Preoperative predictors of nonhome discharge after fenestrated-branched endovascular repair of complex abdominal and thoracoabdominal aortic aneurysms.

BACKGROUND: Nonhome discharge (NHD) has significant implications for patient counseling and discharge planning and is frequently required following fenestrated-branched endovascular aortic repair (FB-EVAR) of complex abdominal aortic aneurysms (CAAA) and thoracoabdominal aortic aneurysms (TAAA). We aimed to identify preoperative predictors of NHD after elective FB-EVAR for CAAA and TAAA and develop a risk calculator able to predict NHD. METHODS: A retrospective review of prospectively collected data on all patients undergoing FB-EVAR between January 2007 and December 2021 at a single institution was performed. Exclusion criteria were admission from a nonhome setting, emergency and repeat FB-EVAR, and discharge to an unknown destination. The cohort was randomly split into separate development (70% of patients) and validation (30%) cohorts to develop a predictive calculator for NHD. Independent variables associated with NHD were assessed in a series of logistic regression analyses from 100 bootstrapped samples of the development set, and a model was developed using the most predictive variables. Resulting parameter estimates were applied to data in the validation set to assess model discrimination and calibration. RESULTS: From the initial cohort of 712 FB-EVAR patients, 644 were included in the study (74% male; mean age, 75.4 ± 7.6 years), including 452 with CAAA (70%) and 192 with TAAA (30%). Early mortality occurred in eight patients (1.2%; 5 in CAAA and 3 in TAAA) and the median hospital stay was 5 days (4 for CAAA and 7 for TAAA). Ninety-seven patients (15%) had a NHD. On multivariable analysis, older age (per year, odds ratio [OR], 1.08; P < .001), female gender (OR, 3.03; P < .001), smoking (OR, 2.86; P = .01), congestive heart failure (OR, 3.05; P = .004), peripheral artery disease (OR, 1.81; P = .07), and extent I (OR, 3.17), II (OR, 2.84), and III (OR, 2.52; all P = .08) TAAAs were associated with an increased likelihood of NHD in the development set. Based on these factors, the risk calculator was developed which accurately predicts NHD in the validation set with an area under the curve of 0.7. CONCLUSIONS: Older, female smokers with congestive heart failure and peripheral artery disease and more extensive aneurysms are at highest risk of NHD after FB-EVAR. Using only preoperative factors, our risk calculator can predict accurately who will have a NHD, allowing enhanced preoperative patient counselling and accelerated hospital discharge.

Prospective evaluation of upper extremity access and total transfemoral approach during fenestrated and branched endovascular repair.

OBJECTIVE: Total transfemoral (TF) access has been increasingly used during fenestrated-branched endovascular aortic repair (FB-EVAR). However, it is unclear whether the potential decrease in the risk of cerebrovascular events is offset by increased procedural difficulties and other complications. The aim of this study was to compare outcomes of FB-EVAR using a TF vs upper extremity (UE) approach for target artery incorporation. METHODS: We analyzed the clinical data of consecutive patients enrolled in a prospective, nonrandomized clinical trial in two centers to investigate the use of FB-EVAR for treatment of complex abdominal aortic aneurysms (CAAA) and thoracoabdominal aortic aneurysms (TAAA) between 2013 and 2022. Patients were classified into TF or UE access group with a subset analysis of patients treated using designs with directional branches. End points were technical success, procedural metrics, 30-day cerebrovascular events defined as stroke or transient ischemic attack, and any major adverse events (MAEs). RESULTS: There were 541 patients (70% males; mean age, 74 ± 8 years) treated by FB-EVAR with 2107 renal-mesenteric TAs incorporated. TF was used in175 patients (32%) and UE in 366 patients (68%) including 146 (83%) TF and 314 (86%) UE access patients who had four or more TAs incorporated. The use of a TF approach increased from 8% between 2013 and 2017 to 31% between 2018 and 2020 and 96% between 2021 and 2022. Compared with UE access patients, TF access patients were more likely to have CAAAs (37% vs 24%; P = .002) as opposed to TAAAs. Technical success rate was 96% in both groups (P = .96). The use of the TF approach was associated with reduced fluoroscopy time and procedural time (each P < .05). The 30-day mortality rate was 0.6% for TF and 1.4% for UE (P = .67). There was no early cerebrovascular event in the TF group, but the incidence was 2.7% for UE patients (P = .035). The incidence of MAEs was also lower in the TF group (9% vs 18%; P = .006). Among 237 patients treated using devices with directional branches, there were no significant differences in outcomes except for a reduced procedural time for TF compared with UE access patients (P < .001). CONCLUSIONS: TF access was associated with a decreased incidence of early cerebrovascular events and MAEs compared with UE access for target artery incorporation. Procedural time was decreased in TF access patients irrespective of the type of stent graft design.

Practice patterns of antiplatelet and anticoagulant therapy after fenestrated/branched endovascular aortic repair.

