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.

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.

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.

Outcomes of the Ankura Stent Graft for Endovascular Repair of Infrarenal Abdominal Aortic Aneurysm.

OBJECTIVE: The purpose of this retrospective cohort study is to report outcomes of endovascular aortic repair (EVAR) with the novel endograft, Ankura (Lifetech Scientific, Shenzen, China). METHODS: We identified all patients who underwent elective EVAR with Ankura stent graft in a tertiary unit from January 2015 to November 2021. Patients with ruptured infrarenal and juxtarenal aortic aneurysms were excluded from the study. All patients were anatomically suitable according to the instructions for use (IFU). Follow-up (FU) included computed tomography angiography (CTA) at 1 month, 12 months, and yearly thereafter if endoleak (EL) was not present. Primary outcomes included technical success (primary and secondary) and 30-day overall mortality and morbidity. Secondary outcomes included late overall and aneurysm-related mortality as well as influence of suprarenal fixation of the endograft on renal function at 12 months using eGFR (CKI-EPI formula). RESULTS: The Ankura endograft was successfully implanted in 116 patients (mean age=71.1 years, 96.5% male). Mean aneurysm diameter was 62.3 mm. Median FU was 34 months (2-72 months). Primary and secondary technical success were 95.7% and 100%, respectively. Overall type I EL was 5% (2 proximal, 3 distal) and type II EL was 13%. Thirty days mortality and morbidity were 0% and 5.2%, respectively. All-cause mortality during FU was 13.9% (n=16); aneurysm-related mortality was 2.6% (n=3). Limb endograft patency was 100%. Freedom from reintervention was 98.2% at 2 years, and 97.4% at 4 and 6 years respectively. There was a statistically significant difference between preoperative (73.69 mL/min/1.73 m2) and postoperative (66.66 mL/min/1.73 m2) eGFR at 12 months (p<0.001). CONCLUSION: Ankura endograft has demonstrated an efficacious durability with low aneurysm-related mortality and high iliac limb patency rate. Elective EVAR is associated with significant decline in renal function at 12 months in our study. Larger series studies are necessary to evaluate long-term safety and efficacy of Ankura endograft. CLINICAL IMPACT: Ankura stent graft is a novel PTFE endograft with suprarenal fixation for infrarenal aneurysm repair. This retrospective cohort study of 116 patients provide a first "picture" of Ankura safety and efficacy in a European tertiary vascular center. High technical success rate, low aneurysm related mortality and high limb patency rate are the main findings of the study with a negative impact of suprarenal fixation on kidney function during follow up.

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.

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.

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.

Medical student recognition of benign anorectal conditions: the effect of attending the outpatient colorectal clinic.

BACKGROUND: Benign anorectal conditions are fairly common. Physicians of various specialties usually see patients with these conditions before being referred to colorectal specialists, frequently with an incorrect diagnosis.We sought to evaluate the effect of attending an outpatient colorectal clinic by medical students on the diagnostic accuracy of these conditions. METHODS: Over a 1-year period, medical students were randomized into a group that attended the clinic, and one that did not. Both groups were shown images of six common benign anorectal conditions. The overall diagnostic accuracy as well as the diagnostic accuracy for each one of these conditions was prospectively evaluated for both groups. RESULTS: Nineteen students attended clinic and 17 did not. Overall diagnostic accuracy was 80.6% for students attending clinic and 43.1% for non-attending students. (p < 0.05) In the attending group, diagnostic accuracy was significantly greater for prolapsed internal hemorrhoids (73.6% versus 35.2%, p < 0.05), thrombosed external hemorrhoid, (73.6% versus 17.6%, p < 0.05) fissure (100% versus 47%, p < 0.05), and anal tags (68.4% versus 11.7%, p < 0.05%). CONCLUSION: Exposure to these conditions during surgical clerkships in medical school may help future specialists provide better care for patients with benign anorectal disorders.