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 ... -  《-》

Effect of bridging stent graft selection for directional branches on target artery outcomes of fenestrated-branched endovascular aortic repair in the United States Aortic Research Consortium.

The purpose of this study was to evaluate the effect of directional branches (DBs) bridging stent choice on target artery (TA) outcomes during fenestrated-branched endovascular repair of complex abdominal and thoracoabdominal aortic aneurysms. Patients enrolled in nine prospective physician-sponsored investigational device exemption studies in the United States between 2005 and 2020 were analyzed. All patients who had at least one TA incorporated by DB using either self-expandable (SESGs), balloon-expandable (BESGs), or hybrid stent graft combinations (HSGs). Endpoints were TA patency and freedom from TA endoleak, instability, and reintervention. There were 800 patients with 2426 renal-mesenteric arteries incorporated by DBs. DB stent selection was SESGs in 1205 TAs (50%), BESGs in 1095 TAs (45%), and HSGs in 126 TAs (5%). SESGs were predominantly used in the first three quartiles of the study period, whereas BESGs comprised 75% of all stents between 2017 and 2020. The median follow-up was 15 months (interquartile range, 6-35 months). At 5 years, BESGs had significantly lower freedom from TA instability (78% ± 4% vs 88% ± 1% vs 96% ± 2%; log-rank P =.010), freedom from TA endoleaks (87% ± 3% vs 97% ± 1% vs 99% ± 1%; log-rank P < .001), and freedom from TA reintervention (83% ± 4% vs 95% ± 1% vs 99% ± 2%; log-rank P <.001) compared with SESGs or HSGs, respectively. For renal arteries, there was no difference in freedom from TA instability for BESGs, SESGs, or HSGs. However, freedom from TA endoleaks and reintervention were lower for renal arteries targeted by BESGs compared with DBs targeted by SESGs and HSGs (83% ± 6% vs 98% ± 1% vs 100%; log-rank P < .001; and 70% ± 10% vs 92% ± 1% vs 96% ± 4%; log-rank P = .022). For mesenteric arteries, DBs targeted by BESGs had lower freedom from TA instability, endoleak, and reintervention than SESGs or HSGs. In stent-specific analysis, iCAST BESGs had the lowest freedom from TA instability either for renal or mesenteric arteries, primarily due to higher rates of TA endoleaks. There was no difference in patency in any scenario. Independent predictors of TA instability were age (+1-year: hazard ratio [HR], 0.97; 95% confidence interval [CI], 0.94-0.99), stent diameter (+1 mm: HR, 0.67; 95% CI, 0.57-0.80), and BESG (HR, 1.8; 95% CI, 1.1-2.9). DBs incorporated using BESGs had lower freedom from TA instability, TA endoleak, and TA reintervention compared with SESGs and HSGs. The patency of DBs was not affected by the type of stent construction. The observed performance disadvantage associated with BESGs appears to have largely been driven by iCAST usage.

Tenorio ER ，Schanzer A ，Timaran CH ，Schneider DB ，Mendes BC ，Eagleton MJ ，Farber MA ，Parodi FE ，Gasper WJ ，Beck AW ，Sweet MP ，Zettervall SL ，Huang Y ，Oderich GS ，U.S. Fenestrated and Branched Aortic Research Consortium ... -  《-》

Outcomes of balloon-expandable versus self-expandable stent graft for endovascular repair of iliac aneurysms using iliac branch endoprosthesis.

The purpose of this study was to compare outcomes of internal iliac artery (IIA) stenting using balloon-expandable (BESG) or self-expandable stent grafts (SESG) during endovascular repair of aortoiliac aneurysms with iliac branch endoprosthesis (IBE; W. L. Gore, Flagstaff, Ariz). We retrospectively reviewed all consecutive patients treated for aortoiliac aneurysms using IBE between 2014 and 2020. IIA stenting was performed using either the IIA side branch SESG or a Gore VBX BESG (W. L. Gore). Indications for use of BESGs were "up-and-over" IBE technique for type IB endoleak after prior endovascular aortic aneurysm repair (EVAR), short IIA length, and need for IIA extension into divisional branches (outside instructions for use). End points included technical success, freedom from buttock claudication, primary IIA patency, and freedom from IIA branch instability (eg, branch-related death or rupture, occlusion, disconnection, or reintervention for stenosis, kink, or endoleak), freedom from type IC/IIIC endoleak, and freedom from secondary interventions. There were 90 patients (86 males and 4 females) with a mean age of 74 ± 7 years treated by EVAR with 108 IBEs. Choice of stent was BESG in 43 and SESG in 65 targeted IIAs. BESGs were used more frequently in patients with prior EVAR (22% vs 2%; P = .003,), isolated IBEs (31% vs 2%; P < .001), and in patients with IIA aneurysms requiring stenting into divisional branches (36% vs 5%; P < .001). Technical success was similar for BESGs and SESGs (97% vs 100%; P = .40), respectively. The mean follow-up was 25 ± 16 months (range, 11-34 months). At 2 years, freedom from buttock claudication was 100% for BESG and 95 ± 3% for SESG (Log-rank 0.26), with no difference in primary patency (BESG, 100% vs SESG, 94 ± 4%; Log-rank 0.94). There were four (9%) IIA-related endoleaks in the BESG group and one (2%) in the SESG group (P = .08). Freedom from IIA branch instability was 87 ± 6% for BESG and 96 ± 3% for SESG at 2 years (Log-rank 0.043). Freedom from type IC/IIIC endoleak was 87 ± 7% for BESG and 98 ± 2% for SESG at the same interval (Log-rank 0.06). There was no difference in freedom from reinterventions for BESG and SESG (92 ± 6% vs 98 ± 2%; Log-rank 0.34), respectively. BESGs were used more frequently during IBE procedures indicated for failed EVAR, isolated common iliac aneurysms, and IIA aneurysms requiring extension into divisional branches. Despite these differences and BESG being used outside instructions for use, both stent types had similar primary patency, freedom from buttock claudication, and freedom from reinterventions. However, BESGs were associated with higher rates of IIA-related branch instability.

