Mortality Rates After Paclitaxel-Coated Device Use in Patients With Occlusive Femoropopliteal Disease: An Updated Systematic Review and Meta-Analysis of Randomized Controlled Trials.

PURPOSE: A late increased mortality risk has been reported in a summary level meta-analysis of patients with femoropopliteal artery occlusive disease treated with paclitaxel-coated angioplasty balloons and stents. However, at the longer follow up timepoints that analysis was limited by small trial numbers and few participants. The aim of this study was to report an updated summary level risk of all-cause mortality after treatment with paclitaxel-coated devices in that same patient group. MATERIALS AND METHODS: We performed a systematic review and meta-analysis of randomized controlled trials to investigate the mortality outcomes associated with paclitaxel-coated devices used to treat patients with occlusive disease of femoropopliteal arteries (last search date December 10, 2020). The single primary endpoint was all-cause mortality. RESULTS: We identified 34 randomized controlled trials (7654 patients; 84% intermittent claudication). There were 622 deaths among 4147 (15.0%) subjects in the paclitaxel device group and 475 deaths among 3507 (13.5%) subjects in the noncoated control group [relative risk ratio (RR) 1.07, 95% confidence interval (CI) 0.96 to 1.20, p=0.20, I2=0%). All-cause mortality was similar between groups at 12 months (34 studies, 7654 patients; RR 0.99, 95% CI 0.81 to 1.22, p=0.94, I2=0%), 24 months (20 studies, 3799 patients; RR 1.16, 95% CI 0.87 to 1.55, p=0.31, I2=0%), and 60 months (9 studies, 2288 patients; RR 1.19, 95% CI 0.98 to 1.45, p=0.08, I2=0%). CONCLUSION: This updated meta-analysis with included additional trials and larger patient numbers shows no evidence of increased risk of all-cause mortality in patients treated with paclitaxel-coated devices, compared with uncoated devices for femoropopliteal disease at all time points to 60 months. There is therefore no justification to limit their use, or alter regulatory body follow-up recommendations in this patient population. SYSTEMATIC REVIEW REGISTRATION: CRD42020216140.

Mortality After Paclitaxel-Coated Device Use in Patients With Chronic Limb-Threatening Ischemia: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.

PURPOSE: To report the risk of all-cause mortality after treatment with paclitaxel-coated devices vs uncoated controls in patients with chronic limb-threatening ischemia (CLTI). MATERIALS AND METHODS: A search of the PubMed, Embase, Cochrane, CINAHL, DARE, and PROSPERO databases was made on 5 November 2019 to identify randomized controlled trials (RCT) using intention-to-treat analysis to compare a paclitaxel-coated device to an uncoated device in PAD patients having clinical follow-up of at least 6 months. Half of the study population had to have CLTI or extractable data on the CLTI subgroup if <50%. The search identified 11 trials having 1450 patients randomized to a paclitaxel-coated device (n=866) or an uncoated control (n=584). There were 1367 (94.3%) patients with CLTI (range 10-429). The single endpoint was all-cause mortality, which was analyzed by pooling the mortality data in a DerSimonian and Laird random effects model. Summary statistics are expressed as relative risk ratios (RR) with a 95% confidence interval (CI). RESULTS: The mean follow-up was 25.6 months (range 6-60); 10 of 11 studies reported a minimum 12-month follow-up. There were 161 (18.6%) deaths among 866 subjects in the paclitaxel device group and 116 deaths among 584 (19.9%) subjects in the non-coated control group (RR 0.93, 95% CI 0.78 to 1.12, p=0.45). CONCLUSION: There was no observed difference in short- to midterm mortality among a pooled patient population of predominately CLTI patients treated with paclitaxel-coated balloons or stents compared with uncoated controls.

Mortality After Paclitaxel-Coated Device Use in Dialysis Access: A Systematic Review and Meta-Analysis.

