Early Outcomes of Interwoven Nitinol Wire Stent Placement versus Endarterectomy for the Treatment of Atherosclerotic Disease of the Common Femoral Artery.

PURPOSE: To compare the clinical outcomes of common femoral artery (CFA) atherosclerotic disease treated with either surgical endarterectomy or an interwoven nitinol wire stent system. MATERIALS AND METHODS: A retrospective review was conducted of all patients with chronic, de novo atherosclerotic CFA disease treated with surgical endarterectomy (CFAE) or stent placement between July 2019 and March 2022. Outcome measures assessed up to 12 months after procedure included clinical improvement, primary restenosis, target vessel revascularization (TVR), major adverse limb events (MALEs), and all-cause mortality. RESULTS: Thirty-nine stents were deployed in 33 patients, and 56 CFAEs were performed in 55 patients. No differences were noted in the rate of primary patency (95.5% vs 94.4%, P = .618), TVR (2.9% vs 1.8%, P = .777), MALE (5.1% vs 5.4%, P = .949), and all-cause mortality (14.1% vs 3.6%, P = .076) between the stent and CFAE groups up to 12 months after procedure. There was greater improvement in median clinical severity in the stent group than in the CFAE group (Rutherford score change of 3.0 vs 1.5, P = .013). The median length of stay was less for the stent group (3 vs 7 days, P = .002), and there was a lower likelihood of severe or disabling adverse events in the stent group (0 vs 9 cases, P = .010). CONCLUSIONS: Patients treated with an interwoven nitinol wire stent had patency rates comparable to those treated with CFAE while having a lower incidence of severe adverse events and a shorter length of hospital stay than those who underwent CFAE.

Editor's Choice - Influence of Proximal Aortic Neck Diameter on Durability of Aneurysm Sealing and Overall Survival in Patients Undergoing Endovascular Aneurysm Repair. Real World Data from the Gore Global Registry for Endovascular Aortic Treatment (GREAT).

OBJECTIVES: Aortic neck diameter is an independent anatomical feature that is poorly understood, yet potentially linked to proximal seal failure and adverse outcome following standard EVAR. The aim of this study was to assess whether large proximal aortic neck (LAN) diameter is associated with adverse outcome using prospectively collected individual patient data from The Global Registry for Endovascular Aortic Treatment (GREAT). METHODS: A total of 3166 consecutive patients, from 78 global centres, receiving Gore Excluder stent grafts for infrarenal abdominal aortic aneurysm repair between 2011 and 2017 were included. Patient demographics, biometrics, operative details, and clinical outcome were analysed. Patients were divided into two groups: normal baseline proximal aortic neck (NAN) diameter (<25 mm on computed tomography aortography), and LAN (≥25 mm). Clinical follow up (including imaging) was available for 76.5% of patients 5 years post-intervention. Primary endpoints analysed were Type IA endoleak and any aortic re-intervention up to 5 years post-procedure. A composite endpoint of Type IA endoleak, re-intervention, aortic rupture, or aortic related mortality was also assessed. RESULTS: A total of 1977 (62.4%) patients were classified NAN and 1189 (37.6%) were LAN. Immediate technical success was achieved in 3164 out of 3166 (>99.9%) of cases. Freedom from Type IA endoleak was achieved in 99.3% at 1 year and 97.3% at 5 years (lower in LAN vs. NAN: 96.8% [CI 93.7-98.4] vs. 98.6% [CI 94.5-99.6], p = .007). Freedom from aortic re-intervention was 93.7% at 1 year and 83.2% at 5 years (78.6% [CI 66.0-87.0] LAN vs. 86.0% [CI 81.8-89.3] NAN, p = .11). Freedom from primary composite endpoint was 95.9% at 1 year and 84.9% at 5 years (81.3% [CI 69.2-89.0] LAN vs. 87.0% [CI 81.6-91.0] NAN, p = .066). Five year survival was lower in the LAN group; 64.6% (CI 50.1-75.7) vs. 76.5% (CI 70.7-81.3), p = .03). CONCLUSION: LAN is associated with delayed Type IA endoleak occurrence and lower overall survival.

The Impact of Intravascular Ultrasound on Femoropopliteal Artery Endovascular Interventions: A Randomized Controlled Trial.

