Incidence of Post-Implantation Syndrome with Different Endovascular Aortic Aneurysm Repair Modalities and Devices and Related Etiopathogenetic Implications.

BACKGROUND: Postimplantation syndrome (PIS) is a systemic inflammatory response occurring in an early phase after abdominal aortic aneurysm (AAA) endovascular aneurysm repair (EVAR). The pathophysiology underlying PIS is still not well understood. It is speculated that the type of the stent graft or the mural thrombus within the AAA may play a role in determining this inflammatory response. At present, there is no consensus about the influence of PIS on clinical outcomes during follow-up. The endovascular aneurysm sealing (EVAS) with the Nellix sac-anchoring endoprosthesis (Nellix Endovascular, Palo Alto, CA) is a novel modality for AAA repair, which obliterates the sac, thus preventing the new onset of thrombus in the aneurysm sac. Our aim was to compare the incidence of postimplantation syndrome following EVAS and after EVAR. Secondary aims were to assess the effect of endoskeleton AFX (Endologix) device compared with other commercially available exoskeleton PTFE stent grafts on the inflammatory response. Finally, we analyzed the potential association of PIS with clinical outcomes. METHODS: From January 2013 to June 2018, 60 AAA patients underwent EVAS (mean age 72 ± 9 years), and 110 patients were submitted to EVAR: 56 AFX devices and 54 other PTFE stent grafts (mean age 74 ± 10 years) at a single center and were retrospectively reviewed. RESULTS: EVAS with the Nellix system was associated with a lower incidence of PIS compared to EVAR using both AFX device and other endografts (8.3, 30, 35%, respectively, P-value = 0.001). No statistically significant difference in PIS incidence was observed after endoskeleton AFX device deployment compared with other EVAR exoskeleton endografts. During follow up, the major complications were proportionally but not significantly (P = 0.43) less frequent after EVAS (10.3%) than after EVAR and after EVAR using AFX device (8.9%) than after EVAR with other PTFE stent grafts (16.4%). During follow up (mean 24 months), adverse outcome rates did not significantly differ in patients with and without PIS (8.0 vs. 13.4% P = 0.43). CONCLUSIONS: Our data confirm the lower risk of PIS following EVAS compared to EVAR. Most importantly, this study highlights the role of new-onset mural thrombus in the genesis of PIS. The lower inflammatory reaction observed after EVAS than after EVAR might be related to the endobags of the Nellix system, which completely seal the aneurysm sac, reducing the new onset of mural thrombus. The systemic inflammatory response does not significantly differ after endoskeleton AFX device deployment compared with other EVAR exoskeleton stent grafts. PIS does not seem to have any significant prognostic implications in terms of early major adverse events.

Nellix Endovascular Aortic Sealing Endoprosthesis Late Explantation for Concomitant Type I Endoleak and Stent Frames Proximal Caudal Migration.

Endovascular aneurysm sealing (EVAS) using the Nellix™ System was introduced in clinical practice with the aim of reducing the incidence of complications such as migration, endoleaks, and reinterventions after conventional endovascular aneurysm repair (EVAR). Although, initial efficacy data on this device have been encouraging, EVAS has also demonstrated to undergo adverse events. Herein, we report a case of Nellix graft explant due to endobags shrinkage after air bubble reabsorption leading to proximal type I A endoleak and stent migration. The focus of this article is on the importance of a more assiduous surveillance of this new device, in particular in those cases with air into the endobags immediately after the procedure; this surveillance should be aimed to timely identify complications which can otherwise lead to consequences that require open conversion.

Single-Center Experience in the Treatment of Visceral Artery Aneurysms.

