Fenestrated-branched Endovascular Aneurysm Repair Research Articles

Fabric Tears and Type IIIb Endoleaks After Fenestrated-Branched Endovascular Aortic Aneurysm Repair

Type IIIb endoleaks from fabric tears after fenestrated-branched endovascular aortic aneurysm repair (F-BEVAR) are rare. The aim of this study was to evaluate patients who had undergone F-BEVAR with investigational devices between 2015 and 2021 in our institution. A total of 268 patients who had undergone F-BEVAR between 2015 and 2021 were analyzed. All patients with type IIIb endoleaks were included in the data collection. The end points were presentation of type IIIb endoleaks and secondary interventions. Three patients had developed type IIIb endoleaks (2 women and 1 man; mean age, 75 years). The first patient was a 74-year-old woman who had undergone F-BEVAR for a thoracoabdominal aortic aneurysm with a device with two branches and two fenestrations. The 4-year postoperative computed tomography angiography (CTA) demonstrated an endoleak behind the branches, which was confirmed to be a fabric tear using dynamic volumetric CTA (Fig 1, A). The patient underwent successful redo F-BEVAR. The second patient was a 74-year-old woman who had undergone branched repair with a device with four branches and an inverted limb bifurcated device after failed endovascular repair. On the 30-day follow-up CTA, an endoleak of indeterminate origin was detected. Further imaging studies, including CTA, dynamic volumetric CTA, and diagnostic angiography confirmed a tear in the graft posterior to a renal branch (Fig 1, B). A redo branched repair was successfully performed. The last patient was a 78-year-old man who had undergone four-vessel F-BEVAR with an inverted limb custom-made device after failed endovascular repair. On the 30-day follow-up visit, a type IIIb endoleak around the crutch of the inverted limb device was identified by CTA, contrast-enhanced ultrasound, and color-Doppler ultrasound (Fig 2). The defect was excluded with an iliac limb extension. Technical success of the reinterventions was 100%, with no deaths. Sac growth before reintervention was identified in all three patients. The mean follow-up was 30 months. Endoleak development had occurred at an average of 17 months after the index operation. The overall frequency of type IIIb endoleaks in our series was 1.1%. Type IIIb endoleaks after F-BEVAR are rare. The management of these cases is technically challenging. Proper multimodality imaging and redo F-BEVAR are crucial for the proper diagnosis and treatment of this rare complication.Fig 2Endoleak around the crutch of inverted limb custom-made device.View Large Image Figure ViewerDownload Hi-res image Download (PPT)

Spinal Cord Ischemia After Thoracoabdominal Aortic Aneurysms Endovascular Repair: From the Italian Multicenter Fenestrated/Branched Endovascular Aneurysm Repair Registry

Purpose: The aim of this study is to report an Italian multicenter experience analyzing the incidence and the risk factors associated with spinal cord ischemia (SCI) in a large cohort of thoracoabdominal aortic aneurysms (TAAAs) treated by fenestrated-branched endovascular aneurysm repair (F-/B-EVAR). Materials and Methods: All consecutive patients undergoing F-/B-EVAR in 4 Italian university centers between 2008 and 2019 were prospectively recorded and retrospectively analyzed. Spinal cord ischemia, 30 day/in-hospital adverse events, and mortality were assessed as early outcomes. Risk factors for SCI were determined by multivariable analysis. Results: A total of 351 patients received F-/B-EVAR for a TAAA. Twenty-eight (8.0%) patients died within 30 postoperative days or during the hospitalization. Regarding SCI, 47 patients (13.4%) developed neurological symptoms related to spinal cord impaired perfusion. Among them, 17 (4.8%) had a major permanent impairment. The multivariable analysis identified that SCI was associated with Crawford extent I to III (odds ratio [OR]: 20.90, p=0.004, 95% confidence interval [CI]=2.69–162.57), and with endovascular procedures performed for ruptured TAAA (OR: 5.74, p=0.010, 95% CI=1.53–21.57). Spinal cord ischemia was also significantly associated with a grade 3 bleeding during the visceral stage (OR: 4.34, p=0.005, 95% CI=1.55–12.16) and a grade 2 renal insufficiency at 30 days (OR: 7.45, p=0.002, 95% CI=2.12–26.18). Conclusion: The present study indicates that SCI is still an open issue after extent I to III TAAA endovascular repair, while its incidence in extent IV TAAA and pararenal/juxtarenal aneurysms is rare. Thoracoabdominal aortic aneurysms extension, urgent TAAA repair for rupture, severe bleeding, and 30 day renal insufficiency have been identified as significant risk factors for SCI. In the presence of such factors, adjunctive strategies may be considered to reduce SCI rates, while in low-risk patients invasive or potentially-risky maneuvers might not be justified.

