Pararenal Aneurysms Research Articles

Physician-modified aortic cuff to "stabilize" paravisceral aortic thrombus and minimize risk of distal embolization during pararenal aneurysm repair with fenestrated stent graft.

As technology and surgeon experience evolve, endovascular repair of complex abdominal aortic aneurysms is often preferred in appropriately selected patients. However, the presence of pedunculated aortic thrombus represents a relative contraindication for endoluminal therapy due embolization risks. Here, we present a 68-year-old woman with a 5.8-cm pararenal aortic aneurysm associated with pedunculated aortic thrombus. She was treated with a modified Cook-Zenith aortic cuff to first entrap the aortic thrombus, followed by treatment of the aneurysm with a modified Z-FEN graft. This cuff modification provides a novel approach to deal with such luminal thrombus.

Complex Aortic Interventions Can Be Safely Introduced to the Clinical Practice by Physicians Skilled in Basic Endovascular Techniques.

Our purpose was to evaluate the risk associated with the learning curve of starting a complex aortic programme in an Eastern European country. A retrospective study was conducted involving the initial 20 patients (16 males, mean age: 65 ± 11 years) undergoing fenestrated/branched endovascular aortic repair in a single centre. Demographic, anatomical, procedural, and postoperative variables were collected. Our elective patient cohort consisted of 9 pararenal aneurysms (45%) and 11 thoracoabdominal aortic aneurysms (55%), with the latter including 4 chronic dissection cases (20%). A total of 71 branch vessels were incorporated (3.5 ± 0.9 per patient). The per vessel technical success rate was 100%. In-hospital mortality was 5% (1/20). At an average follow-up of 14 ± 22 months, the primary clinical success rate was 45% (9/20) and the secondary clinical success was achieved in 75% of cases (15/20). All-cause mortality at 14 months was 20% (4/20; aortic related: 1/20, 5%). Four bridging stent occlusions were found (5.6%). Mortality and reintervention rates were comparable to the initial results of high-volume centres, while the complexity of our cases and the per vessel technical success rate was comparable to the values reported as late experience. The morbidity of the learning curve could be decreased if operators are skilled in basic endovascular procedures.

Physician-Modified Versus Custom-Manufactured Fenestrated-Branched Endografts in the Treatment of Thoracoabdominal and Pararenal Aneurysms: A Vascular Quality Initiative–Medicare Analysis

The use of fenestrated and branched endovascular aneurysm repair (F-BEVAR) has expanded the indications for endovascular repair to patients with thoracoabdominal aortic aneurysms (TAAAs) and pararenal aortic aneurysms (PRAs). Previous reports have indicated that F-BEVAR can be performed with high technical success and lower morbidity and mortality compared with open repair. Although custom-manufactured devices (CMDs) that have been tailored to the patient’s anatomy have been proved effective, their widespread use has been hampered by regulatory issues, the costs, and delays required for device manufacturing.

“Awake” Spinal Cord Monitoring Under Local Anesthesia and Conscious Sedation in Fenestrated and Branched Endovascular Aortic Repair

Introduction Endovascular repair of thoracoabdominal aortic aneurysms carries a risk of spinal cord ischemia, the causes of which remain uncertain. We hypothesized that local anesthesia (LA) with conscious sedation could abrogate the potential suppressive cardiovascular effects of general anesthesia (GA) and facilitate intraoperative monitoring of neurological function. Here, we examine the feasibility of this technique during fenestrated (FEVAR) or branched endovascular aortic repair (BEVAR). Materials and Methods Consecutive patients undergoing FEVAR or BEVAR under LA and conscious sedation by a team at a single center were analyzed. Patients received conscious sedation using intravenous remifentanil and propofol infusions in conjunction with a local anesthetic agent. No patient had a prophylactic spinal drain inserted. Outcome measures included conversion to GA, need for vasopressors and/or spinal drainage, length of stay, complications, and patient survival. Results A total of 44 patients underwent FEVAR or BEVAR under LA and conscious sedation. The cohort included thoracoabdominal aortic aneurysms (n=41) and pararenal aneurysms treated with endografts covering the supraceliac segment (n=3). Four patients (9%) required conversion to GA at a median operative duration of 198 minutes (range 97–495 minutes). Vasopressors were required intraoperatively in 3 of the cases that were converted to GA. No patient developed spinal cord ischemia and none had insertion of a spinal drain. The median hospital length of stay was 4 days (range 2–41 days). Postoperative delirium and hospital-acquired pneumonia was seen in 7% of patients. All patients survived to 30 days, with 95% alive at a median follow-up of 15 months (range 3–26 months). Conclusion LA and conscious sedation is a feasible anesthetic technique for the endovascular repair of thoracoabdominal aortic aneurysms.

