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 ... -  《-》

Perioperative neurologic outcomes of right versus left upper extremity access for fenestrated-branched endovascular aortic aneurysm repair.

Upper extremity (UE) access is frequently used for fenestrated-branched endovascular aortic aneurysm repair (F-BEVAR), particularly for complex repairs. Traditionally, left-side UE access has been used to avoid crossing the arch and the origin of the supra-aortic vessels, which could potentially result in cerebral embolization and an increased risk of perioperative cerebrovascular events. More recently, right UE has been more frequently used as it is more convenient and ergonomic. The purpose of this study was to assess the outcomes and cerebrovascular events after F-BEVAR with the use of right- vs left-side UE access. During an 8-year period, 453 patients (71% male) underwent F-BEVAR at a single institution. UE access was used in more complex repairs. Left UE access was favored in the past, whereas right UE access is currently the preferred UE access side. Brachial artery cutdown was used in all patients for the placement of a 12F sheath. Outcomes were compared between patients undergoing right vs left UE access. End points included cerebrovascular events, perioperative mortality, technical success, and local access-related complications. UE access was used in 361 (80%) patients. The right side was used in 232 (64%) and the left side in 129 (36%) patients for the treatment of 88 (25%) juxtarenal, 135 (38%) suprarenal, and 137 (38%) thoracoabdominal aortic aneurysms. Most procedures were elective (94%). Technical success was achieved in 354 patients (98%). In-patient or 30-day mortality was 3.3%. Five (1%) perioperative strokes occurred in patients undergoing right UE access, of which three were ischemic and two were hemorrhagic. No transient ischemic attacks occurred perioperatively. Two hemorrhagic strokes were associated with permissive hypertension to prevent spinal cord ischemia. No perioperative strokes occurred in patients undergoing left UE access (P = .16). Overall, perioperative strokes occurred with similar frequency in patients undergoing UE (5, 1%) and femoral access only (1, 1%) (P = .99). Arm access-related complications occurred in 15 (5%) patients, 11 (4.8%) on the right side and 4 (6%) on the left side (P = .74). Right UE access can be used for F-BEVAR with low morbidity and minimal risk of perioperative ischemic stroke or transient ischemic attacks. In general, UE access is not associated with an increased risk of perioperative stroke compared with femoral access only. Tight blood pressure control is, however, critical to avoid intracranial bleeding related to uncontrolled hypertension.

Scott CK ，Driessen AL ，Gonzalez MS ，Malekpour F ，Guardiola GG ，Baig MS ，Kirkwood ML ，Timaran CH ... -  《-》

Comparison of upper extremity and transfemoral access for fenestrated-branched endovascular aortic repair.

The use of upper extremity (UE) access is an accepted and often implemented approach for fenestrated/branched endovascular aortic aneurysm repair (F-BEVAR). The advent of steerable sheaths has enabled the performance of F-BEVAR using a total transfemoral (TF) approach without UE access, potentially decreasing the risks of cerebral embolic events. The purpose of the present study was to assess the outcomes of F-BEVAR using UE vs TF access. Prospectively collected data from nine physician-sponsored investigational device exemption studies at U.S. centers were analyzed using a standardized database. All patients were treated for complex abdominal aortic aneurysms (CAAAs) and thoracoabdominal aortic aneurysms (TAAAs) using industry-manufactured fenestrated and branched stent grafts between 2005 and 2020. The outcomes were compared between patients who had undergone UE vs total TF access. The primary composite outcome was stroke or transient ischemia attack (TIA) and 30-day or in-patient mortality during the perioperative period. The secondary outcomes included technical success, local access-related complications, and perioperative mortality. Among 1681 patients (71% men; mean age, 73.43 ± 7.8 years) who had undergone F-BEVAR, 502 had had CAAAs (30%), 535 had had extent IV TAAAs (32%), and 644 had had extent I to III TAAAs (38%). UE access was used for 1103 patients (67%). The right side was used for 395 patients (24%) and the left side for 705 patients (42%). UE access was preferentially used for TAAAs (74% vs 47%; P < .001). In contrast, TF access was used more frequently for CAAAs (53% vs 26%; P < .01). A total of 38 perioperative cerebrovascular events (2.5%), including 32 strokes (1.9%) and 6 TIAs (0.4%), had occurred. Perioperative cerebrovascular events had occurred more frequently with UE access than with TF access (2.8% vs 1.2%; P = .036). An individual component analysis of the primary composite outcome revealed a trend for more frequent strokes (2.3% vs 1.2%; P = .13) and TIAs (0.54% vs 0%; P = .10) in the UE access group. On multivariable analysis, total TF access was associated with a 60% reduction in the frequency of perioperative cerebrovascular events (odds ratio, 0.39; P = .029). No significant differences were observed between UE and TF access in the technical success rate (96.5% vs 96.8%; P = .72), perioperative mortality (2.9% vs 2.6%; P = .72), or local access-related complications (6.5% vs 5.5%; P = .43). In the present large, multicenter, retrospective analysis of prospectively collected data, a total TF approach for F-BEVAR was associated with a lower rate of perioperative cerebrovascular events compared with UE access. Although the cerebrovascular event rate was low with UE access, the TF approach offered a lower risk of stroke and TIA. UE access will continue to play a role for appropriately selected patients requiring more complex repairs with anatomy not amenable to the TF approach.

