One-year aneurysm-sac dynamics are associated with reinterventions and rupture following infrarenal endovascular aneurysm repair.

OBJECTIVE: One-year aneurysm sac changes have previously been found to be associated with mortality and may have the potential to guide personalized follow-up following endovascular aneurysm repair (EVAR). In this study, we examined the association of these early sac changes with long-term reintervention and rupture. METHODS: We identified all patients undergoing first-time EVAR for intact abdominal aortic aneurysm between 2003 and 2018 in the Vascular Quality Initiative with linkage to Medicare claims for long-term outcomes. We included patients with an imaging study at 1 year postoperatively. Aneurysm sac behavior was defined as per the Society for Vascular Surgery guidelines: stable sac (<5 mm change), sac regression (≥5 mm), and sac expansion (≥5 mm). Outcomes included mortality, reintervention, and rupture within 8 years, which were assessed with Kaplan-Meier methods and multivariable Cox regression analysis. Secondarily, we utilized polynomial spline interpolation to demonstrate the continuous relationship of diameter change to 8-year hazard of reintervention, rupture, or mortality as a composite outcome. RESULTS: Of 31,185 EVAR patients, 16,102 (52%) had an imaging study at 1 year and were included in this study. At 1 year, 44% of sacs remained stable, 49% regressed, and 6.2% displayed expansion. Following risk adjustment, compared with a stable sac at 1 year, sac regression was associated with lower 8-year mortality (49% vs 53%; hazard ratio [HR], 0.92; 95% confidence interval [CI], 0.85-0.99; P = .036), reintervention rate (8.9% vs 15%; HR, 0.58; 95% CI, 0.50-0.68; P < .001), and rupture rate (2.0% vs 4.0%; HR, 0.45; 95%CI, 0.29-0.69; P < .001). Conversely, compared with a stable sac, sac expansion was associated with higher 8-year mortality (64% vs 53%; HR, 1.31; 95% CI, 1.14-1.51; P < .001) and reintervention rate (27% vs 15%; HR, 1.98; 95% CI, 1.57-2.51; P < .001), but similar risk of rupture (7.2% vs 4.0%; HR, 1.61; 95% CI, 0.88-2.96; P = .12). Polynomial spline interpolation demonstrated that, compared with no diameter change at 1 year, increased sac regression was associated with an incrementally lower risk of late outcomes, whereas increased sac expansion was associated with an incrementally higher risk of late outcomes. CONCLUSIONS: Following EVAR, compared with a stable sac at 1-year imaging, sac regression and expansion are associated with a lower and higher risk respectively of long-term mortality, reinterventions, and ruptures. Moreover, the amount of regression or expansion seems to be incrementally associated with these late outcomes, too. Future studies are needed to determine how to improve 1-year sac regression, and whether it is safe to extend follow-up intervals for patients with regressing sacs.

Long Term Outcomes of the Gore Excluder Low Permeability Endoprosthesis for the Treatment of Infrarenal Aortic Aneurysms.

OBJECTIVE: This study evaluated the long term outcomes of endovascular aneurysm repair using the Gore Excluder Low Permeability (LP) endoprosthesis across high volume Dutch hospitals. METHODS: A retrospective analysis was conducted of patients treated with the Excluder LP for infrarenal abdominal aortic aneurysm (AAA) in four hospitals between 2004 and 2017. Primary outcomes were overall survival, freedom from re-interventions (overall, inside and outside instructions for use, IFU), and AAA sac dynamics: growth (> 5 mm), stabilisation, and regression (< 5 mm). Secondary outcomes were technical success (device deployment), procedural parameters, and re-interventions. Follow up visits were extracted from patient files, with imaging assessed for complications and AAA diameter. RESULTS: Five hundred and fourteen patients were enrolled, with a median (IQR) follow up of 5.0 (2.9, 6.9) years. Survival rates were 94.0% at one year, 73.0% at five years, and 37.0% at 10 years, with freedom from re-interventions of 89.0%, 79.0%, and 71.0%, respectively. 37.9% were treated outside IFU, leading to significantly more re-interventions over 10 years compared with those treated inside IFU (36.0% vs. 25.0%, respectively; p = .044). The aneurysm sac regressed by 53.5% at one year, 65.8% at five years, and 77.8% at 10 years, and grew by 9.8%, 14.3%, and 22.2%, respectively. Patients with one year sac growth had significantly worse survival (p = .047). Seven patients (1.4%) had a ruptured aneurysm during follow up. Over 15 years, type 1a endoleak occurred in 5.3%, type 1b in 3.1%, type 3 in 1.9%, type 4 in 0.2%, and type 2 in 35.6% of patients. CONCLUSION: This multicentre study of real world endovascular aneurysm repair data using the Gore Excluder LP endoprosthesis demonstrated robust long term survival and re-intervention rates, despite 37.9% of patients being treated outside IFU, with type 4 endoleak being rare. Treatment outside IFU significantly increased re-intervention rates and one year sac growth was associated with statistically significantly worse survival.