OBJECTIVE: Antiplatelet and/or anticoagulant therapy are commonly prescribed after fenestrated/branched endovascular aortic repair (F/BEVAR). However, the optimal regimen remains unknown. We sought to characterize practice patterns and outcomes of antiplatelet and anticoagulant use in patients who underwent F/BEVAR. METHODS: Consecutive patients enrolled (2012-2023) as part of the United States Aortic Research Consortium (US-ARC) from 10 independent physician-sponsored investigational device exemption studies were evaluated. The cohort was characterized by medication regimen on discharge from index F/BEVAR: (1) Aspirin alone OR P2Y12 alone (single-antiplatelet therapy [SAPT]); (2) Anticoagulant alone; (3) Aspirin + P2Y12 (dual-antiplatelet therapy [DAPT]); (4) Aspirin + anticoagulant OR P2Y12 + anticoagulant (SAPT + anticoagulant); (5) Aspirin + P2Y12 + anticoagulant (triple therapy [TT]); and (6) No therapy. Kaplan-Meier analysis and Cox proportional hazards modeling were used to compare 1-year outcomes including survival, target artery patency, freedom from bleeding complication, freedom from all reinterventions, and freedom from stent-specific reintervention. RESULTS: Of the 1525 patients with complete exposure and outcome data, 49.6% were discharged on DAPT, 28.8% on SAPT, 13.6% on SAPT + anticoagulant, 3.2% on TT, 2.6% on anticoagulant alone, and 2.2% on no therapy. Discharge medication regimen was not associated with differences in 1-year survival, bleeding complications, composite reintervention rate, or stent-specific reintervention rate. However, there was a significant difference in 1-year target artery patency. On multivariable analysis comparing with SAPT, DAPT conferred a lower hazard of loss of target artery patency (hazard ratio [HR], 0.48; 95% confidence interval [CI], 0.27-0.84; P = .01). On sub-analyses of renal stents alone or visceral stents alone, DAPT no longer had a significantly lower hazard of loss of target artery patency (renal: HR, 0.66; 95% CI, 0.35-1.27; P = .22; visceral: HR, 0.31; 95% CI, 0.05-1.9; P = .21). Lastly, duration of DAPT therapy (1 month, 6 months, or 1 year) did not significantly affect target artery patency. CONCLUSIONS: Practice patterns for antiplatelet and anticoagulant regimens after F/BEVAR vary widely across the US-ARC. There were no differences in bleeding complications, survival or reintervention rates among different regimens, but higher branch vessel patency was noted in the DAPT cohort. These data suggest there is a benefit in DAPT therapy. However, the generalizability of this finding is limited by the retrospective nature of this data, and the clinical significance of this finding is unclear, as there is no difference in survival, bleeding, or reintervention rates amongst the different regimens. Hence, an "optimal" regimen, including the duration of such regimen, could not be clearly discerned. This suggests equipoise for a randomized trial, nested within this cohort, to identify the most effective antiplatelet/anticoagulant regimen for the growing number of patients being treated globally with F/BEVAR.

3 Year Outcomes of Off-the-shelf Gore Thoracoabdominal Multibranch Endoprosthesis and Physician-Modified Endografts for Complex Abdominal and Thoracoabdominal Aortic Aneurysms.

OBJECTIVE: Fenestrated-branched endovascular aortic repair (FB-EVAR) has shown favorable outcomes for repair of complex aneurysms and thoracoabdominal aortic aneurysms (TAAA). Physician-modified endografting (PMEG) and the Gore Thoracoabdominal Multibranch Endoprosthesis (TAMBE) provide custom and off-the-shelf devices for FB-EVAR, respectively. This study compares the outcomes of TAMBE and PMEG at a single institution. METHODS: A retrospective review of patients who underwent TAMBE as part of the multicenter pivotal trial or PMEG as part of a prospective physician sponsored investigational device exemption at a single institution between 2020-2022 were completed. Patient demographics, characteristics, perioperative and midterm outcomes were compared. RESULTS: A total of 68 patients were included, with 12 in the TAMBE group and 56 in the PMEG group. Baseline characteristics were comparable between groups. Aneurysm type was most often TAAA in both groups (58% TAMBE and 52% PMEG). TAMBE had a higher rate of upper extremity access (100% vs 63%, P=.013) and longer mean procedure time (247 ± 36 vs 189 ± 49 minutes, P<.001). Other intraoperative metrics were similar between groups. Technical success was 100% in TAMBE and 95% in PMEG (P=0.412). There was no 30-day mortality in either group. No major adverse events occurred with TAMBE, while in PMEG cases, 2% had respiratory failure, 2% required dialysis, and 4% experienced spinal cord ischemia. While overall endoleak rates were similar (50% of TAMBE vs 41% of PMEG, P=0.57), type II accounted for all of the endoleaks in the TAMBE group, while type I or III endoleaks were seen in 11% of PMEG patients. At the median follow-up of 26.7 months for the TAMBE group and 21.2 months for the PMEG group, target vessel instability was seen in 10.4% of TAMBE, and 6.9% of PMEG targeted branches (P=0.401). Reintervention was required in 33% of TAMBE patients and 27% of PMEG patients (P=.646). Estimated freedom from reintervention at 3 years were similar (56% TAMBE vs. 62% PMEG, log-rank P=0.910). Freedom from visceral renal target vessel instability at 3 years was 89% for both groups (log-rank P=0.459). Kaplan Meier 3-year estimated survival was 100% for patients in the TAMBE group and 77% for patients in the PMEG group (log-rank P=.157). CONCLUSIONS: At experienced centers, FB-EVAR can be completed with PMEG or TAMBE with comparable, excellent perioperative and midterm outcomes. Reinterventions are frequently needed for both TAMBE and PMEG.

Modified Ex Vivo Renal Reconstruction to Facilitate Fenestrated-Branched Endovascular Repair of a Thoracoabdominal Aortic Aneurysm.

PURPOSE: To report the use of modified ex vivo renal artery (RA) reconstruction in a patient with 2 small right RAs (RRAs) in anticipation of planned fenestrated-branched endovascular aortic repair (FB-EVAR) of thoracoabdominal aortic aneurysm (TAAA). CASE REPORT: A staged hybrid repair was utilized in a patient with Extent II TAAA involving celiac axis (CA), superior mesenteric artery (SMA), single left RA (LRA), and 2 small (<3 mm) RRAs. The first-stage operation consisted of hepato-renal bypass using modified ex vivo renal reconstruction with single end-to-end anastomosis to both RAs using a saphenous vein graft. A second stage FB-EVAR was performed using patient-specific manufactured stent-graft with 3 fenestrations for the CA, SMA, and LRA 6 weeks later. The patient recovered with no complications. At 4 years, the patient had widely patent hepato-renal bypass and target vessels with normal renal function. CONCLUSION: The use of adjunctive hybrid procedures may optimize or facilitate FB-EVAR. In this patient, salvage of 2 small RAs was not ideally suited for branch stenting but was possible using modified ex vivo RA reconstruction with preservation of kidney parenchyma and function. CLINICAL IMPACT: This case report illustrates a hybrid approach to overcome one of the most frequent limitations to total endovascular incorporation of renal arteries, eg small diameter, early bifurcation and multiple vessels. The modified ex vivo technique allows meticulous renal artery reconstruction without the deleterious effect of warm ischemia and without the cumbersome reconstruction of ureter and vein that is needed with traditional on table ex vivo auto transplantation. The technique is used in a minority of cases and adds the morbidity of open approach. Case selection is of paramount importance.

