A sex-based analysis of 5-year outcomes following stenting for the treatment of aorto-iliac occlusive disease.

OBJECTIVES: The aim of this study was to evaluate the impact of sex on mid-term outcomes following stenting for aorto-iliac occlusive disease (AIOD). METHODS: The Covered versus Balloon Expandable Stent Trial (COBEST) compared the safety and efficacy of the covered stent (CS) with those of the bare metal stent (BMS) in the treatment of hemodynamically significant AIOD. It was identified that CS provided a significant benefit. The primary endpoint of our analysis was the rate of primary patency 5 years following stenting for AIOD (inclusive of both CS and BMS) in both sexes. RESULTS: Of the 168 lesions treated, 103 (61%) were present in men and 65 (39%) were present in women. Of the concomitant comorbidities, diabetes mellitus was significantly more common in women (17.5% vs 41.5%, p = .006). Although chronic limb threatening ischemia (CLTI) at the time of intervention was more common in women, the difference was not significant (16.5% vs 24.6%, p = .395). Sex was not associated with the primary patency rate (male; 0.70, 95% confidence interval [CI]: 0.23-2.19, p = .543). When considering both male sex and the utilization of BMS, no significant impact was found on the primary patency rate (hazard ratio [HR]: 3.43, 95% CI: 0.69-17.10, p = .133). All-cause mortality at 60 months was 22.6% in men compared to 19.4% in women (p = .695). CONCLUSIONS: No significant difference was identified in the primary patency rate between the sexes. Further investigation is warranted to ascertain whether sex-specific interventional guidelines are required in this regard.

Twenty-Four-Month Outcomes of Drug-Coated Balloon in Diabetic Patients in the BIOLUX P-III Registry: A Subgroup Analysis.

OBJECTIVES: This study aims to assess the use of drug-coated balloon (DCB) in a large patient population under real-world conditions and, specifically, analyse the impact of diabetes mellitus on long term outcomes following DCB utilisation. METHODS: BIOLUX P-III is a prospective, international, multicentre, registry that was conducted at 41 centres. The present study is a 24-month subgroup analysis of patients with diabetes mellitus having infrainguinal lesions treated with the Passeo-18 Lux DCB. The primary endpoints were freedom from major adverse events (MAEs) within 6 months of intervention and freedom from clinically driven target lesion revascularisation (CD-TLR) within 12 months of intervention. RESULTS: Of the 882 patients in the registry, 418 had diabetes (516 lesions). Most diabetics had concomitant hypertension (88.8%) and hyperlipidaemia (70.3%). Insulin dependence was observed in 48.8% of diabetics. Moreover, smoking (62.2%) and chronic renal insufficiency (41.9%) were also found to be common in this cohort. Chronic limb threatening ischemia (Rutherford class ≥4) was present in 53.1% of all patients. 22.9% of lesions were infrapopliteal, while 22.5% of lesions were treated for in-stent restenosis. The mean target lesion length was 85.6 ± 73.2 mm, and 79.4% of lesions were calcified (of which 17.9% were heavily calcified). Overall, device success was 99.7%. Freedom from MAEs was 90.5% (95% confidence interval (95% CI): 87.2-93.0) at 6 months, 85.4% (95% CI: 81.5-88.6) at 12 months and 80% (95% CI: 75.5-83.8) at 24 months. Freedom from CD-TLR was 95.9% (95% CI: 93.8-97.4), 91.6% (95% CI: 88.7-93.8), and 87.1% (95% CI: 83.5-89.9) at 6, 12, and 24 months, respectively. All-cause mortality at 24 months in diabetics was 16.0% (95% CI: 12.6-20.2), and major target limb amputation was 6.1% (95% CI: 4.1-8.9), which was significantly higher than in non-diabetics (8.4% (95% CI: 6.0-11.6), P = 0.0005 and 1.2% (95% CI: 0.5-2.9), P <0.0001, respectively). At 24 months, 82.0% of patients had improved by ≥1 Rutherford class. CONCLUSION: Treatment of a real-world diabetic patient population with the Passeo-18 Lux DCB resulted in high efficacy and low complication rates, despite the fact that diabetic patients usually suffer from a multitude of concomitant comorbidities. CLINICAL TRIAL REGISTRATION: NCT02276313.

