Descending thoracic aortic mural ulceration is associated with postoperative spinal cord ischemia after branched endovascular aortic aneurysm repair.

OBJECTIVE: Paraplegia is one of the most feared complications after thoracoabdominal aortic aneurysm repair. The purpose of this study is to determine whether aortic thrombus characteristics are associated with spinal cord ischemia (SCI) after branched endovascular aneurysm repair (BEVAR). METHODS: From April 2011 to April 2020, 62 patients underwent elective BEVAR for thoracoabdominal aortic aneurysm and pararenal aortic aneurysms using a low-profile device and had a complete preoperative computed tomography angiography of the aorta from the sinotubular junction to the aortic bifurcation. Aortic thrombus was evaluated for thrombus thickness ≥5 mm, thrombus >2/3 of aortic circumference, and the presence of an ulcer-like thrombus. One point was assigned at each 5 mm axial image if all 3 criteria were met, resulting in a total "shaggy score" for the entire aorta. Data on demographics, procedural details, and outcomes were collected prospectively. All patients underwent a standard spinal cord protection protocol, including routine cerebrospinal fluid drainage. In July 2016, an insulin infusion protocol (IIP) was initiated to maintain postoperative blood glucose levels <120 mg/dL for 48 hours. The primary clinical end point was postoperative SCI. RESULTS: 10 (16%) patients developed postoperative SCI: 6 with transient paraparesis, 2 with persistent paraparesis, and 2 with persistent paraplegia. Patients with SCI were older, had higher shaggy scores, and were less likely to have been on an IIP. There were no significant differences in demographics, aneurysm type, or operative parameters. In a logistic multivariate regression model for SCI, age (odds ratio [OR]: 1.2 [1.1-1.4], P = .02) and shaggy score (OR: 1.2 [1.1-1.4], P = .02) were independently associated with increased risk of SCI, whereas treatment with the IIP was associated with lower risk of SCI (OR: 0.04 [0.006-0.50], P = .05). Of the individual components of the shaggy score, higher descending thoracic aortic ulcer scores were the most strongly associated with postoperative SCI (P = .009). CONCLUSIONS: Preoperative characterization of aortic wall thrombus is an important adjunctive tool for individualized clinical decision-making and patient counseling about the risk of SCI after BEVAR.

Fate of primary determinate and indeterminate target vessel endoleaks after fenestrated-branched endovascular aortic repair.

OBJECTIVE: The aim of this study was to investigate the outcomes of primary determinate and indeterminate target vessel endoleaks (TVELs) after fenestrated-branched endovascular aortic repair (F-BEVAR). METHODS: We conducted a single-center retrospective study (2014-2023) on F-BEVAR for thoracoabdominal (TAAAs) or pararenal aortic aneurysms (PRAAs). TVELs were classified as "primary" if present at the first postoperative computed tomography angiogram. Endoleaks were defined "determinate" (dELs) if the cause (type Ic or IIIc) and implicated target vessel were identifiable and "indeterminate" (iELs) if contrast enhancement was detectable at the level of fenestrations/branches without any evident source. Endoleaks involving multiple inflows (type II and target vessels) were defined as "complex" (cELs). Endpoints were endoleak spontaneous resolution, 1-year aneurysm sac failure to regress (>5 mm diameter decrease), and 4-year endoleak-related secondary interventions. Kaplan-Meier estimates and Cox regression were used for the analysis. RESULTS: There were 142 patients with JRAAs/PRAAs (n = 85; 60%) or TAAAs (n = 57; 40%), with 513 target arteries incorporated through a fenestration (n = 294; 57%) or directional branch (n = 219; 43%). Fifty-nine primary TVELs (12%) were identified in 35 patients (25%), a dEL in 20 patients (14%) and iEL in 15 (11%); 22 (15%) had a determinate or indeterminate cEL. Overall spontaneous resolution rate was 75% (95% confidence interval [CI], 51%-87%) at 4 years. cELs (odds ratio [OR], 5.00; 95% CI, 1.10-49.4; P < .001) and iELs after BEVAR (OR, 9.43; 95% CI, 3.41-56.4; P = .002) were more likely to persist >6 months, and persistent forms were associated with sac failure to regress at 1 year (OR, 1.72; 95% CI, 1.03-12.59; P = .040). Overall freedom from endoleak-related reinterventions was 85% (95% CI, 79%-92%) at 4 years, 92% (95% CI, 87%-97%) for those without primary TVELs and 62% (95% CI, 46%-84%) for those with any primary TVEL (P < .001). In particular, cELs (hazard ratio, 1.94; 95% CI, 1.4-18.81; P = .020) were associated with an increased need for reintervention. In case a secondary intervention was needed, iEL or cEL had an increased risk for multiple secondary procedures (hazard ratio, 2.67; 95% CI, 1.22-10.34; P = .034). CONCLUSIONS: Primary TVELs are frequent after F-BEVAR, and a clear characterization of the endoleak source by computed tomography angiogram is not possible in 40% of patients. Most primary TVELs spontaneously resolve, but during follow-up, patients with any primary TVEL experience a worsened freedom from endoleak-related reinterventions that is mostly driven by persistence of cELs and post-BEVAR iELs. Multiple secondary procedures may be required in case of iELs or cELs.

Efficacy of Endovascular Repair Using Single Left Common Carotid Artery Stent Combined with Castor Single-Branched Stent-Graft in the Treatment of Regional Diseases of Zone 2 of the Aorta.