Comparison of single- and multistage strategies during fenestrated-branched endovascular aortic repair of thoracoabdominal aortic aneurysms.

OBJECTIVE: The aim of this study was to compare outcomes of single or multistage approach during fenestrated-branched endovascular aortic repair (FB-EVAR) of extensive thoracoabdominal aortic aneurysms (TAAAs). METHODS: We reviewed the clinical data of consecutive patients treated by FB-EVAR for extent I to III TAAAs in 24 centers (2006-2021). All patients received a single brand manufactured patient-specific or off-the-shelf fenestrated-branched stent grafts. Staging strategies included proximal thoracic aortic repair, minimally invasive segmental artery coil embolization, temporary aneurysm sac perfusion and combinations of these techniques. Endpoints were analyzed for elective repair in patients who had a single- or multistage approach before and after propensity score adjustment for baseline differences, including the composite 30-day/in-hospital mortality and/or permanent paraplegia, major adverse event, patient survival, and freedom from aortic-related mortality. RESULTS: A total of 1947 patients (65% male; mean age, 71 ± 8 years) underwent FB-EVAR of 155 extent I (10%), 729 extent II (46%), and 713 extent III TAAAs (44%). A single-stage approach was used in 939 patients (48%) and a multistage approach in 1008 patients (52%). A multistage approach was more frequently used in patients undergoing elective compared with non-elective repair (55% vs 35%; P < .001). Staging strategies were proximal thoracic aortic repair in 743 patients (74%), temporary aneurysm sac perfusion in 128 (13%), minimally invasive segmental artery coil embolization in 10 (1%), and combinations in 127 (12%). Among patients undergoing elective repair (n = 1597), the composite endpoint of 30-day/in-hospital mortality and/or permanent paraplegia rate occurred in 14% of single-stage and 6% of multistage approach patients (P < .001). After adjustment with a propensity score, multistage approach was associated with lower rates of 30-day/in-hospital mortality and/or permanent paraplegia (odds ratio, 0.466; 95% confidence interval, 0.271-0.801; P = .006) and higher patient survival at 1 year (86.9±1.3% vs 79.6±1.7%) and 3 years (72.7±2.1% vs 64.2±2.3%; adjusted hazard ratio, 0.714; 95% confidence interval, 0.528-0.966; P = .029), compared with a single stage approach. CONCLUSIONS: Staging elective FB-EVAR of extent I to III TAAAs was associated with decreased risk of mortality and/or permanent paraplegia at 30 days or within hospital stay, and with higher patient survival at 1 and 3 years.

Incidence and risk factors for interval aortic events during staged fenestrated-branched endovascular aortic repair.

OBJECTIVE: Staged endovascular repair of complex aortic aneurysms with first-stage thoracic endovascular aortic repair may decrease the risk of spinal cord ischemia (SCI) associated with fenestrated-branched endovascular aortic repair (FB-EVAR) of thoracoabdominal aortic aneurysms or optimize the proximal landing zone in the cases requiring total aortic arch repair. However, a limitation of multistaged procedures is the risk of interval aortic events (IAEs) including mortality from a ruptured aneurysm. We aim to identify the incidence of and risk factors associated with IAEs during staged FB-EVAR. METHODS: This was a single-center, retrospective review of patients who underwent planned staged FB-EVAR from 2013 to 2021. Clinical and procedural details were reviewed. End points were the incidence of and risk factors associated with IAEs (defined as rupture, symptoms, and unexplained death) and outcomes in patients with or without IAEs. RESULTS: Of 591 planned FB-EVAR patients, 142 underwent first-stage repairs. Twenty-two did not have a planned second stage because of frailty, preference, severe comorbidities, or complications after the first stage and were excluded. The remaining 120 patients (mean age: 73 ± 6 years, 51% female) were planned for second-stage completion FB-EVAR and comprised our cohort. The incidence of IAEs was 13% (16 of 120). This included confirmed rupture in 6 patients, possible rupture in 4, symptomatic presentation in 4, and early unexplained interval death with possible rupture in 2. The median time to IAEs was 17 days (range: 2-101 days), and the median time to uncomplicated completion repairs was 82 days (interquartile range: 30-147 days). Age, sex, and comorbidities were similar between the groups. There were no differences in familial aortic disease, genetically triggered aneurysms, aneurysm extent, or presence of chronic dissection. Patients with IAEs had significantly larger aneurysm diameters than those without IAEs (76.6 vs 66.5 mm, P ≤ .001). This difference persisted with indexing for body surface area (aortic size index: 3.9 vs 3.5 cm/m2, P = .04) and height (aortic height index: 4.5 vs 3.9 cm/m, P ≤ .001). IAE mortality was 69% (11 of 16) compared with no perioperative deaths for those with uncomplicated completion repairs. CONCLUSIONS: The incidence of IAEs was 13% in patients planned for staged FB-EVAR. This represented a notable morbidity, including rupture, which must be balanced with SCI and landing zone optimization when planning repair. Larger aneurysms, especially when adjusted for body surface area, are associated with IAEs. Minimizing time between stages vs single-stage repairs for larger (>7 cm) complex aortic aneurysms in patients with reasonable SCI risk should be considered when planning repair.

Five-year outcomes of physician-modified endografts for repair of complex abdominal and thoracoabdominal aortic aneurysms.

