Surgery versus thrombolysis for initial management of acute limb ischaemia.

BACKGROUND: Both peripheral arterial thrombolysis and surgery can be used in the management of peripheral arterial ischaemia. Much is known about the indications, risks, and benefits of thrombolysis. However, whether thrombolysis works better than surgery for initial management of acute limb ischaemia remains unknown. This is the second update of the review first published in 2002. OBJECTIVES: To determine whether thrombolysis or surgery is the more effective technique in the initial management of acute limb ischaemia due to thromboembolism. SEARCH METHODS: For this update, the Cochrane Vascular Information Specialist (CIS) searched the Cochrane Vascular Specialised Register, CENTRAL, MEDLINE Ovid, Embase Ovid, CINAHL, AMED, and clinical trials registries up to 7 May 2018. SELECTION CRITERIA: All randomised controlled studies comparing thrombolysis and surgery for initial treatment of acute limb ischaemia. DATA COLLECTION AND ANALYSIS: We independently assessed trial quality and extracted data. Agreement was reached by consensus. We performed analyses using odds ratios (ORs) and 95% confidence intervals (CIs). MAIN RESULTS: We identified no new studies for this update. We included five trials with a total of 1292 participants; agents used for thrombolysis were recombinant tissue plasminogen activator and urokinase. Trials were generally of moderate methodological quality. The quality of evidence according to GRADE was generally low owing to risk of bias (lack of blinding), imprecision in estimates, and heterogeneity.Trial results showed no clear differences in limb salvage, amputation, or death at 30 days (odds ratio (OR) 1.02, 95% confidence interval (CI) 0.41 to 2.55, 4 studies, 636 participants; OR 0.97, 95% CI 0.51 to 1.85, 3 studies, 616 participants; OR 0.59, 95% CI 0.31 to 1.14, 4 studies, 636 participants, respectively), and we rated the evidence as low, low, and moderate quality, respectively. Trial results show no clear differences for any of the three outcomes at six months or one year between initial surgery and initial thrombolysis. A single study evaluated vessel patency, so no overall association could be determined (OR 0.46, 95% CI 0.08 to 2.76, 20 participants; very low-quality evidence). Evidence of increased risk of major haemorrhage (OR 3.22, 95% CI 1.79 to 5.78, 4 studies, 1070 participants; low-quality evidence) and distal embolisation (OR 31.68, 95% CI 6.23 to 161.07, 3 studies, 678 participants; very low-quality evidence) was associated with thrombolysis treatment at 30 days, and there was no clear difference in stroke (OR 5.33, 95% CI 0.95 to 30.11, 5 studies, 1180 participants; low-quality evidence). Participants treated by initial thrombolysis had a greater reduction in the level of intervention required, compared with a pre-intervention prediction, at 30 days (OR 9.06, 95% CI 4.95 to 16.56, 2 studies, 502 participants). None of the included studies evaluated time to thrombolysis as an outcome. AUTHORS' CONCLUSIONS: There is currently no evidence in favour of either initial thrombolysis or initial surgery as the preferred option in terms of limb salvage, amputation, or death at 30 days, six months, or one year. Low-quality evidence suggests that thrombolysis may be associated with higher risk of haemorrhagic complications and ongoing limb ischaemia (distal embolisation). The higher risk of complications must be balanced against risks of surgery in each individual case. Trial results show no statistical difference in stroke, but the confidence interval is very wide, making it difficult to interpret whether this finding is clinically important. We used GRADE criteria to assess the quality of the evidence as generally low. We downgraded quality owing to risk of bias, imprecision, and heterogeneity between included studies.

