Angioplasty versus stenting for infrapopliteal arterial lesions in chronic limb-threatening ischaemia.

BACKGROUND: Chronic limb-threatening ischaemia (CLTI) is a manifestation of peripheral arterial disease (PAD) that includes chronic ischaemic rest pain or ischaemic skin lesions, ulcers, or gangrene for longer than two weeks. The severity of the disease depends on the extent of arterial stenosis and the availability of collateral circulation. Treatment for CLTI aims to relieve ischaemic pain, heal ischaemic ulcers, prevent limb loss, improve quality of life, and prolong survival. CLTI due to occlusive disease in the infrapopliteal arterial circulation (below-knee circulation) can be treated via an endovascular technique by a balloon opening the narrowed vessel, so called angioplasty, with or without the additional deployment of a scaffold made of metal alloy or other material, so called stenting. Endovascular interventions in the infrapopliteal vasculature may improve symptoms in patients with CLTI by re-establishing in-line blood flow to the foot. Controversy remains as to whether a balloon should be used alone to open the vessel, or whether a stent should also be deployed. OBJECTIVES: To determine the efficacy and safety of percutaneous transluminal angioplasty (PTA) alone versus PTA with stenting of infrapopliteal arterial lesions (anterior tibial artery, posterior tibial artery, fibular artery (formerly known as peroneal artery), and common tibioperoneal trunk) for patients with chronic limb-threatening ischaemia (CLTI). SEARCH METHODS: The Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register, CENTRAL, MEDLINE, Embase, CINAHL, and AMED databases, as well as World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov trials registers to 25 June 2018. We applied no language restrictions. SELECTION CRITERIA: We planned to include randomised or quasi-randomised controlled trials comparing PTA versus PTA with a stent and including patients aged 18 years or over with CLTI. We defined CLTI as Fontaine stage III (ischaemic rest pain) and IV (ischaemic ulcers or gangrene) or consistent with Rutherford category 4 (ischaemic rest pain), 5 (minor tissue loss), and 6 (major tissue loss), with stenotic (> 50% luminal loss) or occluded infrapopliteal artery, including tibiofibular trunk, anterior tibial artery, posterior tibial artery, and fibular artery. We included all types of stents irrespective of design (e.g. bare-metal, drug-eluting, bio-absorbable). DATA COLLECTION AND ANALYSIS: Two review authors (CC-TH and GNCK) independently selected suitable trials, assessed trial quality, and extracted data. An additional third review author (MLvD) assessed trial quality and, when necessary, acted as arbiter for study selection and data extraction. Outcomes included technical success of the procedure, procedural complications, patency, major amputation, and mortality. We assessed the quality of evidence using the GRADE approach. MAIN RESULTS: We included in the review seven trials with 542 participants. One trial randomised limbs to undergo PTA alone or PTA with stent placement, and the remaining studies randomised participants. Five trials with 476 participants show that the technical success rate was greater in the stent group than in the angioplasty group (odds ratio (OR) 3.00, 95% confidence interval (CI) 1.14 to 7.93; 476 lesions; 5 studies; I² = 23%). Meta-analysis of three eligible trials with 456 participants did not show a clear difference in short-term (within six months) patency between infrapopliteal arterial lesions treated with PTA and those treated with PTA and stenting (OR 0.88, 95% CI 0.37 to 2.11; 456 lesions; 3 studies; I² = 77%). Results also did not show clear differences between treatment groups in procedure complication rate (OR 0.87, 95% CI 0.01 to 53.60; 360 participants; 5 studies; I² = 85%), rate of major amputations at 12 months (OR 1.34, 95% CI 0.56 to 3.22; 306 participants; 4 studies; I² = 0%), and rate of mortality at 12 months (OR 0.71, 95% CI 0.43 to 1.17; 497 participants; 6 studies; I² = 0%). Heterogeneity between studies was high for the outcomes procedure complications and primary patency. The overall methodological quality of the trials included in this review was moderate due to selection and performance bias. Studies used different regimens for pretreatment and post-treatment antiplatelet/anticoagulant medication. We downgraded the certainty of the overall evidence for all outcomes by one level to moderate due to inconsistency of results across studies and large confidence intervals (small numbers of trials and participants). AUTHORS' CONCLUSIONS: Trials show that the immediate technical success rate of restoring luminal patency is higher in the stent group but reveal no clear differences in short-term patency at six months between infrapopliteal arterial lesions treated with PTA with stenting versus those treated with PTA without stenting. We ascertained no clear differences between groups in periprocedural complications, major amputation, and mortality. However, use of different regimens for pretreatment and post-treatment antiplatelet/anticoagulant medication and the duration of its use within and between trials may have influenced the outcomes. Limited currently available data suggest that high-quality evidence is insufficient to show that PTA with stent insertion is superior to use of standard PTA alone without stenting for treatment of infrapopliteal arterial lesions. Further studies should standardise the use of antiplatelets/anticoagulants before and after the intervention to improve the comparability of the two treatments.