Fenestrated and Branched Endovascular Aortic Repair of Thoracoabdominal Aortic Aneurysm With More Than 4 Target Visceral Vessels due to Renovisceral Arterial Anatomical Variations: Feasibility and Early Results

Purpose: This study describes technical success, feasibility, and early results of fenestrated and branched endovascular aortic repair (F/B-EVAR) for treatment of thoracoabdominal aortic aneurysms (TAAAs) or pararenal aneurysms with more than 4 target visceral vessels (TVs) due to renovisceral arterial anatomical variations. Materials and Methods: Patients with TAAAs or pararenal aortic aneurysms who had more than 4 TVs due to renovisceral arterial anatomical variations of renal, celiac, and/or superior mesenteric arteries and received F/B-EVAR between January 2017 and September 2019 at a single aortic center were included in this study. We analyzed technical success, feasibility, and early outcomes. Results: Twelve patients (mean age 70±10 years, 9 males) were included. The anatomical variations included 6 right accessory renal arteries, 8 left accessory renal arteries, and 1 celiac artery variant. Stent-grafts were fenestrated, branched or combined in 6, 5, or 1 patients, respectively. The mean operating time was 346±120 minutes, the mean fluoroscopy time was 80±29 minutes, and the mean radiation dose area product was 430±219 Gy·cm2. The mean contrast volume was 129±45 mL. The total number of TVs was 64; 5 TVs in 9 patients, 6 in 2 patients, and 7 in 1 patient. Technical success was achieved in all cases. The mean intensive care unit stay was 6±5 days, and the mean total hospital stay was 14±10 days. One patient died early (30-day). Early morbidities included respiratory complication in 1 patient, renal insufficiency in 1 patient, and wound infection in 2 patients. No spinal cord ischemia, stroke, or bowel ischemia occurred. Early computed tomography angiography showed 100% patency of the bridging covered stents and TVs. The mean follow-up was 13±4.3 months. No mortality or adverse major event occurred during the follow-up. Two patients with developed type Ic endoleak related to 1 right renal artery and 1 celiac artery covered stent. Patency of the TVs during follow-up was 100%. Conclusion: The use of F/B-EVAR for the treatment of TAAA with more than 4 TVs due to renovisceral arterial anatomical variations in our own experience is feasible and not related to increased morbidity and mortality.

Surgical approaches in juxtarenal and pararenal aortic aneurysms repair.

In this study, surgical tactic features and juxtarenal and pararenal treatment immediate results were analyzed depending on the use of various surgical approaches. Between 2015 and 2019, a total of 89 patients received surgical treatment, of which 52(58%) had juxtarenal aneurysms and 37 (42%) - pararenal aneurysms. During repairs, three types of surgical approaches were used: midline laparotomy, extended retroperitoneal approach and thoraco-phreno-retroperitoneal approach. The patients were divided into three groups accordingly. At the immediate postoperative period, mortality rate equaled 2 (2.2%). The reasons were pulmonary embolism and sepsis. Statistically reliable data were obtained, confirming the advantages of midline laparotomic approach over the lateral retroperitoneal ones, which consisted in a shorter operative time, less pronounced pain syndrome, lesser blood loss, fewer postoperative days. The disadvantages were that enteroparesis occurred more often when the midline laparotomy was used in comparison to extended retroperitoneal or thoraco-phrenoretroperitoneal approaches. Thus, open repairs of juxtarenal and pararenal aortic aneurysms have some specific technical and strategical features which are associated with intraoperative renal ischemia. During open surgical intervention, it is important to first consider the possibility of repair with midline laparotomy. However, lateral retroperitoneal approaches can also be used on a case-by-case basis noting their advantages and disadvantages.

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

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

Preliminary Results of Gore Viabahn Balloon-Expandable Endoprosthesis in Visceral and Renal Arteries of Patients Treated With Branched or Fenestrated Endografts for Complex Aortic Aneurysmal Disease