Acogimiento residencial terapéutico para niños y adolescentes: una declaración de consenso del Grupo de Trabajo Internacional sobre Acogimiento Residencial Terapéutico / Therapeutic Residential Care for Children and Youth: A Consensus Statement of the International Work Group on Therapeutic Residential Care

En muchos países desarrollados a lo largo del mundo las intervenciones en acogimiento residencial para niños y adolescentes se encuentran en un momento de creciente debate. Ante esta situación, se organizó una cumbre internacional en Inglaterra (primavera de 2016) con expertos de 13 países para reflexionar sobre el acogimiento residencial terapéutico (ART). Se partió de la siguiente definición de ART: "el acogimiento residencial terapéutico implica el uso planificado de un ambiente de convivencia multidimensional, construido a propósito, diseñado para desarrollar o proveer tratamiento, educación, socialización, apoyo y protección a niños y jóvenes con necesidades reconocidas de salud mental o conductuales, en cooperación con sus familias y la colaboración de un amplio espectro recursos comunitarios formales e informales». La reunión se caracterizó por el intercambio de información y evidencias y la preparación de una agenda internacional de investigación. Además, se discutieron las bases para una declaración de consenso. Esta declaración, originalmente publicada en inglés y ahora reproducida en español, comprende, entre otras cuestiones, cinco principios básicos de acogimiento que de acuerdo con el grupo de trabajo en acogimiento residencial terapéutico deben guiar el acogimiento residencial de jóvenes que se preste en todo momento (AU)

In many developed countries around the world residential care interventions for children and adolescents have come under increasing scrutiny. Against this background an international summit was organised in England (spring 2016) with experts from 13 countries to reflect on therapeutic residential care (TRC). The following working definition of TRC was leading: «Therapeutic residential care involves the planful use of a purposefully constructed, multi-dimensional living environment designed to enhance or provide treatment, education, socialization, support, and protection to children and youth with identified mental health or behavioral needs in partnership with their families and in collaboration with a full spectrum of community based formal and informal helping resources». The meeting was characterised by exchange of information and evidence, and by preparing an international research agenda. In addition, the outlines of a consensus statement on TRC were discussed. This statement, originally published in English and now reproduced in a Spanish translation, comprises inter alia five basic principles of care that according to the Work Group on Therapeutic Residental Care should be guiding for residential youth care provided at any time (AU)

[Therapeutic Residential Care for Children and Youth: A Consensus Statement of the International Work Group on Therapeutic Residential Care].

Therapeutic Residential Care for Children and Youth: A Consensus Statement of the International Work Group on Therapeutic Residential Care. In many developed countries around the world residential care interventions for children and adolescents have come under increasing scrutiny. Against this background an international summit was organised in England (spring 2016) with experts from 13 countries to reflect on therapeutic residential care (TRC). The following working definition of TRC was leading: “Therapeutic residential care involves the planful use of a purposefully constructed, multi-dimensional living environment designed to enhance or provide treatment, education, socialization, support, and protection to children and youth with identified mental health or behavioral needs in partnership with their families and in collaboration with a full spectrum of community based formal and informal helping resources”. The meeting was characterised by exchange of information and evidence, and by preparing an international research agenda. In addition, the outlines of a consensus statement on TRC were discussed. This statement, originally published in English and now reproduced in a Spanish translation, comprises inter alia five basic principles of care that according to the Work Group on Therapeutic Residental Care should be guiding for residential youth care provided at any time.

The Problem with Big Data: Operating on Smaller Datasets to Bridge the Implementation Gap.

Big datasets have the potential to revolutionize public health. However, there is a mismatch between the political and scientific optimism surrounding big data and the public's perception of its benefit. We suggest a systematic and concerted emphasis on developing models derived from smaller datasets to illustrate to the public how big data can produce tangible benefits in the long term. In order to highlight the immediate value of a small data approach, we produced a proof-of-concept model predicting hospital length of stay. The results demonstrate that existing small datasets can be used to create models that generate a reasonable prediction, facilitating health-care delivery. We propose that greater attention (and funding) needs to be directed toward the utilization of existing information resources in parallel with current efforts to create and exploit "big data."

Is there a continuing role for traditional surgery?

