Sex disparities in popliteal artery aneurysms.

OBJECTIVE: Only 5% of patients with popliteal artery aneurysms (PAAs) are female. Evidence on PAA treatment and outcomes in women is therefore scarce. The POPART Registry provides one of Europe's largest data collections regarding PAA treatment. Data on clinical presentation, aneurysm morphology, and perioperative outcomes after open surgical PAA repair in women will be presented. METHODS: POPART is a multicenter, noninterventional registry for open and endovascular PAA repair, with 42 participating centers in Germany and Luxembourg. All patients aged >18 years who have been treated for PAA since 2010 are eligible for study inclusion. Data collection is based on an online electronic case report form. RESULTS: Of the 1236 PAAs, 58 (4.8%) were in women. There were no significant differences in age or cardiopulmonary comorbidities. However, female patients had a lower prevalence of contralateral PAAs and abdominal aortic aneurysms (P < .05). PAAs in women were more likely to be symptomatic before surgery (65.5% vs 49.4%; P = .017), with 19% of women presenting with acute limb ischemia (vs 11%; P = .067). Women had smaller aneurysm diameters than men (22.5 mm vs 27 mm; P = .004) and became symptomatic at smaller diameters (20 mm vs 26 mm; P = .002). Only 8.6% of women and 11.6% of men underwent endovascular aneurysm repair (P > .05); therefore, the perioperative outcome analysis focused on open surgical repair. In total, 23.5% of women and 16.9% of men developed perioperative complications (P > .05). There were no differences in major cardiovascular events (P > .05), but women showed a higher incidence of impaired wound healing (15.7% vs 7.2%; P = .05) and major amputation (5.9% vs 1.1%; P = .027). Female sex was significantly associated with the need for nonvascular reinterventions within 30 days after surgery (odds ratio: 2.48, 95% confidence interval: 1.26-4.88), whereas no significant differences in the odds for vascular reinterventions were observed (odds ratio: 1.98, 95% confidence interval: 0.68-5.77). In the multiple logistic regression model, female sex, symptomatic PAAs, poor quality of outflow vessels, and graft material other than vein graft were independently associated with perioperative reinterventions. CONCLUSIONS: Women have smaller PAAs, are more likely to be symptomatic before treatment, and are more often affected by nonvascular reinterventions in the perioperative course. As our understanding of aneurysmatic diseases in women continues to expand, sex-specific treatment strategies and screening options for women in well-selected cohorts with modified screening protocols should be continuously re-evaluated.

Intravascular Ultrasound in the Detection of Bridging Stent Graft Instability During Fenestrated and Branched Endovascular Aneurysm Repair Procedures: A Multicentre Study on 274 Target Vessels.

OBJECTIVE: The use of intravascular ultrasound (IVUS) reduces contrast medium use and radiation exposure during conventional endovascular aneurysm repair (EVAR). The aim of this study was to evaluate the safety and efficacy of IVUS in detecting bridging stent graft (bSG) instability during fenestrated and branched EVAR (F/B-EVAR). METHODS: This was a prospective observational multicentre study. The following outcomes were evaluated: (1) technical success of the IVUS in each bSG, (2) IVUS findings compared with intra-operative angiography, (3) incidence of post-operative computed tomography angiography (CTA) findings not detected with IVUS, and (4) absence of IVUS related adverse events. Target visceral vessel (TVV) instability was defined as any branch or fenestration issues requiring an additional manoeuvre or re-intervention. Any IVUS assessment that detected stenosis, kinking, or any geometric TVV issue was considered to be branch instability. All procedures were performed in ad hoc hybrid rooms. RESULTS: Eighty patients (69% males; median age 72 years; interquartile range 59, 77 years) from four aortic centres treated with F/B-EVAR between January 2019 and September 2021 were included: 70 BEVAR (21 off the shelf; 49 custom made), eight FEVAR (custom made), and two F/B-EVAR (custom made), for a total of 300 potential TVVs. Two TVVs (0.7%) were left unstented and excluded from the analysis. The TVVs could not be accessed with the IVUS catheter in seven cases (2.3%). Furthermore, 17 (5.7%) TVVs could not be examined due to a malfunction of the IVUS catheter. The technical success of the IVUS assessment was 91.9% (274/298), with no IVUS related adverse events. Seven TVVs (2.5%) showed signs of bSG instability by means of IVUS, leading to immediate revisions. The first post-operative CTA at least 30 days after the index procedure was available in 268 of the 274 TVVs originally assessed by IVUS. In seven of the 268 TVVs (2.6%) a re-intervention became necessary due to bSG instability. CONCLUSION: This study suggests that IVUS is a safe and potentially valuable adjunctive imaging technology for intra-operative detection of TVV instability. Further long term investigations on larger cohorts are required to validate these promising results and to compare IVUS with alternative technologies in terms of efficiency, radiation exposure, procedure time, and costs.

Intravascular ultrasound enhances the PETTICOAT technique in endovascular therapy for complicated type B aortic dissection with malperfusion syndrome.