First-in-man experience of self-expanding nitinol stents combined with drug-coated balloon in the treatment of femoropopliteal occlusive disease.

Purpose The present study aimed to determine the safety and efficacy of a drug-coated balloon inflated within a thin-strut self-expanding bare-metal stent in patients with severe and complex femoropopliteal occlusive disease. Methods This prospective study used the Pulsar-self-expanding stent and Passeo-18 Lux drug-coated balloon in patients with severe and complex femoropopliteal occlusive disease. The primary endpoint was the 12-month primary patency, and the secondary endpoints included 24-month primary patency, assisted primary patency, secondary patency, and clinically associated target lesion revascularisation. Results The study included 44 patients (51 limbs). The mean age of the patients was 67.6 ± 10.2 years, with 73% men. Chronic limb severity was classified as Rutherford Category III in 41% of the patients, stage IV in 31%, and stage V in 27%. Lesions were predominantly Trans-Atlantic Inter-Society Consensus (TASC 2007) D (51%) and C (45%), with 32 (63%) chronic total occlusions. Procedural success was obtained in all cases. The mean lesion length was 200 ± 74.55 mm (95% CI = 167.09-208.01) with a mean number of stents per limb used of 1.57 ± 0.70 (95% CI = 1.37-1.76). Distal embolisation occurred in two patients. The primary patency rates at the 12- and 24-month follow-up were 94% (95% CI = 82.9-98.1) and 88% (95% CI = 75.7-94.5), respectively. The assisted primary was 94% (95% CI = 82.9-98.1) and secondary patency was 96% (95% CI = 85.2-99.0) at 24-month follow-up. The cumulative stent fracture rate at the 24-month follow-up was 10%. Freedom from clinically driven target lesion revascularisation was 94% (95% CI = 83-98%) at 12-month follow-up and 88% (95% CI = 76-94%) at 24-month follow-up, with two patients requiring a bypass graft. Conclusion Our novel approach involving the combination of a thin-strut bare-metal stent and a drug-coated balloon may be safe and effective, with sustainable and promising clinical outcomes up to 24 months after treatment.

Primary Axillary Venous Aneurysm Associated with Local Neurological Complications.

Primary axillary venous aneurysms (VAs) are rare, and there are only a handful of cases reported previously. The patient can be either asymptomatic or symptomatic and can present with local axillary swelling, dilated venules in overlying skin associated with local discomfort, peripheral neuropathy, or pulmonary embolisms. A 30-year-old man presented with a 4-month history of an uncomfortable lump in his left armpit that was associated with paresthesia radiating down to his left forearm and hand. He had no history of arm swelling and had a normal motor neurological examination. The clinical examination revealed a nontender palpable mass within the left axilla. Venous duplex imaging confirmed the diagnosis of axillary vein aneurysm measuring 6.1 cm. He underwent elective aneurysmorrhaphy repair of the axillary/basilic VA with satisfactory outcome. We present a rare case of a symptomatic primary axillary VA that was managed surgically with complete resolution of symptoms.

Intraoperative Extravascular Ultrasound in the Identification of Flow-Limiting Dissections after Balloon Angioplasty in the Femoropopliteal Segment.

Background: The BIO REACT study is designed to investigate the incremental value of Extravascular UltraSound (EVUS) added to conventional angiography, compared to conventional angiography only for the identification of Flow-Limiting Dissections (FLD) and to evaluate the safety and efficacy of the REsponse Adapted Combination Therapy (REACT) for the treatment of femoropopliteal lesions. Methods: The primary endpoints were the specificity and sensitivity of EVUS added to angiography for the detection of FLD. Secondary endpoints were primary patency of the REACT therapy within 12 months, fCD-TLR, freedom from MAE, major target limb amputations (mTLA) and survival rates within 24 months. Results: A total of 150 patients were included. EVUS added to angiography had an overall sensitivity of 29% and specificity of 93% for the detection of FLD. There was no PSVR cut-off offering a clinically acceptable trade-off between meaningful sensitivity and specificity values for the detection of FLD. At 12 months, treatment with the REACT resulted in primary patency and fCD-TLR of 81.6% and 94.3%, respectively. In addition, freedom from MAE was 94.3% at 12 months. At 24 months, the survival rate was 94.0%. No mTLA was reported up to the 24-month follow-up. Conclusions: The addition of DUS to angiography showed limited value for detecting FLD in femoropopliteal artery disease.

