Secondary Endovascular Procedures Research Articles

Solving Intraoperative Complications During Endovascular Repair of Late Contained Ruptured Aortic Pseudoaneurysm After Surgical De-coarctation: Case Report and Systematic Review of Literature.

We present a case of successful endovascular repair of late ruptured aortic anastomotic pseudoaneurysm following previous left subclavian artery-descending thoracic aorta bypass and concomitant emergency thoracic endovascular aortic repair (TEVAR) of complicated endovascular aortic de-coarctation never previously described is also presented. A review of the intraoperative, 30-day, and follow-up morbidity, mortality, and complications of TEVAR as endovascular treatment of late aneurysm/pseudoaneurysms after surgical aortic de-coarctation was also performed. The systematic review was performed in accordance with the Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) statement and following PICO model. A literature search was conducted on MEDLINE, PubMed, EMBASE, Cochrane Library, Google Scholar, Science Direct, and Web of Science using the words "tevar of late complication of aortic coarctation surgical repair" and "endovascular repair of anastomotic pseudoaneurysm in coarctation" up to June 17, 2022. Data were extracted from study documents about study design, patient's demographics and comorbidities, details about primary surgical repair, type of late complication, time between open surgery and occurrence of complications, details of the secondary endovascular procedure with technical success, early, and follow-up mortality and morbidity. A total of 18 papers were included with 78 patients (48 men, 69.5%). The most frequent type of primary open surgical repair was patch aortoplasty (46, 58.9%). Focusing on aneurysm and pseudoaneurysm as late complications, most of the patients were asymptomatic (45, 57.7%). All patients underwent TEVAR, 14 of them (17.9%) in urgent/emergent setting. The technical success was 98.7%, with 1 intraoperative death due to rupture of the aorta. In total, 31 patients out of 78 (39.7%) showed different complications in the immediate postoperative time, with type II endoleak being the most observed (8/31, 25.8%). The mean follow-up time was about 2 years (26.5 months, range 3-92). Overall, 30-day mortality was 2.6%. Complications occurred in 30 patients (39.4%), 23 of them resolved during the follow-up period. With the limit of low-quality data, TEVAR can be considered a safe and effective option for the treatment of late complications after open surgery for aortic coarctation, even in urgent settings. Different specialists have to face the technical complexities and risks related to treatment of late complications after surgical de-coartaction, which can be either surgical or endovascular, and depend on patient's ages. Although covered stents appear to have some protection from the development of stent fractures, doesn't provide complete protection from late aneurysm formation. In this setting, TEVAR may represent a valuable option, combining the advantages of the covered stent with those of a device that can cover a wider range of aortic length, especially in adult patients. This study shows thoracic endovascular repair can be considered a safe and effective option in clincal practice for the treatment of late complications after open surgery for AC, even in urgent settings.

Secondary endovascular procedures improve overall patency and limb salvage in patients undergoing in situ saphenous vein infragenicular bypass.

Secondary interventions strongly improves patency and limb salvage rates in patients undergoing infrainguinal vein bypass. The aim of this study was to evaluate the influence of secondary endovascular procedures performed during the follow-up on patency and limb salvage in patients with critical limb-threatening ischemia (CLTI) undergoing in situ saphenous vein infragenicular bypass. From January 2018 to December 2019 541 patients in 43 centers have been enrolled into the LIMBSAVE registry (treatment of critical Limb IschaeMia with infragenicular Bypass adopting in situ SAphenous VEin technique). In all patients a strict surveillance program with Duplex scan was established (1, 3, 6, 9, 12, 18, 24 months). During the follow-up indications for endovascular procedures were anastomotic stenoses, improvement of run-in (iliac stenosis) or run-off (tibial vessels' stenoses or occlusions). Two-year estimated outcomes in terms of overall patency, and limb salvage were analyzed by life-table analysis (Kaplan-Meier test). Outcomes obtained in patients undergoing endovascular procedure (Group-endo) were compared by means of Gehan-Breslow-Wilcoxon Test with those obtained in patients with no secondary endovascular procedure during the follow-up (Group-no endo). Two groups were homogeneous in terms of demographics and intraprocedural details. Overall mean duration of follow-up was 12.1 months (range 1-24). During the follow-up period (>30 days) 55 endovascular procedures were performed in 49 patients (9.1%) (Group-endo). Most of endovascular procedures (37/55, 67.3%) was performed to treat stenoses at proximal or distal anastomosis. Secondary endovascular procedures (40/55, 72.7%) were predominantly performed within 6 months from the index procedure. Estimated 2-year overall patency (97.9% vs. 85.2%, P=0.05), and limb salvage (100% vs. 93.9%, P=0.05) rates were significantly better in Group-endo. Secondary endovascular procedures in patients with CLTI undergoing in situ saphenous infragenicular bypass significantly improve the rates of overall patency and limb salvage in the mid-term period.