BACKGROUND: Visceral artery aneurysms (VAAs), although rare, represent a life-threatening disease with high mortality rates. With the more frequent use of diagnostic tests, there has been an incidental detection of these lesions which are mostly asymptomatic. It follows that surgeons are increasingly called to decide on the most appropriate management of VAAs between an open surgical or endovascular approach and among the different endovascular options currently available. The aim of this retrospective study was to evaluate the results of open surgery and interventional endovascular strategies of visceral artery aneurysms with respect to technical success, therapy-associated complications, and postinterventional follow-up in the elective and emergency situation. METHODS: From January 1992 to January 2017, 125 open surgical or endovascular interventions for VAA were performed at our institution. Once the VAA was diagnosed and the indication for treatment was assessed, the preoperative diagnostic work-up consisted of contrast computed tomography (CT) or magnetic resonance imaging (MRI) and, in some patients, digital subtraction angiography. Follow-up included clinical and duplex ultrasound scan (DUS) and contrast-enhanced ultrasound to assess the treated vessel patency and organ perfusion after 1, 6, and 12 months, and yearly thereafter. CT or MRI controls were also performed at 1 year of follow-up and only when DUS was not diagnostic or showed a complication thereafter. After the first 5 years of follow-up, the status of the patient was obtained by a structured telephone survey. RESULTS: The treatment option was endovascular in 56 of 125 cases (44.8%). Technical success was 98.3%. In one case, the procedure was interrupted for the extensive dissection of the afferent vessel. Twenty-six patients were treated by coil embolization while 29 with covered stenting. The endovascular approach was in emergency in two cases (3.6%). In the endovascular group, mortality was nil. Complications occurred in 5 cases (8.9%): 1 subacute intestinal ischemia caused by superior mesenteric artery dissection, 2 aneurysm reperfusion, 1 stent thrombosis, and 1 massive splenic hematoma. In 69 (55.2%) cases, surgical treatment was preferred, with 24 VAA resections and 45 arterial reconstructions. In 20 cases (29%), open surgery was performed in emergency conditions. In the surgical group, 8 emergency patients (40%) died intraoperatively. The mortality after elective surgical interventions was nil. Complications after surgery were 4 graft late thrombosis (5.8%): asymptomatic in three cases and requiring splenectomy in one. CONCLUSIONS: There is no overall consensus regarding the indications for treatment of VAA. Currently in emergent setting, the endovascular approach should be considered as the first choice because of its reduced invasiveness, faster way to access and bleeding control; this accounts for the lower morality of the interventional therapy than open surgery. Endovascular approach is effective for elective repair of VAAs, but procedure-related complications may occur in a not negligible number of patients. Given comparable mortality rates and low procedure-related complication rate, surgical approach still has space in the elective management of VAAs, especially for aneurysms unsuitable or challenging for the endovascular option in patients with low surgical risk. The size, location, and morphology of VAAs, systemic or local comorbidities, and specific anatomical situations such as previous abdominal surgery should dictate treatment choice.

Preliminary results of endovascular aneurysm sealing from the multicenter Italian Research on Nellix Endoprosthesis (IRENE) study.

OBJECTIVE: Because of advances in technology and experience of the operator, endovascular aneurysm repair (EVAR) has supplanted open repair to treat abdominal aortic aneurysm (AAA). The low 30-day mortality and morbidity of EVAR make the endovascular approach particularly suitable for patients at high surgical risk. However, endoleak or endograft migration requiring secondary intervention or open surgical conversion is a limitation of EVAR. The Nellix system (Endologix, Inc, Irvine, Calif) has been designed to seal the entire AAA to overcome these limitations with EVAR. We report the results of a retrospective, multicenter study with endovascular aneurysm sealing (EVAS) aimed to assess technical success, procedure-related mortality, complications, and reinterventions. METHODS: This study included patients selected for elective treatment with the Nellix device per the endovascular repair protocol at 16 Italian vascular centers. All patients were enrolled in a postoperative surveillance imaging program including duplex ultrasound investigations, computed tomography, and magnetic resonance controls following local standards of care. RESULTS: From 2013 to 2015, there were 335 patients (age, 75.5 ± 7.4 years; 316 men) who underwent elective EVAS. In 295 cases (88.0%), EVAS was performed under standard instructions for use of the Nellix system. Preoperative aneurysm diameter was 55.5 ± 9.4 mm (range, 46-65 mm). The inferior mesenteric artery and lumbar arteries emerging from the AAA were patent in 61.8% and 81.3% of cases, respectively. Chimney grafts were electively carried out in eight cases (2.4%). One (0.3%) intraprocedural type IB endoleak was observed and promptly corrected. Device deployment was successful in all patients, with no perioperative mortality. Early (≤30 days) complications included 1 (0.3%) type IA endoleak, 2 (0.6%) type II endoleaks (0.6%), 2 (0.6%) stent occlusions (0.6%), 3 (0.9%) distal embolizations, and 2 (0.2%) femoral artery dissections. Six (2.9%) patients underwent reinterventions. At 1-year follow-up, complications included 3 (1.1%) type II endoleaks, 4 (1.4%) type IA endoleaks, 1 (0.3%) type IB endoleak, 2 (0.7%) distal stent migrations, 5 (1.8%) distal embolizations, and 1 (0.3%) stent occlusion. Twelve patients (3.7%) underwent reinterventions, including four (1.4%) surgical conversions due to aortoduodenal fistula (1), endograft infection (1), and type IA endoleak that was unsuccessfully treated percutaneously (2). Two AAA-related deaths occurred. Freedom from aneurysm-related reintervention was 98.3% at 1-month and 94.7% at 12-month follow-up. CONCLUSIONS: The preliminary results of this real-world multicenter study showed that EVAS with Nellix for the management of AAAs appears feasible. This device platform is associated with acceptable procedure-related mortality and low overall complication and reintervention rates. Definitive conclusions on the value of this novel device await long-term follow-up data.

