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This study aimed to provide a comprehensive overview of the most common intraoperative adverse events that occur during standard endovascular repair and fenestrated-branched endovascular repair to treat abdominal aortic aneurysms, thoracoabdominal aortic aneurysms, and aortic arch aneurysms. Despite advancements in endovascular techniques, sophisticated imaging and improved graft designs, intraoperative difficulties still occur, even in highly standardized procedures and high-volume centers. This study emphasized that with the increased adoption and complexity of endovascular aortic procedures, strategies to minimize intraoperative adverse events should be protocolized and standardized. There is a need for robust evidence on this topic, which could potentially optimize treatment outcomes and durability of the available techniques.

Objective: Several studies have demonstrated advantages of the retroperitoneal approach (RP) over the transperitoneal approach (TP) for infrarenal abdominal aortic aneurysm (AAA) repair. A retrospective analysis was performed comparing the outcomes of a TP vs. RP surgical approach for open complex AAA (cAAA) repair and evaluated their relative use over time. Methods: Patients undergoing open repair for intact cAAA (juxtarenal, suprarenal, or type IV thoraco-abdominal aortic aneurysms) between 2011 and 2019 were identified in the National Surgical Quality Improvement Program. The primary outcome was peri-operative death. Secondary outcomes included peri-operative complications and approach use over time. Multivariable adjustment was performed by creating propensity scores and using inverse probability weighted logistic regression. Results: Among 1 195 patients identified, 729 (61%) underwent cAAA repair via a TP approach and 466 (39%) via an RP approach. Compared with a TP approach, RP patients more frequently had a supracoeliac clamp position (32% vs. 20%, p < .001) and concomitant renal revascularisation (30% vs. 18%, p < .001). After adjustment, an RP approach was associated with lower odds of peri-operative death (4.0% vs. 7.2%; odds ratio [OR] 0.54; 95% confidence interval [CI] 0.32 – 0.91; p = .022). Furthermore, an RP approach was associated with lower odds of any major complication (24% vs. 30%; OR 0.73; 95% CI 0.56 – 0.94), cardiac complications (4.9% vs. 8.2%; OR 0.60; 95% CI 0.37 – 0.96), wound complications (2.1% vs. 6.0%; OR 0.34; 95% CI 0.17 – 0.64), and post-operative sepsis (0.8% vs. 2.4%; OR 0.37; 95% CI 0.12 – 0.99). The proportion of repairs using an RP approach decreased between 2011 – 2015 and 2016 – 2019 (42% vs. 35%, p = .020), particularly for suprarenal and type IV thoraco-abdominal aneurysms (49% vs. 37%, p = .023). Conclusion: In open cAAA repair, the RP approach may be associated with lower peri-operative mortality and morbidity rates compared with the TP approach. However, it was found that the relative use of the RP approach is decreasing over time, even in suprarenal/type IV thoraco-abdominal aneurysms, and repairs using a supracoeliac clamp. Increased use of the RP approach, when appropriate, may lead to improved outcomes following open cAAA repair.

Purpose: The purpose of the study is to ascertain endovascular aneurysm repair (EVAR) suitability in relation to stent-graft-specific instructions for use (IFU) in patients with a ruptured abdominal aortic aneurysm (RAAA). Materials and Methods: Using the preoperative computed tomography angiography (CTA), the aortic morphology of patients undergoing surgical repair of a RAAA in 2 Dutch hospitals between January 2014 and December 2019 was retrospectively assessed. Three-dimensional and central luminal line reconstructions were used. Anatomical suitability was defined according to the IFU of the stent graft system used. Results: Of 128 included patients, 112 (88%) were men and the mean age was 74.1 (SD=7.6) years. Anatomy within IFU for EVAR was present in 31 patients (24%). Overall, 94 patients (73%) were treated with open surgical repair (OSR) and 34 patients (27%) were treated with EVAR. Anatomy within IFU was present in 15 OSR patients (16%) and 16 EVAR patients (47%). In patients with anatomy outside of IFU, 90% (87/97) had unsuitable neck anatomy and 64% (62/97) had insufficient neck length. An unsuitable distal iliac landing zone was observed in 35 patients. Perioperative mortality was 27% (34/128), with no difference between OSR and EVAR (25/94 vs 9/34; p=0.989). Conclusion: Most RAAA patients in this series did not have aortic anatomy within IFU for EVAR, mainly due to insufficient neck length. However, whether anatomy outside of IFU equates to unsuitability for EVAR in an emergency setting remains a matter of debate and warrants further research. Clinical Impact The treatment of a ruptured abdominal aortic aneurysm can consist of endovascular repair or open repair. Retrospective anatomical assessment shows that most patients do not have anatomy inside the instructions for use for endovascular aneurysm repair, mainly due to insufficient neck length. Whether anatomy outside the instructions for use equates unsuitability for endovascular aneurysm repair remains a matter of debate.

