NEXUS Arch: A Multicenter Study Evaluating the Initial Experience With a Novel Aortic Arch Stent Graft System.

OBJECTIVE: To assess the initial clinical experience with a novel endograft system (NEXUS Aortic Arch Stent Graft System) designed to treat aortic arch pathologies and address the morphology and hemodynamic challenges of the aortic arch. SUMMARY BACKGROUND DATA: The aortic arch remains the most challenging part of the aorta for both open and endovascular repair. Transcatheter aortic arch repair has the potential to significantly reduce surgical risks. METHODS: Patients underwent transcatheter aortic arch repair with a single branch, 2 stent graft system, implanted over a through-and-through guidewire from the brachiocephalic trunk, to the descending aorta with an ascending aorta stent graft. The ascending aorta stent graft is deployed into a designated docking sleeve to connect the 2 stent grafts and isolate the aortic arch pathology. Proximal landing zone in all cases was in Zone 0. Anatomical inclusion criteria included adequate landing zone in the ascending aorta, brachiocephalic trunk, and descending thoracic aorta. Preparatory debranching procedure was performed in all patients with carotid-carotid crossover bypass and left carotid to left subclavian bypass, or parallel graft from descending aorta to left subclavian artery. Safety and performance were evaluated through 1 year. Survival analysis used the Kaplan-Meier method. RESULTS: Twenty-eight patients, 79% males, with a mean age of 72.2 ± 6.2 years were treated with 100% procedural success. Isolated aortic arch aneurysm was the principle pathology in 17 (60.7%) of patients, while chronic aortic dissection was the principle pathology in 6 (21.4%) of patients. The remaining 5 (17.8%) had combined or other pathologies. At 1 month, the vascular pathology was excluded in 25 of 26 alive patients (96.1%). The 30 days mortality rate was 7.1%, stroke rate was 3.6% (all nondisabling), and combined mortality/stroke rate was 10.7%. One-year mortality was 10.7%, without device or aneurysm-related death. Two patients (7.1%) reported stroke or transient ischemic attack at 1 year that recovered completely. One year combined mortality/stroke rate was 17.8%. There were 3 patients (10.7%) that had device-related unplanned reinterventions through 1 year. CONCLUSIONS: The NEXUS Aortic Arch Stent Graft System, a novel single branch, 2 stent graft system used for endovascular aortic arch repair that requires landing in the ascending aorta, demonstrates a high success rate with excellent 1 year safety and performance.

Endovascular Treatment of Spontaneous and Isolated Infrarenal Acute Aortic Syndrome with Unibody Aortic Stent-Grafts.

INTRODUCTION: Spontaneous acute aortic syndrome (IAAS) is rarely localized in the infrarenal aorta. The endovascular approach is preferred over conventional open surgery with fewer complications. However, dedicated endovascular devices for IAAS treatment are unavailable. The aim was to report a large single-center experience using unibody stent-grafts to address IAAS. METHODS: From April 2016 to March 2019, a retrospective analysis of patients presenting spontaneous and isolated IAAS was performed. Patients addressed with the unibody stent-graft (AFX endovascular AAA system; Endologix Inc., Irvine, CA) were included in the study. Indications to IAAS treatment were persistent symptoms and/or dilated abdominal aorta (>3 cm). The measured outcomes were technical success; early outcomes (<30 days) including mortality, morbidity, symptoms recurrence, and endoleak occurrence; and late outcomes (>30 days) including mortality, symptoms recurrence, endoleak occurrence, stent-graft patency, and survival. Median follow-up was 23.77 ± 10 months. RESULTS: Twenty-one patients with IAAS were included. Indications to treatment were symptoms in 14 (67%) patients and dilated abdominal aorta in 7 (33%). Technical success was achieved in all cases. No perioperative mortality and 1 (4.8%) early femoral access complication was encountered. During the follow-up were registered 1 (4.8%) aortic unrelated death and 1 (4.8%) stent-graft limb stenosis. The 36 months estimated survival and freedom from reintervention were 92% (CI: 37-43; SE: 1.7) and 94% (CI: 37-44; SE: 1.7), respectively. CONCLUSIONS: The endovascular treatment of IAAS with unibody stent-graft (AFX endovascular AAA system; Endologix Inc.) is safe and effective with promising mid-term outcomes. The use of unibody stent-grafts expands the endovascular indication, despite the usual anatomic IAAS features. Larger studies with longer follow-up are required to validate the outcomes of the reported technique.

Endovascular Treatment of Spontaneous Internal Carotid Artery Dissection with Proximal Embolic Protection Device.