PURPOSE: To observe the short-term efficacy of thoracic endovascular aortic repair (TEVAR) using a single left common carotid artery chimney stent combined with a Castor single-branched stent-graft (SC-TEVAR) in the treatment of zone 2 (Z2) aortic diseases. MATERIALS AND METHODS: To conduct a retrospective analysis of 20 patients with Z2 aortic diseases who were treated in our department from June 2021 to April 2022. The lesions included true aortic degenerative aneurysms with diameter ≥5.0 cm and penetrating aortic ulcers with depth >1.0 cm or basal width >2.0 cm. All 20 patients accepted the SC-TEVAR treatment, which was a new hybrid method to assure the flow of the left common carotid artery (LCCA) and left subclavian artery (LSA). This method was defined as a concomitant chimney stent for LCCA and a Castor single-branched stent graft for the aorta and LSA. The baseline data and intraoperative data were collected to evaluate the safety and efficacy of this method. The patency of the target blood vessel and any associated complications were evaluated at 1 and 6 months postoperatively, to analyze the safety and efficacy of this new method. RESULTS: After discharge from the hospital, all patients were followed up by a specific follow-up team. At 6 monthly follow-up period, there were no cardiac events, stroke, hemiplegia, type I endoleak, type II endoleak, proximal stent graft-induced new entries, distal stent graft-induced new entries, wound infection, or bleeding. Only 1 patient developed an inguinal wound hematoma and got conservative treatment. Importantly, no patients developed stenosis or occlusion of the LCCA or LSA. The patency of branched arteries was 100%. The technical success rate was 90%. CONCLUSION: SC-TEVAR appears to be a new and relatively simple, safe, and effective treatment for Z2 aortic diseases. CLINICAL IMPACT: This was a single-center retrospective cohort study. A total of 20 patients with zone 2 aortic diseases accepted a new hybrid surgical method named SC-TEVAR. This method was not complicated and could be finished with only 3 peripheral artery exposure. The result showed no mortality, 100% patency of the branch artery, and 90% of technical success in 6 months of follow-up time. SC-TEVAR showed a satisfactory result in this retrospective study and could be promoted as an easy method to treat zone 2 aortic diseases.

Endovascular Salvage of Type Ia and Ib Endoleaks Using a Physician-Modified Fenestrated/Branched Endograft and an Iliac Branch Device Via Unilateral Transfemoral Arterial Access.

PURPOSE: This study aims to explore the feasibility and effectiveness of a unilateral transfemoral access endovascular salvage technique for complex abdominal aortic aneurysms with concurrent type Ia and Ib endoleaks following previous endovascular repair. CASE REPORT: A 69-year-old female with multiple comorbidities presented with an extent IV thoracoabdominal aortic aneurysm complicated by type Ia and Ib endoleaks and chronically occluded left iliac endoprosthesis after prior endovascular repair. Given the patient's medical complexities, open explant repair was deemed high risk. The case was successfully managed using a physician-modified fenestrated/branched endograft (PM-F/BEVAR) and an iliac branch device (IBD) deployed through a single percutaneous transfemoral access. CONCLUSION: The presented case demonstrates the safety and efficacy of PM-F/BEVAR with concomitant IBD deployment via unilateral transfemoral access. This innovative approach allows endovascular salvage in cases with restricted iliofemoral access and avoids the complexities associated with upper extremity or aortic arch manipulation. While acknowledging the technical challenges, this technique offers a viable alternative for salvaging failed endovascular repairs, emphasizing the importance of real-time modifications in achieving successful outcomes. Further studies and long-term follow-up are warranted to validate the broader applicability and durability of this approach in the management of complex abdominal aortic aneurysms with multiple endoleaks. CLINICAL IMPACT: Although not the conventional approach, unilateral transfemoral access can be utilized to implant either a physician-modified fenestrated aortic endograft or an iliac branch device. Such an approach avoids complicating issues related to upper extremity access. This innovative technique may be necessary when there is a failed prior EVAR in the setting of significant contralateral iliofemoral occlusive disease. Doing both procedures in the same setting to resolve a type Ia and Ib endoleak is feasible as demonstrated in this case report. Expanding the endovascular armamentarium to address EVAR failure will be increasingly useful in the future, especially given the morbidity profile of EVAR explantation.

Effect of Family History of Aortic Disease on Outcomes of Fenestrated and Branched Endovascular Aneurysm Repair of Complex Aortic Aneurysms.

OBJECTIVE: The clinical significance of family history (FH) of aortic disease on the outcomes of fenestrated and branched endovascular aneurysm repair (FB-EVAR) has not been well described. This study aimed to assess how FH of aortic disease affects outcomes following FB-EVAR for complex aortic aneurysms (CAAs). METHODS: This study retrospectively reviewed the clinical data of consecutive patients enrolled in 10 ongoing, prospective, non-randomised, physician sponsored, investigational device exemption studies to evaluate FB-EVAR (2005 - 2022) in the United States Aortic Research Consortium database. Patients were stratified by presence or absence of FH of any aortic disease in any relative. Patients with confirmed genetically triggered aortic diseases were excluded. Primary outcomes were 30 day major adverse events (MAEs) and late survival. Secondary outcomes included late secondary interventions and aneurysm sac enlargement. RESULTS: During the study period, 2 901 patients underwent FB-EVAR. A total of 2 355 patients (81.2%) were included in the final analysis: 427 (18.1%) with and 1 928 (81.9%) without a FH of aortic disease. Patient demographics, clinical characteristics, and aneurysm extent were similar between the groups. Patients with a FH of aortic disease more frequently had prior open abdominal aortic repair, but less frequently had prior endovascular aneurysm repair (p < .050). There were no statistically significant differences in 30 day mortality (4% vs. 2%; p = .12) and MAEs (12% vs. 12%; p = .89) for patients with or without a FH of aortic disease. Three year survival estimates were 71% (95% confidence interval [CI] 67 - 78%) and 71% (95% CI 68 - 74%), respectively (p = .74). Freedom from secondary intervention and aneurysm sac enlargement were also not statistically significantly different between groups. CONCLUSION: A FH of aortic disease had no impact on 30 day or midterm outcomes of FB-EVAR of CAAs. In the absence of an identified genetically triggered aortic disease, treatment selection for CAAs should be based on clinical risk and patient anatomy rather than FH of aortic disease.

Renovisceral artery alterations due to branched endovascular aortic repair and respiratory-induced deformations.

