Stent Grafts In Patients Research Articles

Durability of a Second-generation Balloon-expandable Covered Stentgraft in Patients Treated With Fenestrated, Branched, and the Chimney Endovascular Aortic Aneurysm Repair Techniques

Durability of a Second-generation Balloon-expandable Covered Stentgraft in Patients Treated With Fenestrated, Branched, and the Chimney Endovascular Aortic Aneurysm Repair Techniques

Mid-term results of "off-label" use of the Endurant stentgraft in patients with infrarenal abdominal aortic aneurysms.

EVAR is the preferred treatment modality for patients with an infrarenal abdominal aortic aneurysm with suitable anatomy. Each manufacturer of aortic stentgrafts has specific anatomic requirements. In some patients, it is not possible to adhere to the instructions for use, but alternative treatment is also not possible. In these patients, EVAR can be performed outside instructions for use. In this study, all consecutive patients in whom an Endurant II or IIS stentgraft was used between 1 January and 31 December were reviewed. We compared the two patient groups in whom this stentgrafts was used outside and inside instructions for use. Patients with planned adjuvant therapy, for example, chimney procedure or iliac side branches, were excluded. In 74 of 178 (41.6%) patients, the instructions for use were not adhered. The main reason was pathology of the aortic neck. There were more patients with type IA endoleak, this difference was borderline significant (p = .06). There were more patients with limb occlusion in the early postoperative period, but at the end of the follow-up period, the incidence was comparable. Aneurysm-related mortality and all-cause mortality were comparable in both groups. In this study, real-life experience with the Endurant II and IIS stentgraft is described. Non-adherence with instructions for use was associated with a higher risk of endoleak type IA (p = .06). In the early postoperative period, there were more patients with limb occlusion; this finding was not observed anymore at the end of the follow-up period.

Outcomes of thoracic endovascular aortic repair using fenestrated stent grafts in patients with thoracic aortic distal arch aneurysms.

Thoracic endovascular aortic repair (TEVAR) for aortic arch aneurysms is challenging because of anatomical restrictions and the presence of cervical branches. Revascularization of the cervical branch is required when conventional commercial stent grafts are used. TEVAR using fenestrated stent grafts (FSG) often does not require additional procedures to revascularize cervical branches. This study aimed to evaluate the features and initial and midterm outcomes of TEVAR using fenestrated stent grafts. From April 2007 to December 2016, 101 consecutive patients underwent TEVAR using fenestrated stent grafts for distal aortic arch aneurysms at a single centre. Technical success, complications, freedom from aneurysm-related death, secondary intervention and aneurysm progression were retrospectively investigated. All the patients underwent TEVAR using fenestrated stent grafts. The 30-day mortality rate was zero. Cerebral infarction, access route problems and spinal cord injury occurred in 4, 3 and 2 patients, respectively. Each type of endoleak was observed in 38 of the 101 patients during the course of the study; 20/38 patients had minor type 1 endoleaks at the time of discharge. The endoleak disappeared in 2 patients and showed no significant change in 8 patients; however, the aneurysm expanded over time in 10 patients. Additional treatment was performed in 8 of the 10 patients with type 1 endoleaks and dilatation of the aneurysm. The rate of freedom from aneurysm-related death during the observation period was 98%. TEVAR with FSG is a simple procedure, with few complications. Additional treatment has been observed to reduce aneurysm-related deaths, even in patients with endoleaks and enlarged aneurysms. Based on this study, the outcomes of endovascular repair of aortic arch aneurysms using a fenestrated stent graft seem acceptable.

Impact on early outcome after endovascular repair of type B dissection without proximal landing zone using Castor single-branched stent graft-a retrospective cohort study.