Purpose: Octogenarians are known to have less-favorable outcomes following ruptured abdominal aortic aneurysm (rAAA) repair compared with their younger counterparts. Accurate information regarding perioperative outcomes following rAAA-repair is important to evaluate current treatment practice. The aim of this study was to evaluate perioperative outcomes of octogenarians and to identify factors associated with mortality and major complications after open surgical repair (OSR) or endovascular aneurysm repair (EVAR) of a rAAA using nationwide, real-world, contemporary data. Methods: All patients that underwent EVAR or OSR of an infrarenal or juxtarenal rAAA between January 1, 2013, and December 31, 2018, were prospectively registered in the Dutch Surgical Aneurysm Audit (DSAA) and included in this study. The primary outcome was the comparison of perioperative outcomes of octogenarians versus non-octogenarians, including adjustment for confounders. Secondary outcomes were the identification of factors associated with mortality and major complications in octogenarians. Results: The study included 2879 patients, of which 1146 were treated by EVAR (382 octogenarians, 33%) and 1733 were treated by OSR (410 octogenarians, 24%). Perioperative mortality of octogenarians following EVAR was 37.2% versus 14.8% in non-octogenarians (adjusted OR=2.9, 95% CI=2.8–3.0) and 50.0% versus 29.4% following OSR (adjusted OR=2.2, 95% CI=2.2–2.3). Major complication rates of octogenarians were 55.4% versus 31.8% in non-octogenarians following EVAR (OR=2.7, 95% CI=2.1–3.4), and 68% versus 49% following OSR (OR=2.2, 95% CI=1.8–2.8). Following EVAR, 30.6% of the octogenarians had an uncomplicated perioperative course (UPC) versus 49.5% in non-octogenarians (OR=0.5, 95% CI=0.4–0.6), while following OSR, UPC rates were 20.7% in octogenarians versus 32.6% in non-octogenarians (OR=0.5, 95% CI=0.4–0.7). Cardiac or pulmonary comorbidity and loss of consciousness were associated with mortality and major complications in octogenarians. Interestingly, female octogenarians had lower mortality rates following EVAR than male octogenarians (adjusted OR=0.7, 95% CI=0.6–0.8). Conclusion: Based on this nationwide study with real-world registry data, mortality rates of octogenarians following ruptured AAA-repair were high, especially after OSR. However, a substantial proportion of these octogenarians following OSR and EVAR had an uneventful recovery. Known preoperative factors do influence perioperative outcomes and reflect current treatment practice.

Objective: Acute kidney injury (AKI) is a well known complication following cardiovascular procedures. The objective was to assess the incidence, risk factors, and prognostic significance of AKI after infrarenal endovascular aneurysm repair (EVAR) and complex EVAR (cEVAR; fenestrated or branched EVAR). Methods: Consecutive patients undergoing elective infrarenal EVAR or cEVAR between 2000 and 2018 in two large teaching hospitals in the Netherlands were included. AKI was determined by serum creatinine levels increasing > 1.5 times or by an absolute increase of 26.5 mmol/L from baseline value (KDIGO criteria). The primary outcome was incidence of peri-operative AKI development. Secondary outcomes included mid-term renal function (RIFLE criteria), overall survival, and risk factors for AKI development. To determine survival and risk factors for AKI, multivariable Cox regression and logistic regression analyses were performed, accounting for pre-operative renal function and other confounders. Results: In total, 540 patients who underwent infrarenal EVAR with 147 patients who underwent cEVAR also included. The incidence of AKI was 8.7% (n = 47) in infrarenal EVAR patients and 23% (n = 34) in cEVAR patients (fenestrated EVAR 18%; branched EVAR 38%). In contrast to patients without AKI, the renal function of surviving patients with AKI remained significantly reduced at six weeks and did not return to pre-operative values following infrarenal EVAR (three year estimated glomerular filtration rate [eGFR] 59.3 ± 23.1 mL/min/1.73m2 vs. pre-operative eGFR 74.0 ± 21.7 mL/min/1.73m2; p = .006) or following cEVAR (three year eGFR 52.0 ± 23.7 mL/min/1.73m2 vs. pre-operative eGFR 65.4 ± 18.6 mL/min/1.73m2; p = .082). After risk adjusted analysis, compared with non-AKI, post-operative AKI development was associated with a higher three year mortality rate following both infrarenal and cEVAR (infrarenal EVAR mortality hazard ratio [HR 1.6, 95% confidence interval [CI] 1.01 – 2.7 [p = .046]; cEVAR mortality HR 2.4, 95% CI 1.1 – 5.2 [p = .033]). Following multivariable logistic regression, pre-operative chronic kidney disease (eGFR < 60 mL/min/1.73m2; odds ratio [OR] 2.2, 95% CI 1.03 – 4.8) and neck diameter (OR 1.1, 95% CI 1.01 – 1.2) were significantly associated with AKI following infrarenal EVAR, whereas for cEVAR only contrast volume (OR 1.1, 95% CI 1.0 – 1.2]) was found to be statistically significantly associated with AKI. Conclusion: AKI is a well described complication following infrarenal EVAR and is common after cEVAR. As AKI seems to be associated with permanent renal deterioration and lower survival, efforts to prevent AKI are essential. Future studies are required to assess what factors are associated with a higher risk of developing AKI following cEVAR.

Background: Endovascular aneurysm sealing (EVAS), using the Nellix endovascular aneurysm sealing system, has been associated with high reintervention and migration rates. However, prior reports have suggested that EVAS might be related to a lower all-cause mortality compared with endovascular aneurysm repair (EVAR). In the present study, we examined the 5-year all-cause mortality trends after EVAS and EVAR. Methods: We compared the 333 EVAS patients in the EVAS-1 Nellix U.S. investigational device exemption trial with 16,497 infrarenal EVAR controls from the Vascular Quality Initiative, treated between 2014 and 2016, after applying the exclusion criteria from the investigational device exemption trial (ie, hemodialysis, creatinine >2.0 mg/dL, rupture). As a secondary analysis, we stratified the patients by aneurysm diameter (

