One-Year Outcomes of CGuard Double Mesh Stent in Carotid Artery Disease: A Systematic Review and Meta-Analysis.

Background: Prospective single and multicenter studies have shown improved outcomes of patients who underwent carotid artery stenting with the novel CGuard dual-layer mesh stent at 1 year. Objectives: The aim of this study is to conduct a systematic review and meta-analysis of all published studies to assess 1-year efficacy and outcomes of CGuard in patients with carotid stenting. Methods: A systematic search was performed. All studies enrolling at least 20 patients were included in our analysis. The primary endpoints were death (all-cause, cardiovascular and ipsilateral stroke-related death) and stroke rate at 1 year. The secondary endpoint was in-stent restenosis at 1 year. Results: The final analysis included 1709 patients. The one-year all-cause mortality rate was 2.97% (39/1699, 95% CI: 1.26-6.86%, I2 = 67%, t2 = 0.3442, p < 0.01), cardiovascular-related death was 0.92% (10/1616, 95% CI: 0.35-2.39%, I2 = 34%, t2 = 0.2302, p = 0.18), and ipsilateral stroke-related death was 0.3% (1/1649, 95% CI: 0.1-0.87%, I2 = 0%, t2 = 0, p = 0.69). The one-year ipsilateral stroke rate was 1.21% (16/1649, 95% CI: 0.58-2.5%, I2 = 28%, t2 = 0.1433, p = 0.23), transient ischemic attacks (TIAs) rate was 1.78% (19/1149, 95% CI: 1.11-2.84%, I2 = 0%, t2 = 0, p = 0.69), and total composite 1-year stroke/TIA rate was 2.97% (32/1149, 95% CI: 1.84-4.77%, I2 = 0%, t2 = 0, p = 0.41). The in-stent restenosis rate at 1 year was 1.06% (13/1653, 95% CI: 0.48-2.34%, I2 = 28%, t2 = 0.2308, p = 0.22). Conclusions: This meta-analysis shows that CAS with CGuard is safe with minimal neurological adverse events and in-stent restenosis rate at 1 year.

Endograft Anaconda in Endovascular Aneurysm Repair: A Systematic Review of Literature and Meta-Analysis.

BACKGOUND: The number of endovascular abdominal aortic aneurysm repairs (EVARs) has surpassed the number of open surgical repair of AAAs worldwide with a great variety of endografts being available. The aim of this study is to conduct a systematic review of the literature and meta-analysis of studies reporting patients with infrarenal abdominal aortic aneurysm (AAA) subjected to EVAR with the Anaconda endograft. METHODS: We performed a systematic review of multiple electronic databases for studies including patients with infrarenal AAA who were subjected to elective EVAR with Anaconda endograft exclusively. We conducted a proportional meta-analysis cumulating the results of the included studies. The endpoints were first month overall mortality, first and second-year survival after EVAR, AAA-related deaths, incidence of endoleaks, endograft migration, endograft occlusion, open conversion, and primary and secondary technical success. The mean value for each separate studied factor was calculated, and the respective percentage or incidence was extracted so that it can be compared to endograft outcome studies in the literature. We assessed the methodologic quality of studies by using the Briggs Institute critical appraisal tool. RESULTS: Seven observational studies were found including 954 patients (males 91.9%, mean age 73.38 ± 6.97 years). The mean transverse diameter of AAAs was 56.83 ± 9.97 mm. The mean proximal aortic neck diameter and length were 23.06 ± 3.33 mm and 24.14 ± 12.16 mm, respectively. Increased aortic neck calcification and aortic neck thrombus were present in 12.5% of patients. The 30-day overall mortality post-EVAR was 1.3%, 1 and 2-year survival rates were 95.9% and 91.4%, respectively. The mean follow-up period in the studies was 46.59 ± 15.5 months. AAA-related mortality was 1.3%. Primary technical success was 97.9% and secondary success was 99.3%. Open conversion was required in 3.4% of all patients (0.6% during the primary operation [Prim. Op]). The most common endoleak was type II, reported in 17.4% of all patients. Early type Ia endoleak was reported in 1.5% of patients and late type Ia in 1.7%. Overall, 2 endoleaks type III and 1 type IV were reported. Endograft migration occurred in 1.7% of patients. Main body and/or one/both iliac legs thrombotic occlusion was found totally in 7.6% of patients (5 main body occlusions and 64 iliac leg occlusions). CONCLUSIONS: The use of Anaconda endograft in electively treated patients with infrarenal AAAs presented good results with high technical success and low postoperative and mid-term complications, except for an increased incidence of stent-graft thrombosis, which seems to be the "Achilles heel" of the device.