OBJECTIVE: To present the value of intravascular ultrasound (IVUS) in diagnosis and treatment of complicated type B aortic dissection (TBD) with malperfusion (MP). Especially the value of IVUS regarding the treatment strategy, reoperation rate, acute kidney injury (AKI) and false lumen thrombosis (FLT) was investigated. METHODS: Retrospective analysis of 25 TBD cases with MP treated with endovascular therapy from April 2019 to August 2022. In 17 cases angiography & IVUS were applied during the operation (IVUS group) and in 8 cases angiography was used without IVUS (control group) for final intraoperative control. IVUS was used to assess the true lumen collapse and to decide if additional bare stenting was necessary or not. Details from patients' charts and documentation from surgeries were analyzed. The endovascular technique included thoracic endovascular aortic repair (TEVAR) with primary entry sealing and -if needed- bare stenting of the true lumen distal of the entry tears using the PETTICOAT (Provisional Extension To Induce Complete Attachment) technique. RESULTS: All patients presented with pain localized mostly (48%) in thorax and abdomen. In all patients the proximal entry tear of the dissection was covered using TEVAR. The PETTICOAT technique was applied in 13 cases (52%), whereas most combined procedures were applied in the IVUS group (12 compared to 1; p=0,02). A total of 3 patients (1 in the control group; 12,5% and 2 in the IVUS group; 11,8%) underwent a bowel resection. Totally 8 patients (32%) underwent a reoperation in aorta (3 during the hospital stay). There were no statistical differences between IVUS and control group regarding the preoperative findings, the reoperation rates and the postoperative complications. 5 patients died (4 during the hospital stay), 1 in control and 4 in IVUS group; p=0,53. The follow up included a clinical and a computed tomography angiography (CTA) examination. No statistically significant difference regarding occurrence and extension of FLT was observed between the two groups. CONCLUSIONS: The IVUS and control groups showed no difference in survival rates. The use of IVUS extended the indication for PETTICOAT technique with statistically significant difference. A milder form of AKI presented in the IVUS group compared to the control group. In addition, a stronger correlation between IVUS and the avoidance of an aorta reoperation was observed, though it did not reach statistical significance.

The optimal operative protocol to accomplish CO2-EVAR resulting from a prospective interventional multicenter study.

OBJECTIVES: Carbon dioxide (CO2) angiography for endovascular aortic repair (CO2-EVAR) is used to treat abdominal aortic aneurysms (AAAs), especially in patients with chronic kidney disease or allergy to iodinated contrast medium (ICM). However, some technical issues regarding the visualization of the lowest renal artery (LoRA) and the best quality image through angiographies performed from pigtail or introducer sheath are still unsolved. The aim of this study was to analyze different steps of CO2-EVAR to create an operative standardized protocol. METHODS: Patients undergoing CO2-EVAR were prospectively enrolled in five European centers from 2019 to 2021. CO2-EVAR was performed using an automated injector (pressure, 600 mmHg; volume, 100 cc); a small amount of ICM was injected in case of difficulty in LoRA visualization. LoRA visualization and image quality (1 = low, 2 = sufficient, 3 = good, 4 = excellent) were analyzed at different procedure steps: preoperative CO2 angiography from pigtail and femoral introducer sheath (first step), angiographies from pigtail at 0%, 50%, and 100% of proximal main body deployment (second step), contralateral hypogastric artery (CHA) visualization with CO2 injection from femoral introducer sheath (third step), and completion angiogram from pigtail and femoral introducer sheath (fourth step). Intraoperative and postoperative CO2-related adverse events were also evaluated. χ2 and Wilcoxon tests were used for statistical analysis. RESULTS: In the considered period, 65 patients undergoing CO2-EVAR were enrolled (55/65 [84.5%] male; median age, 75 years [interquartile range (IQR), 11.5 years]). The median ICM injected was 17 cc (IQR, 51 cc); 19 (29.2%) of 65 procedures were performed with 0 cc ICM. Fifty-five (84.2%) of 65 patients underwent general anesthesia. In the first step, median image quality was significantly higher with CO2 injected from femoral introducer (pigtail, 2 [IQR, 3] vs introducer, 3 [IQR, 3]; P = .008). In the second step, LoRA was more frequently detected at 50% (93% vs 73.2%; P = .002) and 100% (94.1% vs 78.4%; P = .01) of proximal main body deployment compared with first angiography from pigtail; similarly, image quality was significantly higher at 50% (3 [IQR, 3] vs 2 [IQR, 3]; P ≤ .001) and 100% (4 [IQR, 3] vs 2 [IQR, 3]; P = .001) of proximal main body deployment. CHA was detected in 93% cases (third step). The mean image quality was significantly higher when final angiogram (fourth step) was performed from introducer (pigtail, 2.6 ± 1.1 vs introducer, 3.1 ± 0.9; P ≤ .001). The intraoperative (7.7%) and postoperative (12.5%) adverse events (pain, vomiting, diarrhea) were all transient and clinically mild. CONCLUSIONS: Preimplant CO2 angiography should be performed from femoral introducer sheath. Gas flow impediment created by proximal main body deployment can improve image quality and LoRA visualization with CO2. CHA can be satisfactorily visualized with CO2 alone. Completion CO2 angiogram should be performed from femoral introducer sheath. This operative protocol allows performance of CO2-EVAR with 0 cc or minimal ICM, with a low rate of mild temporary complications.