The early safety and efficacy of Castor branch stents have been demonstrated. However, the effect of aortic arch morphology on endovascular therapy remains an unresolved issue. This study aims to assess the impact of aortic arch morphology on the early outcomes of endovascular repair using Castor stent graft in patients who have acute type B aortic dissection involving the left subclavian artery (LSA). This is a retrospective cohort study. From January 2019 to December 2021, forty-one patients scheduled for thoracic endovascular aortic repair (TEVAR) of TBADs from Beijing Anzhen Hospital were enrolled in this retrospective cohort study and divided into two groups based on the length of the proximal landing zone left common carotid artery-LSA (PLZ LCCA-LSA), specifically the distance between the LCCA and the LSA (group A ≤10 mm and group B >10 mm). The study recorded technical success, mortality and aortic-related post-operative adverse events. Morphological indices were analyzed including the bird-beak configuration. The bird-beak configuration refers to the wedge-shaped gap between the undersurface of the endograft and the lesser curvature of the arch. The relationship between the risk of bird-beak configuration and PLZ was assessed with logistic regression analysis. Meanwhile, the relationship between the risk of aortic-related adverse events and bird-beak configuration was assessed with logistic regression analysis. Follow-up data were analyzed by Kaplan-Meier life table analysis. The study included 41 patients with a mean age of 63.1±9.2 years, of which 80.5% were male. 18 patients from group A and 23 patients from group B were included in the comparative analysis. There were no significant differences in aortic-related adverse events, bird-beak phenomenon and re-intervention between groups A and B in 30-day outcomes. Six-month outcomes: aortic-related adverse events and the bird-beak phenomenon were observed in 11 (26.8%) and 12 (29.3%) patients, respectively. There was a significant difference in the occurrence of aortic-related adverse events (P=0.036) and bird-beak phenomenon (P=0.002) between groups A and B. In comparison to group B, the aortic-related adverse event rate was significantly higher in group A, with event-free rates of 83.3%, 83.3%, and 72.2% at 1, 3, and 6 months, respectively (P=0.020). Multivariable logistic regression analyses revealed that PLZ LCCA-LSA length [odds ratio (OR) 0.79; 95% CI: 0.64 to 0.97; P=0.026] was significantly associated with the occurrence of the bird-beak configuration, and bird-beak (OR 17.19; 95% CI: 2.24 to 131.81; P=0.006) was a significant risk factor for aortic-related adverse events. TEVAR with LSA revascularization has good early outcomes. However, it is more susceptible to aortic adverse events when the PLZ LCCA-LSA is less than 10 mm in length. This should be carefully considered, taking into account the risks and benefits.

FORWARD Study of GORE VIABAHN Balloon-Expandable Endoprostheses and Bare Metal Stents in the United States, European Union, United Kingdom, Australia, and New Zealand When Placed to Treat Complex Iliac Occlusive Disease: Protocol for a Randomized Superiority Trial.

The recommendations for the use of and selection of covered stent grafts in patients with aortoiliac occlusive disease are limited. The GORE VBX FORWARD clinical study aims to demonstrate the superiority of the GORE VIABAHN VBX Balloon Expandable Endoprosthesis (VBX device) for primary patency when compared to bare metal stenting (BMS) for the treatment of complex iliac artery occlusive disease. A prospective, multicenter, randomized control study in the United States, European Union, United Kingdom, Australia, and New Zealand will enroll patients with symptomatic, complex iliac artery occlusive disease. In this study, iliac artery occlusive disease is defined as a unilateral or bilateral disease with single or multiple lesions (with >50% stenosis or chronic total occlusion) each between 4 and 11 cm in length. In an attempt to more closely match real-world practices, patients with minor tissue loss (Rutherford class 5) and patients requiring hemodialysis will be included. Baseline aortoiliac angiography will be performed to assess target lesion characteristics and determine final patient eligibility. Once the patient is confirmed and guidewires are in place across the target lesions, the patient will be randomized in a 1:1 format to treatment with either the VBX device or a BMS. The BMS can be balloon- or self-expanding and must be approved for the iliac artery occlusive disease indication. Patients, the independent core laboratory reviewers, and Clinical Events Committee members will be blinded from the assigned treatment. Dual antithrombotic medical therapy is required through a minimum of 3 months post procedure. The primary end point is 12‑month primary patency and will be adjudicated by an independent imaging core laboratory and Clinical Events Committee. Key secondary end points will be tested for superiority and include technical, acute procedural, and clinical success; changes in Ankle-brachial index; patient quality of life; primary patency; freedom from restenosis; primary-assisted patency; secondary patency; freedom from target lesion revascularizations; cumulative reintervention rate; amputation-free survival; survival; and change in Rutherford category. Study follow-up will continue through 5years. Outcomes will be reported following study completion. Enrollment is anticipated to start in October 2023. The results of this study will provide definitive, level 1 clinical evidence to clinicians on the optimal choice of stent device to use for the treatment of complex iliac artery occlusive disease. The FORWARD study is powered for superiority and includes only complex, unilateral, or bilateral lesions involving the common or external iliac arteries. This study is a multidisciplinary endeavor involving vascular surgery, interventional cardiology, and interventional radiology across multiple countries with a blinded core laboratory review of end points in hopes that the outcomes will be widely accepted and incorporated into practice guidelines for optimal treatment of patients with complex iliac artery occlusive disease. ClinicalTrials.gov NCT05811364; https://clinicaltrials.gov/study/NCT05811364. PRR1-10.2196/51480.