Long-Term Effects of Acute Kidney Injury Following Endovascular Femoropopliteal Intervention: Insights From a Multicenter Trial.

PURPOSE: To examine the association between acute kidney injury (AKI) severity and duration with cardiovascular mortality, following endovascular treatment of femoropopliteal disease, and whether it is AKI in itself that confers an increased risk of cardiovascular mortality. METHODS: A retrospective analysis of prospectively collected data obtained between 2014 and 2019 from 3 vascular centers. Renal function was followed up for a minimum of 90 days. Electronic records were queried to establish a cause of death, where applicable. Patients were excluded if unable to provide written informed consent or if presenting with acute limb ischemia. Primary outcomes were the hazard ratios for cardiovascular death (AKI patients vs no AKI; no AKI vs stage 1 AKI vs stage 3 AKI; and no AKI vs transient AKI vs established AKI). Propensity score-matched analysis was used to establish whether developing AKI, in patients with similar demographics and procedural characteristics, is associated with a higher risk of cardiovascular death. RESULTS: Overall 239 patients developed AKI, and this was associated with an increased risk of cardiovascular mortality (hazard risk [HR]: 4.3, 95% confidence intervals [CIs]: 2.1-6.8, pairwise comparison p value=0.006]. This was dependent on the severity of the AKI stage (HR 5.4, 95% CI: 2.4-7.3, pairwise comparison p value=0.01) and duration (HR 4.2, 95% CI: 2.3-6.2, pairwise comparison p value=0.04). The propensity score-matched analysis showed that even when patients are matched for comorbidity and procedural characteristics, AKI confers an increased risk of mortality (p=0.04). CONCLUSIONS: Acute kidney injury is common after femoropopliteal endovascular therapy. It confers an increased risk of long-term cardiovascular mortality, which is still present when renal decline is transient, and highest for patients with established decline in renal function. CLINICAL IMPACT: This is the first study in the setting of peripheral arterial disease to show that acute kidney injury has an adverse effect on cardiovascular mortality, in the long-term, that is dependent on its severity, and present even when the AKI is transient. We have also shown that this difference in cardiovascular mortality becomes more pronounced from the medium-term, and thus closer follow-up of these patients is required.

Obstructive Jaundice Caused by a Large Intact Abdominal Aortic Aneurysm. Case Report and Literature Review.

BACKGROUND: Obstructive jaundice caused by abdominal aortic aneurysm (AAA) is an extremely rare clinical presentation. We present an 85-year-old male with a large intact AAA causing obstructive jaundice and review the relevant literature. METHODS AND RESULTS: The patient was referred to our hospital with jaundice and a palpable pulsatile abdominal mass. Computerized tomography (CT) angiogram and magnetic resonance cholangiopancreatography (MRCP) revealed an infrarenal AAA with maximal diameter of 8.5 cm compressing the pancreatic head and common bile duct, causing obstructive jaundice with elevated levels of total, and direct bilirubin. The patient was subjected to endovascular aneurysm repair (EVAR). Blood bilirubin gradually decreased to normal levels. No complications were reported during the immediate postoperative and at 3-month follow up period. Literature review suggests that our case is one of the largest intact AAAs which have been reported to cause biliary obstruction. CONCLUSIONS: AAAs causing secondary obstructive jaundice is an uncommon clinical presentation requiring high clinical suspicion during differential diagnosis, so that patients can receive proper and early diagnosis and treatment.

Polymer Free Amphilimus Drug Eluting Stent for Infrapopliteal Arterial Disease in Patients with Critical Limb Ischemia: A New Device in the Armamentarium.

Background and Objectives: Endovascular technologies have significantly improved the outcome of patients with critical limb ischemia (CLI). Drug eluting stents (DES) have documented their efficacy against percutaneous transluminal angioplasty (PTA) and bare metal stents (BMS) in infrapopliteal arterial occlusive disease. However, late in-stent neoatherosclerosis may lead to vascular lumen loss and eventually thrombosis. Polymer free DES constitute a new technology aiming to improve long term patency which their action is still under investigation. The purpose of this study is to report the mechanism of action and to provide a literature review of a novel polymer free amphilimus eluting stent (Cre8, Alvimedica, Instabul, Turkey) in infrapopliteal arterial disease. Methods: Publications listed in electronic databases, European Union Drug Regulating Authorities Clinical Trials Database, as well as scientific programmes of recent interventional vascular conferences were searched. Three studies were included. We analyzed primary and secondary patency, major amputation rate, freedom from CD-TLR, and mortality. Results: Cre8 was implanted in 79 patients with CLI. Most of the patients (n = 65) were Rutherford class 5-6 (82.3%), and diabetes mellitus (DM) was present in 66 patients (83.5%). Mean primary patency was 82.5% at 12 months. Mean lesion stented length was 20 mm and 35 mm in two studies. Mean limb salvage was 91.3% at 12 months. Freedom from CD-TLR was reported in two out of the three studies and was 96% and 83.8%. Mortality was 15% and 23.8% in the same studies, whilst it was not reported in one study. Conclusion: Stenting of infrapopliteal arteries with Cre8 is safe and feasible in patients with CLI and diabetes. All studies have shown very good primary patency and freedom from CD-TLR at 12 and 24 months. Larger observational prospective studies and randomized trials are necessary to establish long term effectiveness and clinical outcomes using the non-polymer Cre8 DES.

