and fluorography and halving the frames per second in fluoroscopy. The switch was complemented by hybrid operating room staff education and training in radiation protection. We compared two samples of 50 patients treated before the switch (normal dose) with 50 patients treated after the switch (Eco dose). Procedures were categorized into two different grades of complexity, standard and complex, intended as fenestrated/chimney/snorkel and EVAR plus additional embolization to prevent endoleak type II. We evaluated patient demographics, Air Kerma (AK), dose area product (DAP), and procedural data (fluoroscopy time, number of fluorographies, and iodinated contrast). Staff radiation dose was measured with film badge dosimeter on C-arm. RESULTS: The Eco-dose protocol witnessed a DAP reduction of 53% in standard EVARs and of 57% in complex EVARs and an AK reduction of 45% in standard and 57% in complex EVAR. The image quality in 2016 was perceived acceptable, as proven by the fact that fluoroscopy time, number of fluorographies, and contrast medium volumes did not have to be increased. We achieved a reduction in staff dose of 25.6%. CONCLUSIONS: Optimized angiographic system setting significantly reduced the radiation dose both to the patients and to the staff assuring safe EVAR procedures.

Integrating Pharmacomechanical Treatments for Pulmonary Embolism Management within a Hub-and-Spoke System in the Swiss Ticino Region.

The Swiss Ticino regional pulmonary embolism response team (PERT) features direct access to various pharmacomechanical PE management options within a hub/spoke system, by integrating evidence, guidelines' recommendations and personal experiences. This system involves a collaborative management of patients among the hospitals distributed throughout the region, which refer selected intermediate-high or high PE patients to a second-level hub center, located in Lugano at Cardiocentro Ticino, belonging to the Ente Ospedaliero Cantonale (EOC). The hub provides 24/7 catheterization laboratory activation for catheter-based intervention (CBI), surgical embolectomy and/or a mechanical support system such as extracorporeal membrane oxygenation (ECMO). The hub hosts PE patients after percutaneous or surgical intervention in two intensive care units, one specialized in cardiovascular anesthesiology, to be preferred for patients without relevant comorbidities or with hemodynamic instability and one specialized in post-surgical care, to be preferred for PE patients after trauma or surgery or with relevant comorbidities, such as cancer. From April 2022 to December 2023, a total of 65 patients were referred to the hub for CBI, including ultrasound-assisted catheter-directed thrombolysis (USAT) or large-bore aspiration intervention. No patient received ECMO or underwent surgical embolectomy.

Endovascular repair of peripheral and visceral aneurysms with the Cardiatis multilayer flow modulator: one-year results from the Italian Multicenter Registry.

PURPOSE: To assess the efficacy of the Cardiatis multilayer flow modulator (CMFM), a bare cobalt alloy self-expanding stent, in the treatment of peripheral and visceral artery aneurysms. METHODS: In this multicenter (n=22), prospective, voluntary registry, 54 patients (47 men; mean age 68 years, range 19-87) who underwent CMFM deployment for peripheral (n=35) or visceral aneurysms (n=19) in a variety of target arteries were enrolled between June 2009 and June 2010. Among the 54 lesions, 44 had a total of 53 side branches. The main effectiveness endpoint was stent and side branch patency with no aneurysm rupture or reperfusion at 1, 6, and 12 months after stent implantation. Outcome measures were complete aneurysm thrombosis and sac shrinkage. The safety endpoint was freedom of complications (death, aneurysm rupture, endoleak, need for reintervention, stent foreshortening, stent occlusion, and access-site sequelae). Aneurysms were categorized as saccular (type I) or fusiform (type II) without a side branch or with branch(es) in the sac (subtype A), neck (subtype X), or both (subtype AX). Kaplan-Meier estimates were calculated for primary and secondary endpoints. Sac shrinkage was correlated to aneurysm morphology subtypes and presence/absence of mural thrombus. RESULTS: Technical success was achieved in all patients. Mortality at 1 year was 5.5% (n=3), including 1 perioperative death. Six patients were lost to follow-up. There was no aneurysm rupture. Six (11.1%) stents occluded over the 1-year period; 3 asymptomatic patients were not treated, 2 symptomatic patients had successful stent dilation to restore patency, and 1 symptomatic patient required bypass (the only side branch lost). Cumulative primary and secondary patency estimates were 86.9% and 90.7% at 1 year. The cumulative side branch patency was 96.1% and the freedom from all complications was 83.0% at 1 year. Complete aneurysm thrombosis was recorded in 42 (93.3%) of 45 patients at 1 year. Percent diameter reduction was 15.5%, 3.8%, and 11.0% at 1, 6, and 12 months (p<0.05), respectively. Presence of mural thrombus did not influence the time course of shrinkage (p>0.05), while complex lesion anatomy (presence of side branches) delayed shrinkage (p<0.05). CONCLUSION: Results at 1 year show that CMFM can be safely used in the treatment of PAA and VAA, with good results in terms of freedom from rupture, patency of the stents and side branches, complete aneurysm thrombosis, shrinkage, and acceptable freedom from morbidity and mortality.