OBJECTIVE: This study quantified respiratory-induced dynamics of branch vessels before and after thoracoabdominal aortic aneurysm (TAAA) branched endovascular aneurysm repair (bEVAR). METHODS: Patients with TAAA were recruited prospectively and treated with bEVAR, predominantly with Zenith t-Branch and BeGraft Peripheral PLUS bridging stents. Using SimVascular software, three-dimensional geometric models of the vessels and implants were constructed from computed tomography angiograms during both inspiratory and expiratory breath-holds, preoperatively and postoperatively. From these models, branch take-off angles, end-stent angles (transition from distal end of stent to native artery), and curvatures were computed. Paired, two-tailed t tests were performed to compare inspiratory vs expiratory geometry and pre- vs postoperative deformations. RESULTS: We evaluated 52 (12 celiac arteries [CA], 15 superior mesenteric arteries [SMA], and 25 renal arteries [RA]) branched renovisceral vessels with bridging stents in 15 patients. Implantation of bridging stents caused branch take-off angle to shift inferiorly in the SMA (P = .015) and RA (P = .014) and decreased the respiratory-induced branch angle motion in the CA and SMA by approximately 50%. End-stent angle increased from before to after bEVAR for the CA (P = .005), SMA (P = .020), and RA (P < .001); however, respiratory-induced deformation was unchanged. Bridging stents did not experience significant bending owing to respiration. CONCLUSIONS: The decrease in respiratory-induced deformation of branch take-off angle from before to after bEVAR should decrease the risk of device disengagement and endoleak. The unchanging respiratory-induced end-stent bending, from before to after bEVAR, means that bEVAR maintains native vessel dynamics distal to the bridging stents. This factor minimizes the risk of tissue irritation owing to respiratory cycles, boding well for branch vessel patency. The longer bridging stent paths associated with bEVAR may enable smoother paths subject to less dynamic bending, and potentially lower fatigue risk, compared with fenestrated EVAR.

Characterization and management of type II and complex endoleaks after fenestrated/branched endovascular aneurysm repair.

INTRODUCTION: Endoleaks are more common after fenestrated/branched endovascular aneurysm repair (F/B-EVAR) than infrarenal EVAR secondary to the length of aortic coverage and number of component junctions. Although reports have focused on type I and III endoleaks, less is known regarding type II endoleaks after F/B-EVAR. We hypothesized that type II endoleaks would be common and often complex (associated with additional endoleak types), given the potential for multiple inflow and outflow sources. We sought to describe the incidence and complexity of type II endoleaks after F/B-EVAR. METHODS: F/B-EVAR data prospectively collected at a single institution in an investigational device exemption clinical trial (G130210) were retrospectively analyzed (2014-2021). Endoleaks were characterized by type, time to detection, and management. Primary endoleaks were defined as those present on completion imaging or at first postoperative imaging, and secondary were those on subsequent imaging. Recurrent endoleaks were those that developed after a successfully resolved endoleak. Reinterventions were considered for type I or III endoleaks or any endoleak associated with sac growth >5 mm. Technical success defined as the absence of flow in the aneurysm sac at procedure conclusion and methods of intervention were captured. RESULTS: Among 335 consecutive F/B-EVARs (mean ± standard deviation follow-up: 2.5 ± 1.5 years), 125 patients (37%) experienced 166 endoleaks (81 primary, 72 secondary, and 13 recurrent). Of these 125 patients, 50 (40% of patients) underwent 71 interventions for 60 endoleaks. Type II endoleaks were the most frequent (n = 100, 60%), with 20 identified during the index procedure, 12 (60%) of which resolved before 30-day follow-up. Of the 100 type II endoleaks, 20 (20%; 12 primary, 5 secondary, and 3 recurrent) were associated with sac growth; 15 (75%) of those with associated sac growth underwent intervention. At intervention, 6 (40%) were reclassified as complex, with a concomitant type I or type III endoleak. Initial technical success for endoleak treatment was 96% (68 of 71). There were 13 recurrences, all of which were associated with complex endoleaks. CONCLUSIONS: Nearly half of the patients who underwent F/B-EVAR experienced an endoleak. The majority were classified as type II, with nearly a fifth associated with sac expansion. Interventions for a type II endoleak frequently led to reclassification as complex, with a concomitant type I or III endoleak not appreciated on computed tomography angiography and/or duplex. Further study is needed to determine if the primary treatment goal for complex aneurysm repair is sac stability or sac regression, as this would inform both the importance of properly classifying endoleaks noninvasively and the intervention threshold for managing type II endoleaks.

Effects of Iliac Tortuosity Index on Fenestrated Endovascular Aortic Aneurysm Repair for Pararenal and Thoracoabdominal Aortic Aneurysms.