Total Aortic Arch Replacements With a 4 Branched Frozen Elephant Trunk (FET) Graft in Acute Aortic Dissection (DeBakey type I)

Total Aortic Arch Replacements With a 4 Branched Frozen Elephant Trunk (FET) Graft in Acute Aortic Dissection (DeBakey type I)

Prospective Multicentre Cohort Study of Fenestrated and Branched Endografts After Failed Endovascular Infrarenal Aortic Aneurysm Repair with Type Ia Endoleak

Failed endovascular infrarenal aortic aneurysm repair (EVAR) due to development of late type Ia endoleak exposes patients to the risk of rupture and should be treated. The purpose of this study was to evaluate the results of fenestrated/branched EVAR (F/BEVAR) for treatment of failed EVAR with type Ia endoleak. From January 2010 to December 2019, a prospective multicentre study was conducted (ClinicalTrials.gov identifier: NCT04532450) that included 85 consecutive patients who had undergone F/BEVAR to treat a type Ia endoleak following EVAR. The primary outcome was overall freedom from any re-intervention or death related to the F/BEVAR procedure. In 30 cases (35%) EVAR was associated with a short < 10 mm or angulated (> 60°) infrarenal aortic neck, poor placement of the initial stent graft (n= 3, 4%), sizing error (n= 2, 2%), and/or stent graft migration (n= 7, 8%). Type Ia endoleak was observed after a period of 59 ± 25 months following EVAR. The authors performed 82 FEVAR (96%) and three BEVAR (4%) procedures with revascularisation of 305 target arteries. Overall technical success was 94%, with three failures including one persistent Type Ia endoleak and two unsuccessful stent graft implantations. Intra-operative target artery revascularisation was successful in 303 of 305 attempts. The in hospital mortality rate was 5%. Cardiac, renal and pulmonary complications occurred in 6%, 14%, and 7% of patients, respectively. Post-operative spinal cord ischaemia occurred in four patients (4.7%). At three years, the survival rate was 64% with overall freedom from any re-intervention or aneurysm related death of 40%, and freedom from specific F/BEVAR re-intervention of 73%. At three years, the secondary patency rate of the target visceral arteries was 96%. During follow up, 27 patients (33%) required a revision procedure of the fenestrated (n= 11) or index EVAR stent graft (n= 16), including six open conversions. While manufactured F/BEVAR was effective in treating type Ia endoleak in patients with failed EVAR, it was at the cost of a number of secondary endovascular and open surgical procedures.

Single-center midterm results with the low-profile Zenith Alpha thoracic endovascular stent graft

ObjectiveThe analysis of endovascular treatment of thoracic aortic diseases using new low-profile stent grafts in large series is crucial to understanding the durability of these devices. The present study reports the midterm outcomes of a single-center experience using the Zenith Alpha thoracic endovascular stent graft. MethodsThe outcomes of 270 procedures performed on 262 patients (197 men; mean age, 70.5 ± 9.5 years) using the Zenith Alpha thoracic endovascular stent graft from November 2013 to December 2019 for different thoracic aortic diseases were analyzed. The primary endpoints were 30-day clinical success and midterm (5-year) clinical success. The secondary endpoints were the adverse event rate at 30 days and midterm and access- and device-related complications. The follow-up of surviving patients was performed using computed tomography angiography and office visits at 1, 6, and 12 months and annually thereafter. Kaplan-Meier analysis was performed for overall survival, and freedom from thoracic aortic endovascular repair–related mortality and related reinterventions. ResultsThe overall 30-day mortality was 5.2% (2.5% for elective and 30.8% for nonelective cases). Type I endoleaks were identified in six patients. The 30-day primary technical and clinical success rates were 97.8% and 92.6%, respectively. Femoral cutdown was used in 41.1% of cases and percutaneous access in 58.5%. The rate of femoral artery complications after the percutaneous approach was 5.1%, with the need for surgical conversion in 1.9%. The stroke rate was 4.1% (major stroke, 2.2%), and the spinal cord ischemia rate was 3.7% (permanent paraplegia, 0.7%). Of the 248 survivors, 239 complied with the follow-up protocol with adequate computed tomography angiograms available images. Overall follow-up survival was 94.0% at 1 year, 91.6% at 2 years, 88.9% at 3 years, and 88.5% at 5 years. The unplanned secondary endovascular procedure rate was 5.3%. No stent fractures or new-onset type I endoleaks due to stent graft migration were observed in the study cohort. ConclusionsThe midterm outcomes of this new generation of low-profile devices were satisfactory. The reported low incidence of secondary procedures and the absence of migrations are promising for the long-term durability of these devices.