AFX unibody stent graft: Effective and safe for the treatment of severe aorto-iliac occlusive disease.

The primary objective of this study was to determine the primary, assisted primary and secondary patency rates of the Endologix AFX stent-graft in patients considered high risk for open surgery with complex aorto-iliac occlusive disease. The secondary objective was to determine 30-day major adverse cardiovascular and cerebrovascular events. A retrospective review was undertaken of clinical records of 38 patients who underwent AFX stent-graft placement for aorto-iliac occlusive disease from 2016 to 2019. Patient data was de-identified and entered into a REDcap secure database. Descriptive statistical analysis (means and standard deviations) and Kaplan-Meier survival curves were created to determine the duration of patency of the AFX stent-graft system. Primary patency rates at 6, 12 and 24months were 92%, 92% and 84%, respectively. Assisted primary patency rates at these times were 100%, 100% and 93% with secondary patency of 100% maintained throughout. The incidence of 30-day major adverse cardiovascular and cerebrovascular events was 8% and major adverse limb events was 3%. One death unrelated to the AFX device occurred during the study period though outside of the 30-day peri-operative period. Primary, assisted primary and secondary patency rates of AFX stent-grafts, when used to treat aorto-iliac occlusive disease, are high. This study supports the use of the AFX stent-graft for the endovascular treatment of complex aorto-iliac occlusive disease as an alternative to other endovascular options as well as a safe alternative to open aorto-iliac or aorto-femoral bypass in patients who are at high risk for open procedures.

Endurant Stent Graft in Patients with Challenging Neck Anatomy “One Step Outside Instructions for Use”: Early and Midterm Results from the EAGLE Registry

The aim of the Endurant for Challenging Anatomy: Global Experience (EAGLE) registry is to evaluate prospectively the technical and clinical success rate of a stentgraft used in patients with challenging neck anatomy outside the instructions for use (IFU) but within objective anatomical limits.

Optimal Sizing of Aortic Stent Graft for Blunt Thoracic Aortic Injury Considering Hypotension-Related Decrease in Aortic Diameter

Purpose: To evaluate the optimal sizing of an aortic stent graft in patients with blunt thoracic aortic injury (BTAI), considering the decrease in diameter in hypovolemic status. Materials and Methods: From 2014 to 2020, 25 patients who underwent thoracic endovascular aortic repair (TEVAR) for BTAI were included. Hemodynamic parameters in the emergency room (ER) and just before the main procedure (MP) were collected. The aortic sizes were measured during initial computed tomography (CT) on arrival in the ER, aortography (AG) during TEVAR, and final CT in the outpatient clinic. The appropriateness of the inserted stent graft size was investigated. Results: The mean values of the final CT/initial CT and final CT/initial AG (proximal descending thoracic aorta [pDTA]) were 113% and 105%, respectively. The final CT/initial CT (pDTA; 122.2% vs 108.8%, p=0.01) and final CT/initial AG (pDTA; 113.4% vs 102.1%, p<0.01) were significantly higher in patients with systolic blood pressure (SBP; MP) ≤90 mm Hg. The final CT/initial CT (pDTA; 120.4% vs 109.0%, p=0.03) and final CT/initial AG (pDTA; 111.4% vs 102.6%, p=0.01) were significantly higher in patients with mean blood pressure (MBP; MP) ≤70 mm Hg. On an average, the inserted stent grafts were oversized by 130% on initial AG. Based on the final CT scan, the inserted stent graft was as large as 122%. Conclusion: In the case of hemodynamic instability with SBP (MP) ≤90 mm Hg or MBP (MP) ≤70 mm Hg, despite adequate resuscitation, an oversized TEVAR stent graft of 130% can reduce the occurrence of endoleak and is sufficiently safe. Clinical Impact Despite sufficient resuscitation, the aorta size measured during TEVAR in patients with hemodynamic instability with systolic BP <90 mmHg and mean BP <70 mmHg may be reduced by more than 15% compared to that in the normal state. In this study, the mean size of the stent grafts were oversized by 130% on initial aortography, but were oversized by 122% based on final CT. When the stent graft was oversized by 130% in TEVAR for hemodynamic unstable patient with BTAI, the patient reached the proper oversizing subsequent to hemodynamic recovery.