The objective was to retrospectively evaluate perioperative and midterm results of Gore Viabahn balloon-expandable endoprosthesis (VBX; W. L. Gore & Associates, Flagstaff, Ariz) as a visceral bridging stent in fenestrated and branched procedures. From January 2007 to December 2019, 127 fenestrated and branched endovascular aneurysm repairs for complex aortic disease were performed and 460 visceral vessels were included in the repair (3.6 vessels per patient). Data concerning such interventions were prospectively recorded in a certified institutional registry. A retrospective analysis of the registry was performed, and 103 visceral vessels treated with Gore VBX in 28 patients between July 2018 and December 2019 were found. Perioperative results were analyzed in terms of technical success, VBX-related adjunctive procedures, 30-day patency, and reinterventions. The follow-up program consisted of a computed tomography angiography scan at 1 month and yearly thereafter and duplex ultrasound examination at 3 months and every 6 months thereafter. Follow-up results were analyzed in terms of bridging stent-related patency, complications, and reinterventions. The indication for intervention was a thoracoabdominal aneurysm in 18 cases, a juxtarenal dilation in 5 patients, a pararenal aneurysm in 3 patients, a proximal para-anastomotic aneurysm after open aortic reconstruction in 1 case, and a short-neck (<5 mm) aneurysm in another patient. All patients underwent an elective intervention. In 19 cases, a fenestrated graft was placed, and in 4, a branched graft; in the remaining 5 cases, a combination of both fenestrations and branches was the configuration of choice. Overall, 55 renal arteries, 25 superior mesenteric arteries, and 23 celiac trunks were treated with Gore VBX. Technical success was 100%. Additional stent placement into a target visceral vessel to extend the distal landing zone was required in five vessels (4.9%). The asymptomatic occlusion (1/103 [0.9%]) of the VBX for a celiac trunk affected by subocclusive stenosis preoperatively was recorded 20 days after the procedure and was left untreated. No perioperative reinterventions were performed. Median duration of follow-up was 4.4 months (range, 1-14 months); no occlusion was documented. Reintervention rate was 0.9% (1/103); a type IC endoleak from a celiac trunk was diagnosed 3 months after the procedure and was treated with distal placement of another VBX stent graft into the celiac trunk, with complete resolution of the endoleak. In our experience of 103 target visceral vessels, the Gore VBX stent graft guaranteed satisfying perioperative results, providing optimal delivery and adaptability into target vessels. Further investigation is needed to evaluate follow-up results, especially in terms of resistance to the continuous aortic remodeling and the pinching load related to vessel pulsatility.

The Influence of Three-Dimensionally Printed Aortic Models on the Evolution of Physician-Modified Stent Grafts for the Urgent Treatment of Thoracoabdominal and Juxtarenal Aortic Diseases

The objective was to describe the outcomes of high-risk patients with anatomy unsuitable for commercially available stent grafts who underwent fenestrated endovascular aneurysm repair of symptomatic or contained rupture of pararenal aneurysms (PRAs) or thoracoabdominal aortic aneurysms (TAAAs) using physician-modified stent grafts (PMSGs) planned on both three-dimensional (3D) image analysis software and 3D printed aortic models (3DAMs).

Impact of Intentional Coverage of Accessory Renal Arteries on Renal Function Among Patients Treated by Fenestrated-Branched Endografts

The objective of this study was to evaluate the impact of intentional accessory renal artery (ARA) coverage on renal function after fenestrated-branched endovascular aneurysm repair (F-BEVAR) for pararenal aneurysm or thoracoabdominal aortic aneurysm (TAAA). We analyzed the clinical data of 289 patients enrolled in a prospectively nonrandomized study to evaluate outcomes of F-BEVAR between 2013 and 2018. Thirty-two patients with solitary kidneys were excluded. Outcomes were analyzed in patients with intentional ARA coverage and controls who had preservation of all renal arteries, including patients with no ARAs and those who had preservation of ARAs. Acute kidney injury (AKI) was defined by RIFLE criteria (Risk, Injury, Failure, Loss of kidney function, and End-stage renal disease), and renal function deterioration (RFD) was determined by >30% decline in estimated glomerular filtration rate. End points included 30-day mortality and major adverse events, AKI, and freedom from RFD. There were 257 patients (183 male; mean age, 75 ± 8 years) included in the study, 51 (20%) with ARA coverage (Ø = 2.6 ± 0.7 mm) and 206 controls (13 with ARA preservation; Ø = 3.5 ± 0.5 mm). There were no differences in demographics, cardiovascular risk factors, and aneurysm extent. Technical success was achieved in all patients with ARA coverage and in 99% of controls (P = 1.0). Neither of the two technical failures was attributed to the ARA incorporation. There were two (1%) deaths within 30 days, both among controls. Patients with ARA coverage had more major adverse events (35% vs 22%; P = .04) due to higher incidence of AKI (22% vs 10%; P = .03). None of the 13 patients who had ARA preservation developed AKI. Mean follow-up was 18 ± 15 months. At 3 years, there was no significant difference in freedom from RFD for ARA coverage and controls (65% ± 9% vs 73% ± 5%; P = .08), respectively. By multivariate analysis, ARA coverage (odds ratio [OR], 2.4; P = .03) was a predictor for AKI, and renal reintervention for stenosis (OR, 2.7; P = .007), extent II TAAA (OR, 3.3; P = .001), and postprocedure AKI (OR, 5.0; P < .001) were predictors for RFD. Intentional ARA covered during F-BEVAR was associated with twofold higher incidence of AKI, with a nonsignificant trend toward lower freedom from RFD. Factors associated with RFD included renal reinterventions for stenosis, extent II TAAA, and postprocedure AKI. Incorporation of ARAs during F-BEVAR, when technically feasible, may help decrease risk of AKI.