Perioperative neurologic outcomes of right versus left upper extremity access for fenestrated-branched endovascular aortic aneurysm repair

ObjectiveUpper extremity (UE) access is frequently used for fenestrated-branched endovascular aortic aneurysm repair (F-BEVAR), particularly for complex repairs. Traditionally, left-side UE access has been used to avoid crossing the arch and the origin of the supra-aortic vessels, which could potentially result in cerebral embolization and an increased risk of perioperative cerebrovascular events. More recently, right UE has been more frequently used as it is more convenient and ergonomic. The purpose of this study was to assess the outcomes and cerebrovascular events after F-BEVAR with the use of right- vs left-side UE access. MethodsDuring an 8-year period, 453 patients (71% male) underwent F-BEVAR at a single institution. UE access was used in more complex repairs. Left UE access was favored in the past, whereas right UE access is currently the preferred UE access side. Brachial artery cutdown was used in all patients for the placement of a 12F sheath. Outcomes were compared between patients undergoing right vs left UE access. End points included cerebrovascular events, perioperative mortality, technical success, and local access-related complications. ResultsUE access was used in 361 (80%) patients. The right side was used in 232 (64%) and the left side in 129 (36%) patients for the treatment of 88 (25%) juxtarenal, 135 (38%) suprarenal, and 137 (38%) thoracoabdominal aortic aneurysms. Most procedures were elective (94%). Technical success was achieved in 354 patients (98%). In-patient or 30-day mortality was 3.3%. Five (1%) perioperative strokes occurred in patients undergoing right UE access, of which three were ischemic and two were hemorrhagic. No transient ischemic attacks occurred perioperatively. Two hemorrhagic strokes were associated with permissive hypertension to prevent spinal cord ischemia. No perioperative strokes occurred in patients undergoing left UE access (P = .16). Overall, perioperative strokes occurred with similar frequency in patients undergoing UE (5, 1%) and femoral access only (1, 1%) (P = .99). Arm access-related complications occurred in 15 (5%) patients, 11 (4.8%) on the right side and 4 (6%) on the left side (P = .74). ConclusionsRight UE access can be used for F-BEVAR with low morbidity and minimal risk of perioperative ischemic stroke or transient ischemic attacks. In general, UE access is not associated with an increased risk of perioperative stroke compared with femoral access only. Tight blood pressure control is, however, critical to avoid intracranial bleeding related to uncontrolled hypertension.

Endovascular repair of intercostal and visceral aortic patch aneurysms following open thoracoabdominal aortic aneurysm repair

PurposeReoperative open surgical repair (OSR) of thoracoabdominal aortic aneurysms (TAAAs) is associated with high morbidity and mortality. The aim of this study was to analyze outcomes of fenestrated–branched endovascular aneurysm repair (F-BEVAR) for the treatment of intercostal or visceral aortic patch aneurysms after OSR of TAAAs. MethodsWe reviewed the clinical data and outcomes of consecutive patients treated at 8 academic centers by F-BEVAR for visceral and intercostal aortic patch aneurysms after OSR of TAAAs (2011-2019). All patients had involvement of at least one target vessel requiring incorporation by a fenestration or directional branch. End points were technical success, 30-day and/in-hospital mortality, major adverse events, patient survival, target vessel patency/instability, and freedom from reintervention. ResultsThere were 29 patients with a median age of 70 (interquartile range, 63-74) years. Seven patients (24%) had connective tissue disorders. Technical success was 100%. There were no 30-day/in-hospital mortalities. Major adverse events occurred in 5 patients (17%), including estimated blood loss >1 L in 3 patients (10%), acute kidney injury and respiratory failure in 2 patients (7%) each, and transient paraparesis in 1 patient (3%). Median follow-up was 14 (interquartile range, 7-37) months. At 2 years, primary and secondary patency, freedom from target artery instability, freedom from reintervention, and patient survival were 95%, 100%, 83%, 61%, and 96%, respectively. ConclusionsF-BEVAR could be considered as an alternative to reoperative OSR in patients with visceral or intercostal aortic patch aneurysms. This series showed no mortality and a low rate of major adverse events, but a significant need for reintervention.

Sex-related outcomes after fenestrated-branched endovascular aneurysm repair for thoracoabdominal aortic aneurysms in the U.S. Fenestrated and Branched Aortic Research Consortium

