Comparative outcomes of open,hybrid, and fenestrated branched endovascular repair of extent II and III thoracoabdominal aortic aneurysms

ObjectiveOpen repair of extent II and III thoracoabdominal aortic aneurysms (TAAA) is associated with substantial morbidity. Alternative strategies, such as hybrid operations combining proximal thoracic endovascular aortic repair with either staged open distal TAAA repair or visceral debranching (hybrid), as well as fenestrated/branched endografts (FEVAR), have been increasingly reported; however, benefits of these approaches compared with direct open surgery remain unclear. The purpose of this study was to compare outcomes of these three different strategies in the management of extent II/III TAAA.MethodsAll extent II/III TAAA repairs (2002-2018) for nonmycotic, degenerative aneurysm or chronic dissection at a single institution were reviewed. The primary end point was 30-day mortality. Secondary end points included incidence of spinal cord ischemia (SCI), complications, unplanned re-operation, 90-day readmission, and out-of-hospital survival. To mitigate impact of covariate imbalance and selection bias, intergroup comparisons were made using inverse probability weighted-propensity analysis. Cox regression was used to estimate survival while cumulative incidence was used to determine reoperation risk.ResultsOne hundred ninety-eight patients (FEVAR, 92; hybrid, 40; open, 66) underwent repair. In unadjusted analysis, compared with hybrid/open patients, FEVAR patients were significantly older with more cardiovascular risk factors, but less likely to have a connective tissue disorder or dissection-related indication. Unadjusted 30-day mortality and complication rates were: 30-day mortality, FEVAR 4%, hybrid 13%, open 12% (P = .01); and complications, FEVAR 36%, hybrid 33%, open 50% (P = .11). Permanent SCI was not different among groups (FEVAR 3%, hybrid 3%, open 6%; P = .64). In adjusted analysis, 30-day mortality risk was greater for open vs FEVAR (hazard ratio, 3.6; 95% confidence interval, 1.4-9.2; P = .01) with no difference for hybrid vs open/FEVAR. There was significantly lower risk of any SCI for open vs FEVAR (hazard ratio, 0.3; 95% confidence interval, 0.09-0.96; P = .04); however, no difference in risk of permanent SCI was detected among the three groups. There was no difference in complications or unplanned reoperation, but open patients had the greatest risk of unplanned 90-day readmission. There was a time-varying effect on survival probability, with open repair having a significant survival disadvantage in the first 1 to 6 months after the procedure compared with hybrid/FEVAR patients (Cox model P = .03), but no difference in survival at 1 and 5 years (1- and 5-year survival: FEVAR, 86 ± 3%, 55 ± 8%; hybrid, 86 ± 5%, 60 ± 11%; open 69 ± 7%, 59 ± 8%; Cox-model P = .10).ConclusionsExtent II/III TAAA repair, regardless of operative strategy, is associated with significant morbidity risk. FEVAR is associated with the lowest 30-day mortality risk compared with hybrid and open repair when estimates are adjusted for preoperative risk factors. These data support greater adoption of FEVAR as first-line therapy to treat complex TAAA disease in anatomically suitable patients who present electively.     

Exclusion of complex aortic aneurysm with chimney endovascular aortic repair is applicable in a minority of patients treated with fenestrated endografts

OBJECTIVESThe Medtronic Endurant II stent graft has recently received Conformité Européenne (CE) approval for the use in chimney endovascular aortic repair (ChEVAR) for the treatment for juxtarenal aortic aneurysms. The aim of this study was to assess the percentage of patients treated by fenestrated endovascular repair who would have been alternatively suitable for the treatment by the CE approved Medtronic ChEVAR. Open in a separate windowMETHODSPreoperative computed tomography scans of 100 patients who underwent fenestrated endovascular aortic repair (FEVAR) between April 2013 and February 2017 were retrospectively assessed for the applicability of the ChEVAR technique according to the Medtronic instructions for use. Eligibility criteria included an aortic neck diameter of 19–30 mm, a minimum infrarenal neck length of 2 mm, a total proximal sealing zone of at least 15 mm, thrombus in the aortic neck in ˂25% of the circumference, and maximum aortic angulations of 60° in the infrarenal, 45° in the suprarenal segment and ˂45° above the superior mesenteric artery.RESULTSAccording to CE-approved inclusion criteria, 19 individuals (19%) would have been eligible for ChEVAR. In 81 patients, at least 1 measure was found outside instructions for use: (i) excluding factor was detected in 26 patients, (ii) incongruous measures in 28 patients and in 27 patients, 3–5 measures were outside the instructions for use. The most frequently identified excluding factor was an insufficient infrarenal neck at ˂2 mm length (n = 63; 63%).CONCLUSIONSPatients with juxta- or pararenal aneurysm treated by FEVAR are in 19% of the cases alternatively suitable for the treatment by ChEVAR within CE-approved instructions for use. While ChEVAR is suitable in many emergency cases, FEVAR offers a broader applicability in an elective setting.     