Thirty-Day Results of the Novel CGuard-Covered Stent in Patients Undergoing Carotid Artery Stenting.

OBJECTIVE: The aim of this study was to provide early-term evaluation, safety, and efficacy of the novel CGuard (Inspire MD, Tel Aviv, Israel) micromesh self-expanding stent with embolic protection system (EPS) during carotid artery stenting (CAS) procedure. MATERIALS AND METHODS: All patients who underwent CAS with CGuard carotid stent system from January 2018 to September 2020 in a tertiary center were prospectively evaluated. Primary endpoints included technical success and perioperative neurological events (0-48 hours). Secondary endpoint was the rate of neurologic, cardiac events, and death (major adverse event or MAE) at 30 days. Patency of CGuard, peak systolic velocity (PSV), and end diastolic velocity (EDV) were evaluated at 30 days with duplex ultrasound. RESULTS: A total of 103 patients underwent CAS procedure. Forty patients were symptomatic, and 63 patients were asymptomatic with stenosis greater than 70%. Technical success was 100%. Local anesthesia was applied in 94 patients (93%). Embolic protection devices were used in 6 patients (5.8%). Access site complications were 1.9%. Mean internal carotid artery stenosis diameter reduced from 79.47% to 14.68%. Two patients had transient ischemic attack (1.9%) and 1 patient experienced a cerebral hyperperfusion syndrome (CHS) perioperatively. External carotid artery (ECA) occlusion occurred in 1.9%. Four patients experienced jaw claudication (3.8%) postoperatively. Mean time of operation was 41 minutes. Mean duration of hospitalization was 3.1 days. The 30-day rate of MAE was 0%. CGuard patency was 100%, mean internal carotid PSV was reduced from 251.57 to 77.29 cm/s, and mean internal carotid EDV was reduced from 154.62 to 24.63 cm/s at 30 days. CONCLUSION: Our study shows that CGuard stent with EPS is an effective and safe device for treatment of carotid artery stenosis with acceptable low perioperative neurologic events, even with low embolic protection device usage. Larger multicenter and randomized studies are necessary to confirm its long-term efficacy.

Position Paper on Young Vascular Surgeons Training of the Mediterranean Federation for the Advancing of Vascular Surgery (MeFAVS): State of the Art and Perspectives.

The Mediterranean Federation for the Advancing of Vascular Surgery (MeFAVS) was founded in 2018, with the aim to promote cooperation among vascular professionals within Mediterranean countries. Due to its prominent social and economic impact on national health systems, diabetic peripheral artery was selected as the very first topic to be investigated by the federation. In this second paper, different experiences from delegates of participating countries were shared to define common strategies to harmonize, standardize, and optimize education and training in the Vascular Surgery specialty.

Outcomes of Endovascular Aneurysm Repair Using the Anaconda Stent-Graft.

Purpose: To report outcomes of elective endovascular aneurysm repair (EVAR) using the Anaconda stent-graft in a tertiary vascular center. Materials and Methods: A retrospective study was conducted of 271 patients (mean age 71.5 years; 260 men) who underwent elective EVAR for abdominal aortic aneurysm using the Anaconda stent-graft from January 2006 to January 2017. Median aneurysm diameter was 58 mm (range 50-90). All patients were anatomically suitable for EVAR according to the 2003 version of the instructions for use. Follow-up included computed tomography angiography at 1, 6, and 12 months and yearly thereafter for the first 4 years and then every 2 years. Primary outcomes included technical success and 30-day aneurysm-related mortality and complications; secondary outcomes were overall and aneurysm-related mortality and aneurysm-related morbidity in follow-up. Results: The Anaconda stent-graft was implanted successfully in all patients. Primary and secondary technical success rates were 99.6% and 100%, respectively. Three patients (1.1%) died within 30 days of causes unrelated to the aneurysm, while 15 patients (5.5%) suffered perioperative complications. Median follow-up was 72 months (range 14-141). The overall type I endoleak rate was 4.7% (11 proximal, 2 distal). Late aneurysm-related complications were observed in 48 patients (17.3%); aneurysm-related mortality was 1.4% (n=4). Non-aneurysm-related mortality was 21.0% (n=57). Freedom from reintervention was 95.2% at 1 year, 98% at 2 years, and 90% at 6 years. There was no significant difference in the overall limb graft occlusion rate between the second- and third-generation devices. Conclusion: Results in our cohort study demonstrate that the Anaconda stent-graft has satisfactory early and late results with low aneurysm-related mortality.