ObjectiveFenestrated-branched endovascular aneurysm repair (FBEVAR) has expanded the treatment of patients with thoracoabdominal aortic aneurysms (TAAAs). Previous studies have demonstrated that women are less likely to be treated with standard infrarenal endovascular aneurysm repair because of anatomic ineligibility and experience greater mortality after both infrarenal and thoracic aortic aneurysm repair. The purpose of the present study was to describe the sex-related outcomes after FBEVAR for treatment of TAAAs. MethodsThe data from 886 patients with extent I to IV TAAAs (excluding pararenal or juxtarenal aneurysms), enrolled in eight prospective, physician-sponsored, investigational device exemption studies from 2013 to 2019, were analyzed. All data were collected prospectively, audited and adjudicated by clinical events committees and/or data safety monitoring boards, and subject to Food and Drug Administration oversight. All the patients had been treated with Cook-manufactured patient-specific FBEVAR devices or the Cook t-Branch off-the-shelf device (Cook Medical, Brisbane, Australia). ResultsOf the 886 patients who underwent FBEVAR, 288 (33%) were women. The women had more extensive aneurysms and a greater prevalence of diabetes (33% vs 26%; P = .043) but a lower prevalence of coronary artery disease (33% vs 52%; P < .0001) and previous infrarenal endovascular aneurysm repair (7.6% vs 16%; P < .001). The women had required a longer operative time from incision to surgery end (5.0 ± 1.8 hours vs 4.6 ± 1.7 hours; P < .001), experienced lower technical success (93% vs 98%; P = .002), and were less likely to be discharged to home (72% vs 83%; P = .009). Despite the smaller access vessels, the women did not have an increased incidence of access site complications. Also, the 30-day outcomes were broadly similar between the sexes. At 1 year, no differences were found between the women and men in freedom from type I or III endoleak (91.4% vs 92.0%; P = .64), freedom from reintervention (81.7% vs 85.3%; P = .10), target vessel instability (87.5% vs 89.2%; P = .31), and survival (89.6% vs 91.7%; P = .26). The women had a greater incidence of postoperative sac expansion (12% vs 6.5%; P = .006). Multivariable modeling adjusted for age, aneurysm extent, aneurysm size, urgent procedure, and renal function showed that patient sex was not an independent predictor of survival (hazard ratio, 0.83; 95% confidence interval, 0.50-1.37; P = .46). ConclusionsWomen undergoing FBEVAR demonstrated metrics of increased complexity and had a lower level of technical success, especially those with extensive aneurysms. Compared with the men, the women had similar 30-day mortality and 1-year outcomes, with the exception of an increased incidence of sac expansion. These data have demonstrated that FBEVAR is safe and effective for women and men but that further efforts to improve outcome parity are indicated.

Effect of aortic angulation on the outcomes of fenestrated-branched endovascular aortic repair

ObjectiveTo investigate the effect of aortic angulation on the early and midterm outcomes of fenestrated-branched endovascular aneurysm repair for thoracoabdominal aortic aneurysms (TAAA) or pararenal aortic aneurysms (PRAA). MethodsWe retrospectively reviewed the data of consecutive patients enrolled in a prospective nonrandomized physician-sponsored investigational device exemption study (2013-2018). The infrarenal, suprarenal, and supraceliac aortic angles were measured on three-dimensional reconstructions of the preoperative computed tomography angiogram; a 45° cutoff was used for the analysis. End points were technical success, freedom from endograft-related complications (defined by type IA/IB/IIIA/IIIB/IIID endoleaks, and limb thrombosis); and freedom from target vessel instability (defined by branch-related death, occlusion, rupture or reintervention for stenosis, endoleak, or disconnection). Cox proportional hazard multivariable regression analyses were preformed to assess impact of covariates. ResultsThere were 298 patients treated for 102 PRAAs (34%) and 196 TAAAs (66%) (78 extent IV, 118 extent I-III) with 1156 renal-mesenteric vessels incorporated. An angulation of >45° was present in the infrarenal aortic axis in 94 patients (32%), suprarenal axis in 39 (13%), and supraceliac axis in 93 (31%). A supraceliac angle of >45° was more common with extent I-III TAAAs (P = .01). Technical success was 97% and was not significantly related to aortic angulation; the total operating time and fluoroscopy time were significantly longer in patients with any aortic angulation of >45°. Freedom from endograft-related complications was 93% (95% confidence interval [CI], 90%-97%) at 42 months, and was not associated with infrarenal (HR, 1.0; 95% CI, 0.4-2.9; P = .976), suprarenal (HR, 1.7; 95% CI, 0.5-1.8; P = .428), or supraceliac (HR, 0.9; 95% CI, 0.3-2.6; P = .886) aortic angles of >45°. Overall freedom from target vessel instability was 92% (95% CI, 90%-94%) at 42 months. By multivariable analysis, target vessel instability was not affected by an infrarenal angle of >45° (HR, 1.5; 95% CI, 0.9-2.4; P = .135) and a supraceliac angle of >45° (HR, 0.9; 95% CI, 0.5-1.5; P = .627), but was associated with a suprarenal angle of >45° (HR, 5.6; 95% CI, 3.5-9.1; P < .001), even after adjustment for aneurysm extent and type of bridging stent. In this subgroup of patients, the use of directional branch vs fenestration (P = .10) and the type of bridging stent (P = .10) did not significantly impact target vessel instability. ConclusionsFenestrated-branched endovascular aneurysm repair can achieve excellent early and midterm results among patients with an aortic angulation of >45°, with no increase in rates of graft-related complications. However, increased aortic angulation was associated with longer operative and fluoroscopy times. The suprarenal aortic angle was the most important determinant of more target vessel events, independent of stent design or which bridging stent was selected.

