Carotid Endarterectomy After Intracranial Endovascular Thrombectomy for Acute Ischaemic Stroke in Patients with Carotid Artery Stenosis.

OBJECTIVE: Recent randomised controlled trials demonstrated the benefit of intracranial endovascular thrombectomy (EVT) in acute ischaemic stroke. There is no consensus, however, on how to treat concomitant extracranial carotid artery stenosis after EVT. The aim of this study was to evaluate the outcome in patients treated with carotid endarterectomy (CEA) after EVT, comparing complication rates among patients undergoing CEA for stroke without previous EVT. METHODS: This was a registry study of all patients (n = 3 780) treated with CEA after stroke in Sweden and the capital Helsinki region, Finland, from January 2011 to September 2020. Sixty three patients (1.7%; 0.5% 2011, 4.3% 2019) underwent EVT prior to CEA. The primary outcome was 30 day stroke and death rate. RESULTS: The EVT+CEA group had major stroke as the qualifying neurological event (QNE) in 79%, but just 5.9% had this in the CEA only group (p < .001). Intravenous thrombolysis was administered before EVT in 54% of patients in the EVT+CEA group, but in just 12% in those receiving CEA only (p < .001). The combined stroke and death rate at 30 days for EVT+CEA was 0.0% (95% confidence interval [CI] 0.0 - 5.7). One patient had a post-operative TIA, none had post-operative intracerebral or surgical site haemorrhage. CEA was performed within a median of seven days (interquartile range 4, 15) after QNE, and 75% had CEA ≤14 days from QNE. The main reason to postpone CEA was an infarct larger than one third of the middle cerebral artery territory. The stroke and death rate in patients treated with CEA only was 3.7% (95% CI 3.2 - 4.4), CEA was performed a median of eight days after QNE, and in 79.7% in ≤14 days. The three year survival after EVT+CEA was 93% (95% CI 85 - 100), compared with 87% (95% CI 86 - 88) after CEA only. Cox regression analysis adjusting for age showed no increased all cause mortality after EVT+CEA (HR 1.3, 95% CI 0.6 - 2.7, p = .52). CONCLUSION: These results indicate that CEA is safe to perform after previous successful EVT for acute ischaemic stroke. Results were comparable with those undergoing CEA only, despite the EVT+CEA patients having more severe stroke symptoms prior to surgery, and timing was similar.

Five Year Results of Off the Shelf Fenestrated Endografts for Elective and Emergency Repair of Juxtarenal Abdominal Aortic Aneurysm.

OBJECTIVE: Fenestrated endovascular aneurysm repair (FEVAR) is a well established treatment for complex abdominal aortic aneurysms (AAAs). FEVAR with custom made devices (CMDs) has limitations in both the emergency and elective settings due to time consuming manufacture. "Off the shelf" (OTS) fenestrated stent grafts are a potential solution. The primary goal was to evaluate the five year outcome of the COOK Zenith p-Branch OTS device at a single centre. METHODS: Patients with juxtarenal AAA meeting the inclusion criteria for the COOK Zenith p-Branch device were enrolled in a prospective, non-randomised, non-comparative trial from July 2012 to September 2015. Demographic, anatomical, procedure related, and five year follow up data were collected, analysed, and adjudicated by a core laboratory. The primary aims were to assess intervention free survival and overall survival at five years. RESULTS: Twenty-three patients were treated and 21 completed follow up. Mean time to p-Branch implantation after patient presentation was 28 hours (range 0-122 hours) in emergency cases and 67 days (range 20-112 days) in elective cases. Median procedure time was 283 minutes (range 161-475 minutes) and technical success was 91%. Mean follow up was 45 months (standard deviation ± 24.4 months). The most common adverse events were renal injuries. Primary target vessel patency was 96.4% and 94.0% after one and five years respectively. Mean time to first re-intervention was 469 days (range 0-1 567 days). Survival during the follow up period was 76%, with no aneurysm related deaths. CONCLUSION: FEVAR with the COOK Zenith p-Branch device is safe and effective for juxtarenal AAA in a selected patient population, in both elective and emergency settings. Long term outcomes are acceptable although inferior to CMDs. Mid and long term outcomes emphasise the p-Branch as a possible endovascular treatment for juxtarenal aortic pathology where CMD is not an option. Further innovation to address target vessel complications is needed, as these seem more prevalent than after repair with CMDs.

Mid-term Outcomes of Endovascular Repair of Ruptured Thoraco-abdominal Aortic Aneurysms with Off the Shelf Branched Stent Grafts.