Venous cutdown versus the Seldinger technique for placement of totally implantable venous access ports.

BACKGROUND: Totally implantable venous access ports (TIVAPs) provide patients with a safe and permanent venous access, for instance in the administration of chemotherapy for oncology patients. There are several methods for TIVAP placement, and the optimal evidence-based method is unclear. OBJECTIVES: To compare the efficacy and safety of three commonly used techniques for implanting TIVAPs: the venous cutdown technique, the Seldinger technique, and the modified Seldinger technique. This review includes studies that use Doppler or real-time two-dimensional ultrasonography for locating the vein in the Seldinger technique. SEARCH METHODS: The Cochrane Vascular Trials Search Co-ordinator searched the Cochrane Vascular Specialised Register (last searched August 2015) and the Cochrane Central Register of Controlled Trials (CENTRAL) (2015, Issue 7), as well as clinical trials registers. SELECTION CRITERIA: We included randomised or quasi-randomised controlled clinical trials that randomly allocated people requiring TIVAP to the venous cutdown, Seldinger, or modified Seldinger technique. Two review authors independently assessed studies for inclusion eligibility, with a third review author checking excluded studies. DATA COLLECTION AND ANALYSIS: Two review authors independently extracted data. We assessed all studies for risk of bias. We assessed heterogeneity using Chi(2) statistic and variance (I(2)statistic) methods. Dichotomous outcomes, summarised as odds ratio (OR) with 95% confidence interval (CI), were: primary implantation success, complications (in particular infection), pneumothorax, and catheter complications. We conducted separate analyses to assess the two access veins, subclavian and internal jugular (IJ) vein, in the Seldinger technique versus the venous cutdown technique. We used both intention-to-treat (ITT) and on-treatment analyses and pooled data using a fixed-effect model. MAIN RESULTS: We included nine studies with a total of 1253 participants in the review. Five studies compared Seldinger technique (subclavian vein access) with venous cutdown technique (cephalic vein access). Two studies compared Seldinger (IJ vein) versus venous cutdown (cephalic vein). One study compared the modified Seldinger technique (cephalic vein) with the venous cutdown (cephalic vein), and one study compared the Seldinger (subclavian vein) versus the Seldinger (IJ vein) technique.Seldinger technique (subclavian or IJ vein access) versus venous cutdown (cephalic vein): We included seven trials with 1006 participants for analysis. Both ITT (OR 0.40; 95% CI 0.25 to 0.65) and on-treatment analysis (OR 0.59; 95% CI 0.36 to 0.98) showed that the Seldinger technique for implantation of TIVAP had a higher success rate compared with the venous cutdown technique. We found no difference between overall peri- and postoperative complication rates: ITT (OR 1.16; 95% CI 0.76 to 1.75) and on-treatment analysis (OR 0.93; 95% CI 0.62 to 1.40). In the Seldinger group, the majority of the trials reported use of the subclavian vein for venous access, with only a limited number of trials utilising the IJ vein for access. When individual complication rates of infection, pneumothorax, and catheter complications were analysed, the Seldinger technique (subclavian vein access) was associated with a higher rate of catheter complications compared to the venous cutdown technique: ITT (OR 6.77; 95% CI 2.31 to 19.79) and on-treatment analysis (OR 6.62; 95% CI 2.24 to 19.58). There was no difference in incidence of infections, pneumothorax, and other complications between the groups.Modified Seldinger technique (cephalic vein) versus venous cutdown (cephalic vein): We identified one trial with 164 participants. ITT analysis showed no difference in primary implantation success rate between the modified Seldinger technique (69/82, 84%) and the venous cutdown technique (66/82, 80%), P = 0.686. We observed no differences in the peri- or postoperative complication rates.Seldinger (subclavian vein access) versus Seldinger (IJ vein access): We identified one trial with 83 participants. The primary success rate was 84% (37/44) for Seldinger (subclavian vein) versus 74% (29/39) for the Seldinger (IJ vein). There was a higher overall complication rate in the subclavian group (48%) compared to the jugular group (23%), P = 0.02. However, when specific complications were compared individually, we found no differences between the groups.The overall quality of the trials included in this review was moderate. The methods used for randomisation were inadequate in four of the nine included studies, but sensitivity analysis excluding these trials did not alter the outcome. The nature of the interventions, either venous cutdown or Seldinger techniques, meant that it was not feasible to blind the participant or personnel, therefore we judged this to be at low risk of bias. The majority of participants in the included trials were oncology patients at tertiary centres, and the outcomes were applicable to the typical clinical scenario. For all outcomes, when comparing venous cutdown and Seldinger technique, serious imprecision was evident by wide confidence intervals in the included trials. The quality of the overall evidence was therefore downgraded from high to moderate. Due to the limited number of included studies we were unable to assess publication bias. AUTHORS' CONCLUSIONS: Moderate-quality evidence showed that the Seldinger technique has a higher primary implantation success rate compared with the venous cutdown technique. The majority of trials using the Seldinger technique used the subclavian vein for venous access, and only a few trials reported the use of the internal jugular vein for venous access. Moderate-quality evidence showed no difference in the overall complication rate between the Seldinger and venous cutdown techniques. However, when the Seldinger technique with subclavian vein access was compared with the venous cutdown group, there was a higher reported incidence of catheter complications. The rates of pneumothorax and infection did not differ between the Seldinger and venous cutdown group. We identified only one trial for each of the comparisons modified Seldinger technique (cephalic vein) versus venous cutdown (cephalic vein) and Seldinger (subclavian vein access) versus Seldinger (IJ vein access), thus a definitive conclusion cannot be drawn for these comparisons and further research is recommended.