Sex-Related Outcomes Following Drug Balloon Angioplasty in Patients from the BIOLUX P-III Registry: A Subgroup Analysis.

PURPOSE: To evaluate the use of drug-coated balloons in a real-world patient population with peripheral arterial disease and analyse the impact of sex on mid-term outcomes following their utilisation. METHODS: The BIOLUX P-III is a prospective, international, multi-centre, registry of patients with infra-inguinal lesions treated using the Passeo-18 Lux, a drug-coated balloon. Our study is a 24-month subgroup analysis of these patients; primary endpoints were freedom from major adverse events and clinically driven target lesion re-vascularisation within 12 months post-intervention. RESULTS: Of the 877 patients in the registry, 561 (64.0%) were male and 316 (36.0%) were female. Chronic limb threatening ischaemia (Rutherford class ≥ 4) occurred in 35.7% of males and 40.6% of females. Rates of freedom from major adverse events and clinically driven target lesion re-vascularisation at 12 months were 87.3% (95% confidence interval [CI] 84.2-89.9) and 90.4% (95% CI 86.5-93.3), and 92.3% (95% CI 89.9-94.1) and 92.9% (95% CI 89.7-95.1) in males and females, respectively. All-cause mortality at 24 months was 12.0% (95% CI 9.4-15.3) in males and 11.9% (95% CI 8.6-16.5) in females. The major target limb amputation rate at 24 months was 9.1% (95% CI 6.9-11.9) in males and 4.0% (95% CI 2.3-7.0) in females. CONCLUSION: Treatment with the Passeo-18 Lux DCB demonstrated high efficacy and low complication rates. Despite the greater proportion of chronic limb threatening ischaemia observed in females, males were at a greater risk of ipsilateral major limb amputation and major adverse events following drug-coated balloon utilisation. CLINICAL TRIAL REGISTRATION: NCT02276313. LEVEL OF EVIDENCE: Level 4.

Trends and outcomes in Australian carotid artery revascularization surgery: 2010-2017.

BACKGROUND: Carotid endarterectomy (CEA) and carotid artery stenting (CAS) reduce the risk of stroke in patients with severe carotid stenosis. The aim was to compare contemporary treatment trends and outcomes after CEA and CAS between states of Australia. METHODS: A retrospective analysis was conducted on data from the Australasian Vascular Audit between 2010 and 2017. The primary endpoint was perioperative stroke or death (S/D). We also analysed stroke and death independently and revascularization rates per 100 000 population. RESULTS: A total of 15 413 patients underwent carotid revascularization (CEA 14 070; CAS 1343). S/D rates were similar for CEA and CAS (1.9% versus 1.8%; P = 0.37; symptomatic 2.1% versus 2.3%; P = 0.12; asymptomatic 1.5% versus 1.1%; P = 0.67). Patients ≥80 years (2.7% versus 1.7%; P = 0.01), those who had shunts (2.2% versus 1.7%; P = 0.03) or surgery in teaching hospitals (2.6% versus 1.4%; P = 0.02) had higher rates of S/D after CEA. Patients whose proceduralist used a cerebral protection device had lower S/D rates after CAS for symptomatic disease (4.8% versus 2.2%; P = 0.03). There was a wide variation in practice between states, where CAS as a proportion of total carotid procedures ranged from 0% to 17%, and a wide variation in outcomes, with rates of S/D varying between 1.4-6.6% for CEA and 0-6.7% after CAS. CONCLUSION: Outcomes after CAS are equivalent to CEA when performed by vascular surgeons, however significant variation exists for both choice of revascularization procedure and perioperative outcomes between states. Further investigation is needed to determine whether clinical care pathways should be revised to achieve consistency and quality of outcomes.