OBJECTIVES: The aim of this study was to investigate whether the addition of intravascular ultrasound (IVUS) guidance during femoropopliteal artery interventions reduced the rate of binary restenosis within 12 months compared with angiographic guidance alone. BACKGROUND: IVUS is more accurate than angiography for assessment of vessel size and disease severity. Low-level studies suggest that the use of IVUS in femoropopliteal endovascular interventions improves outcomes, but currently, no level 1 evidence exists. METHODS: This was a prospective single-center trial of 150 patients undergoing femoropopliteal endovascular intervention, randomized (1:1) to guidance by angiography or angiography and IVUS. The primary outcome measure was freedom from binary restenosis, on duplex ultrasound, within 12 months. Secondary outcomes included clinically driven target lesion revascularization, disagreements in imaging findings between modalities, and changes in treatment caused by IVUS. RESULTS: Freedom from binary restenosis at 12 months was significantly higher in the IVUS group (72.4% vs 55.4%; P = 0.008). There was no significant difference between groups for clinically directed target lesion revascularization (84.2% and 82.4%; P = 0.776). Mean vessel diameter was significantly larger with IVUS (5.60 mm vs 5.10 mm; P < 0.001). A change in treatment occurred caused by IVUS in 79% of cases. Binary restenosis was lower in the IVUS group for cases treated with drug-coated balloons (9.1% vs 37.5%; P = 0.001). CONCLUSIONS: The use of IVUS resulted in a significant reduction in the rate of restenosis after endovascular intervention. This is the first randomized controlled trial to demonstrate that IVUS improves outcomes in femoropopliteal interventions. This benefit may primarily relate to cases treated with drug-coated balloons. (Does the use of intravascular ultrasound improve outcomes of endovascular interventional procedures for peripheral vascular disease of the superficial femoral artery or popliteal artery?; ACTRN12614000006640).

Study protocol for a Prospective, Randomized controlled trial of stEnt graft and Drug-coated bAlloon Treatment for cephalic arch stenOsis in dysfunctional arteRio-venous fistulas (PREDATOR).

BACKGROUND: Treatment of cephalic arch stenosis (CAS) is associated with high risk of failure and complications. Although stent-graft (SG) placement has improved patency rates, stent edge restenosis has been raised as a potential limiting factor for SG usage in CAS. This study aims to evaluate the safety and efficacy of combining stent graft placement with paclitaxel-coated balloon (PCB) angioplasty versus PCB alone in the treatment of CAS. METHODS: This is an investigator-initiated, prospective, international, multicenter, open-label, randomized control clinical trial that plans to recruit 80 patients, who require fistuloplasty from dysfunctional arteriovenous fistula (AVF) from CAS. Eligible participants are randomly assigned to receive treatment with SG and PCB or PCB alone in a 1:1 ratio post-angioplasty (n = 40 in each arm). Randomization is stratified by de novo or recurrent lesion, and the participants are followed up for 1 year. The primary endpoints of the study are target lesion primary patency (TLPP) and access circuit primary patency (ACPP) rates at 6-months. The secondary endpoints are TLPP and ACPP at 3- and 12-month; target lesion and access circuit assisted primary and secondary patency rates at 3, 6, and 12-months and the total number of interventions; complication rate; and cost-effectiveness. DISCUSSION: This study will evaluate the clinical efficacy and safety of combination SG and PCB implantation compared to PCB alone in the treatment of CAS for hemodialysis patients.

Stroke and transient ischaemic attack awareness.