Objective: With increasing experience in fenestrated endovascular aneurysm repair (FEVAR) over time, devices designed to treat juxta-/pararenal aortic aneurysms have evolved in complexity to extend to more proximal landing zones and incorporate more target vessels. We assessed perioperative outcomes in patients who underwent juxta-/pararenal FEVAR with supraceliac vs infraceliac sealing in the Vascular Quality Initiative. Methods: We identified all patients who underwent elective FEVAR (commercially available FEVAR and physician-modified endografts) for juxta-/pararenal aortic aneurysms in the Vascular Quality Initiative between 2014 and 2021. Supraceliac sealing was defined as proximal sealing in aortic zone 5, or zone 6 with a celiac scallop/fenestration/branch or celiac occlusion. Primary outcomes were perioperative and 3-year mortality. Secondary outcomes included completion endoleaks, in-hospital complications, and factors associated with 3-year mortality. We calculated propensity scores and used inverse probability-weighted Cox regression and logistic regression modeling to assess outcomes. Results: Among 1486 patients identified, 1246 patients (84%) underwent infraceliac sealing, and 240 patients (16%) underwent supraceliac sealing. Of the supraceliac patients, 74 (31%) had a celiac scallop, 144 (60%) had a celiac fenestration/branch, and 22 (9.2%) had a celiac occlusion (intentional or unintentional). After risk-adjusted analyses, there were no differences in perioperative mortality following supraceliac sealing compared with infraceliac sealing (2.3% vs 2.5%; hazard ratio [HR], 0.67; 95% confidence interval [CI], 0.26-1.8; P = .42), or 3-year mortality (12% vs 15%; HR, 0.89; 95% CI, 0.53-1.5; P = .67). Compared with infraceliac sealing, supraceliac sealing was associated with lower odds of type-IA completion endoleaks (odds ratio [OR], 0.24; 95% CI, 0.05-0.67), but higher odds of any complication (12% vs 6.9%; OR, 1.6; 95% CI, 1.01-2.5) including cardiac complications (5.5% vs 1.9%; OR, 2.6; 95% CI, 1.3-5.1), lower extremity ischemia (3.0% vs 0.9%; OR, 3.2; 95% CI, 1.02-9.5), and acute kidney injury (16% vs 11%; OR, 1.6; 95% CI, 1.05-2.3). Though non-significant, there was a trend towards higher risk of spinal cord ischemia following supraceliac sealing compared with infraceliac sealing (1.7% vs 0.8%; OR, 2.2; 95% CI, 0.70-6.4). There were no differences in bowel ischemia between groups (1.7% vs 1.5%; OR, 0.83; 95% CI, 0.24-1.23). A more proximal aneurysm disease extent was associated with higher 3-year mortality (HR zone 8 vs 9, 1.7; 95% CI, 1.1-2.5), whereas procedural characteristics had no influence. Conclusions: Compared with sealing at an infraceliac level, supraceliac sealing was associated with lower risk of type IA endoleaks and similar mortality. However, clinicians should be aware that supraceliac sealing was associated with higher perioperative morbidity. Future studies with longer follow-up are needed to adequately assess durability differences to comprehensively weigh the risks and benefits of utilizing a higher sealing zone within the visceral aorta for juxta-/pararenal FEVAR.

We thank Shirasu et al. for their comments on our recent study. Shirasu et al. describe impressive in hospital mortality results following open surgical repair (OSR) for an intact abdominal aortic aneurysm (AAA) in Japan (2.0% down to 1.2%), using data from the National Clinical Database. Although we found similar trends using data from our nationwide mandatory verified quality registry, the peri-operative mortality in the Netherlands is higher. However, our operative mortality is comparable with other vascular registries. The difference in mortality between Japan and the Netherlands could be due to selection bias, differences in input to the database, and differences in caseload per hospital. [...]

Objectives A short-stay endovascular aneurysm repair (SS-EVAR) pathway for infrarenal abdominal aortic aneurysms offers the potential to improve service efficiency and patient satisfaction by reducing the hospital length of stay. This study aimed to determine whether the implementation of a novel set of patient selection criteria for a theoretical SS-EVAR pathway could facilitate an expansion of the proportion of suitable patients, whilst maintaining patient safety and limiting unplanned emergency readmissions. Methods Two SS-EVAR selection criteria (low and high risk) were generated based upon patient pre-operative comorbidities. The low risk criteria essentially selected fit and healthy individuals, whereas the high risk criteria included patients with a range of comorbidities that could still theoretically enable enrolment onto a SS-EVAR pathway. A retrospective analysis, whereby both criteria were applied to all elective EVARs recorded in the National Vascular Registry between 2013 and 2016 at a single tertiary vascular unit was performed. Rates and timings of postoperative complications, reinterventions and unplanned readmissions for patients meeting each criteria were assessed. Results In total, 188 patients were included (92% male, mean age 75.4 ± 7.2 years). Twenty-nine patients (15%) met the low risk criteria. Two (7%) of these experienced an inpatient complication which were both detected within 24 h of operation (including one who required reintervention), and no patients in this group had an unplanned readmission within 30 days. One-hundred and ten patients (59%) met our high risk criteria and 19 (17%) experienced an inpatient complication, with 4 (4%) of these occurring beyond 24 h post-EVAR (three urinary problems and one acute on chronic kidney injury). Six (6%) of these patients required a reintervention; however, all of these complications were detected within 24 h. Two (2%) high risk cohort patients required unplanned readmission within 30 days for a femoral pseudoaneurysm and musculoskeletal back pain. Conclusions With high risk patient selection criteria and appropriate post-operative safeguards, up to 60% of infrarenal abdominal aortic aneurysms patients could be safely enrolled onto a next-day discharge SS-EVAR pathway with minimal readmissions, thus allowing more effective resource utilisation.