Purpose: To report the risk of all-cause mortality in patients who underwent dialysis access treatment using paclitaxel-coated devices compared with percutaneous transluminal angioplasty (PTA) with an uncoated balloon. Materials and Methods: A systematic review and meta-analysis of randomized controlled trials were performed to investigate the mortality outcomes associated with paclitaxel-coated devices in the treatment of patients with a failing dialysis access (last search date February 28, 2019). The primary endpoint was all-cause mortality. This analysis included 8 studies comparing paclitaxel-coated balloon (PCB) angioplasty (n=327) and PTA (n=331) in the treatment of failing dialysis access. None investigated paclitaxel-coated stents. Mortality data were pooled using a random effects model. Statistical heterogeneity was evaluated with a chi-square test and the I2 statistic. Summary statistics are expressed as relative risk ratios (RR) with a 95% confidence interval (CI). Results: At the pooled mean follow-up of 13.5 months (median 12, range 6-24) all-cause mortality was similar in the PCB group (13.8%) compared with PTA (11.2%; RR 1.26, 95% CI 0.85 to 1.89, p=0.25; I2=0%). Subgroup analysis, stratified according to length of follow-up, confirmed that there were no statistically significant differences in mortality at short- and midterm follow-up [6-month (8 studies): 5.2% vs 4.8%, RR 1.24, 95% CI 0.62 to 2.47, p=0.55; 12-month (6 studies): 6.3% vs 6.0%, RR 1.06, 95% CI 0.43 to 2.63, p=0.90; and 24-month (3 studies): 19.0% vs 13.5%, RR 1.38, 95% CI 0.90 to 2.12, p=0.14). Conclusion: The analysis found no difference in short- to midterm mortality among patients treated with a drug-coated balloon compared with PTA. With proven benefit and no evidence of harm, the authors recommend ongoing use of PCB for the failing dialysis access.

Is There a Role for Heli-FX Endoanchors in Treating Type 1B Common Iliac Artery Endoleaks?

OBJECTIVES: The management of type 1B endoleaks following endovascular aortic aneurysm repair (EVAR) can be challenging. The Heli-FX Endoanchor system effectively treats proximal type 1A endoleaks but has not been used for type 1B common iliac artery endoleaks. This study demonstrates that it is both safe and effective in being used in the common iliac artery (CIA) limb of an EVAR. METHODS: A retrospective review of patients identified through coding and medical records was performed to extract information on demographics, aneurysmal features, operative features, and postoperative outcomes. This was then collated and analysed thoroughly and compared to existing research. RESULTS: Four patients with six type 1B CIA endoleaks were treated with Heli-FX Endoanchors in the CIA limbs of EVAR grafts. There was 100% technical success rate with complete exclusion of the endoleaks at 6 months. With mean follow up of 714 days, there were no Endoanchor-specific complications. One patient required explantation of the aortic endograft due to contralateral limb fracture, where it was found that an Endoanchor had penetrated the common iliac vein, requiring primary closure. CONCLUSIONS: Heli-FX Endoanchors were effective within this cohort of patients, though key risks were identified. Adjacent anatomy to the CIA must be considered, which also have nearly half the arterial thickness compared to the aorta. Pre-operative planning is essential given the theoretical risk of placing Endoanchors.

Complex thoracic aortic dissection treated by aorto-biiliac bypass and juxta-renal removal of aortic fenestrations.

Thoracic aortic dissections are a life-threatening pathology. They occur when there is an intimal tear causing separation of the layers of the aorta. Thoracic aortic dissections can be acute or chronic and depending on the pattern of the dissection can be difficult to treat. No acute dissections are the same, and herein we describe a case of a 62-male presenting with an acute thoracic aortic dissection requiring acute aorto-biiliac bypass and juxta-renal removal of aortic fenestrations.

Vascular tracheobronchial compression syndrome secondary to contained ruptured thoracic aortic aneurysm.

Vascular tracheobronchial compression syndrome is the compression of the trachea or pulmonary bronchus by a vascular structure. It is primarily a diagnosis in children and secondary to congenital vascular anomalies. In adults, vascular tracheobronchial compression syndrome can be either congenital or required with a vast majority of congenital conditions found incidentally on imaging. Acquired conditions are largely due to aortic arch aneurysms or kinking of the aorta. The case described herein illustrates the rare case of a saccular thoracic aneurysm causing compression of the left primary bronchus. Patients may have a history of gradual onset of symptoms involving both the airway and oesophagus. Vascular tracheobronchial compression syndrome may go undetected and asymptomatic throughout an individual's lifespan, however as described herein this syndrome may also be life-threatening.

Fenestration of the common iliac vein: an unusual cause of deep venous thrombus.

Iliac venous anomalies are reported in 20.9% of patients; however, fenestration or bifurcation of the common iliac vein only accounts for ~0.4% of patients [ 1]. Herein, we present and discuss the rare case of an iliofemoral deep vein thrombosis precipitated by a fenestrated left common iliac vein.