Distal aortic perfusion during thoracoabdominal aneurysm repair for prevention of paraplegia.

BACKGROUND: During thoracoabdominal aortic aneurysm (TAAA) surgery, decreased spinal cord perfusion can result in neurological deficits such as paraplegia and paraparesis. Distal aortic perfusion, alone or in combination with other adjuncts, may counter the decrease in spinal cord perfusion and hence reduce the risk of spinal cord injury. OBJECTIVES: To determine the effectiveness of distal aortic perfusion with or without other adjuncts against other adjuncts without use of distal perfusion during TAAA surgery in reducing the risk of developing paraplegia and paraparesis. SEARCH METHODS: The Cochrane Peripheral Vascular Diseases Group Specialised Register (last searched 5 January 2012) and CENTRAL (Issue 4, 2011) were searched for publications describing randomised controlled trials of distal aortic perfusion during thoracoabdominal aortic aneurysm surgery. Reference lists of relevant studies were checked. SELECTION CRITERIA: Randomised or quasi-randomised controlled clinical trials of distal aortic perfusion during TAAA repair. DATA COLLECTION AND ANALYSIS: Studies identified for potential inclusion were independently assessed for inclusion by at least two authors, with excluded trials arbitrated by the third author. MAIN RESULTS: There were no randomised controlled trials identified. AUTHORS' CONCLUSIONS: Currently, there are no randomised controlled trials to support the role of distal aortic perfusion in TAAA surgery for prevention of neurological injury. However, randomised controlled trials are not always feasible based on ethical grounds. Observational studies suggest that distal aortic perfusion alone or in combination with other adjuncts, that is cerebrospinal fluid (CSF) drainage, reduces the rate of neurologic deficit across all types of TAAA; in particular making a striking difference in the rate of neurologic deficit following type II TAAA repair. In the absence of randomised controlled trials, we recommend a standardised approach to reporting through registry studies to strengthen the evidence base for distal aortic perfusion.