Effect of celiac axis compression on target vessel-related outcomes during fenestrated-branched endovascular aortic repair

ObjectiveTo report the effect of median arcuate ligament (MAL) compression on outcomes and technical aspects of celiac artery (CA) stenting during fenestrated-branched endovascular aneurysm repair for thoracoabdominal aortic aneurysms (TAAA) or pararenal aortic aneurysms. MethodsWe retrospectively reviewed the clinical and anatomic data on 300 consecutive patients enrolled in a prospective nonrandomized physician-sponsored investigational device exemption study from 2013 to 2018. From this group, 230 patients with CA incorporation by fenestration or directional branch were included. MAL compression was defined by preoperative computed tomography angiogram as a J-hook narrowing of the proximal CA at the level of the ligament; the shift angle between the downward and upward segments within the CA was measured. End points were technical success, rates of intraoperative or early (30-days) CA branch revision, and freedom from target vessel instability, defined by any death or rupture owing to target vessel complication, occlusion, or reintervention for stenosis, endoleak, or disconnection. ResultsCA incorporation was performed using fenestrations in 118 patients (51%) and directional branches in 112 (49%). MAL compression was present in 97 patients (42%), resulting in a stenosis of more than 50% in 48 (49%). MAL compression was more often present in patients with extent I to III TAAAs compared with extent IV TAAA-pararenal aortic aneurysms (56% vs 31%; P < .001). Technical success rate was 99%. Patients with MAL compression more often received a directional branch (65% vs 37%; P < .001), self-expanding bridging stent grafts (32% vs 16%; P = .007), adjunctive bare metal stents (46% vs 24%; P = .001), and coverage of the gastric artery (44% vs 22%; P < .001). An intraoperative (n = 6, 2.6%) or early (n = 1, 0.4%) revision of the CA branch was required in seven patients (3%) owing to dissection/occlusion (n = 2 [0.9%]), kinking/stenosis (n = 3 [1.3%]), stent dislodgement (n = 1 [0.4%]), or type IC endoleak (n = 1 [0.4%]). A shift angle of less than 120° was the most significant factor associated with CA branch revision (odds ratio, 10.9; 95% confidence interval, 2.3-88.9; P = .013). Freedom from CA branch instability was 97 ± 2% at 4 years, and this outcome was not associated with MAL compression (hazard ratio, 0.83; 95% confidence interval, 0.14-5.02; P = .588) or any other predictor. ConclusionsMAL compression was more common in extent I to III TAAAs, and related to additional challenges for CA stenting in fenestrated-branched endovascular aneurysm repair. This process may include bare metal stenting, gastric artery coverage, or early revision, especially in presence of an angulation of less than 120°. However, durable results can be achieved for CA incorporation despite these difficulties.

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

ObjectiveSpinal 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. MethodsWe 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. ResultsProphylactic 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). ConclusionsThe 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.

Sex-related Outcomes After Fenestrated-Branched Endovascular Aneurysm Repair for Thoracoabdominal Aortic Aneurysms in the US Fenestrated and Branched Aortic Research Consortium

Fenestrated-branched endovascular aneurysm repair (F-BEVAR) has expanded the treatment of patients with thoracoabdominal aortic aneurysms (TAAAs). Prior studies have demonstrated that women are less likely to be treated with routine endovascular aneurysm repair due to anatomic ineligibility and experience higher mortality following both infrarenal and thoracic aortic aneurysm repair. The purpose of this study was to describe sex-related outcomes after F-BEVAR for treatment of TAAA. A total of 886 patients with extent I to V TAAAs (excluding pararenal or juxtarenal aneurysms), enrolled in eight prospective physician-sponsored investigational device exemption studies from 2007 to 2019, were analyzed. All data were collected prospectively, audited and adjudicated by clinical events committees and/or data safety monitoring boards, and subject to US Food and Drug Administration oversight. All patients were treated with Cook manufactured patient-specific F-BEVAR devices or the Cook t-Branch off-the-shelf device. Of 886 patients who underwent F-BEVAR, 288 (33%) were women (Table I). Women had more extensive aneurysms, higher prevalence of diabetes, lower prevalence of coronary artery disease, and lower prevalence of prior endovascular aneurysm repair. Women had longer operative times, lower technical success (93 vs 98%; P = .002), and longer length of stay (Table II). Women were more commonly treated with low-profile devices and had smaller target vessels with no difference in access site complications. Thirty-day mortality was 2% in both men and women. Early outcomes were equivalent except women experienced increased risk of permanent paralysis 2.9% versus 0.9% (P < .05). Multivariable model adjusting for age, aneurysm extent, aneurysm size, urgent procedure and renal function demonstrated that patient sex was not an independent predictor of survival (hazard ratio, 0.9; 95% confidence interval, 0.53-1.53; P = .69). At 1 year, freedom from type I or III endoleak (92.5% vs 92.5%; P = .91), reintervention (82.8% vs 85.8%; P = .19), branch vessel instability (86.4% vs 89.7%; P = .54), and survival (89.9% vs 91.6%; P = .37) did not differ between men and women. Women experienced a higher incidence of postoperative sac expansion (13% vs 6.4%; P = .006). F-BEVAR performed on women demonstrate metrics of increased complexity and have a lower level of technical success. Women experienced a higher risk of perioperative spinal cord injury but no increase in 30-day mortality. Female sex is not associated with disadvantaged 1-year outcomes; however, they did experience twice the rate of sac expansion at last follow-up. These data demonstrate that F-BEVAR is safe and effective among women despite being slightly higher risk. Further efforts to improve outcome parity are indicated.Table IPatient demographicsWomen (n = 276)Men (n = 568)P valueAge74 (7.4)74 (7.4).98Medical comorbidities Coronary artery disease33%53%<.0001 Cerebrovascular disease23%19%.18 Hypertension89%91%.41 Hyperlipidemia66%71%.14 Diabetes mellitus33%26%.043 Chronic obstructive pulmonary disease35%35%.85 Renal failure requiring dialysis3%10%.56 Prior aortic surgery44%46%.68 Prior endovascular aneurysm repair7.6%16%<.001 Dissection5.7%7.5%.99 Smoking status87%89%.46TAAA extent<.0001 I9.4%7.2% II36%20% III25%18% IV28%53% V1%0.5%Aneurysm size (cm)6.4 (1.3)6.5 (1.1).20Symptomatic/urgent presentation2.3%1.4%.39TAAA, Thoracoabdominal aortic aneurysm.Data are reported as mean (standard deviation) or as percentage where indicated. Open table in a new tab Table IIDevice and operative detailsWomen (n = 276)Men (n = 568)P valueDevice design Target vessels3.4 (0.9)3.4 (0.9).50 t-Branch14%13%.58 No. of branches1.4 (1.6)1.2 (1.6).08 No. of fenestrations1.7 (1.6)2.0 (1.8).002 Low profile55%46%.034 Preloaded system26%23%.22 Distal landing zone in the infrarenal aorta42%24%<.0001 Distal landing zone in the iliac arteries58%76%<.0001 Celiac stent diameter, mm7.3 (1.9)7.1 (2.6).33 SMA stent diameter, mm7.5 (0.9)8.2 (1.1)<.0001 RRA stent diameter, mm5.9 (0.7)6.3 (0.8)<.0001 LRA stent diameter, mm5.9 (0.9)6.1 (1.1)<.0001Operative details Operative time, hours5.0 (1.8)4.6 (1.7)<.001 Examination dose, mGy1882 (2397)3606 (2418).10 Contrast volume, mL117 (56)111 (59).20 Technical success93%98%.002 ICU Length of stay, days3.8 (3.3)3.0 (3.5).004 Hospital length of stay, days9.5 (25)6.9 (18).14ICU, Intensive care unit; LRA, left renal artery; RRA, right renal artery; SMA, superior mesenteric artery.Data are reported as mean (standard deviation) or as percentage where indicated. Open table in a new tab

