| 1. |
- Lundgren, Fredrik, et al.
(author)
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PTFE bypass to below-knee arteries : distal vein collar or not? A prospective randomised multicentre study
- 2010
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In: European Journal of Vascular and Endovascular Surgery. - : Elsevier BV. - 1078-5884 .- 1532-2165. ; 39:6, s. 747-754
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Journal article (peer-reviewed)abstract
- BackgroundPatency and limb salvage after synthetic bypass to the arteries below-knee are inferior to that which can be achieved with autologous vein. Use of a vein collar at the distal anastomosis has been suggested to improve patency and limb salvage, a problem that is analysed in this randomised clinical study.MethodsPatients with critical limb ischaemia undergoing polytetrafluoroethylene (PTFE) bypass to below-knee arteries were randomly either assigned a vein collar or not in two groups – bypass to the popliteal artery below-knee (femoro-popliteal below-knee (FemPopBK)) and more distal bypass (femoro-distal bypass (FemDist)). Follow-up was scheduled until amputation, death or at most 5 years, whichever event occurred first.ResultsIn the FemPopBK and in the FemDist groups, 115/202 and 72/150 were randomised to have a vein collar, respectively. Information was available for 345 of 352 randomised patients (98%).At 3 years, primary patency was 26% (95% confidence interval (CI) 18–38) with a vein collar and 43 (33–58) without a vein collar for femoro-popliteal bypass and 20 (11–38), and 17 (9–33) for femoro-distal bypass, respectively. The corresponding figures for limb salvage were 64 (54–75) and 61 (50–74) for femoro-popliteal bypass, and 59 (46–76) and 44 (32–61) for femoro-distal bypass with and without a vein collar, respectively. Log-rank-test for the whole Kaplan–Meier life table curve showed no statistically significant differences with or without vein collar primary patency: p = 0.0853, p = 0.228; secondary patency: p = 0.317, p = 0.280; limb salvage: p = 0.757, p = 0.187 for FemPopBK and FemDist, respectively. The use of a vein collar did not influence patency or limb salvage.ConclusionThis study failed to show any benefit for vein collar with PTFE bypass to a below-knee artery.
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| 2. |
- Vallo Hult, Helena, 1976-, et al.
(author)
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Egenmonitorering : evidenskartläggning genom sammanställning av systematiska översikter för utvalda diagnosgrupper
- 2023
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Reports (other academic/artistic)abstract
- BackgroundIn Region Västra Götaland (VGR), the development of remote patient monitoring is given high priority, aiming for improvements for patients and reduction of healthcare costs. In this report we defined remote patient monitoring as continuous follow-up of relevant health-related parameters of patients located outside healthcare facilities (e.g. at home). Measurements taken by analogue or digital devices, objective and/or subjective assessments, are delivered digitally to the patient and to a healthcare professional. The healthcare professional provides the patient with feedback on the reported data (feedback may be automatically generated if data are within a predefined range). The plan in VGR is to introduce remote monitoring in selected diagnosis groups – some of which already started using remote monitoring.AimThe aim of this report was to provide an overview of systematic reviews regarding remote monitoring(as add on or replacement of visits in current standard of care) compared to standard of care in 25 selected diagnosis groups.MethodIn order to clarify how remote monitoring is intended to be used in the 25 diagnosis groups, representatives from the respective clinical areas were interviewed. As the scope of this project covered many diagnosis groups, the search was limited to systematic reviews (SRs) of randomised (RCTs) or non-randomised clinical trials. The relevance of each identified SR for our PICO(Population, Intervention, Comparator and Outcomes) was assessed by at least two project members (one clinical representative and one from HTA-centrum). Relevant SRs were assessed by at least two project members using SNABBSTAR, a tool developed by The Swedish Agency for Health Technology Assessment and Assessment of Social Services (SBU) for assessment of risk of bias/systematic errors in SRs. The tool consists of six steps and assessment of an SR is stopped as soon as the criteria for a specific level are not met.The steps are: 1. Definition of PICO and literature search; 2. Inclusion/exclusion according to PICO, listing of included studies; 3. Risk of bias assessments; 4. Evidence synthesis/meta-analyses; 5. Certainty of evidence consideration; 6. Documentation of excluded studies, conflicts of interest, and an a priori published SR protocol.SNABBSTAR evaluates how useful an SR is by assessing the methodology used in the SR. In the current project, SRs reaching at least SNABBSTAR level 4 were considered to provide relevant data synthesis. As reaching SNABBSTAR level 5 or 6 is considered necessary for reliable conclusions, we cited key conclusions only from SRs reaching these levels. We did not extract any data from the included SRs.ResultsThe literature search resulted in 3,332 hits. Of these, 279 were read in full text to assess their relevance for the PICO. Seventy-five SRs were considered relevant and were included; these were assessed by SNABBSTAR.