Combined fenestrated-branched endovascular repair of the aortic arch and the thoracoabdominal aorta

ObjectiveThe aim of our study was to evaluate patients who underwent extensive endovascular aortic stent graft coverage (from the aortic arch to abdominal aorta) in terms of early and midterm clinical outcomes.MethodsA retrospective multicenter study was undertaken. All patients were treated with extensive endovascular aortic stent graft coverage with fenestrated and branched endografts at three experienced endovascular centers.ResultsBetween 2012 and 2017, there were 33 patients (22 male [67%]) treated with a combination of fenestrated-branched stent grafts in the aortic arch and the thoracoabdominal aorta. Most of the patients (20/33 [61%]) had fenestrated-branched endovascular aneurysm repair (fb-EVAR) of the thoracoabdominal aorta as a second-stage procedure after thoracic arch (fb-Arch) repair, 10 had fb-Arch repair as the first procedure, and three patients had a single-stage procedure. The mean age was 67 ± 13 years, and the mean interval between procedures was 13 ± 12 months. For fb-Arch repair, 20 fenestrated and 13 branched devices were used; for fb-EVAR, 23 fenestrated, 5 branched, and 5 composite devices were used. The use of spinal drainage was more common in fb-EVAR (20/33 [61%]). Technical success was 100%. Mean hospital stay was 15 ± 13 days for fb-Arch repair and 12 ± 9 days for fb-EVAR. Two patients died in the hospital after fb-EVAR, resulting in a 30-day mortality of 6% (2/33). No deaths occurred during the fb-Arch repair component or in the single-stage cases. Four patients developed spinal cord injury (12%), 1 had permanent paraplegia (3%), and 2 patients had a neurologic event (1 stroke [3%] and 1 transient ischemic attack [3%]). Six patients (18%) died during a mean follow-up of 23 ± 17 months. The survival at 12 months after the second procedure was 72%, and the freedom from any reintervention was 82%. The 12-month freedom from reintervention was 87% for fb-Arch repair and 81% for fb-EVAR.ConclusionsExtensive endovascular coverage of the aorta for aortic disease seems to be a feasible procedure in experienced centers, with acceptable perioperative morbidity and mortality. Spinal cord ischemia appears acceptable despite extensive aortic coverage.     

A reliable method for renal volume measurement and its application in fenestrated endovascular aneurysm repair

ObjectiveRenal volume has been shown to correlate with renal function. Renal volume and renal function both decline steadily in the sixth decade of life and beyond. We sought to assess (1) the inter-rater reliability for manually measuring renal volume using computed tomography and (2) change in renal volume over time as it relates to renal function in fenestrated endovascular aortic aneurysm repair (FEVAR).MethodsThis study was conducted as part of a physician-sponsored investigational new device (#NCT01538056). First, 30 consecutive kidneys of preoperative FEVAR patients were independently measured by two raters using manual segmentation and three-dimensional modeling software. Renal volumes were calculated and compared. Intraclass correlation was calculated between the two observers. Second, renal volumes were then recorded for 85 patients undergoing FEVAR with follow-up out to 5 years. Demographic data, comorbidities, creatinine, glomerular filtration rate (GFR), renal artery stenosis or occlusion, and bilateral renal volume measurements were analyzed. Multivariate analysis was performed to delineate association of these variables with total renal volume (TRV).ResultsThe intraclass correlation coefficient for our renal volume measurements was 0.97 (95% confidence interval, 0.81-0.99), indicating excellent correlation. Renal volume was strongly correlated with GFR. Our multivariate analysis model predicts a 17.9 mL/min increase in GFR with each 20% increase in TRV. After adjustment for all other known correlates of renal function, renal volume remained as the only significant predictor of renal function.ConclusionsRenal volume can be measured with high reliability using manual segmentation and computed tomography scans. In our baseline analysis, TRV was strongly correlated with renal function. These findings support the potential for renal volume as a surrogate for renal function.     

Long-term outcomes comparing endovascular and open abdominal aortic aneurysm repair in octogenarians

ObjectivePatients older than 80 years have significantly lower early mortality with endovascular aneurysm repair (EVAR) compared with open repair for abdominal aortic aneurysms (AAAs), but long-term results remain poorly studied. We analyzed the results of both emergent and elective AAA repair in patients aged 80 years or older who had at least 5 years of follow-up.MethodsRetrospective review of a prospectively collected vascular surgery database was performed to identify all patients who underwent elective repair of an AAA between 2007 and 2012 and were 80 years of age or older at the time of surgery. Open and EVAR groups were compared using univariate statistics.ResultsThe study cohort was composed of 314 patients 80 years of age or older (median, 83 years; interquartile range, 5 years) who underwent repair (96 open, 218 EVAR). The groups had similar comorbidities, except that EVAR patients were more likely to be male and open repair patients were more likely to have larger aneurysms. Compared with open repair, elective early postoperative mortality was significantly lower for EVAR patients (1% vs 14%; P < .001). Overall mean life expectancy was 5.9 years (EVAR, 5.8 years; open repair, 5.8 years; P = .98). The 1-year survival was significantly higher for EVAR (92.9%) than for open repair (84.1%; P = .02). The 2-year survival (EVAR, 83.4%; open repair, 74.6%; P = .07) and 5-year survival (EVAR, 57.8%; open repair, 60.3%; P = .98) did not differ between EVAR and open repair. Reintervention rates (EVAR, 18%; open repair, 2%; P = .05) were higher in the endovascular treatment group.ConclusionsEVAR results in an improved 1-year mortality in octogenarians compared with open repair, although 5-year survival is similar between the groups. With average life expectancies of >5 years and an 18% reintervention rate, diligent follow-up is required after EVAR even in elderly patients.     