Five Year Patient Outcomes of Endovascular Abdominal Aortic Aneurysm Repair in the ENDURANT France Registry

Endovascular repair is the preferred method of treatment for infrarenal abdominal aortic aneurysms with numerous publications from multiple geographic regions showing excellent patient outcomes. Since the original ACE (Anevrysme de l'aorte abdominale: Chirurgie versus Endoprothese) randomised control trial, studies of French specific population have also contributed significantly to the body of evidence in support of endovascular abdominal aortic repair. In the ENDURANT France registry, 180 patients were consecutively enrolled from 20 French centres starting in 2012. Investigational sites included public and private practice and differing centre volumes to be as representative of real world French experience as possible. The aim of this study was to present the five year outcomes from this registry. Instructions for use (IFU) were respected in 97.8% (176/180) of patients. At five years, the Kaplan-Meier overall survival was 69.9%±3.5% and the freedom from aneurysm related death was 97.6%±1.2%. The freedom from Type IA endoleaks was 94.5%±1.7%, freedom from endoleaks of any type was 70.1±3.4%, and freedom from secondary endovascular procedure 90.4%±2.6%. In addition, 61.6% (45/73) of patients exhibited sac shrinkage at five years. In this five year report of the Endurant France registry, survival, re-intervention, and freedom from endoleak rates were comparable to recent EVAR registries and there was a high sac shrinkage rate. Secondary procedure and aneurysm rupture were lower than those of ACE, the French RCT which included older generation devices. This prospective registry demonstrates favourable five year outcomes of the Endurant stent graft used within IFU.

Has Endovascular Aortic Repair Reached a State of Perfection or is There Still Work to be Done?

In this issue, Becquemin et al.1 demonstrate promising long term results using the Endurant stent graft in a multicentre French single arm post-market registry, with a Kaplan–Meier five year freedom from type IA endoleaks and secondary endovascular procedures of 94.5 ± 1.7% and 90.4 ± 2.6%, respectively. Proponents of endovascular aortic repair (EVAR) may use this study as another example that EVAR has almost reached a state of perfection. However, we should still be aware of a few areas of concern and improvement.

Outcomes of elective use of the chimney endovascular technique in pararenal aortic pathologic processes

ObjectiveIn the treatment of pararenal abdominal aortic aneurysms and aortic pathologic processes, chimney endovascular aneurysm repair (CHEVAR) represents an alternative technique for urgent cases. The aim of the study was to evaluate the outcomes of CHEVAR in the elective setting. MethodsWe performed a retrospective analysis of prospectively collected records of 165 consecutive asymptomatic CHEVAR patients who were treated between March 2009 and January 2018 with the Endurant stent graft (Medtronic, Santa Rosa, Calif). A total of 244 chimney grafts (CGs) were implanted. The primary end point was clinical success, defined as freedom from procedure-related mortality, persistent type IA endoleak, occlusion or high-grade stenosis (>70%) of CGs, and any chimney technique-related secondary procedure for the entire follow-up period. Secondary clinical success included patients with successful treatment of a primary end point with a secondary endovascular procedure. ResultsAll 244 targeted chimney vessels were successfully cannulated. Total perioperative morbidity was 7.8% (n = 13), including 3 (1.8%) cases of bowel ischemia, 1 (0.6%) patient with renal ischemia, and 1 patient (0.6%) with stroke. Median follow-up was 25.5 ± 2.2 months. Both 30-day and follow-up procedure-related mortality rates were 1.8% (n = 3). Primary and secondary freedom from persistent type IA endoleak rates were 96.4% (n = 159) and 99.4% (n = 164), respectively. Primary and secondary CG patency rates were 92.2% (n = 225) and 95.9% (n = 234), respectively. The rate of reinterventions related to the chimney technique was 10.9% (n = 18), and 83.3% of them were performed by endovascular means. The estimated cumulative primary patency and freedom from persistent type IA endoleak were 87.5% and 95.3%, respectively, and the primary and secondary clinical successes rates at midterm were 80.3% and 87.5%, respectively. ConclusionsThe elective use of CHEVAR with the Endurant stent graft in our series showed favorable midterm clinical results, which are similar to the published results of other total endovascular modalities. A prospective randomized trial of elective treatment of pararenal abdominal aortic aneurysms and aortic pathologic processes with current endovascular options is needed to assess the value of CHEVAR in the elective setting.