Despite recent NICE guidance there remains a definite role for surgery in the management of varicose veins. A lot of the available evidence that has driven the transformation of care towards endovenous treatments is of good quality yet published by enthusiasts. No endovenous studies have reported long term results as far out from intervention as the open studies, yet in the meta-analysis from Murad et al, the authors suggested from their results that when surgery was compared with all endoluminal ablation therapies, surgery was associated with a non-significant reduction in the risk of varicose vein recurrence (RR0.63; 95%CI 0.37--1.07). Much of the longer-term data on recurrence following open surgery for primary varicose veins dates back well over 15 years ago. This is prior to the inclusion of routine duplex assessment and sub-specialty designation. The recent Cochrane review (13 randomised controlled studies, 3081 patients). The overall conclusion was that UGFS, EVLT and RFA were at least as effective as surgery in the treatment of the LSV. This meta-analysis did not include the CLASS (Comparison of LAser, Surgery and foam Sclerotherapy as a treatment for varicose veins) trial in which measures of clinical success were similar among the groups. Only 48% of the patients screened were eligible for the CLASS study and of these, only 24% of the eligible patients agreed to take part in the study. Similarly in the study by Carradice out of a total of 772 patients assessed for suitability, 442 did not meet the inclusion criteria. There is no doubt that endovenous surgery will increasingly become first line treatment for patients with symptomatic superficial venous reflux specifically in patients with SSV reflux. However, given the device related limitations with endothermal techniques specifically with regard to adverse anatomical features allied to the poorer results of UGFS within the treatment of LSV reflux, there is without doubt still a role for more traditional open surgical techniques that can be delivered with good short and long term outcomes and still being delivered in a cost effective manner.

Primary care trust commissioning of varicose vein intervention--new guidance needed?

OBJECTIVES: In light of evidence of national variability in service commissioning of varicose vein intervention, our aim was to evaluate the current state of primary care trust commissioning for all forms of varicose vein intervention in England. We also sought to clarify the extent to which access to endovenous and surgical varicose vein services is being restricted. METHODS: Under the Freedom of Information Act (2001), a structured email survey was sent to 108 primary care trusts in England. Trusts were asked how many elective endovenous laser therapy and open procedures were commissioned from 2008 to 2011 and they were asked to submit their commissioning policy for analysis. The 'qualifying criteria' expressed in each policy were analysed by theme and geographical region. RESULTS: Of 108 surveys, 95 (88%) were completed and returned. Of these, 91 (96%) stated that varicose vein interventions were actively commissioned. Eighty-eight (97%) of primary care trusts that commissioned varicose vein interventions stated that access was restricted. Qualifying criteria varied considerably between regions. CONCLUSIONS: Access to varicose vein intervention appears to be restricted, with national variation in commissioning across England. This might have an impact on patient care and surgical training. We propose that a national decision be made about which varicose vein patients should be offered funding for treatment on the National Health Service.

Fibrinolytic agents for peripheral arterial occlusion.

BACKGROUND: Peripheral arterial thrombolysis is used in the management of peripheral arterial ischaemia. Streptokinase was originally used but safety concerns led to a search for other agents. Urokinase and recombinant tissue plasminogen activator (rt-PA) have increasingly become established as first line agents for peripheral arterial thrombolysis. Potential advantages of these agents include improved safety, greater efficacy and a more rapid response. Recently drugs such as pro-urokinase, recombinant staphylokinase and alfimperase have been introduced. This is an update of a review first published in 2010. OBJECTIVES: To determine which fibrinolytic agents are most effective in peripheral arterial ischaemia. SEARCH METHODS: For this update the Cochrane Peripheral Vascular Diseases Group Trials Search Co-ordinator (TSC) searched the Specialised Register (last searched March 2013) and CENTRAL (2013, Issue 3) for randomised controlled trials (RCTs) comparing fibrinolytic agents to treat peripheral arterial ischaemia. SELECTION CRITERIA: RCTs comparing fibrinolytic agents to treat peripheral arterial occlusion. DATA COLLECTION AND ANALYSIS: Data were analysed for the outcomes vessel patency, time to lysis, limb salvage, amputation, death, complications including major haemorrhage, stroke, and distal embolization. MAIN RESULTS: Five RCTs involving a total of 687 participants with a range of clinical indications were included. No new studies were included in this update. In one three-pronged study, vessel patency was greater with intra-arterial recombinant tissue plasminogen activator (rt-PA) than with intra-arterial streptokinase (P < 0.04) or intravenous rt-PA (P < 0.01). In participants with peripheral arterial occlusion there was no statistically significant difference in limb salvage at 30 days with either urokinase or rt-PA, though this may reflect the small numbers in the studies. Incidences of haemorrhagic complications varied with fibrinolytic regime but there was no statistically significant difference between intra-arterial urokinase and intra-arterial rt-PA. In the three-pronged study intravenous rt-PA and intra-arterial streptokinase were associated with a significantly higher risk of haemorrhagic complications than with intra-arterial rt-PA (P < 0.05). AUTHORS' CONCLUSIONS: There is some evidence to suggest that intra-arterial rt-PA is more effective than intra-arterial streptokinase or intravenous rt-PA in improving vessel patency in people with peripheral arterial occlusion. There was no evidence that rt-PA was more effective than urokinase for patients with peripheral arterial occlusion and some evidence that initial lysis may be more rapid with rt-PA, depending on the regime. Incidences of haemorrhagic complications were not statistically significantly greater with rt-PA than with other regimes. However, all of the findings come from small studies and a general paucity of results means that it is not possible to draw clear conclusions.