EndoSuture aneurysm repair versus fenestrated aneurysm repair in patients with short neck abdominal aortic aneurysm

ObjectiveThe aim of this study was to compare midterm results of EndoAnchors in EndoSuture aneurysm repair (ESAR) versus fenestrated endovascular aneurysm repair (FEVAR) in short neck abdominal aortic aneurysm (AAA).MethodsAll patients who underwent an ESAR procedure for a short neck AAA at our center between September 2017 and May 2020 were considered for analysis. To form the control group, preoperative computed tomography angiography of patients who underwent FEVAR for juxtarenal AAA between April 2012 and May 2020 were reviewed and patients who met short neck criteria selected. A propensity-matched score on neck length and neck diameter was calculated, resulting in 18 matched pairs. AAA shrinkage, type Ia endoleaks (EL), AAA-related reinterventions, and AAA-related deaths were compared.ResultsThe median AAA diameter was 54 mm (interquartile range [IQR], 52-61 mm) versus 58 mm (IQR, 53-63 mm) with a median neck length of 8 mm (IQR, 6-12 mm) vs 10 mm (IQR, 6-13 mm) in ESAR and FEVAR patients, respectively. Technical success was 100% in both groups. Procedural success was 94% in the ESAR group versus 100% in the FEVAR group. The median procedure duration was 138 mm (IQR, 113-182 mm) vs 240 mm (IQR, 199-293 mm) ( P < .001) and the median length of stay was 2 days (IQR, 2-3 days) vs 7 days (IQR, 6-7 days) (P < .001) in ESAR and FEVAR patients, respectively. No major hospital complications were observed in ESAR patients compared with two in FEVAR patients (11%) with one transient acute kidney injury and one transient paraplegia. The median follow-up was 23 months (IQR, 19-33 months) vs 36 months (IQR, 22-57 months) with 67% versus 61% AAA shrinkage in the ESAR and FEVAR groups, respectively (P = .73). No type Ia EL, proximal neck-related reinterventions, or AAA-related deaths were observed in either group. No AAA-related reintervention was observed in the ESAR group versus three reinterventions in the FEVAR group (P = .23).ConclusionsESAR seems to be a safe technique with no major postoperative complications or reinterventions observed during follow-up. It seems to offer similar midterm results as FEVAR in terms of type Ia EL, aneurysm shrinkage, and aneurysm-related mortality. ESAR seems to be a good off-the-shelf alternative to FEVAR in case of technical constraints.     

Physician-modified endografts for urgent and emergent aortic pathology

Symptomatic or ruptured thoracoabdominal aortic aneurysms (TAAA) carry a high morbidity and mortality. Modern fenestrated and/or branched endovascular devices (B/FEVAR) have improved the immediate peri-operative mortality of TAAA and have increased the number of people that can undergo repair - in those who might otherwise be prohibitively high risk for surgery. Most modern B/FEVAR are custom made devices that require 6-12 weeks to assemble and ship to the site of implantation. Thus, patients who require more urgent repair due to symptomatic or ruptured aneurysms may not have access to this potentially life saving technology. Physician-modified endografts (PMEGs), or traditional endografts that have been back-table modified to have fenestrations or branches, have partially fixed this problem as they can be constructed in less than an hour and can provide similar results to modern custom made devices. Here we review the existing data behind the use of PMEGs in urgent and emergent aortic pathology and summarize a case describing one methodology for PMEG construction that has been standardized at our institution.     

Systematic review of contemporary outcomes of endovascular and open thoracoabdominal aortic aneurysm repair