Analysis of Midterm Outcomes of Endovascular Aneurysm Repair in Octogenarians From the ENGAGE Registry

Purpose: To assess periprocedural results and secondary endovascular procedure outcomes over 5 years in patients aged ≥80 vs <80 years undergoing endovascular aneurysm repair (EVAR). Materials and Methods: Data from the Endurant Stent Graft Natural Selection Global post-market registry (ENGAGE) were used for the analyses. A total of 1263 consecutive patients were enrolled in the prospective, observational, single-arm registry and divided into 2 groups according to age: ≥80 years (290, 22.9%) and <80 years (973, 77.1%). Baseline patient characteristics, risk scores according to the Society for Vascular Surgery (SVS) reporting standards, American Society of Anesthesiologists (ASA) classification, quality of life assessments [EuroQol 5 (EQ5D) index], and treatment outcomes, including all-cause mortality, aneurysm-related mortality, major adverse events, secondary endovascular procedures, and endoleaks were compared between groups. Results: Octogenarians were classified into the highest category of the SVS risk stratification system; however, this did not result in a significant difference in the 30-day mortality [1.4% (4/290) vs 1.2% (12/973) for controls; p=0.85] or major adverse event rates [5.2% (15/290) vs 3.6% (35/973), p=0.23]. Multivariable analysis confirmed that age ≥80 years, pulmonary disease, large aneurysm diameter, and renal insufficiency were significantly associated with all-cause mortality, whereas diameter was the only parameter associated with increased aneurysm-related mortality. The differences in freedom from secondary endovascular procedures over 5 years between octogenarians and controls did not reach statistical significance (88.5% vs 83.2%, p=0.07). Conclusion: EVAR can be performed in individuals aged ≥80 years with no statistically significant difference in midterm aneurysm-related deaths compared with younger patients. The findings in this elderly patient cohort show that EVAR can be safely performed with acceptable morbidity rates in octogenarians.

Percutaneous AXillary Artery (PAXA) Access at the First Segment During Fenestrated and Branched Endovascular Aortic Procedures

The aim of this study was to assess the feasibility and safety of percutaneous axillary access with vessel closure device closure after puncturing the first segment during endovascular treatment of complex aneurysms with fenestrated and branched endografts (F/BEVAR). The PAXA (Percutaneous AXillary Access) study is a physician initiated, single centre, ambispective, non-randomised study (clinicaltrials.gov: NCT03223311). The primary endpoint was the closure success rate defined as the absence of any vascular injury to achieve haemostasis at the puncture site, requiring any treatment other than manual compression or adjunctive endovascular ballooning. The secondary endpoints were minor access complications, cerebrovascular complication rate, short term access vessel patency, and study cohort anatomical evaluation of the axillary artery. Sixty-four patients required an upper extremity access during F/BEVAR procedure during study period (November 2016 to July 2019) and were screened for the PAXA study: 59 patients (47 males; median age: 75 years, IQR 69-78) met the study inclusion criteria and were enrolled (one patient had bilateral access). Closure success was obtained in 54 cases (90%) with no open conversion required: five patients received abare or covered stenting to the AXA and in one patient mechanical failure of the delivery system wasrecorded. No 30 day permanent peripheral nerve injuries and two non-ipsilateral ischaemic strokes (3.4%) were recorded. Seven patients (12%) had access haematomas managed conservatively associated with closure failure (p=.002), oral anticoagulants therapy (p=.005) and procedure length (p=.028). Atshort term follow up (6 months), no late complications were observed, and all access vessels were patent. PAXA on the first segment using a large sheath (10-16F) is technically feasible, relatively safe withno need for open conversion but it may require access related secondary endovascular procedures. Further prospective studies are needed to modify the device instruction for use and to put the procedure on label.

