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 ... -  《-》

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 ... -  《-》

Effect of thoracoabdominal aortic aneurysm extent on outcomes in patients undergoing fenestrated/branched endovascular aneurysm repair.

The outcomes after open repair of thoracoabdominal aneurysms (TAAAs) have been definitively demonstrated to worsen as the TAAA extent increases. However, the effect of TAAA extent on fenestrated/branched endovascular aneurysm repair (F/BEVAR) outcomes is unclear. We investigated the differences in outcomes of F/BEVAR according to the TAAA extent. We reviewed a single-institution, prospectively maintained database of all F/BEVAR procedures performed in an institutional review board-approved registry and/or physician-sponsored Food and Drug Administration investigational device exemption trial (trial no. G130210). The patients were stratified into two groups: group 1, extensive (extent 1-3) TAAAs; and group 2, nonextensive (juxtarenal, pararenal, and extent 4-5) TAAAs. The perioperative outcomes were compared using the χ2 test. Kaplan-Meier analysis of 3-year survival, target artery patency, reintervention, type I or III endoleak, and branch instability (type Ic or III endoleak, loss of branch patency, target vessel stenosis >50%) was performed. Cox proportional hazards modeling was used to assess the independent effect of extensive TAAA on 1-year mortality. During the study period, 299 F/BEVAR procedures were performed for 87 extensive TAAAs (29%) and 212 nonextensive TAAAs (71%). Most repairs had used company-manufactured, custom-made devices (n = 241; 81%). Between the two groups, no perioperative differences were observed in myocardial infarction, stroke, acute kidney injury, dialysis, target artery occlusion, access site complication, or type I or III endoleak (P > .05 for all). The incidence of perioperative paraparesis was greater in the extensive TAAA group (8.1% vs 0.5%; P = .001). However, the incidence of long-term paralysis was equivalent (2.3% vs 0.5%; P = .20), with nearly all patients with paraparesis regaining ambulatory function. On Kaplan-Meier analysis, no differences in survival, target artery patency, or freedom from reintervention were observed at 3 years (P > .05 for all). Freedom from type I or III endoleak (P < .01) and freedom from branch instability (P < .01) were significantly worse in the extensive TAAA group. Cox proportional hazards modeling demonstrated that F/BEVAR for extensive TAAA was not associated with 1-year mortality (hazard ratio, 1.71; 95% confidence interval, 0.91-3.52; P = .13). Unlike open TAAA repair, the F/BEVAR outcomes were similar for extensive and nonextensive TAAAs. The differences in perioperative paraparesis, branch instability, and type I or III endoleak likely resulted from the increasing length of aortic coverage and number of target arteries involved. These findings suggest that high-volume centers performing F/BEVAR should expect comparable outcomes for extensive and nonextensive TAAA repair.

Diamond KR ，Simons JP ，Crawford AS ，Arous EJ ，Judelson DR ，Aiello F ，Jones DW ，Messina L ，Schanzer A ... -  《-》

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 ... -  《-》

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

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

Tenorio ER ，Kärkkäinen JM ，Mendes BC ，DeMartino RR ，Macedo TA ，Diderrich A ，Hofer J ，Oderich GS ... -  《-》