Period-dependent Associations between Hypotension during and for Four Days after Noncardiac Surgery and a Composite of Myocardial Infarction and Death: A Substudy of the POISE-2 Trial.

BACKGROUND: The relative contributions of intraoperative and postoperative hypotension to perioperative morbidity remain unclear. We determined the association between hypotension and a composite of 30-day myocardial infarction and death over three periods: (1) intraoperative, (2) remaining day of surgery, and (3) during the initial four postoperative days. METHODS: This was a substudy of POISE-2, a 10,010-patient factorial-randomized trial of aspirin and clonidine for prevention of myocardial infarction. Clinically important hypotension was defined as systolic blood pressure less than 90 mmHg requiring treatment. Minutes of hypotension was the exposure variable intraoperatively and for the remaining day of surgery, whereas hypotension status was treated as binary variable for postoperative days 1 to 4. We estimated the average relative effect of hypotension across components of the composite using a distinct effect generalized estimating model, adjusting for hypotension during earlier periods. RESULTS: Among 9,765 patients, 42% experienced hypotension, 590 (6.0%) had an infarction, and 116 (1.2%) died within 30 days of surgery. Intraoperatively, the estimated average relative effect across myocardial infarction and mortality was 1.08 (98.3% CI, 1.03, 1.12; P < 0.001) per 10-min increase in hypotension duration. For the remaining day of surgery, the odds ratio was 1.03 (98.3% CI, 1.01, 1.05; P < 0.001) per 10-min increase in hypotension duration. The average relative effect odds ratio was 2.83 (98.3% CI, 1.26, 6.35; P = 0.002) in patients with hypotension during the subsequent four days of hospitalization. CONCLUSIONS: Clinically important hypotension-a potentially modifiable exposure-was significantly associated with a composite of myocardial infarction and death during each of three perioperative periods, even after adjustment for previous hypotension.

An Alternative Approach for Treating a Type Ia Endoleak after Conventional EVAR Using the Nellix Endovascular Aneurysm Sealing.

BACKGROUND: To report the use of a Nellix endovascular aneurysm sealing (EVAS) device, to successfully treat a type Ia endoleak (EL) after an endovascular aortic repair (EVAR). CASE REPORT: A 70-year-old man was diagnosed with a 90-mm aortic aneurysm, suspicious for being inflammatory. It was initially treated successfully, with a Medtronic Endurant (Medtronic, Minneapolis, MN, USA). Five years after the index endovascular repair, an asymptomatic type Ia EL was detected on duplex ultrasound and computed tomographic angiogram. Other endovascular solutions in the form of proximal cuff, chimney was considered difficult to execute due to challenges in planning, manipulation, and renal cannulation caused by the short proximal sealing zone above the existing stent graft and the constraints of the previous endograft. Thus, a relining of the previous endoprothesis was performed using the Nellix system (Endologix, Inc., Irvine, CA, USA). One-year follow-up imaging demonstrated successful resolution of the EL and persistent sealing of the Nellix device. CONCLUSIONS: Nellix EVAS system can be an alternative and safe option for relining a stent graft with a type Ia EL. Nellix platform can be added to the clinician's armamentarium for treating type Ia EL after conventional EVAR of infrarenal abdominal aortic aneurysm (AAA).

Hypertension, Acute Stent Thrombosis, and Paraplegia 6 Months after Thoracic Endovascular Aortic Repair for Blunt Thoracic Aortic Injury in a 22-Year-Old Patient.