Five-Year Outcomes From the United States Pivotal Trial of Valiant Captivia Stent Graft for Blunt Aortic Injury

The Clinical PeRformancE of the Valiant Thoracic Stent Graft with Capitvia Delivery System for the EndovaSCUlar treatment of Blunt Thoracic Aortic Injuries (RESCUE) study evaluating thoracic endovascular repair using the Valiant Captivia endograft for blunt thoracic aortic injury reported promising 30-day outcomes. We now describe 5 years of follow-up of this cohort. Fifty patients (mean age 40.7 ± 17.4 years, 76% male, mean injury severity score 38 ± 14.4) were treated for blunt thoracic aortic injury (2010 to 2012) with this endograft. Seventy percent (n= 35) of blunt thoracic aortic injury extent was grade III or higher. Extent of arch repair required full (40%) or partial (18%) left subclavian artery coverage. At 5 years, clinical and imaging compliance was 90.3% (28 of 31) and 67.7% (21 of 31), respectively. Thirty-day mortality was 8%. Three additional patients died of non-device-related causes (respiratory failure, infection, metastatic cancer) through 5-year follow-up, yielding a Kaplan-Meier survival of 85.2% through 5 years. Neither stroke nor spinal cord ischemia was observed at 5 years. Two type II endoleaks seen at 30 days resolved spontaneously, and no additional endoleaks were described in the study cohort through 5 years. No secondary endovascular procedures or conversion to open surgery were reported through 5 years. Four subjects underwent left subclavian revascularization for symptomatic indications. Finally, complete exclusion of the traumatic injury was maintained with no incidences of stent graft kinking, fracture, loss of patency, or migration through 5 years in all patients. This multicenter clinical trial describes excellent 5-year outcomes and durable exclusion of blunt thoracic aortic injury using a novel stent graft system. Thoracic endovascular repair with this endograft appears to be a safe and effective treatment option for patients with blunt thoracic aortic injury.

Female sex is associated with comparable 5-year outcomes after contemporary endovascular aneurysm repair despite more challenging anatomy

BackgroundWomen with abdominal aortic aneurysms less often meet anatomic criteria for endovascular repair and experience worse perioperative and long-term survival. MethodsWe compared long-term survival, aneurysm-related mortality, and rates of endoleaks and reinterventions between male and female patients in the Endurant Stent Graft Natural Selection Global Postmarket Registry (ENGAGE) using 2:1 propensity score matching. ResultsThere were 1130 male patients and 133 female patients, yielding 399 patients after matching (266 male patients, 133 female patients). Female patients were older, with smaller aneurysms, smaller iliac arteries, and shorter, more angulated necks, and they were more often treated outside the device instructions for use (all P < .001). Through 5 years, female patients experienced overall mortality comparable to that of well-matched male patients (34% vs 38%, respectively; hazard ratio, 0.89 [0.61-1.29]; P = .54) and lower aneurysm-related mortality (0% vs 3%; P = .047). Female patients experienced higher rates of any postoperative type IA endoleak through 5 years (10% vs 1%; P < .001) but comparable rates of secondary endovascular procedures (14% vs 16%; P = .40). Female sex was independently associated with significantly higher risk of long-term type IA endoleaks (hazard ratio, 4.8 [1.2-20.8]; P = .04), even after accounting for anatomic factors. No female patient experienced aneurysm rupture during follow-up, and only one female patient underwent conversion to open repair. ConclusionsDespite more challenging anatomy, female patients in the ENGAGE registry had long-term outcomes comparable to those of male patients. However, female patients experienced higher rates of type IA endoleaks. Although standard endovascular aneurysm repair remains a viable solution for most women, whether high-risk patients may be better served with open surgery, custom-made devices, EndoAnchors (Aptus Endosystems, Sunnyvale, Calif), or chimneys is worthy of further study.

Handmade fenestrated stent grafts to preserve all supra-aortic branches in thoracic endovascular aortic repair

ObjectiveTo evaluate the efficacy and safety of a zone 0 landing aortic stent graft with handmade fenestrations for the preservation of all supra-aortic branches in thoracic endovascular aortic repair (TEVAR). MethodsThis study included 13 consecutive patients who underwent TEVAR using zone 0 landing handmade fenestrated stent grafts to preserve all supra-aortic branches from July 2016 to April 2017. Technical success was defined as the resolution of the primary aortic pathology as well as the preservation of all supra-aortic branches through the accurate alignment of the fenestration. Outcomes including technical success, perioperative morbidity and mortality, requirement of secondary interventions, and graft patency were analyzed. ResultsIn this study, 11 patients presented with aortic dissection, 1 presented with thoracic aortic aneurysm with impending rupture, and 1 presented with penetrating aortic ulcer of the thoracic aorta. The technical success rate of the primary procedure was 100%. Over a mean follow-up of 20 months, secondary endovascular procedures were performed in 6 patients to resolve 3 cases of stent graft-induced new entry, 2 cases of type Ib endoleak, and 1 case of new false lumen formation. During the study period, no complication resulting from proximal landing and fenestration occurred. ConclusionsOur experience of using handmade fenestrated stent grafts revealed preliminary results of using the grafts to preserve all supra-aortic branches in TEVAR, and results demonstrated the feasibility of this technique for achieving total arch replacement endovascularly in selective patients. Further technical advancement is anticipated, and larger studies with long-term follow-up are required.