OBJECTIVE: There is paucity of data on the durability of physician modified endografts (PMEGs) for complex abdominal (CAAAs) and thoracoabdominal aortic aneurysms (TAAAs) despite widespread use. The aim of this study was to evaluate and compare the early and long-term outcomes of fenestrated-branched endovascular aortic repair (FB-EVAR) for CAAAs and TAAAs using PMEGs. METHODS: We reviewed clinical data and outcomes of patients treated by FB-EVAR using PMEGs for CAAAs (defined as short-neck infrarenal, juxtarenal, and pararenal AAAs) and TAAAs between 2007 and 2019. All patients were treated by a dedicated team with extensive manufactured device experience. Endpoints included 30-day mortality and major adverse events, patient survival and freedom from aortic-related mortality (ARM), freedom from secondary intervention, target artery (TA) patency, and freedom from TA endoleak and TA instability. RESULTS: Of 645 patients undergoing FB-EVAR, 156 patients (24%) treated with PMEG (121 males; mean age, 75 ± 8 years) were included. There were 89 CAAAs, 33 extent IV TAAAs and 34 extent I to III TAAAs. A total of 452 renal-mesenteric targets (3.1 ± 1.0 vessels/patient) were incorporated. Patients with TAAAs had significantly (P < .05) larger aneurysms (73 ± 11 vs 68 ± 14 mm), more TAs incorporated (3.4 ± 0.9 vs 2.8 ± 1.0), and more often had previous aortic repair (54% vs 27%). Technical success was higher in patients treated for CAAAs (99% vs 91%; P = .04). Thirty-day and/or in-hospital mortality was 5.7% and was significantly lower for CAAAs compared with TAAAs (2% vs 10%; P = .04), with three of nine early mortalities (33%) among patients treated emergently. After a mean follow-up of 49 ± 38 months, there were 12 aortic-related deaths (7.6%), including nine early deaths (5.7%) from perioperative complications and three late deaths (1.9%) from rupture. At 5 years, patient survival was 41%. Patients treated for CAAAs had higher 5-year freedom from ARM (P = .016), TA instability (P = .05), TA endoleak (P = .01), and TA secondary interventions (P = .05) with a higher, but non-significant, freedom from sac enlargement ≥5 mm (P = .11). Primary and secondary TA patency was 91% ± 2% and 99% ± 1%, respectively. Sac regression ≥5 mm occurred in 67 patients (43%) and was associated with increased survival (hazard ratio, 0.54; 95% confidence interval, 0.37-0.80) compared with those without sac regression. CONCLUSIONS: FB-EVAR using PMEGs was performed with acceptable long-term outcomes. Overall patient survival was low due to significant underlying comorbidities. Patients treated for CAAAs had higher freedom from ARM, TA instability, TA endoleak, TA secondary interventions, and a trend towards higher freedom from sac enlargement compared with patients treated for TAAAs. Sac regression was associated with improved patient survival.

Dual-Lumen Stenting of Dissected Superior Mesenteric Artery During Fenestrated Branched Endovascular Repair of a Post-dissection Thoracoabdominal Aortic Aneurysm.

PURPOSE: Long-segment aortic branch dissections have been considered a relative contraindication for fenestrated-branched endovascular aneurysm repair (FB-EVAR). This case report describes a technique of dual-lumen stenting of a fully-dissected superior mesenteric artery (SMA) to preserve patency of the true and false lumens during FB-EVAR. CASE REPORT: A 67-year-old man presented with a 6.0 cm extent III chronic post-dissection thoracoabdominal aortic aneurysm. The patient had highly-complex anatomy including dissection of the entire SMA. The true and false lumens of the dissected SMA were noted to be supplying different branches, requiring preservation of both lumens. The patient underwent a staged physician-modified FB-EVAR. A modified endograft containing 5 fenestrations and 1 branch cuff was introduced and the celiac, true-lumen SMA, and 3 renal arteries were sequentially catheterized using staggered deployment of the modified endograft. The false lumen SMA stent was catheterized via the branch cuff. Molded parallel grafting ("eye-of-the-tiger") technique was used to achieve double D configuration between the true and false lumens of the SMA. CONCLUSION: This case demonstrates feasibility of dual-lumen stenting to incorporate dissected target vessels during FB-EVAR while preserving flow to both the true and false lumens and the second-order branches they supply. CLINICAL IMPACT: We report a novel technique that allows incorporation of branch vessels affected by long segment dissection during fenestrated branched endovascular aortic repairs. This has potential advantage of preserving flow to all secondary branches of the dissected target vessels, while reducing the risk of type Ic endoleak.

Three-Dimensional Printing to Guide Fenestrated/Branched TEVAR in Triple Aortic Arch Branch Reconstruction With a Curative Effect Analysis.

PURPOSE: To summarize experience with and the efficacy of fenestrated/branched thoracic endovascular repair (F/B-TEVAR) using physician-modified stent-grafts (PMSGs) under 3D printing guidance in triple aortic arch branch reconstruction. MATERIALS AND METHODS: From February 2018 to April 2022, 14 cases of aortic arch aneurysms and 30 cases of aortic arch dissection (22 acute aortic arch dissection and 8 long-term aortic arch dissection)were treated by F/B-TEVAR in our department, including 34 males and 10 females, with an average age of 59.84 ± 11.72 years. Three aortic arch branches were affected in all patients. A 3D-printed model was made according to computed tomography angiography images and used to guide the fabrication of PMSGs. All patients were followed up. RESULTS: A total of 132 branches were successfully reconstructed with no case of conversion to open surgery. The average operation time was 4.97 ± 1.40 hours, including a mean 44.05 ± 7.72 minutes for stent-graft customization, the mean postoperative hospitalization duration was 9.91 ± 4.47 days, the average intraoperative blood loss was 480.91 mL (100-2810 mL), and the mean postoperative intensive care unit monitoring duration was 1.02 days (0-5 days). No deaths occurred within 30 days of surgery. Postoperative neurological complications occurred in 1 case (2.3%), and retrograde type A dissection occurred in 1 case (2.3%). CONCLUSION: Compared with conventional surgery, triple aortic arch branch reconstruction under the guidance of 3D printing is a minimally invasive treatment method with the advantages of accurate positioning, rapid postoperative recovery, few complications, and reliable short- to mid-term effects. CLINICAL IMPACT: At present the PMSG usually depend on imaging data and software calculation. With the guidance of 3D printing technology, image data could be transformed into 3D model, which has improved the accuracy of the positioning of the fenestrations. The diameter reduction technique and the internal mini cuff technique have made a complement to the slimed-down fenestration selection process and the low rate of endoleak. As reproducible study, our results may provide reference for TEVAR in different cases.

Frequency and type of interval adverse events during the waiting period to complex aortic endovascular repair.