Multiple superficial femoral artery pseudoanurysms following sub intimal application of paclitaxel coated technology.

Drug coated balloons (DCB) are a commonly used endovascular option for treating patients presenting with symptomatic peripheral vascular disease. DCB have illustrated to increase primary patency and thus have been a popular choice in addressing restenosis caused by neointimal hyperplasia. Pseudoaneurysms (PSA) are a common vascular pathology, the causes of which include iatrogenic, trauma, stent fractures and angioplasty balloon overuse. Herein, we describe the case where a patient developed multiple superficial femoral artery (SFA) PSA potentially secondary to the subintimal application of paclitaxel.

A staged hybrid approach to an aberrant right subclavian artery with symptomatic Kommerell's diverticulum.

Aberrant right subclavian is a rare anomaly presenting in 0.3-3.0% of the population. Kommerell's diverticulum is an aneurysm associated with this phenomen; data relating to its incidence is sparse. Currently there are no well-established guidelines for the treatment of Kommerell's diverticulum, limitation being the rare occurrence of disease and heterogenous population with disease presentation. This case report illustrates a novel approach to the repair of a symptomatic Kommerrel's diverticulum with severe coronary disease. Management should be tailored on a case by case basis to the individual patient.

Blunt thoracic aorta injuries, an Australian single centre's perspective.

BACKGROUND: Blunt thoracic aortic injuries (BTAI) are potentially life-threatening emergencies. The management paradigm has shifted from open repair to a predominantly endovascular approach. We evaluated the trends in managing BTAI at our centre over the last decade and compared them to current international guidelines. METHODS: We retrospectively reviewed all patients who presented with BTAI to our level one trauma centre, Westmead Hospital, New South Wales, Australia between 1 January 2010 and 31 December 2019. Patient demographics, injury grade and location, imaging features, management details and outcomes were analysed. RESULTS: BTAI is rare, with 39 patients identified at our institute over the last 10 years. Of these, seven died in the emergency department from their associated injuries (17.9%). Of the 32 survivors, 27 underwent surgical management with an endovascular stent-graft placement, and the remaining five patients were treated non-operatively. No patients were treated via an open surgical approach. All patients were diagnosed via computed tomography angiography. There were one death and two endoleaks amongst patients who underwent Thoracic endovascular aortic repair (TEVAR). The death occurred secondary to severe traumatic brain injury. Two patients illustrated neurological changes however these were associated with the original injury. No patients failed non-operative management. CONCLUSION: This study demonstrates that at our level one trauma centre, patients with BTAI are managed in accordance with international guidelines. All patients underwent computed tomography angiography for diagnosis and grading of injury. All patients requiring surgical management underwent TEVAR. Furthermore, our data support that select patients with grade I injuries can safely be managed non-operatively.

Use of Paclitaxel Eluting Stents in Arteriovenous Fistulas: A Pilot Study.

PURPOSE: We report short-term patency outcomes of a proof of concept study conducted to determine the efficacy of drug-eluting stent (DES) for the treatment of arteriovenous fistula (AVF) stenosis in hemodialysis patients. MATERIALS AND METHODS: This is a single-center, retrospective observational study involving 10 patients with AVF dysfunction treated with DESs between January 2017 and December 2017. The primary outcome was AVF patency confirmed by sonographic and clinical assessment at 1 month and 6 to 9 months after treatment. RESULTS: A total of 12 DESs were deployed in 10 patients with dysfunctional AVF (radiocephalic: 7, brachiocephalic: 3). During the early follow up (mean: 28.6 days), primary access circuit and DES patency was 100%, with an average volume flow rate of 886.4 mL/min. Nine patients were available for short-term follow up (mean: 202.4 days; 1 unrelated death), with a mean volume flow rate of 1,048.9 mL/min. The primary DES patency was 7/9 (77.8%), and 3 patients required angioplasty at other parts of the circuit (primary access circuit patency: 4/9 [44.4%]). The assisted primary access circuit patency was 77.8%. In 2 patients, the ultrasound revealed that the DESs were thrombosed without any antecedent stenosis; they were salvaged with angioplasty. Both patients previously underwent 2 DESs implanted and recently stopped dual antiplatelet therapy. B-mode sonographic assessment at all timepoints showed minimal intimal ingrowth on the stent struts. CONCLUSION: This study demonstrates acceptable short-term patency for DESs in the treatment of AVF stenosis. Dual antiplatelet therapy is probably mandatory in the short term.