The Semibranch: A New Tool for Complex Aortic Pathologies.

PURPOSE: To describe the semibranch as new tool to treat patients with thoracoabdominal, para- and juxtarenal aortic pathologies. TECHNIQUE: The technique is demonstrated in 2 patients with aortic pathologies. First, a 76-year-old woman with a type Ia endoleak after endovascular repair of abdominal aneurysm (EVAR). Due to the short mainbody of the EVAR and suprarenal extension of the pathology, a 4-branched device with integrated bifurcation was chosen. To realize a branched device in small diameters of the suprarenal aorta, 2 semibranches, for the superior mesenteric artery (SMA) and the celiac trunc (CT), were planned. The second patient, a 75-year-old man, had a juxtarenal aneurysm. Due to small diameters of the aorta, semibranches for the SMA and the CT were planned. In both cases, a total transfemoral approach was used with a steerable sheath. Placement, cannulation of the semibranch, forwarding of the bridging stentgraft, and sealing was uneventful. All 4 semibranches were successful in sealing the aneurysm. CONCLUSION: The semibranch is another tool in the armamentarium of the endovascular interventionalist, which can expand the range of patients that can be treated. Especially patients with small aortic diameter or short distances between target vessels with the same offspring angle can profit from the semibranch design. CLINICAL IMPACT: The semibranch is a new tool to treat thoracoabdominal as well para- and juxtarenal aortic pathologies. Due to its reduced length, packaging density can be higher and diameter of the stentgraft can be larger. It closes the gap in pathologies where fenestration are not suitable (kinked aortas) and there is not enough space for standard inner branches (small diameters).

Realignment of Migrated Celiac Stent Graft After Branched Stent Graft Implantation Through Retrograde Cannulation of the Superior Mesenteric Artery Using a Single Vascular Access.

PURPOSE: The purpose of the study was to present an endovascular management of a type IIIc endoleak (EL) in a patient with migration of the bridging stent graft of the celiac trunk (CT) after branched aortic aneurysm repair with retrograde cannulation of the superior mesenteric artery (SMA). TECHNIQUE: The therapy was applied in a 62-year-old man who underwent a branched EVAR 2 years ago. Meanwhile, the patient was treated due to type Ia EL 6 months ago. The patient suffered in the last days from unclear hemorrhage clinically correlated with weakness. In the computed tomography angiography (CTA), an EL IIIc with a migration of the bridging stent graft from the CT branch was displayed. As vascular access, the left axillar artery was used. Due to the misaligned bridging stent graft, an antegrade cannulation was impossible, so cannulation was performed retrograde through the SMA using pancreaticoduodenal and gastroduodenal arteries. Thereafter, the EL could be repaired with bridging stent grafts. The postinterventional control showed a satisfying reconstruction without EL or embolization. CONCLUSION: Most of the complications such as type IIIc EL after complex endovascular repair can also be treated endovascularly. This sophisticated treatment requires that necessary materials and experience are available.

Bilateral Implantation of Double-Branched Iliac Branch Devices for Endovascular Repair of Aorto-Bi-Iliac Aneurysm With Concomitant Hypogastric Aneurysms: The Quadruple Branch.

PURPOSE: The purpose of this report is to describe the use of a double-branched custom-made iliac branch device (IBD) for the endovascular repair of an aorto-bi-iliac aneurysm with concomitant bilateral hypogastric aneurysms. TECHNIQUE: A 61-year-old man on peritoneal dialysis underwent a computed tomography (CT) of the infrarenal aorta before planned kidney transplantation. The CT showed an asymptomatic aorto-bi-iliac aneurysm of 54 mm involving the hypogastric artery (HA) bilaterally (right HA 31 mm; left HA 40 mm). The treatment consisted of an endovascular aortic repair (EVAR) and the bilateral implantation of custom-manufactured IBDs with double inner branches to preserve both superior and inferior gluteal arteries. At 1 year follow-up, the patient remains free of symptoms and the postoperative CT showed a successfully excluded aneurysm with patent bridging stent grafts to all HA branches. CONCLUSION: The bilateral implantation of double-branched IBDs is a feasible technique. Preservation of both hypogastric arteries and its branches can be achieved with this technique and therefore decrease the risk of buttock claudication and other ischemic complications.

Retrograde Approach for Antegrade Inner Branches in a Precannulated Off-the-Shelf Multibranch Device.