BACKGROUND: The aim of this study was to report the feasibility and outcomes with the endovascular treatment of spontaneous internal carotid artery dissections (ICADs) using a proximal embolic protection device (EPD). METHODS: This is a retrospective analysis of patients treated for spontaneous symptomatic ICAD using a proximal EPD from January 2017 to December 2018. Indication for treatment was the presence of neurologic symptoms. Early outcomes measured included technical success, perioperative mortality, and major cardiovascular or cerebrovascular complications. Late outcomes were recurrent neurologic symptoms, patency, and reinterventions. RESULTS: A total of 4 male patients with ICAD were included. A preoperative cerebral computed tomography positive for cerebral ischemic events was reported in all cases. In 3 patients, the neurologic symptoms consisted of a transient ischemic attack; the remaining patient presented an amaurosis fugax and aphasia. In 2 patients, ICAD was associated with a carotid significant stenosis. In all patients, the reported approach was feasible with no complications and complete anatomic dissection resolution. At a mean follow-up of 18 months, all stents are patent and no restenosis recurrence or complications were registered. CONCLUSIONS: The use of proximal EPDs allowed the treatment of ICAD under flow arrest, minimizing the risk of stroke during the endovascular maneuvers. Larger series are required to validate this treatment strategy.

Improved technique for sheath supported contralateral limb gate cannulation in endovascular abdominal aortic aneurysm repair.

Background: To present a technique of sheath supported contralateral limb gate (CLG) cannulation of modular bifurcated stent-graft in endovascular abdominal aortic repair. Materials and methods: After totally percutaneous bilateral femoral access, the 9F introducer sheath is exchanged to a 30 cm 12 fr introducer sheath over a stiff wire contralateral to the intended main stent-graft insertion side and advanced into the aorta below the lowest renal artery. Parallel to the stiff wire within the sheath an additional standard J-tip guidewire with a 5 fr Pigtail angiographic catheter is advanced to the level of the renal arteries. After main body deployment, the 12 fr introducer sheath and J-tip wire with pigtail catheter are retracted until the CLG opening level, maintaining the stiff "buddy" wire in position to support the 12 fr sheath, maintaining its distal opening close to the contralateral gate opening to achieve easy cannulation. Results: Retrospective analysis of video archive from July 2016 to February 2018 evidenced 55 recorded EVAR cases. All CLG cannulations were obtained with Standard J-tip or Terumo Glidewire wires and with Pig-Tail or Berenstein catheters. Technical success was 100 %. Mean fluoroscopy time to accomplish CLG cannulation was 37.6 33 (range 1-105) seconds. The aortic carrefour angulation on coronal axis strongly correlates with cannulation time p = <.001, with longer cannulation time for higher carrefour angulations on coronal axis (Pearson correlation coefficient 0.47). Conclusions: The use of 12 fr sheath with parallel wire introduction technique, appears to be a safe and reliable tool to facilitate CLG cannulation during EVAR procedures.

CT Angiography of the Aorta: Contrast Timing by Using a Fixed versus a Patient-specific Trigger Delay.

Background Optimal timing of the CT scan relative to the contrast media bolus remains a challenging task given the shorter scan durations of modern CT scanners, as well as interpatient variability. Purpose To compare contrast opacification in CT angiography of the aorta between a cohort with fixed trigger delay and a cohort with patient-specific individualized trigger delay for contrast media timing with bolus tracking. Materials and Methods In this prospective study (January-August 2018), CT angiography of the thoracoabdominal aorta with bolus tracking was performed in two different study cohorts: one with a fixed trigger delay of 4 seconds (fixed cohort) and one with a patient-specific trigger delay (individualized cohort). All CT and contrast media protocol parameters were kept identical among cohorts. Objective image quality was evaluated by one reader; two readers assessed subjective image quality. Student t test was used to test for differences in mean attenuation; the Wilcoxon-Mann-Whitney test was used to test for differences in noise, contrast-to-noise ratio, and subjective image quality. Results The fixed cohort had 108 study participants (16 women; mean age ± standard deviation, 72 years ± 10); the individualized cohort had 108 participants (16 women; mean age, 72 years ± 12). The trigger delay in the individualized cohort ranged from 6.4-11.3 seconds (mean, 9.2 seconds). There was higher overall attenuation in the individualized cohort than in the fixed cohort (486 HU ± 92 for individualized vs 438 HU ± 99 for fixed; P < .001), with increasing differences from the aortic arch (8 HU) to the iliac arteries (95 HU). The regression model indicated uniform attenuation in the individualized cohort and decreasing attenuation in the fixed cohort (decrease of 87 HU by the iliac arteries; P < .001). There was no difference between cohorts for image noise (20 vs 19; P = .41), but contrast-to-noise ratio (21 vs 19; P = .04) and subjective image quality were higher in the individualized cohort than in the fixed cohort (excellent or good image quality, 100% vs 67%; P < .001). Conclusion Compared with a fixed delay time after bolus tracking, a patient-specific individualized trigger delay improves image quality and provides uniform contrast attenuation for CT angiography of the aorta. ©RSNA, 2019.