Thoracic endovascular aortic repair (TEVAR) is a less invasive option for managing traumatic injuries of the descending aorta in polytraumatized patients. Concerns arise when treating young patients with TEVAR. A 22-year-old male was admitted to the emergency department following a high-impact road traffic collision. Whole-body computed tomography (CT) scan documented multiple injuries, including rupture of descending thoracic aorta just below the isthmus. There was no evidence of paraplegia or stroke. We decided to treat him in an endovascular fashion with a Zenith Cook (Cook Incorporated, Bloomington, IN) endograft. Final angiography confirmed the proper positioning of the device, no infoldings, and the optimal filling of the thoracic aorta downstream of the endoprosthesis. In the postoperative period, the patient showed high blood pressure which was treated with 4 different antihypertensive drugs. He was discharged on cardioaspirine. CT scan control was scheduled after 30 days and 6 months, but he referred to our emergency department after less than 6 months with paraplegia, abdominal pain, and acute renal failure. He had independently discontinued antiplatelet therapy 3 months before. Emergency CT control documented the presence of intimal flap and thrombus at the distal edge of the device. The magnetic resonance imaging revealed ischemic damage of the spinal cord. We decided to reline the endograft using another Zenith Cook device with very good results. Renal failure and bowel pain gradually improved, but paraplegia is still present. TEVAR is the most suitable treatment for blunt thoracic aortic injury in the modern era. Concerns arise from what can happen to a young aorta receiving a stiff endovascular graft that should be carried all lifelong. These devices have been associated with acute hypertension and cardiac remodeling. Less stiffer stent grafts should be studied for young patients. High attention must be posed in the follow-up for the immediate resolution of eventual problems.

One-Year Outcomes after Ruptured Abdominal Aortic Aneurysms Repair: Is Endovascular Aortic Repair the Best Choice? A Single-Center Experience.

BACKGROUND: Treatment of ruptured abdominal aortic aneurysms (rAAAs) is still burdened by high morbidity and mortality. Although endovascular aortic repair (EVAR) offers encouraging results in elective setting, its role as first-line strategy to treat rAAA is still debated. Our aim was to compare early and late outcomes in patients undergoing open surgical repair (OSR) versus EVAR for rAAAs. METHODS: A retrospective review of data extracted from medical records identified 105 consecutive patients with rAAA who were submitted to open or endovascular repairs from 2008 to 2016. The primary end point was to assess the rAAA-related mortality in the immediate postoperative period, within 1 month and 1 year after OSR, and EVAR; secondary endpoints included the following: length of stay, AAA-related postoperative complications such as acute limb ischemia, myocardial infarction, renal and respiratory failure, and rAAA-related re-interventions. Statistical analysis was performed using the Fisher exact test, χ2 test, and logistic regression calculations. Early and midterm survival rates were assessed with Cox model. RESULTS: Of the 105 patients with rAAA, 70.48% underwent OSR including 41.89% which was hemodynamically (Hd) unstable and the remaining 29.52% was submitted to rEVAR. (all Hd stable). Compared with EVAR group, the OSR group had a higher rAAA-related mortality rate for both Hd stable and Hd unstable patients: 18.92% vs. 6.45% at 24 hr; (P = 0.185) 39.19% vs. 19.35% at 30 days (P = 0.082); 44.59% vs. 38.71% at 1 year (P = 0.734) If only Hd stable patients were considered, mortality following OSR and EVAR was as follows: 6.98% vs. 6.45% at 24 hr (P = 0.703); 27.91% vs. 19.35% at 30 days (P = 0.567); 32.56% vs. 38.71% at 1 year (P = 0.764). Mean length of stay for patients was 15 days after OSR and 10 days after rEVAR (P = 0.002). At 1-year follow-up, the overall rAAA-related complications incidence was higher in the rEVAR group than that in the OSR group (47.85% vs. 18.33%; P = 0.008); re-interventions were 18.33% in OSR group vs. 21.82% in EVAR group (P = 0.917). Cox model showed that instability and coronary artery disease were predictors of overall mortality of rAAAs. CONCLUSIONS: EVAR does not independently reduce 1-year mortality in comparison with OSR in Hd stable patients. Urgent EVAR for rAAAs in unstable patients can be limited by logistical problems. It follows that patients selected for OSR have a more complex aortic anatomy and worse Hd status than those submitted to rEVAR. rEVAR burdened by a higher incidence of procedure-related complications than OSR. Reconfiguration of acute aortic services and establishment of standardized institutional protocols might be advisable for improvements in the management of ruptured AAA. A careful evaluation of whether the benefits of an endovascular strategy translate into long term benefit is needed before definitive conclusions can be drawn about the advantages of EVAR as first-line strategy for ruptured aneurysms.