PURPOSE: The purpose of this technical note was to describe the application of the combination of precannulated branches and a femoral approach for bridging stent graft deployment in branched endovascular aneurysm repair. TECHNIQUE: The technique is shown in a 65-year-old woman treated for thoracoabdominal aneurysm type I with endovascular repair using a multibranched device. The stent graft is an off-the-shelf device with 4 precannulated inner branches. Access to the precannulated branches is gained using a steerable sheath from retrograde femoral access instead of using access via the upper extremities. For this purpose, a 0.018" wire introduced to the precannulated tube is snared into the steerable sheath. Next, the steerable sheath is guided into a stable position inside the branch. With this technique, the implantation of this off-the-shelf multibranch device could be completed safe and quickly with a full femoral approach avoiding upper extremity access. CONCLUSION: The combination of a precannulated multibranch stent graft with a full femoral approach for target vessel revascularisation is a feasible and quick method for complex endovascular repair.

Snare-Dragging Technique to Target the Hypogastric Artery in an Iliac Bifurcation Dissection.

PURPOSE: To describe snare-assisted vessel targeting to selectively overcome a dissection in the iliac bifurcation and gain antegrade access to the hypogastric artery (HA). TECHNIQUE: The technique is demonstrated in a 64-year-old woman with an asymptomatic Crawford type III thoracoabdominal aneurysm. A 2-stage endovascular repair, consisting of a thoracic endovascular aortic repair (TEVAR) and a branched endovascular aortic repair was planned. In the control angiography after TEVAR, a disrupted plaque with consequent dissection in the right iliac bifurcation was detected. The perfusion of the common iliac artery and external iliac artery resulted impaired. The targeting of the right HA through a contralateral antegrade approach failed, whereas an ipsilateral retrograde approach was possible but unsuitable for therapeutic purposes. Using the catheter of the retrograde ipsilateral access, a snare from a contralateral crossover was cached and dragged into the HA, allowing the targeting of the vessels and further endovascular therapy with angioplasty and stenting. Follow-up 8 months postoperatively demonstrated the patency of the stents and well-preserved perfusion in the right iliac bifurcation. CONCLUSION: The snare-dragging technique can be used to gain access to vessels presenting challenging conformations or dissections. This application may be a valuable support for complex endovascular treatment in a variety of patients. CLINICAL IMPACT: The snare-dragging technique can be used to gain access to vessels presenting challenging conformations or dissections. It allows the catheterization to be establish from the easiest and safest approach and then "transferred" from one access to the other. It avoids the risk of repeated loss of catheterization due to unstable and unfavorable working angles, and it saves time and radiation. It permits different material combinations, adapting to the available resources and materials. We believe that the current technique may increase the strategy spectrum available for endovascular therapy and complex endovascular procedures.

Spinal Stroke: Outcome Attenuation by Erythropoietin and Carbamylated Erythropoietin and Its Prediction by Sphingosine-1-Phosphate Serum Levels in Mice.

Spinal strokes may be associated with tremendous spinal cord injury. Erythropoietin (EPO) improves the neurological outcome of animals after spinal cord ischemia (SCI) and its effects on ischemia-induced endoplasmic reticulum (ER) stress and the unfolded protein response (UPR) are considered possible molecular mechanisms. Furthermore, sphingosin-1-phosphate (S1P) is suggested to correlate with SCI. In this study, the effect of recombinant human EPO (rhEPO) and carbamylated EPO (cEPO-Fc) on the outcome of mice after SCI and a prognostic value of S1P were investigated. SCI was induced in 12-month-old male mice by thoracic aortal cross-clamping after administration of rhEPO, cEPO-Fc, or a control. The locomotory behavior of mice was evaluated by the Basso mouse scale and S1P serum levels were measured by liquid chromatography-tandem mass spectrometry. The spinal cord was examined histologically and the expressions of key UPR proteins (ATF6, PERK, and IRE1a, caspase-12) were analyzed utilizing immunohistochemistry and real-time quantitative polymerase chain reaction. RhEPO and cEPO-Fc significantly improved outcomes after SCI. The expression of caspase-12 significantly increased in the control group within the first 24 h of reperfusion. Animals with better locomotory behavior had significantly higher serum levels of S1P. Our data indicate that rhEPO and cEPO-Fc have protective effects on the clinical outcome and neuronal tissue of mice after SCI and that the ER is involved in the molecular mechanisms. Moreover, serum S1P may predict the severity of impairment after SCI.

Fever Management after TEVAR in Patients with Aortic Dissection.