Duplication of the superficial femoral artery: comprehensive review of imaging literature and insight into embryology.

An extremely rare case of duplicated superficial femoral artery (SFA) was incidentally observed on computed tomography angiogram (CTA) of the lower limbs for presurgical planning for an osteomyocutaneous fibula flap in a patient with T4a oropharyngeal squamous cell carcinoma (SCC). To our knowledge, this is the sixth reported case in the imaging literature. We performed a comprehensive review of the English literature and discuss the underlying embryological origin underpinning this rare anatomical variant.

Unusual case of skull metastasis from hepatocellular carcinoma.

Hepatocellular carcinoma with a skull metastasis is a rare clinical entity especially in Western countries. The authors of the present article report a case of solitary skull metastasis from hepatocellular carcinoma in a 75-year-old lady who had no prior history of the primary disease or liver dysfunction. The clinicopathological and radiological features are reviewed and discussed.

Monocyte chemoattractant protein-1 and nitric oxide promote adipogenesis in a model that mimics obesity.

OBJECTIVE: An increasing body of evidence is emerging linking adipogenesis and inflammation. Obesity, alone or as a part of the metabolic syndrome, is characterized by a state of chronic low-level inflammation as revealed by raised plasma levels of inflammatory cytokines and acute-phase proteins. If inflammation can, in turn, increase adipose tissue growth, this may be the basis for a positive feedback loop in obesity. We have developed a tissue engineering model for growing adipose tissue in the mouse that allows quantification of increases in adipogenesis. In this study, we evaluated the adipogenic potential of the inflammogens monocyte chemoattractant protein (MCP)-1 and zymosan-A (Zy) in a murine tissue engineering model. RESEARCH METHODS AND PROCEDURES: MCP-1 and Zy were added to chambers filled with Matrigel and fibroblast growth factor 2. To analyze the role of inducible nitric oxide synthase (iNOS), the iNOS inhibitor aminoguanidine was added to the chamber. RESULTS: Our results show that MCP-1 generated proportionally large quantities of new adipose tissue. This neoadipogenesis was accompanied by an ingrowth of macrophages and could be mimicked by Zy. Aminoguanidine significantly inhibited the formation of adipose tissue. DISCUSSION: Our findings demonstrate that low-grade inflammation and iNOS expression are important factors in adipogenesis. Because fat neoformation in obesity and the metabolic syndrome is believed to be mediated by macrophage-derived proinflammatory cytokines, this adipose tissue engineering system provides a model that could potentially be used to further unravel the pathogenesis of these two metabolic disorders.

Angiogenic growth factor synergism in a murine tissue engineering model of angiogenesis and adipogenesis.

De novo tissue generation stimulated by three angiogenic growth factors administered in a factorial design was studied in an in vivo murine tissue engineering chamber. A silicone chamber was implanted around the epigastric pedicle and filled with Matrigel with 100 ng/ml of recombinant mouse vascular endothelial growth factor-120 (VEGF120), recombinant human basic fibroblastic growth factor (FGF-2), or recombinant rat platelet-derived growth factor-BB (PDGF-BB) added as single, double, or triple combinations. Angiogenesis, supporting tissue ingrowth, and adipogenesis were assessed at 2 and 6 weeks by immunohistochemistry and morphometry. At 2 weeks angiogenesis was synergistically enhanced by VEGF120 + FGF-2 (P = 0.019). FGF-2 (P = 0.008) and PDGF-BB (P = 0.01) significantly increased connective tissue/inflammatory cell infiltrate (macrophages, pericytes, and preadipocytes) in double and triple combinations compared with control. At 6 weeks sequential addition of growth factors increased the percent volume of adipose tissue (P < 0.0005, each main effect), with a synergistic increase in adipose tissue in combination treatments (P < 0.0005). Groups containing 300 ng/ml of single growth factors produced significantly less adipose tissue than the triple growth factor combination (P < 0.0005, VEGF120 and PDGF-BB; P < 0.001, FGF-2). In conclusion, angiogenic growth factor combinations increased early angiogenesis and cell infiltration resulting in synergistically increased adipose tissue growth at 6 weeks. Two way and higher level synergies are likely to be important in therapeutic applications of angiogenic growth factors.