Juxtarenal Inflammatory Aneurysm Treated with Bilateral Iliac-Renal Bypass Using the Gore Hybrid Device and Total Sealing of the Aneurysmal Sac with a Nellix Device.

The aim of this study is to present the treatment of a juxtarenal inflammatory aneurysm using a Nellix device (Endologix, Inc., Irvine, CA) to seal the entire aneurysmatic aorta combined with bilateral iliac-renal bypass using the Gore hybrid vascular graft (W. L. Gore & Associates, Inc., Flagstaff, AZ). A 63-year-old man was diagnosed with a 6-cm juxtarenal inflammatory aneurysm. It was initially decided to treat him with an aorto-aortic bypass and to revascularize the 2 renal arteries with "graft to renal artery bypass" using Gore hybrid vascular grafts. Due to the high intraoperative bleeding preparing the proximal neck and the tight adhesion of the aorta to the adjacent structures, we decided to change our plans and to treat the patient using the Nellix system combined with bilateral iliac-renal bypass using the Gore hybrid vascular grafts. Contrast computed tomography control at 1 month showed complete sealing of the aneurysm sac and patent iliac renal bypasses. The reported case demonstrated that the Nellix Endovascular Aneurysm Sealing system combined with Gore hybrid vascular grafts for bilateral iliac-renal bypass showed that it can be an effective modality for the treatment of juxtarenal, inflammatory aortic aneurysm and revascularization of the renal arteries from the distal iliac arteries.

A Peculiar Case of Type 1 Endoleak after Nellix Endovascular Aneurysm Sac Sealing: Clinical Presentation and Management.

We report a case of type 1 endoleak with an outflow via a lumbar artery (LA) following Nellix endovascular aneurysm sealing (EVAS) to discuss the specific peculiarities and management of this complication. A 64-year-old man (acetylsalicylic acid 3) underwent Nellix EVAS for an asymptomatic infrarenal aortic aneurysm. The 6-month duplex scanning ultrasound and magnetic resonance imaging showed a type IA endoleak with an outflow via an LA combined with a stable aneurysmal sac size. The subsequent 9-month imaging controls showed no changes of the endoleak cavity, but there was a slight enlargement in proximal neck size associated with the distal migration of both Nellix grafts. Thus, catheter-directed embolization with detachable coils first of the LA origin and then of the endoleak cavity was carried out. Postoperative course was uneventful. The patient is endoleak free with stable sac size on 6-month computed tomography imaging investigations following the secondary intervention.

Therapeutical Options in the Management of Carotid Dissection.

BACKGROUND: The best management of carotid artery dissection (CAD) is still controversial ranging from antiplatelet medication to open surgery or endovascular treatment. In this retrospective study, we assessed the safety and efficacy of endovascular stent angioplasty for the treatment of CAD. METHODS: From February 2006 to February 2016, 44 patients (28 women and 16 men, age range 25-65 years, mean 42) with CAD were included in this study. The internal carotid artery dissection was spontaneous in 32 patients and posttraumatic in the remaining 12 (in 1 case, it was bilateral). Twenty-eight patients were treated by intravenous heparin infusion followed by standard oral anticoagulation. Carotid artery stenting was carried out in 14 cases with recurrent ischemic events despite optimal anticoagulation management. Two patients with an open trauma of the neck were submitted to a common carotid to internal carotid bypass (CC-CI bypass). The follow-up ranged from 6 to 60 months and was performed clinically first and with Doppler ultrasound and computed tomography or magnetic resonance at 6, 12, and 24 months. RESULTS: Follow-up ranged from 6 to 60 months. Mortality was nil. All patients submitted to the endovascular or surgical management had an immediate relief of their neurologic symptoms with no procedure-related complications. No thrombosis or restenosis of the CC-CI bypass or of carotid artery stents occurred during intraoperative and postoperative period and follow-up. CONCLUSION: An alternative therapeutic option is mandatory in a subset of patients regarded as being at high risk for stroke because anticoagulant therapy was either contraindicated or failed clinically with recurrent transient ischemic attacks/transient symptoms associated with brain infarction. In these selected cases, endovascular stent placement seems to be a safe and effective option to restore vessel lumen integrity and prevent stroke.

Treatment of a Juxtarenal Aneurysm with a Parallel Graft in the Left Renal Artery and Polymer-Based Technology to Seal the Entire Aneurysmal Sac.

