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 ... -  《-》

Fenestrated and branched endovascular aneurysm repair outcomes for type II and III thoracoabdominal aortic aneurysms.

Thoracoabdominal aortic aneurysm (TAAA) repair remains a challenging clinical pathology. Endovascular technology, in particular the evolution of fenestrated and branched (F/B) endografts used in endovascular aneurysm repair (EVAR) has provided a less invasive method of treating these complex aneurysms. This study evaluated the technical and clinical outcomes of F/B-EVAR for extensive type II and III TAAA. Data from 354 high-risk patients enrolled in a physician-sponsored investigational device exemption trial (2004-2013) undergoing F/B-EVAR for type II and III TAAA were evaluated. Technical success, perioperative clinical outcomes, and midterm outcomes (36 months) for branch patency, reintervention, aneurysm-related death, and all-cause mortality were analyzed. Data are presented as mean ± standard deviation and were assessed using Kaplan-Meier, univariate, and multivariate analysis. F/B-EVARs incorporating 1305 fenestration/branches were implanted with 96% of target vessels successfully stented. Completion aortography showed 2.8% patients had a type I or III endoleak. Procedure duration (6.0 ± 1.7 vs 5.5 ± 1.6 hours; P < .01) and hospital stay (13.1 ± 10.1 vs 10.2 ± 7.4 days; P < .01) were longer for type II TAAA. Perioperative mortality was greater in type II repairs (7.0% vs 3.5%; P < .001). Permanent spinal cord ischemia occurred in 4% and renal failure requiring hemodialysis occurred in 2.8% of patients. Twenty-seven branches (7.6%) required reintervention for stenosis or occlusion; and celiac artery, superior mesenteric artery, and renal artery secondary patency at 36 months was 96% (95% confidence interval [CI], 0.93-0.99), 98% (95% CI, 0.97-1.0), and 98% (95% CI, 0.96-1.0), respectively. Eighty endoleak repairs were performed in 67 patients, including 55 branch-related endoleaks, 4 type Ia, 5 type Ib, and 15 type II endoleaks. At 36 months, freedom from aneurysm-related death was 91% (95% CI, 0.88-0.95), and freedom from all-cause mortality was 57% (95% CI, 0.50-0.63). The treatment of type II TAAA (P < .01), age (P < .01), and chronic obstructive pulmonary disease (P < .05) negatively affected survival. F/B-EVAR is a robust treatment option for patients at increased risk for conventional repair of extensive TAAAs. Technical success and branch patency are excellent, but some patients will require reintervention for branch-related endoleak. Aneurysm extent portends a higher risk of perioperative and long-term morbidity and mortality. Additional efforts are needed to improve outcomes and understand the utility of this treatment option in the general TAAA population.

Eagleton MJ ，Follansbee M ，Wolski K ，Mastracci T ，Kuramochi Y ... -  《-》

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 ... -  《-》

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 ... -  《-》

Results of fenestrated and branched endovascular aortic aneurysm repair after failed infrarenal endovascular aortic aneurysm repair.

Failure of infrarenal endovascular aneurysm repair (EVAR) due to loss of proximal seal is increasingly common. Open surgical conversion can be challenging and has been associated with significant morbidity and mortality. The aim of this study was to evaluate the use of fenestrated-branched EVAR (F/BEVAR) for the treatment of patients with prior EVAR failure. Consecutive patients enrolled as part of the Aortic Research Consortium in six prospective, nonrandomized, physician-sponsored investigational device exemption studies evaluating F/BEVAR between 2012 and 2018 were included in this study. The cohort was stratified according to whether the F/BEVAR procedure was performed after EVAR failure. Demographics, operative details, perioperative complications, and length of stay were compared between groups. Postprocedural survival, type I or type III endoleak, target artery patency, target artery instability, and reintervention rates were calculated using Kaplan-Meier method and compared between groups. A total of 893 patients underwent F/BEVAR; 161 (18%) were treated after failed EVAR and 732 (82%) were treated without prior EVAR. Patients with failed EVAR were more often men (84% vs 66%; P < .01) with larger aneurysms (6.9 cm vs 6.4 cm; P < .01). There were no differences in aneurysm extent (P = .20) between groups; for the entire cohort, there were 19% juxtarenal, 9.2% suprarenal, and 72% thoracoabdominal aneurysms. The average number of targeted arteries per patient was 3.6 in both groups. The procedural technical success (99% vs 97%; P = .15) did not differ between groups, but radiation dose (4750 vs 2920 mGy; P = .02), dose-area product (154,572 vs 82,842 mGy·cm2; P < .01), and operative time (5.2 vs 4.6 hours; P < .01) were significantly higher in the failed EVAR group. Median intensive care unit length of stay (2.9 days) and total length of stay (6.3 days) did not differ between groups. The 30-day mortality rate (failed EVAR, 2.5%; no EVAR, 1.1%; P = .25) and 30-day major adverse event rates did not differ between groups. Kaplan-Meier estimates of freedom from type I or type III endoleak (91.9% vs 92.5%; P = .65), target artery patency (97.3% vs 97.0%; P = .91), freedom from target artery instability (86.3% vs 88.8%; P = .53), and freedom from reintervention at 1 year (84.7% vs 88.7%; P = .10) did not differ between the failed EVAR and no EVAR groups, respectively. One-year survival was decreased in the failed EVAR group (86.3% vs 91.9%; P = .02), but this effect did not persist on multivariable analysis (hazard ratio, 1.52; 95% confidence interval, 0.88-2.62; P = .14). In this multicenter study, F/BEVAR was safe and effective in patients with prior failed EVAR, with nearly identical outcomes to those of patients without prior EVAR. However, differences in procedural metrics indicate higher level of technical challenge in performing F/BEVAR in patients with prior failed EVAR.

Schanzer A ，Beck AW ，Eagleton M ，Farber MA ，Oderich G ，Schneider D ，Sweet MP ，Crawford A ，Timaran C ，U.S. Multicenter Fenestrated/Branched Aortic Research Consortium ... -  《-》