ObjectiveThe purpose of the study was to provide a systematic review of the literature reporting the contemporary early outcomes after endovascular and open repair of thoracoabdominal aortic aneurysms (TAAAs).MethodsMEDLINE and Embase were searched for studies from January 2006 to March 2018 that reported either endovascular (using branched or fenestrated endografts) or open repair of TAAA in at least 10 patients. Outcomes of interest included perioperative mortality, spinal cord injury (SCI), renal failure requiring dialysis, and stroke. Pooled proportions were determined using a random-effects model.ResultsThe analysis included 71 studies, of which 24 and 47 reported outcomes after endovascular and open TAAA repair, respectively. Endovascular cohort patients were older and had higher rates of coronary artery disease, chronic obstructive pulmonary disease, and diabetes. Endovascular repair was associated with higher rates of SCI (13.5%; 95% confidence interval [CI], 10.5%-16.7%) compared with open repair (7.4%; 95% CI, 6.2%-8.7%; P < .01) but similar rates of permanent paralysis (5.2% [95% CI, 3.8%-6.7%] vs 4.4% [95% CI, 3.3%-5.6%]; P = .39), lower rates of postoperative dialysis (6.4% [95% CI, 3.2%-9.5%] vs 12.0% [95% CI, 8.2%-16.3%]; P = .03) but similar rates of being discharged on permanent dialysis (3.7% [95% CI, 2.0%-5.9%] vs 3.8% [95% CI, 2.9%-5.3%]; P = .93), a trend to lower stroke (2.7% [95% CI, 1.9%-3.6%] vs 3.9% [95% CI, 3.0%-4.9%]; P = .06), and similar perioperative mortality (7.4% [95% CI, 5.9%-9.1%] vs 8.9% [95% CI, 7.2%-10.9%]; P = .21).ConclusionsThis systematic review summarizes the contemporary literature results of endovascular and open TAAA repair. Endovascular repair studies included patients with more comorbidities and were associated with higher rates of SCI but similar rates of permanent paraplegia, whereas open repair studies had higher rates of postoperative dialysis but similar rates of being discharged on permanent dialysis. Perioperative mortality rates were similar. Universally adopted reporting standards for patient characteristics, outcomes, and the conduct of contemporary comparative studies will allow better assessment and comparisons of the risks associated with the two surgical treatment options for TAAA.     

Reinterventions in the modern era of thoracic endovascular aortic repair

ObjectiveUsing a national data set, we sought to describe the population of patients and the nature and timing of reinterventions after thoracic endovascular aortic repair (TEVAR) by aortic disease as well as their impact on survival.MethodsWe evaluated the national data set for TEVAR in the Vascular Quality Initiative from 2010 to 2017. Student t-test and χ² analysis were used to compare continuous and categorical variables in the reintervention and no reintervention groups, respectively. Freedom from reintervention and survival analysis was performed using Kaplan-Meier methods.ResultsA total of 7006 patients were evaluated: 51.2% thoracic aortic aneurysm, 33.5% type B dissection (TBD), 7.0% penetrating aortic ulcer, 6.7% trauma, and 1.6% intramural hematoma. Overall, 553 patients (7.9%) underwent at least one reintervention, with an in-hospital reintervention rate of 3.5%. Reinterventions were most commonly performed for TBD (11.5%), with reinterventions for other diseases occurring at lower rates: thoracic aortic aneurysm, 6.7%; intramural hematoma, 5.4%; penetrating aortic ulcer, 4.8%; and trauma, 1.8%. The most common cause of reintervention across all aortic diseases was type I endoleak. The most common long-term reinterventions were placement of endovascular stent graft (65%), other surgical treatments (15.9%), other endovascular treatment (13%), endovascular branch treatment (12.4%), surgical treatment with no device removal (11.0%), and surgical branch treatment (10.4%). Freedom from reintervention was decreased for TBD compared with other diseases (P < .001). There was no difference in survival comparing patients undergoing reinterventions and those without (P = .87). However, patients undergoing in-hospital reintervention trended toward increased mortality (P = .075).ConclusionsWhereas reinterventions were not rare after TEVAR, there was no difference in mortality between patients undergoing reintervention and those without. Patients undergoing TEVAR for TBD demonstrated the highest reintervention rate. This study highlights the importance of long-term follow-up to address disease-specific patterns of reintervention.     

Current practice of aneurysm management in the UK

INTRODUCTION

The aim of this study is to establish the current practice of aneurysm management, to assess the introduction of fenestrated endovascular aneurysm repair (FEVAR) and to establish the criteria for its use and its role in the UK.

METHODS

All UK centres performing FEVAR and centres with an established interest in infra-renal endovascular aneurysm repair (EVAR) were invited to respond to an open-ended questionnaire about abdominal aortic aneurysm (AAA) management.

RESULTS

A response was obtained from over 90% of UK FEVAR centres. Results showed marked regional differences in aneurysm management, in particular with regard to indications for complex aneurysm management.

CONCLUSION

The trend in the UK is towards endovascular repair. However, there are still variations in unit policies, indicating regional differences in patient management.     

The use of a low-profile stent graft with a polymer ring sealing technology combined with bare renal stent (vent technique) in patients with juxtarenal aneurysm not eligible for open surgery and fenestrated endograft