Incidence, natural course, and outcome of type II endoleaks in infrarenal endovascular aneurysm repair based on the ENGAGE registry data

ObjectiveThe purpose of this study was to report the incidence, natural history, and outcome of type II endoleaks in the largest prospective real-world cohort to date. MethodsPatients were extracted from the prospective Endurant Stent Graft Natural Selection Global Postmarket Registry (ENGAGE). Two groups were analyzed: first, patients with an isolated type II endoleak; and second, patients with a type II endoleak who later presented with a type I endoleak. A health status analysis between patients with an early type II endoleak and patients with no endoleak was performed. Second, an attempt was made to identify risk factors in patients with a type II endoleak who later presented with a type I endoleak. ResultsThrough 5 years of follow-up, a total of 197 (15.6%) patients with isolated type II endoleaks were identified. Most were detected within the first 30 days (n = 73 [37.1%]) and through the first year (n = 73 [37.1%]), with the remainder being detected after 1 year of follow-up (n = 51 [25.8%]). Patients with a type II endoleak had a higher incidence of aneurysm growth and more secondary endovascular procedures (15.4% vs 7.5% at 5 years; P < .001). Overall survival was higher in the isolated type II endoleak group compared with patients with no endoleak (77.2% vs 67.0% at 5 years; P = .010). Twenty-two patients (10%) with a type II endoleak were diagnosed with a late type I endoleak (type IA, n = 10; type IB, n = 12), with a secondary intervention rate of 67.5% through 5 years. There was no difference in health status scores between patients with an early type II endoleak and patients without any type of endoleak at 1-year follow-up. ConclusionsIn the ENGAGE registry, isolated type II endoleaks are present in 15.6% of patients during follow-up. The majority do not require secondary intervention, and an early isolated type II endoleak does not have an impact on health status through 1 year. However, a small group of patients with a type II endoleak will present with a type I endoleak, resulting in a high secondary intervention rate and significant risk of aneurysm-related complications.

Endosuture aneurysm repair in patients treated with Endurant II/IIs in conjunction with Heli-FX EndoAnchor implants for short-neck abdominal aortic aneurysm

ObjectiveEndovascular repair of abdominal aortic aneurysm (AAA) remains a challenging clinical scenario when there is a short or nonexistent segment of healthy infrarenal aorta. This study sought to determine the safety and effectiveness of endosuture aneurysm repair (ESAR) using the Endurant II/IIs endograft (Medtronic Vascular, Santa Rosa, Calif) in conjunction with Heli-FX EndoAnchors (Medtronic Vascular) in the treatment of short-neck AAA. MethodsIn this subgroup analysis, 70 patients were identified from the Aneurysm Treatment Using the Heli-FX EndoAnchor System Global Registry (ANCHOR) who had an infrarenal neck length <10 mm down to 4 mm based on core laboratory measurements. Primary outcomes included technical success of the index procedure, rate of type IA endoleak at 1 month and 12 months, and rate of secondary procedures at 12 months. ResultsIn this short-neck cohort (n = 70), the average neck length and diameter were 6.9 ± 1.6 mm and 25.7 ± 4.0 mm, respectively. Investigators reported an overall procedural success rate of 97.1% and a technical success rate of 88.6%. The duration of the implant procedure, EndoAnchor implantation, and total fluoroscopy time was 148.0 ± 80.0 minutes, 17.1 ± 11.5 minutes, and 35.3 ± 22.0 minutes, respectively, and an average of 5.5 ± 2.1 EndoAnchors were implanted per patient. Through the 30-day follow-up, type IA endoleaks were reported in four patients, of which three resolved spontaneously by the 12-month follow-up. There was an additional type IA endoleak through the 12-month follow-up that has not resulted in AAA enlargement or required a secondary procedure. The Kaplan-Meier estimate for freedom from secondary endovascular procedures and all-cause mortality is 95.4% and 92.7% through 365 days, respectively. No patient in the short-neck cohort experienced main body stent migration, increase in maximum aneurysm diameter, or aneurysm rupture or required conversion to open surgical repair through 12 months. ConclusionsIn this analysis of the short-neck cohort from ANCHOR, the Endurant II/IIs endograft in conjunction with Heli-FX EndoAnchor implants (ESAR) appears to be a safe and effective treatment option with a high technical success rate and low incidence of type IA endoleaks and secondary interventions. Despite the complex and hostile anatomies, the ESAR method required short procedure and fluoroscopy times. These short-term outcomes suggest that ESAR could be complementary to therapies currently available for treatment of hostile AAA anatomy and a viable off-the-shelf endovascular treatment option for patients with short-neck AAAs, although long-term follow-up is critically important.

