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.

Endovascular reconstruction of the inferior vena cava in a patient presenting with deep venous thrombosis with concomitant inferior vena cava hypoplasia and aneurysmal dilatation of the iliac veins.

INTRODUCTION: Congenital malformations of the inferior vena cava are rare and remain an under recognised cause of spontaneous deep venous thrombosis (DVT). The purpose of this case report is to highlight the rare occurrence of a concomitant iliac vein aneurysm and the feasibility of endovascular reconstruction in the presence of extensive iliocaval thrombus burden, especially in cases where other treatment modalities have been unsuccessful. REPORT: This is the report of a 25-year-old male who presented with acute onset left lower limb pain/swelling secondary to extensive iliocaval DVT. This was due to multiple abnormalities of the venous system including hypoplasia of the IVC with aneurysmal dilatation of the iliac veins. He failed an initial management strategy of anticoagulation and thrombolysis but subsequently underwent endovascular reconstruction of the iliocaval system via venoplasty and stenting. Complete symptom resolution and venous patency, including resolution of venous aneurysmal disease, were maintained at twelve-month follow-up. DISCUSSION: Reduction of the iliac vein diameter so early after successful reconstruction suggests that the iliac venous aneurysm was secondary to significant venous hypertension, and that if the obstruction causing it is treated, the vein can return to a normal vessel diameter.

Impact of closed-incision negative pressure wound dressings on surgical site infection following groin incisions in vascular surgery; a single-centre experience.

OBJECTIVES: Surgical site infection (SSI) is a common complication in vascular surgery, and is associated with increased patient morbidity, readmission and reintervention. The aim of this study was to assess the impact of closed-incision negative pressure wound therapy (CiNPWT) upon rate of SSI and length of hospital stay. METHODS: This study was reported in line with the STROBE guidelines. We assessed the baseline incidence of SSI from a 12-month retrospective cohort and, following a change in practice intervention with CiNPWT, compared to a 6-month prospective cohort. The primary endpoint was incidence of SSI (according to CDC-NHSN guidelines) while secondary endpoints included length of hospital stay, readmission, reintervention and Days Alive and Out of Hospital (DAOH) to 90-days. RESULTS: A total of 127 groin incisions were performed: 76 (65 patients) within the retrospective analysis and 51 (42 patients) within the prospective analysis (of whom 69% received CiNPWT). The primary endpoint of SSI was seen in 21.1% of the retrospective cohort and 9.8% of the prospective cohort (p = .099). Readmission was found to be significantly associated with the retrospective cohort (p = .016) while total admission (inclusive of re-admission) was significantly longer in those in the retrospective cohort (p = .013). DAOH-90 was 83 days (77-85) following introduction of the CiNPWT protocol as compared to the retrospective cohort (77 days (64-83), p = .04). CONCLUSION: Introduction of CiNPWT was associated with a reduced length of hospital stay and improved DAOH-90. Further trials on CINPWT should include patient-centred outcomes and healthcare cost analysis.

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.

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.

Hepatic artery aneurysm: A case report of a novel approach to an age old problem.

INTRODUCTION: Visceral artery aneurysms are a relatively uncommon but potentially devastating pathology. The most common site is the splenic artery followed by the hepatic (Stanley et al., 1986) [1]. In the event of rupture, mortality has been estimated at anywhere between 20% and 100% (Schweigert et al., 2011) [2]. Emergency surgery in such a scenario has previously been dependent on an open approach with high morbidity and mortality associated (Schweigert et al., 2011) [2]. The advent of endovascular techniques may improve both short and long term outcomes as highlighted in this case. PRESENTATION OF CASE: We present the case of a ruptured common hepatic artery aneurysm presenting with acute abdominal pain and haemodynamic instability. Minimally invasive surgery in the form of endovascular repair via two covered stents from the coeliac trunk in to the splenic artery (excluding flow in to the common hepatic artery aneurysm) allowed for immediate management without the significant morbidity and mortality with which open surgery is associated. DISCUSSION: This resulted in resolution of acute haemorrhage while liver perfusion was maintained via the portal vein and arterial collaterals. Follow-up highlighted both short and medium term success. CONCLUSION: This case highlights that endovascular management in the case of visceral artery aneurysm rupture is a viable option while also portraying several important anatomic considerations essential to hepatic perfusion.