PURPOSE: To evaluate the effect of iliac tortuosity on procedural metrics and outcomes of patients with complex aortic aneurysms (cAAs) undergoing repair with fenestrated/branched endografts (f/b-EVAR [endovascular aortic aneurysm repair]). MATERIAL AND METHODS: The study is a single-center, retrospective review of a prospectively maintained database of patients undergoing aneurysm repair using f/b-EVAR between the years 2013 and 2020 at our institution. Included patients had at least 1 preoperative computed tomography angiography (CTA) available for analysis. Iliac artery tortuosity index (TI) was calculated using centerline of flow imaging from a 3-dimensional work station based on the formula: (centerline iliac artery length / straight-line iliac artery length). The associations between iliac artery tortuosity and procedural metrics, including total operative time, fluoroscopy time, radiation dose, contrast volume, and estimated blood loss (EBL), were evaluated. RESULTS: During this period, 219 patients with cAAs underwent f/b-EVAR at our institution. Ninety-one patients (74% men; mean age = 75.2±7.7 years) met criteria for inclusion into the study. In this group, there were 72 (79%) juxtarenal or paravisceral aneurysms and 18 (20%) thoracoabdominal aortic aneurysms and 5 patients (5.4%) with failed previous EVAR. The average aneurysm diameter was 60.1±0.74 mm. Overall, 270 vessels were targeted, and 267 (99%) were successfully incorporated, including 25 celiac arteries, 67 superior mesenteric arteries, and 175 renal arteries. The mean total operative time was 236±83 minutes, fluoroscopy time was 87±39 minutes, contrast volume was 81±47 mL, radiation dose 3246±2207 mGy, and EBL was 290±409 mL. The average left and right TIs for all patients were 1.5±0.3 and 1.4±0.3, respectively. On multivariable analysis, the interval estimates suggest positive association between TI and procedural metrics to a certain degree. CONCLUSIONS: In the current series, we found no definitive association between iliac artery TI and procedural metrics, including operative time, contrast used, EBL, fluoroscopy time, and dose in patients undergoing cAA repair using f/b-EVAR. However, there was a trend toward association between TI and all these metrics on multivariable analysis. This potential association needs to be evaluated in a larger series. CLINICAL IMPACT: Iliac artery tortuosity should not exclude patients with complex aortic aneurysms from being offered fenestrated or branched stent graft repair. However, special considerations should be taken to mitigate the impact of access tortuosity on alignment of fenestrations with target vessels, including use of extra stiff wires, through and through access and delivering the fenestrated/branched device into another (larger) sheath such as a Gore DrySeal in patients with arteries large enough to accommodate such sheaths.

Multicentre International Registry of Open Surgical Versus Percutaneous Upper Extremity Access During Endovascular Aortic Procedures.

OBJECTIVE: To investigate access failure (AF) and stroke rates of aortic procedures performed with upper extremity access (UEA), and compare results of open surgical vs. percutaneous UEA techniques with closure devices. METHODS: A physician initiated, multicentre, ambispective, observational registry (SUPERAXA - NCT04589962) was carried out of patients undergoing aortic procedures requiring UEA, including transcatheter aortic valve replacement, aortic arch, and thoraco-abdominal aortic endovascular repair, pararenal parallel grafts, renovisceral and iliac vessel repair. Only vascular procedures performed with an open surgical or percutaneous (with a suture mediated vessel closure device) UEA were analysed. Risk factors and endpoints were classified according to the Society for Vascular Surgery and VARC-3 (Valve Academic Research Consortium) reporting standards. A logistic regression model was used to identify AF and stroke risk predictors, and propensity matching was employed to compare the UEA closure techniques. RESULTS: Sixteen centres registered 1 098 patients (806 men [73.4%]; median age 74 years, interquartile range 69 - 79 years) undergoing vascular procedures using open surgical (76%) or percutaneous (24%) UEA. Overall AF and stroke rates were 6.8% and 3.0%, respectively. Independent predictors of AF by multivariable analysis included pacemaker ipsilateral to the access (odds ratio [OR] 3.8, 95% confidence interval [CI] 1.2 - 12.1; p = .026), branched and fenestrated procedure (OR 3.4, 95% CI 1.2 - 9.6; p = .019) and introducer internal diameter ≥ 14 F (OR 6.6, 95% CI 2.1 - 20.7; p = .001). Stroke was associated with female sex (OR 3.4, 95% CI 1.3 - 9.0; p = .013), vessel diameter > 7 mm (OR 3.9, 95% CI 1.1 - 13.8; p = .037), and aortic arch procedure (OR 7.3, 95% CI 1.7 - 31.1; p = .007). After 1:1 propensity matching, there was no difference between open surgical and percutaneous cohorts. However, a statistically significantly higher number of adjunctive endovascular procedures was recorded in the percutaneous cohort (p < .001). CONCLUSION: AF and stroke rates during complex aortic procedures employing UEA are non-negligible. Therefore, selective use of UEA is warranted. Percutaneous access with vessel closure devices is associated with similar complication rates, but more adjunctive endovascular procedures are required to avoid surgical exposure.

Mortality and Major Adverse Events Improve With Increased Institutional Experience for Fenestrated and Branched Endovascular Aortic Repair.

OBJECTIVE: Our objective was to evaluate temporal trends in outcomes at our institution in the context a more heterogenous application of fenestrated/branched endovascular aneurysm repair (F/BEVAR). METHODS: Patient and aneurysm characteristics, procedure details, and postoperative outcomes were collected for consecutive patients undergoing F/BEVAR between 2002 and February 2019 at our institution. Outcomes were compared between tertile 1 (T1, 2002-2010, n=47), T2 (2011-2014, n=47), and T3 (2015-February 2019, n=47). RESULTS: We included 141 patients (74.8 ± 8.1 years, 83% male) with a mean follow-up of 28.0 ± 31.6 months. Proportion of patients with hypertension (63.8% T1, 85.1% T3, p=0.009), diabetes (6.4% T1, 29.7% T3, p=0.005), chronic obstructive pulmonary disease (COPD; 27.6% T1, 42.5% T3, p=0.07), and history of stroke (4.2% T1, 17% T3, p=0.07) increased over time. Aneurysm diameter (65.3±11.4mm) and extent (56.0% juxtarenal/pararenal, 22.0% type IV, 22.0% type I-III) did not differ between groups. Custom made devices were implanted in 96.5% of cases with 3.4 ± 0.7 vessels reimplanted/case. There was a trend toward increased history of aortic surgery (p=0.008) and less custom made devices (p=0.007) in T3.Total procedure time (383.5±119.2 minutes T1, 316.2±88.4 T3, p=0.02), contrast volume (222.8±109.1 mL T1, 139.2±62.7ml T3, p<0.0001), and estimated blood loss (601.3±458.1 mL T1, 413.3±317.7 mL T3, p=0.02) decreased over time. Overall 30-day mortality was 6.3%, 10.6%-T1, 6.3%-T2, and 2.1%-T3 (p=0.09). We noted significant improvement in survival over time; 1- and 3-year survival was 79% and 56%, 89% and 83%, and 90% and 90%, for T1, T2, and T3, respectively (p=0.007). In all, 467 of 480 target vessels were revascularized (97.3% success). Reintervention rate (30-day: 13.5%, follow-up: 34.7%) and reintervention free survival was not significantly different between groups. Any major adverse event (MAE) occurred in 36.9% of patients overall with a significant decrease from early (51.1%), mid (34.9%), to late in our experience (25.5%, p=0.03). In multivariate analyses, increasing institutional experience (T3), procedure time, age, and sex were independent predictors of major adverse events. CONCLUSION: We have shown improvement in F/BEVAR outcomes including mortality, MAEs, and procedural metrics with increasing institutional experience. We postulate that a combination of advancements in technique, surgical team and postoperative care experience, graft design and stent technologies, and patient selection contributed to improvement in outcomes.