A Budget Impact Model for the use of Drug-Eluting Stents in Patients with Symptomatic Lower-Limb Peripheral Arterial Disease: An Australian Perspective.

PURPOSE: Improvement in long-term outcomes through innovative, cost-effective medical technologies is a focus for endovascular procedures aimed at treating symptomatic lower-limb peripheral arterial disease (PAD). The advent of drug-eluting stents (DES) has improved symptomatic PAD treatment via a reduction in high rates of target lesion revascularisation (TLR). The present study aimed to compare the 5-year financial impact of treatment with Eluvia, a new paclitaxel-eluting stent, versus treatment with Zilver PTX, a drug-coated stent, among patients in Australia by developing a budget impact model (BIM). METHODS: A BIM was developed from an Australian public hospital payer perspective using Australian national cost weights (AUD), published literature, and public hospital audit data. Clinical outcomes, including clinically driven TLRs (CD-TLRs), adverse events, and length of stay, were based on the 2-year results of the IMPERIAL trial, which compared Eluvia DES to Zilver PTX. RESULTS: Assuming EVP eligibility rate of 80% and DES uses rate ranging from 10 to 28% (superficial femoral artery lesions only), the 5-year model forecasted a treatment population between 14,428 and 40,399 patients. The model estimated 1499-4198 fewer CD-TLRs and 16,515-46,243 fewer hospital days with Eluvia DES use. This translated to 5-year potential savings of $4.3-$12.1 million to the Australian public hospital payer attributable to reduced CD-TLRs for Eluvia DES and $33.1-$92.6 million to Australian public hospitals owing to reduced adverse events and hospital bed days. CONCLUSION: Eluvia DES use as treatment for symptomatic lower-limb PAD could lead to potential savings for the Australian public healthcare system based on improved patient outcomes.

Large spontaneous median sacral artery pseudoaneurysm masquerading as hip pain.

We report the case of an 81-year-old man who presented with severe right hip pain and reduced physical function secondary to a large spontaneous median sacral artery pseudoaneurysm measuring 83.5 × 55.4 mm. The patient had no history of recent trauma, infective or inflammatory disease, or any recent procedures. The patient was taking apixaban for atrial fibrillation. Percutaneous coil embolization was used to occlude the pseudoaneurysm. This case describes a novel disease, spontaneous median sacral artery pseudoaneurysm, presenting with hip pain.

Transplantation of crossed fused renal ectopia.

Crossed fused renal ectopia is a type of congenital fused anomaly of the kidney. This type of kidney, when encountered, can be used as a donor organ to provide useful solution to the critical shortage of available organs for transplantation.

Management challenges of late presentation Dacron patch infection after carotid endarterectomy.

An 83-year-old man presented 4 years after right carotid endarterectomy (CEA) with an infection of his prosthetic Dacron patch. Initial scans (CT angiogram and whole body labelled white cell scan) were clear with no infection or collection noted. Systemically, the patient presented well with no recorded fevers. With an occluded left internal carotid artery and severely stenosed vertebral arteries, surgery presented a high risk of major stroke due to the lack collateral supply and this was discussed extensively. The patient subsequently declined surgical management, and he was monitored closely on an outpatient basis. He presented again a year later with ongoing haemoserous ooze from the CEA site. Subsequently a two-stage procedure was performed, where initially a stent was inserted, followed by patch excision and debridement. A muscle flap was then mobilised over the opening. This new approach to carotid patch infections should gain traction over time as a safer alternative for high-risk patients.

Stent outcomes for infrapopliteal arterial occlusive disease.