Background The treatment of juxtarenal abdominal aortic aneurysms is challenging. Open surgical repair is not a viable option for many patients. The use of endovascular aneurysm sealing (EVAS) with chimney grafts (Ch-EVAS) has been proposed as an immediately available, off-the-shelf option for individuals with juxtarenal aneurysms who require urgent treatment or are unsuitable for fenestrated or branched devices. This study reports the outcomes from our first patients to undergo this procedure. Methods Data were collected prospectively for 62 consecutive patients undergoing Ch-EVAS at our institution. The procedures were undertaken for intact juxtarenal or suprarenal aneurysms in patients who were unfit for open repair or needed urgent treatment or when the aneurysm morphology was unsuitable for treatment with fenestrated or branched endografts. Results Between July 2013 and June 2016, there were 62 patients who were treated with Ch-EVAS; 77.4% were male, and the mean age was 73.9 years. Median aneurysm diameter was 64.5 mm. Eight suprarenal aneurysms were treated, with three chimney grafts. Of 54 juxtarenal aneurysms treated, 21 cases used two chimney grafts and 33 cases used one chimney graft. Median follow-up was 407 days. Eleven patients underwent reintervention. There were five type IA endoleaks, all successfully treated. One type IB and one type II endoleak occurred, neither requiring treatment. There were four minor strokes. Chimney patency is 97%. Conclusions These results in a group of high-risk patients suggest that Ch-EVAS is a viable alternative to custom-made devices in patients who are unfit for open surgery. Longer term follow-up and data from the international registry will determine the widespread applicability and durability of this technique.

Objective: Several studies have demonstrated the advantages of a retroperitoneal (RP) vs a transperitoneal (TP) approach during open repair of infrarenal abdominal aortic aneurysms (AAAs). We compared the outcomes after open repair of complex AAAs (cAAAs) using an RP vs a TP approach and evaluated the relative use of these approaches over time. Methods: We identified all patients who had undergone open intact cAAA repair in the Vascular Quality Initiative from 2003 to -2019 and created 1:1-propensity score-matched cohorts stratified by the operative approach (RP vs TP). The primary outcome was perioperative mortality. The secondary outcomes included perioperative complications and approach usage over time. To create 1:1 propensity score-matched cohorts, the patients were matched for demographics, comorbidities, and anatomic and/or intraoperative characteristics, including proximal clamp site and renal revascularization. The approach usage over time was determined by plotting the proportion of RP usage over time for the overall open cAAA cohort and subgroups of repairs using a supraceliac cross clamp, repair with concomitant renal revascularization, and repairs performed at high-volume centers (highest quintile, >11 cases annually). Results: Of a total of 4613 patients, 2843 (62%) had undergone open cAAA repair using the TP approach and 1770 (38%) using the RP approach. Of the 1256 matched pairs, the RP approach was associated with lower risk of perioperative mortality compared with the TP approach (3.9% vs 6.8%; relative risk [RR], 0.57; 95% confidence interval [CI], 0.41-0.80; P = .001). Furthermore, the RP approach was associated with a lower risk of cardiac complications (7.2% vs 9.6%; RR, 0.75; 95% CI, 0.58-0.98), bowel ischemia (3.1% vs 5.4%; RR, 0.56; 95% CI, 0.39-0.84), and postoperative dialysis (3.3% vs 5.5%; RR, 0.59; 95% CI, 0.41-0.87). Overall, the proportion of patients who had undergone repair via an RP approach became lower over time (−1.0%/y; 95% CI, −1.5 to −0.5; P < .001). A similar trend in the decrease was found for the patients who had undergone repair with a supraceliac clamp (−2.3%/y; 95% CI, −3.6 to −1.0; P < .001) and in the high-volume hospitals (−2.1%/y; 95% CI, −3.4 to −0.8; P = .001), although no statistically significant decrease in RP usage was found for the patients who had undergone concomitant renal revascularization (−0.9%/y; 95% CI, −2.6 to 0.8; P = .28). Conclusions: For open cAAA repair, an RP approach was associated with lower perioperative mortality and complications compared with a TP approach. However, the relative usage of the RP approach has been decreasing over time. An increased adoption of the RP approach, when appropriate, might lead to improved outcomes with open cAAA repair.

Objective: Although proximal neck dilatation following infrarenal endovascular aneurysm repair (EVAR) is common and is associated with proximal graft failure, little is known about sealing zone dilatation and its clinical relevance following fenestrated EVAR (FEVAR). We studied proximal seal dilatation (PSD) dynamics following FEVAR and assessed its clinical significance. Methods: We included all consecutive patients treated for a juxta-/supra-renal aneurysm with fenestrated EVAR using the Zenith Fenestrated Endovascular Graft (Cook Medical, Bloomington, Ind) from 2008 to 2018 in two large teaching hospitals in the Netherlands. The primary outcome was PSD over time and was determined using a linear mixed-effects model. Secondary outcomes included associations for early PSD and difference in aortic dilatation at the level of the covered stent compared with the bare stent. Proximal seal-related adverse events were also obtained. Results: Our cohort included 84 patients with a median computed tomography angiography follow-up time of 24.5 months (interquartile range [IQR], 17-42 months). Maximum aneurysm diameter was 60.1 mm (IQR, 56.9-67.2 mm). Mean proximal seal diameter at baseline was 26.2 mm (standard deviation [SD], ±2.8 mm), mean stent oversizing was 20.1% (SD, ±9.1%), and mean proximal seal length was 29.5 mm (SD, ±11.7 mm). Proximal seal dilatation of 1.7 mm (95% confidence interval [CI], 1.4-2.1 mm) was found in the first year, decelerating thereafter (second year, 0.9 mm/year; 95% CI, 0.7-1.1 mm/y). Over 10% PSD at 1 year occurred in 22 patients (27%) and was associated with stent graft oversizing (odds ratio, 1.1; 95% CI, 1.03-1.2; P = .008) and a lower number of target vessels (four fenestrations/ref two fenestrations: odds ratio, 0.13; 95% CI, 0.02-0.74; P = .029). At last available imaging, dilatation difference was higher at the level of the covered stent compared with the bare stent (3.0 mm [IQR, 1.3-5.1 mm] vs 1.6 mm [IQR, 0.8-2.5 mm]; P < .001). During the study period, only one patient (1.2%) developed a proximal seal-related adverse event (type IA endoleak). Conclusions: PSD is present following FEVAR, occurring at a faster rate in the first year and subsequently decelerating thereafter, similarly to neck dilatation after standard infrarenal EVAR. Although its clinical implication seems to remain limited in the first years following implantation, further research is required to assess the effect of PSD on long-term FEVAR outcomes.