Patient-Specific Rehearsal Feasibility Before Endovascular Repair of Ruptured Abdominal Aortic Aneurysm.

Purpose: To evaluate the feasibility of a patient-specific rehearsal (PsR) before emergency endovascular aneurysm repairs (eEVAR) and its influence on the operation. Materials and Methods: From February 2016 to October 2016, 10 consecutive patients (mean age 75±7.4 years; 9 men) presenting with a ruptured abdominal aortic aneurysm (rAAA) suitable for standard EVAR were enrolled in the study. A 3-dimensional (3D) model of the abdominal aorta was generated on a virtual reality simulator based on the patient's computed tomography (CT) images. Following the patient-specific simulation setup, PsR was conducted during patient admission or in parallel with the preoperative eEVAR workup. Measured outcomes were PsR feasibility only in the first 4 patients and impact on operative performance thereafter (changes in device selection, the planning process, clinical outcomes, perioperative mortality, and complication rates). Technical metrics and timing of system setup, rehearsal, interval from patient arrival to the actual procedure, and eEVAR were recorded. Results: Mean time for 3D model creation was 21.3±7.8 minutes (range 13-37); there was a significant positive relationship between aortic neck diameter and segmentation time (p=0.003). The overall mean time for simulator setup and PsR was 54±14 minutes (range 37-80); PsR alone was completed in a mean 31±40 minutes (95% confidence interval -60 to -2.2). The actual eEVAR procedure duration was 69±16 minutes (range 45-90). No delay in the actual eEVAR procedure was registered owing to the PsR pathway. In 6 patients, preprocedure rehearsal induced changes in operative strategy, including device selection, main body introduction side, and/or deployment configuration. In 4 cases, rehearsal was performed twice to achieve optimal performance. Conclusion: PsR before eEVAR was feasible in all cases and caused no time delays in the actual eEVAR procedure. PsR optimized eEVAR planning by identifying optimal strategy for stent-graft component selection and deployment.

Disparities in Contemporary Treatment Rates of Abdominal Aortic Aneurysms Across Western Countries.

OBJECTIVE/BACKGROUND: Several abdominal aortic aneurysm (AAA) screening programs have demonstrated a similar prevalence of this disease in Westerns countries, ranging from 1.2% to 2.8%. However, the annual rate of AAA repair is significantly less even, and its relationship to AAA prevalence is not clear. The objective was to perform a systematic review, describing an international overview in the yearly rate of AAA repairs. METHODS: The number of elective and emergency AAA repairs was obtained via thorough review of publications indexed in PubMed and Scopus from 2010 to October 2018. Portuguese data were obtained from the national administrative database of health care. Data from the UK were extracted from the National Vascular Registry's 2015 annual report. Each country's population was assessed from published national censuses, thus allowing estimation of the number of AAAs treated per 100,000 habitants. RESULTS: Data from 14 countries were obtained. The yearly number of elective operations per 100,000 habitants was 2.2 in Hungary, 3.8 in Portugal, 5.3 in Spain, 5.9 in Iceland, 6.5 in Finland, 7.0 in New Zealand, 7.8 in the UK, 10.0 in Denmark, 10.2 in Sweden, 13.3 in the USA, 14.8 in Norway, 15.3 in the Netherlands, 15.6 in Italy, and 17.3 in Germany. The yearly rate of ruptured repairs was 0.5 in Hungary, 1.5 in Portugal, 1.8 in Spain, 1.7 in Iceland, 1.7 in Finland, 1.3 in New Zealand, 1.8 in the UK, 3.3 in Denmark (2013), 2.7 in Sweden (2013), 1.7 in the USA, 2.1 in Norway, 3.1 in the Netherlands, 2.3 in Italy, and 2.7 in Germany. CONCLUSION: The rate of AAA treatment is highly variable, with a nearly eightfold variance between the countries with the highest and lowest rates of elective repair. Correlation between elective and ruptured repairs was not clear. A deeper understanding of the reasons for the disparities in AAA treatment among Western countries is of the utmost importance.

Single-Center Experience and Preliminary Results of Intravascular Ultrasound in Endovascular Aneurysm Repair.

