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.

Embolisation for pulmonary arteriovenous malformation.

BACKGROUND: Pulmonary arteriovenous malformations are abnormal direct connections between the pulmonary artery and pulmonary vein which result in a right-to-left shunt. They are associated with substantial morbidity and mortality mainly from the effects of paradoxical emboli. Potential complications include stroke, cerebral abscess, pulmonary haemorrhage and hypoxaemia. Embolisation is an endovascular intervention based on the occlusion of the feeding arteries the pulmonary arteriovenous malformations thus eliminating the abnormal right-to-left-shunting. This is an update of a previously published review. OBJECTIVES: To determine the efficacy and safety of embolisation in patients with pulmonary arteriovenous malformations including a comparison with surgical resection and different embolisation devices. SEARCH METHODS: We searched the Cystic Fibrosis and Genetic Disorders Group's Trials Register; date of last search: 10 April 2017.We also searched the following databases: the Australian New Zealand Clinical Trials Registry; ClinicalTrials.gov; International Standard Randomised Controlled Trial Number Register; International Clinical Trials Registry Platform Search Portal (last searched 27 August 2017). to be updatedWe checked cross-references and searched references from review articles. SELECTION CRITERIA: Trials in which individuals with pulmonary arteriovenous malformations were randomly allocated to embolisation compared to no treatment, surgical resection or embolisation using a different embolisation device. DATA COLLECTION AND ANALYSIS: Studies identified for potential inclusion were independently assessed for eligibility by two authors, with excluded studies further checked by a third author. No trials were identified for inclusion in the review and hence no analysis was performed. MAIN RESULTS: There were no randomised controlled trials included in the review; one ongoing trial has been identified which may be eligible for inclusion in the future. AUTHORS' CONCLUSIONS: There is no evidence from randomised controlled trials for embolisation of pulmonary arteriovenous malformations. However, randomised controlled trials are not always feasible on ethical grounds. Accumulated data from observational studies suggest that embolisation is a safe procedure which reduces morbidity and mortality. A standardised approach to reporting with long-term follow-up through registry studies can help to strengthen the evidence for embolisation in the absence of randomised controlled trials.

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.

Embolisation for pulmonary arteriovenous malformation.

BACKGROUND: Pulmonary arteriovenous malformations are abnormal direct connections between the pulmonary artery and pulmonary vein which result in a right-to-left shunt. They are associated with substantial morbidity and mortality mainly from the effects of paradoxical emboli. Potential complications include stroke, cerebral abscess, pulmonary haemorrhage and hypoxaemia. Embolisation is an endovascular intervention based on the occlusion of the feeding arteries the pulmonary arteriovenous malformations thus eliminating the abnormal right-to-left-shunting. OBJECTIVES: To determine the efficacy and safety of embolisation in patients with pulmonary arteriovenous malformations including a comparison with surgical resection and different embolisation devices. SEARCH METHODS: We searched the Cystic Fibrosis and Genetic Disorders Group's Trials Register; date of last search: 31 March 2014.We also searched the following databases: the Australian New Zealand Clinical Trials Registry; ClinicalTrials.gov; International Standard Randomised Controlled Trial Number Register; International Clinical Trials Registry Platform Search Portal (last searched 1 July 2014).We checked cross-references and searched references from review articles. SELECTION CRITERIA: Trials in which individuals with pulmonary arteriovenous malformations were randomly allocated to embolisation compared to no treatment, surgical resection or embolisation using a different embolisation device. DATA COLLECTION AND ANALYSIS: Studies identified for potential inclusion were independently assessed for eligibility by two authors, with excluded studies further checked by a third author. No trials were identified for inclusion in the review and hence no analysis was performed. MAIN RESULTS: There were no randomised controlled trials included in the review; one ongoing trial has been identified which may be eligible for inclusion in the future. AUTHORS' CONCLUSIONS: There is no evidence from randomised controlled trials for embolisation of pulmonary arteriovenous malformations. However, randomised controlled trials are not always feasible on ethical grounds. Accumulated data from observational studies suggest that embolisation reduces morbidity. A standardised approach to reporting with long-term follow-up through registry studies can help to strengthen the evidence for embolisation in the absence of randomised controlled trials.

Embolisation for pulmonary arteriovenous malformation.