OC24 ENDOVASCULAR SURGERY FOR ACUTE THORACIC AORTIC SYNDROMES

Background and Aim: Surgery of thoracic aortic emergencies is challenging and carries significant high morbidity and mortality rate. In the last decade, Thoracic EndoVascular Aortic Repair (TEVAR) has shown improved early and late outcome, mostly in emergency. To assess early and long-term results after TEVAR for thoracic aortic emergencies we retrospectively reviewed our experience. Methods: From March 2001 to March 2018, out of 289 patients undergone TEVAR, we retrospectively reviewed 191 patients, 164 (85.9%) men; aged from 19 to 84 years, treated in urgent/emergent conditions: 51 patients (26.7%) for contained or free rupture of degenerative aneurysms, 118 (61.8%) for complicated acute or chronic type B aortic dissections and 22 (11.5%) for traumatic aortic injuries. Results: The overall 30 days mortality was 4.4% (8 patients). Open surgical conversion was not required.. Periprocedural complications included arterial rupture or dissection (5.7%; 11 patients) and TIA/stroke (1.6%; 3 patients). Left subclavian artery (LSA) overstenting was achieved in 79 patients (41.3%). Follow-up ranged from 2 to 204 months and included clinical examinations and serial CT-scan. There were 8 late deaths aorta-related (4.4%). A secondary endovascular procedure was required in 13 pts (7.1%). One patient (0.5%), with retrograde aortic dissection, required open surgery. No patient with LSA overstenting required a secondary revascularization or showed subclavian steal phenomenon. Conclusions: The early and mid-term technical and clinical results supports the safety and effectiveness of thoracic endovascular surgery in patients with acute aortic syndromes too. More cases and longer follow-up are required.

RF19 ENDOVASCULAR SURGERY FOR TYBE B AORTIC DISSECTION: IS THERE A DIFFERENCE BETWEEN ACUTE AND CHRONIC?

Background and aim: Open surgery for type B Aortic Dissection remains a clinical challenge with high morbidity and mortality. Thoracic EndoVascular Aortic Repair (TEVAR) is developing as a strong alternative to open surgery for treatment of acute and chronic type B Aortic Dissection. TEVAR has shown improved early and late results, compared with open surgery or medical therapy, mostly in complicated patients. To assess if there are some differences in clinical outcome after TEVAR for acute or chronic TAAD, we reviewed our long term experience. Methods: From March 2001 to March 2018, out of 289 patients underwent TEVAR, 141 were treated for TAAD (48.8%), 88 for acute (within 14 days) and 53 for chronic dissection (after 14 days). The procedures were performed in a hybrid operating room. Patients received general anesthesia and mechanical ventilation with invasive monitoring. The delivery system was inserted through femoral or iliac artery. Results: The overall 30-days mortality was 3.5% (5 patients), All deaths were the result of preoperative malperfusion. There were no neurological complications or paraplegia. At long-term follow-up, aortic related mortality was 7.8% (11 patients) A secondary endovascular or conventional procedure was required in 26 patients (18.4%). There were no statistically significant differences between groups. Conclusions: Early and late outcome supports the safety and effectiveness of TEVAR for type B aortic dissection without differences between acute and chronic group. Mortality and morbidity is predominantly related to the patient preoperative status. However, long-term follow-up is mandatory to confirm clinical safety of this procedure

Potential cytotoxic risk and chronical inflammation after exposure to graphene platelets