Learning curve of fenestrated and branched endovascular aortic repair for pararenal and thoracoabdominal aneurysms

ObjectiveThe objective of this study was to review the learning curve for fenestrated-branched endovascular aortic repair (F-BEVAR) of pararenal and thoracoabdominal aortic aneurysms (TAAAs). MethodsWe reviewed the clinical data of 334 consecutive patients (255 males, mean age 75 ± 7 years) who underwent F-BEVAR between 2007 and 2016 in a single institution. Outcomes were analyzed in four quartiles of experience (Q1-Q4). Study outcomes included trends in patient characteristics, device design, procedural variables, 30-day mortality, and major adverse events (MAEs). ResultsThere were 178 patients (53%) treated for pararenal aneurysms and 156 (47%) for TAAAs. During the study period, there was a statistically significant increase in the proportion of TAAAs and in the number of vessels incorporated. Despite this, there was a steady decrease in 30-day mortality (6% in Q1 to 0% in Q4; P < .04) and in the rate of MAEs (60% in Q1 to 29% in Q4; P<.001). By linear regression analysis, there was significant decline in estimated blood loss (1358 ± 1517 mL in Q1 to 486 ± 520 mL in Q4; P < .001), total operating time (325 ± 116 minutes in Q1 to 248 ± 92 minutes in Q4; P < .001), total fluoroscopy time (121 ± 59 minutes in Q1 to 85 ± 39 minutes in Q4; P < .001), contrast volume (201 ± 92 mL in Q1 to 160 ± 61 mL in Q4; P = .002), and radiation dose (4141 ± 2570 mGy in Q2 to 2543 ± 1895 mGy in Q4; P < .001). Independent predictors of MAEs were total operating time (odds ratio [OR], 1.6; 95% confidence interval [CI], 1.3-1.8; P < .001), Society for Vascular Surgery total score (OR, 1.1; 95% CI, 1.02-1.2; P = .009), and quartile 1 (OR, 3.0; 95% CI, 1.7-5.2; P < .001). ConclusionsThis study demonstrates significant improvement in perioperative mortality, MAEs, procedural variables, and secondary interventions in patients treated by F-BEVAR, despite the increase in complexity of aneurysm pathology during the study period. Also, better patient selection contributed to improve outcomes.

Outcomes of target vessel endoleaks after fenestrated-branched endovascular aortic repair

ObjectiveThe objective of this study was to determine the incidence rate, outcomes, and risk factors of target vessel-related endoleaks after fenestrated-branched endovascular aortic repair (F-BEVAR) for pararenal aneurysms or thoracoabdominal aortic aneurysms (TAAAs). MethodsWe reviewed consecutive patients treated by F-BEVAR between 2007 and 2017. Target vessel endoleaks were identified by computed tomography angiography (CTA). Follow-up included CTA and duplex ultrasound before discharge, at 2 months, at 6 months, and annually thereafter. Primary endoleaks were detected by predismissal CTA; secondary endoleaks were absent on the first CTA and were identified during follow-up. End points were spontaneous resolution of primary endoleaks, secondary interventions, and aneurysm rupture. Multivariable analyses were performed for risk factors of target vessel endoleaks and predictors of spontaneous resolution. ResultsA total of 382 patients (mean age, 75 ± 8 years; 75% male) underwent F-BEVAR for 195 pararenal aneurysms and 187 TAAAs with 1204 renal-mesenteric arteries targeted by 981 fenestrations and 223 directional branches. Fifty-two target vessel endoleaks were identified in 41 patients; 41 were type IIIC (interattachment), 10 were type IC (distal bridging stent sealing zone), and 1 was type IIIB (bridging stent fabric tear). Thirty-three patients (9%) had primary target vessel endoleaks in 41 target vessels (3%). Eight patients (2%) developed 11 secondary target vessel endoleaks. Directional branches were more prone to primary endoleaks (13/223 [6%]) in comparison to fenestrations (28/981 [3%]; P = .03). However, branch endoleaks resolved more often spontaneously (11/14 [79%]) compared with fenestration endoleaks (14/38 [37%]; P = .008). Other risk factors for target vessel endoleaks included inner aortic diameter ≥30 mm at the target vessel origin, four or more targeted vessels, TAAA (for primary endoleaks), and physician-modified endograft (for secondary endoleaks). Four patients with primary endoleaks underwent successful reintervention before discharge, and 29 were observed with a mean follow-up of 24 ± 21 months. Of the 41 primary endoleaks, 25 resolved spontaneously in 20 patients (61%) at first follow-up with no recurrences. Of the observed endoleaks, 11 persisted in 9 patients, and 8 of those endoleaks were treated in 7 patients. All secondary target vessel endoleaks required reintervention. There was one possible aneurysm rupture attributed to persistent secondary target vessel endoleak. ConclusionsTarget vessel endoleak on CTA at discharge occurs in 1 of 10 patients treated by F-BEVAR. Of these, two-thirds resolve spontaneously, especially those affecting directional branches. Among patients with a persistent endoleak, endovascular reintervention is usually successful and aneurysm rupture is rare.