Midterm Outcomes and Aneurysm Sac Dynamics Following Fenestrated Endovascular Aneurysm Repair after Previous Endovascular Aneurysm Repair.

OBJECTIVE: Fenestrated endovascular aneurysm repair (FEVAR) is a feasible option for aortic repair after endovascular aneurysm repair (EVAR), due to improved peri-operative outcomes compared with open conversion. However, little is known regarding the durability of FEVAR as a treatment for failed EVAR. Since aneurysm sac evolution is an important marker for success after aneurysm repair, the aim of the study was to examine midterm outcomes and aneurysm sac dynamics of FEVAR after prior EVAR. METHODS: Patients undergoing FEVAR for complex abdominal aortic aneurysms from 2008 to 2021 at two hospitals in The Netherlands were included. Patients were categorised into primary FEVAR and FEVAR after EVAR. Outcomes included five year mortality rate, one year aneurysm sac dynamics (regression, stable, expansion), sac dynamics over time, and five year aortic related procedures. Analyses were done using Kaplan-Meier methods, multivariable Cox regression analysis, chi square tests, and linear mixed effect models. RESULTS: One hundred and ninety-six patients with FEVAR were identified, of whom 27% (n = 53) had had a prior EVAR. Patients with prior EVAR were significantly older (78 ± 6.7 years vs. 73 ± 5.9 years, p < .001). There were no significant differences in mortality rate. FEVAR after EVAR was associated with a higher risk of aortic related procedures within five years (hazard ratio [HR] 2.6; 95% confidence interval [CI] 1.1 - 6.5, p = .037). Sac dynamics were assessed in 154 patients with available imaging. Patients with a prior EVAR showed lower rates of sac regression and higher rates of sac expansion at one year compared with primary FEVAR (sac expansion 48%, n = 21/44, vs. 8%, n = 9/110, p < .001). Sac dynamics over time showed similar results, sac growth for FEVAR after EVAR, and sac shrinkage for primary FEVAR (p < .001). CONCLUSION: There were high rates of sac expansion and a need for more secondary procedures in FEVAR after EVAR than primary FEVAR patients, although this did not affect midterm survival. Future studies will have to assess whether FEVAR after EVAR is a valid intervention, and the underlying process that drives aneurysm sac growth following successful FEVAR after EVAR.

How We Would Treat Our Own Thoracoabdominal Aortic Aneurysm.

This manuscript is intended to provide a comprehensive review of the current state of knowledge on endovascular repair of thoracoabdominal aortic aneurysms (TAAAs). The management of these complex aneurysms requires an interdisciplinary and patient-specific approach in high-volume centers. An index case is used to discuss the diagnosis and treatment of a patient undergoing fenestrated-branched endovascular aneurysm repair for a TAAA.

The effect of supraceliac versus infraceliac landing zone on outcomes following fenestrated endovascular repair of juxta-/pararenal aortic aneurysms.

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.

The association between diabetes mellitus and its management with outcomes following endovascular repair for descending thoracic aortic aneurysm.