Endovascular Stent-graft Repair of Combined Renal Artery Aneurysm and Arteriovenous Fistula.

Renal artery aneurysm with concomitant presence of arteriovenous fistula is an extremely rare entity. Few reports have been described in the literature. Nowadays, endovascular repair with covered stents or transarterial embolization with coils or glue has become the first line of treatment. We present the successful repair of a distal renal artery aneurysm combined with arteriovenous fistula with stent graft.

Endovascular Repair of Blunt Thoracic Aortic Trauma: Is Postimplant Hypertension an Incidental Finding?

BACKGROUND: Blunt thoracic aortic injury (BTAI) is the second most common cause of death in trauma patients. Nowadays, thoracic endovascular aortic repair (TEVAR) has become the treatment of choice because of lower rates of mortality, paraplegia, and stroke. However, concerns have been raised whether graft implantation is related to the development of hypertension in the postoperative period. The aim of this study was to report short- and long-term outcomes of patients undergoing TEVAR for BTAIs at a tertiary hospital and to investigate postimplant hypertension. METHODS: Between January 2005 and January 2016, 23 patients with blunt thoracic aortic trauma underwent TEVAR. Median age was 44 years (range, 18-73). Among them, 14 (60.9%) patients were diagnosed with aortic rupture, whereas 9 (39.1%) with pseudoaneurysm. Α single thoracic stent graft was deployed in 21 patients, and the rest 2 patients received 2 stent grafts. RESULTS: Complete exclusion of the injury was feasible in all subjects (100% primary success). The left subclavian artery (SCA) was intentionally covered in 6 patients (26%). Intraoperative complications included one nonfatal stroke managed conservatively and one external iliac artery rupture treated with iliofemoral bypass. One patient (4.3%) died on the first postoperative day in the intensive care unit (ICU) because of hemorrhagic shock. The overall 30-day mortality and morbidity were 4.3% and 8.7%, respectively. New-onset postimplantation arterial hypertension was observed in 8 (34.8%) previously nonhypertensive patients. Younger age (P = 0.027) and SCA coverage (P = 0.01) were identified as potential risk factors for the development of postimplant hypertension, whereas the presence of concomitant injuries (P = 0.3) and intraoperative complications (P = 0.1) were not. After a median follow-up of 100 months (range, 18-120), 6 of them still remain on antihypertensive therapy, whereas the other 2 did not require permanent treatment. CONCLUSIONS: TEVAR is a safe approach in the treatment of BTAI associated with low short- and long-term morbidity and mortality rates. Lower age and SCA coverage may contribute to the development of postimplant hypertension. Further larger cohort studies are warranted to elucidate the underlying mechanisms of postimplant hypertension.

Active proximal sealing in the endovascular repair of abdominal aortic aneurysms: early results with a new stent-graft.

PURPOSE: To investigate the performance of a new device that uses the STRATA polytetrafluoroethylene graft material and a mechanism that provides active proximal sealing in order to prevent type Ia endoleak during endovascular aneurysm repair (EVAR). METHODS: Between April 2013 and July 2014, 21 consecutive patients (all men; median age 71 years, range 60-84 years) with abdominal aortic aneurysm (median diameter 5.9 cm, range 4.9-7.8 cm) and suitable anatomy were offered elective EVAR using the AFX endograft. These patients had an irregular, conical, tapered, or bulging proximal neck, for which this specific device was considered appropriate. Aneurysm exclusion and incidence of type Ia endoleak were the primary outcomes; secondary outcomes included mortality, morbidity, migration, and other graft-related complications. RESULTS: Primary technical success was 90%; 2 intraoperative type Ia endoleaks due to low endograft deployment were treated with additional proximal cuffs. During a median follow-up of 10 months (range 2-15 months), no type I endoleak was observed. One type II endoleak was encountered, with no associated sac enlargement. There was no stent-graft migration or any other device-related complication. One patient had a nonfatal myocardial infarction and another developed renal failure requiring transient dialysis. No deaths occurred. CONCLUSION: In this early experience, this newly available device appears to be safe and efficient in providing seal along irregularly shaped necks over the short term.