BACKGROUND: Intravascular ultrasound (IVUS) has been introduced as diagnostic adjunct to provide new insights into the diagnosis and therapy of vascular disease. Herein, we compared the outcomes of conventional endovascular aneurysm repair (EVAR) and EVAR with IVUS in patients presenting with infrarenal abdominal aortic aneurysm using a propensity-matched cohort. METHODS: From May 2013 to August 2017, 221 patients were retrospectively analyzed. Of that, 122 patients were eligible for inclusion and underwent propensity score matching. Perioperative mortality and morbidity, renal function impairment, endoleak incidence, mean contrast medium usage, operative time, radiation exposure (including fluoroscopy time, dose-area product [DAP], and digital subtraction angiography [DSA] runs), survival, and freedom from reintervention were the outcomes measured. RESULTS: After matching, 52 patients were included, 26 in the conventional EVAR group and 26 in the EVAR with IVUS group. No perioperative mortality or type I/III endoleak were registered. One perioperative lymphatic fistula and one iliac limb occlusion were observed. In the EVAR with IVUS group, a significant reduction of contrast medium (92 [vs. 51 ± 17] vs. 51 [20-68] mL; P = 0.003) and radiation exposure including fluoroscopy time (12 [9-16] vs. 20 [12-25] min; P = 0.001), DAP (15 [9-21] vs. 32 [16-44] G*cm2; P = 0.002), and DSA runs (2 [1-3] vs. 3 [2-4]; P = 0.04) was reported. No differences were observed in terms of glomerular filtration rate (86 [45-121] vs. 90 [38-117] mL/min; P = 0.14) and operation time (176 [124-210] vs. 179 [120-210]; P = 0.48). Survival at 36 months was 93% for standard EVAR and 92% for EVAR with IVUS (P = 0.845). Freedom from reintervention at 36 months was 85.5% in both the groups (P = 0.834). CONCLUSIONS: In this preliminary experience, the use of IVUS during EVAR was feasible with no registered postoperative complications. A significant reduction of contrast medium usage and radiation exposure was observed with the use of IVUS. The IVUS is an adjunctive tool to consider in the vascular surgeon armamentarium, especially in centers where advanced radiological tools of imaging fusion are not available.

Early outcomes with a single-sided access endovascular stent.

OBJECTIVE: The objective of this study was to report the 1-year follow-up study results of the new Horizon stent graft (Endospan, Herzliya, Israel) from two different prospective consecutive trials. The Horizon abdominal aortic aneurysm stent graft system is a 14F profile system requiring only a single access site. It consists of three modules, introduced separately: base limb (iliac to iliac limb); distal aortic limb; and proximal aortic limb with a bare suprarenal crown and active fixation. METHODS: Data from the first in man (FIM) clinical study with 10 patients enrolled and the pivotal study with 30 patients were analyzed. Outcomes measured were freedom from major adverse events (MAEs) including all-cause mortality, myocardial infarction, renal failure, respiratory failure, paraplegia, stroke, bowel ischemia, and procedural blood loss ≥1000 mL. Performance end points included successful delivery and deployment of the device, freedom from aneurysm growth ≥5 mm, type I or type III endoleak, stent graft occlusion, conversion to open surgery, rupture, and stent graft migration. RESULTS: In the FIM study, one conversion to open surgery with >1000 mL of blood loss was registered perioperatively. In the pivotal study, no perioperative MAE was registered. Overall, at 1-year follow-up, two deaths and one aneurysm growth unrelated to endoleak were registered. CONCLUSIONS: The results of both the FIM and pivotal studies demonstrated that 39 of 40 procedures were successful for delivery and deployment of the Horizon stent graft. No MAE was registered during the follow-up. The primary safety and performance end points were met in both studies.

Identification of optimal device combinations for the chimney endovascular aneurysm repair technique within the PERICLES registry.