Physician-modified fenestrated Navion endograft for the treatment of a symptomatic postdissection thoracoabdominal aneurysm.

We report the case of a physician-modified four-fenestration endograft for the emergent treatment of a 65-year-old patient with postdissection thoracoabdominal aneurysm deemed unfit for open surgery. The patient, after elective thoracic endovascular aneurysm repair as the first stage of a preplanned two-stage total thoracoabdominal endovascular repair, presented acute onset of dyspnea and thoracic pain. Computed tomography angiography (CTA) showed signs of contained rupture. The Valiant Navion thoracic endograft was used for the creation of a physician-modified four-fenestration stent graft. A diameter-reducing wire technique was used to constrain posteriorly the prosthetic graft and to allow intraprocedural partial deployment. The modified stent graft was finally folded into its original sheath and implanted; four balloon-expandable stent grafts were used as bridging components. Postoperative CTA showed a residual type IIIc endoleak that was treated with a relining procedure 4 months later. At the 20-month follow-up, the patient is alive and well and CTA shows complete seal of the thoracic aneurysm with persisting small type IIIc endoleak in the abdominal aneurysm. A physician-modified endograft can be considered a valuable option in case of urgent treatment of TAAA in patients deemed unfit for open surgery when off-the-shelf devices are not available or contraindicated.

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.

Emergency management of iatrogenic arterial injuries with a low-profile balloon-expandable stent-graft: Preliminary results.

Endovascular treatment of arterial injuries with stent-graft is a reliable alternative approach in patients not suitable for embolization or at high risk for surgery. The aim of our study was to evaluate the efficacy and the safety of the BeGraft stent-graft, a low-profile balloon expandable covered stent, for emergency endovascular treatment of iatrogenic arterial injuries.Between August 2015 and September 2018, 34 consecutive patients (mean age 71 ±â€Š12 years, 9 females) underwent implantation of BeGraft stent-grafts for iatrogenic arterial injuries (22 active bleedings, 11 pseudoaneurysms, and 1 enteric-iliac fistula). The primary endpoints were technical and clinical success and rates of major and minor complications. The secondary endpoint was the patency of the device during the follow-up. Imaging follow-up was performed by duplex ultrasound and/or computed tomography angiography (according to lesion site/target vessel), at 1-6-12-15 and 24 months.In all 34 patients (100%), the lesion or the defect was effectively excluded with a cumulative amount of 42 stent-grafts. The clinical success was documented in 30/34 patients (88.2%). Neither device- or procedure-related deaths, or major complications occurred. A minor complication was reported in 1 patient (2.9%), successfully treated during the same procedure. Thirty (88.2%) patients were available for a mean follow-up time of 390 ±â€Š168 days (minimum 184, maximum 770), with no observed loss of patency, yielding a 100% Kaplan-Meier cumulative survival patency function. The percentage of patent patients was 30/30 at 6 months, 22/22 at 12 months, and 5/5 at 15 months.Endovascular treatment of iatrogenic arterial injuries with the BeGraft stent-graft is minimally invasive and effective, with good patency rate at midterm follow-up.

Mid-Term Outcomes of Complex Endografting for Chronic Post-Dissection Thoracoabdominal Aortic Aneurysms.

PURPOSE: To report early and mid-term results of post-aortic dissection thoracoabdominal aneurysms (pD-TAAA) treated by complex endografting in three tertiary referral hospitals. MATERIALS AND METHODS: A review of all patients with pD-TAAA unfit for open surgery treated with complex endovascular repair from 2012 to 2018 was performed. Simple thoracic endografts (TEVAR) were excluded. Staged procedures in case of extensive aortic coverage were always planned. RESULTS: In total, 21 patients (16 males, mean age 63 ± 10 years) with pD-TAAA underwent aortic repair by fenestrated or branched thoracoabdominal endografts for visceral vessels. Mean TAAA diameter was 61 ± 6.2 mm. Spinal cord drainage was performed in all patients. A staged approach was used in 12 (57%) cases. Technical success was achieved in 18 (86%) patients. No in-hospital deaths occurred. Two patients experienced transient post-procedural spinal cord ischemia. At 30 days, six type II endoleaks (29%), two type Ic endoleak (9.5%) and one type IIIc endoleak (5%) were reported. At a mean follow-up of 23 ± 13 months, no late aortic-related deaths occurred. Three patients underwent reintervention for type Ic and IIIc endoleaks. No visceral vessel occlusion was observed. Estimated freedom from reintervention at 12 and 24 months was 85.7 ± 0.7%. In 13 cases, TAAA diameter decreased at least 5 mm, while increased > 5 mm in only one case. Complete false lumen thrombosis was achieved in 18 patients (86%). CONCLUSION: Complex endografting for pD-TAAA showed favorable mid-term results. Staged and carefully planned endovascular procedures may represent a safe and effective therapeutic option in patients deemed at high risk of open repair.