Impact of Chronic Kidney Disease and Acute Kidney Injury on Survival After Fenestrated-Branched Endovascular Aneurysm Repair for Thoracoabdominal Aortic Aneurysms

Fenestrated-branched endovascular aneurysm repair (F/B-EVAR) has extended the treatment of thoracoabdominal aortic aneurysms (TAAAs) to “high surgical risk” patients, including patients with chronic kidney disease (CKD). Previous studies have demonstrated that both CKD and acute kidney injury (AKI) are associated with decreased survival after open TAAA repair. The purpose of this study was to assess the impact of CKD and AKI on survival after F/B-EVAR. A total of 105 patients with TAAAs, enrolled in a prospective physician-sponsored investigational device exemption study (G130193) from 2014 to 2019, were analyzed. 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 device (Cook Medical, Bloomington, Ind). CKD was defined as CKD stage 3 to stage 5 without hemodialysis, and a single patient receiving hemodialysis preoperatively was excluded. AKI was determined within 48 hours and at 30 days postoperatively using RIFLE criteria (“risk” or “injury”). Survival was analyzed using Kaplan-Meier analysis, and associated factors were identified using Cox proportional hazards model. Risk factors for AKI were analyzed using logistic regression. Of 105 patients who underwent F/B-EVAR, 46 (43.8%) had CKD. Overall 30-day mortality was 3.81% (4/105). Whereas freedom from 30-day mortality was significantly lower in CKD patients (91.4% vs 100%; P = .02), 2-year survival was not different between CKD and non-CKD patients (78.3% vs 91.5%; P = .12). AKI occurred in 34 patients (32.4%), and there was no difference in survival at 30 days (94.1% vs 97.2%; P = .47) or at 2 years (73.5% vs 91.5%; P = .08) in patients with and without AKI, respectively. CKD patients who developed AKI after F/B-EVAR (CKD + AKI) had significantly lower 2-year survival in comparison to patients without AKI (±CKD; 58.8% vs 90.9%; P = .008; Fig). Multivariable analysis identified CKD + AKI (hazard ratio [HR], 3.2; 95% confidence interval [CI], 1.04-10.07; P = .04) and intraoperative blood loss (HR, 1.001; 95% CI, 1.00-1.001; P = .04) as risk factors for decreased 2-year survival. Increased procedure time was an independent risk factor for AKI (HR, 1.01; 95% CI, 1.00-1.001; P = .04). CKD, sex, renal artery diameter, renal artery stenosis ≥50%, contrast material volume, and intraoperative blood loss showed no significant correlation with AKI. Patients with CKD have increased perioperative mortality after F/B-EVAR but similar 2-year survival compared with patients without CKD. AKI occurs frequently after F/B-EVAR, and patients with pre-existing CKD who develop AKI after F/B-EVAR have markedly worse 2-year survival. Further studies focused on identification of risk factors for AKI and development of strategies to prevent AKI during F/B-EVAR are necessary and may significantly improve patient outcomes.

