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

To 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). We 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. There 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. Fenestrated-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.

Squizzato F ，Oderich GS ，Balachandran P ，Tenorio ER ，Mendes BC ，De Martino RR ... -  《-》

Prospective, nonrandomized study to evaluate endovascular repair of pararenal and thoracoabdominal aortic aneurysms using fenestrated-branched endografts based on supraceliac sealing zones.

To investigate outcomes of manufactured fenestrated and branched endovascular aortic repair (F-BEVAR) endografts based on supraceliac sealing zones to treat pararenal aortic aneurysms and thoracoabdominal aortic aneurysms (TAAAs). A total of 127 patients (91 male; mean age, 75 ± 10 years old) were enrolled in a prospective, nonrandomized single-center study using manufactured F-BEVAR (November 2013-March 2015). Stent design was based on supraceliac sealing zone in all patients with ≥ four vessels in 111 (89%). Follow-up included clinical examination, laboratory studies, duplex ultrasound, and computed tomography imaging at discharge, 1 month, 6 months, and yearly. End points adjudicated by independent clinical event committee included mortality, major adverse events (any mortality, myocardial infarction, stroke, paraplegia, acute kidney injury, respiratory failure, bowel ischemia, blood loss >1 L), freedom from reintervention, and branch-related instability (occlusion, stenosis, endoleak or disconnection requiring reintervention), target vessel patency, sac aneurysm enlargement, and aneurysm rupture. There were 47 pararenal, 42 type IV, and 38 type I-III TAAAs with mean diameter of 59 ± 17 mm. A total of 496 renal-mesenteric arteries were incorporated by 352 fenestrations, 125 directional branches, and 19 celiac scallops, with a mean of 3.9 ± 0.5 vessels per patient. Technical success of target vessel incorporation was 99.6% (n = 493/496). There were no 30-day or in-hospital deaths, dialysis, ruptures or conversions to open surgical repair. Major adverse events occurred in 27 patients (21%). Paraplegia occurred in two patients (one type IV, one type II TAAAs). Follow-up was >30 days in all patients, >6 months in 79, and >12 months in 34. No patients were lost to follow-up. After a mean follow-up of 9.2 ± 7 months, 23 patients (18%) had reinterventions (15 aortic, 8 nonaortic), 4 renal artery stents were occluded, five patients had type Ia or III endoleaks, and none had aneurysm sac enlargement. Primary and secondary target vessel patency was 96% ± 1% and 98% ± 0.7% at 1 year. Freedom from any branch instability and any reintervention was 93% ± 2% and 93% ± 2% at 1 year, respectively. Patient survival was 96% ± 2% at 1 year for the entire cohort. Endovascular repair of pararenal aortic aneurysms and TAAAs, using manufactured F-BEVAR with supraceliac sealing zones, is safe and efficacious. Long-term follow-up is needed to assess the impact of four-vessel designs on device-related complications and progression of aortic disease.

Oderich GS ，Ribeiro M ，Hofer J ，Wigham J ，Cha S ，Chini J ，Macedo TA ，Gloviczki P ... -  《-》

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

To 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. We 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. CA 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. MAL 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.

Squizzato F ，Oderich GS ，Tenorio ER ，Mendes BC ，DeMartino RR ... -  《-》

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

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

Piazza M ，Squizzato F ，Xodo A ，Gubert A ，Grego F ，Antonello M ... -  《-》

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

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

Tenorio ER ，Oderich GS ，Farber MA ，Schneider DB ，Timaran CH ，Schanzer A ，Beck AW ，Motta F ，Sweet MP ，U.S. Fenestrated and Branched Aortic Research Consortium Investigators ... -  《-》