OBJECTIVE: Prior literature is conflicted regarding the effect of diabetes mellitus (DM) on outcomes after endovascular repair of aortic aneurysms. In this study, we aimed to examine the association between DM and outcomes after thoracic endovascular aneurysm repair (TEVAR) for thoracic aortic aneurysm (TAA). METHODS: We identified patients who underwent TEVAR for TAA of the descending thoracic aorta in the Vascular Quality Initiative between 2014 and 2022. We created two cohorts, DM and nonDM, based on the patient's preoperative DM status, and secondarily substratified patients with DM by management strategy: dietary management, noninsulin medications, and insulin therapy cohorts. Outcomes included perioperative and 5-year mortality, in-hospital complications, indications for repair, and 1-year sac dynamics, which were analyzed with multivariable cox regression, multivariable logistic regression, and χ2 tests, respectively. RESULTS: We identified 2637 patients, of which 473 (18%) had DM preoperatively. Among patients with DM, 25% were diet controlled, 54% noninsulin medications, and 21% insulin therapy. Within patients who underwent TEVAR for TAA, the proportions of ruptured presentation were higher in the dietary-managed (11.1%) and insulin-managed (14.3%) cohorts relative to noninsulin therapy (6.6%) and those without DM (6.9%). After multivariable regression analysis, we found that DM was associated with similar perioperative mortality (odds ratio, 1.14; 95% confidence interval [CI], 0.70-1.81) and 5-year mortality compared with patients without DM (hazard ratio, 1.15; 95% CI, 0.91-1.48). Furthermore, all in-hospital complications were comparable between patients with DM and patients without DM. Compared with patients without DM, dietary management of DM was significantly associated with higher adjusted perioperative mortality (OR, 2.16; 95% CI, 1.03-4.19) and higher 5-year mortality (hazad ratio, 1.50; 95% CI, 1.03-2.20), although this was not the case for other DM subgroups. All cohorts displayed similar 1-year sac dynamics, with sac regression occurring in 47% of patients without DM vs 46% of patients with DM (P = .27). CONCLUSIONS: Preoperatively, patients with DM who underwent TEVAR had a higher proportion of ruptured presentation when treated with diet or insulin medications than when treated with noninsulin medications. After TEVAR for descending TAA, DM was associated with a similar risk of perioperative and 5-year mortality as nonDM. In contrast, dietary therapy for DM was associated with significantly higher perioperative mortality and 5-year mortality.

Mortality analysis of endovascular aneurysm sealing versus endovascular aneurysm repair.

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 (<5.5 cm and ≥5.5 cm). We calculated propensity scores after adjusting for demographics, comorbidities, and anatomic characteristics and applied inverse probability weighting to compare the risk-adjusted long-term mortality using Kaplan-Meier and Cox regression analyses. RESULTS: After weighting, the EVAS group had experienced similar 5-year mortality compared with the controls from the Vascular Quality Initiative (EVAS vs EVAR, 18% vs 14%; hazard ratio [HR], 1.1; 95% confidence interval [CI], 0.71-1.7; P = .70). The subgroup analysis demonstrated that for patients with an aneurysm diameter of <5.5 cm, EVAS was associated with higher 5-year mortality compared with EVAR (19% vs 11%; HR, 2.4; 95% CI, 1.7-4.7; P = .013). In patients with an aneurysm diameter of ≥5.5 cm, EVAS was associated with lower mortality within the first 2 years (2-year mortality: HR, 0.29; 95% CI, 0.13-0.62; P = .002). However, compared with EVAR, EVAS was associated with higher mortality between 2 and 5 years (HR, 1.9; 95% CI, 1.2-3.0; P = .005), with no mortality difference at 5 years (18% vs 17%; HR, 0.82; 95% CI, 0.4-1.4; P = .46). CONCLUSIONS: Within the overall population, EVAS was associated with similar 5-year mortality compared with EVAR. EVAS was associated with higher mortality for those with small aneurysms (<5.5 cm). For those with larger aneurysms (≥5.5 cm), EVAS was initially associated with lower mortality within the first 2 years, although this advantage was lost thereafter, with higher mortality after 2 years. Future studies are required to evaluate the specific causes of death and to elucidate the potential beneficial mechanism behind sac obliteration that leads to this potential initial survival benefit. This could help guide the development of future grafts with better proximal fixation and sealing that also incorporate sac obliteration.

Changes in renal-mesenteric duplex ultrasound velocities after fenestrated and branched endovascular aortic aneurysm repair.