Editor's Choice – Endurant Stent Graft in Patients with Challenging Neck Anatomy “One Step Outside Instructions for Use”: Early and Midterm Results from the EAGLE Registry

The aim of the Endurant for Challenging Anatomy: Global Experience (EAGLE) registry is to evaluate prospectively the technical and clinical success rate of a stentgraft used in patients with challenging neck anatomy outside the instructions for use (IFU) but within objective anatomical limits. This was a prospective, international, multicentre, observational study. From 1 February 2012 to 1 September 2017, patients with an abdominal aortic aneurysm with a challenging infrarenal neck that were deemed suitable for endovascular aneurysm repair were included prospectively at 23 European centres. Patients were distributed by anatomy into three groups: short neck (SN; infrarenal neck 5 - 10 mm in combination with suprarenal angulation [α] ≤ 45° and infrarenal angulation [β] ≤ 60°); medium neck (MN; infrarenal neck 10 - 15 mm with α ≤ 60° and β 60° - 75° or α 45°- 60° and β ≤ 75°; and long angulated neck (LN; infrarenal neck ≥ 15 mm with α ≤ 75° and β 75°- 90° or α 60°- 75° and β ≤ 90°. All computed tomography scans were reviewed by an independent core laboratory. Primary outcomes were technical and clinical success. Secondary endpoints were peri-operative major adverse events, all cause mortality, aneurysm related mortality, endoleaks, migration, and secondary intervention. One hundred and fifty patients (81.3% male) were included (SN= 55, MN= 16, LN= 79). The median follow up was 36 ± 12.6 months. In the overall cohort, the technical success rate was 93.3%. Estimated freedom from aneurysm related death was 97.3% at three years. Freedom from secondary interventions was 84.7% at three years. Estimated clinical success was 96.0%, 90.8%, and 83.2% at 30 days, one year, and three years, respectively. Estimated freedom from all cause mortality, late type IA endoleak, and migration at three years was 75.1%, 93.7%, and 99.3%, respectively. The early and midterm results of the EAGLE registry show that endovascular repair with the Endurant stentgraft in selected patients with challenging infrarenal neck anatomy yields results in line with large "real world" registries. Long term results are awaited for more definitive conclusions.

Early and midterm results of frozen elephant trunk operation with Evita open stent-graft in patients with Marfan syndrome: results of a multicentre study

BackgroundEndovascular treatment of patients with Marfan syndrome (MFS) is not recommended. Hybrid procedures such as frozen elephant trunk (FET), which combines stent-graft deployment with an integrated non-stented fabric graft for proximal grafting and suturing, have not been previously evaluated. The aim of this study was to assess the safety and feasibility of FET operation in patients with MFS.MethodsPatients enrolled in the International E-vita Open Registry (IEOR) who underwent FET procedure between January 2001 and February 2020 meeting Ghent criteria for MFS were included in the study. Early and midterm results were retrospectively analyzed. Preoperative, postoperative and follow-up computed tomography angiography scans were analysed.ResultsWe analyzed 37 patients [mean age 38 ± 11 years, 65% men]. Acute or chronic aortic dissection was present in 35 (95%) patients (14 and 21 patients respectively). Two (5%) patients had an aneurysm without dissection. Malperfusion syndrome was present in 4 patients. Twenty-nine (78%) patients had history of aortic surgical interventions. The 30-day and in-hospital mortality amounted to 8 and 14% respectively. False lumen exclusion was present in 73% in stented segment in last postoperative CT. The overall 5-year survival was 71% and freedom from reintervention downstream was 58% at 5 years. Of the nine patients who required reintervention for distal aortic disease, one patient died.ConclusionsFET operation for patients with MFS can be performed with acceptable mortality and morbidity. In long-term follow-up no reinterventions on the aortic arch were required. FET allows for easier second stage operations providing platform for surgical and endovascular reinterventions.

Endovascular treatment of traumatic aortic rupture using iliac extension stent-grafts in patients with small aortic diameters.