BACKGROUND: Post-implantation syndrome (PIS) is characterised as a noninfectious continuous fever and a concomitant rise in inflammatory markers shortly after thoracic endovascular aortic repair (TEVAR). This current study aims to analyse the risk factors of PIS, postoperative major adverse cardiac events (MACE), and overall survival as well as the correlation between new-onset mural thrombus and the risk of developing PIS after TEVAR in patients with type B aortic dissection (TBAD). Patients were included who had a B dissection, both acute and chronic forms. In the acute form, both acutely complicated and uncomplicated patients were included in the study. A main point of our investigation is the postoperative fever management of PIS patients. METHODS: A total of 90 patients with type B dissection underwent TEVAR in the University Hospital of Muenster between 2016 and 2020. The occurrence of PIS was defined as the presence of fever (> 38°C lasting longer than 24 hours in hospital) and leucocytosis (white blood cell count > 12000/µL). Patients with other possible reasons for fever and/or leucocytosis, such as a urinary tract infection (UTI), pneumonia, or sepsis, were excluded beforehand. Besides demographic and operation-related data, inflammatory markers and therapeutic measures were evaluated before and 5 days postoperatively. Computed tomography scans were examined to calculate the volume of preexistent and new-onset mural thrombus after TEVAR. RESULTS: Of 90 patients, 40 patients were excluded because of recent infection or bypass surgery. Of the 50 patients included in the study, 10 patients developed post-implantation syndrome. Younger patients significantly more often developed PIS after TEVAR (52.2 ± 11.6 vs. 61.5 ± 13.6, p = 0.045). New-onset thrombus after TEVAR was significantly higher in PIS patients (61 cm³ vs. 12 cm³, p < 0.001) and PIS patients often received more medical examinations (investigation of X-ray, U status, and blood cultures). There was no significant difference in overall survival for 40 months and in the incidence of MACE. CONCLUSIONS: PIS may be related to an increased rate of new-onset thrombus. A more robust conclusion is not justified according to our study. There is no difference in overall survival.

Early outcomes associated with use of the Zenith TX2 Dissection Endovascular Graft for the treatment of Stanford type B aortic dissection.

OBJECTIVE: To evaluate short term outcomes related to the use of the Zenith TX2 Dissection Endovascular Graft (ZDEG) and the Zenith Dissection Bare stent (ZDES) for the treatment of Stanford type B aortic dissections. METHODS: This retrospective multicenter case cohort study collated data from 10 European institutions for patients with both complicated and uncomplicated type B aortic dissection treated with ZDEG and ZDES between 2011 and 2018. The primary end point was mortality at 30 and 90 days. Secondary end points included complications related to TEVAR, such as, type Ia endoleak, stroke, paraparesis, paraplegia, and retrograde type A dissection (RTAD). Statistical analysis was carried out using the t test, or one-way analysis of variance and the χ2 or Fisher exact tests. RESULTS: We treated 120 patients (87 male; mean age, 62.7 ± 12.2years) either in the acute 76 (63.3%), subacute 16 (13.3%), or chronic 28 (23.3%) phase. Seven patients (5.8%) died within 30 days after the index procedure and two (1.7%) between 30 and 90 days. There was one instance of postoperative RTAD in a patient treated for rupture. Stroke and paraplegia occurred in three (2.5%) and five (4.2%), patients, respectively. Eight patients (6.7%) had a type Ia endoleak in the perioperative period. There were no instances of paraplegia, no permanent dialysis, and no requirement for adjunctive superior mesenteric or celiac artery stenting in the 33 patients (27.5%) who were treated by concurrent placement of ZDES distal to the ZDEG. The length and distal oversizing of ZDEG components used was less in this group. CONCLUSIONS: The present series demonstrates a low (<1%) RTAD rate and favorable morbidity and mortality. The lower rate of paraplegia, dialysis, and visceral artery stenting in the cohort that had adjunctive use of ZDES is compelling and merits further assessment.

First-in-Human Clinical Application of the Medyria TrackCath System in Endovascular Repair of Complex Aortic Aneurysms (ACCESS Trial): A Prospective Multicenter Single-Arm Clinical Trial.

PURPOSE: The Medyria TrackCath Catheter (MedTCC) is an innovative, thermal convection-based blood flow velocity (BFV) tracking catheter that may be used during complex aortic endovascular procedures for identification and catheterization of target orifices. The ACCESS Trial analyzes the safety and performance of the MedTCC for targeted vessel catheterization to generally evaluate the feasibility of thermal convection-based BFV. MATERIALS AND METHODS: We performed a first-in-human, proof-of-concept, prospective single-arm multicenter clinical trial between March 2018 and February 2019 in patients who underwent endovascular aortic procedures at 4 high-volume centers. During these procedures, the MedTCC was advanced over a guidewire through the femoral access. The D-shape was enfolded in the reno-visceral part of the aorta and target orifices were identified and catheterized with a guidewire via the side port of the MedTCC through BFV tracking. BFV measurements were performed at baseline (Baseline-BFV), alignment to the orifice (Orifice-BFV), and following catheterization (Confirmation-BFV) to prove correct identification and catheterization of target orifices. The procedural success rate, the catheterization success rate, procedure-related parameters, and (serious) adverse events ((S)AE) during the follow-up were analyzed. RESULTS: A total of 38 patients were included in the safety group (SG) and 26 in the performance group (PG). The procedural success rate was 89% (PG), the MedTCC catheterization success rate was 98% (PG). The MedTCC reliably measured BFV changes indicated by significant differences in BFV between Baseline-BFV and Orifice-BFV (p<0.05). Median (interquartile range; IQR) fluoroscopy time per orifice was 5.0 (1.5-8.5) minutes [total surgery 49 (26-74) minutes], median (IQR) contrast agent used per orifice was 1.0 (0-5.0) mL [total surgery 80 (40-100) mL], and median (IQR) MedTCC-based procedural time was 3.0 (2.0-6.0) minutes. There was no device-related SAE. CONCLUSIONS: The ACCESS Trial suggests that BFV measurement allows for reliable target orifice identification and catheterization. The use of MedTCC is safe and generates short fluoroscopy time and low contrast agent use, which in turn might facilitate complex endovascular procedures.