BACKGROUND: Presenting the treatment of a juxtarenal aneurysm using a Nellix device combined with a chimney stent in a renal artery. CASE REPORT: A 72-year-old woman was diagnosed with a 5.5-cm bilobed juxtarenal aneurysm. She underwent successful aneurysm repair with the Nellix system combined with a chimney stent in the left renal artery. Angio computed tomography control showed complete sealing of the aneurysm sac and patent chimney stent. CONCLUSIONS: Endovascular aneurysm sealing combined with chimney may be a valid way to treat juxtarenal aneurysms, and the conformable polymer-filled endobags may provide a durable seal around the chimney-graft preventing gutter formation.

Outcomes in the emergency endovascular repair of blunt thoracic aortic injuries.

Thoracic aorta blunt injury (BAI) is a highly lethal lesion. A large number of victims die before obtaining emergency care. Thoracic endovascular aneurysm repair (TEVAR) is a less invasive method compared with open surgery and may change protocols for BAI treatment. This retrospective study was developed to evaluate the potential issues about thoracic endografting in the management of these patients. Twenty-seven patients with a BAI underwent aortic stent grafting. Intervention was preceded by the treatment of more urgent associated lesions in nine cases. In-hospital mortality was 7.4%. No paraplegia or ischemic complications developed because of the coverage of the left subclavian artery. In one case (3.2%), a type I endoleak was detected, proximal endograft infolding in two cases (7.4%) and endograft distal migration in further two cases were detected during follow-up (6-110 months). Thoracic endovascular aneurysm repair of BAI showed encouraging results in terms of perioperative mortality and morbidity. Concerns still remain about the potential mid- and long-term complications in younger patients.

Persistent type II endoleak: two cases of successful sacotomy.

Endovascular treatment of persistent type II endoleak may not resolve the complication. We report two cases of sacotomy performed to treat this problem: the first case was in an emergency setting for aneurismal sac rupture, and the second occurred in an elective surgery setting after several unsuccessful endovascular procedures. In both cases, sacotomy allowed us identify the bleeding sources without aortic cross-clamping and endograft explantation. By minimizing hemodynamic modifications and reducing operative time, this procedure can be carried out even in patients considered unfit for surgery. Sacotomy could be considered as an alternative in selected cases of persistent type II endoleak with aneurysm sac enlargement.

Carotid artery free-floating thrombus caused by paradoxical embolization from greater saphenous vein ascending thrombophlebitis.

Stroke of unknown origin in young patients is seen to be closely correlated with patent foramen ovale (PFO) than stroke in patients with established stroke mechanisms. We report a case of a young woman without cardiovascular risk factors who was admitted to our emergency department with listlessness and altered mental status. The clinical examination revealed right lower limb swelling. Magnetic resonance imaging and contrast-enhanced computed tomographic scans revealed a free floating thrombus of the left internal carotid artery (ICA) with a large bilateral frontal ischemic lesion. The diagnosis of a medium-sized PFO with moderate right-to-left contrast shunting was made after transesophageal echocardiography. No other cardiac sources for embolization were detected, while an ascending thrombophlebitis of the right greater saphenous vein was detected by venous Doppler ultrasonography. These findings support the diagnosis of ICA free-floating thrombus caused by paradoxical embolization (via the PFO) of clot from the greater saphenous vein. The patient underwent emergency saphenofemoral disconnection with femoral vein thrombectomy and subsequently carotid artery thrombectomy under general anesthesia. No carotid atheromatous wall lesions were detected at surgical exploration; no immunologic pathology, hypercoagulable status, or malignancy were recorded. No hemorrhagic cerebral complications were observed in the postoperative period, and the patient had an improvement of her neurologic status (a reduction of the National Institutes of Health Stroke Scale score from 7 to 3). Her recovery was uneventful. The patient was transferred for rehabilitation on postoperative day 5 with oral anticoagulation. Six-month ultrasound follow-up revealed deep and superficial venous system and carotid artery patency. The patient was asymptomatic and anticoagulation was discontinued. Paradoxical cerebral embolization through a PFO is a rare phenomenon that, in our patient, appeared to have resulted in stroke caused by a free-floating thrombus in the ICA. Accurate evaluation of carotid and lower limb veins by duplex scan is mandatory in cases of stroke of unknown origin, and urgent surgical repair can be useful in order to improve the clinical outcome.