Chamseddin K ，Timaran CH ，Oderich GS ，Tenorio ER ，Farber MA ，Parodi FE ，Schneider DB ，Schanzer A ，Beck AW ，Sweet MP ，Zettervall SL ，Mendes B ，Eagleton MJ ，Gasper WJ ，U.S. Aortic Research Consortium ... -  《-》

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 ... -  《-》

Upper extremity access for fenestrated endovascular aortic aneurysm repair is not associated with increased morbidity.

Fenestrated endovascular aortic aneurysm repair (FEVAR) is an alternative to open repair in patients with complex abdominal aortic aneurysms who are neither fit nor suitable for standard open or endovascular repair. Chimney and snorkel grafts are other endovascular alternatives but frequently require bilateral upper extremity access that has been associated with a 3% to 10% risk of stroke. However, upper extremity access is also frequently required for FEVAR because of the caudal orientation of the visceral vessels. The purpose of this study was to assess the use of upper extremity access for FEVAR and the associated morbidity. During a 5-year period, 148 patients underwent FEVAR, and upper extremity access for FEVAR was used in 98 (66%). Outcomes were compared between those who underwent upper extremity access and those who underwent femoral access alone. The primary end point was a cerebrovascular accident or transient ischemic attack, and the secondary end point was local access site complications. The mean number of fenestrated vessels was 3.07 ± 0.81 (median, 3) for a total of 457 vessels stented. Percutaneous upper extremity access was used in 12 patients (12%) and open access in 86 (88%). All patients who required a sheath size >7F underwent high brachial open access, with the exception of one patient who underwent percutaneous axillary access with a 12F sheath. The mean sheath size was 10.59F ± 2.51F (median, 12F), which was advanced into the descending thoracic aorta, allowing multiple wire and catheter exchanges. One hemorrhagic stroke (one of 98 [1%]) occurred in the upper extremity access group, and one ischemic stroke (one of 54 [2%]) occurred in the femoral-only access group (P = .67). The stroke in the upper extremity access group occurred 5 days after FEVAR and was related to uncontrolled hypertension, whereas the stroke in the femoral group occurred on postoperative day 3. Neither patient had signs or symptoms of a stroke immediately after FEVAR. The right upper extremity was accessed six times without a stroke (0%) compared with the left being accessed 92 times with one stroke (1%; P = .8). Four patients (4%) had local complications related to upper extremity access. One (1%) required exploration for an expanding hematoma after manual compression for a 7F sheath, one (1%) required exploration for hematoma and neurologic symptoms after open access for a 12F sheath, and two patients (2%) with small hematomas did not require intervention. Two (two of 12 [17%]) of these complications were in the percutaneous access group, which were significantly more frequent than in the open group (two of 86 [2%]; P = .02). Upper extremity access appears to be a safe and feasible approach for patients undergoing FEVAR. Open exposure in the upper extremity may be safer than percutaneous access during FEVAR. Unlike chimney and snorkel grafts, upper extremity access during FEVAR is not associated with an increased risk of stroke, despite the need for multiple visceral vessel stenting.

Knowles M ，Nation DA ，Timaran DE ，Gomez LF ，Baig MS ，Valentine RJ ，Timaran CH ... -  《-》