OBJECTIVE: The aim of the present study was to evaluate the frequency and type of adverse events that can occur during the waiting period to complex aortic endovascular repair. METHODS: We performed a retrospective study of all elective patients with complex aortic aneurysms (including pararenal, suprarenal, thoracoabdominal, and aortic arch aneurysms) that had required a custom-made device (CMD) from Cook Medical (Bloomington, Ind) at a tertiary referral vascular center (November 2010 to May 2020). The waiting period was defined as the interval between the date of the stent graft order and the date of the procedure or cancellation. Interval adverse events were defined as any event that had occurred during the waiting period and led to either mortality, aneurysm rupture, or cancellation of the planned procedure. RESULTS: A total of 235 patients (mean age, 72 years; 25% female) had had a CMD graft ordered (201 planned as a single-stage procedure). The median waiting time until surgery was 106 days (interquartile range [IQR], 77-146 days) in the whole cohort and 101 days (IQR, 77-140 days) for the single-stage cohort. The planned procedure was performed electively in 219 patients (93%), with an overall 30-day elective mortality of 2% (n = 5). A total of 16 interval adverse events occurred during the waiting period. Of these 16 events, 10 were aneurysm ruptures and 6 were cancellations of the procedure owing to non-aneurysm-related deaths (3% of the entire cohort). A total of 10 interval deaths were registered (4.2%), 4 of which were aneurysm related. The risk of rupture during the waiting period (Kaplan-Meier) was 6.1% ± 2.3% at 180 days. The median interval from the stent graft order to aneurysm rupture was 101 days (IQR, 54-200 days). Of the 10 aneurysm ruptures that had occurred, 6 had undergone emergent repair, with 0% mortality at 30 days (one open repair, one t-Branch, one physician-modified endograft, two cases for which the CMD was already available, one case for which a different CMD was available). CONCLUSIONS: The median waiting time from the stent graft order to implantation was ∼15 weeks. During this waiting period, a substantial proportion of patients could experience adverse events, either related to aneurysm rupture or underlying comorbidities. The risk of rupture during the waiting period exceeded the risk of perioperative mortality. Thus, efforts to decrease this risk could significantly improve the outcomes. A combination of different techniques might play a vital role in reducing the mortality after cases of interval rupture.

Incidence, predictive factors, and outcomes of intraprocedure adverse events during fenestrated-branched endovascular aortic repair of complex abdominal and thoracoabdominal aortic aneurysms.

OBJECTIVE: To evaluate the incidence of intraoperative adverse events (IAEs) and their impact on outcomes after fenestrated-branched endovascular aortic repair (FB-EVAR) of complex abdominal aortic aneurysms and thoracoabdominal aortic aneurysm (TAAAs). METHODS: We reviewed the clinical and imaging data of 600 consecutive patients (445 males; mean age, 75 ± 8 years) who underwent FB-EVAR between 2007 and 2019 in a single institution. IAE was defined as any intraoperative complication or technical problem requiring additional and unplanned procedures, and was classified as access-related, target artery (TA)-related, or graft-related. End points included rates of IAEs, 30-day or in-hospital mortality, major adverse events, patient survival, freedom from secondary intervention, and TA instability. RESULTS: A total of 122 IAEs were identified in 105 patients (18%). IAEs were TA-related in 55 patients (9%), access-related in 46 patients (8%), and graft-related in seven patients (1%). Female sex was more frequent among patients with IAEs (44% vs 22%; P < .001). Patients with IAEs had smaller renal artery diameter (-0.4 mm, 5.4 ± 0.8 mm vs 5.8 ± 0.9 mm; P < .001), and were treated more often for TAAAs (72% vs 54%; P < .03). Technical success was achieved in 96.5% of patients and was lower for patients with IAEs (82% vs 99%; P < .001). Major adverse events were significantly more frequent among patients who had IAEs (odds ratio [OR], 1.98; 95% confidence interval [CI], 1.21-3.25), most due to acute kidney injury (27% vs 11%; P < .001) including new-onset dialysis (5% vs 1%; P = .01). On multivariate logistic regression model, female sex (OR, 2.5; 95% CI, 1.5-4.0), TA stenosis >50% (OR, 2.0; 95% CI, 1.3-3.3), and Crawford Extent II TAAA (OR, 1.9; 95% CI, 1.1-3.3) were predictive of IAEs, whereas preloaded design (OR, 0.6; 95% CI, 0.4-0.9) and TA diameter (+1 mm; OR, 0.6; 95% CI, 0.4-0.9) were protective of IAEs. IAEs negatively affected secondary intervention (hazard ratio [HR], 1.6; 95% CI, 1.1-2.3) and TA instability (HR, 2.5; 95% CI, 1.2-5.4); however, IAEs did not affect patient survival (HR, 1.0; 95% CI, 0.7-1.4). CONCLUSIONS: IAEs are common, occurring in nearly one of five patients treated with FB-EVAR for complex aortic aneurysms, and have a negative impact on clinical outcomes. IAEs were associated with female sex, TA diameter, and more extensive aortic disease.

Effect of obesity on radiation exposure, quality of life scores, and outcomes of fenestrated-branched endovascular aortic repair of pararenal and thoracoabdominal aortic aneurysms.