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.

Successful percutaneous transgluteal embolization of a complex arteriovenous malformation feeding a hypogastric artery aneurysm.

Pelvic arteriovenous malformation (AVM) is a rare condition mostly requiring a complex therapeutic strategy. The surgical approach is challenging and burdened by relatively high mortality and morbidity rates. No guidelines are available for the endovascular treatment of AVM because the literature is limited to small case series and case reports. We present a complex case of a pelvic AVM associated with an internal iliac artery aneurysm in a patient previously treated with a common to external prosthetic substitution for aneurysm and proximal ligation of internal iliac artery.

Incidence of New Ischaemic Brain Lesions After Carotid Artery Stenting with the Micromesh Roadsaver Carotid Artery Stent: A Prospective Single-Centre Study.

AIMS: Several randomized trials of patients with carotid stenosis show increased adverse neurological events with stenting versus endarterectomy in the 30-day post-procedure. This study examines the incidence of new ischaemic lesions in patients treated in our centre using the new Roadsaver stent. METHODS AND RESULTS: Between September 2015 and January 2016, 23 consecutive patients (age 74.3 ± 7.3 years, 17.4 % female) underwent carotid artery stenting with the Roadsaver stent, a nitinol double-layer micromesh device. A distal protection device was used in all cases. Diffusion-weighted magnetic resonance imaging was performed 24 h before, and 24 h and 30 days after the procedure. The 24-h post-procedure imaging showed 15 new ipsilateral ischaemic lesions in 7 (30.4 %) patients: median volume 0.076 cm3 (interquartile range 0.065-0.146 cm3). All lesions were asymptomatic. The 30-day imaging showed complete resolution of all lesions and no new ischaemic lesions. Follow-up clinical and ultrasound examinations at 30 days and 6 months recorded no adverse cardiac or cerebrovascular events. CONCLUSIONS: Protected stenting with micromesh Roadsaver stent showed good safety and efficacy in the treatment of carotid stenosis, with a low incidence of delayed embolic events and new ipsilateral ischaemic brain lesions. These preliminary results are encouraging, but need to be confirmed with larger populations.

Carotid artery stenting with a new-generation double-mesh stent in three high-volume Italian centres: clinical results of a multidisciplinary approach.

AIMS: Carotid artery stenting (CAS) is still associated with higher periprocedural cerebrovascular events (CEs) compared to vascular surgery. The Roadsaver carotid artery stent is a double layer micromesh stent which reduces plaque prolapse and embolisation by improving plaque coverage. Its clinical impact on neurological outcome was unknown. The aim of this study was therefore to report the clinical results of a large real-world population from three different centres receiving a Roadsaver stent to treat carotid artery disease. METHODS AND RESULTS: One hundred and fifty (150) patients (age 74±8 yrs, 75% male, symptomatic 29%) treated with CAS using the Roadsaver carotid stent in three high-volume Italian centres were included in the study. Intraprocedural optical coherence tomography (OCT) evaluation was performed in 26 patients, with an off-line analysis by a dedicated core laboratory. All patients underwent duplex ultrasound and neurological evaluation at 24 hours and at 30 days. CAS was technically successful in all cases (stent diameter: 8.6±0.8 mm, stent length: 25.0±4.5 mm). No in-hospital or 30-day CEs were observed. OCT evaluation detected a low rate of plaque prolapse (two patients, 7.7%). Duplex ultrasound showed stent and external carotid artery patency in all cases both before discharge and at 30-day follow-up. CONCLUSIONS: The Roadsaver stent is a safe and promising technology for CAS, with a low percentage of plaque prolapse and good short-term clinical outcome. Larger studies with longer follow-up are necessary to confirm this favourable clinical outcome.

Role of different techniques for the placement of Denver peritoneovenous shunt (PVS) in malignant ascites.

The aim of the study is to evaluate 3 different techniques of Denver peritoneovenous shunt (PVS) placement. Fifty-three patients with malignant ascites underwent placement of 55 Denver PVS by a surgical (33 cases) or percutaneous (18) or laparoscopically assisted (4) procedure. There were 2 cases of postoperative mortality due to cardiac failure, and 7 cases of shunt obstruction (2 of them required replacement). Twenty patients underwent subsequent palliative treatment with chemotherapy or surgery. Complication and control of ascites rates are similar for the 3 techniques. Placement of Denver PVS for the treatment of malignant ascites appears to be a safe and useful procedure. Surgical dissection of the jugular vein is not mandatory. The percutaneous technique is the easiest, fastest, and least invasive procedure. Laparoscopic-assisted positioning is recommended if a peritoneal biopsy and/or abdominal exploration is required for a definitive diagnosis.