Background Duplex ultrasonography (DUS) currently has limited applicability in the diagnosis and surveillance of thoracic aortic pathologies because of associated limitations. This study investigates the feasibility of using an optimised DUS protocol to detect descending thoracic aortic pathology. Methods This was a prospective, case control cohort study. Patients with computed tomography (CT) confirmed thoracic aortic pathology underwent DUS of the thoracic aorta. A control group known to have no thoracic pathology also underwent DUS. The sonographer performing DUS was blinded to the CT findings, and recorded the presence of pathology or any dilated aortic segment where visualised. Diameter cutoff points of 35 mm and 40 mm were compared. Results Forty patients were scanned (20 cases and 20 controls). All patients but one had a technically adequate assessment of the thoracic aorta (at least one view of the descending thoracic aorta). Using a size threshold of 40 mm, 16 out of 19 cases and two out of 20 control patients would have been recommended for definitive imaging. Using a cutoff of 35 mm, this became 18 out of 19 cases and six of 20 controls. Sensitivity and specificity were 100% and 70% for a threshold of 35 mm, and 84% and 90% for a threshold of 40 mm. Conclusions DUS has the potential to be used as a diagnostic modality for thoracic aortic pathology, and may have a role in surveillance for some patients for whom CT scanning is contraindicated. Further validation and refinements to this technique are required. However, this study provides proof of concept.

Item does not contain fulltext OBJECTIVE: Randomized trials have shown an initial survival benefit of endovascular over conventional open abdominal aortic aneurysm repair but no long-term difference up to 6 years after repair. Longer follow-up may be required to demonstrate the cumulative negative impact on survival of higher reintervention rates associated with endovascular repair. METHODS: We updated the results of the Dutch Randomized Endovascular Aneurysm Management (DREAM) trial, a multicenter, randomized controlled trial comparing open with endovascular aneurysm repair, up to 15 years of follow-up. Survival and reinterventions were analyzed on an intention-to-treat basis. Causes of death and secondary interventions were compared by use of an events per person-year analysis. RESULTS: There were 178 patients randomized to open and 173 to endovascular repair. Twelve years after randomization, the cumulative overall survival rates were 42.2% for open and 38.5% for endovascular repair, for a difference of 3.7 percentage points (95% confidence interval, -6.7 to 14.1; P = .48). The cumulative rates of freedom from reintervention were 78.9% for open repair and 62.2% for endovascular repair, for a difference of 16.7 percentage points (95% confidence interval, 5.8-27.6; P = .01). No differences were observed in causes of death. Cardiovascular and malignant disease account for the majority of deaths after prolonged follow-up. CONCLUSIONS: During 12 years of follow-up, there was no survival difference between patients who underwent open or endovascular abdominal aortic aneurysm repair, despite a continuously increasing number of reinterventions in the endovascular repair group. Endograft durability and the need for continued endograft surveillance remain key issues.

Elective repair of thoracic aortic aneurysms is a prophylactic procedure performed when the risk of aneurysm rupture is judged to outweigh perioperative risk. It has been demonstrated that mortality because of any cause in the 5 years after repair in frail surgical candidates is high, despite the fact that perioperative mortality is relatively favorable and aortic-related death is reduced.1,2 Patient selection, therefore, is vital if survival gains are to be achieved through elective repair of thoracic aneurysms. Preoperative factors are known to affect life expectancy after surgery, but the effect of perioperative complications on subsequent survival has not been reported. Patients undergoing elective thoracic aneurysm repair for thoracic aortic aneurysm from the updated MOTHER (Medtronic Thoracic Endovascular Registry) were studied, which comprises 7 clinical trials and 1 institutional series.3 Subjects with aneurysmal chronic aortic dissection were excluded. Perioperative complications were classified as neurological, cardiac, renal, respiratory, or access vessel-related. For all clinical trials, adverse events were reported via the trial data-collection process and were adjudicated by a review panel according to trial protocol. For the St George’s Vascular Institute cohort, all adverse events were reviewed …

Background Endovascular 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. Methods Data 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. Results There 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. Conclusions EVAS 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.

Objective Reducing length of stay (LOS) following surgery offers the potential to improve resource utilisation. Endovascular aneurysm repair (EVAR) is now delivered with a low level of morbidity and as such may be deliverable as a “23 hour stay” intervention. This systematic review aims to assess safety, feasibility and cost effectiveness of a short stay EVAR pathway. Methods A database search of Ovid MEDLINE (1996 – April 2018) and Embase (1974 – April 2018) was completed. Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines were used. A Newcastle–Ottawa Scale was applied to assess study bias. Results In total, 570 papers were identified through the literature search, of which 32 abstracts were screened. This led to nine papers being assessed for eligibility. From five suitable studies, 450 (75%) patients were successfully discharged the same or next day after EVAR. Complications most often occurred within 3 hours of surgery, and major complications requiring intensive treatment unit admission occurred within 6 hours. Readmission rates were 0–5% for those discharged early, with no difference in 30 day readmission. Early discharge led to a statistically significant cost saving of £13,360 (LOS four days) to £9844 (LOS one day). Conclusion Selected patients can safely undergo EVAR using a short stay pathway. A period of monitoring 6 h post-operatively for low risk patients would be sufficient. Reducing length of stay after EVAR in the UK from the current median of three days to 1.5 days would free 4361 bed days and lead to a saving of approximately £1,800,000 annually.