BACKGROUND: The aim of the present study was to assess the effect of obesity on procedural metrics, radiation exposure, quality of life (QOL), and clinical outcomes of fenestrated-branched endovascular aortic repair (FB-EVAR) of pararenal and thoracoabdominal aortic aneurysms. METHODS: We reviewed the clinical data from 334 patients (236 men; mean age, 75 ± 8 years) enrolled in a prospective nonrandomized study to evaluate FB-EVAR from 2013 to 2019. The patients were classified using the body mass index (BMI) as obese (BMI ≥30 kg/m2) or nonobese (BMI <30 kg/m2). QOL questionnaires (short-form 36-item questionnaire) and imaging studies were obtained preoperatively and at 2 months and 6 months postoperatively, and annually thereafter. The procedures were performed using two different fixed imaging systems. The end points included procedural metrics (ie, total operative time, fluoroscopic time, contrast volume), radiation exposure, technical success, 30-day mortality, and major adverse events, QOL changes, freedom from target vessel instability, freedom from reintervention, and patient survival. RESULTS: The aneurysm extent was a pararenal aortic aneurysm in 117 patients (35%) and a thoracoabdominal aortic aneurysm in 217 patients (65%). Both groups had similar demographics, cardiovascular risk factors, and aneurysm extent, except for a greater incidence of hyperlipidemia and diabetes among the obese patients (P < .05). No significant differences were found in the procedural metrics or intraprocedural complications between the groups, except that the obese patients had greater radiation exposure than the nonobese patients (mean, 2.5 vs 1.6 Gy; P < .001), with the highest radiation exposure in those obese patients who had undergone the procedure using system 1 (fusion alone) instead of system 2 (fusion and digital zoom; mean, 4.1 vs 1.5 Gy; P < .001). Three patients had died within 30 days (0.8%), with no difference in mortality or major adverse events between the groups. The mental QOL scores had improved in the obese group at 2 and 12 months compared with the nonobese patients, with persistently higher scores up to 3 years. At 3 years, the obese and nonobese patients had a similar incidence of freedom from target vessel instability (74% ± 6% vs 80% ± 3%; P = .99, log-rank test), freedom from reintervention (66% ± 6% vs 73% ± 4%; P = .77, log-rank test), and patient survival (83% ± 5% vs 75% ± 4%; P = .16, log-rank test). CONCLUSIONS: FB-EVAR was performed with high technical success and low mortality and morbidity, with no significant differences between the obese and nonobese patients. The procedural metrics and outcomes were similar, with the exception of greater radiation exposure among obese patients, especially for the procedures performed using system 1 with fusion alone compared with system 2 (fusion and digital zoom). Obese patients had higher QOL mental scores at 2 and 12 months, with a similar reintervention rate, target vessel outcomes, and survival compared with nonobese patients.

Staged total arch replacement, followed by fenestrated-branched endovascular aortic repair, for patients with mega aortic syndrome.

OBJECTIVE: The aim of the present study was to review the clinical outcomes of a staged approach using total arch replacement (TAR) with an elephant trunk or a frozen elephant trunk, followed by fenestrated-branched endovascular aortic repair (F-BEVAR) for patients with mega aortic syndrome. METHODS: We reviewed the clinical data and outcomes of 11 consecutive patients (8 men; mean age, 71 ± 7 years) treated by staged TAR and F-BEVAR from January 2014 to December 2018. The F-BEVAR procedures were performed under a prospective, nonrandomized, physician-sponsored investigational device exemption protocol. All patients had had mega aortic syndrome, defined by an ascending aorta, arch, and extent I-II thoracoabdominal aortic aneurysm. The endpoints were 30-day mortality, major adverse events (MAE), patient survival, freedom from reintervention, and freedom from target vessel instability. RESULTS: Of the 11 patients, 6 had developed chronic postdissection aneurysms after previous Stanford A (three A11, two A10, one A9) dissection repair and 5 had had degenerative aneurysms with no suitable landing zone in the aortic arch. The thoracoabdominal aortic aneurysms were classified as extent I in four patients and extent II in seven. One patient had died within 30 days after TAR (9.0%). However, none of the remaining 10 patients who had undergone F-BEVAR had died. First-stage TAR resulted in MAE in three patients (27%), including one spinal cord injury. The mean length of stay was 12 ± 6 days. The mean interval between TAR and F-BEVAR was 245 ± 138 days with no aneurysm rupture during the interval. Second-stage F-BEVAR was associated with MAE in two patients (20%), including spinal cord injury in one patient from spinal hematoma due to placement of a cerebrospinal fluid drain. The mean follow-up period was 14 ± 10 months. At 2 years postoperatively, patient survival, primary patency, secondary patency, and freedom from renal-mesenteric target vessel instability was 80% ± 9%, 94% ± 6%, 100%, and 86% ± 8%, respectively. No aortic-related deaths occurred during the follow-up period. Four patients had required reintervention, all performed using an endovascular approach. CONCLUSIONS: A staged approach to treatment of mega aortic syndrome using TAR and F-BEVAR is a feasible alternative for selected high-risk patients. Larger clinical experience and longer follow-up are needed.

Impact of intentional accessory renal artery coverage on renal outcomes after fenestrated-branched endovascular aortic repair.

OBJECTIVE: The objective of this study was to evaluate the impact of intentional coverage of accessory renal arteries (ARAs) on renal outcomes after fenestrated-branched endovascular aortic repair (FB-EVAR) for pararenal aortic aneurysms or thoracoabdominal aortic aneurysms. METHODS: We analyzed the clinical data of 296 patients enrolled in a prospective nonrandomized study to evaluate outcomes of FB-EVAR between 2013 and 2018. Patients with solitary kidneys, intraoperative loss of main renal arteries, or pre-existing stage V chronic kidney disease were excluded. Two groups were analyzed: patients with intentional ARA coverage; and controls, who had complete preservation. End points included 30-day mortality; major adverse events; acute kidney injury (AKI), defined by RIFLE criteria (Risk, Injury, Failure, Loss of kidney function, and End-stage renal disease); renal function deterioration (RFD), defined by >30% decline in baseline estimated glomerular filtration rate; and presence of renal infarcts. RESULTS: There were 254 patients (184 male; mean age, 75 ± 8 years) included in the study, 56 (22%) with intentional ARA coverage and 198 controls, of whom 16 had ARA preservation. ARA diameter was smaller in patients who had intentional coverage vs preservation (2.7 ± 0.9 mm vs 3.4 ± 0.2 mm; P < .001). There was no difference in demographics, cardiovascular risk factors, and aneurysm extent. All ARAs intended to be incorporated were successfully stented. Patients with ARA coverage had a higher frequency of kidney infarction (75% vs 25%; P < .001). There were two (1%) deaths within 30 days, both among controls. Patients with ARA coverage had more major adverse events (32% vs 19%; P = .04) because of higher incidence of AKI (21% vs 9%; P = .02). None of the 16 patients who had ARA preservation developed AKI. At 3 years, freedom from RFD was lower for patients who had ARA coverage compared with controls (55% ± 9% vs 76% ± 5%; log-rank, P = .02). By multivariate analysis, predictors of AKI were ARA coverage (odds ratio, 2.8; 95% confidence interval [CI], 1.2-6.2; P = .01) and estimated blood loss >1 L (odds ratio, 3.8; 95% CI, 1.2-12.3; P = .03). Postoperative AKI (hazard ratio [HR], 4.4; 95% CI, 2.4-8.1; P < .001), renal reintervention for stenosis (HR, 3.2; 95% CI, 1.6-6.7; P = .002), aneurysm diameter (HR, 1.04; 95% CI, 1.02-1.06; P < .001), and ARA coverage (HR, 2.0; 95% CI, 2.4-8.1; P = .02) were predictors of RFD. CONCLUSIONS: Intentional ARA coverage during FB-EVAR was associated with a threefold increase in AKI and with lower freedom from RFD. Factors associated with RFD included postoperative AKI, renal reinterventions for stenosis, and ARA coverage. Incorporation of ARAs during FB-EVAR, when it is technically feasible, helps decrease risk of AKI and RFD.

