Percutaneous AXillary Artery (PAXA) Access at the First Segment During Fenestrated and Branched Endovascular Aortic Procedures.

The aim of this study was to assess the feasibility and safety of percutaneous axillary access with vessel closure device closure after puncturing the first segment during endovascular treatment of complex aneurysms with fenestrated and branched endografts (F/BEVAR). The PAXA (Percutaneous AXillary Access) study is a physician initiated, single centre, ambispective, non-randomised study (clinicaltrials.gov: NCT03223311). The primary endpoint was the closure success rate defined as the absence of any vascular injury to achieve haemostasis at the puncture site, requiring any treatment other than manual compression or adjunctive endovascular ballooning. The secondary endpoints were minor access complications, cerebrovascular complication rate, short term access vessel patency, and study cohort anatomical evaluation of the axillary artery. Sixty-four patients required an upper extremity access during F/BEVAR procedure during study period (November 2016 to July 2019) and were screened for the PAXA study: 59 patients (47 males; median age: 75 years, IQR 69-78) met the study inclusion criteria and were enrolled (one patient had bilateral access). Closure success was obtained in 54 cases (90%) with no open conversion required: five patients received a bare or covered stenting to the AXA and in one patient mechanical failure of the delivery system was recorded. No 30 day permanent peripheral nerve injuries and two non-ipsilateral ischaemic strokes (3.4%) were recorded. Seven patients (12%) had access haematomas managed conservatively associated with closure failure (p = .002), oral anticoagulants therapy (p = .005) and procedure length (p = .028). At short term follow up (6 months), no late complications were observed, and all access vessels were patent. PAXA on the first segment using a large sheath (10-16F) is technically feasible, relatively safe with no need for open conversion but it may require access related secondary endovascular procedures. Further prospective studies are needed to modify the device instruction for use and to put the procedure on label.

Bertoglio L ，Grandi A ，Melloni A ，Kahlberg A ，Melissano G ，Chiesa R ... -  《-》

Percutaneous axillary artery access for fenestrated and branched thoracoabdominal endovascular repair.

The aim of this study was to assess the safety and effectiveness of upper extremity access (UEA) with percutaneous closure of the axillary artery (AxA) during endovascular treatment of thoracoabdominal aortic aneurysms with fenestrated and branched endografts. Between January 2014 and 2017, 34 out of 37 patients (92%) required UEA during a staged branched and fenestrated endovascular approach. A percutaneous AxA (pAxA) approach was used in 14 consecutive patients (41%) with the off-label use of two Perclose ProGlide (Abbott Vascular, Santa Clara, Calif) devices. The results of patients who had received a pAxA access were analyzed; technical success was defined as successful arterial closure with no evidence of persistent bleeding or arterial occlusion requiring secondary interventions. Early (30 days) and short-term (6 months) success rates were recorded. The anatomic characteristics of the AxA of the entire cohort (34 cases) were studied. Primary technical success of pAxA was 100%; in one case, an adjunctive Perclose ProGlide device was used to achieve complete closure. No secondary open or endovascular procedures were required. At predischarge computed tomography, no intimal defects, pseudoaneurysms, or signs of bleeding were observed, and all patients were discharged without neurologic deficits related to the AxA puncture site. All 14 patients are alive at follow-up, and 9 of 14 patients completed a 6-month clinical follow-up with computed tomography examination; no late complications were observed at the site of UEA percutaneous repair. With regard to the anatomic characteristics of the AxA, the vessel diameters in the first and third segments were statistically different (P < .001) with a median difference of 1.5 mm (1.0-2.0 mm), with no differences between the right and left sides. The distance between the end of the first segment of the AxA and the origin from the aortic arch was statistically different between the right and left sides, with a median difference of 36 mm (17-50 mm). A positive linear correlation was found between the diameter of the AxA and the height of the patients. AxA is adequate in terms of both caliber and lack of calcifications as an access vessel for large-sheath catheterizations, and it might be considered an alternative UEA for complex aortic endovascular procedures thanks to its proximity to visceral target vessels. In this preliminary experience, percutaneous closure of AxA access with the Perclose ProGlide device is clinically safe and technically feasible with high rates of success.