BACKGROUND: Pulmonary arteriovenous malformations are abnormal direct connections between the pulmonary artery and pulmonary vein which result in a right-to-left shunt. They are associated with substantial morbidity and mortality mainly from the effects of paradoxical emboli. Potential complications include stroke, cerebral abscess, pulmonary haemorrhage and hypoxaemia. Embolisation is an endovascular intervention based on the occlusion of the feeding arteries the pulmonary arteriovenous malformations thus eliminating the abnormal right-to-left-shunting. OBJECTIVES: To determine the efficacy and safety of embolisation in patients with pulmonary arteriovenous malformations including a comparison with surgical resection and different embolisation devices. SEARCH METHODS: We searched the Cystic Fibrosis and Genetic Disorders Group's Trials Register; date of last search: 09 February 2012.We also searched the following databases: the Australian New Zealand Clinical Trials Registry; ClinicalTrials.gov; International Standard Randomised Controlled Trial Number Register; International Clinical Trials Registry Platform Search Portal (last searched 15 May 2012).We checked cross-references and searched references from review articles. SELECTION CRITERIA: Trials in which individuals with pulmonary arteriovenous malformations were randomly allocated to embolisation compared to no treatment, surgical resection or embolisation using a different embolisation device. DATA COLLECTION AND ANALYSIS: Studies identified for potential inclusion were independently assessed for eligibility by two authors, with excluded studies further checked by a third author. No trials were identified for inclusion in the review and hence no analysis was performed. MAIN RESULTS: There were no randomised controlled trials identified. AUTHORS' CONCLUSIONS: There is no evidence from randomised controlled trials for embolisation of pulmonary arteriovenous malformations. However, randomised controlled trials are not always feasible on ethical grounds. Accumulated data from observational studies suggest that embolisation reduces morbidity. A standardised approach to reporting with long-term follow-up through registry studies can help to strengthen the evidence for embolisation in the absence of randomised controlled trials.

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.

Non-traumatic cerebrospinal fluid rhinorrhea caused by ethmoid sinus osteoma.

Cerebrospinal fluid (CSF) rhinorrhea is a rare complication of ethmoid sinus osteoma, considering its benign and indolent nature. We present a 36-year-old female patient with symptomatic CSF rhinorrhea as a primary presentation of ethmoid sinus osteoma. We have highlighted the imaging features and emphasised the importance of imaging in the diagnosis of spontaneous CSF leak.

Embolisation therapy for pulmonary arteriovenous malformations.

BACKGROUND: Pulmonary arteriovenous malformations are abnormal direct connections between the pulmonary artery and pulmonary vein which result in a right-to-left shunt. They are associated with substantial morbidity and mortality mainly from the effects of paradoxical emboli. Potential complications include stroke, cerebral abscess, pulmonary haemorrhage and hypoxaemia. Embolisation therapy is a form of treatment based on the occlusion of the feeding arteries to a pulmonary arteriovenous malformation and can prevent many of these debilitating and life-threatening complications. OBJECTIVES: To determine the efficacy and safety of embolisation therapy in people with pulmonary arteriovenous malformations including a comparison with surgical resection and different embolisation devices. SEARCH STRATEGY: We searched the Cystic Fibrosis and Genetic Disorders Group's Trials Registers (last searched 07 September 2009). We also searched the following databases: the Australian New Zealand Clinical Trials Registry; ClinicalTrials.gov; International Standard Randomised Controlled Trial Number Register; International Clinical Trials Registry Platform Search Portal (last searched 22 November 2009). We checked cross-references and searched references from review articles. Finally, we contacted manufacturers and specialised centres for unpublished and ongoing trials. SELECTION CRITERIA: Trials in which individuals with pulmonary arteriovenous malformations were randomly allocated to embolisation therapy compared to no treatment, surgical resection or a different embolisation device. Studies identified for potential inclusion were independently assessed for eligibility by two authors, with excluded studies further checked by a third author. DATA COLLECTION AND ANALYSIS: No trials were identified. As this was the case, no analysis was performed. MAIN RESULTS: There were no randomised controlled trials identified. AUTHORS' CONCLUSIONS: Currently there are no randomised controlled trials to support or refute embolisation therapy for treatment of pulmonary arteriovenous malformations. However, randomised controlled trials are not always feasible on ethical grounds. Observational studies suggest that embolisation therapy reduces mortality and morbidity compared to no treatment in patients. A standardised approach to reporting with long-term follow up through registry studies can help to strengthen the evidence base for embolisation therapy in the absence of randomised controlled trials. Future viable randomised controlled trials may compare different embolisation devices against each other.