Lima GB ，Tenorio ER ，Marcondes GB ，Khasawneh MA ，Mendes BC ，DeMartino RR ，Shuja F ，Colglazier JJ ，Kalra M ，Oderich GS ... -  《-》

Performance of Viabahn balloon-expandable stent compared with self-expandable covered stents for branched endovascular aortic repair.

The objective of this study was to compare the performance between the Viabahn balloon-expandable stent (VBX; Viabahn [W. L. Gore & Associates, Flagstaff, Ariz]) and a covered self-expandable stent (SES; Fluency [Bard Peripheral Vascular, Tempe, Ariz]) used as bridging stents for directional branches during fenestrated or branched endovascular aneurysm repair of complex aortic aneurysms. Patients with thoracoabdominal aortic aneurysms (type I-IV) or pararenal aortic aneurysms either at high risk for open repair or unsuitable for endovascular repair with commercially available devices were prospectively enrolled in 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 had data 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 were expressed as median (interquartile range). Kaplan-Meier curves were used to estimate long-term results. Groups were compared with the log-rank test. P value <.05 was considered statistically significant. During the period from July 2012 through June 2019, there were 263 patients treated for complex aortic aneurysm (thoracoabdominal aortic aneurysm) with fenestrated or branched endografts. The devices used were either custom-manufactured devices or off-the-shelf p-Branch or t-Branch (Cook Medical, Bloomington, Ind) devices. The median age was 71 years (interquartile range, 66-79 years); 70% were male, and 81% were 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 into the repair was 977, with branches representing 18.4% (179 branches). Among these 179 branches, the celiac artery, superior mesenteric artery, right renal artery, and left renal artery received 54 (30%), 56 (31%), 38 (21%), and 31 (18%) branches, respectively. VBX and SES groups represented 96 (54%) and 81 (46%) of the branches implanted. The celiac artery, superior mesenteric artery, right renal artery, and left renal artery received VBX as a bridging stent in 40%, 46.7%, 33.8%, and 32.2% respectively. The overall cohort survival rate was 78.5% at 24 months. There was no branch-related rupture or mortality. Primary patency at 24 months (VBX, 98.1%; SES, 98.6%; log-rank, P = .95), freedom from endoleak (VBX, 95.6%; SES, 98.6%; log-rank, P = .66), freedom from secondary intervention (VBX, 94.7%; SES, 98.1%; log-rank, P = .33), and freedom from branch instability (VBX, 95.6%; SES, 97.2%; log-rank, P = .77) were similar between groups. This 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 a high-volume, experienced aortic center, the VBX stent is a safe and effective bridging stent option during branched endovascular aortic repair. Multicenter studies with a larger cohort and longer follow-up are necessary to validate these findings.

Motta F ，Parodi FE ，Knowles M ，Crowner JR ，Pascarella L ，McGinigle KL ，Marston WA ，Kibbe MR ，Ohana E ，Farber MA ... -  《-》

First/Preliminary Experience of Gore Viabahn Balloon-Expandable Endoprosthesis as Bridging Stent in Fenestrated and Branched Endovascular Aortic Repair.

The aim of this study is to evaluate the preliminary outcomes of the Gore® Viabahn® balloon-expandable endoprosthesis (VBX) as bridging stent for fenestrated/branched aortic endograft. Between April and June 2018, patients undergoing fenestrated and branched-endovascular aortic repair were prospectively collected. Anatomical, procedural, and postoperative data of patients treated with VBX as bridging stents to connect fenestrations/branches to target visceral vessels (TVVs) were analyzed. Technical success and any TVV-related adverse event were assessed before discharge, at 30 days, and after 6 months of follow-up. Fifteen patients undergoing fenestrated and branched-endovascular aortic repair for juxta/pararenal aneurysms (11), proximal type I endoleak after endovascular aortic repair (1), and thoracoabdominal aneurysms (3) were included in the study. Overall, 60 TVVs-celiac trunk (n = 14), superior mesenteric artery (n = 13), renal arteries (n = 30), hypogastric artery (n = 3)-were accommodated by fenestrations (n = 51), branches (n = 7), and scallops (n = 2). The bridging stent graft was a VBX in 40 (67%) TVVs. A renal artery dissection was successfully managed by a self-expandable bare metal stent. Overall, relining of a bridging stent graft was required in 2 TVVs revascularized by fenestrations (superior mesenteric artery: n = 1, renal artery: n = 1). One intraoperative type III endoleak from renal fenestration was detected and successfully sealed by an adjunctive flaring maneuver. Technical success was achieved in all cases. At 5-day, 1 VBX (1/40: 2.5%) lost its sealing in a renal artery revascularized by a branch (type II thoracoabdominal aortic aneurysm) and required reintervention and relining with a self-expandable stent graft. No TVV occlusion or reintervention occurred <30 days or after 6 months of follow-up. According to these preliminary results, the Gore Viabahn VBX balloon-expandable endoprosthesis can be safely used as bridging stent graft for fenestrated or branched endografts. A longer follow-up with a larger case load is necessary in order to validate this preliminary experience.

Gallitto E ，Faggioli G ，Pini R ，Mascoli C ，Sonetto A ，Abualhin M ，Logiacco A ，Ricco JB ，Gargiulo M ... -  《-》