Retrograde Approach for Antegrade Inner Branches in a Precannulated Off-the-Shelf Multibranch Device.

PURPOSE: The purpose of this technical note was to describe the application of the combination of precannulated branches and a femoral approach for bridging stent graft deployment in branched endovascular aneurysm repair. TECHNIQUE: The technique is shown in a 65-year-old woman treated for thoracoabdominal aneurysm type I with endovascular repair using a multibranched device. The stent graft is an off-the-shelf device with 4 precannulated inner branches. Access to the precannulated branches is gained using a steerable sheath from retrograde femoral access instead of using access via the upper extremities. For this purpose, a 0.018" wire introduced to the precannulated tube is snared into the steerable sheath. Next, the steerable sheath is guided into a stable position inside the branch. With this technique, the implantation of this off-the-shelf multibranch device could be completed safe and quickly with a full femoral approach avoiding upper extremity access. CONCLUSION: The combination of a precannulated multibranch stent graft with a full femoral approach for target vessel revascularisation is a feasible and quick method for complex endovascular repair.

Outcomes of Upper Extremity Access with Surgical Exposure of the Axillary Artery in Fenestrated and Branched Endovascular Aneurysm Repair.

OBJECTIVE: This study aims to assess the safety of upper extremity access with surgical exposure of the axillary artery in fenestrated and branched endovascular aneurysm repair (F/B-EVAR), evaluating neurological and local complications as well as re-interventions associated with the technique. METHODS: All patients undergoing an F/B-EVAR procedure with surgical exposure of the axillary artery between January 2010 and March 2020 were included in this retrospective single centre study. Endpoints were neurological and access related complications and re-interventions related to the upper extremity access. Complications related to the technique included stroke/transient ischaemic attack, wound infection, peripheral nerve injury, and arterial complications. RESULTS: 264 patients (192 male, mean age 70 ± 7 years) were included. Upper extremity access was performed over the left axillary artery in 257 (97%) of the cases, and over the right axillary artery in the remaining seven cases. Six (2.2%) patients had early complications related to the arterial access: four with post-operative bleeding and two with acute arm ischaemia. Two patients with post-operative bleeding and both patients with ischaemic complications required re-intervention. One of these patients with arm ischaemia died five weeks after the re-intervention due to sepsis complications related to patch infection. Sixteen (6%) patients presented with transient arm paraesthesia or sensory neurological deficit post-operatively. The symptoms completely recovered in all cases with no residual deficits. Peri-operative ischaemic stroke occurred in three (1%) patients (two minor, one major). No other access related complications were recorded during follow up in any of the patients with no cases of late stenosis/occlusion. CONCLUSION: Upper extremity access with surgical exposure of the axillary artery is a safe method for antegrade catheterisation of fenestrations and branches in complex endovascular aneurysm repair.

Effect of branch length and tortuosity on the outcomes of branched endovascular repair of thoracoabdominal aneurysms using self-expandable bridging stent graft.

OBJECTIVE: We investigated the effect of the length and tortuosity of directional branches on the mid-term outcomes of branched endovascular aneurysm repair (BEVAR) for thoracoabdominal aortic aneurysms (TAAA). METHODS: We retrospectively reviewed single-center data of consecutive patients who had undergone BEVAR for TAAA from 2015 to 2019. Three-dimensional computed tomography angiogram reconstructions (Aquarius iNtuition software; TeraRecon, Durham, NC) of the first postoperative imaging studies were used to measure the branch total length (TL), branch vertical length (VL), and branch tortuosity index (TI). The branch TL was measured as the centerline distance between the branch proximal radiopaque marker and the distal edge of the bridging stent. The VL was measured as the centerline distance between the branch distal radiopaque marker and the origin of the target artery. The TI was measured in accordance with the Society for Vascular Surgery reporting standard. The primary end point was freedom from branch instability, defined as any branch-related death, occlusion, or rupture and any reintervention for stenosis, endoleak, or disconnection. Cox proportional hazards were used to identify predictors of branch instability. A penalized spline function was used to identify the relationship between branch instability and the branch TL and VL. RESULTS: Postimplantation analysis was conducted on 32 TAAAs (extent I-III, n = 18 [56%]; extent IV, n = 14 [44%]), with 123 arteries included through a directional branch. A covered self-expanding bridging stent was used in all cases. Intraoperative reinforcement with an additional bare metal stent was performed in 85 cases (69%). The overall freedom from branch instability at 3 years was 88% (95% confidence interval [CI], 81%-94%). Five cases of occlusion and eight cases of branch-related endoleak occurred. A concomitant endoleak and severe stenosis requiring intervention developed in three cases. The Cox model with splines showed that the minimal risk of branch instability was achieved with a branch TL of 60 to 100 mm (P = .002) and a branch VL of 25 to 50 mm (P = .038). A TI of >1.15 was a predictor of branch complications (hazard ratio [HR], 8.6; 95% CI, 2.4-31.4; P < .001). After multivariate analysis, aneurysm diameter (HR, 1.08; 95% CI, 0.03-1.15; P = .003), TI >1.15 (HR, 6.81; 95% CI, 2.17-27.33; P < .001), and TL <60 or >100 mm (P = .002) were significantly associated with branch instability. CONCLUSIONS: The branch length and TI seemed to play an important role in BEVAR outcomes. The lowest branch instability rates were obtained with a branch TL of 60 to 100 mm, and this should be considered during planning and implantation. A branch TI >1.15 might require a more strict monitoring to prevent mid- and long-term complications.