Long-Term Outcomes of Open Repair and Fenestrated Endografting for Pararenal Aortic Aneurysms in a Concurrent Propensity Adjusted Comparison

Introduction - The choice of the best treatment in case of para-renal aortic aneurysms(p-AAA) is under investigation. Open surgical repair (OSR) still represents the gold standard for treatment, but it is associated to high surgical stress for the patient. Complex endovascular reconstructions with fenestrated endografts (fEVAR) require dedicated materials and specific expertise and are usually reserved to high risk patients. The difference in baseline characteristics of the populations treated with endovascular and open repair might influence short and long-term results. Methods - We performed a multicenter retrospective analysis on p-AAA electively treated with OSR or with fEVAR at three tertiary institutions. Endpoints of the study were the evaluation of perioperative (<30 days) significant morbidity, perioperative and late mortality, early and late reinterventions. Statistical analysis was conducted on the entire population and on a propensity score matched population. Propensity score was constructed on the basis of age, sex, medical history of coronary artery disease and chronic renal failure. Results - Mean age at time of surgery was 73 ± 7 years. Patients in the fEVAR group resulted significantly older than the patients in the OSR group and had more frequently a medical history positive for coronary artery disease and previous stroke. The groups did not significantly differ for any of the other preoperative characteristics. The baseline differences were corrected applying the propensity score method. Patients undergoing OSR resulted at higher risk to develop a perioperative systemic complication (p=.03); specifically, respiratory failure resulted more frequent in the OSR group (p=.02). Early reinterventions were more frequent in the fEVAR group, but the difference did not reach statistical significance. These findings were confirmed in the Propensity adjusted analysis, where also cardiac complications resulted higher in the OSR (p=.02). No difference in terms of peri-operative mortality was confirmed. Long term results showed higher survival and low reintervention rates in the OSR group in the unmatched population, with a small but significant difference in the risk of late visceral artery occlusion-stenosis after fEVAR. After adjustment with the propensity analysis, no differences in terms of late survival were found between the two groups. Conclusion - In selected patients with iuxta- and para-renal aneurysms, endovascular treatment and open repair may afford similar early and 5-year survival. Higher risks of peri-operative systemic complications after open surgery are counter-balanced by higher risks of late visceral vessel patency issues and need of reintervention after fenestrated endografting. Both procedures are safe and effective in the long-term in experienced centers, where single patient evaluation should drive the treatment strategy.

Prospective Assessment of a Protocol using Neuromonitoring, Early Limb Reperfusion and Selective Temporary Aneurysm Sac Perfusion to Prevent Spinal Cord Injury During Fenestrated-branched Endovascular Aortic Repair

Introduction - Spinal cord injury (SCI) is a devastating complication of thoracoabdominal aortic aneurysm (TAAA) repair. The aim of this study was to analyze the outcomes of a standardized protocol using continuous neuromonitoring, lower limb (LL) reperfusion and selective temporary aneurysm sac perfusion (TASP) to prevent SCI in patients undergoing fenestrated-branched endovascular repair (F-BEVAR). Methods - Patients enrolled in a prospective, non-randomized single-center study between 2014 and 2017 underwent a SCI prevention protocol for TAAAs or >5-cm supraceliac coverage, including staged thoracic endovascular aortic repair (TEVAR) for Extent I-II TAAAs, cerebrospinal fluid (CSF) drainage, permissive hypertension (mean arterial pressure [MAP] >80 mmHg), LL reperfusion and neuromonitoring. A >75% decrease in motor evoked (MEP) and somatosensory evoked potential (SSEP) amplitude triggered standardized maneuvers. Selective TASP was indicated in patients with persistent decline or delayed recovery (>10 min) in MEP/SSEPs despite maneuvers. End-points adjudicated by independent clinical event committee and included mortality and rates of immediate and delayed (>6 hours) SCI. Results - SCI prevention protocol was indicated in 166 of 232 patients (72%) treated by F-BEVAR for pararenal aneurysms in 22 patients, Extent IV TAAAs in 59 and Extent I-III TAAAs in 85 (Figure). CSF drainage was successful in 162 patients (98%) and stable neuromonitoring was achieved in all patients. Eighty-eight patients (53%) had changes in neuromonitoring starting 50±37 minutes after introduction of the aortic device. Changes in neuromonitoring improved with maneuvers in all except for 10 patients (11%) who had persistent decline in MEP/SSEPs after LL reperfusion. All 10 patients had TASP by leaving a renal-mesenteric branch or contralateral iliac gate incomplete. There was one 30-day or in-hospital mortality (0.4%) due to a subarachnoid hemorrhage from CSF drainage. Ten patients (4%) developed SCIs, including 6 paraplegia and 4 paraparesis. SCIs were immediate in 4 and delayed in 6 with an incidence of 1% for pararenal, 0% for Extent IV, 13% for Extent III and 10% for Extent I-II TAAAs. The probable cause of SCI was hemodynamic compromise in 6 patients, embolic in 2 and epidural hematoma in 2. SCIs occurred in 1/78 patients (1%) with normal neuromonitoring and in 9/88 patients (10%) who had decline in MEP/SSEPs (P=0.02). Among the 10 patients with TASP, neurologic exam was normal in 8 and showed SCI in 2. TASP closure was completed in all patients at 22±16 days, with one SCI 2 days after completion. All 3 patients with post-TASP SCI had complete recovery to ambulatory status. Overall, 2 patients (1%) had permanent paraplegia, which was immediate and probably embolic in both. Factors associated with SCI included extent I-III TAAAs, change in neuromonitoring and need for TASP. Conclusion - This prospective non-randomized study showed that a standardized protocol was associated with low rate of permanent paraplegia (1%). The predominance of SCIs among patients with Extent I-III TAAAs confirms that this protocol may be avoided in lower risk patients (e.g. pararenal and Extent IV TAAAs) due to potential risk of spinal and cerebral hemorrhagic complications from CSF drainage. Although TASP does not completely prevent SCI, it may optimize recovery to ambulatory status. Further investigation is needed to evaluate the benefits of TASP to prevent permanent paraplegia.