Predictors affecting in-hospital mortality of ruptured abdominal aortic aneurysms: a Greek multicenter study.

BACKGROUND: Endovascular aortic repair (EVAR) is being used with increasing frequency for the treatment of ruptured abdominal aortic aneurysms (rAAAs), although conflicting results have been reported concerning perioperative mortality. The aim of our study was to evaluate potential difference in mortality rates between EVAR and open surgical repair (OSR) and identify independent risk factors for in-hospital mortality in rAAAs. This study also aimed to evaluate the Glasgow Aneurysm Score (GAS) in predicting in-hospital mortality. A time-trend analysis of EVAR for ruptured AAAs was also performed. METHODS: Prospectively collected data from 7 public hospitals in Greece concerning rAAA repairs between January 2006 and April 2012 were analyzed. Primary outcome was in-hospital mortality. Multivariate logistic regression analysis was used to identify independent risk factors. The receiver-operator characteristic curve was used to determine the value of the GAS in predicting in-hospital death. Time-trend analysis, depicting annual changes (%), concerning EVAR for ruptured AAAs was also conducted. RESULTS: A total of 418 patients (92.3% men, mean age = 74.3 ± 8.8) with rAAAs were recorded during the study period. Among them, 113 patients (27%) underwent EVAR. Overall in-hospital mortality was 45.2%, whereas in-hospital mortality after EVAR and OSR was 20.4% and 54.3%, respectively (P < 0.001). Multivariate analysis evidenced that hemodynamic instability (P < 0.001), OSR (P < 0.001), age ≥80 years (P < 0.001), coronary artery disease (P < 0.001), and renal insufficiency (P = 0.02) independently increased in-hospital mortality. Area under the curve of GAS was 0.80 (95% confidence interval [CI] = 0.75-0.85, P < 0.001) for OSR and 0.64 (95% CI = 0.51-0.77, P = 0.04) for EVAR. Annual increase of proportion (%) of EVAR for rupture was 5% (P = 0.004). CONCLUSIONS: EVAR is being used with increasing frequency for the treatment of rAAAs and it appears to be associated with lower in-hospital mortality compared with OSR, after adjustment for hemodynamic instability and known atherosclerotic risk factors. Preoperative predictors of in-hospital mortality such as GAS should be probably modified in these patients.

Study Protocol of a Prospective, Monocentric, Single-Arm Study Investigating the Correlation of Endograft Properties with Aortic Stiffness in Abdominal Aortic Aneurysm Patients Subjected to Endovascular Aortic Repair.

The number of endovascular aortic repairs (EVARs) has surpassed the number of open surgical repairs of abdominal aortic aneurysms (AAAs) worldwide. The available commercial endoprostheses are composed of materials that are stiffer than the native aortic wall. As a consequence, the implantation of stent-graft endoprostheses during EVAR increases aortic rigidity and thus aortic stiffness, resulting in a decrease in abdominal aorta compliance. EVAR has been found to have a possibly harmful effect not only on heart functions but also on other vascular beds, including kidney function, due to the decrease in aortic compliance that it causes. Aortic stiffness is measured by various hemodynamic indices like the pulse wave velocity (PWV), the central aortic pressure (CAP), and the augmentation index (AIx). In the literature, there are increasing numbers of studies investigating the properties of endografts, which are strongly related to increases in aortic stiffness. However, there is a lack of data on whether there is a correlation between the length of various endografts implanted during EVAR and the increase in the PWV, CAP, and AIx postoperatively compared to the preoperative values. The aim of this prospective, observational, monocentric, single-arm study is to investigate the correlation between endograft length and the postoperative increase in the PWV, CAP, and AIx in patients subjected to EVAR. Additionally, this study intends to identify other endograft properties related to increases in the PWV, CAP, and AIx. Other endpoints to be studied are the existence of immediate postoperative myocardial and kidney injury after EVAR. The prediction of cardiovascular events caused by endograft-related increased aortic stiffness could contribute to the improvement of various endograft properties so that the impact of endografts on the native aortic wall can be minimized.

Impaired renal function is associated with mortality and morbidity after endovascular abdominal aortic aneurysm repair.