OBJECTIVESTo evaluate outcomes after thoracic endovascular aortic repair in young patients sustaining traumatic blunt aortic injury (BAI) using iliac extension stent-grafts because of small aortic diameters measuring <24 mm.METHODSRetrospective analysis regarding clinical presentation, trauma management, endovascular techniques and outcome of patients with a small descending aorta involving an iliac extension stent-graft to treat traumatic BAI.RESULTSAmong 48 patients who suffered a BAI and underwent thoracic endovascular aortic repair, 7 received iliac extension stent-grafts. They were 27.4/[standard deviation (SD): −13.1] years old and 6 out of 7 were male. The iliac extension stent-graft was used as distal stent-graft, and a thoracic stent-graft was used in most patients as proximal extension. We achieved overall technical success in all patients during a procedure lasting 92.6 (SD: 54.9) min. One patient died 2 days after the endovascular procedure of hypoxic brain injury, and another died after 17 days of liver failure. That patient had also suffered a spinal cord injury following the procedure, as the stent-graft had been deployed in Ishimaru Zone 2, and the carotid to subclavian bypass had to be omitted because of his critical condition. Control computed tomographic angiographs was available in 6 patients after 7.7 (SD: 5.1) days and showed no endoleak. The surviving patients were discharged after 18.4 (SD: 13.4) days.CONCLUSIONSTreating traumatic BAI using iliac extension stent-grafts in young patients with small aortic diameters is feasible. We observed no mortality caused by the BAI or related to endovascular therapy within this small patient cohort.

Follow-up Results of Endovascular Aneurysm Repair Following Abdominal Visceral Debranching.

The aim of this study is to present a series of six cases with thoracoabdominal aneurysm treated with hybrid technique in our center. Between May 2015 and December 2018, the data of six patients with thoracoabdominal aneurysms and various comorbidities who underwent visceral debranching followed by endovascular aortic aneurysm repair were reviewed retrospectively. Patients' mean age was 65.3±19.6 years. All of them were male. Comorbidities were old age, congestive heart failure, coronary artery disease, chronic obstructive pulmonary disease, previous surgical interventions, and/or esophageal hemangioma. Except for one patient who underwent coronary artery bypass grafting (inflow was taken from ascending aorta), debranching was performed from the right iliac artery. Debranching of four visceral arteries (superior mesenteric artery, celiac trunk, and bilateral renal right arteries) was performed in three patients, of three visceral arteries (superior mesenteric artery, celiac trunk, right renal artery) was performed in one, and of two visceral arteries (superior mesenteric artery, celiac trunk) was performed in two patients. Great saphenous vein and 6-mm polytetrafluoroethylene grafts were used in one and five patients, respectively, for debranching. Endovascular aneurysm repair was performed following debranching procedures as soon as the patients were stabilized. In total, three patients died at the early, mid, and long-term follow-up due to multiorgan failure, pneumonia, and unknown reasons. Hybrid repair of thoracoabdominal aneurysms may be an alternative to fenestrated or branched endovascular stent grafts in patients with increased risk factors for open surgical thoracoabdominal aneurysm repair; however, the procedure requires experience and care.

Outcomes of off-the-shelf multibranched stent grafts with intentional occlusion of directional branches using endovascular plugs during endovascular repair of complex aortic aneurysms

ObjectiveTo evaluate the technique and outcomes of intentional occlusion of directional branches (DBs) using endovascular plugs during branched endovascular aortic repair using off-the-shelf Zenith t-Branch thoracoabdominal (TAAA) stent grafts. MethodsWe reviewed the clinical data and outcomes of all consecutive patients treated by branched endovascular aortic repair using off-the-shelf Zenith t-Branch TAAA stent-graft (Cook Medical, Bloomington, Ind) in seven academic centers from 2013 to 2019. All patients had at least one DB intentionally occluded using extension of the branch with balloon or self-expandable covered stent, followed by placement of endovascular plugs. Intentional occlusion was indicated in patients with variations in the normal four-vessel renal-mesenteric anatomy, pre-existing dialysis, or in those who failed catheterization of a target vessel. End points were 30-day/in-hospital mortality, major adverse events, secondary interventions, target artery (TA) patency, TA instability, and patient survival. ResultsThere were 100 patients, 65 male and 35 female, with median age of 71 years (interquartile range [IQR], 66-75 years). Of these, 31 patients (31%) had urgent/emergent operations for symptomatic/contained ruptured aneurysms. The median aneurysm diameter was 72 mm (IQR, 61-85 mm). A total of 290 renal-mesenteric arteries were incorporated with a median of three (IQR, 3-3) vessels/patient. Indications for DB occlusion were less than four suitable renal-mesenteric targets in 84 patients or pre-existing dialysis and inability to catheterize a target vessel in eight patients each. There were 110 DBs occluded by vascular plugs, including 48 celiac axis, one superior mesenteric artery, and 61 renal DBs. Thirty-day/in-hospital mortality was 10%, including 9% for elective and 13% for urgent/emergent procedures. Major adverse events occurred in 44 patients (44%), including acute kidney injury in 19 patients (19%), estimated blood loss >1 L in 12 patients (12%), respiratory failure and new onset dialysis in six patients (6%) each, bowel ischemia in five patients (5%), and myocardial infarction and paraplegia in two patients (2%) each. The median follow-up was 5 months (range, 1-13 months). Eighteen patients (18%) required secondary interventions, none for problems related to the occluded DB. There were no endoleaks related to the occluded DB. At 2 years, primary and secondary patency and freedom from TA instability were 93% ± 3%, 97% ± 2%, and 91% ± 4%, respectively. Freedom from secondary interventions and patient survival were 75% ± 6% and 63% ± 7%, respectively. ConclusionsIntentional occlusion of DBs using endovascular plugs allows versatile use of a four-vessel off-the-shelf multi-branched TAAA stent graft in patients with variations in the normal renal and mesenteric anatomy or when technical difficulties prevent successful target vessel stenting. There were no endoleaks or secondary interventions associated with the occluded DB.