ObjectiveIn cases of juxtarenal abdominal aortic aneurysm (jAAA), endovascular aneurysm repair (EVAR) involves the use of custom-made fenestrated stent grafts, which usually need large-diameter access vessels, superior costs, and a certain time between graft planning and delivery. We report our preliminary experience using the bare renal stent technique (called vent) in combination with the ultralow-profile stent graft Ovation (Endologix, Irvine, Calif) to seal jAAAs in patients evaluated to be unfit for open surgery and not suitable for fenestrated endograft.MethodsA single-center retrospective review of jAAAs treated by Ovation vent technique from January 2015 to December 2018 was conduced. The vent procedure consisted of a modified, off-label deployment of the sealing ring of the ultralow-profile Ovation stent graft close to renal orifices in combination with short bare-metal stents. The exclusion criterion was a diameter >31 mm at the level of the lowest renal artery. Early technical and clinical results, estimated midterm survival, renal artery patency, freedom from type IA endoleak, freedom from reintervention, and freedom from neck enlargement (>2 mm) were reported.ResultsOverall, 38 patients had jAAA and were considered unfit for open repair and not eligible for fenestrated EVAR. The proximal neck was <5 mm in all cases (mean, 3.3 ± 1.2 mm). Vent renal stents were implanted bilaterally in 16 patients. Primary technical success was 94.7% (36/38), with satisfactory cannulation of all renal arteries and sealing of the aneurysm in all but two cases because of type IA endoleaks that were treated immediately with success. Primary clinical success at 1 month was 100%. During a median follow-up period of 22.4 ± 3.6 months (range, 1-46 months), no abdominal aortic aneurysm-related deaths occurred, and no patient was lost to follow-up. The survival curve at 1 year and 2 years was, respectively, 96.4% and 91.6% (standard error, 0.57%). There were no cases of neck dilation or endograft migration. Freedom from reintervention at 12 months and 24 months was 100% and 89.5%, respectively (standard error, 0.7%); freedom from type IA endoleak was 100% and patency of the renal artery was 100% at 2 years.ConclusionsThe described technique includes the use of a low-profile stent graft with a polymer ring sealing technology combined with bare renal stents that are not competing for the same room. This early experience shows that the vent technique is safe and feasible and increases the range of treatment of those patients with jAAA who are unfit for open repair and for fenestrated EVAR because of several anatomic constraints.     

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.     

Clinical presentation,operative management,and long-term outcomes of rupture after previous abdominal aortic aneurysm repair

ObjectiveThe aim of the present study was to evaluate the presentation trends, intervention, and survival of patients who had been treated for late abdominal aortic aneurysm rupture (LAR) after open repair (OR) or endovascular aortic aneurysm repair (EVAR).MethodsWe reviewed the clinical data from a single-center, retrospective database for patients treated for LAR from 2000 to 2020. The end points were the 30-day mortality, major postoperative complication, and survival. The outcomes between LAR managed with EVAR (group I) vs OR were compared (group II).ResultsOf 390 patients with infrarenal aortic rupture, 40 (10%) had experienced aortic rupture after prior aortic repair and comprised the LAR cohort (34 men; age 78 ± 8 years). LAR had occurred before EVAR in 30 and before OR in 10 patients. LAR was more common in the second half of the study with 32 patients after 2010. LAR after prior OR was secondary to ruptured para-anastomotic pseudoaneurysms. After initial EVAR, LAR had occurred despite reintervention in 17 patients (42%). The time to LAR was shorter after prior EVAR than after OR (6 ± 4 vs 12 ± 4 years, respectively; P = .003). Treatment for LAR was EVAR for 25 patients (63%; group I) and OR for 15 (37%, group II). LAR after initial OR was managed with endovascular salvage for 8 of 10 patients. Endovascular management was more frequent in the latter half of the study period. In group I, fenestrated repair had been used for seven patients (28%). Salvage for the remaining cases was feasible with EVAR, aortic cuffs, or limb extensions. The incidence of free rupture, time to treatment, 30-day mortality (8% vs 13%; P = .3), complications (32% vs 60%; P = .1), and disposition were similar between the two groups. Those in group I had had less blood loss (660 vs 3000 mL; P < .001) and less need for dialysis (0% vs 33%; P < .001) than those in group II. The median follow-up was 21 months (interquartile range, 6-45 months). The overall 1-, 3-, and 5-year survival was 76%, 52%, and 41%, respectively, and was similar between groups (28 vs 22 months; P = .48). Late mortality was not related to the aorta.ConclusionsLAR after abdominal aortic aneurysm repair has been encountered more frequently in clinical practice, likely driven by the frequency of EVAR. However, most LARs, including those after previous OR, can now be salvaged with endovascular techniques with lower morbidity and mortality.     

Cloud-based fusion imaging improves operative metrics during fenestrated endovascular aneurysm repair