OBJECTIVE: Stenting of renal and mesenteric vessels may result in changes in velocity measurements due to arterial compliance, potentially giving rise to confusion about the presence of stenosis during follow-up. The aim of our study was to compare preoperative and postoperative changes in peak systolic velocity (PSV, cm/s) after placement of the celiac axis (CA), superior mesenteric artery (SMA) and renal artery (RAs) bridging stent grafts during fenestrated-branched endovascular aortic repair (FB-EVAR) for treatment of complex abdominal aortic aneurysms (AAA) and thoracoabdominal aortic aneurysms. METHODS: Patients were enrolled in a prospective, nonrandomized single-center study to evaluate FB-EVAR for treatment of complex AAA and thoracoabdominal aortic aneurysms between 2013 and 2020. Duplex ultrasound examination of renal-mesenteric vessels were obtained prospectively preoperatively and at 6 to 8 weeks after the procedure. Duplex ultrasound examination was performed by a single vascular laboratory team using a predefined protocol including PSV measurements obtained with <60° angles. All renal-mesenteric vessels incorporated by bridging stent grafts using fenestrations or directional branches were analyzed. Target vessels with significant stenosis in the preoperative exam were excluded from the analysis. The end point was variations in PSV poststent placement at the origin, proximal, and mid segments of the target vessels for fenestrations and branches. RESULTS: There were 419 patients (292 male; mean age, 74 ± 8 years) treated by FB-EVAR with 1411 renal-mesenteric targeted vessels, including 260 CAs, 409 SMAs, and 742 RAs. No significant variances in the mean PSVs of all segments of the CA, SMA, and RAs at 6 to 8 weeks after surgery were found as compared with the preoperative values (CA, 135 cm/s vs 141 cm/s [P = .06]; SMA, 128 cm/s vs 125 cm/s [P = .62]; RAs, 90 cm/s vs 83 cm/s [P = .65]). Compared with baseline preoperative values, the PSV of the targeted vessels showed no significant differences in the origin and proximal segment of all vessels. However, the PSV increased significantly in the mid segment of all target vessels after stent placement. CONCLUSIONS: Stent placement in nonstenotic renal and mesenteric vessels during FB-EVAR is not associated with a significant increase in PSVs at the origin and proximal segments of the target vessels. Although there is a modest but significant increase in velocity measurements in the mid segment of the stented vessel, this difference is not clinically significant. Furthermore, PSVs in stented renal and mesenteric arteries were well below the threshold for significant stenosis in native vessels. These values provide a baseline or benchmark for expected PSVs after renal-mesenteric stenting during FB-EVAR.

Assessing Endovascular Aneurysm Repair Suitability According to Graft-Specific Instructions for Use in Patients With a Ruptured Abdominal Aortic Aneurysm.

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.

Nationwide Outcomes of Octogenarians Following Open or Endovascular Management After Ruptured Abdominal Aortic Aneurysms.

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.

A Systematic Review of Endovascular Repair Outcomes in Atherosclerotic Chronic Mesenteric Ischaemia.

OBJECTIVE: Chronic mesenteric ischaemia (CMI) treatment focuses on symptom relief and prevention of disease progression. Endovascular repair represents the main treatment modality, while data on the associated antiplatelet regimen are scarce. The aim of this meta-analysis was to assess the early and midterm outcomes of endovascular repair in patients with CMI. DATA SOURCES: Randomised controlled trials and observational studies (1990 - 2022) reporting on early and midterm endovascular repair outcomes in patients with atherosclerotic CMI. REVIEW METHODS: The PRISMA guidelines and PICO model were followed. The protocol was registered to PROSPERO (CRD42023401685). Medline, Embase (via Ovid), and Cochrane databases were searched (end date 21 February 2023). The Newcastle-Ottawa Scale was used for risk of bias assessment, and GRADE for evidence quality assessment. Primary outcomes were technical success, 30 day mortality, and symptom relief, assessed using prevalence meta-analysis. The role of dual antiplatelet therapy (DAPT) was investigated using meta-regression analysis. RESULTS: Sixteen retrospective studies (1 224 patients; mean age 69.8 ± 10.6 years; 60.3% female) reporting on 1 368 target vessels (57.8% superior mesenteric arteries) were included. Technical success was 95.0% (95% CI 93 - 97%, p = .28, I2 19%, low certainty), the 30 day mortality rate was 2.0% (95% CI 2 - 4%, p = .93, I2 36%, low certainty), and immediate symptom relief was 87.0% (95% CI 80 - 92%, p < .010, I2 85%, very low certainty). At mean follow up of 28 months, the mortality rate was 15.0% (95% CI 9 - 25%, p = .010, I2 86%, very low certainty), symptom recurrence 25.0% (95% CI 21 - 31%, p < .010, I2 68%, very low certainty) and re-intervention rate 26.0% (95% CI 17 - 37%, p < .010, I2 92%, very low certainty). Single antiplatelet therapy (SAPT) and DAPT performed similarly in the investigated outcomes. CONCLUSION: Endovascular repair for CMI appears to be safe as first line treatment, with a low peri-operative mortality rate and acceptable immediate symptom relief. During midterm follow up, symptom recurrence and need for re-intervention are not uncommon. SAPT appears to be equal to DAPT in post-operative outcomes.