Use of the AFX Stent Graft in Patients with Extremely Narrow Aortic Bifurcation: A Multicenter Retrospective Study.

Introduction This study analyzed the patient outcomes following endovascular aortic aneurysm repair (EVAR) for infrarenal aortic pathologies with very narrow aortic bifurcations using the AFX stent graft. Methods The data was retrieved from the archived medical records of 35 patients treated for abdominal aortic aneurysm (AAA) (48.6%) or penetrating aortic ulcer (PAU) (51.4%) with very narrow aortic bifurcation between January 2013 and May 2020. Patient survival, freedom from endoleak (EL), and limb occlusion were estimated applying the Kaplan–Meier method. Results The mean follow-up time was 20.4 ± 22.8 months. The mean aortic bifurcation diameter was 15.8 ± 2.2 mm. Technical success was 100%, and no procedure-related deaths occurred. Two type II ELs occurred within 30-day follow-up. We observed one common iliac artery stenosis at four months and one type III EL at 54 months in the same patient, both of which required re-intervention. Overall patient survival was 95 ± 5% (AAA: 100%; PAU: 89 ± 10%), freedom from limb occlusion was 94 ± 5% (AAA: 91 ± 9%; PAU: 100%), freedom from type II EL was 94 ± 4% (AAA: 88 ± 8%; PAU: 100%), and freedom from EL type III was 83 ± 15% (AAA: 80 ± 18%; PAU: 100%) at the end of the follow-up period. Conclusions Very narrow aortic bifurcations may predispose patients to procedure-related complications following EVAR. Our results suggest a safe use of the AFX stent graft in such scenarios. The overall short- and long-term procedure-related patient outcomes are satisfying albeit they may seem superior for PAU when compared to AAA.

Acute Complex Endovascular Aortic Repair - Off-the-shelf vs. Surgeon-modified Stent Grafts

Treatment of complex abdominal and thoracoabdominal aortic aneurysms is challenging. Open surgical repair is a high-risk operation, especially in emergency cases. Endovascular aneurysm repair with a patient-specific custom-made stent graft in patients with symptomatic or ruptured complex aortic aneurysms is not possible, due to the manufacturing time required. In such cases, alternative endovascular techniques can be used. The "off-the-shelf" and "surgeon-modified" stent grafts are valid options for the endovascular treatment of complex aneurysms in urgent and emergent patients. The former are standardised commercially manufactured fenestrated or branched stent grafts, which are available off-the-shelf with an anatomical feasibility in 50 - 80% of the patients. The "surgeon-modified" stent grafts refer to a technique, in which a commercially available stent graft is modified by the surgeon under sterile conditions directly before the implantation, in order to add the required fenestrations, scallops and/or branches. The modification takes approximately 60 - 120 min and haemodynamic stability of the patient is mandatory. Because of the off-label use of the commercial stent graft, detailed patient consent about the modification complications and risks should be performed whenever possible. A comparison of results on mortality and morbidity between "off-the-shelf" and "surgeon-modified" stent grafts has been published, although a direct comparison would be unfair for several reasons (different design, lack of extensive outcomes reports, long learning curve and different modification techniques). The "surgeon-modified" and "off-the-shelf" fenestrated/branched stent grafts are used in the treatment of high-risk patients with symptomatic or contained ruptured complex aneurysms. The outcomes of the two techniques are good, although the long-term durability of the former should be further investigated.