The JOTEC iliac branch device for exclusion of hypogastric artery aneurysms: ABRAHAM study.

OBJECTIVE: Hypogastric artery aneurysms (HAAs) are rare but life-threatening in cases of rupture. Open or endovascular techniques traditionally aimed at occluding the hypogastric artery (HA) have considerable risk of pelvic ischemia. Iliac branch devices (IBDs) are indicated for aortoiliac aneurysms; however, they have also been used lately for HAAs. Currently, there are no reports about patient outcomes focusing on HAA therapy using IBDs. We retrospectively analyzed early and midterm outcomes using IBDs for HAAs. METHODS: Patients who received IBDs for HAAs at our department from January 1, 2012, through March 1, 2018, were included. Exclusion criteria were as follows: no HA involvement, emergency procedures, and HA stent grafting without IBD. Perioperative and follow-up data were collected from medical records. RESULTS: There were 18 IBDs (only IBD, n = 4; IBD + endovascular aneurysm repair [EVAR], n = 7; IBD ± EVAR + side branch occlusion, n = 7) implanted into 14 male patients (76 ± 4 [70-83] years). There were no intraoperative complications, and the technical success rate was 100%. After 19 ± 11 (2-39) months of follow-up, two hybrid (external iliac artery occlusion, n = 1; EVAR graft kinking, n = 1) and four endovascular reinterventions due to two type IB (side branch coiling + stent graft extension) and two type IIIB (stent grafting) endoleaks were required. One IBD-related type II endoleak revealed constant aneurysm diameters during follow-up. One small type IB endoleak was self-limited. Estimated freedom from reintervention was 31% ± 23% at 2.7 years. The clinical success and patency rate was 100%. The IBD-related mortality was 0%. CONCLUSIONS: The IBD for HAA shows good early and midterm results. Adequate sealing of HA landing zones and side branch occlusion are technically challenging but crucial to prevent type IB and type II endoleaks.

Preliminary outcome of Nellix-in-Nellix extensions in patients treated with failed endovascular aneurysm sealing.

BACKGROUND: The 1-year results of the use of the Nellix (Endologix Inc, Irvine, Calif) endovascular aneurysm sealing (EVAS) device were initially promising. However, midterm complications including migration and aneurysm growth occurred more frequently than expected, which provided an incentive to refine the instructions for use. Strategies for the management of complications arising after endovascular aneurysm repair are often not applicable for EVAS, given the unique configuration of the Nellix device, and new techniques are needed. This study analyzes the clinical outcomes of both elective and emergency deployment of a new Nellix device within a primarily placed device, for failure of EVAS, which we refer to as a Nellix-in-Nellix application (NINA). METHODS: This is a global, retrospective, observational cohort study focusing on the early outcome of NINA for failed EVAS, including data from 11 European institutions and 1 hospital in New Zealand. RESULTS: A total of 41 patients were identified who underwent a NINA procedure. Of these, 32 (78%) were placed electively and 9 (22%) were placed on an emergency basis. Seven patients were initially treated with chimney EVAS (n = 5 in the elective NINA group and n = 2 in the emergency NINA group). The average time between the primary EVAS procedure and NINA was 573 days (interquartile range, [IQR] 397-1078 days) and 478 days (IQR, 120-806) for the elective and emergency groups, respectively. The indication for elective NINA was endoleak with migration (50%), endoleak without migration (25%), migration without endoleak (16%), and other (9%). Chimney grafts were used in 21 of 32 patients in the elective group and 3 of 9 patients in the emergency group. Technical success was achieved in 94% of patients in the elective group and 100% of patients in the emergency group. At latest follow-up (median, 104 days; IQR, 49-328 days), there were three aneurysm-related deaths (9%), no ruptures, and five device-related reinterventions (16%) within the elective group. In the emergency group (median follow-up, 23 days; IQR, 7-61 days), there were four aneurysm-related deaths and three aneurysm-related reinterventions. CONCLUSIONS: In conclusion, a NINA can be used to treat late failures of EVAS with an acceptable technical success rate and can be used when more established treatment options are unfeasible or contraindicated. The durability of this technique needs to be further reviewed.

Prospective Study of the Iliac Branch Device E-liac in Patients with Common Iliac Artery Aneurysms: 12 Month Results.