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| 3. |
- Fändriks, Lars, 1956, et al.
(author)
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Bariatric surgery for diabetes mellitus type 2 control in adults with BMI<35 kg/m2
- 2016
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Reports (other academic/artistic)abstract
- Background: Obesity is strongly linked to diabetes and premature mortality, mainly from cardiovascular causes. In 2013, the prevalence of obesity (BMI ≥ 30 kg/m2) in adults in Sweden was 14 %. The prevalence of diabetes mellitus in Sweden is approximately 5 % with a slow increase due to an ageing population. In 2015, 73,225 patients in VGR had a diagnosis of diabetes mellitus. The treatment of overweight and obesity in adults is based on three principles: lifestyle changes, pharmacological treatment and surgery. Today, weight reducing (bariatric) surgery can be offered to individuals with BMI ≥40 kg/m2, and patients with BMI ≥35 kg/m2 with an obesity associated disease, in particular diabetes mellitus type 2 (T2D). Bariatric surgery in persons with BMI < 35 kg/m2 is currently not endorsed in Swedish national guidelines (National Board of Health and Welfare, 2015). Glycaemic stabilisation is reported to occur very early after surgery, before any significant weight loss. In a recent joint statement by several international diabetes organizations, it was proposed that bariatric surgery should be considered to be an option to treat T2D in patients with BMI 30.0–34.99 kg/m2 and inadequately controlled hyperglycaemia despite optimal medical treatment. Objective: To study if bariatric surgery in patients with T2D and a BMI <35 kg/m2 is superior to standard treatment with regard to diabetes control. Search methods and study selection criteria: During January 2016 two authors performed systematic searches in PubMed, Embase, the Cochrane Library and a number of HTA-databases for systematic reviews, randomized (RCT) and non-randomised controlled studies. Due to the small number of original articles fulfilling the inclusion criteria we chose to only include and critically appraise original articles. Main results: The literature search resulted in four RCTs and six cohort studies (two reporting on the same population) comparing results of bariatric surgery with medical treatment in T2D patients with BMI <35 kg/m2. The studies had limitations mainly related to, e.g., short follow-up, some inconsistency, indirectness due to different interventions or unclear patient selection, and imprecision. Mortality was reported in two studies with only one reported death. Remission of T2D was studied in three RCTs and four cohort studies. The frequency of T2D remission during 1–3 years follow-up may be higher after bariatric surgery compared with non-surgical standard care (GRADE ⊕⊕ ). Diabetes related and cardiovascular complications were not studied. Health related quality of life (SF-36) was reported in one RCT and physical wellbeing may improve after bariatric surgery compared with medical treatment (GRADE ⊕⊕ ). Regarding glycaemic control, bariatric surgery compared with non-surgical standard care probably reduces HbA1c (GRADE ⊕⊕⊕ ), may reduce fasting plasma glucose (GRADE ⊕⊕ ) but the effect on the number of glucose-lowering medications is uncertain (GRADE ⊕ ). Bariatric surgery compared with non-surgical standard care probably reduces BMI (GRADE ⊕⊕⊕ ) but the effects on other metabolic risk factors are uncertain (GRADE ⊕ ). Risks and complications: The rate of surgical complications was reported from four to 17% ranging from mild to more severe complications requiring surgical intervention. Concluding remarks: This systematic review shows that bariatric surgery compared with medical treatment may increase the frequency of diabetes remission and probably results in improved glycaemic control in adults with overweight or obesity (BMI< 35 kg/m2, mainly 30 – 34.99 kg/m2) during 1–3 years follow-up. The bariatric surgical procedures mainly performed in Sweden today (Roux-en-Y gastric bypass, vertical sleeve gastrectomy) were investigated in only half of the current studies. Data on long term efficacy and safety are lacking and there are no results indicating reduced risk of cardiovascular disease, cancer or death. No relevant health economic analyses are available.