OBJECTIVE: To assess the mid-term outcomes and feasibility of branched endovascular repair (b-EVAR) of ruptured thoracoabdominal aortic aneurysms (rTAAAs). METHODS: All patients undergoing b-EVAR of rTAAAs between 2011 and 2016 were included. Pre-, intra and postoperative imaging was reviewed to assess technical success, outcomes, and feasibility of b-EVAR in the emergent setting. RESULTS: Eleven emergency b-EVAR of rTAAAs (10 aneurysms and 1 chronic dissection) were performed using off-the-shelf (OTS) branched stentgrafts. Only 18% of patients complied to the anatomical instruction-for-use of the OTS device; a small aortic lumen and occluded target vessels were the main violations. Median operative time was 430 (IQR 395-629) minutes. Technical failure was 36% including one intraoperative death, one target vessel catheterization failure, one type Ia and one type III endoleak. Thirty-day mortality was 27%. Only early re-intervention was for the type Ia endoleak. Spinal cord ischemia occurred in 4 patients (30%), of which 2 recovered completely. Median clinical follow-up were 15 (IQR 7-39) months respectively. The median clinical follow-up index (FUI) was 0.65 (0.32-0.95). Overall survival was 75 ± 21.7% at 18 months. Four branch occlusions occurred; one renal stent occlusion led to permanent hemodialysis. Branch patency was 87.5 ± 8.3% and 72.2 ± 12% at 1 and 2 years, respectively. One stentgraft migrated but no late major endoleak occurred. CONCLUSION: Emergency b-EVAR of rTAAA with OTS device is feasible despite a low anatomical suitability. With proper adjunctive procedures, it can be offered to most hemodynamically stable patients. These time-consuming complex procedures are not suitable for unstable patients. Often the procedure is done as life-saving in the emergency setting and reinterventions may be needed later. Consequently, the success rates are lower than in the elective setting. These results need to be confirmed by larger studies and longer follow-up.

80-kVp CT angiography for endovascular aneurysm repair follow-up with halved contrast medium dose and preserved diagnostic quality.

BACKGROUND: Follow-up of endovascular aneurysm repair (EVAR) with life-long computed tomography angiography (CTA) surveillance exposes patients with impaired renal function to repeated risks of contrast medium-induced nephropathy (CIN). PURPOSE: To retrospectively compare vascular attenuation, image noise, contrast-to-noise ratio (CNR), subjective image quality and effective radiation dose (mSv) for CTA with a 16-multirow detector CT (MDCT) equipment at 80 kVp after EVAR using a contrast medium (CM) dose that is half of that used at 120 kVp. MATERIAL AND METHODS: Forty patients with estimated glomerular filtration rate (eGFR) <45 mL/min underwent 80-kVp CTA with 160 mg I/kg, and 40 patients with eGFR ≥45 mL/min 120-kVp CTA with 320 mg I/kg (maximum dose weight, 80 kg). Arterial phase analysis included vascular attenuation, image noise and CNR, and calculated effective dose. Subjective image quality was assessed on a 4-point scale by two blinded readers at three different levels as well as overall. RESULTS: Median values in the 80/120 kVp cohorts were: age, 74-75 years; body weight, 77/80 kg; BMI 24/27 kg/m(2); CM dose, 13/25 gram-iodine; gram-iodine/GFR ratio, 0.35/0.38; mean aortic attenuation, 313/326 HU; image noise, 26/32 HU; CNR 10-11; subjective image quality score, 3.0-3.5 (Reader 1) and 3.0-3.3 (Reader 2); number of non-diagnostic examinations, 0/1; and effective dose, 4.5/5.1 mSv. There was no statistically significant difference in aortic CNR and effective dose between the 80 and 120 kVp cohorts. CONCLUSION: 80 kVp 16-MDCT with halved CM dose tailored to body weight for CTA follow-up of EVAR may provide satisfactory diagnostic results compared to common standards and be beneficial for patients at risk of CIN, though the present CT equipment may limit the use of the method to patients below 90 kg or with a BMI below 35 kg/m(2).

Suitability of the Zenith p-Branch Standard Fenestrated Endovascular Graft for Treatment of Ruptured Abdominal Aortic Aneurysms.