OBJECTIVES: At 12 months follow up of the PLIANT study, clinical success and efficacy of the E-liac Stent Graft System (JOTEC GmbH, Hechingen, Germany) were evaluated. Clinical success was defined as aneurysm exclusion (no type I, III, IV endoleak) with primary patency of the internal iliac artery (IIA) and external iliac artery (EIA) on the E-liac implantation side. METHODS: In this prospective multicentre European observational study, clinical and morphological data of 45 patients (93% male, mean age 72 y) were prospectively collected in 11 European centres between July 2014 and June 2016. Forty patients underwent an aorto-iliac (three patients bilaterally) treatment and five an isolated iliac treatment. RESULTS: At 12 months follow up, data were available for 42 patients. Overall clinical success at 12 months was 90%, with a survival rate of 100%. Four patients (10%) did not achieve clinical success, one with an internal iliac artery (IIA) occlusion on the E-liac implantation side, one with an infrarenal type Ia endoleak, and two with type Ib endoleaks in IIA. At 12 months the primary patency rate in the internal iliac artery on the iliac side branch implantation side was 98%. Two patients (5%) received E-liac related re-interventions: one caused by an edge stenosis at the distal end of the graft limb in the external iliac artery (EIA) and one caused by thrombo-embolism in the external iliac artery. Thus, for the EIA, primary and secondary patency rates were 98% and 100%, respectively. CONCLUSIONS: The low device related re-intervention rate of 5%, the high survival rate of 100%, and the high primary patency rates of 98% for the IIA and EIA at 12 month follow up demonstrate the safety and efficacy of the E-liac Stent Graft System. Long term 36 month results are awaited to confirm the efficacy and durability.

Initial Clinical Experience Using the Low-Profile Altura Endograft System With Double D-Shaped Proximal Stents for Endovascular Aneurysm Repair.

PURPOSE: To report the initial clinical results of endovascular aneurysm repair (EVAR) using the low-profile (14-F) Altura Endograft System, which features a double "D-shaped" stent design with suprarenal fixation and modular iliac components that are deployed from distal to proximal. METHODS: From 2011 to 2015, 90 patients (mean age 72.8±8.3 years; 79 men) with abdominal aortic aneurysm (AAA; mean diameter 53.8±5.7 mm) were treated at 10 clinical sites in 2 prospective, controlled clinical studies using the Altura endograft. Outcomes evaluated included mortality, major adverse events (MAEs: all-cause death, stroke, paraplegia, myocardial infarction, respiratory failure, bowel ischemia, and blood loss ≥1000 mL), and clinical success (freedom from procedure-related death, type I/III endoleak, migration, thrombosis, and reintervention). RESULTS: Endografts were successfully implanted in 89 (99%) patients; the single failure was due to delivery system malfunction before insertion in the early-generation device. One (1%) patient died and 4 patients underwent reinterventions (1 type I endoleak, 2 iliac limb stenoses, and 1 endograft occlusion) within the first 30 days. During a median follow-up of 12.5 months (range 11.5-50.9), there were no aneurysm ruptures, surgical conversions, or AAA-related deaths. The cumulative MAE rates were 3% (3/89) at 6 months and 7% (6/89) at 1 year. Two patients underwent coil embolization of type II endoleaks at 6.5 months and 2.2 years, respectively. Clinical success was 94% (84/89) at 30 days, 98% (85/87) at 6 months, and 99% (82/83) at 1 year. CONCLUSION: Early results suggest that properly selected AAA patients can be safely treated using the Altura Endograft System with favorable midterm outcome. Thus, further clinical investigation is warranted to evaluate the role of this device in the treatment of AAA.

Prospective study of the E-liac Stent Graft System in patients with common iliac artery aneurysms: 30-Day results.

OBJECTIVES: To study the safety and feasibility of the E-liac Stent Graft System® in patients with aorto/iliac aneurysms. METHODS: A prospective multicentric European registry of patients receiving the E-liac Stent Graft System® was conducted. Endpoints of the study included the technical success as well as periprocedural events and 30-day endoleaks, reinterventions, internal and external iliac artery patency and mortality. RESULTS: Between July 2014 and June 2016, a total of 45 patients (93% men, mean age 72 years, range 53-90 years) were enrolled at 11 sites in four European countries. Five patients received an isolated iliac treatment. Thirty-seven patients were treated with a combination of an abdominal stent graft and a unilateral E-liac and three in combination with bilateral E-liac. All E-liac Stent Grafts (48) were implanted in the intended position and the internal iliac arteries were successfully bridged. Two patients did not receive clinical success, due to endoleak type Ia of the aortic stent graft. At 30-day follow-up, clinical success rate was 96%. Three successful endovascular reinterventions were performed within the 30-day follow-up: one due to a type Ia endoleak in the common iliac artery, one due to type Ia endoleak of the aortic stent graft, and one due to bilateral lower limb claudication provoked by stent graft limb stenosis. At 30-day, a 100% survival rate and complete absence of pelvic or buttock ischemia/claudication were reported. Primary patency at 30 days was 100% for the internal iliac artery and 98% for the external iliac artery with an assisted patency of 100% in the latter. CONCLUSIONS: The high clinical success rate, low rates of device-related reinterventions (2%), and excellent patency rate demonstrate the safety and feasibility of the E-liac Stent Graft System. Long-term results are awaited to state efficacy and durability. Clinical Trials.gov. Identifier no. NCT02209194.