The Clinical PeRformancE of the Valiant Thoracic Stent Graft with Capitvia Delivery System for the EndovaSCUlar treatment of Blunt Thoracic Aortic Injuries (RESCUE) study evaluating thoracic endovascular repair using the Valiant Captivia endograft for blunt thoracic aortic injury reported promising 30-day outcomes. We now describe 5 years of follow-up of this cohort.Fifty patients (mean age 40.7 ± 17.4 years, 76% male, mean injury severity score 38 ± 14.4) were treated for blunt thoracic aortic injury (2010 to 2012) with this endograft. Seventy percent (n = 35) of blunt thoracic aortic injury extent was grade III or higher. Extent of arch repair required full (40%) or partial (18%) left subclavian artery coverage. At 5 years, clinical and imaging compliance was 90.3% (28 of 31) and 67.7% (21 of 31), respectively.Thirty-day mortality was 8%. Three additional patients died of non–device-related causes (respiratory failure, infection, metastatic cancer) through 5-year follow-up, yielding a Kaplan-Meier survival of 85.2% through 5 years. Neither stroke nor spinal cord ischemia was observed at 5 years. Two type II endoleaks seen at 30 days resolved spontaneously, and no additional endoleaks were described in the study cohort through 5 years. No secondary endovascular procedures or conversion to open surgery were reported through 5 years. Four subjects underwent left subclavian revascularization for symptomatic indications. Finally, complete exclusion of the traumatic injury was maintained with no incidences of stent graft kinking, fracture, loss of patency, or migration through 5 years in all patients.This multicenter clinical trial describes excellent 5-year outcomes and durable exclusion of blunt thoracic aortic injury using a novel stent graft system. Thoracic endovascular repair with this endograft appears to be a safe and effective treatment option for patients with blunt thoracic aortic injury.

One-Year Outcomes of Endovascular Aneurysm Repair in High-Risk Patients Using the Endurant Stent-Graft

Purpose: To evaluate the outcome and survival of patients with extensive comorbid conditions after endovascular aneurysm repair (EVAR) and objectify which of 2 medical comorbidity classifications is more accurate in predicting adverse outcomes. Methods: All 1263 patients (mean age 73.1 years; 1129 men) treated using the Endurant Stent Graft system and entered in the prospective global postmarketing ENGAGE registry ( ClinicalTrials.gov identifier NCT00870051) were grouped using the American Society of Anesthesiologists (ASA) classification and the Society for Vascular Surgery/American Association for Vascular Surgery (SVS/AAVS) medical comorbidity grading system. Patients assigned to ASA III and IV and SVS/AAVS 2 and 3 categories were considered high risk. Primary outcome was 1-year all-cause mortality. Secondary outcomes included technical and clinical success, major adverse events (MAE), aneurysm rupture, endoleaks, and secondary endovascular procedures. One-year follow-up of the entire ENGAGE cohort was the endpoint of the study. Results: A total of 1263 patients were included. The overall technical success rate was high, the lowest being 97.4% in the ASA I group. The overall 30-day and 1-year Kaplan-Meier survival estimates were 98.7% and 92.5%, respectively. All cause 1-year mortality was higher in the ASA III and IV groups, but this did not reach statistical significance (5.2% and 5.7% for ASA I and II vs 9.0% and 9.9% for ASA III and IV, p=0.12). In the SVS/AAVS groups, 1-year all-cause mortality significantly increased with the SVS/AAVS score to 11.3% in the SVS/AAVS 3 group (p=0.002). There were significantly more MAEs in the SVS/AAVS 3 group at 1 year (p<0.001 for group 1 vs 3 and group 2 vs 3). Conclusion: Endovascular aneurysm repair has evolved, and high technical success and low mortality and morbidity can be achieved in high-risk patients. When treating high-risk patients, the perioperative risks should always be weighed against the expected gains. In contrast to the ASA classification, the SVS/AAVS medical comorbidity grading system is a useful tool to predict occurrence of MAEs and 1-year survival in patients undergoing EVAR.

A Single-Center Experience of Aortic and Iliac Artery Aneurysm Treated with Multilayer Flow Modulator

The aim of this study was to analyze our series of endovascular treatments using a multilayer flow modulator (MFM) and to show the midterm results. At our institution, 8 patients were treated with an MFM. Four patients presented with an aortic aneurysm (2 type II thoracoabdominal aortic aneurysms [TAAAs], 1 type IV TAAA, and 1 juxtarenal abdominal aortic aneurysm) and 4 with an aneurysm involving the common iliac artery. Mortality, rupture and secondary intervention, major complications, patency of collateral vessels, and volume analysis were evaluated. Treated patients were followed up with computed tomography angiography at 1, 3, 6, and 12 months. Results showed no 30-day mortality or major complications; technical success was achieved in 87.5% of patients, patency of collateral vessels was reached in all cases at intraoperative completion angiography. Mean follow-up was 22.1 months (range, 18-30), survival rate was 87.5%, and one case of death unrelated to MFM treatment was reported. During follow-up, MFM and collateral vessel patency were observed in all cases. Secondary endovascular or open surgical procedures were not needed during follow-up. Volume analysis showed a slight increase in patients with aortic aneurysm, and an overall trend to increase in thrombosis was observed in all cases. Endovascular treatment of aneurysms with MFM seems to have encouraging midterm results. Should our results be confirmed by larger series and longer follow-up studies, MFM may become a viable alternative to other endovascular approaches.