PURPOSE: To evaluate the anatomic suitability of the Zenith pivot branch (p-branch) fenestrated device in ruptured abdominal aortic aneurysms (rAAA). METHODS: Contrast-enhanced computed tomography (CT) images of 206 patients (mean age 75±8 years; 175 men) with rAAA were evaluated in a dedicated 3-dimensional vascular workstation. All aneurysms found unsuitable for standard infrarenal repair were evaluated for Zenith p-branch suitability according to the Investigational Device Exemption protocol for both device configurations (A, pivot fenestrations at the same level; B, right renal fenestration located more cranially). RESULTS: The suitability of the p-branch (A or B configuration) for short neck aneurysms (<15 mm; n=89) was 49%; of the 26 different combinations of exclusion criteria, a mismatch between a renal artery takeoff and the positioning of the corresponding fenestration was the most common. For juxta- and pararenal aneurysms (neck length <10 mm; n=66), suitability was 48%. Suitability assessed by target vessel positioning only (excluding all other limiting factors) was 58% for short neck aneurysms (n=52) and 55% for juxta- and pararenal aneurysms (n=36). CONCLUSION: Approximately half of patients with short neck rAAAs would be suitable for the Zenith p-branch fenestrated device according to the instructions for use. In almost 60%, the pivot fenestrations can accommodate the corresponding target vessels. More studies are needed to confirm these findings.

Impact of renal chimney grafts on anatomical suitability for endovascular repair in ruptured abdominal aortic aneurysm.

PURPOSE: To evaluate the impact of renal chimney grafts on anatomical suitability for endovascular aneurysm repair (EVAR) in ruptured abdominal aortic aneurysm (rAAA). METHODS: Contrast-enhanced computed tomography images of 206 patients with rAAA [175 men (mean age 75 ± 7.8 years) and 31 women (mean age of 76 ± 7.5 years)] were evaluated in a dedicated 3-dimensional vascular workstation. Assessment of infrarenal EVAR suitability was based on predefined anatomical variables reflecting the Instructions for Use of commercially available stent-grafts. In patients where aneurysm neck length was the only limiting factor for suitability, reevaluation of the proximal sealing zone was done, accounting for chimney grafts in one or both renal arteries. RESULTS: Seventy (34%) rAAA patients were anatomically suitable for EVAR: 65 (37%) of 175 men and 5 (16%) of 31 women (p < 0.01). Eighty-nine (65%) of the 136 unsuitable patients had aneurysm necks < 15 mm long; short neck was the only exclusion criterion in 33 (24%) cases. In the 33 short-necked aneurysms without other limiting factors, a proximal sealing zone > 15 mm could potentially be achieved with one or two renal chimney grafts in 12 (36%) and 25 (76%) patients, respectively, increasing overall suitability to 40% and 46%. If access issues could also be solved and a similar strategy with chimneys for the renal arteries was applied, the EVAR suitability would increase further to 58%. CONCLUSION: Roughly one third of patients with rAAA are anatomically suitable for EVAR; short aneurysm neck is the most common exclusion criteria. In appropriate cases, chimney grafts in one or both renal arteries may increase overall suitability by 12%. Suitability increases to ~ 60% when iliac access issues are additionally overcome.

Management of the treatment delay in symptomatic carotid artery stenosis.

Saving time to intervention is crucial in patients with symptomatic carotid artery stenosis (SCAS). We introduced a fast-track protocol (FTP). Time frames from the onset of symptoms to intervention before and after the introduction of an FTP were analyzed. SCAS patients (403 patients/405 procedures) were evaluated according to whether surgery was performed before (group 1) or after (group 2) the introduction of the FTP. Time frames to surgery, causes of delay and frequency of recurrent events are reported. The median time delay decreased from 17 to 12 days (p<0.001), but time to ultrasound examination remained unchanged. Surgery was within 2 weeks in 41% in group 1 and in 57% in group 2 (p=0.001). Of 181 (30%) patients treated according to the FTP, 54 were operated within 7 days (median), and 80% had the intervention within 2 weeks. Time to surgery decreased significantly after the introduction of the FTP.

Short- and midterm results of the fascia suture technique for closure of femoral artery access sites after endovascular aneurysm repair.