Evolution of fenestrated/branched endovascular aortic aneurysm repair complexity and outcomes at an organized center for the treatment of complex aortic disease.

BACKGROUND: Fenestrated/branched endovascular aneurysm repair (F/BEVAR) volume has increased rapidly, with favorable outcomes at centers of excellence. We evaluated changes over time in F/BEVAR complexity and associated outcomes at a single-center complex aortic disease program. METHODS: Prospectively collected data of all F/BEVAR (definition: requiring ≥1 fenestration/branch), procedures performed in an institutional review board-approved registry and/or physician-sponsored investigational device exemption trial (IDE# G130210), were reviewed (11/2010-2/2019). Patients were stratified by surgery date into thirds: early experience, mid experience, and recent experience. Patient and operative characteristics, aneurysm morphology, device types, perioperative and midterm outcomes (survival, freedom from type I or III endoleak, target artery patency, freedom from reintervention), were compared across groups. RESULTS: For 252 consecutive F/BEVARs (early experience, n = 84, mid experience, n = 84, recent experience, n = 84), 194 (77%) company-manufactured custom-made devices, 11 (4.4%) company-manufactured off-the-shelf devices, and 47 (19%) physician-modified devices, were used to treat 5 (2.0%) common iliac, 97 (39%) juxtarenal, 31 (12%) pararenal, 116 (46%) thoracoabdominal, and 2 (0.8%) arch aneurysms. All patients had follow-up for 30-day events. The mean follow-up time for the entire cohort was 589 days (interquartile range, 149-813 days). On 1-year Kaplan-Meier analysis, survival was 88%, freedom from type I or III endoleak was 91%, and target vessel patency was 92%. When stratified by time period, significant differences included aneurysm extent (thoracoabdominal, 33% early experience, 40% mid experience, and 64% recent experience; P < .001) and target vessels per case (four-vessel case, 31% early experience, 39% mid experience, and 67% recent experience; P < .0001). There was no difference, but a trend toward improvement, in composite 30-day events (early experience, 39%; mid experience, 23%; recent experience, 27%; P = .05). On Kaplan-Meier analysis, there was no difference in survival (P = .19) or target artery patency (P = .6). There were differences in freedom from reintervention (P < .01) and from type I or III endoleak (P = .02), with more reinterventions in the early experience, and more endoleaks in the recent period. CONCLUSIONS: Despite increasing repair complexity, there has been no significant change in perioperative complications, overall survival, or target artery patency, with favorable outcomes overall. Type I or III endoleaks remain a significant limitation, with increased incidence as the number of branch arteries incorporated into the repairs has increased.

Risk factors for spinal cord injury and complications of cerebrospinal fluid drainage in patients undergoing fenestrated and branched endovascular aneurysm repair.

OBJECTIVE: Spinal cord injury (SCI) is one of the most devastating complications of thoracoabdominal aortic aneurysm (TAAA) repair. Cerebrospinal fluid drainage (CSFD) is routinely used to prevent and to treat SCI during open TAAA repair. However, the risks and benefits of CSFD during fenestrated-branched endovascular aneurysm repair (F/B-EVAR) are unclear. This study aimed to determine the risk of SCI after F/B-EVAR and to assess the risks and benefits of CSFD. METHODS: We analyzed 106 consecutive patients with TAAAs treated with F/B-EVAR from 2014 to 2019 in a prospective physician-sponsored investigational device exemption study (G130193). Data were collected prospectively and audited by an independent external monitor. All patients were treated with Cook manufactured patient-specific F/B-EVAR devices or the Cook t-Branch devices (Cook Medical, Bloomington, Ind). CSFD was used at the discretion of the principal investigator. Risk factors for SCI were identified, and CSFD complications were assessed. RESULTS: Prophylactic CSFD was used in 78 patients (73.6%), and 28 patients (26.4%) underwent F/B-EVAR without CSFD. Four patients (3.8%) with prophylactic CSFD developed SCI, including two patients (1.9%) with permanent paraplegia (Tarlov grade 1-2) and two patients (1.9%) with paraparesis (Tarlov grade 3). Multivariate analysis revealed that greater extent of thoracic aortic coverage (odds ratio, 1.06; 95% confidence interval, 1.00-1.11; P = .02) and intraoperative blood loss (odds ratio, 1.00; 95% confidence interval, 1.00-1.002; P = .04) were the significant risk factors for SCI. Six patients (7.6% [6/78]) experienced major CSFD-related complications, including subarachnoid hemorrhage in 2.6% (2), spinal hematoma in 2.6% (2), cerebellar hemorrhage in 1.3% (1), and spinal drain fracture requiring surgical laminectomy in 1.3% (1). Minor CSFD-related complications occurred in 20 patients (25.6% [20/78]), including paresthesia during CSFD insertion (10), minimal bloody cerebrospinal fluid (7), drain malfunction (2), and reflex hypotension (1). Technical difficulties during CSFD catheter placement were noted in seven patients (9.0%). Excluding four patients with SCI, intensive care unit stay was 3.3 ± 4.0 days in the CSFD group vs 1.2 ± 0.9 days in the no-CSFD group (P = .007). Total hospital length of stay was 6.0 ± 4.9 days in the CSFD group vs 3.5 ± 1.9 days in the no-CSFD group (P = .01). CONCLUSIONS: The incidence of SCI after F/B-EVAR with selective CSFD was low, and risk factors for SCI were greater with extent of thoracic aortic coverage and intraoperative blood loss. However, the incidence of major CSFD-related complications exceeded the incidence of SCI, and CSFD significantly increased both intensive care unit and total hospital length of stay. Therefore, routine prophylactic CSFD may not be justified, and a prospective randomized trial of CSFD in patients undergoing F/B-EVAR seems appropriate.