Differences in procedural metrics and clinical outcomes among patients treated by fenestrated-branched endovascular repair of thoracoabdominal aortic aneurysms using infrarenal aortic versus iliac sealing zones.

OBJECTIVE: The purpose of the present study was to assess the outcomes of fenestrated-branched endovascular aortic repair (FB-EVAR) using infrarenal aortic vs iliac sealing zones. METHODS: We reviewed the clinical data of 430 consecutive patients enrolled in a prospective nonrandomized study to evaluate FB-EVAR from 2013 to 2020. The outcomes were analyzed for patients with extent I to IV thoracoabdominal aortic aneurysms who had undergone FB-EVAR with distal implantation in the native infrarenal aorta. The minimum anatomic criteria for the use of infrarenal aortic seal was a >3-cm length of parallel aorta with a diameter of 18 to 32 mm without excessive thrombus or calcification. A control group matched for the extent of aortic disease with an iliac artery seal was used to compare the following endpoints: 30-day mortality, major adverse events, freedom from type Ib endoleak (TIbE), freedom from secondary interventions, and changes in the infrarenal aortic diameter. RESULTS: A total of 110 patients (55 men; mean age, 73 ± 8 years) were included in the present study, 55 with an infrarenal aortic distal seal and 55 with the iliac arteries as the sealing zone. Both groups had similar clinical characteristics and aneurysm extent and diameter, except for a greater number of men and higher serum creatinine in the iliac seal group. Technical success was obtained in 106 patients (96%) and was greater for the iliac sealing zone group (100% vs 93%; P = .04). The use of the infrarenal aortic sealing zone was associated with shorter endovascular (148 ± 56 minutes vs 191 ± 61 minutes; P < .001) and fluoroscopy (76 ± 28 minutes vs 96 ± 32 minutes; P < .001) times and lower radiation exposure (cumulative air kerma, 1.4 ± 1.4 Gy vs 2.1 ± 2.0 Gy; P = .02; dose area product, 147 ± 75 Gy ∙ cm2 vs 208 ± 102 Gy ∙ cm2; P = .006). One patient had died (1%) within 30 days. No differences were found in the major adverse events among the patients treated with infrarenal aortic vs iliac sealing zones (22% vs 18%; P = .63), including any spinal cord injury (13% vs 9%; P = .54) and grade 3 spinal cord injury (7% vs 7%; P = 1.0). The mean clinical follow-up was 24 ± 18 months. TIbE occurred in one patient in each group (P = 1.0). The 3-year freedom from TIbE and freedom from secondary intervention rate was 98% ± 2% and 67% ± 8% for the infrarenal aortic seal group and 97% ± 3% and 67% ± 8% for the iliac seal group, respectively (P = NS). Among the patients treated with infrarenal aortic sealing zones, the mean enlargement of the infrarenal aortic diameter was 5 ± 3.2 mm at 3 years. No late TIbE due to disease progression had developed in the infrarenal aorta. CONCLUSIONS: Infrarenal aortic and iliac artery seal zones are safe and effective during FB-EVAR, provided the patients have suitable segments. The use of the infrarenal aortic sealing zone had modest procedural advantages such as shorter endovascular and fluoroscopy times and lower radiation exposure. No differences were found in the clinical outcomes or development of TIbEs.

Editor's Choice - Pre-Operative Moderate to Severe Chronic Kidney Disease is Associated with Worse Short-Term and Mid-Term Outcomes in Patients Undergoing Fenestrated-Branched Endovascular Aortic Repair.

OBJECTIVE: To review experience of fenestrated-branched endovascular aortic repair (F-BEVAR) for pararenal/thoraco-abdominal aortic aneurysms (PRAA/TAAA) and to assess the association between pre-operative moderate to severe chronic kidney disease (CKD) and post-operative outcomes. METHODS: All consecutive patients undergoing (elective and non-elective) F-BEVAR at a single centre (1 January 2011 - 1 July 2019) were identified. Renal function was calculated as the estimated glomerular filtration rate (eGFR) using the Modification of Diet in Renal Disease formula. Accordingly, presence of moderate to severe CKD was defined as eGFR < 60 mL/min/1.73m2. RESULTS: Overall, 202 consecutive patients (mean age 72 ± 8 years; 25% women) underwent F-BEVAR for the treatment of PRAA/TAAA during the study period. Of these, 51 had a history of moderate to severe CKD (none on chronic haemodialysis). No statistically significant differences were found in demographics and major comorbidities between patients with or without a history of CKD. The overall peri-operative mortality rate was 2%, without statistically significant differences between study groups (p = .26). Patients with prior CKD had statistically significantly higher rates of acute kidney injury (AKI) (37% vs. 12%, p < .001). At three years, overall survival was statistically significantly lower in patients with history of CKD compared with those without pre-operative CKD (57% vs. 82%, p = .010). Similarly, freedom from renal function decline at three years was statistically significantly poorer in patients with prior history of CKD compared with those without pre-operative CKD (43% vs. 80%, p = .020). In a multivariable analysis CKD was independently associated with higher odds of peri-operative AKI (OR 2.8, 95% CI 1.9 - 5.8, p = .030), renal function decline (OR 4.9, 95% CI 1.7 - 9.2, p = .003), and all cause mortality (HR 3.2, 95% CI 1.2 - 8.6, p = .020). CONCLUSION: Despite low peri-operative mortality rates that are comparable to patients with unimpaired renal function, occurrence of AKI was statistically significantly higher in subjects with pre-existing moderate to severe CKD. History of CKD was independently associated to renal function decline and poorer midterm survival.