PURPOSE: To evaluate the midterm outcomes and potential risk factors associated with the fascia suture technique (FST) for closure of femoral artery access sites after percutaneous endovascular aneurysm repair (EVAR). METHODS: Between April 2007 and April 2008, 100 consecutive EVAR cases were evaluated retrospectively. A third of the procedures were emergent (16 ruptured aneurysms). Of the 187 femoral access sites, 160 (85.5%) were closed by the FST as a first choice. Pre- and postoperative chart and imaging data were collected from computerized medical records for analysis of demographics and the rate of complications (bleeding, infection, thrombosis, pseudoaneurysms, and stenosis). Preoperative risk factors for FST failure were analyzed with regard to obesity (based on the subcutaneous fat layer), plaque at the femoral access site, and stenosis based on the pre- and 1-year postoperative computed tomography scans. RESULTS: Of the 160 FST closures, 146 (91.3%) were technically successful. The 14 (8.8%) technical failures were converted to open cutdown intraoperatively because of bleeding (11, 6.8%), inadequate limb perfusion (2, 1.2%), and a broken guidewire (1, 0.6%). Two (1.2%) pseudoaneurysms required surgical repair after 2 weeks. Data from the 1-year follow-up showed no signs of increased stenosis, thrombosis, or formation of plaque. Nine small (<1 cm(3)) pseudoaneurysms were detected and managed conservatively. No preoperative risk factors were associated with FST failure. CONCLUSION: The fascia suture technique seems to be safe, effective, and simple to use for closing percutaneous access sites after EVAR. Complications are rare, and the outcome is not affected by obesity, femoral calcification, or femoral artery stenosis.

Fenestrated endovascular repair for juxtarenal aortic pathology.

OBJECTIVE: To evaluate the outcomes after fenestrated endovascular aortic repair (f-EVAR) in a tertiary European referral center. METHODS: All patients treated with commercially available custom-made f-EVAR between September 2002 and June 2007 were prospectively enrolled in a computerized database including co-morbidities and aneurysm morphology. Patients were retrospectively analyzed. Follow-up consisted of clinical examinations and computed tomography (CT) scanning. RESULTS: A total of 54 patients were included in this study. Median age was 72 (interquartile range [IQR] 68-76) years and 85% were men. Median preoperative aneurysm diameter was 60 (53-66) mm. One hundred thirty-four vessels were targeted (43 scallops, 91 fenestrations) and 96 stents were placed (69 bare, 27 covered). Target vessel catheterization was achieved in 98% of cases. Two patients (3.7%) died within 30 days, 1 from trash embolization and multiorgan failure and 1 from retroperitoneal bleeding caused by a renal artery perforation. Three type I endoleaks occurred intraoperatively, two sealed pre-discharge and one was treated with a Palmaz stent (Cordis, Miami Lakes, Fla) on postoperative day 4. Thirteen patients had type II endoleaks, and 2 required treatment. The median clinical follow-up was 25 (12-32) months with median CT follow-up of 22 (4-26) months. Aneurysm diameter decreased >or=5 mm in 47%, was unchanged in 50%, and increased >or=5 mm in 3% of patients at 1 year. There were three type II endoleaks at 1-year follow-up, one of which was successfully treated after 19 months due to aneurysm growth. Ninety-six percent of target vessels remained patent during the study period and all occlusions occurred within the first year of follow-up. Five target vessels occluded (2 renal arteries [RAs] and 3 superior mesenteric arteries [SMAs]) without symptoms during follow-up and successful reinterventions were done on 2 stenosed RAs. Three patients suffered creatinine increase but none needed dialysis. One late aneurysm-related death occurred due to massive bleeding during redo surgery for infection. CONCLUSION: Despite complex anatomy or severe comorbidities in these patients f-EVAR has acceptable short- and midterm results in this series which includes a learning curve and offers a valid treatment alternative to patients unsuitable for standard EVAR or open repair.

Staged proximal deployment of the Zenith TX2 thoracic stent-graft: a novel technique to improve conformance to the aortic arch.

PURPOSE: To present a modification of the Zenith TX2 thoracic stent-graft that allows staged proximal deployment to improve apposition to the aortic wall. TECHNIQUE: Three standard Zenith TX2 thoracic stent-grafts and 3 modified versions were deployed in a glass model of the aortic arch. Deployment sequences were analyzed. In a patient with a 6-cm thoracic aortic aneurysm after a type B dissection, the modified Zenith TX2 thoracic stent-graft was deployed successfully and without complications; the proximal part of the stent-graft protruded less into the arch, significantly improving wall apposition. CONCLUSION: Staged proximal deployment with a modified Zenith TX2 thoracic stent-graft can improve orientation and wall apposition of the first Z stent. A better proximal apposition may prevent early and late stent-graft complications.

Topical haemostatics in renal trauma--an evaluation of four different substances in an experimental setting.