Aneurysm Sac Dynamics and its Prognostic Significance Following Fenestrated and Branched Endovascular Aortic Aneurysm Repair.

OBJECTIVE: This study aimed to assess aneurysm sac dynamics and its prognostic significance following fenestrated and branched endovascular aneurysm repair (F/BEVAR). METHODS: Patients undergoing F/BEVAR for degenerative complex aortic aneurysm from 2008 to 2020 at two large vascular centres with two imaging examinations (30 day and one year) were included. Patients were categorised as regression and non-regression, determined by the proportional volume change (> 5%) at one year compared with 30 days. All cause mortality and freedom from graft related events were assessed using Kaplan-Meier methods. Factors associated with non-regression at one year and aneurysm sac volume over time were examined for FEVAR and BEVAR independently using multivariable logistic regression and linear mixed effects modelling. RESULTS: One hundred and sixty-five patients were included: 122 FEVAR, of whom 34% did not regress at one year imaging (20% stable, 14% expansion); and 43 BEVAR, of whom 53% failed to regress (26% stable, 28% expansion). Following F/BEVAR, after risk adjusted analysis, non-regression was associated with higher risk of all cause mortality within five years (hazard ratio [HR] 2.56, 95% confidence interval [CI] 1.09 - 5.37; p = .032) and higher risk of graft related events within five years (HR 2.44, 95% CI 1.10 - 5.26; p = .029). Following multivariable logistic regression, previous aortic repair (odds ratio [OR] 2.56, 95% CI 1.11 - 5.96; p = .029) and larger baseline aneurysm diameter (OR/mm 1.04, 95% CI 1.00 - 1.09; p = .037) were associated with non-regression at one year, whereas smoking history was inversely associated with non-regression (OR 0.21, 95% CI 0.04 - 0.96; p = .045). Overall following FEVAR, aneurysm sac volume decreased significantly up to two years (baseline vs. two year, 267 [95% CI 250 - 285] cm3vs. 223 [95% CI 197 - 248] cm3), remaining unchanged thereafter. Overall following BEVAR, aneurysm sac volume remained stable over time. CONCLUSION: Like infrarenal EVAR, non-regression at one year imaging is associated with higher five year all cause mortality and graft related events risks after F/BEVAR. Following FEVAR for juxtarenal aortic aneurysm, aneurysm sacs generally displayed regression (66% at one year), whereas after BEVAR for thoraco-abdominal aortic aneurysm, aneurysm sacs displayed a concerning proportion of growth at one year (28%), potentially suggesting a persistent risk of rupture and consequently requiring intensified surveillance following BEVAR. Future studies will have to elucidate how to improve sac regression following complex EVAR, and whether the high expansion risk after BEVAR is due to advanced disease extent.

Long Term Health Related Quality of Life After Acute Type B Aortic Dissection: a Cross Sectional Survey Study.