OBJECTIVE: The ideal stent combination for chimney endovascular aneurysm repair remains undetermined. Therefore, we sought to identify optimal aortic and chimney stent combinations that are associated with the best outcomes by analyzing the worldwide collected experience in the PERformance of chImney technique for the treatment of Complex aortic pathoLogiES (PERICLES) registry. METHODS: The PERICLES registry was reviewed for patients with pararenal aortic disease electively treated from 2008 to 2014. Eleven different aortic devices were identified with three distinct subgroups: group A (n = 224), nitinol/polyester; group B (n = 105), stainless steel/polyester; and group C (n = 69), nitinol/expanded polytetrafluoroethylene. The various chimney stent subtypes included the balloon-expandable covered stent (BECS), self-expanding covered stent, and bare-metal stent. Deidentified aortic and chimney device combinations were compared for risk of chimney occlusion, type IA endoleak, and survival. Effects of high-volume centers (>100 cases), use of an internal lining chimney stent, number of chimney stents, and number of chimney stent subtypes deployed were also considered. We considered demographics, comorbidities, and aortic anatomic features as potential confounders in all models. RESULTS: The 1- and 3-year freedom from BECS chimney occlusion was not different between groups (group A, 96% ± 2% and 87% ± 5%; groups B and C, 93% ± 3% and 76% ± 10%; Cox model, P = .33). Similarly, when non-BECS chimney stents were used, no difference in occlusion risk was noted for the three aortic device groupings; however, group C patients receiving BECS did have a trend toward higher occlusion risk relative to group C patients not receiving a BECS chimney stent (hazard ratio [HR], 4.0; 95% confidence interval [CI], 0.85-18.84; P = .08). Patients receiving multiple chimney stents, irrespective of stent subtype, had a 1.8-fold increased risk of occlusion for each additional stent (HR, 1.8; 95% CI, 1.2-2.9; P = .01). Use of a bare-metal endolining stent doubled the occlusion hazard (HR, 2.1; 95% CI, 1.0-4.5; P = .05). Risk of type IA endoleak (intraoperatively and postoperatively) did not significantly differ for the aortic devices with BECS use; however, group C patients had higher risk relative to groups A/B without BECS (C vs B: odds ratio [OR], 3.2 [95% CI, 1-11; P = .05]; C vs A/B: OR, 2.4 [95% CI, 0.9-6.4; P = .08]). Patients treated at high-volume centers had significantly lower odds for development of type IA endoleak (OR, 0.2; 95% CI, 0.1-0.7; P = .01) irrespective of aortic or chimney device combination. Mortality risk was significantly higher in group C + BECS vs group A + BECS (HR, 5.3; 95% CI, 1.6-17.5; P = .006). The 1- and 3-year survival for groups A, B, and C (+BECS) was as follows: group A, 97% ± 1% and 92% ± 3%; group B, 93% ± 3% and 83% ± 7%; and group C, 84% ± 7% and 63% ± 14%. Use of more than one chimney subtype was associated with increased mortality (HR, 3.2; 95% CI, 1.4-7.5; P = .006). CONCLUSIONS: Within the PERICLES registry, use of nitinol/polyester stent graft devices with BECS during chimney endovascular aneurysm repair is associated with improved survival compared with other aortic endografts. However, this advantage was not observed for non-BECS repairs. Repairs incorporating multiple chimney subtypes were also associated with increased mortality risk. Importantly, increasing chimney stent number and bare-metal endolining stents increase chimney occlusion risk, whereas patients treated at low-volume centers have higher risk of type IA endoleak.

Primary Endovascular Elective Repair and Repair of Ruptured Isolated Iliac Artery Aneurysms Is Durable-Results of 72 Consecutive Patients.

PURPOSE: To evaluate outcome of endovascular elective repair and repair of ruptured isolated iliac artery aneurysms (IIAAs) as a primary treatment strategy. MATERIALS AND METHODS: All patients with an IIAA undergoing endovascular treatment were included. Aneurysms were classified according to an anatomic classification and treated with coiling of the internal iliac artery, stent graft placement in the common to external iliac artery, or placement of a bifurcated aortoiliac stent graft. Between November 1996 and November 2015, 72 patients with 85 IIAAs underwent endovascular repair. Mean age was 73.9 years ± 9.2. Common iliac artery was involved in 63 patients (74.1%), internal iliac artery was involved in 21 patients (24.7%), and external iliac artery was involved in 1 patient (1.2%). Mean diameter was 5 cm (range, 2.5-11 cm). Emergency repair was performed in 19 patients owing to rupture (26.4%). RESULTS: Overall primary technical success rate was 95.8% with conversion rate to open surgery of 4.2% (all in the emergency group) and in-hospital mortality rate of 1.4%. During mean follow-up of 4.3 years ± 3.3 (median 3.8 y; range, 0-14.2 y), 17 endoleaks were observed (6 type I, 10 type II, 1 type IIIa). Overall reintervention rate was 16.7%. Primary patency rate was 98.6%. During the follow-up period, 22 deaths occurred (30.6%), including 2 aneurysm-related deaths (2.8%). CONCLUSIONS: Primary endovascular repair of IIAAs shows excellent results and should be considered as first-line therapy. Surgical backup should be available in emergency cases.

Safety of percutaneous axillary artery access with a suture-mediated closing device for parallel endograft aortic procedures - a retrospective pilot study.