BACKGROUND: Renal function may be associated with poor outcome following endovascular abdominal aortic aneurysm repair (EVAR), but this relationship has not been adequately investigated. The aim of this study is to evaluate the association of estimated glomerular filtration rate (eGFR) with cardiovascular events and all-cause mortality after EVAR. METHODS: Prospective cohort study of patients undergoing elective EVAR; eGFR was calculated using the Chronic Kidney Disease Epidemiology Collaboration formula, and patients were divided in four groups (eGFR ≥ 90 mL/min/1.73 m(2), group 1; 60-89, group 2; 30-59, group 3; <30, group 4). Composite end point consisted of death, nonfatal myocardial infarction, stroke, and vascular complications. Kaplan-Meier curves were constructed, and between-group comparisons were performed adjusted for variables that differed at baseline. RESULTS: A total of 383 patients (mean age, 69 ± 8 years; mean abdominal aortic aneurysm diameter, 6.2 ± 1.4 cm) were included. Over a mean follow-up of 34 ± 12 months, the following events occurred: 20 deaths (5.2%), 15 nonfatal myocardial infarctions (3.9%), 9 nonfatal strokes (2.3%), and 7 peripheral vascular complications (1.8%). Patients with an eGFR <30 had the highest mortality (35%) and incidence of complications (80%) as per the end point (P = .009 and P < .001, respectively). Adjusted Cox-regression analysis showed that a higher eGFR at baseline by 1 mL/min/1.73 m(2) was associated with a 5% lower likelihood of complications as per the end point (P < .001; hazard ratio, 0.95; 95% confidence interval, 0.94-0.97) and a 6% lower likelihood of death (P < .001; hazard ratio, 0.94; 95% confidence interval, 0.92-0.97). CONCLUSIONS: Impaired renal function is associated with an increase in cardiovascular events and mortality following elective EVAR.

The effectiveness of intralesional injection of platelet-rich plasma in accelerating the healing of chronic ulcers: an experimental and clinical study.

The purpose of this prospective experimental and clinical study is to evaluate the effectiveness of the intralesional injection of platelet-rich plasma (PRP), in the management of non-healing chronic wounds. Skin defects were created in the ears of 20 white New Zealand rabbits. In the study group, autologous PRP was injected intralesionally. The control group was treated conservatively. Nineteen out of 20 cases of the study group healed within a mean time of 24·9 days. In the control group, seven defects healed within a mean period of 26·7 days, seven ulcers did not heal at day 28 and in six cases a full thickness ear defect was recorded. For a 3-year period, 26 patients with chronic ulcers underwent surgical debridement and intralesional injection of PRP. A histological study was performed before and 7 days after PRP injection. Ten patients healed within a mean period of 7 weeks. In 16 cases, PRP prepared the wound bed for the final and simpler reconstructive procedure. Intralesional injection is a newly described method for application of PRP and represents an effective therapeutic option when dealing with non-healing wounds.

12-Month Outcomes of Carotid Artery Stenting With CGuard MicroNET-Covered Stent: A Single-Center Study in 113 Patients.

Dual layer mesh stents constitute a novel treatment option for patients who undergo carotid artery stenting (CAS). The aim of this prospective study is to report 12 month outcomes of patients who underwent CAS with CGuard (Inspire MD, Tel Aviv, Israel) microNET self-expanding stent with embolic protection system in a tertiary center from October 2018 to March 2022. Primary endpoints included in-stent restenosis >70% verified by ultrasound (DUS), ipsilateral transient ischemic attack (TIA), and stroke at 12 months. Secondary endpoints included cardiovascular-related mortality (stroke, myocardial infarction, heart failure) and all-cause mortality during follow-up. One hundred thirteen patients were included in the study (male 72.5%), symptomatic 47.8%. Median follow-up was 25 months (2-48). By 12 months, there was one in-stent occlusion that manifested as stroke (1/113, 0.8%) but no other forms of in-stent restenosis. Two patients experienced contralateral TIA (1.7%). CVRM was 3.5% (4 MI) and all-cause mortality was 6% at follow-up. This prospective study shows that CAS with CGuard MicroNET-covered stent is safe with minimal neurological adverse events at 12 months follow-up. Larger, and longer-term studies are necessary to define CGuard long-term safety and protection against carotid-related stroke.

The effectiveness and safety of direct oral anticoagulants compared to conventional pharmacologic thromboprophylaxis in hip fracture patients: A systematic review and meta-analysis of randomized controlled trials.