Large aortic pseudoaneurysm and subsequent spondylodiscitis as a complication of endovascular treatment of iliac arteries.

Both aortic pseudoaneurysm following endovascular aortoiliac reconstruction and spondylodiscitis subsequent to endograft infections are rare complications. We present a case of aortic false aneurysm following iliac arteries treatment complicated by spondylodiscitis after its endovascular repair. In this patient, a huge aortic pseudoaneurysm was diagnosed and treated in an emergency setting a few days after the procedure. A left aortomonoiliac endograft was placed and a femoro-femoral crossover bypass was performed. Afterward, the patient developed a stent graft infection and a lumbar spondylodiscitis. The patient was managed with a conservative treatment and, after 4 years, he continues to live. Analyzing this case, we would like to point out the following aspects: any procedure, although well established and technically simple, can cause life-threatening complications; hematomas resulting from endovascular exclusion of large pseudoaneurysms could be drained, to prevent bacterial infections.

Mid- and long-term results of endovascular treatment in thoracic aorta blunt trauma.

STUDY AIM: Evaluation of results in blunt injury of the thoracic aorta (BAI) endovascular treatment. MATERIALS AND METHODS: Sixteen patients were treated for BAI. Thirteen patients had associated polytrauma, 4 of these had a serious hypotensive status and 4 had an hemothorax. In the remaining 3, two had a post-traumatic false aneurysm of the isthmus and 1 had a segmental dissection. In those 13 patients a periaortic hematoma was associated to hemothorax in 4. All patients were submitted to an endovascular treatment, in two cases the subclavian artery ostium was intentionally covered. RESULTS: One patient died for disseminated intravascular coagulation. No paraplegia was recorded. No ischemic complications were observed. A type I endoleak was treated by an adjunctive cuff. During the followup (1-9 years) 3 patients were lost. A good patency and no endoleaks were observed in all cases. One infolding and 1 migration of the endografts were corrected by an adjunctive cuff. CONCLUSION: The medium and long term results of the endovascular treatment of BAI are encouraging with a low incidence rate of mortality and complications. More suitable endo-suite and endografts could be a crucial point for the further improvement of these results.

Post-implantation syndrome: the impact of different devices for endovascular abdominal aortic aneurysm repair and related etiopathogenetic implications.

BACKGROUND: Postimplantation syndrome (PIS) is a systemic inflammatory response occurring in early phase after abdominal aortic aneurysm (AAA) endovascular repair (EVAR). PIS can also occur after endovascular aneurysm sealing (EVAS) with Nellix system which prevent new onset of mural thrombus inside. Aim was to compare the incidence of PIS after EVAS and EVAR to evaluate the possible role of the new-onset thrombus inside the aneurysmal sac. Secondary aims were to assess the effect of AFX (Endologix) endoskeleton compared with other commercially available exoskeleton PTFE stent grafts on inflammatory response and its relationship with the clinical outcomes. METHODS: From 2013 to 2017, data on 60 elective EVAS with Nellix system (Endologix, Irvine, CA, USA) and 110 EVAR with ePTFE devices (56 AFX devices and 54 other stent grafts) for AAA patients were retrospectively collected. PIS was defined as composite of body temperature ≥38 °C coinciding with leukocyte count >12,000/mL and hs-CPR >10 mg/L. New-onset thrombus volume after EVAR was calculated by: endograft volume - preoperative luminal volume=volume of new-onset thrombus, whereas post-EVAS thrombus volume was calculated from difference between AAA volume and volume of Nellix endobags, including balloon expandable stents. Nonparametric χ2 distribution with corresponding P values were used to assess differences among categorical variables with regard to endograft type. Threshold of statistical significance was P<0.05. Subgroup analysis of outcomes by stent-graft design was performed using independent-samples t-test. RESULTS: EVAS with Nellix system was associated with lower incidence of PIS compared to EVAR using both AFX device and other endografts (8.3%, 30%, 35%, respectively, P=0.001). No significant new-onset of mural thrombus occurred following EVAS while an avarage new-onset thrombus of 21% and 14% was found in EVAR group A and group B, respectively. No statistically significant difference of PIS incidence was observed after endoskeleton AFX device deployment compared with other EVAR exoskeleton endografts. During follow-up, major complications were proportionally but not significantly (P=0.43) less frequent after EVAS (10.3%) than after EVAR and after EVAR using AFX device (8.9%) than after EVAR with other PTFE stent grafts (16.4%). CONCLUSIONS: The etiology and pathophysiology of PIS is not yet well understood. It is speculated that the type of the stent graft or the mural thrombus within the AAA may play a role in determing this inflammatory response. In this study, PIS was significantly less frequent after EVAS than EVAR. The lower inflammatory reaction observed after EVAS might be related to the endobags of Nellix system which completely seal the aneurysm sac reducing the new onset of mural thrombus. This could confirm the role of new-onset mural thrombus in the genesis of PIS. The systemic inflammatory response does not significantly differ after endoskeleton AFX device deployment compared with other EVAR exoskeleton stent grafts. PIS does not seem to have any significant prognostic implications in terms of major adverse events.

