Utility and safety of axillary conduits during endovascular repair of thoracoabdominal aneurysms.

Endovascular treatment of thoracoabdominal aortic aneurysms (TAAAs) with branched and fenestrated stent grafts often requires upper extremity arterial access for antegrade delivery of bridging covered stents into the visceral arteries. Axillary, brachial, and radial artery approaches have been described, but data on the safety and utility of the different approaches remain limited. We have preferentially used axillary artery conduits for upper extremity arterial access during endovascular repair of TAAA and describe our technique and report our experience herein. Thirty-two patients were treated within an investigator-sponsored investigational device exemption clinical trial of endovascular repair of TAAAs using custom-manufactured stent grafts. In 29 of these cases, the axillary artery was exposed through an infraclavicular incision, and an axillary conduit was used for antegrade delivery of bridging visceral artery stent components. In all cases, a 12F sheath was placed through the conduit for delivery of stent graft components. The left axillary artery was used in 27 of these 29 cases, and the right axillary artery was used in 2 patients. Proximal brachial artery access was used in two patients, and one patient did not require upper extremity access. Aneurysms treated included pararenal (n = 3) and Crawford TAAA extent I (n = 1), extent II (n = 3), extent III (n = 10), and extent IV (n = 15). Patients have been followed up to 2 years after the procedure, with a mean follow-up of 226 days. Axillary conduits were used to deliver a total of 170 stent components placed into 81 branches and 27 fenestrations with 99.1% technical success (one accessory renal branch could not be cannulated). There were no intraoperative complications related to the construction or use of the conduit. There were two postoperative complications (6.9%) potentially attributable to the conduit; one patient experienced ipsilateral hand weakness and one patient had postoperative minor stroke, which resolved by the first postoperative visit. There were no cases of arm ischemia, wound hematoma, or reoperation related to the conduit. The use of an axillary conduit during endovascular repair of complex aortic aneurysms provides safe and effective upper extremity access for delivery of visceral branches. Moreover, axillary conduits facilitate delivery of 12F sheaths without interrupting upper extremity perfusion and provide a shorter working distance compared with brachial artery approaches.

Stern JR ，Ellozy SH ，Connolly PH ，Meltzer AJ ，Schneider DB ... -  《-》

Lateral Axillary Exposure for Antegrade Access during Endovascular Repair of Complex Abdominal Aortic and Thoracoabdominal Aneurysms.

During endovascular treatment of pararenal aortic aneurysms (PAA) and thoracoabdominal aortic aneurysms (TAAA), our antegrade vascular access of choice is a lateral axillary exposure (LAE). We directly access the axillary artery with multiple sheaths followed by primary closure of the axillary artery at case completion. The aim of this study is to describe our technique and to report our results with this approach. This study is a single-institution, retrospective review of 53 patients who were treated with parallel grafts for endovascular repair of PAA and TAAA from 2006 to 2018. The aortic repairs requiring LAE included: 9 cases of endo-leaks from prior endovascular repair, 20 TAAAs, and 24 PAAs. The axillary artery was exposed with a vertical axillary skin incision followed by retraction of the lateral border of the pectoralis major to expose the axillary artery distal to the pectoralis minor. A 5-French (F) through 12F sheaths were used to directly access the axillary artery for delivery of endovascular devices. Two hundred and sixty reno-visceral stents were delivered through 125 axillary sheaths in an antegrade fashion to 114 arteries without intraoperative complications or technical failures. Two postoperative complications included an access-site hematoma managed conservatively (1.9%) and a left brachial vein thrombosis treated with anticoagulation (1.9%). There were no cases of cerebrovascular or peripheral neurologic events, upper extremity ischemia, or reoperation related to LAE. LAE is a valid approach for upper extremity access during the endovascular repair of complex aortic aneurysms requiring simultaneous delivery of multiple reno-visceral devices. It does not require the use of a prosthetic conduit. There were no neurologic events or upper extremity ischemia in our series.

Aru RG ，Miller JC ，Clark AH ，Hubbuch J ，Hughes TG ，Bounds MC ，Minion DJ ，Tyagi SC ... -  《-》

Outcomes of upper extremity access during fenestrated-branched endovascular aortic repair.

Upper extremity (UE) access is frequently used during fenestrated-branched endovascular aortic repair (F-BEVAR) to facilitate catheterization of downgoing vessels. Limitations include risk of cerebral embolization and of UE arterial or peripheral nerve injury. The aim of this study was to assess outcomes of F-BEVAR using UE access. We reviewed the clinical data of 334 consecutive patients (74% males; mean age 75 ± 8 years) treated by F-BEVAR for thoracoabdominal aortic aneurysms or pararenal aortic aneurysms between 2007 and 2016. Patients who underwent F-BEVAR with an UE approach for catheterization of the renal and/or mesenteric arteries were included in the study. End points were technical success, mortality, and a composite of access-related complications including cerebral embolization (stroke/transient ischemic attack), peripheral nerve injury, and axillary-brachial arterial complications requiring intervention. There were 243 patients (73%) treated by F-BEVAR with UE access, including 147 patients (60%) with thoracoabdominal aortic aneurysms and 96 patients (40%) with pararenal aortic aneurysms. A total of 878 renal-mesenteric arteries were incorporated by fenestrations or branches with a mean of 3.6 ± 0.8 vessels per patient. All patients had surgical exposure of the brachial artery. The left side was selected in 228 (94%) and the right side in 15 (6%). The technical success of target vessel incorporation was achieved in 99% of patients (870 of 878). Arterial closure was performed using primary repair in 213 patients (88%) or bovine patch angioplasty in 29 (12%). Patch closure was required in 13% of patients (21 of 159) treated by 10- to 12F sheaths and 8% (7 of 83) of those who had 7- to 8F sheaths (P = .19). There were six deaths (2.5%) at 30 days or within the hospital stay, none owing to access-related complications. Major access-related complication occurred in eight patients (3%), with no difference between the 10- to 12F (6 of 159 [4%]) or 7- to 8F sheaths (2 of 83 [2%]; P = .45). Two patients (1%) had transient median nerve neuropraxia, which resolved within 1 year. One patient (0.5%) required surgical evacuation of an access site hematoma. There were no UE arterial pseudoaneurysms, occlusions, or distal embolizations. Five patients (2%) had strokes (three minor, two major), occurring more frequently with right side (2 of 15 [13%]) as compared with left-sided access (3 of 228 [1%]; P = .03). After a mean follow-up of 38 ± 15 months, there were no other access-related complications or reinterventions. UE arterial access with surgical exposure was associated with a low rate of complications in patients treated with F-BEVAR. Closure with patch angioplasty is frequently needed, but there were no arterial occlusions, pseudoaneurysms, or distal embolizations requiring secondary procedures.

Mirza AK ，Oderich GS ，Sandri GA ，Tenorio ER ，Davila VJ ，Kärkkäinen JM ，Hofer J ，Cha S ... -  《-》

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 ... -  《-》

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 ... -  《-》