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 ... -  《-》

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 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 ... -  《-》

Outcomes of fenestrated and branched endovascular repair of complex abdominal and thoracoabdominal aortic aneurysms.

More than 80% of infrarenal aortic aneurysms are treated by endovascular repair. However, adoption of fenestrated and branched endovascular repair for complex aortic aneurysms has been limited, despite high morbidity and mortality associated with open repair. There are few published reports of consecutive outcomes, inclusive of all fenestrated and branched endovascular repairs, starting from the inception of a complex aortic aneurysm program. Therefore, we examined a single center's consecutive experience of fenestrated and branched endovascular repair of complex aortic aneurysms. This is a single-center, prospective, observational cohort study evaluating 30-day and 1-year outcomes in all consecutive patients who underwent fenestrated and branched endovascular repair of complex aortic aneurysms (definition: requiring one or more fenestrations or branches). Data were collected prospectively through an Institutional Review Board-approved registry and a physician-sponsored investigational device exemption clinical trial (G130210). We performed 100 consecutive complex endovascular aortic aneurysm repairs (November 2010 to March 2016) using 58 (58%) commercially manufactured custom-made devices and 42 (42%) physician-modified devices to treat 4 (4%) common iliac, 42 (42%) juxtarenal, 18 (18%) pararenal, and 36 (36%) thoracoabdominal aneurysms (type I, n = 1; type II, n = 4; type III, n = 12; type IV, n = 18; arch, n = 1). The repairs included 309 fenestrations, branches, and scallops (average of 3.1 branch arteries/case). All patients had 30-day follow-up for 30-day event rates: three (3%) deaths; six (6%) target artery occlusions; five (5%) progressions to dialysis; eight (8%) access complications; one (1%) paraparesis; one (1%) bowel ischemia; and no instances of myocardial infarction, paralysis, or stroke. Of 10 type I or type III endoleaks, 8 resolved (7 with secondary intervention, 1 without intervention). Mean follow-up time was 563 days (interquartile range, 156-862), with three (3%) patients lost to follow-up. On 1-year Kaplan-Meier analysis, survival was 87%, freedom from type I or type III endoleak was 97%, target vessel patency was 92%, and freedom from aortic rupture was 100%. Average lengths of intensive care unit stay and inpatient stay were 1.4 days (standard deviation, 3.3) and 3.6 days (standard deviation, 3.6), respectively. These results show that complex aortic aneurysms can now be treated with minimally invasive fenestrated and branched endovascular repair. Endovascular technologies will likely continue to play an increasingly important role in the management of patients with complex aortic aneurysm disease.

Schanzer A ，Simons JP ，Flahive J ，Durgin J ，Aiello FA ，Doucet D ，Steppacher R ，Messina LM ... -  《-》

Outcomes and complications after fenestrated-branched endovascular aortic repair.

To report the outcomes of patients enrolled in a physician-sponsored investigational device exemption trial for endovascular treatment of complex thoracoabdominal aortic aneurysms with fenestrated and/or branched devices. This study represents a retrospective analysis of a prospectively maintained database of patients enrolled in a physician-sponsored investigational device exemption trial for endovascular treatment of complex thoracoabdominal aneurysms between July 2012 and July 2017. Subjects included high-risk patients for open repair and patients with unsuitable anatomy for either standard endovascular aneurysm repair or Zenith (Cook Medical, Bloomington, Ind) fenestrated device. Aneurysm classification was based upon Crawford classification. We included the pararenal and paravisceral aneurysms in the type IV aneurysm group, because the repair of these aneurysms usually involved treatment of all four visceral branches. The endografts implanted were custom manufactured devices or off-the-shelf devices based on the Cook Zenith platform. Variables analyzed included preoperative demographics and comorbidities, anatomic aneurysmal characteristics, procedural details, and perioperative complications. One -hundred fifty patients with a mean age of 71 ± 7.9 years were treated; 69% were male. Tobacco use (93%) and hypertension (91%) were the most common risk factors. Fifty-seven patients (38%) had a history of previous aortic repair. The mean aneurysm diameter was 62 ± 12 mm and 14 (9%) aneurysms were associated with chronic dissection. A total of 573 visceral vessels were incorporated (celiac artery/superior mesenteric artery [287 vessels], renal arteries [275 vessels], and 11 additional vessels) and 539 were stented. The celiac artery/superior mesenteric artery received a fenestrated design in 76.1% of cases. Branch designs were used in the renal artery in 13.2%, with the remainder treated with fenestrations. Spinal cord drainage was used in 51% of patients (76/150). The mean operative time, fluoroscopy time, and estimated blood loss were 283 ± 89 minutes, 83 ± 38 minutes, and 417 ± 404 mL, respectively. There were five patients (3.3%) with intraoperative complications, resulting in one intraoperative death. The early mortality was 2.7% (4/150). Major complications included respiratory failure in 7% (10/150), stroke and myocardial infarction in 0.7% each (1/150), and paraplegia in 2.7% (4/150). Acute kidney injury occurred in 4.7% of patients (7/150), two of whom required temporary dialysis. Thirty-nine percent of patients experienced at least one complication. Early branch vessel patency was 99.8% (525/526). Survival, primary, and primary-assisted branch patency at 2 years of follow-up were 79%, 97%, and 99%, respectively. Endovascular repair of complex aneurysms is safe and effective when performed in a high-volume center experienced in aortic disease management. Branch vessels patency and the low incidence of paraplegia and mortality support expanded use to treat most complex thoracoabdominal aortic aneurysms.

Motta F ，Crowner JR ，Kalbaugh CA ，Marston WA ，Pascarella L ，McGinigle KL ，Kibbe MR ，Farber MA ... -  《-》