An exploratory cross-sectional study of subclinical vascular damage in patients with polymyalgia rheumatica.

The aim of the study was to investigate the presence of subclinical vascular damage in polymyalgia rheumatica (PMR). We enrolled PMR patients having major cardiovascular risk factors (MCVRF) and, as controls, patients with MCVRF. All underwent: color Doppler ultrasound to evaluate the common carotid intima-media thickness (IMT), the anterior-posterior abdominal aortic diameter (APAD), and the prevalence of carotid artery stenosis; the cardio-ankle vascular index (CAVI) to measure arterial stiffness together with the ankle-brachial index (ABI) to investigate the presence of lower-extremity peripheral arterial disease. Finally, we measured the serum levels of adipocytokines implicated in vascular dysfunction. As a result, 48 PMR and 56 MCVRF patients were included. An increase of IMT (1.07/0.8-1.2 vs 0.8/0.8-1.05; p = 0.0001), CAVI (8.7/7.8-9.3 vs 7.6/6.9-7.8; p < 0.0001) and APAD values (21.15/18.1-25.6 vs 18/16-22; p = 0.0013) was found in PMR patients with respect to controls. No differences were reported in the prevalence of carotid artery stenosis or ABI values between the two groups. A significant correlation between IMT and CAVI in PMR and MCVRF subjects (r2 = 0.845 and r2 = 0.556, respectively; p < 0.01) was found. Leptin levels (pg/mL; median/25th-75th percentile) were higher in PMR than in MCVRF subjects (145.1/67-398.6 vs 59.5/39.3-194.3; p = 0.04). Serum levels of adiponectin (ng/mL) were higher in PMR patients (15.9/10.65-24.1 vs 6.1/2.8-22.7; p = 0.01), while no difference in serum levels of resistin (ng/mL) was found between PMR and MCVRF subjects (0.37/0.16-0.66 vs 0.26/0.14-1.24). Our study shows an increased subclinical vascular damage in PMR patients compared to those with MCVRF, paving the way for further studies aimed at planning primary cardiovascular prevention in this population.

Early and mid-term outcomes of a novel Endovascular Aneurysm Sealing (EVAS) system in patients with infrarenal abdominal aortic aneurysms.

BACKGROUND: Endovascular aneurysm sealing (EVAS) using the Nellix system is a promising technology for Abdominal Aortic Aneurysm (AAA) treatment. Long-term data is unavailable regarding the potential modifications of the EndoBags and their content, and the polymer behavior over time. We present our initial clinical experience with this sac anchoring endoprosthesis in 24 patients with a maximum 12 months follow-up. METHODS: From December 2013 to March 2015, 24 patients with an infrarenal AAA were treated with the Nellix™ System. Computed tomography angiography (CTA) scan control was performed at 30 days, and follow-up magnetic resonance angiography (MRA) and ultrasounds were performed at 30 days, 6 and 12 months. Median and peak systolic velocities in the suprarenal aorta were measured preoperatively and during follow-up using phase contrast sequences and Argus (Siemens, Erlangen, Germany) software of the MRA. RESULTS: We achieved 100% technical success, 0% aneurysm-related mortality and 0% endoleaks. One patient (4%) experienced early acute thrombosis of a single Nellix stent, successfully treated with thrombolysis. Sac shrinkage occurred in 80% of cases with 12-months follow-up. CONCLUSIONS: Our preliminary clinical experience is promising, with 100% early technical success and satisfactory sealing of the aneurysm sac. Postprocedural controls during 1-year follow-up revealed no morphologic changes of the aneurysm wall, stable device and endobag position, and gradual dissolution of the air initially trapped within the EndoBags. Aneurysmal sac shrinkage occurs and probably is due to the remodeling of the thrombus around the EndoBags and the dissipation of the air bubbles into the EndoBags.