Bertoglio L ，Mascia D ，Cambiaghi T ，Kahlberg A ，Melissano G ，Chiesa R ... -  《-》

Percutaneous Axillary Artery Access for Endovascular Treatment of Complex Thoraco-abdominal Aortic Aneurysms.

The aim of this study was to determine the feasibility and safety of percutaneous axillary artery (AxA) access using vascular closure devices (VCD) for endovascular repair (ER) of thoraco-abdominal aortic aneurysms (TAAA) using fenestrated, branched, and chimney stent grafts. Between September 2013 and December 2017, 40 high risk patients (27 men; mean age: 72.7 ± 7.4 years) with TAAA underwent total percutaneous endovascular aortic repair by percutaneous puncture of the third segment of the left AxA, using a 12F sheath for delivery of the bridging visceral stent grafts. Percutaneous closure was performed using ultrasound guidance and two Perclose ProGlide VCDs per puncture site. Endpoints were device success defined as successful haemostasis of the axillary puncture site by VCD, procedure success defined as endovascularly assisted haemostasis of the AxA, major cerebrovascular and peripheral neurological complications, and 30 day mortality. The median diameter of the AxA in the third segment was 6.5 mm (range 4.4-10.4 mm). The procedure success was 100%. Device success was achieved in 33 patients (82.5%). Device success in patients with AxA diameter >5 mm was 97%. All patients with diameter of the AxA <5 mm developed stenosis or occlusions of the vessel (n = 6), which were treated by percutaneous stent implantation. One bleeding at the AxA puncture site was treated with trans-femoral implantation of a covered stent. No secondary open procedures were required. No neurological deficit of the left upper limb was seen at discharge. Overall mortality at 30 days was 10%. Direct puncture of the AxA in the third segment and its use as an access vessel for large sheaths during total percutaneous treatment of complex endovascular aortic procedures appear to be feasible and safe in arteries with a diameter >5 mm. Complications can be managed using endovascular techniques.

Branzan D ，Steiner S ，Haensig M ，Scheinert D ，Schmidt A ... -  《-》

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 ... -  《-》

Percutaneous transaxillary access for endovascular aortic procedures in the multicenter international PAXA registry.

The aim of the study was to demonstrate the safety and effectiveness of a suture-mediated vascular closure device to perform hemostasis after an axillary artery access during endovascular procedures on the aortic valve, the aorta and its side branches. A physician-initiated, international, multicenter, retrospective registry was designed to evaluate the success rate (VARC-2 reporting standards) of percutaneous transaxillary access closure with a suture-mediated closure device. Secondary end points were minor access vascular complications, transient peripheral nerve injury, stroke, and influence on periprocedural outcomes of puncture technique. Three hundred thirty-one patients (median age, 76 years; 69.2% males) in 11 centers received a percutaneous transaxillary access during endovascular cardiac (n = 166) or vascular (n = 165) procedures. The closure success rate was 84.6%, with 5 open conversions (1.5%), 45 adjunctive endovascular procedures (13.6%), and 1 nerve injury (0.3%). Secondary closure success was obtained in 325 patients (98%) after 7 bare stenting, 37 covered stenting, and 1 thrombin injection. Introducer sheaths 16F or larger (odds ratio, 3.70; 95% confidence interval, 1.22-11.42) and balloon-assisted hemostasis (odds ratio, 4.45; 95% confidence interval, 1.27-15.68) were associated with closure failure. A threshold of five percutaneous axillary accesses was associated with decreased rates of open conversion, but not with increased primary closure success. Primary closure success was 90.3% in the 175 patients with sheaths smaller than 16F, performed after the first 5 procedures in each center. Temporary nerve injury and stroke were observed in 2% and 4% of patients, respectively. Percutaneous transaxillary aortic procedures, in selected patients, can be performed with low rates of open conversion. The need for additional endovascular bailout procedures is not negligible when introducers sheaths 16F or larger are required.

Bertoglio L ，Conradi L ，Howard DPJ ，Kaki A ，Van den Eynde W ，Rio J ，Montorfano M ，Dias NV ，Ronchey S ，Parlani G ，Chiesa R ，Schewel J ，of the PAXA Collaborators ... -  《-》