Endovascular aortic repair in patients with challenging anatomies: the EXTREME study.

The aim of this study was to report the 30-day technical and clinical success with endovascular repair using the ultra-low-profile Ovation stent graft in patients judged to be outside the instructions for use (IFU) for conventional endografts, while amenable to treatment within the IFU for Ovation. One hundred and twenty-two patients (78.65±7.67 years; 111 male) were enrolled. Patients were evaluated as being outside the IFU for standard endografts because of the absence of a suitable proximal aortic neck in 109 cases (89.3%), of inadequate access vessels in 13 (10.7%), or both in 111 (90.9%). Mean aneurysm (abdominal aortic aneurysm [AAA]) diameter was 52.96±10.1 mm; mean aortic neck length was 7.75±6.05 mm. Technical success (98.4%) was achieved in all but two patients due to a type Ia endoleak. At completion angiography, 15 (12.3%) patients presented a type II endoleak. All patients underwent 30-day follow-up. Primary clinical success at one month was 96.8%, assisted clinical success 98.4%. There were no type I endoleaks, while 12 (9.8%) type II endoleaks were still evident, in the absence of sac expansions. Two patients (1.6%) presented an asymptomatic limb occlusion. Our experience suggests that, in a selected population of patients with challenging anatomy outside the IFU for conventional endografts, endovascular aneurysm repair (EVAR) using the Ovation stent graft can be performed safely with satisfactory immediate outcomes.

Endovascular Aneurysm Repair with Bifurcated Stent Grafts in Patients with Narrow Versus Regular Aortic Bifurcation: Systematic Review and Meta-analysis of Comparative Studies

Narrow aortic bifurcation (NAB) is considered as a risk factor for endograft limb thrombosis. The purpose of the study was to investigate the effect of narrow aortic bifurcation on outcomes of elective endovascular aneurysm repair (EVAR). A systematic review that conformed to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines was performed. We searched electronic bibliographic databases using a combination of controlled vocabulary (thesaurus) and free-text terms to identify relevant studies comparing outcomes of EVAR in patients with NAB versus those with regular aortic bifurcation. Pooled estimates of dichotomous outcomes were calculated using odds ratio (OR) and those of continuous outcomes using mean difference and 95% confidence interval (CI). To account for expected heterogeneity, the random-effects model was applied for statistical analysis. Six observational studies were included, reporting a total of 2,673 patients (412 with NAR and 2,261 with friendly anatomy). Perioperative mortality was similar between the groups (OR 1.14, 95% CI 0.30-4.34, P=0.85, I2=0%). Limb stenosis and kinking requiring additional intraoperative procedures was significantly more common among patients with NAB (OR 3.02, 95% CI 2.16-4.22, P<0.00001, I2=0%). Nevertheless, 30-day reintervention rate was similar between the groups, as was the rate of limb occlusion during follow-up. Available evidence suggests that at the expense of significantly more intraoperative additional procedures, EVAR with bifurcated devices can be safely performed in patients with NAB.

Early and midterm outcomes of endovascular aneurysm repair with an ultra-low-profile endograft from the Triveneto Incraft Registry

