Outcomes of a novel upper extremity preloaded delivery system for fenestrated-branched endovascular repair of thoracoabdominal aneurysms.

The aim of this study was to evaluate the feasibility and outcomes of endovascular repair of thoracoabdominal aortic aneurysms (TAAAs) using a novel low profile (LP) device with upper extremity preloaded guidewire system (PGS) and compare procedural metrics and outcomes with a standard multibranch stent graft (t-Branch; Cook Medical, Bloomington, Ind). We reviewed the clinical data of 232 consecutive patients treated by fenestrated-branched endovascular aortic repair for TAAA and enrolled in a prospective nonrandomized trial between 2014 and 2017. Patients who had repair using t-Branch or patient-specific TAAA devices using upper extremity LP-PGS were included. End points were technical success, operative and fluoroscopic time, patient radiation exposure, time from arterial access to complete device deployment, total contrast volume, and 30-day rates of major adverse events (MAEs) and mortality. There were 54 patients, including 33 males (67%) and 21 females (33%), with a mean age of 73 ± 9 years old. Forty-nine patients (91%) had extent I-III and five patients (9%) had extent IV TAAAs. Device design was t-Branch in 24 patients (44%) and LP-PGS in 30 patients (56%). A total of 206 renal-mesenteric arteries were incorporated with no difference between groups (mean, 3.8 ± 0.6 target vessels/patient; P = .92). Patients treated by t-Branch device had larger mean aneurysm diameter (79 ± 16 vs 66 ± 10 mm; P = .0006). All patients had transbrachial approach. Technical success was achieved in all patients in both groups. Patients treated by LP-PGS devices had lower radiation dose (1250 ± 849 vs 3154 ± 2421 mGy; P = .003) and shorter operating time for complete device deployment (105 ± 42 vs 123 ± 34 minutes; P = .043). There was no difference in mean operative time (252 ± 69 vs 273 ± 56 minutes; P = .23), fluoroscopy time (82 ± 29 vs 96 ± 35 minutes; P = .08) or contrast volume (163 ± 59 vs 197 ± 75 mL; P = .07) comparing LP-PGS and t-Branch respectively. There was no 30-day or in-hospital mortality. There were no differences in MAEs, which occurred in 18 patients (33%) in both groups (P > .05). Endovascular TAAA repair using the standard or LP-PGS multibranch stent graft was associated with high technical success, no mortality, and a low rate of MAEs in this study. Patients treated by upper extremity LP-PGS had shorter time to complete device deployment, suggesting decreased technical demand with preloaded systems.

Mirza AK ，Tenorio ER ，Kärkkäinen JM ，Pather K ，Kratzberg J ，Mendes BC ，DeMartino RR ，Oderich GS ... -  《-》

Outcomes of low- and standard-profile fenestrated and branched stent grafts for treatment of complex abdominal and thoracoabdominal aortic aneurysms.

We compared the outcomes of fenestrated-branched (FB) endovascular abdominal aortic aneurysm repair (EVAR) using low-profile (LP) and standard-profile (SP) stent grafts for the treatment of complex abdominal aortic aneurysms (CAAAs) and thoracoabdominal aortic aneurysms (TAAAs). We reviewed the clinical data of 466 consecutive patients (70% male; mean age, 74 ± 8 years) enrolled in a prospective nonrandomized study to investigate FB-EVAR for the treatment of CAAAs and TAAAs (2013-2021). The endpoints compared between the patients treated with LP (18F-20F) and SP (20F-22F) devices included procedural metrics, access-related complications, major adverse events (MAE), patient survival, freedom from secondary intervention, thromboembolic events, stent graft integrity issues, aneurysm sac enlargement, and the rate of sac shrinkage. Of the 466 aneurysms treated by FB-EVAR, 138 were CAAAs and 141 were extent IV and 187 extent I to III TAAAs, with a mean number of 3.9 ± 0.5 vessels stented per patient. LP devices had been used in 239 patients (51%) and SP devices in 227 patients (49%). LP devices had been used more frequently for chronic dissections (12% vs 7%; P = .041) and with preloaded systems (77% vs 65%; P = .005) and bilateral percutaneous femoral access (83% vs 74%; P = .020) and less frequently with upper extremity access (67% vs 88%; P < .001) and iliac conduits (2% vs 6%; P = .020). The patients treated using LP devices had experienced similar technical success (96% vs 97%; P = .527), with a shorter total operating time (225 ± 81 minutes vs 243 ± 78 minutes; P = .018), lower radiation exposure (median, 0.93 Gy; interquartile range [IQR], 0.94; vs median, 1.01 Gy; IQR, 0.91 Gy; P < .001), and less use of contrast (median, 135 mL; IQR, 68 mL; vs median, 144 mL; IQR, 80 mL; P = .008). No differences were found in the rates of iliofemoral access complications between the LP and SP device groups (1.3% vs 3.5%; P = .107). At 30 days, 5 patients had died (1%) and MAEs had occurred in 89 patients (19%), with no differences between the two groups. The mean follow-up was 28 months (95% confidence interval, 25-30 months). At 4 years, the patients treated with LP devices had had similar freedom from all-cause mortality (69% ± 6% vs 68% ± 4%; P = .199), freedom from aortic-related mortality (97% ± 1% vs 98% ± 1%; P = .488), freedom from any secondary intervention (65% ± 6% vs 70% ± 4%; P = .433), freedom from thromboembolic events (98% ± 1% vs 99% ± 1%; P = .364) and aneurysm sac enlargement (93% ± 3% vs 91% ± 3%; P = .293). However, the LP group had had less freedom from any integrity-related issues (92% ± 5% vs 100%; P < .001). The cumulative risk of sac shrinkage was greater for patients treated with LP devices (adjusted hazard ratio, 2.040; 95% confidence interval, 1.516-2.744; P < .001). FB-EVAR was performed with low rates of mortality and MAEs, irrespective of the device profile. However, the procedures performed with LP devices had had less need for iliac conduits and had had better procedural metrics. The use of LP devices resulted in higher rates of sac shrinkage. However, the results on stent graft integrity require future investigation.