OBJECTIVE: Acute type B aortic dissection (ATBD) is a rare yet serious cardiovascular event that potentially has an impact on health related quality of life (HRQoL). However, long term follow up data on this topic are scarce. This study aimed to review the long term HRQoL among patients treated for ATBD. METHODS: In this multicentre, cross sectional survey study, consecutive treated patients with ATBD between 2007 and 2017 in four referral centres in the Netherlands were retrospectively included and baseline data were collected. Between 2019 and 2021 the 36 Item Short Form Survey (SF-36) was sent to all surviving patients (n = 263) and was compared with validated SF-36 scores in the Dutch general population stratified by age and sex. RESULTS: In total, 144 of 263 surviving patients completed the SF-36 (response rate 55%). Median (IQR) age was 68 (61, 76) years at completion of the questionnaire, and 40% (n = 58) were female. Initial treatment was medical in 55% (n = 79), endovascular in 41% (n = 59), and surgical in 4% (n = 6) of ATBD patients. Median follow up time was 6.1 (range 1.7-13.9; IQR 4.0, 9.0) years. Compared with the general population, patients scored significantly worse on six of eight SF-36 subdomains, particularly physical domains. Apart from bodily pain, there were no substantial differences in HRQoL between male and female ATBD patients. Compared with sex matched normative data, females scored significantly worse on five of eight subdomains, whereas males scored significantly lower on six subdomains. Younger patients aged 41-60 years seemed more severely impaired in HRQoL compared with the age matched general population. Treatment strategy did not influence HRQoL outcomes. Follow up time was associated with better Physical and Mental Component Summary scores. CONCLUSION: Long term HRQoL was impaired in ATBD patients compared with the Dutch general population, especially regarding physical status. This warrants more attention for HRQoL during clinical follow up. Rehabilitation programmes including exercise and physical support might improve HRQoL and increase patients' health understanding.

Identifying high risk for proximal endograft failure after endovascular aneurysm repair in patients suitable for both open and endovascular elective aneurysm repair.

OBJECTIVE: Proximal endograft failure (type Ia endoleak or migration) after endovascular aneurysm repair (EVAR) is associated with hostile aneurysm neck morphology. Neck scoring systems were developed to predict proximal endograft failure but were studied in retrospective studies, which, due to selection bias, may have led to an overestimation of bad outcomes after EVAR. To predict patients who benefit from open repair, preoperative neck morphology and occurrence of long-term proximal endograft failure were investigated in patients enrolled in the endovascular arm of the Dutch Randomized Endovascular Aneurysm Management (DREAM) trial who were suitable for open repair by definition and have long-term follow-up. METHODS: A post-hoc on-treatment analysis of patients after EVAR was performed in 171 patients. Aneurysm neck morphology was quantified using the aneurysm severity grading (ASG) neck score calculated on preoperative computed tomography angiography images. The ASG neck score was used to predict proximal endograft failure. Receiver operating characteristic analysis was performed to calculate a threshold to divide favorable and unfavorable aneurysm necks (low and high risk); positive and negative likelihood-ratios were calculated accordingly. Freedom from proximal endograft failure was compared between groups using Kaplan-Meier analysis. RESULTS: During a median follow-up of 7.6 years, 20 patients suffered proximal endograft failure. Receiver operating characteristic analysis showed an area under the curve of 0.77 (95% confidence interval [CI], 0.65-0.90; P < .001), indicating acceptable prediction. The threshold was determined at ASG neck score ≥5; 30 patients had unfavorable neck morphology, of whom 11 developed proximal endograft failure. The positive likelihood-ratio was 4.4 (95% CI, 2.5-7.8), and the negative likelihood-ratio was 0.51 (95% CI, 0.3-0.8). Twelve years postoperatively, freedom from proximal endograft failure was 91.7% in the favorable group and 53.2% in the unfavorable group, a difference of 38.5% (95% CI, 13.9-63.1; P < .001). CONCLUSIONS: In this study, the ASG neck score predicted proximal endograft failure during the entire follow-up. This exhibits the persistent risk for proximal endograft failure long after EVAR and calls for ongoing surveillance especially in patients with unfavorable aneurysm necks.

A retroperitoneal operative approach is associated with improved perioperative outcomes compared with a transperitoneal approach in open repair of complex abdominal aortic aneurysms.

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.

Proximal seal dilatation following fenestrated endovascular repair for complex abdominal aortic aneurysms.

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.

Retroperitoneal versus Transperitoneal Approach for Open Repair of Complex Abdominal Aortic Aneurysms.

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.