Fenestrated-branched endovascular aortic repair in patients with chronic kidney disease.

OBJECTIVE: Renal function impairment is a common complication after open repair of complex abdominal aortic aneurysms and thoracoabdominal aortic aneurysms (TAAAs). The purpose of this study was to assess renal perioperative outcomes and renal function deterioration after fenestrated-branched endovascular aneurysm repair (F/BEVAR) in patients with chronic kidney disease (CKD). METHODS: The study included 186 patients who underwent F/BEVAR between 2013 and 2018 for suprarenal, juxtarenal, and type I to type IV TAAAs. Glomerular filtration rate (GFR) was calculated using the Modification of Diet in Renal Disease (MDRD) study equation. Postoperative acute kidney injury (AKI) and CKD were defined using RIFLE criteria (Risk, Injury, Failure, Loss, and End-stage renal disease) and CKD staging system (stage ≥3, GFR <60 mL/min/1.73 m2), respectively. For those without baseline CKD, renal decline was defined as a drop in GFR <60 mL/min/1.73 m2 (ie, progression to CKD stage 3 or higher). For patients with baseline renal dysfunction, GFR decline ≥20% or progression in CKD stage (ie, from stage 3 to stage 4) was considered renal decline. RESULTS: CKD was present in 83 patients (44.6%). Postoperative AKI was diagnosed in 27 patients (14.5%); 13 (48.1%) had history of CKD and 14 (51.9%) had adequate renal function preoperatively (P = .8). None of these patients required permanent renal replacement therapy. Intraoperative technical success was 100%. Overall 30-day mortality was 1.1%. There was no difference in 30-day mortality in patients with (1.2%) and without (1.0%) CKD (P = .5). During a median follow-up time of 12 months (interquartile range, 6-23 months), renal decline was observed in 21 patients (25.3%) with previous CKD and in 11 patients (10.6%) without CKD (P = .01). Among patients with previous CKD, 18 patients (9%) progressed from stage 3 CKD to stage 4. In patients with progression in CKD stage, two (5%) had renal stent stenosis requiring restenting. Among patients with renal decline, 13 had juxtarenal aneurysms (21.3%), 27 had suprarenal aneurysms (44.3%), and 21 had TAAAs (34.3%; P = .4). Subset analysis of patients who developed AKI in the immediate postoperative period found that patients with a history of CKD were less likely to experience freedom from renal decline. CONCLUSIONS: F/BEVAR is an effective and safe procedure for patients with complex abdominal aortic aneurysms and TAAAs, even among patients with CKD. The frequency of AKI was not affected by pre-existing CKD. Midterm outcomes demonstrated that progression of CKD was more frequent among patients with pre-existing CKD, but permanent renal replacement therapy was not required. Anatomic extent of aneurysms did not affect CKD progression. CKD patients are susceptible to renal decline over time if they experience AKI in the postoperative period. Therefore, preventing AKI in the postoperative period should be regarded as a priority. Long-term effects of CKD after F/BEVAR remain to be elucidated.

Evolution from physician-modified to company-manufactured fenestrated-branched endografts to treat pararenal and thoracoabdominal aortic aneurysms.

OBJECTIVE: The purpose of this study was to review treatment trends and outcomes of patients who underwent fenestrated-branched endovascular aneurysm repair (F-BEVAR) of pararenal aneurysms (PRAs) or thoracoabdominal aortic aneurysms (TAAAs) using physician-modified endografts (PMEGs) or company-manufactured devices (CMDs). METHODS: We reviewed the clinical data of 316 consecutive patients (242 male patients; mean age, 75 ± 8 years) who underwent F-BEVAR between 2007 and 2016. F-BEVAR was performed under two prospective investigational device exemption protocols since 2013. End points were mortality, major adverse events (MAEs), patient survival, reintervention, branch instability, aneurysm-related mortality, renal function deterioration, and target vessel patency. RESULTS: There were 145 patients (46%) treated by PMEGs (84 PRAs, 26 extent IV and 35 extent I-III TAAAs) and 171 patients (54%) who had CMDs (88 PRAs, 42 extent IV and 41 extent I-III TAAAs). Choice of endograft evolved from PMEGs in 131 patients (83%) treated in the first half of experience to CMDs in 144 patients (91%) treated in the second half of experience (P < .001). Patients treated by PMEGs had significantly (P < .05) larger aneurysms, more chronic pulmonary and kidney disease, and higher comorbidity severity scores. A total of 1081 renal-mesenteric arteries were targeted in both groups. Technical success was lower for PMEGs (98% vs 99.5%; P = .02). Thirty-day mortality was 5.5% for PMEGs (PRAs, 1.2%; extent IV 3.8% and extent I-III, 17.1%) and 0% for CMDs (P = .0018). Patients treated by PMEGs had significantly more (P < .001) MAEs (48% vs 23%) and longer hospital stay (9 ± 10 days vs 6 ± 6 days; P = .001). Mean follow-up was significantly longer for patients treated by PMEGs (38 ± 26 months vs 14 ± 12 months; P < .001). At 3 years, patient survival (68% ± 4% vs 67% ± 8%; P = .11), freedom from reintervention (68% ± 4% vs 68% ± 8%; P = .17), primary (94% ± 2% vs 92% ± 2%; P = .64) and secondary target vessel patency (98% ± 1% vs 98% ± 1%; P = .89), and freedom from renal function deterioration (75% ± 4% vs 65% ± 6%; P = .24) were similar for patients treated by PMEGs or CMDs, respectively. CONCLUSIONS: Choice of F-BEVAR evolved from PMEGs to almost exclusively CMDs under physician-sponsored investigational device exemption protocols. PMEG patients had more comorbidities and larger aneurysms. CMDs were performed with higher technical success, no mortality, and fewer MAEs.

Intraoperative complications during standard and complex endovascular aortic repair.

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.