Impact of Renal Function on Early and Late Survival After Endovascular Thoracoabdominal and Pararenal Aortic Aneurysm Repair

Renal dysfunction can be a prohibitive risk for open repair of complex thoracoabdominal aortic aneurysms (TAAAs) and pararenal aneurysms (PRAs). However, the impact of renal dysfunction from branched/fenestrated aneurysm repair (B-FEVAR) on outcomes is poorly defined. The objective was to review the association of renal function with early and long-term mortality after B-FEVAR. This study reviewed the clinical data of consecutive patients enrolled in a prospective nonrandomized study to investigate B-FEVAR for PRAs and TAAAs at a single institution with 1-year follow up (2013-2017). Patients were categorized by preoperative chronic kidney disease (CKD) classification, and early and long-term mortality was assessed. During the study interval, 231 patients underwent B-FEVAR, including 80 PRAs, 89 type I to type III TAAAs, and 62 type IV TAAAs. Mean age was 74.6 years (standard deviation, 6.7 years), and 71% were male. There were 126 CKD stage 1/2 patients, 96 CKD stage 3 patients, and 9 CKD stage 4/5 patients (all with baseline creatinine concentration >2.0 mg/dL). No patients were on dialysis at time of procedure. Patients with CKD stage 4/5 had similar demographics to those with normal renal function but had slightly larger aneurysms (6.5 vs 7 cm; P = .15). Early 30-day mortality was 1.35% (n = 3) for those with CKD stage 1 to stage 3 vs 0% in CKD stage 4/5 (P = .73). Similarly, 1-year survival was similar (95% vs 88%; log-rank, P = .98) for CKD stage 1 to stage 3 patients vs CKD stage 4/5 patients, respectively. Median follow-up time was 2.6 years (interquartile range, 1.5-3.7 years). Two CKD stage 4/5 patients died in follow-up. CKD stage 4/5 patients had similar survival during follow-up (hazard ratio, 1.02; 95% confidence interval, 0.2-4.2). Although it was a small sample size for evaluation, selected patients with CKD stage 4/5 may have similar short- and long-term mortality to that of patients with normal/moderate renal dysfunction after B-FEVAR. Although it is a major contraindication to open repair, renal dysfunction may not be as prohibitive for endovascular repair in well-selected patients.

SS23. Outcome of an Off-the-Shelf Device for Treating Juxtarenal Aneurysm: Lessons From the Ventana Trial