The Impact of Reinterventions on Survival After Fenestrated and Branched Endovascular Aneurysm Repair

Fenestrated and branched endografting techniques are widely accepted for treatment of juxtarenal and pararenal abdominal aortic aneurysms (AAAs) and thoracoabdominal aortic aneurysms (TAAAs) in patients at high surgical risk. However, long-term results are largely unknown, particularly in terms of reintervention rate and subsequent impact on overall outcome. The aim of this study was therefore to evaluate early and midterm reinterventions after fenestrated-branched endovascular aneurysm repair (F/B-EVAR) for juxtarenal and pararenal AAAs and TAAAs and their impact on follow-up survival. Between 2006 and 2019, all consecutive patients undergoing F/B-EVAR for juxtarenal and pararenal AAAs or TAAAs were prospectively enrolled. Cases requiring reinterventions were clustered and retrospectively analyzed. Reinterventions were classified as access related (R1), aortoiliac related (R2), and target visceral vessel related (R3). Reinterventions and survival were assessed by Kaplan-Meier analysis; Cox regression was used to determined their predictors. Overall, 221 F/B-EVAR procedures were performed for 111 (50.3%) juxtarenal and pararenal AAAs and 110 (49.7%) TAAAs in an elective (182 [82%]) or urgent (39 [18%]) setting. At 30 days, 27 (12%) patients needed reinterventions: R1, 9 (4%); R2, 4 (2%); and R3, 14 (6%). The mean follow-up was 29 ± 15 months. Forty-one (19%) patients underwent reinterventions (single, 30 [14%]; multiple, 11 [5%]) for a total of 52 reinterventions: R1, 18 (35%); R2, 6 (12%); and R3, 28 (53%). Eight (15%) reinterventions were performed in an urgent setting. Endovascular and open reinterventions were performed in 32 (62%) and 20 (38%) cases, respectively. Open reinterventions were frequently access related (R1, 16; R2 + R3, 4; P < .001). Technical success was 95% (39 patients); failures consisted of one splenic artery rupture and one renal artery loss. Patients undergoing reinterventions more frequently had a primary urgent F/B-EVAR procedure (urgent, 12 [39%]; elective, 29/182 [16%]; P < .001) and TAAAs (TAAAs, 34/41 [83%]; juxtarenal and pararenal AAAs, 7/41 [17%]; P < .001). TAAAs had a higher incidence of R3 (TAAAs, 26/28 [93%]; juxtarenal and pararenal AAA, 2/28 [7%]; P < .001) and multiple reinterventions (TAAAs, 9/11 [82%]; juxtarenal and pararenal AAAs, 2/11 [18%]; P = .03) compared with juxtarenal and pararenal AAAs. Survival at 1 year and 3 years was 88% and 75%, and freedom from reintervention was 88% and 75% at 1 year and 3 years, respectively. Patients who underwent reinterventions had lower 3-year survival (reinterventions, 61%; no reinterventions, 77%; P = .02), but this was not confirmed by the multivariate analysis, in which TAAAs (hazard ratio, 2.3; 95% confidence interval, 1.1-4.8; P = .03) and urgent primary F/B-EVAR procedures (hazard ratio, 2.5; 95% confidence interval, 1.2-4.9; P = .01) were the only independent predictors of late mortality. Reinterventions after F/B-EVAR are not uncommon and are related to target visceral vessels in only half of cases. Most reinterventions can be performed by endovascular techniques and in an elective setting, and they are more frequent after urgent primary F/B-EVAR and TAAA procedures. Their technical success rate is excellent (95%) and does not have an impact on survival, which is conversely dependent on TAAA and urgent primary F/B-EVAR repair.

Selective Versus Routine Spinal Drain Use for Fenestrated-Branched Endovascular Aortic Repair

Spinal drains are used to ameliorate spinal cord ischemia (SCI), but their use may result in inherent morbidity and mortality. The role of spinal drains for fenestrated-branched endovascular aneurysm repair (F/B-EVAR) has not been demonstrated. The aim of this study was to assess the outcomes of spinal cord protection with and without the routine use of spinal drains during F/B-EVAR. A retrospective single-center study was performed using a prospectively maintained data set of all patients undergoing F/B-EVAR during a 4-year period. The primary end point of the study was the frequency of SCI. Prophylactic spinal drain was placed preoperatively in 33 patients (23%) with a median time for removal of 3 days (interquartile range [IQR], 2-3 days). Routine intraoperative neuromonitoring was used. Spinal cord protection relied primarily on maintaining a perioperative systolic blood pressure between 140 and 160 mm Hg or a mean arterial pressure >90 mm Hg, avoiding hypotension, preservation of as many collateral beds as possible, staged repairs, and early lower extremity reperfusion based on neuromonitoring. A total of 145 patients, 104 men (71%) and 41 women (28%) with a median age of 70 years (IQR, 53-62 years) underwent F/B-EVAR. Branched custom-made devices (11%), fenestrated custom-made devices (70%), and off-the-shelf t-Branch (Cook Medical, Bloomington, Ind) device (17%) were used with a median number of branches/fenestrations of four (IQR, three-four). The Society for Vascular Surgery classification of implantation zones was determined as follows: 9 (6%) zone 2, 17 (13%) zone 3, 16 (12%) zone 4, and 89 (68%) zone 5. SCI was present in eight patients (5.5%) and classified according to the Society for Vascular Surgery SCI grading system as follows: one grade 1, five grade 2, and two grade 3a. A high implantation zone (1-4) was not associated with SCI (P = .9). Similarly, prophylactic spinal drain did not demonstrate association with the occurrence of SCI (three [9%] vs five [4%], with and without spinal drain, respectively; P = .3). For patients with high implantation zones, staged repair was performed in 38 patients (26%) at a median time of 2 months (IQR, 2-6 months). Among these patients, the frequency of SCI was 13%. Staged repair was associated with an 80% reduction in the frequency of SCI (odds ratio, 0.19; 95% confidence interval, 0.04-.084; P = .02). F/B-EVAR can be performed with a minimal risk of SCI without the need for routine prophylactic spinal drains. High implantation zones did not predict SCI after F/B-EVAR; however, staged repair significantly decreased the risk of SCI after F/B-EVAR.