BACKGROUND: The aim of this study was to evaluate the technical success of percutaneous ultrasound-guided access to the infraclavicular axillary artery with a suture-mediated closing device for patients requiring large-sized upper extremity access. PATIENTS AND METHODS: In 18 consecutive patients (17 male, one female, mean age 73.5 ± 9.6 years, range 52-88 years), artery accesses with the preclosing modification for chimney endografts was gained with 20 ultrasound-guided infraclavicular axillary. Retrospectively, the following endpoints were analysed: technical success of percutaneous ultrasound-guided puncture of the infraclavicular axillary artery as well as introduction and deployment, primary successful haemostasis by preclosing, bailout procedures, overall complication rate including local vascular, cerebrovascular, and peripheral neurological complications. RESULTS: Ultrasound-guided puncture and preclosing procedure was successful in all patients. Mean sheath size was 9.4 ± 1.6 French. Ultrasound-guided puncture as well as introduction and deployment were successful in all patients (100 %). Primary successful haemostasis by preclosing was 70 % (14/20). Postclosing with one or two devices enabled successful haemostasis in another 15 %. Bailout stent graft implantation was necessary in three accesses (15 %), either by transfemoral (n = 2) or transbrachial (n = 1) route. Overall complication rate was 16.5 %, all of them were minor haematomas. CONCLUSIONS: Percutaneous ultrasound-guided infraclavicular axillary artery access with preclosing modification seems feasible and safe. The access related complication rate is low and complications can potentially be managed by endovascular means.

Predilation technique with balloon angioplasty to facilitate percutaneous groin access of large size sheath through scar tissue.

Purpose Percutaneous remote access for endovascular aortic repair is an advantageous alternative to open access. Previous surgery in the femoral region and the presence of synthetic vascular grafts in the femoral/iliac arteries represent major limitations to percutaneous remote access. The aim of this study was to evaluate an original technique used for enabling percutaneous remote access for thoracic or abdominal endovascular aortic repair in patients with scar tissue and/or a vascular graft in the groin. Methods Twenty-five consecutive patients with a thoracic (11/25; 44%) or an aortic aneurysm (14/25; 66%) and with a synthetic vascular graft in the groin (16/25; 64%) or a redo groin access (9/25; 36%) were managed through the percutaneous remote access. In all patients, a percutaneous transluminal angioplasty balloon was used to predilate the scar tissue and the femoral artery or the synthetic vascular graft after preclosing (ProGlide®; Abbott Vascular, Santa Clara, CA, USA). In 10 patients, requiring a 20 Fr sheath, a 6 mm percutaneous transluminal angioplasty balloon was used; and in the remaining 15, requiring a 24 Fr sheath, an 8 mm percutaneous transluminal angioplasty balloon. Preclosing was exclusively performed using ProGlide®. Mean follow-up was 15 months. Results In all cases, stent-graft deployment was successful. There was one surgical conversion (4%; 1/25) due to bleeding from a femoral anastomosis. Two cases required additional percutaneous maneuvers (postclosing with another system in one patient and endoluminal shielding with stent-graft in the other patient). No pseudoaneurysm or access complication occurred during the follow-up. Conclusions Percutaneous access in redo groins with scar tissue and/or synthetic vascular graft using ultrasound-guided punction, preclosing with ProGlide® system and predilation with percutaneous transluminal angioplasty balloon to introduce large size sheath as used for endovascular aortic repair showed to be feasible, safe and with few local complications.

Endovascular grafts for abdominal aortic aneurysm.

During the last two decades, endovascular technology has revolutionized the management of patients with abdominal aortic aneurysm (AAA). Today, endovascular aortic repair (EVAR) is the treatment of choice for the majority of patients with an AAA. Randomized controlled trials provide robust evidence for the indication of AAA repair and the rationale for the use of EVAR in selected patients. However, despite that, practice varies and several areas need further elucidation. Important future challenges and areas of research include the role of medical therapy in AAA, whether the indication for repair should be any different in women and in the elderly, and long-term follow-up of patients undergoing complex EVAR with adjuncts, both for elective treatment and for ruptured AAA. Continuous rapid technical and clinical development is to be expected. In this paper, we review the current practice and evidence of stenting in AAA.

Patient-specific Rehearsal Before EVAR: Influence on Technical and Nontechnical Operative Performance. A Randomized Controlled Trial.