ObjectiveEndovascular treatment of complex aortic pathology has been associated with increases in procedural-related metrics, including the operative time and radiation exposure. Three-dimensional fusion imaging technology has decreased the radiation dose and iodinated contrast use during endovascular aneurysm repair. The aim of the present study was to report our institutional experience with the use of a cloud-based fusion imaging platform during fenestrated endovascular aneurysm repair (FEVAR).MethodsA retrospective review of a prospectively maintained aortic database was performed to identify all patients who had undergone FEVAR with commercially available devices (Zenith Fenestrated; Cook Medical Inc, Bloomington, IN) between 2013 and 2020 and all endovascular aneurysm repairs performed using Cydar EV Intelligent Maps (Cydar Medical, Cambridge, UK). The Cydar EV cohort was reviewed further to select all FEVARs performed with overlay map guidance. The patient demographic, clinical, and procedure metrics were analyzed, with a comparative analysis of FEVAR performed without and with the Cydar EV imaging platform. Patients were excluded from comparative analysis if the data were incomplete in the dataset or they had a documented history of prior open or endovascular abdominal aortic aneurysm repair.ResultsDuring the 7-year study period, 191 FEVARs had been performed. The Cydar EV imaging platform was implemented in 2018 and used in 124 complex endovascular aneurysm repairs, including 69 consecutive FEVARs. A complete dataset was available for 137 FEVARs. With exclusion to select for de novo FEVAR, a comparative analysis was performed of 53 FEVAR without and 63 with Cydar EV imaging guidance. The cohorts were similar in patient demographics, medical comorbidities, and aortic aneurysm characteristics. No significant difference was noted between the two groups for major adverse postoperative events, length of stay, or length of intensive care unit stay. The use of Cydar EV resulted in nonsignificant decreases in the mean fluoroscopy time (69.3 ± 28 minutes vs 66.2 ± 33 minutes; P = .598) and operative time (204.4 ± 64 minutes vs 186 ± 105 minutes; P = .278). A statistically significant decrease was found in the iodinated contrast volume (105 ± 44 mL vs 83 ± 32 mL; P = .005), patient radiation exposure using the dose area product (1,049,841 mGy/cm² vs 630,990 mGy/cm²; P < .001) and cumulative air kerma levels (4518 mGy vs 3084 mGy; P = .02) for patients undergoing FEVAR with Cydar EV guidance.ConclusionsAt our aortic center, we have observed a trend toward shorter operative times and significant reductions in both iodinated contrast use and radiation exposure during FEVAR using the Cydar EV intelligent maps. Intelligent map guidance improved the efficiency of complex endovascular aneurysm repair, providing a safer intervention for both patient and practitioner.     

Five-year reintervention after endovascular abdominal aortic aneurysm repair in the Vascular Quality Initiative

ObjectivePatients who undergo endovascular abdominal aortic aneurysm repair (EVR) remain at risk for reintervention and rupture. We sought to define the 5-year rate of reintervention and rupture after EVR in the Vascular Quality Initiative (VQI).MethodsWe identified all patients in the VQI who underwent EVR from 2003 to 2015. We linked patients in the VQI to Medicare claims for long-term outcomes. We stratified patients on baseline clinical and procedural characteristics to identify those at risk for reintervention. Our primary outcomes were 5-year rates of reintervention and late aneurysm rupture after EVR. We assessed these with Kaplan-Meier survival estimation.ResultsWe studied 12,911 patients who underwent EVR. The mean age was 75.5 years, 79.9% were male, 3.9% were black, and 89.1% of operations were performed electively. The 5-year rate of reintervention for the entire cohort was 21%, and the 5-year rate of late aneurysm rupture was 3%. Reintervention rates varied across categories of EVR urgency. Patients who underwent EVR electively had the lowest 5-year rate of reintervention at 20%. Those who underwent surgery for symptomatic aneurysms had higher rates of reintervention at 25%. Patients undergoing EVR emergently for rupture had the highest rate of reintervention, 27% at 4 years (log-rank across the three groups, P < .001). Black race and aneurysm size of 6.0 cm or greater were associated with significantly elevated reintervention rates (black, 31% vs white, 20% [log-rank, P < .001]; aneurysm size 6.0 cm or greater, 27% vs all others, <20% [log-rank, P < .001]). There were no significant associations between age or gender and the 5-year rate of reintervention.ConclusionsMore than one in five Medicare patients undergo reintervention within 5 years after EVR in the VQI; late rupture remains low at 3%. Black patients, those with large aneurysms, and those who undergo EVR urgently and emergently have a higher likelihood of adverse outcomes and should be the focus of diligent long-term surveillance.     

Intraoperative adverse events and early outcomes of custom-made fenestrated stent grafts and physician-modified stent grafts for complex aortic aneurysms

ObjectivePhysician-modified fenestrated stent grafts (PMSGs) are a useful option for urgent or semiurgent treatment of complex abdominal aortic aneurysms (CAAAs). The aim of this study was to describe in-hospital outcomes of custom-made fenestrated stent grafts (CMSGs) and PMSGs for the treatment of CAAAs and thoracoabdominal aortic aneurysms (TAAAs).MethodsIn this single-center, retrospective study, all consecutives patients with CAAAs or TAAAs undergoing endovascular repair using Zenith CMSGs (Cook Medical, Bloomington, Ind) or PMSGs between January 2012 and November 2017 were included. End points were intraoperative adverse events, in-hospital mortality, postoperative complications, reinterventions, target vessel patency, and endoleaks.ResultsNinety-seven patients were included (CMSGs, n = 69; PMSGs, n = 28). The PMSG group included more patients assigned to American Society of Anesthesiologists class 4 (n = 14 [50%] vs n = 16 [23%]; P = .006) and more TAAAs (n = 17 [61%] vs n = 10 [15%]; P < .0001). Intraoperative adverse events were recorded in eight (11%) patients in the CMSG group vs six (21%) patients in the PMSG group. No intraoperative death or open conversion occurred. In-hospital mortality rates were of 4% (n = 3) in the CMSG group and 14% in the PMSG group (n = 4). Chronic renal failure was an independent preoperative risk factor of postoperative death or complications (odds ratio, 4.88; 95% confidence interval, 1.65-14.43; P = .004). Rates of postoperative complications were 22% (n = 15) and 25% (n = 7) in the CMSG and PMSG groups. Spinal cord ischemia rates were 4% (n = 3) and 7% (n = 2) in the CMSG and PMSG groups. Reintervention rates were 16% (n = 11) in the CMSG group and 32% (n = 9) in the PMSG group. At discharge, target vessel patency rate in CMSGs was 98% (n = 207/210). All target vessels (n = 98) were patent in the PMSG group. Endoleaks at discharge were observed in 24% of the CMSG group (n = 16) vs 8% of the PMSG group (n = 2).ConclusionsOur study showed clinically relevant differences of several important in-hospital outcomes in the CMSG and PMSG groups. Larger cohorts and longer follow-up are needed to allow direct comparison. PMSGs may offer acceptable in-hospital results in patients requiring urgent interventions when CMSGs are not available or possible.     