Treatment Outcome Trends for Non-Ruptured Abdominal Aortic Aneurysms: A Nationwide Prospective Cohort Study.

OBJECTIVE: The Dutch Surgical Aneurysm Audit (DSAA) initiative was established in 2013 to monitor and improve nationwide outcomes of aortic aneurysm surgery. The objective of this study was to examine whether outcomes of surgery for intact abdominal aortic aneurysms (iAAA) have improved over time. METHODS: Patients who underwent primary repair of an iAAA by standard endovascular (EVAR) or open surgical repair (OSR) between 2014 and 2019 were selected from the DSAA for inclusion. The primary outcome was peri-operative mortality trend per year, stratified by OSR and EVAR. Secondary outcomes were trends per year in major complications, textbook outcome (TbO), and characteristics of treated patients. The trends per year were evaluated and reported in odds ratios per year. RESULTS: In this study, 11 624 patients (74.8%) underwent EVAR and 3 908 patients (25.2%) underwent OSR. For EVAR, after adjustment for confounding factors, there was no improvement in peri-operative mortality (aOR [adjusted odds ratio] 1.06, 95% CI 0.94 - 1.20), while major complications decreased (2014: 10.1%, 2019: 7.0%; aOR 0.91, 95% CI 0.88 - 0.95) and the TbO rate increased (2014: 68.1%, 2019: 80.9%; aOR 1.13, 95% CI 1.10 - 1.16). For OSR, the peri-operative mortality decreased (2014: 6.1%, 2019: 4.6%; aOR 0.89, 95% CI 0.82 - 0.98), as well as major complications (2014: 28.6%, 2019: 23.3%; aOR 0.95, 95% CI 0.91 - 0.99). Furthermore, the proportion of TbO increased (2014: 49.1%, 2019: 58.3%; aOR 1.05, 95% CI 1.01 - 1.10). In both the EVAR and OSR group, the proportion of patients with cardiac comorbidity increased. CONCLUSION: Since the establishment of this nationwide quality improvement initiative (DSAA), all outcomes of iAAA repair following EVAR and OSR have improved, except for peri-operative mortality following EVAR which remained unchanged.

Incidence, Prognostic Significance, and Risk Factors of Acute Kidney Injury Following Elective Infrarenal and Complex Endovascular Aneurysm Repair.

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/1.73m2vs. 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/1.73m2vs. 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.

Association of Hospital Volume with Perioperative Mortality of Endovascular Repair of Complex Aortic Aneurysms: A Nationwide Cohort Study.

OBJECTIVE: We evaluate nationwide perioperative outcomes of complex EVAR and assess the volume-outcome association of complex EVAR. SUMMARY OF BACKGROUND DATA: Endovascular treatment with fenestrated (FEVAR) or branched (BEVAR) endografts is progressively used for excluding complex aortic aneurysms (complex AAs). It is unclear if a volume-outcome association exists in endovascular treatment of complex AAs (complex EVAR). METHODS: All patients prospectively registered in the Dutch Surgical Aneurysm Audit who underwent complex EVAR (FEVAR or BEVAR) between January 2016 and January 2020 were included. The effect of annual hospital volume on perioperative mortality was examined using multivariable logistic regression analyses. Patients were stratified into quartiles based on annual hospital volume to determine hospital volume categories. RESULTS: We included 694 patients (539 FEVAR patients, 155 BEVAR patients). Perioperative mortality following FEVAR was 4.5% and 5.2% following BEVAR. Postoperative complication rates were 30.1% and 48.7%, respectively. The first quartile hospitals performed <9 procedures/yr; second, third, and fourth quartile hospitals performed 9-12, 13-22, and ≥23 procedures/yr. The highest volume hospitals treated the significantly more complex patients. Perioperative mortality of complex EVAR was 9.1% in hospitals with a volume of < 9, and 2.5% in hospitals with a volume of ≥13 (P = 0.008). After adjustment for confounders, an annual volume of ≥13 was associated with less perioperative mortality compared to hospitals with a volume of < 9. CONCLUSIONS: Data from this nationwide mandatory quality registry shows a significant effect of hospital volume on perioperative mortality following complex EVAR, with high volume complex EVAR centers demonstrating lower mortality rates.