OBJECTIVE: To assess the effect of patient-specific virtual reality rehearsal (PsR) before endovascular infrarenal aneurysm repair (EVAR) on technical performance and procedural errors. BACKGROUND: Endovascular procedures, including EVAR, are executed in a complex multidisciplinary environment, often treating high-risk patients. Consequently, this may lead to patient harm and procedural inefficiency. PsR enables the endovascular team to evaluate and practice the case in a virtual environment before treating the real patient. METHODS: A multicenter, prospective, randomized controlled trial recruited 100 patients with a nonruptured infrarenal aortic or iliac aneurysm between September 2012 and June 2014. Cases were randomized to preoperative PsR or standard care (no PsR). Primary outcome measures were errors during the real procedure and technical operative metrics (total endovascular and fluoroscopy time, contrast volume, number of angiograms, and radiation dose). RESULTS: There was a 26% [95% confidence interval (CI) 9%-40%, P = 0.004) reduction in minor errors, a 76% (95% CI 30%-92%, P = 0.009) reduction in major errors, and a 27% (95% CI 8.2%-42%, P = 0.007) reduction in errors causing procedural delay in the PsR group. The number of angiograms performed to visualize proximal and distal landing zones was 23% (95% CI 8%-36%, P = 0.005) and 21% (95% CI 7%-32%, P = 0.004) lower in the PsR group. CONCLUSIONS: PsR before EVAR can be used in different hospital settings by teams with various EVAR experience. It reduces perioperative errors and the number of angiograms required to deploy the stent graft, thereby reducing delays. Ultimately, it may improve patient safety and procedural efficiency.

CT Angiography of the Aorta: Prospective Evaluation of Individualized Low-Volume Contrast Media Protocols.

Purpose To prospectively develop individualized low-volume contrast media (CM) protocols adapted to tube voltage in patients undergoing computed tomographic (CT) angiography of the aorta. Materials and Methods The study was approved by the institutional review board and local ethics committee. All patients provided written informed consent. CT angiography was performed by using automated attenuation-based tube voltage selection (ATVS) (range, 70-150 kVp; 10-kVp increments). Iodine attenuation curves from an ex vivo experiment in a phantom were used to design CM protocols for CT angiography of the thoracoabdominal aorta in 129 consecutive patients (hereafter, cohort A). Further modified CM protocols based on results in cohort A were designed with the aim of homogeneous vascular attenuation of 300-350 HU across tube voltages and were applied to another 61 consecutive patients (cohort B). Three independent blinded radiologists assessed subjective image quality, and one reader determined objective image quality. The Kruskal-Wallis test was performed to test for differences in subjective image quality, and linear regression was performed to test for differences in objective image quality between the automatically selected tube voltages. Results Experiments revealed tube voltage-dependent iodine attenuation curves, which were used to determine the CM protocols in cohort A; these ranged from 68 mL at 110 kVp to 45 mL at 80 kVp. In both cohorts, ATVS selected 80 kVp in 62 patients, 90 kVp in 84, 100 kVp in 33, and 110 kVp in 11. In cohort A, image quality that was satisfactory or better was attained in 126 (98%) of 129 patients who had no significant differences in subjective image quality between tube voltages (P = .106) but who did have significant differences in attenuation and contrast-to-noise ratio (CNR) (P < .001 for both). In cohort B, the further-modified CM protocol (from 33 mL at 80 kVp to 68 mL at 110 kVp) yielded image quality that was satisfactory or better in all 61 (100%) patients, without significant differences in subjective image quality (P = .178), and without significant differences between tube voltage and attenuation (P = .108), noise (P = .250), or CNR (P = .698). Conclusion Individualized low-volume CM protocols based on automatically selected tube voltages are feasible and yield diagnostic image quality for CT angiography of the aorta. (©) RSNA, 2016 Online supplemental material is available for this article.

The Gore Hybrid Vascular Graft in renovisceral debranching for complex aortic aneurysm repair.