The different effect of branches and fenestrations on early and long-term visceral vessel patency in complex aortic endovascular repair

BackgroundAortic endovascular treatment with fenestrated or branched devices (f/bEVAR) requires a connection between the aortic graft and the visceral vessel (VV). However, data on the perioperative and long-term fate of the VVs remain scarce. The aim of our study was to evaluate the VV loss (VVL) according to the type of revascularization performed (fenestrations vs branched) and the necessity for adjunctive visceral procedures (AVPs).MethodsFrom 2012 to 2017, all f/bEVAR procedures for juxtarenal abdominal aortic aneurysms (JAAAs), pararenal abdominal aortic aneurysms (PAAAs), and thoracoabdominal aortic aneurysms (TAAAs) were considered. The perioperative VVL, AVPs, and graft configuration were considered and evaluated during the follow-up period.ResultsIn 158 patients, 523 VVs were considered, 140 (26%) in JAAAs, 165 (32%) in PAAAs, and 218 (42%) in TAAAs. Branches were used for 114 vessels (52%) in TAAAs, 8 (5%) in PAAAs, and 0 (0%) in JAAAs. The overall perioperative VVL was 20 (3.8%) and was significantly greater in TAAAs than in PAAAs or JAAAs (6.4% vs 2.4% vs 1.4%; P = .03). The branches resulted in greater perioperative VVL compared with fenestration (9% [11 of 122] vs 2% [9 of 401]; P = .0001). A significant VVL difference between the branches and fenestrations was identified selectively only for the renal arteries: 11 of 52 (21%) vs 6 of 224 (2.5%; P = .001). The results of the multivariate analysis confirmed the independent greater risk of VVL for branches and renal arteries (odds ratio, 4.7; 95% confidence interval, 12.5-1.7; P = .04; odds ratio, 7.1; 95% confidence interval, 52.6-1.05; P = .05, respectively). AVPs were performed in 43 VVs (8.2%) because of dissection (n = 2; 0.4%), stenosis (m = 3; 0.6%), bleeding (n = 3; 0.6%), or kinking between the bridging stent graft and the VV (n = 35; 7%). A significant difference between the branches and fenestrations was seen only for kinking between the bridging stent graft and VV (12% [15 of 112] vs 5% [20 of 401]; P = .005). At 5 years, the incidence of VVL was 2% ± 1%. The fenestrations had significantly greater freedom from VVL compared with the branches (100% vs 87% ± 6%; P = .04), which was confirmed selectively for TAAAs (100% vs 87% ± 6%; P = .04). The use of AVPs did not affect long-term visceral patency.ConclusionsEarly and late VVL was infrequent in complex aortic procedures but seemed to occur more frequently in branches than in fenestration, especially for renal arteries. AVPs were often required to correct artery kinking but this did not affect the long-term patency.     

Intraoperative contrast-enhanced ultrasound examination for endoleak detection after complex and infrarenal endovascular aortic repair