Incorporation of Celiomesenteric Trunk With Double Kissing Directional Branches During Fenestrated-Branched Endovascular Aortic Repair.

PURPOSE: Common celiomesenteric trunk (CMT) is a rare anatomical variation that occurs in 0.5% to 3.4% of the general population. Its presence may complicate planning and implantation of fenestrated and branched stent-grafts because the wide diameter and short length of the CMT to its bifurcation does not allow sufficient sealing for placement of bridging stents. CASE REPORT: We report a patient with thoracoabdominal aortic aneurysm (TAAA) and CMT treated by fenestrated-branched endovascular aortic repair (FB-EVAR) using double kissing directional branches to incorporate the celiac axis and superior mesenteric artery. Pitfalls of stent design and implantation are outlined. CONCLUSION: Double kissing directional branches should be considered as an alternative to incorporate vessels with early bifurcation such as a CMT.

Lumbar drain complications in patients undergoing fenestrated or branched endovascular aortic aneurysm repair: Development of an institutional protocol for lumbar drain management.

OBJECTIVE: Lumbar drain placement with cerebrospinal fluid (CSF) drainage is an effective adjunct for reducing the risk of spinal cord ischemia in patients undergoing complex aortic aneurysm repair. However, lumbar drain placement is a challenging procedure with potential for significant complications. We sought to characterize complications of lumbar drain placement in a large, single-center experience of patients who underwent fenestrated or branched endovascular aneurysm repair (F/BEVAR). METHODS: All patients who underwent F/BEVAR and attempted lumbar drain placement from 2010 to 2019 were retrospectively reviewed. All lumbar drains were placed by four cardiovascular anesthesiologists who compose the complex aortic anesthesia team. Lumbar drain placement was guided by a set protocol and used whenever the aortic stent graft coverage was planned to extend more proximal than 40 mm above the celiac artery. Details relating to lumbar drain placement, management, and frequency and type of associated complications were characterized. RESULTS: During the study period, 256 patients underwent F/BEVAR, of whom 100 (39%) were planned for lumbar drain placement. Successful placement occurred in 98 (98%) of the cases. All lumbar drains were placed before induction of general anesthesia, using fluoroscopy guidance in 28 cases (28%). The most common level of placement was L4-5 (n = 42 [42%]). The majority (n = 82 [82%]) were left in place ≤48 hours; 21% were removed during the first 24 hours, and 61% were removed between 24 and 48 hours. Nonfunctionality was the most common complication, occurring in 16 (16%) patients. Catheter dislodgment or fracture, CSF leak, and postdural puncture headache were observed in 4 (4%), 7 (7%), and 4 (4%) patients, respectively. The most common bleeding complication was the presence of asymptomatic blood in the CSF (n = 11 [11%]), whereas subarachnoid hemorrhage combined with intraventricular hemorrhage occurred in three patients (3%); none of these patients required surgical drainage or intervention. No infectious complications were observed. CONCLUSIONS: Lumbar drain placement for CSF drainage is a commonly employed adjunct to prevent spinal cord ischemia in F/BEVAR. Our experience demonstrates that lumbar drain placement can be performed successfully but is associated with a significant rate of nonfunctionality and a diverse range of complications that, fortunately, do not commonly have significant long-term sequelae.

Secondary interventions after fenestrated and branched endovascular repair of complex aortic aneurysms.

OBJECTIVE: The use of fenestrated and branched endografts for the treatment of complex aortic aneurysms is increasing. Despite the low morbidity and mortality associated with these repairs, reintervention rates in the midterm and long term remain a concern. The purpose of this study was to investigate our experience with reinterventions after fenestrated and branched endovascular aneurysm repair (F/BEVAR). METHODS: We performed a retrospective analysis of all patients treated with F/BEVAR at our institution during the years 2009 to 2019. Among them, we identified those who required reinterventions during the period of follow-up. Data collected included patients' demographics, type of treated aneurysm, indications for reintervention, and methods of repair. RESULTS: During the study period, 47 patients underwent F/BEVAR. A total of 160 branches were placed. Of those, 12 patients (25%) underwent 15 secondary interventions for late-occurring complications. Among those requiring reinterventions, mean age was 70 years (range, 59-80 years), and 10 (83%) were male. The majority of those requiring reinterventions were treated for thoracoabdominal aortic aneurysms. Mean time to reintervention was 14 months (range, 2-32 months). Indications for reinterventions included separation of side branches from fenestrations (nine), separation of side branches (three), type IA endoleak (one), type II endoleak (one), and limb occlusion (one). All endoleaks were detected on routine follow-up imaging. All reinterventions were performed using endovascular techniques. Mean follow-up after reinvention was 22 months (range, 1-53 months). During this period, no patient required open conversion. Follow-up imaging revealed successful obliteration of the endoleak, and none experienced continued growth of the sac. CONCLUSIONS: Reinterventions after F/BEVAR are not uncommon. The majority of reinterventions are performed for endoleaks that are due to failure at the level of the fenestrations or component separation. These endoleaks can be treated successfully with endovascular methods and do not require open conversion. Because of the possibility of development of late endoleaks, continual monitoring of these patients is required after the primary procedure.

Outcomes of endovascular repair of chronic postdissection compared with degenerative thoracoabdominal aortic aneurysms using fenestrated-branched stent grafts.