Effect of Aortic Angulation on the Outcomes of Fenestrated-Branched Endovascular Aneurysm Repair

The objective was to investigate the effect of aortic angulation on the early and midterm outcomes of fenestrated-branched endovascular aneurysm repair for thoracoabdominal aortic aneurysms (TAAAs) or pararenal aortic aneurysms.

Dual fluoroscopy with live-image digital zooming significantly reduces patient and operating staff radiation during fenestrated-branched endovascular aortic aneurysm repair

ObjectiveFenestrated-branched endovascular aneurysm repair (F/B-EVAR) is a complex procedure that generates high radiation doses. Magnification aids in vessel cannulation but increases radiation. The aim of the study was to compare radiation doses to patients and operating room staff from two fluoroscopy techniques, standard magnification vs dual fluoroscopy with live-image digital zooming during F/B-EVAR. MethodsAn observational, prospective, single-center study of F/B-EVAR procedures using Philips Allura XperFD20 equipment (Philips Healthcare, Amsterdam, The Netherlands) was performed during a 42-month period. Intravascular ultrasound, three-dimensional fusion, and extreme collimation were used in all procedures. Intraoperative live-image processing was performed with two imaging systems: standard magnification in 123 patients (81%) and dual fluoroscopy with live-image digital zooming in 28 patients (18%). In the latter, the live “processed” zoomed images are displayed on examination displays and live images are displayed on reference displays. The reference air kerma was collected for each case and represents patient dose. Operating staff personal dosimetry was collected using the DoseAware system (Philips Healthcare). Patient and staff radiation doses were compared using nonparametric tests. ResultsMean age was 71.6 ± 11.4 years. The median body mass index was 27 kg/m2 (interquartile range [IQR], 24.4-30.6 kg/m2) and was the same for both groups. Procedures performed with dual fluoroscopy with digital zooming demonstrated significantly lower median patient (1382 mGy [IQR, 999-2045 mGy] vs 2458 mGy [IQR, 1706-3767 mGy]; P < .01) and primary operator radiation doses (101 μSv [IQR, 34-235 μSv] vs 266 μSv [IQR, 104-583 μSv]; P < .01) compared with standard magnification. Similar significantly reduced radiation doses were recorded for first assistant, scrub nurse, and anesthesia staff in procedures performed with dual fluoroscopy. According to device design, procedures performed with four-fenestration/branch devices generated higher operator radiation doses (262 μSv [IQR, 116.5-572 μSv] vs 171 μSv [IQR, 44-325 μSv]; P < .01) compared with procedures with three or fewer fenestration/branches. Among the most complex design (four-vessel), operator radiation dose was significantly lower with digital zooming compared with standard magnification (128.5 μSv [IQR, 70.5-296 μSv] vs 309 μSv [IQR, 150-611 μSv]; P = .01). ConclusionsCurrent radiation doses to patients and operating personnel are within acceptable limits; however, dual fluoroscopy with live-image digital zooming results in dramatically lower radiation doses compared with the standard image processing with dose-dependent magnification. Operator radiation doses were reduced in half during procedures performed with more complex device designs when digital zooming was used.

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.

Combined fenestrated-branched endovascular repair of the aortic arch and the thoracoabdominal aorta