Treatment of juxtarenal and short-neck infrarenal aneurysms can be successfully performed with fenestrated endografts. Our objective in this report was to summarize an initial experience with an “off-the-shelf” fenestrated technology and to inform vascular specialists about the outcomes for these patients following a decision to halt enrollment in the trial related to concerns regarding endograft performance. There were 125 patients treated at 27 institutions as part of an initial feasibility and pivotal trial designed to assess the safety, feasibility, and performance of an endograft designed to treat juxtarenal and pararenal aneurysms without the need for patient-specific customization of the endograft. Patient anatomy was not amenable to therapy with standard infrarenal endografts and was assessed by a core laboratory and independent physician for appropriateness of application of this novel technology. Patients were assessed in the hospital and at 1 month, 6 months, and 12 months and annually thereafter with computed tomography and physical examination, with core laboratory evaluation of imaging studies for assessment of renal artery status, device integrity, endoleak, device migration, and aneurysm size and morphology. Early data with this graft revealed a high rate of technical success (98%) and low perioperative mortality (1%) and renal failure (4.8%). Procedural technical success was 97%. Mean follow-up is now 42.9 months for patients in pilot and feasibility trials outside the United States and 39.8 months for those patients enrolled in the pivotal trial in the United States. Whereas freedom from rupture has been high both outside the United States and in the United States, reintervention has been necessary for renal issues (29% in the United States, 21% outside the United States) and endoleak (9.2% in the United States, 25% outside the United States) at a rate higher than anticipated. Aneurysm-related death has occurred in three patients (2.4%) during follow-up. Off-the-shelf technology with early cannulation of the renal arteries and single-system deployment for delivery of aortic and branch devices allows simple, quick device deployment. However, long-term success of this type of device will require significant modifications to the system to allow reduced need for secondary intervention and improved long-term device performance.

IFT16. Long-term Outcomes of Visceral and Renal Arteries in Patients Treated With Branched/Fenestrated Endografts for Complex Abdominal Aortic Aneurysms

To retrospectively analyze perioperative and late Results of branched and fenestrated endografts implanted in patients with complex abdominal aortic aneurysms (AAA), paying particular attention to the long-term outcomes of stented visceral and renal arteries From January 2007 to August 2018, 953 endovascular repairs of AAA were performed. Data concerning these interventions were prospectively recorded in a certified institutional registry. A retrospective analysis of the registry was performed and 100 interventions performed for complex (thoracoabdominal, pararenal and juxtarenal) AAA were found. Perioperative analyzed. Follow-up program consisted of duplex ultrasound examination at 1 month and every 6 months and of angiocomputed tomography scan at 1 month and yearly thereafter. Follow-up Results were analyzed with Kaplan-Meier curves in terms of survival, freedom from AAA-related complications and reinterventions. Primary and secondary patency of the stented visceral and renal arteries were assessed. The indication for the intervention was a proximal para-anastomotic aneurysm following open aortic reconstruction in eight cases. Among the remaining 92 patients, 47 had a thoracoabdominal aneurysm, 34 a pararenal aneurysm and 11 a juxtarenal one. All but three patients had an elective intervention. In 58 cases, a fenestrated graft was placed, whereas in 17 cases a branched graft was used; 25 patients had both fenestrations and branches. Overall, 359 renal and visceral vessels were treated: 193 renal arteries, 94 superior mesenteric arteries and 72 celiac trunks. The technical success rate was 99%. Perioperative mortality was 4%; eight perioperative reinterventions were required. The overall complication rate was 21%, with nine cases of spinal cord ischemia, leading to paraplegia in four cases. Median duration of follow-up was 38 months (range, 1-98 months); all the patients who survived the intervention were followed-up. Estimated 5-year survival was 68.5% (standard error [SE], 0.05); there were neither ruptures nor conversions to open surgery. Freedom from reintervention at 5 years was 84.5% (SE, 0.05). Complications at the visceral and renal arteries occurred in five patients, in three cases requiring a reintervention: one acute thrombosis of both renal and visceral arteries, treated with thrombolysis, one thrombosis and one symptomatic stenosis of a renal artery, both treated with adjunctive stenting. Two patients with asymptomatic renal and mesenteric thrombosis were medically managed. The estimated 5-year primary and secondary patency rates were 85% (SE ,0.05) and 98.8% (SE, 0.06), respectively Late complications of the visceral and renal arteries following endovascular treatment of complex AAA are rare and they can be safely managed with endovascular means.

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

ObjectiveThe 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). MethodsWe 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. ResultsThere 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. ConclusionsChoice 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.

Impact of onlay fusion and cone beam computed tomography on radiation exposure and technical assessment of fenestrated-branched endovascular aortic repair