ObjectiveThe aim of this pilot study was to evaluate intraoperative contrast-enhanced ultrasound (iCEUS) examination for endoleak (EL) detection after complex endovascular aortic repairs (EVAR) in comparison with the standard angiographic completion control.MethodsTwenty-one patients (16 male; median age, 73 years [range, 54-81 years]) who underwent single-stage EVARs at our center between October 2016 and October 2018 were included prospectively. The procedures comprised fenestrated and/or branched EVAR (n = 14; 66%), infrarenal EVAR (n = 5; 24%), infrarenal EVAR with bilateral iliac side branch implantation (n = 1; 5%), and infrarenal EVAR with occluder implantation into the internal iliac artery (n = 1; 5%). The used endografts included 14 custom made devices (Cook, Australia Pty Ltd, Brisbane, Australia, n = 6; Vascutek Terumo, Glasgow, Scotland, n = 8) and seven standard infrarenal endografts (Medtronic Inc, Santa Rosa, Calif, n = 5; Vascutek Terumo, Glasgow, Scotland, n = 1; Cook, n = 1). All patients underwent an angiographic completion control for EL detection followed by iCEUS examination. The iCEUS examination was performed by the same examiner who was blinded to the angiography result. In addition to the comparison of the angiographic results to iCEUS examination, iCEUS examination was also compared with the computed tomography angiography (CTA) before discharge (median time to CTA, 5 days [range, 1-7 days]).ResultsAngiography detected eight type II EL, defining the EL origin in four cases. In addition to detecting all of those eight EL, iCEUS examination revealed eight more type II EL not seen on angiography (P = .002) and allowed a definition of the EL origin in all cases. CTA before discharge showed a persistence of only 5 of the 16 type II EL detected by iCEUS examination (31%, P = .002).ConclusionsAn iCEUS examination can be used as another adjunct to decrease exposure to contrast agent and radiation during EVAR, including complex procedures. A replacement of the completion angiography by iCEUS examination is conceivable for infrarenal EVAR, but also for endovascular type IV or type V repairs. Future studies with larger patient numbers will help to further validate iCEUS examination during complex EVAR.     

Migration and sac expansion as modes of midterm therapeutic failure after endovascular aneurysm sealing

BackgroundEndovascular aneurysm sealing (EVAS) is a disruptive technology to treat abdominal aortic aneurysm (AAA). The use of sac filling rather than endograft fixation was designed to treat aortic aneurysms in a wide range of morphologic appearances and to reduce endoleaks. There are few data reporting outcomes beyond postoperative follow-up. This study reports outcomes up to 5 years for Nellix (Endologix, Irvine, Calif) EVAS.MethodsData were prospectively collected for EVAS patients from the time of adoption of EVAS in 2013. All patients treated with the Nellix device are included in this study, and as such, it reports on infrarenal, ruptured, and iliac aneurysms as well as the Nellix-in-Nellix application. Juxtarenal and suprarenal aneurysms were treated using the EVAS system with parallel grafts into the visceral vessels and are included. Therapeutic failure, a composite outcome of migration, sac expansion >5 mm, type Ia and type Ib endoleak, and secondary aortic rupture, was the primary outcome along with all-cause mortality, aneurysm-related mortality, and reintervention rates.ResultsThere were 295 EVAS cases undertaken between March 2013 and July 2018. Indications for treatment were infrarenal (n = 185), juxtarenal and suprarenal (n = 73), ruptured (n = 18), and iliac (n = 13) aneurysms. There were 15 reinterventions using the Nellix-in-Nellix application. In some cases, EVAS was used to salvage failing endovascular or open aneurysm repairs. Median follow-up was 2.42 years (interquartile range, 1.07-3.57 years).Therapeutic failure was observed in 98 of the 295 cases (33.2%) overall and exceeded 50% in some subgroups. In 71 cases (24.1%), reintervention was performed, with reasons for no reintervention being mainly physiologic. Complications leading to therapeutic failure were most commonly seen beyond 2 years of follow-up. There were 15 secondary ruptures (5.36%), and 9 EVAS devices required explantation either electively or for aortic rupture.ConclusionsEVAS with the Nellix device has not met expectations, and early encouraging results have been eroded. The incidence of therapeutic failure has been high, occurring 2 years and beyond after implantation. The Nellix system has been voluntarily recalled by Endologix, and the CE mark has subsequently been suspended. The adoption of EVAS as a disruptive technology highlights the need for cautious adoption of novel technologies and the strict governance around such arrangements.     

Comparative early and midterm results of open juxtarenal and infrarenal aneurysm repair

Background and aims Since the introduction of endovascular aortic aneurysm repair (EVAR) for aortic aneurysms, the number of juxtarenal aortic aneurysms (JRA) has been growing steadily due to selection bias (neck morphology for EVAR). This case-match study compares the perioperative outcome and midterm results of suprarenally clamped JRA with infrarenal aortic aneurysms (AAA). Methods From 1997 to 2004, patients who received open surgery with suprarenal clamping for JRA were included in the study and compared to matched patients with infrarenal clamping (AAA). Measurements analyzed were the in-hospital mortality and morbidity. Midterm results were obtained through clinical investigation and magnetic resonance angiography imaging. Results Thirty-five patients (mean age, 68.4 years; 30 male and 5 female) received suprarenal cross-clamping for JRA. The overall in-hospital mortality for JRA and for the controls (AAA) with elective aortic repair was 4.5% (6.1% JRA; 3% AAA, p = 0.058). The morbidity of JRA was elevated according to the rate of pulmonary complications (p = 0.021) and the need for re-operation (p = 0.019). The mean follow-up time was 2.3 years (range, 8–96 months). At follow-up, 28 patients (80%) from the JRA group and 29 patients from the AAA group (82.9%) were alive. Conclusion Open aortic surgery for JRA with the need for suprarenal cross-clamping shows a slightly elevated in-hospital mortality rate without statistical significance and equal midterm mortality results in comparison with infrarenally clamped aortic aneurysms.