ObjectiveThe aim of our study was to evaluate patients who underwent extensive endovascular aortic stent graft coverage (from the aortic arch to abdominal aorta) in terms of early and midterm clinical outcomes. MethodsA retrospective multicenter study was undertaken. All patients were treated with extensive endovascular aortic stent graft coverage with fenestrated and branched endografts at three experienced endovascular centers. ResultsBetween 2012 and 2017, there were 33 patients (22 male [67%]) treated with a combination of fenestrated-branched stent grafts in the aortic arch and the thoracoabdominal aorta. Most of the patients (20/33 [61%]) had fenestrated-branched endovascular aneurysm repair (fb-EVAR) of the thoracoabdominal aorta as a second-stage procedure after thoracic arch (fb-Arch) repair, 10 had fb-Arch repair as the first procedure, and three patients had a single-stage procedure. The mean age was 67 ± 13 years, and the mean interval between procedures was 13 ± 12 months. For fb-Arch repair, 20 fenestrated and 13 branched devices were used; for fb-EVAR, 23 fenestrated, 5 branched, and 5 composite devices were used. The use of spinal drainage was more common in fb-EVAR (20/33 [61%]). Technical success was 100%. Mean hospital stay was 15 ± 13 days for fb-Arch repair and 12 ± 9 days for fb-EVAR. Two patients died in the hospital after fb-EVAR, resulting in a 30-day mortality of 6% (2/33). No deaths occurred during the fb-Arch repair component or in the single-stage cases. Four patients developed spinal cord injury (12%), 1 had permanent paraplegia (3%), and 2 patients had a neurologic event (1 stroke [3%] and 1 transient ischemic attack [3%]). Six patients (18%) died during a mean follow-up of 23 ± 17 months. The survival at 12 months after the second procedure was 72%, and the freedom from any reintervention was 82%. The 12-month freedom from reintervention was 87% for fb-Arch repair and 81% for fb-EVAR. ConclusionsExtensive endovascular coverage of the aorta for aortic disease seems to be a feasible procedure in experienced centers, with acceptable perioperative morbidity and mortality. Spinal cord ischemia appears acceptable despite extensive aortic coverage.

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

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

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

ObjectiveThe 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). MethodsWe 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. ResultsThere 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. ConclusionsDespite 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.

Dual Fluoroscopy With Live-Image Zooming Significantly Reduces Patient and Operating Staff Radiation During Fenestrated-Branched Endovascular Aortic Aneurysm Repair

Fenestrated-branched endovascular aneurysm repair (F/BEVAR) is a complex procedure that generates high radiation dose. Use of magnification views aids in the success of vessel cannulation but increases the overall radiation dose. The aim of the study was to compare the radiation doses to patients and operating room staff from two fluoroscopy techniques, standard magnification vs dual fluoroscopy with live-image digital zooming during F/BEVAR.

Performance of Viabahn Balloon-Expandable Stent Compared With Self-expanding Covered Stents for Fenestrated-Branched Endovascular Aortic Repair

The objective of this study was to compare the performance between Viabahn (W. L. Gore & Associates, Flagstaff, Ariz) balloon-expandable stent (VBX) and self-expanding covered stents (SESs; Viabahn and Fluency [Bard Peripheral Vascular, Tempe, Ariz]) used as bridging stents for directional branches during fenestrated-branched endovascular aneurysm repair of complex aortic aneurysms. Patients with thoracoabdominal aortic aneurysms (type I-IV) or pararenal aortic aneurysms unsuitable for either open repair or endovascular repair with commercially available devices were prospectively enrolled into a physician-sponsored investigational device exemption trial. Descriptive statistics of the cohort included demographics, risk factors, and anatomic and device characteristics. Individual branches were grouped as either VBX or SES and were analyzed for primary patency, branch-related type I or type III endoleaks, branch instability, branch-related secondary intervention, and branch-related aortic rupture or death. Categorical variables were expressed as total and percentage and continuous variables as median (interquartile range). Kaplan-Meier curves were used to estimate long-term result. Groups were compared with the log-rank test. P value < .05 was considered statistically significant. During the period from July 2012 through April 2019, there were 263 patients treated for complex aortic aneurysm with fenestrated-branched endovascular aneurysm repair. The devices used were either a custom-manufactured device or off-the-shelf p-Branch or t-Branch devices (Cook Medical, Bloomington, Ind). The median age was 71 years (interquartile range, 66-79 years), 70% male, and 81% white. The most common cardiac risk factors were smoking (92%), hypertension (91%), hyperlipidemia (78%), and chronic obstructive pulmonary disease (52%). The total number of vessels incorporated to repair was 977, with branches representing 18.4% (179 branches). Among the 179 branches were 54 (30%) celiac artery, 56 (31%) superior mesenteric artery, 38 (21%) right renal artery, and 31 (18%) left renal artery. VBX and SES groups represented, respectively, 53% (n = 95) and 47% (n = 84) of the total (Fig).The overall cohort survival rate at 24 months was 78.5% ± 3%. There was no branch-related rupture or death. Primary patency at 24 months (VBX, 98.1%; SES, 98.6%; log-rank, P = .98), freedom from endoleak (VBX, 97.3%; SES, 98.6%; log-rank, P = .63), freedom from secondary intervention (VBX, 91.5%; SES, 95%; log-rank, P = .69), and freedom from branch instability (VBX, 95.5%; SES, 97.3%; log-rank, P = .72) were similar between groups (Fig 2). The initial experience with VBX stents demonstrated excellent primary patency and similarly low rates of branch-related complications and endoleaks, with no branch-related aortic rupture or death. Our results demonstrate that in high volume and experienced aortic center, the VBX stent is a safe and effective bridging stent option during branched endovascular aortic repair. Multicenter studies with longer follow-up are necessary to validate our initial results.Fig 2Freedom from branch instability (BI). CI, Confidence interval; SES, self-expanding covered stent; VBX, Viabahn balloon-expandable stent.View Large Image Figure ViewerDownload Hi-res image Download (PPT)