BACKGROUND: Damage control is valuable in hemodynamically unstable trauma patients. To improve the hemostasis of packing, topical hemostatic agents have been suggested. The effects of such agents are unclear in trauma situations. The purpose of this study was to investigate the hemostatic capacity, and the stability of the hemostatic clot, of four substances with different mode of action in an experimental traumatic bleeding model. METHODS: A standardized heminefrectomy was performed in 180 heparinized and normotensive Sprauge-Dawley rats. Four different substances were studied (separately and in combinations) in a randomized fashion: gelatin (sponge and matrix), bovine thrombin, freeze-dried recombinant factor VIIa (rFVIIa), and microporous polysaccharide hemospheres. Eight treatment groups (15 animals/group) were considered, primary endpoint was hemostasis within 20 minutes of observation. The effective treatment groups were evaluated in a second set in the same experimental model, but with a prolonged observation time after hemostasis (60 minutes) to control the stability of the clot. RESULTS: Those animals treated with gelatin in the comparative study, with and without thrombin or rFVIIa, obtained hemostasis. Thrombin and rFVIIa alone did not have any hemostatic capacity. Only 20% to 25% of the animals obtained hemostasis with microporous polysaccharide hemospheres alone or in combination with rFVIIa. In the prolonged observation study, gelatin alone and in combination with thrombin or rFVIIa was studied. On average, 34% (20%-54%) of the animals rebled with no significant difference between the treatment groups. CONCLUSIONS: Gelatin-containing products provided a fast hemostasis in this experimental model. One third of the animals rebled, regardless of whether thrombin or rFVIIa was added. Further studies are demanded to confirm these results clinically.

A significant correlation between body surface area and infrarenal aortic diameter is detected in a large screening population with possibly clinical implications.

BACKGROUND: Screening for abdominal aortic aneurysm (AAA) in elderly men reduces aneurysm related mortality. AAA is commonly defined as an infrarenal aortic diameter (IAD) of ≥30 mm, which is based on the definition of an arterial aneurysm as a focal dilation of 150% or more compared to the expected diameter of about 20 mm. The IAD has been shown to correlate to body surface area (BSA). The aim of this study was to investigate the possibility to use an individualized AAA-criteria by using a BSA-based model to refine the screening for AAA. METHODS: We conducted an observational single center cohort study of 25 236 65-year old men invited to AAA screening in Malmö, Sweden 2010-2015. Out of the 19 738 (78.5%) attendees, 14 846 (58.8%) completed a health questionnaire including height, weight and smoking habits. Linear regression analysis was performed between BSA and IAD, taking smoking habits into account. This regression was used to calculate the predicted IAD for each individual according to their BSA. RESULTS: There was a significant correlation between BSA and aortic diameter, rho =0.26 (95% CI: 0.25, 0.28). AAA defined as an IAD≥30 mm was found in 226 men (1.5%) whereas AAA defined as ≥150% larger IAD than predicted according to the individual BSA was found in 299 men (1.9%), a relative difference in AAA detection rate of more than 30% (P<0.001). CONCLUSIONS: We have found a statistically significant correlation between BSA and IAD in a homogenous screening population that could have clinical implications. In men with low BSA, IAD <30 mm might still be ≥150% larger than predicted according to BSA, whereas in men with high BSA, IAD≥30 mm might not be ≥150% larger than predicted. Further follow-up of these subjects is planned to investigate if the first group have an "aneurysm-in-formation," challenging the diagnostic criteria for AAA.

In vitro and in vivo evaluation of chemically modified degradable starch microspheres for topical haemostasis.

Degradable starch microspheres (DSMs) are starch chains cross-linked with epichlorhydrin, forming glycerol-ether links. DSMs have been used for many years for temporary vascular occlusion and drug delivery in treatment of malignancies. They are also approved and used for topical haemostasis by absorbing excess fluid from the blood and concentrating endogenous coagulation factors, thereby facilitating haemostasis. This mechanism of action is not sufficient for larger bleedings in current chemical formulations of DSMs, and modification of DSMs to trigger activation of platelets or coagulation would be required for use in such applications. Chemical modifications of DSMs with N-octenyl succinic anhydride, chloroacetic acid, acetic anhydride, diethylaminoethyl chloride and ellagic acid were performed and evaluated in vitro with thrombin generation and platelet adhesion tests, and in vivo using an experimental renal bleeding model in rat. DSMs modified to activate platelets in vitro were superior in haemostatic capacity in vivo. Further studies with non-toxic substances are warranted to confirm these results and develop the DSM as a more effective topical haemostatic agent.