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 ... -  《-》

Long-term durability of multibranched endovascular repair of thoracoabdominal and pararenal aortic aneurysms.

The objective of this study was to assess the durability of multibranched endovascular repair of thoracoabdominal aortic aneurysms (TAAAs) and pararenal aortic aneurysms by examining the rates of late-occurring (beyond 30 days) complications. There were 146 patients who underwent endovascular TAAA repair using a stent graft, with a total of 538 caudally oriented self-expanding branches. Four patients died in the perioperative period and were excluded, leaving 142 patients (mean age, 73 ± 8 years; 35 [24.7%] women). Follow-up included clinical examination and computed tomography angiography at 1 month, 6 months, and 12 months and yearly thereafter. Mean aneurysm diameter was 67 ± 9 mm. Sixty-seven TAAAs (47.2%) were Crawford type I, II, III, or V; 75 (52.8%) were type IV or pararenal. Three patients (2.1%) died >30 days after operation from perioperative complications. During a mean follow-up of 36 months (±28 months), there were four additional aneurysm-related deaths: one (0.7%) as a result of aneurysm rupture in the presence of untreatable type I endoleak, one (0.7%) after conversion to open repair for stent graft infection, one (0.7%) after occlusion of superior mesenteric artery and celiac branches, and one (0.7%) due to bilateral renal branch occlusion. There was one additional open conversion for stent graft infection (0.7%). Nineteen patients (13.3%) underwent 20 reinterventions for late-occurring complications, including 11 (7.7%) for renal branch occlusion or stenosis, 1 (0.7%) for mesenteric branch stenosis, 4 (2.8%) for graft limb occlusion, 1 (0.7%) for type IB endoleak (distal stent graft migration), and 1 (0.7%) for type III endoleak (fabric erosion); 2 (1.4%) open conversions were performed for stent graft infection. There were no late type IA endoleaks. By Kaplan-Meier analysis, freedom from aneurysm-related death was 91.1% and freedom from aneurysm-related death or reintervention was 76.8% at 5 years. The 5-year overall survival rate of 49.1% reflects the high rate of cardiopulmonary comorbidity. Although renal branch occlusion (23 occlusions of 256 renal branches [8.9%]) was the most common late complication, only five patients required permanent dialysis. Total endovascular repair of TAAAs and pararenal aortic aneurysms using axially oriented cuffs is safe, effective, and durable in the long term.

Walker J ，Kaushik S ，Hoffman M ，Gasper W ，Hiramoto J ，Reilly L ，Chuter T ... -  《-》

Adapting to a total endovascular approach for complex aortic aneurysm repair: Outcomes after fenestrated and branched endovascular aortic repair.

This study reports the feasibility of adopting a total endovascular approach for the treatment of complex abdominal aortic aneurysms (AAAs) at a European aortic center and compares the short- and midterm results against those from large and multicenter studies. All patients treated endovascular aortic repair (EVAR) for juxta/pararenal AAAs or thoracoabdominal aortic aneurysms (TAAAs), both elective and acute, as well as reoperations, from 2010 to 2015 were included. Treatment was fenestrated (FEVAR) or branched (BEVAR), and outcomes were analyzed for technical success and mortality at 30 and 90 days and by Kaplan-Meier curve estimates at 3 years. Outcomes on target vessels were reported as freedom from branch instability in the follow-up period. Reinterventions, endoleaks and perioperative and postoperative morbidities were analyzed. A total of 71 patients were treated for juxta/pararenal AAA (n = 40) or TAAA (n = 31): 14 type II, 4 type III, and 13 type IV. There were 47 FEVAR (including 2 physician-modified fenestrated grafts) and 24 BEVAR procedures performed. Four TAAAs were ruptured. No open repairs were performed for these pathologies in this period. Mortality was 2.8% (n = 2) at 30 days and 9.9% at 90 days (n = 7). One late rupture occurred in a patient whose treatment was a technical failure. Survival at 3 years was 77.9% ± 5.6% overall, 90.9% ± 5.2% for juxta/pararenal AAAs, and 60.7% ± 10.3% for TAAAs. Graft deployment was successful in 69 of 71 patients. Revascularization was successful in 205 of 208 target vessels (98.6%): 51 of 51 superior mesenteric arteries, 27 of 27 celiac arteries, and 127 of 130 renal arteries. There were 131 fenestrated bridging stent grafts and 74 branched bridging stent grafts. Technical success was 68 of 71 (95.7%). There were nine cases of branch instability (5 BEVARs, 4 FEVARs) in five patients (7.0%). Seven vessels (5 renal arteries and 2 superior mesenteric arteries) underwent reintervention: 5 for stenoses, 1 for occlusion, and 1 for stent migration. Freedom from branch instability at 3 years was 92.7% ± 2.5% overall, 88.6% ± 6.4% for BEVAR, and 94.6% for FEVAR. The short- and midterm results obtained here indicate that the benefits of a total endovascular treatment for complex aortic aneurysms, as demonstrated by large and multicenter studies, can be adapted and replicated at other centers with a dedicated aortic service. This may help guide future considerations of how to refer or treat this complex patient group.

Budtz-Lilly J ，Wanhainen A ，Eriksson J ，Mani K ... -  《-》

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 ... -  《-》

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 ... -  《-》