This study aimed to determine if the different stent types used in the treatment of infrapopliteal arterial occlusive disease provide any significant advantage over one another at 6 and 12-month follow-up. Consecutive patients undergoing stenting of infrapopliteal lesions were enrolled into a non-randomised prospective registry and followed-up for 1 year. Outcome measures included binary restenosis, target lesion revascularisation, major amputation, and change in Rutherford-Becker score and ankle-brachial index (ABI).Thirty-three patients were enrolled including four patients with bilateral disease. There were 20 target vessels in the drug-eluting stent (DES) group, 13 target vessels in the balloon-expandable bare metal stent (BE-BMS) group and 14 target vessels in the self expandableb are metal stent (SE-BMS) group. Most of the patients in the study were octogenarians except in the SE-BMS group where the mean age was 73 ± 9 years. At 12 months, seven patients had died (DES = 6, BE-BMS = 1) from cardiac and cancer-related diseases. In-stent and peri-stent binary restenosis were non-statistically different between all three groups. There was a nonstatistically significant trend towards higher target vessel revascularisation in the BE-BMS group. Survival curves in all stent types demonstrated restenosis to occur within the first 6 months post-procedure. There was no significant difference in the change in Rutherford-Becker score or ABI between the groups. No major limb amputations occurred during the 12-month period. In conclusion,we did not detect a significant difference in stent performance between the different stent types used to treat infrapopliteal arterial occlusive disease. The choice of stent did not seem to affect patient survival or major amputation-free survival at 1-year follow-up.

Balloon angioplasty compared with stenting for treatment of femoropopliteal occlusive disease: a meta-analysis.

BACKGROUND: The goal of this study was to review the currently available literature and to compare the short and long-term results of primary stenting and angioplasty of femoropopliteal occlusive disease by performing a meta-analysis review. METHODS: A systematic review of the literature that was published between September 2000 and January 2007 was performed. All studies that reported data on the long-term results after balloon dilatation or stent implantation were included if at least one-year primary patency or restenosis rate was presented; the study follow-up was at least 1 year and the number of subjects at the start of study was at least 20 patients. Three investigators independently extracted the data. The Pooled survival curves were then constructed for graft patency according to a random-effects protocol for meta-analysis. RESULTS: Twenty-four articles were initially identified but only seven were selected and included in this meta-analysis: seven were RCTs publications and one was a retrospective study comparing the outcome of angioplasty and stenting of the femoropopliteal segment. In our meta-analysis, there were a total of 934 patients with 452 patients who underwent balloon angioplasty (273 patients were male) and 482 patients who underwent stenting (297 patients were male). Primary patency at 1-year and postoperative ABI post intervention was used to evaluate the pooled odds ratio (OR) of all studies. The pooled OR of all studies estimate for the 12-month patency rates was 0.989 (95% confidence interval [CI], 0.623 to 1.570, P = .962) showing no difference in outcome between the two groups (SE 0.269% to 1.025%). The pooled OR estimate for the postoperative ABI was 0.869 (95% CI, 0.557 to 1.357, P = .561) showing a slight advantage in favor of the angioplasty group but the P value was not statistically significant (SE 0.282% to 1.326%). The 1-year primary patency rates following balloon angioplasty ranged from 45% to 84.2% and at 2 years it varied from 25% to 77.2%. In the stent implantation group, the 1-year primary patency rates varied from 63% to 90%, and 2-year primary patency ranged from 46% to 87%. Heterogeneity was seen among studies, and publication bias could not be excluded. CONCLUSIONS: The results of our meta-analysis suggest that stent placement in the femoropopliteal occlusive disease does not increase the patency rate when compared with angioplasty alone at 1 year. This conclusion should be viewed in the light of study-design considerations and all limitations in this meta-analysis that may have an impact of the outcome of stenting and angioplasty after a 1-year follow-up.

Fracture of a carotid stent: an unexpected complication.

We present the first reported case of a carotid artery stent fracture where a Nitinol stent was used for the management of carotid artery stenosis. An 83-year-old man underwent right carotid artery stenting in July 2005. On follow-up ultrasound, stenosis of the right internal carotid artery was noted. In January 2006, he underwent left carotid artery stenting and at this procedure, precontrast assessment of the right neck revealed a complete fracture through the waist of the stent in the right internal carotid artery. This fractured segment correlated with the area of stenosis reported at the previous ultrasound. In July 2006, this gentleman underwent successful removal of the carotid stent with uneventful carotid endarterectomy and synthetic patch repair. Carotid artery stenting is a newer and alternative modality to carotid endarterectomy for the treatment of carotid artery stenting. More data are emerging to support its safety and efficacy. An unexpected complication can happen with any procedure and complications help define the follow-up management of subsequent patients undergoing this procedure.