ObjectiveThe objective of this study was to analyze the impact of advanced imaging applications and cone beam computed tomography (CBCT) on radiation exposure of the patient and operator and detection of technical problems during fenestrated-branched endovascular aortic repair (F-BEVAR) for treatment of pararenal aneurysms and thoracoabdominal aortic aneurysms (TAAAs). MethodsWe reviewed the clinical data of 386 consecutives patients (289 male; mean age, 75 ± 8 years) treated by F-BEVAR for 196 pararenal aneurysms and 190 TAAAs (mean, 3.4 ± 0.9 targeted vessels/patient) between 2007 and 2017. Radiation exposure (cumulative air kerma) was analyzed in three fixed imaging systems used between 2007 and 2011 (system 1), 2012 and 2016 (system 2), and 2016 and 2017 (system 3). Onlay fusion and CBCT were available with systems 2 and 3, whereas digital zoom with fusion overlay was used with system 3. Operator effective dose was measured per month using a radiation dosimeter badge. Computed tomography angiography and CBCT were analyzed for findings requiring immediate revision or secondary interventions. End points were patient radiation exposure; operator effective dose; procedure technical success; and 30-day rates of mortality, major adverse events, and secondary interventions. ResultsF-BEVAR was performed using system 1 in 98 patients, system 2 in 198 patients, and system 3 in 90 patients. Use of onlay fusion/CBCT was 0% with system 1, 42% with system 2, and 98% with system 3. Procedures performed with onlay fusion/CBCT had significantly (P < .05) higher technical success (99.4% vs 98.8%) and lower contrast material volume (155 ± 58 mL vs 172 ± 80 mL), fluoroscopy time (83 ± 34 minutes vs 94 ± 49 minutes), and cumulative air kerma (2561 ± 1920 mGy vs 3767 ± 2307 mGy). Despite higher case volume and increasing complexity during the experience, operator effective dose decreased to 9 ± 4 × 10−2 mSv/case with system 3 compared with 26 ± 3 × 10−2 mSv/case with system 1 and 20 ± 2 × 10−2 mSv/case with system 2 (P = .001). Among 219 patients who had no CBCT, 18 (8%) had computed tomography angiography findings that prompted secondary interventions before dismissal. Conversely, among 167 patients who had CBCT, 14 patients (8%) had intraoperative CBCT findings requiring immediate revision, with no additional secondary interventions. Patients treated with onlay fusion/CBCT had significantly (P < .05) lower mortality (4% vs 1%), major adverse events (43% vs 19%), and secondary interventions (10% vs 4%) at 30 days. ConclusionsRadiation exposure and operator effective dose significantly decreased with evolution of F-BEVAR experience and use of advanced imaging applications such as onlay fusion and CBCT. CBCT allowed immediate assessment and identified intraoperative technical problems, leading to immediate revision and avoiding early secondary interventions.

Risk factors for early and late mortality after fenestrated and branched endovascular repair of complex aneurysms

BackgroundThe objective of this study was to evaluate outcomes after fenestrated and branched endovascular aneurysm repair (F-BEVAR) performed in high-risk patients to treat pararenal (PR) aneurysms and thoracoabdominal aortic aneurysms (TAAAs) and to identify those patients likely to benefit from this treatment. MethodsA prospective single-center review of patients treated electively for PR aneurysm and TAAA using F-BEVAR between 2004 and 2016 was performed. Survival was estimated using the Kaplan-Meier method. Risk factors associated with 30-day morbidity and mortality during follow-up were determined using multivariate statistical techniques and a Cox regression model including all variables that were significant on univariate analysis (P < .05). ResultsThere were 468 patients (median age, 71.6 years) identified, with American Society of Anesthesiologists score ≥3 in 94.7%. There were 221 (47.2%) type I to type III TAAAs and 247 (52.8%) type IV and type V TAAAs and PR aneurysms, with a median diameter of 58 mm. Technical success for target vessel stenting was 99.1% (1493/1506). The 30-day mortality rate was 4.9% (23 patients). The spinal cord ischemia rate was 3.8% (18 patients). Twenty patients (4.3%) required postoperative dialysis and four patients (0.8%) long-term dialysis after discharge. Median follow-up was 29 months. Survival at 1 year, 3 years, and 5 years was 86.7% (95% confidence interval [CI], 83.1-89.6), 73.3% (95% CI, 68.3-77.6), and 59.6% (95% CI, 53.4-65.2), respectively. Freedom from any target vessel occlusion and freedom from secondary procedures were 96.2% (95% CI, 93.8-97.7) and 88.2% (95% CI, 84.8-90.9) at 1 year and 90.0% (95% CI, 84.5-91.9) and 70.2% (95% CI, 63.9-75.6) at 5 years, respectively. In multivariate analysis, early mortality was associated with procedure time (hazard ratio [HR], 1.007 per minute; 95% CI, 1.003-1.010; P < .001), TAAA preoperative diameter (HR, 1.053 per millimeter; 95% CI, 1.020-1.087; P = .001), and chronic kidney disease (HR, 3.139; 95% CI, 1.369-7.196; P = .007). Mortality during the first 24 months of follow-up was associated with Crawford types I to III (HR, 1.526; 95% CI, 1.061-2.196; P = .023) compared with infradiaphragmatic repairs, chronic kidney disease (HR, 1.874; 95% CI, 1.294-2.712; P < .001), and TAAA preoperative diameter (HR, 1.027 per millimeter; 95% CI, 1.010-1.044; P = .002). In addition to these risk factors, mortality after 24 months of follow-up was also associated with age at repair (HR, 1.055 per year; 95% CI, 1.021-1.090; P = .001). ConclusionsF-BEVAR performed in high-risk patients is associated with favorable outcomes. Judicious selection of patients should take into consideration the reported risk factors associated with early and late mortality.