Surgery versus thrombolysis for initial management of acute limb ischaemia.

BACKGROUND: Peripheral arterial thrombolysis is technique used in the management of peripheral arterial ischaemia. Much is known about the indications, risks and benefits of thrombolysis. However, it is not known whether thrombolysis works better than surgery in the initial treatment of acute limb ischaemia. OBJECTIVES: To determine the preferred initial treatment, surgery or thrombolysis, for acute limb ischaemia. SEARCH METHODS: For this update the Cochrane Peripheral Vascular Diseases Group Trials Search Co-ordinator searched the Specialised Register (last searched March 2013) and CENTRAL (2013, Issue 2). SELECTION CRITERIA: All randomised studies comparing thrombolysis and surgery for the initial treatment of acute limb ischaemia. DATA COLLECTION AND ANALYSIS: Each author independently assessed trial quality and extracted data. Agreement was reached by consensus. MAIN RESULTS: Five trials with a total of 1283 participants were included. There was no significant difference in limb salvage or death at 30 days, six months or one year between initial surgery and initial thrombolysis. However, stroke was significantly more frequent at 30 days in thrombolysis participants (1.3%) compared to surgery participants (0%) (Odds ratio (OR) 6.41; 95% confidence interval (CI) 1.57 to 26.22). Major haemorrhage was more likely at 30 days in thrombolysis participants (8.8%) compared to surgery participants (3.3%) (OR 2.80; 95% CI 1.70 to 4.60); and distal embolization was more likely at 30 days in thrombolysis participants (12.4%) compared to surgery participants (0%) (OR 8.35; 95% CI 4.47 to 15.58).Participants treated by initial thrombolysis underwent a less severe degree of intervention (OR 5.37; 95% CI 3.99 to 7.22) and displayed equivalent overall survival compared to initial surgery (OR 0.87; 95% CI 0.61 to 1.25). AUTHORS' CONCLUSIONS: Universal initial treatment with either surgery or thrombolysis cannot be advocated on the available evidence. There is no overall difference in limb salvage or death at one year between initial surgery and initial thrombolysis. Thrombolysis may be associated with a higher risk of ongoing limb ischaemia and haemorrhagic complications including stroke. The higher risk of complications must be balanced against risks of surgery in each person.

Spontaneous aortic dissection within an infrarenal AAA.

Aortic dissection occurring in the infrarenal abdominal aorta is uncommon. We present the case of a patient presenting with an enlarging abdominal aortic aneurysm and concurrent dissection (with associated radiological imaging) and briefly discuss the literature relating to this phenomenon.

Fibrinolytic agents for peripheral arterial occlusion.