Purpose: To describe the imaging characteristics of the Nellix Endovascular Aneurysm Sealing (EVAS) System on serial computed tomography (CT) surveillance. Methods: Sixty-eight patients undergoing EVAS were enrolled in a surveillance protocol that included CT scans prior to hospital discharge and at 3, 6, and 9 months postoperatively. Images were analyzed for the presence of gas within the endobag, endoleak, and for maximum radiodensity measured in Hounsfield units (HU) within the uppermost, middle, and lowermost regions of each endobag. Results: Gas was seen within the endobags of all 68 EVAS repairs at the first postoperative CT compared with 2 (5.6%) of 36 undergoing the 3-month scan. The endobags appeared radiodense during initial imaging, and the median (interquartile range) radiodensity of the Nellix polymer decreased from 158.3 HU (149.5; 169.5) at the postoperative CT to 81.0 HU (74.0; 88.0) at 3 months, excluding 3 cases in which contrast pre-fill was utilized. Type I endoleak was seen at the periphery of the aneurysm sac or in the cleft between the endobags, with a substantially different appearance to endoleak after endovascular aneurysm repair. Conclusion: The evolution of CT appearances after EVAS was characteristic and predictable. The device endobags were initially radiodense, which may impact the detection of endoleak within 3 months of EVAS. Endoleaks after EVAS were seen in a different anatomical area to endoleaks after conventional stent-graft repair.

Purpose: To report the application of the Nellix endovascular aneurysm sealing (EVAS) device, including two chimney grafts, to successfully treat a type Ia endoleak. Case Report: An 87-year-old man had an asymptomatic 7.6-cm infrarenal abdominal aortic aneurysm (AAA) and a 4.5-cm right internal iliac artery aneurysm treated using an aortouni-iliac stent-graft. Two years after the index endovascular repair, an asymptomatic type Ia endoleak was detected on duplex ultrasound; the computed tomographic angiogram (CTA) demonstrated significant sac enlargement and stent-graft migration. Initial attempts to treat the leak with 2 aortic cuffs only reduced the size of the endoleak. Another procedure was undertaken using the Nellix device with chimney grafts to increase the proximal sealing zone above the existing stent-graft. Imaging postoperatively demonstrated successful resolution of the endoleak and continuing patency of both renal artery chimney stent-grafts. CTA at 6 months demonstrated persistent sealing of the endoleak. Conclusion: The use of the EVAS system may represent another endovascular solution that can be added to the clinician’s repertoire for treating type Ia endoleak after conventional endovascular repair of infrarenal AAA.

PURPOSE To investigate in an in vitro juxtarenal aneurysm flow model the feasibility and efficacy of using a sac-sealing endoprosthesis in a chimney graft configuration. METHODS In two experiments, a Nellix sac-sealing endoprosthesis was used as the main graft in a double-branched chimney graft configuration, using a self-expanding Viabahn stent-graft and a balloon-expandable Advanta V12 stent-graft in a pressurized silicone juxtarenal aneurysm flow model. In two consecutive experiments, the chimney graft balloons were inflated (1) at the beginning of and (2) to simulate varying renal ischemic times half-way through the injection of the sac-sealing polymer into the Nellix endobags. The balloons and were kept inflated until the endobags were filled and the polymer was cured. The aneurysm model was connected to a roller pump, pumping gelatin-water at a rate of 100 beats per minute. Before and after 24 hours of continuous flow, computed tomography (CT) scans were made using contrast injection. The CT scans were reconstructed and analyzed for gutter cross-sectional area, total gutter volume, chimney graft compression, and volume of space between the aneurysm wall and the endoprosthesis. RESULTS Differences in gutter size between both types of chimney grafts were minimal. Chimney graft compression exceeded 50% if the balloons were inflated in the chimney grafts halfway through polymer injection into the endobag. Twenty-four hours of flow did not influence chimney graft patency or gutter size. CONCLUSION In a juxtarenal aneurysm flow model, we demonstrated the technical feasibility of a sac-sealing endoprosthesis in a chimney graft configuration. This early evidence suggests that balloon dilation of chimney grafts should occur over the entire period of polymer injection and curing to prevent considerable chimney graft compression.

Purpose: To assess the feasibility and safety of the endovascular aneurysm sealing (EVAS) technique in the treatment of acute abdominal aortic aneurysm (AAA). Methods: A retrospective, multicenter, observational study was conducted at 8 centers (7 European and 1 in New Zealand) experienced with EVAS in the elective setting. From February 2013 to April 2015, 58 patients (mean age 74±9 years; 46 men) with an acute AAA were treated (28 ruptured and 30 symptomatic). The primary endpoint of the study was 30-day mortality; secondary endpoints included endoleak, reinterventions, and 30-day morbidity. Results: The overall intensive care unit and hospital stays were 2.2±6.6 days and 9.7±11.4 days, respectively. Thirty-day mortality rates were 32% (9/28) for the ruptured group and 7% (2/30) for the symptomatic group, with morbidity rates of 57% and 17%, respectively. Early endoleak was present in only 2 (3%) patients, one in each group; both leaks were type Ia. Reinterventions within 30 days were performed in 8 patients in the ruptured group; in the symptomatic patients, the only perioperative reintervention was embolization a type Ia endoleak. The mean follow-up was 9.3±3.1 months in the ruptured group and 12.4±5.4 months in the symptomatic group. The mean aneurysm diameter at 30-day follow-up was 71.8±16.0 mm compared with 74.7±15.7 mm preoperatively in the ruptured group and 66.1±13.5 mm compared with 65.8±13.0 mm in the symptomatic group. Conclusion: EVAS in the acute setting appears safe and feasible and concordant with the literature for endovascular aneurysm repair. More robust prospective and comparative data are required to establish the position of the technique in the treatment algorithm of acute AAA.