Dias-Neto M ，Tenorio ER ，Lima GBB ，Baghbani-Oskouei A ，Saqib N ，Mendes BC ，Mirza AK ，Oderich GS ... -  《-》

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 ... -  《-》

Expanded Use of Preloaded Branched and Fenestrated Endografts for Endovascular Repair of Complex Aortic Aneurysms.

The aim of this study was to report the expanded use of preloaded catheters and wires of fenestrations and directional branches to facilitate access to renal and mesenteric target arteries during endovascular repair of complex aortic aneurysms. This was an observational retrospective cohort multicentre study. Prospectively collected data from six physician sponsored investigational device exemption studies at US centres were analysed. Patients were treated with fenestrated and branched aortic endografts for pararenal and thoraco-abdominal aortic aneurysms (TAAAs) between 2012 and 2017. Technical success was defined as successful intra-operative catheterisation and stenting of all intended target visceral arteries. Univariable and stratified analyses were performed to identify differences in outcomes between repairs using preloaded and standard devices. There were 564 patients (73% men, mean age 73 ± 8 years) treated for 168 pararenal aortic aneurysms (29.8%), 216 type IV TAAAs (38.3%), and 180 type I - III TAAAs (31.9%). Preloaded grafts (PGs) were used in 387 (68.6%) patients and standard grafts (SGs) in 177 (31.4%). PGs were used preferentially for type IV TAAAs (45% vs. 24%; p < .001), whereas standard devices were used more frequently among patients with type I - III TAAAs (24% vs. 49%; p < .001). The majority of custom made devices were preloaded (95% vs. 21%; p < .001). A total of 2 157 target arteries were incorporated (mean 3.9/patient) utilising 1 469 fenestrations (68.1%), 603 directional branches (27.9%), and 85 double wide scallops (3.9%). Most PGs included fenestrations (80% vs. 43%; p < .001), whereas directional branches were more frequent in standard devices (17% vs. 53%; p < .001). Contrast volume, fluoroscopy time, radiation dose, and operative time were not significantly different between preloaded and standard devices. Upper extremity access was more frequent for PGs (87% vs. 72%; p < .001). Overall technical success was 98.8% and comparable for both preloaded and standard grafts (99.5% vs. 97.2%; p = .022). The 30 day stroke rate was similar for PGs and SGs (2.3% and 1.7%%, respectively). The 30 day mortality rate was 1.9%, and low for both PGs and SGs (0.8% vs. 4.5%; p = .003). Endovascular repair of complex aortic aneurysms is safe and effective. The expanded use of preloaded catheters and wires of fenestrations and directional branches for target artery incorporation is associated with a high technical success and low early mortality.

Timaran CH ，Oderich GS ，Tenorio ER ，Farber MA ，Schneider DB ，Schanzer A ，Beck AW ，Sweet MP ，Aortic Research Consortium ... -  《-》

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 ... -  《-》