OBJECTIVE: The objective of this study was to analyze outcomes of fenestrated-branched endovascular aneurysm repair (F/BEVAR) for treatment of postdissection and degenerative thoracoabdominal aortic aneurysms (TAAAs). METHODS: We reviewed the clinical data of 240 patients with extent I to extent III TAAAs enrolled in seven prospective physician-sponsored investigational device exemption studies from 2014 to 2017. All patients had manufactured off-the-shelf or patient-specific fenestrated-branched stent grafts used to target 888 renal-mesenteric arteries with a mean of 3.7 vessels per patient. End points included mortality, major adverse events (any-cause mortality, stroke, paralysis, dialysis, myocardial infarction, respiratory failure, bowel ischemia, and estimated blood loss >1 L), technical success, target artery patency, target artery instability, occlusion or stenosis, endoleak, rupture or death, reintervention, and renal function deterioration. RESULTS: There were 50 patients (21%) treated for postdissection TAAAs and 190 (79%) who had degenerative TAAAs. Postdissection TAAA patients were significantly younger (67 ± 9 years vs 74 ± 8 years; P < .001), were more often male (76% vs 52%; P = .002), and had more prior aortic repairs (84% vs 67%; P = .02) and larger renal (6.4 ± 1.2 mm vs 5.8 ± 0.9 mm; P < .001) and mesenteric (8.9 ± 1.7 mm vs 7.8 ± 1.4 mm; P < .001) target artery diameters. There was no difference in aneurysm diameter (66 ± 13 mm vs 67 ± 11 mm; P = .50), extent I or extent II TAAA classification (64% vs 56%; P = .33), and length of supraceliac coverage (22 ± 9.5 cm vs 20 ± 10 cm; P = .38) between postdissection and degenerative patients, respectively. Preloaded guidewire systems (66% vs 43%; P = .003) and fenestrations as opposed to directional branches (58% vs 24%; P < .001) were used more frequently to treat postdissection patients. Technical success was 100% for postdissection TAAAs and 99% for degenerative TAAAs (P = .14). At 30 days, there was no difference in mortality (2% postdissection, 3% degenerative), major adverse events (24% postdissection, 26% degenerative; P = .73), spinal cord injury (6% postdissection, 12% degenerative; P = .25), paraplegia (2% postdissection, 7% degenerative; P = .19), and dialysis (0% postdissection, 5% degenerative; P = .24). Mean follow-up was 14 ± 12 months. Endoleaks were significantly more frequent in patients with postdissection TAAAs (76%) compared with degenerative TAAAs (43%; P < .001). At 2 years, there was no difference in patient survival (84% ± 7% vs 72% ± 4%; P = .13), freedom from aorta-related death (98% ± 2% vs 94% ± 2%; P = .45), primary (95% ± 2% vs 97% ± 1%; P = .93) and secondary target artery patency (99% ± 1% vs 98% ± 1%; P = .48), target artery instability (89% ± 3% vs 91% ± 1%; P = .17), and freedom from reintervention (58% ± 10% vs 67% ± 5%; P = .23) for postdissection and degenerative TAAAs, respectively. CONCLUSIONS: Despite minor differences in demographics, anatomic factors, and stent graft design, F/BEVAR was safe and effective with nearly identical outcomes in patients with postdissection and degenerative TAAAs. Larger clinical experience and longer follow-up are needed to better evaluate differences in mortality, spinal cord injury, target artery instability, and reintervention.

Outcomes of directional branches using self-expandable or balloon-expandable stent grafts during endovascular repair of thoracoabdominal aortic aneurysms.

OBJECTIVE: The objective of this study was to evaluate outcomes of directional branches using self-expandable stent grafts (SESGs) or balloon-expandable stent grafts (BESGs) during fenestrated-branched endovascular aneurysm repair of thoracoabdominal aortic aneurysms. METHODS: Patients treated by fenestrated-branched endovascular aneurysm repair were enrolled in a prospective study from 2014 to 2018. We included in the analysis patients who had target vessels incorporated by directional branches using either SESG (Fluency [Bard, Covington Ga] or Gore Viabahn [W. L. Gore & Associates, Flagstaff, Ariz]) or BESG (Gore VBX). Target artery instability (TAI) was defined by a composite of any stent stenosis, separation, or type IC or type IIIC endoleak requiring reintervention and stent occlusion, aneurysm rupture, or death due to target artery complication. End points included technical success, target artery patency, freedom from TAI, freedom from type IC or type IIIC endoleak, and freedom from target artery reintervention. RESULTS: There were 126 patients (61% male; mean age, 73 ± 8 years) included in the study. A total of 335 renal-mesenteric arteries were targeted by directional branches using SESGs in 62 patients and 176 arteries or BESGs in 54 patients and 159 arteries. Patients in both groups had similar thoracoabdominal aortic aneurysm classification and aneurysm and target artery diameter, but SESG patients had significantly (P < .05) shorter stent length (-7 mm) and larger stent diameter (+1 mm) and more often had adjunctive bare-metal stents (72% vs 15%). Technical success was achieved in 99% of patients, with one 30-day death (0.7%). Mean follow-up was significantly longer among patients treated by SESGs compared with BESGs (23 ± 12 months vs 8±8 months; P < .0001). TAI occurred in 27 directional branches (8%), including 11 type IC endoleaks (2 SESGs, 9 BESGs), 10 stenoses (3 SESGs, 7 BESGs), 4 occlusions (3 SESGs, 1 BESGs), 4 type IIIC endoleaks (2 SESGs, 2 BESGs), and 1 stent separation (SESG), resulting in 20 target artery reinterventions in 16 patients (5 SESGs and 11 BESGs). At 1 year, SESGs had higher primary patency (97% ± 2% vs 96% ± 2%; P = .004), freedom from TAI (96% ± 2% vs 88% ± 3%; P < .0001), freedom from type IC or type IIIC endoleaks (98% ± 1% vs 92% ± 3%; P = .0004), and freedom from target artery reinterventions (98% ± 1% vs 88% ± 4%; P < .0001) compared with BESGs. There was no difference in secondary patency for SESGs and BESGs (98% ± 1% vs 99% ± 1%; P = .75). Factors associated with TAI were large stent diameter (odds ratio, 0.6; P < .0001) and use of VBX stent graft (odds ratio, 6.5; P < .0001). CONCLUSIONS: Directional branches were associated with high technical success and low rates of stent occlusion, independent of stent type. However, primary patency, freedom from TAI, and freedom from type IC or type IIIC endoleaks was lower for BESGs compared with SESGs.