Background: The optimal cell-matrix combination for robust and sustained myocardial restoration has not been identified. The present study utilizes embryonic stem cells as the substrate of bioartificial myocardial tissue and evaluates engraftment in, and functional recovery of, the recipient heart. Methods: Collagen type I was populated with undifferentiated green fluorescent protein (GFP)-positive mouse embryonic stem cells. An intramural left ventricular pouch was fashioned after ligation of the left anterior descending artery in an athymic nude rat heterotopic heart transplant model. The bioartificial mixture (0.125 ml) was implanted in the infarcted area within the pouch. Echocardiography was performed to assess fractional shortening in: Group I, infarcted rats that received cell-matrix implants; Group II, rats given matrix implant without cells; Group III, rats given no matrix or cells; and Group IV, rats receiving transplanted hearts without ligation (n = 5/group). Hearts were stained for GFP, cardiac markers (connexin-43, α-sarcomeric actin), hematoxylin-eosin (H&E) and trichrome. Results: Embryonic stem cells formed stable intramyocardial grafts that were incorporated into the surrounding area without distorting myocardial geometry, thereby preventing ventricular wall thinning (anterior wall thickness was: Group I, 1.4 ± 0.1 mm; Group II, 1.0 ± 0.1 mm, Group III, 0.9 ± 0.2 mm; and Group IV, 1.3 ± 0.2 mm). The inoculated cells expressed connexin-43 and α-sarcomeric actin in vivo. Fractional shortening was better in embryonic stem cell-treated animals (Group I, 21.5 ± 3.5%; Group II, 12.4 ± 2.8%; Group III, 8.2 ± 2.9%; Group IV, 23.2 ± 4.2%). Conclusions: Embryonic stem cells are an efficient alternative substrate for myocardial tissue engineering and can prevent myocardial wall thinning and improve contractility after implantation into injured myocardium in a 3-dimensional matrix. Copyright © 2005 by the International Society for Heart and Lung Transplantation.

ObjectivesMost tissue-engineering approaches to restore injured heart muscle result in distortion of left ventricular geometry. In the present study we suggest seeding embryonic stem cells in a liquid matrix for myocardial restoration.MethodsUndifferentiated green fluorescent protein–labeled mouse embryonic stem cells (2 × 106) were seeded in Matrigel (B&D, Bedford, Mass). In a Lewis rat heterotopic heart transplant model an intramural left ventricular pouch was fashioned after ligation of the left anterior descending coronary artery. The liquid mixture (0.125 mL) was injected in the resulting infarcted area within the pouch and solidified within a few minutes after transplantation (37°C). Five recipient groups were formed: transplanted healthy hearts (group I), infarcted control hearts (group II), matrix recipients alone (group III), the study group that received matrix plus cells (group IV), and a group that received embryonic stem cells alone (group V). After echocardiography 2 weeks later, the hearts were harvested and stained for green fluorescent protein and cardiac muscle markers (connexin 43 and α-sarcomeric actin).ResultsThe graft formed a sustained structure within the injured area and prevented ventricular wall thinning. The inoculated cells remained viable and expressed connexin 43 and α-sarcomeric actin. Fractional shortening and regional contractility were better in animals that received bioartificial tissue grafts compared with control animals (infarcted, matrix only, and embryonic stem cells only: group I, 17.0% ± 3.5%; group II, 6.6% ± 2.1%; group III, 10.3% ± 2.2%; group IV, 14.5% ± 2.5%; and group V, 7.8% ± 1.8%).ConclusionsLiquid bioartificial tissue containing embryonic stem cells constitutes a powerful new approach to restoring injured heart muscle without distorting its geometry and structure.

To present treatment of a juxtarenal aneurysm using the Nellix endovascular aneurysm sealing system (EVAS) and a chimney stent.A 79-year-old woman was diagnosed with a 6-cm juxtarenal aneurysm. Standard endovascular aneurysm repair was not possible due to lack of an adequate infrarenal landing zone, and poor iliac access and angulated visceral aortic branches precluded a custom-made fenestrated solution. The patient was not a suitable candidate for open surgery due to significant comorbidity, so she underwent successful endovascular aneurysm repair with the Nellix EVAS system and a renal chimney stent. Follow-up imaging at 6 months showed a sealed aneurysm sac and patent renal chimney stent.The Nellix EVAS system obliterates the aneurysm sac using polymer-filled endobags. The ability of the endobags to conform to adjacent structures may offer advantages over conventional endografts when combined with parallel grafts designed to treat juxtarenal aneurysms.

Purpose: To assess the feasibility and report preliminary results of ruptured abdominal aortic aneurysm (rAAA) repair with endovascular aneurysm sealing (EVAS), a novel therapeutic alternative whose feasibility has not been established in rAAAs due to the unknown effects of the rupture site on the ability to achieve sealing. Case Report: Between December 2013 and April 2014, 5 patients (median age 71 years, range 57–90; 3 men) with rAAAs were treated with the Nellix EVAS system at a single institution. Median aneurysm diameter was 70 mm (range 67–91). Aneurysm morphology in 4 of the 5 patients was noncompliant with instructions for use (IFU) for both EVAS and standard stent-grafts; the remaining patient was outside the IFU for standard stent-grafts but treated with EVAS under standard IFU for the Nellix system. Median Hardman index was 2 (range 0–3). Two patients died of multiorgan failure after re-laparotomy and intraoperative cardiac arrest, respectively. Among survivors, all devices were patent with no signs of endoleak or failed aneurysm sac sealing at 6 months (median follow-up 9.2 months). Conclusion: EVAS for the management of infrarenal rAAAs appears feasible. The use of EVAS in emergency repairs may broaden the selection criteria of the current endovascular strategy to include patients with more complex aneurysm morphology.