BACKGROUND: Direct oral anticoagulants (DOACs) are recommended as a possible pharmacologic venous thromboembolism (VTE) prophylaxis in patients undergoing total hip arthroplasty (THA) and total knee arthroplasty (TKA). However, current guidelines did not introduce recommendations for administration of DOACs as an option for pharmacologic VTE prophylaxis in patients undergoing hip fracture surgery (HFS). The purpose of this study is to compare the effectiveness and safety of DOACs administered for pharmacologic VTE prophylaxis in patients undergoing HFS to conventional pharmacologic VTE prophylaxis, as well as mortality between these thromboprophylaxis medications. METHODS: We performed a systematic review of multiple electronic databases for randomized controlled trials (RCTs) including patients who were subjected to HFS and prescribed either DOACs as pharmacologic VTE prophylaxis or a conventional VTE prophylaxis drug. We conducted a meta-analysis comparing effectiveness, safety and mortality of these agents between the patient groups studied. Three endpoints were studied. The first one regarding the effectiveness of the agents included clinical manifestations of VTE. The second one regarding the safety of the agents included clinical presentation of bleeding. The latter endpoint studied was mortality of patient groups studied. We generated forest plots to depict the relative risk of the above clinical manifestations between the two studied patient groups and to investigate if there is statistical significance for each patient group to present any of these clinical manifestations. Additionally, we calculated the inconsistency (I2) statistic and assessed the risk of bias of RCTs included in our meta-analysis by using the modified Cochrane collaboration tool. RESULTS: We selected 2 RCTs in this review including 279 patients totally. Patients of control groups in both eligible studies were administered enoxaparin, which is a low molecular weight heparin (LMWH). The meta-analysis found no statistically significant difference between patients prescribed DOACs and patients prescribed LMWH for VTE (95% CI 0.19 to 1.13, RR=0.46, p=0.09), deep vein thrombosis (DVT) (95% CI 0.21 to 1.32, RR=0.53, p=0.17) and pulmonary embolism (PE) (95% CI 0.03 to 3.12, RR=0.33, p=0.33), major bleeding events (95% CI 0.57 to 1.78, RR=1.01, p=0.97), minor bleeding events (95% CI 0.72 to 1.64, RR=1.09, p=0.69), all bleeding events (95% CI 0.79 to 1.38, RR=1.05, p=0.74) and mortality (95% CI 0.01 to 8.0, RR=0.33, p=0.5). The major risk of bias of the selected RCTs was the fact that either the researchers or the patients could have knowledge whether the latter were administered DOACs or LMWHs. DISCUSSION: DOACs are not inferior compared to LMWHs regarding their effectiveness, safety and mortality in patients subjected to HFS. Further studies with larger patient samples should be conducted in the future, so that safer results and conclusions could be reached.

Helical EndoStaples enhance endograft fixation in an experimental model using human cadaveric aortas.

OBJECTIVE: This study evaluated the contribution of Aptus EndoStaples (Aptus Endosystems, Sunnyvale, Calif) in the proximal fixation of eight endografts used in the endovascular repair of abdominal aortic aneurysms (EVAR). METHODS: Nine human cadaveric aortas were exposed, left in situ, and transected to serve as fixation zones. The Zenith (Cook, Bloomington, Ind), Anaconda (Vascutek, Inchinnan, Scotland, UK), Endurant (Medtronic, Minneapolis, Minn), Excluder (W. L. Gore and Associates, Flagstaff, Ariz), Aptus (Aptus Endosystems), Aorfix (Lombard Medical, Didcot, UK), Talent (Medtronic), and AneuRx (Medtronic) stent grafts were proximally deployed and caudal displacement force (DF) was applied via a force gauge, recording the DF required to dislocate each device ≥20 mm from the infrarenal neck. Measurements were repeated after four and six EndoStaples were applied at the proximal fixation zone, as well as after a Dacron graft was sutured at the proximal neck in standard fashion. Finally, a silicone tube was used as a control fixation zone to test the DF of grafts with EndoStaples in a material that exceeded the integrity of a typical human cadaveric aorta and provided a consistent substrate to examine the differential effect of variable degrees of EndoStaple implantation using zero, two, four, and six EndoStaples. RESULTS: In the cadaveric model, the mean DF required to dislocate the endografts without the application of EndoStaples was 19.73 ± 12.52 N; this increased to 49.72 ± 12.53 N (P < .0001) when four EndoStaples where applied and to 79.77 ± 28.04 N when six EndoStaples were applied (P = .003). The DF necessary to separate the conventionally hand-sutured Dacron graft from the aorta was 56 N. In the silicone tube model, the Aptus endograft without EndoStaples withstood 3.2 N of DF. The DF increased to 39 ± 3 N when two EndoStaples were added, to 71 ± 6 N when four were added, and to 98 ± 5 N when six were added. In eight of the 13 cadaver experiments conducted with four and six EndoStaples, the displacement occurred as a result of complete aortic transection proximal to the fixation site, indicating that aortic tissue integrity was the limiting factor in these experiments. CONCLUSIONS: The fixation of eight different endografts was increased by a mean of 30 N with four Aptus EndoStaples and by a mean of 57 N with six EndoStaples in this model. Endostaples can increase endograft fixation to levels equivalent or superior to that of a hand-sewn anastomosis. The application of six EndoStaples results in aortic tissue failure above the fixation zone, demonstrating fixation strength that exceeds inherent aortic integrity in these cadavers.