OBJECTIVE: This study reports our initial experience with the Gore Hybrid Vascular Graft (GHVG; W. L. Gore & Associates, Flagstaff, Ariz) for staged hybrid open renovisceral debranching and endovascular aneurysm repair in patients affected by thoracoabdominal aortic aneurysms and pararenal abdominal aortic aneurysms (PAAAs). METHODS: Between December 2012 and December 2013, we analyzed outcomes of 13 patients who underwent open surgical debranching of renovisceral vessels for thoracoabdominal aortic aneurysm and PAAAs. All patients were considered at high risk for conventional surgery. Inclusion criterion was treatment by open surgical debranching of at least one visceral artery (renal artery, superior mesenteric artery [SMA], or celiac trunk [CT]) using the GHVG. In a second step, the aortic stent graft was implanted to exclude the aneurysm. If required, parallel grafts to the remaining visceral arteries were deployed in the same procedure. One patient had a symptomatic descending thoracic aortic aneurysm and another had a ruptured PAAA. Perioperative measured outcomes were immediate technical success rate, mortality, and morbidity. Median follow-up was 24.8 months (range, 0-15; mean, 8.2; standard deviation, 4 months). RESULTS: All open surgical debranching of renovisceral vessels were completed as intended. GHVG was used to revascularize 20 visceral vessels in 13 patients with a mean of 1.54 vessels per patient. Six renal arteries (30%; 2 right and 4 left), 9 SMAs (45%), and 5 CTs (25%) were debranched. In nine of 13 (66%) patients, other renovisceral arteries were addressed with chimney/periscope, Viabahn Open Revascularization Technique, and end-to-side anastomosis. Two of 13 patients (15%) died of bowel ischemia. Neither patient had GHVG revascularization to the SMA or CT. Perioperative complications occurred in three patients (23%; 1 renal hematoma, 1 respiratory insufficiency, and 1 small-bowel ischemia related to a SMA GHVG thrombosis). At 24 months, estimated survival was 85%, and estimated primary and secondary patency were 94% and 100%, respectively. CONCLUSIONS: This limited series extracted from a more consistent hybrid procedure experience showed a mortality rate similar to most recent reports. Technical feasibility and the short-term patency rate of the GHVG for renovisceral debranching during staged hybrid open and endovascular procedures were satisfactory. Use of GHVGs may represent a useful revascularization adjunct to minimize visceral ischemia in these challenging patients.

Aortic rupture following an EVAR secondary to graft erosion.

Significant type 3 endoleak as a defect in the graft material, especially associated with endograft rupture, is a rare complication. A 68-year-old male patient with aortic plaque rupture was treated with endovascular graft placement. The patient was readmitted two years later with severe abdominal pain, a large retroperitoneal hematoma and contrast extravasation below the location where the aortic plaque had presented. Before an aortic infrarenal cuff could be placed during a control angiography, a large graft hole and a significant type 3 endoleak were observed. The sharp aortic plaque may have been responsible for the endograft tear.

The "Open Branch" Technique: A New Way to Prevent Paraplegia After Total Endovascular Repair of Thoracoabdominal Aneurysm.

INTRODUCTION: Staged endovascular treatment of thoracoabdominal aortic aneurysms (TAAA) has been proved to be an effective strategy to reduce the risk of spinal cord ischemia (SCI). Several techniques have been described: some imply the staged coverage of the aorta, other the temporarily perfusion of the sac through a branch left unstented or a dedicated branch that will be occluded later. The aim of those is to facilitate the expansion of the collateral network that perfuses the spinal cord. However, each of them, have some disadvantages such as the need of two interventions of big magnitude and the risk of target vessel occlusion or endograft displacement. We describe a new technique to treat TAAA in a staged manner. TECHNIQUE: The first step of our technique is the thoracoabdominal endograft deployment with the branching of all target vessels; one of these is branched with a bare stent inside which a covered stent will be placed in a second step, which can be perfomed under local anesthesia. We named this technique "open branch" (OB). Before insertion of the covered stent, a balloon is inflated inside the bare stent to simulate the complete sac exclusion to evaluate eventual neurological complication. RESULTS: Two patients with Crawford type II TAAA and one with a suprarenal aneurysm following the open repair of an infrarenal aortic aneurysm were treated. No cases of SCI were observed after the two procedures. Median interval time between the two procedures was 8, 6 weeks (4-16). Between the two steps, no aneurysm growth or rupture and no branch occlusion or endograft displacement was observed. CONCLUSIONS: These three cases of "OB" technique show that this is a safe and feasible alternative strategy to treat TAAA in a staged manner.

Hemodynamic Conditions may Influence the Oversizing of Stent Grafts and the Postoperative Surveillance of Patients with Ruptured Abdominal Aortic Aneurysm Treated by EVAR.

BACKGROUND: To report the causes of second rupture in patients treated with a stent graft for ruptured abdominal aortic aneurysm (rAAA). CASE REPORT: A 69-year-old man was admitted for abdominal pain and hypovolemic shock 22 months after endovascular exclusion of an rAAA with an aortomonoiliac stent graft and a crossover bypass despite normal duplex ultrasound and sac shrinkage at 1 year. During emergent laparotomy, a type IA endoleak was discovered and the aortomonoiliac stent graft was explanted. A Dacron bypass was interposed between the infrarenal aorta and the iliac extension stent graft. CONCLUSIONS: Considering the literature, this report has 3 implications for the endovascular treatment of rAAA. First, 30% oversizing is preferable to 15% when treating an rAAA assessed by computed tomography angiography (CTA) performed during permissive hypotension. Second, the surveillance program should rely on CTA and not on a duplex examination to detect any endoleaks or migration. Finally, partial stent graft explantation is a valid option for decreasing aortic clamping time.