To determine gutter size and stent-graft geometry in an in vitro juxtarenal aneurysm model using various chimney graft (CG) configurations.Two silicone juxtarenal aortic aneurysm models were constructed combining different diameters of the aorta and renal artery. In a single-branched CG configuration, 2 sizes (23 and 28.5 mm) of Excluder stent-grafts were tested individually with 2 sizes of 2 types of CGs: Advanta balloon-expandable (BE) stent-grafts (6×59 and 12×61 mm) and Viabahn self-expanding (SE) stent-grafts (6×50 and 13×50 mm). All combinations were tested with a short (10-mm) and long (20-mm) sealing zone between the CG and main graft (total 16 configurations). Immediately after deployment, the CG configuration was scanned using a 64-slice computed tomography scanner. Gutter sizes were measured at different levels of the sealing zone.At the top of the sealing zone, the gutters were significantly larger in the BE CGs compared to SE CGs in combination with the 23-mm main graft (p=0.021). At the bottom of the sealing zone, there were no statistically significant differences (p=0.77). No significant differences were seen using the 28.5-mm main graft. Median gutter size was larger in the 6-mm CGs. The length of the sealing zone had no influence on gutter size. Significant compression of the main graft was found using 12 or 13-mm CGs compared to 6-mm CGs (p=0.001).In this in vitro study, the CG configurations with BE stent-grafts show larger gutters than configurations with SE stent-grafts in small main grafts. Main graft compression is increased using wider CG stent-grafts.

To describe a novel hybrid technique to address two challenges in endovascular repair of chronic dissecting thoracic aortic aneurysm (dTAA): obtaining an adequate seal of the stent-graft in a half-moon-shaped fibrotic aortic lumen and preserving flow into the distal true and false lumens.The technique is demonstrated in a 52-year-old man who presented with progressive asymptomatic dilatation of the thoracic aorta 9 years after undergoing a Bentall procedure for a Stanford type A dissection followed by arch replacement and elephant trunk construction. Imaging at this admission showed a 6.8-cm dissecting aneurysm extending distally to ∼4 cm above the celiac trunk; the dissection included both common iliac arteries. The patient refused a thoracotomy, so a hybrid procedure was devised to resect the intimal flap via a median subxyphoid incision and transperitoneal approach through the lesser sac. Two overlapping Zenith TX-2 stent-grafts were deployed into the elephant trunk, terminating just above the surgically created "flow divider" at the level of the celiac trunk. Imaging showed adequate sealing at both ends of the stent-graft and a type II endoleak that persisted into follow-up, but the aneurysm diameter decreased to 6.4 cm, and there was unobstructed flow into the visceral, renal, and iliac arteries.In this case of chronic dTAA, open surgical removal of a segment of the dissection flap via a subxyphoid incision provided a distal landing zone for subsequent endoluminal repair, with exclusion of the aneurysm and preservation of antegrade flow in both true and false lumens.

BACKGROUND: For patients with large abdominal aortic aneurysms, randomized trials have shown an initial overall survival benefit for elective endovascular repair over conventional open repair. This survival difference, however, was no longer significant in the second year after the procedure. Information regarding the comparative outcome more than 2 years after surgery is important for clinical decision making. METHODS: We conducted a long-term, multicenter, randomized, controlled trial comparing open repair with endovascular repair in 351 patients with an abdominal aortic aneurysm of at least 5 cm in diameter who were considered suitable candidates for both techniques. The primary outcomes were rates of death from any cause and reintervention. Survival was calculated with the use of Kaplan-Meier methods on an intention-to-treat basis. RESULTS: We randomly assigned 178 patients to undergo open repair and 173 to undergo endovascular repair. Six years after randomization, the cumulative survival rates were 69.9% for open repair and 68.9% for endovascular repair (difference, 1.0 percentage point; 95% confidence interval [CI], -8.8 to 10.8; P=0.97). The cumulative rates of freedom from secondary interventions were 81.9% for open repair and 70.4% for endovascular repair (difference, 11.5 percentage points; 95% CI, 2.0 to 21.0; P=0.03). CONCLUSIONS: Six years after randomization, endovascular and open repair of abdominal aortic aneurysm resulted in similar rates of survival. The rate of secondary interventions was significantly higher for endovascular repair. (ClinicalTrials.gov number, NCT00421330.)

Background The relationship between numerous risk factors and perioperative mortality after cardiovascular surgery has been studied extensively. While improved perioperative survival and fewer cardiovascular events have been related to statin therapy, its effect on long-term survival after aneurysm repair remains to be elucidated. The aim of this study is to determine the effect of statin therapy on long-term survival after open and endovascular aneurysm repair and to identify other cardiovascular and patient-related risk factors in this respect. Methods A post-hoc analysis of a randomized trial comparing open and endovascular abdominal aortic aneurysm repair was performed. In this multicenter trial, 351 patients were randomly assigned to undergo either open abdominal aortic aneurysm repair or endovascular repair. Patients who were on lipid-lowering medication at their inclusion in the trial (n = 135) were compared with those who were not (n = 216). Results During 6 years of follow-up, 118 (33.6%) patients died after randomization. Statin therapy, baseline characteristics, Society for Vascular Surgery/International Society for Cardiovascular Surgery risk factors, aneurysm size, reinterventions, antiplatelet or anticoagulant agents, and β-blockers were used to identify prognostic factors influencing survival. After identification of significant factors in a Kaplan-Meier analysis, a multivariable Cox regression analysis was applied. Statin therapy at inclusion in the trial was independently associated with better overall survival after open or endovascular aneurysm repair (hazard ratio [HR], 0.5; 95% confidence interval [CI], 0.3-0.8; P =.004). Statins were especially associated with fewer cardiovascular deaths (HR, 0.4; 95% CI, 0.2-0.9; P =.025). Several risk factors were associated with poor survival after open and endovascular aneurysm repair: age >70 (HR, 3.4; 95% CI, 2.2-5.0; P .05). Conclusions Despite the limitations of a post-hoc analysis of a prospectively maintained trial, we conclude that statin therapy at the beginning of the trial is independently associated with improved long-term survival after open or endovascular aneurysm repair, while age above 70 years, a history of cardiovascular disease, and tobacco use are associated with decreased long-term survival. © 2014 by the Society for Vascular Surgery.