ObjectiveWe evaluated the early and midterm outcomes of the Incraft (Cordis Corp, Bridgewater, NJ) ultra-low-profile endograft by analyzing data from the Triveneto Incraft Registry (TIR). MethodsTIR is an independent multicenter cohort registry of 10 vascular surgery units in the Triveneto area (Northeast Italy). A prospective analysis of patients electively treated with Incraft from September 2014 to June 2019 was performed. The main outcomes were technical success, major 30-day complications, 30-day aneurysm-related death, freedom from reintervention, and mortality rate during follow-up and were analyzed using Kaplan-Meier curves. Univariable Cox regression was used to evaluate the associations between anatomic complexity factors and reintervention. ResultsDuring the study period, 209 patients were included in the registry. Their mean age was 76.9 ± 7.7 years and the Society for Vascular Surgery comorbidity score was 0.97 ± 0.52. Most patients (n = 181; 86.6%) had presented with at least one complex anatomic factor: aortic neck angle α <135° in 31 patients (14.8%), conic neck in 17 patients (8.2%), iliac tortuosity index τ >1.5 in 102 (48.8%), iliac artery calcification >50% in 106 (50.7%), and external iliac artery <6 mm in 45 (21.5%). The concurrent presence of two or more complex iliac anatomic factors was present in 67 patients (32.1%). The technical success rate was 99.5%, and the early major complication rate was 1.5% (one limb occlusion, one iliac branch stenosis, one type III endoleak [EL]). No 30-day mortality was recorded. The mean follow-up period was 18.5 ± 13.2 months. The overall mortality was 9.5% (n = 18), none related to the aneurysm. The freedom from reintervention rate was 92.1%. Of these patients, six (3.2%) had been treated for type II EL embolization, one (0.5%) for type IA EL, four (2.1%) for iliac branch occlusion, and one (0.5%) for flow-limiting external iliac artery dissection. None of the single anatomic factors analyzed were predictive of reintervention. However, the association of two or more complex iliac anatomic factors was predictive of related reintervention (hazard ratio, 7.25; P = .014). The crude reintervention rate in this complex subgroup of patients was low (4 of 67; 6%). ConclusionsData from the TIR have demonstrated excellent early and midterm outcomes of endovascular aneurysm repair using the Incraft stent graft in patients with complex anatomy. The concurrent presence of two or more complex iliac anatomic factors still represent an issue for endovascular aneurysm repair success. However, the technical characteristics of this device resulted in low intervention rates, even for patients with these challenging issues.

Preliminary Experience Using a Covered Stent Graft in Patients with Acute Ischemic Stroke and Carotid Tandem Lesion.

Endovascular treatment with a covered heparin-bonded stent graft has been shown to be feasible and safe for treatment of peripheral artery disease, but its role in carotid disease remains unclear. The purpose of this study was to determine the feasibility and safety of a covered stent graft in treating cervical carotid artery disease in a consecutive series of patients with acute ischemic stroke (AIS) due to tandem lesion in a single high-volume Comprehensive Stroke Center. A retrospective review of all patients that underwent carotid endovascular interventions during mechanical thrombectomy for AIS using a self-expanding covered stent graft at Vall d'Hebron University Hospital between 2016 and 2018 was conducted. Patient clinical and angiographical characteristics as well as postoperative outcome and follow-up were recorded. A total of eight patients were treated with the covered stents, and we observed significant improvement in stroke severity at 24h in 5/8 patients (mean NIHSS 18 ± 5 vs 12 ± 8, p = 0.02). Successful recanalization (TICI 2b-3) after thrombectomy was achieved in 5/8 (62.5%) patients. One stent occluded during the procedure. At 3-month follow-up, stents were patent in three (37.5%) patients (two with mRS 3 and one with mRS 1). The stents of the remaining four patients (62.5%) were occluded (one with mRS 2 and three with mRS 4), although the patients did not show signs of stroke recurrence. The preliminary results of our study show that the self-expanding covered stent graft did not achieve satisfactory patency at 90-days among patients with AIS and tandem lesions, suggesting that its use in the carotid circulation may not be recommended in the context of AIS.

Management of Uncomplicated Type B Aortic Dissection

Acute aortic dissection has an incidence of approximately half that of symptomatic abdominal and thoracic aneurysm of the aorta and more than twice the mortality of population-based controls. While urgent undelayed open surgery is the strategy of choice in proximal dissection, medical management has been the mainstay of treatment for uncomplicated distal or type B aortic dissection, but endovascular intervention is now considered a potential treatment option for all type B dissection due to its success in complicated cases. Endovascular repair can be technically demanding in aortic dissection, and timing of the repair can have a significant influence on anatomical and clinical outcome. Observational reports of feasibility and reasonable safety are flanked by only two randomised trials; the Acute Dissection Stent Grafting or Best Medical Treatment (ADSORB) trial demonstrated improved remodelling in acute dissection and the INvestigation of STEnt grafts in patients with type B Aortic Dissections (INSTEAD) trial showed better long-term survival in patients treated endovascularly in the subacute phase. Meta-analyses and other large clinical studies have demonstrated mixed results. Due to some risks associated endovascular repair and the requirement of specialist aortic care (which is not always available), a pragmatic approach for current management could involve high intensity serial imaging in the acute phase of a type B aortic dissection, thereby identifying complicated cases for early intervention and selection of patients at high risk of disease progression for deferred endovascular management in the subacute phase within 90 days.