Acute Limb Ischemia-Much More Than Just a Lack of Oxygen.

Acute ischemia of an extremity occurs in several stages, a lack of oxygen being the primary contributor of the event. Although underlying patho-mechanisms are similar, it is important to determine whether it is an acute or chronic event. Healthy tissue does not contain enlarged collaterals, which are formed in chronically malperfused tissue and can maintain a minimum supply despite occlusion. The underlying processes for enhanced collateral blood flow are sprouting vessels from pre-existing vessels (via angiogenesis) and a lumen extension of arterioles (via arteriogenesis). While disturbed flow patterns with associated local low shear stress upregulate angiogenesis promoting genes, elevated shear stress may trigger arteriogenesis due to increased blood volume. In case of an acute ischemia, especially during the reperfusion phase, fluid transfer occurs into the tissue while the vascular bed is simultaneously reduced and no longer reacts to vaso-relaxing factors such as nitric oxide. This process results in an exacerbative cycle, in which increased peripheral resistance leads to an additional lack of oxygen. This whole process is accompanied by an inundation of inflammatory cells, which amplify the inflammatory response by cytokine release. However, an extremity is an individual-specific composition of different tissues, so these processes may vary dramatically between patients. The image is more uniform when broken down to the single cell stage. Because each cell is dependent on energy produced from aerobic respiration, an event of acute hypoxia can be a life-threatening situation. Aerobic processes responsible for yielding adenosine triphosphate (ATP), such as the electron transport chain and oxidative phosphorylation in the mitochondria, suffer first, thus disrupting the integrity of cellular respiration. One consequence of this is irreparable damage of the cell membrane due to an imbalance of electrolytes. The eventual increase in net fluid influx associated with a decrease in intracellular pH is considered an end-stage event. Due to the lack of ATP, individual cell organelles can no longer sustain their activity, thus initiating the cascade pathways of apoptosis via the release of cytokines such as the BCL2 associated X protein (BAX). As ischemia may lead to direct necrosis, inflammatory processes are further aggravated. In the case of reperfusion, the flow of nascent oxygen will cause additional damage to the cell, further initiating apoptosis in additional surrounding cells. In particular, free oxygen radicals are formed, causing severe damage to cell membranes and desoxyribonucleic acid (DNA). However, the increased tissue stress caused by this process may be transient, as radical scavengers may attenuate the damage. Taking the above into final consideration, it is clearly elucidated that acute ischemia and subsequent reperfusion is a process that leads to acute tissue damage combined with end-organ loss of function, a condition that is difficult to counteract.

Deficiency in lymphotoxin ß receptor protects from atherosclerosis in apoE-deficient mice.

RATIONALE: Lymphotoxin ß receptor (LTbR) regulates immune cell trafficking and communication in inflammatory diseases. However, the role of LTbR in atherosclerosis is still unclear. OBJECTIVE: The aim of this study was to elucidate the role of LTbR in atherosclerosis. METHODS AND RESULTS: After 15 weeks of feeding a Western-type diet, mice double-deficient in apolipoprotein E and LTbR (apoE(-/-)/LTbR(-/-)) exhibited lower aortic plaque burden than did apoE(-/-) littermates. Macrophage content at the aortic root and in the aorta was reduced, as determined by immunohistochemistry and flow cytometry. In line with a decrease in plaque inflammation, chemokine (C-C motif) ligand 5 (Ccl5) and other chemokines were transcriptionally downregulated in aortic tissue from apoE(-/-)/LTbR(-/-) mice. Moreover, bone marrow chimeras demonstrated that LTbR deficiency in hematopoietic cells mediated the atheroprotection. Furthermore, during atheroprogression, apoE(-/-) mice exhibited increased concentrations of cytokines, for example, Ccl5, whereas apoE(-/-)/LTbR(-/-) mice did not. Despite this decreased plaque macrophage content, flow cytometric analysis showed that the numbers of circulating lymphocyte antigen 6C (Ly6C)(low) monocytes were markedly elevated in apoE(-/-)/LTbR(-/-) mice. The influx of these cells into atherosclerotic lesions was significantly reduced, whereas apoptosis and macrophage proliferation in atherosclerotic lesions were unaffected. Gene array analysis pointed to chemokine (C-C motif) receptor 5 as the most regulated pathway in isolated CD115(+) cells in apoE(-/-)/LTbR(-/-) mice. Furthermore, stimulating monocytes from apoE(-/-) mice with agonistic anti-LTbR antibody or the natural ligand lymphotoxin-α1ß2, increased Ccl5 mRNA expression. CONCLUSIONS: These findings suggest that LTbR plays a role in macrophage-driven inflammation in atherosclerotic lesions, probably by augmenting the Ccl5-mediated recruitment of monocytes.