Suprarenal graft fixation in endovascular abdominal aortic aneurysm repair is associated with a decrease in renal function.

INTRODUCTION: Suprarenal endograft fixation is routinely used in the endovascular repair of abdominal aortic aneurysms (EVAR) to enhance proximal endograft attachment but can be associated with an adverse outcome in renal function. This prospective study assessed the effect of suprarenal fixation on serum creatinine concentration and estimated glomerular filtration rate (eGFR), calculated by the Modified Diet in Renal Disease equation, 12 months after elective EVAR. METHODS: Patients undergoing elective EVAR were divided into suprarenal vs infrarenal fixation groups matched for age, sex, smoking, and aneurysm diameter. Serum creatinine and eGFR were measured at baseline, 6, and 12 months. RESULTS: Included were 92 patients (two women) with a mean age of 71 ± 7 years, with 46 in each group. No device-related complications were noted. Serum creatinine did not differ significantly between groups at 6 (P = .24) or 12 (P = .08) months but significantly increased in the suprarenal group at 12 months (1.08 ± 0.36 to 1.16 ± 0.36 mg/dL; P < .001) vs baseline. The eGFR (mL/min/1.73 m(2)) did not differ significantly at baseline between the suprarenal (85 ± 27) and infrarenal (80 ± 28; P = .33) groups or at 6 months (88 ± 29 vs 77 ± 24, respectively; P = .07). At 12 months, the suprarenal group had a lower eGFR (73 ± 23) than the infrarenal group (84 ± 26; P = .027). The eGFR at 12 months showed a significant decrease in the suprarenal (80 ± 28 to 73 ± 23; P < .001) but not in the infrarenal group (85 ± 27 to 84 ± 26; P = .48). The drop in eGFR differed significantly at 12 months in the infrarenal vs the suprarenal (0.82 vs -6.94; P < .001) group. No patient progressed to end-stage renal disease or disclosed a drop in eGFR > 30%. CONCLUSIONS: In contrast to previous studies, this study suggests that suprarenal endograft fixation in elective EVAR is associated with a drop in eGFR at 12 months.

One-year outcomes following primary stenting of infrapopliteal steno-occlusive arterial disease using a non-polymer sirolimus-eluting stent: Results from a prospective single-centre cohort study.

Background: Clinical outcomes using new generation drug-eluting stents designed specifically for infrapopliteal disease are not widely available, especially in comparison to paclitaxel-based therapies. This series reports 1-year outcomes in patients with diabetes and chronic limb threatening ischaemia (CLTI) undergoing angioplasty, with a sirolimus-eluting tibial stent (Cre8, Alvimedica, Turkey), evaluating the feasibility, safety, and efficacy of this new device. Outcomes were compared to matched patients undergoing infrapopliteal angioplasty using a paclitaxel-coated balloon (DCB). Patients and Methods: Patients with diabetes and CLTI requiring infrapopliteal intervention were recruited prospectively to undergo angioplasty and primary stenting using the Cre8 sirolimus-eluting stent between January 2018 and October 2020 at a single high-volume vascular centre; outcomes were compared to a group of patients with diabetes and CLTI who had undergone infrapopliteal angioplasty using a DCB. All patients were followed up for at least 12 months using a uniform protocol with duplex ultrasound and examination. The primary outcome measure was target lesion patency (<50% restenosis). Clinically driven target lesion revascularisation (CD-TLR), amputations, Rutherford stage, and mortality were also recorded. Results: A total of 54 patients (61 target lesions; median age: 69 years, 74% male) were included [27 with the Cre8 device (main group) vs. 27 with a DCB (historical controls)]. Primary patency at 12 months was 81% in the Cre8 group vs. 71% in the control group (p = 0.498). Overall, four (15%) patients in the Cre8 group vs. three (11%) patients in the control group underwent a major amputation within 12 months (p = 1.0). CD-TLR (all endovascular) did not differ between groups at 12 months (4% Cre8 vs. 10% control group, p = 0.599). Rutherford stage improvement at 12 months was superior for the Cre8 group (52% vs. 15% improved by at least one stage, p = 0.039). One-year mortality was 15% in the Cre8 group vs. 22% in the control group, p = 0.726. Conclusions: Primary stenting with the Cre8 stent is feasible and safe in diabetic patients and CLTI. When compared to patients undergoing angioplasty with a DCB, there were no significant differences regarding primary patency, CD-TLR, major amputations, and mortality at 12 months. Those treated with a Cre8 stent were more likely to have an improvement in their Rutherford stage.