OBJECTIVE: This study examined the knowledge of stroke warning signs and risk factors among the general public, including what they would do if they were to develop such symptoms. DESIGN, SETTING AND PARTICIPANTS: Population study of randomly selected members of the general public in Adelaide, South Australia. A simple survey assessed knowledge of stroke warning signs and gave four options for management. The survey was conducted on three separate occasions: before, immediately after and 3 months after the National Stroke Foundation's National Stroke Week in 2009. MAIN OUTCOME MEASURES: The outcome measures were the public perception of risk factors and warning signs of stroke and what the members of the public would do if presented with a range of warning signs. They were also asked about their knowledge of the Face, Arms, Speech, Time (FAST) test. RESULTS: The three surveys were completed by 251 members of the public. Hypertension and smoking were recognised as risk factors for stroke by 71% and 53% of respondents respectively. Before National Stroke Week, slurred speech was identified by 51% and both slurred speech and upper limb sensory loss was identified by 62% as warning signs to provoke presentation to an emergency department (ED). Amaurosis, upper limb sensory loss, upper limb numbness and upper limb weakness were correctly identified individually as warning signs to attend an ED by fewer than one-third of respondents. There was no significant difference in the survey results following National Stroke Week. CONCLUSIONS: Public awareness of the symptoms of stroke, and what to do about them, is limited. There was little improvement after the national week-long awareness campaign. The lack of public awareness about stroke warning signs must be addressed to reduce mortality and morbidity from stroke.

Reconstruction of the iliocaval venous confluence using arterial stent technology.

Reconstruction of the iliocaval confluence remains a challenge for physicians performing interventions in the deep venous system. We report a case of caval bi-iliac occlusion in which arterial stent technology in the form of the AFX2 unibody stent graft (Endologix, Irvine, Calif) was used to achieve anatomic reconstruction of the iliocaval confluence.

Reconstruction of the aorto-iliac segment in occlusive disease using the AFX unibody graft.

BACKGROUND: The endovascular era has evolved the treatment of aorto-iliac occlusive disease (AIOD). Many institutions now use minimally invasive techniques including kissing iliac stents and covered endovascular reconstruction of the aortic bifurcation. These negate the high morbidity of open surgical reconstruction but do not allow for a crossover approach to treat infra-inguinal disease. The AFX stent does both by anatomically reconstructing the bifurcation in AIOD despite being marketed for aneurysmal aortic disease. This large, single-centre case series assesses the outcomes of treatment of AIOD using the AFX stent. METHODS: Patients with AIOD who presented to our institution between September 2016 and August 2018 were considered for AFX stenting if kissing iliac stents extending into the aorta or aortobifemoral bypass was required. Patient, treatment and outcome data were recorded with a primary outcome of primary patency at 12 months. RESULTS: AFX stenting was performed in 29 patients, with an average age of 69 years, 52% (15/29) patients had critical limb ischaemia. Technical success occurred in 100% of patients with clinical success in 96% (28/29). There were no cases of 30 day and 3 (10%) cases of 12 month mortality, 2 (7%) major and 7 (24%) minor complications arose. Median length of stay was 3 days. Primary patency at 12 months was 100% (n = 24). CONCLUSION: AFX stenting is a safe with satisfactory early results for the treatment of AIOD. The minimally invasive technique and preservation of cross-over approach makes AFX stenting a considered option for the treatment of AIOD.

Perioperative high-dose oxygen therapy in vascular surgery.

BACKGROUND: Patients undergoing infrainguinal bypass surgery have reduced baseline tissue oxygen tension and high rates of wound infections. The hypoxaemia worsens during surgery, potentially reducing the ability to combat bacterial lodgement. We investigated whether high-dose perioperative oxygen administration to patients undergoing infrainguinal arterial surgery results in increased tissue oxygenation. METHODS: Ten consecutive patients undergoing infrainguinal arterial surgery had transcutaneous partial pressure of oxygen (TcpO(2)) measured preoperatively, intraoperatively after arterial clamps applied, postoperatively and at discharge. Measurements were taken with inspired oxygen concentration (F(i)O(2)) of 30% then 80%. Arterial blood gases were measured at the same times. RESULTS: Tissue oxygenation showed no difference intraoperatively while arterial clamps were in place, but significantly higher tissue oxygenation was seen with use of high-dose oxygen (F(i)O(2) 80%) postoperatively (P<0.05). Carbon dioxide levels in tissue increased while arterial clamps were in place (P<0.01) and pH fell intraoperatively and following reperfusion (P<0.05). CONCLUSION: The administration of high-dose oxygen to vascular surgical patients undergoing lower-limb arterial surgery results in increased tissue oxygen concentrations when perfusion is not reduced by the presence of arterial clamps. These results suggest the administration of high-dose oxygen intraoperatively may be beneficial in reducing wound infections, but further research is required.