BACKGROUND: Peripheral arterial thrombolysis is used in the management of peripheral arterial ischaemia. Streptokinase was originally used but safety concerns led to a search for other agents. Urokinase and recombinant tissue plasminogen activator (rt-PA) have increasingly become established as first line agents for peripheral arterial thrombolysis. Potential advantages of these agents include improved safety, greater efficacy and a more rapid response. Recently drugs such as pro-urokinase, recombinant staphylokinase and alfimperase have been introduced. OBJECTIVES: To determine which fibrinolytic agents are most effective in peripheral arterial ischaemia. SEARCH STRATEGY: The Cochrane Peripheral Vascular Diseases Group searched their Specialised Register (last searched October 2009) and the Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library (last searched 2009, Issue 4) for randomised controlled trials (RCTs) comparing fibrinolytic agents to treat peripheral arterial ischaemia. SELECTION CRITERIA: RCTs comparing fibrinolytic agents to treat peripheral arterial occlusion. DATA COLLECTION AND ANALYSIS: Data were analysed for the outcomes vessel patency, time to lysis, limb salvage, amputation, death, complications including major haemorrhage, stroke, and distal embolization. MAIN RESULTS: Five RCTs involving a total of 687 patients with a range of clinical indications were included. In one three-pronged study, vessel patency was greater with intra-arterial recombinant tissue plasminogen activator (rt-PA) than with intra-arterial streptokinase (P < 0.04) or intravenous rt-PA (P < 0.01). In patients with peripheral arterial occlusion there was no statistically significant difference in limb salvage at 30 days with either urokinase or rt-PA, though this may reflect the small numbers in the studies. Incidences of haemorrhagic complications varied with fibrinolytic regime but there was no statistically significant difference between intra-arterial urokinase and intra-arterial rt-PA. In the three-pronged study intravenous rt-PA and intra-arterial streptokinase were associated with a significantly higher risk of haemorrhagic complications than with intra-arterial rt-PA (P < 0.05). AUTHORS' CONCLUSIONS: There is some evidence to suggest that intra-arterial rt-PA is more effective than intra-arterial streptokinase or intravenous rt-PA in improving vessel patency in people with peripheral arterial occlusion. There was no evidence that rt-PA was more effective than urokinase for patients with peripheral arterial occlusion and some evidence that initial lysis may be more rapid with rt-PA, depending on the regime. Incidences of haemorrhagic complications were not statistically significantly greater with rt-PA than with other regimes. However, all of the findings come from small studies and a general paucity of results means that it is not possible to draw clear conclusions.

Type II endoleaks: predictable, preventable, and sometimes treatable?

OBJECTIVE: The purpose of this study was to evaluate the effect of preoperative coil embolization of lumbar and inferior mesenteric arteries on the incidence of type II endoleak after endovascular abdominal aortic aneurysm repair. METHODS: The subjects were consecutive patients who underwent EVAR between January 1996 and January 2001. Patent aortic side branches were identified with preprocedural spiral computed tomographic scanning and calibrated angiography. Coil embolization was performed before EVAR. Patients were followed up with plain radiographs and ultrasound and dual phase spiral computed tomographic scans. Digital subtraction angiography was performed when endoleak was suspected. The outcome measures were the incidence of type II endoleaks and changes in maximum aortic sac diameter (Dmax). RESULTS: Forty patients underwent EVAR, with a median duration of follow-up of 24 months (range, 3 to 48 months). Before surgery, the inferior mesenteric artery was patent in 16 patients (45%) and the lumbar arteries in 21 patients (53%). Inferior mesenteric artery embolization was successful in 13 of 16 patients (81%). Lumbar embolization was attempted in 13 patients and was successful in eight (62%). During EVAR, successful sac exclusion was achieved in 38 patients (95%). None of the patients who underwent embolization before EVAR had type II endoleak develop, eight of 13 patients (62%) with patent lumbar arteries had endoleaks develop (P =.006), and three of these patients subsequently underwent successful coil embolization. Type II endoleak was associated with a 2.0-mm median increase in Dmax (P =.045). A 3.0-mm median reduction in Dmax was seen in the absence of type II endoleak (P =.002). CONCLUSION: Type II endoleaks are predictable, preventable, and sometimes treatable. Significant sac shrinkage occurs in the absence of lumbar endoleak but not in the presence of type II endoleak.