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| 5. |
- Jivegård, Lennart, 1950, et al.
(author)
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Effects of three months of low molecular weight heparin (dalteparin) treatment after bypass surgery for lower limb ischemia--a randomised placebo-controlled double blind multicentre trial.
- 2005
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In: European journal of vascular and endovascular surgery : the official journal of the European Society for Vascular Surgery. - : Elsevier BV. - 1078-5884. ; 29:2, s. 190-8
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Journal article (peer-reviewed)abstract
- OBJECTIVES: To test the hypothesis that long-term postoperative dalteparin (Fragmin), Pharmacia Corp) treatment improves primary patency of peripheral arterial bypass grafts (PABG) in lower limb ischemia patients on acetylsalicylic acid (ASA) treatment. DESIGN: Prospective randomised double blind multicenter study. MATERIALS AND METHODS: Using a computer algorithm 284 patients with lower limb ischemia, most with pre-operative ischemic ulceration or partial gangrene, from 12 hospitals were randomised, after PABG, to 5000 IU dalteparin or placebo injections once daily for 3 months. All patients received 75 mg of ASA daily for 12 months. Graft patency was assessed at 1, 3 and 12 months. RESULTS: At 1 year, 42 patients had died or were lost to follow-up. Compliance with the injection schedule was 80%. Primary patency rate, in the dalteparin versus the control group, respectively, was 83 versus 80% (n.s.) at 3 months and 59% for both groups at 12 months. Major complication rates and cardiovascular morbidity were not different between the two groups. CONCLUSIONS: In patients on ASA treatment, long-term postoperative dalteparin treatment did not improve patency after peripheral artery bypass grafting. Therefore, low molecular weight heparin treatment cannot be recommended for routine use after bypass surgery for critical lower limb ischemia.
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| 6. |
- Perlander, Angelica, et al.
(author)
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Amputation-free survival, limb symptom alleviation, and reintervention rates after open and endovascular revascularization of femoropopliteal lesions in patients with chronic limb-threatening ischemia
- 2020
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In: Journal of Vascular Surgery. - : Elsevier BV. - 0741-5214. ; 72:6, s. 1987-1995
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Journal article (peer-reviewed)abstract
- Background: The optimal strategy for revascularization in chronic limb-threatening ischemia (CLTI) is not yet completely known and is still under debate. Endovascular treatment methods predominate despite limited evidence for their advantage. In this concurrent, prospective observational cohort study, we investigated outcomes after open and endovascular revascularization in the femoropopliteal segment for CLTI. Methods: Between March 2011 and January 2015, there were 190 patients presenting with CLTI with the principal target lesion in the superficial femoral or popliteal segment who underwent endovascular intervention (n = 117) or bypass surgery (n = 73) and were observed prospectively. The choice of revascularization technique was based on international and local guidelines. All patients were observed for 2 years. The primary end point was amputation-free survival (AFS) assessed with Kaplan-Meier estimates; secondary end points included CLTI symptom alleviation rates and reintervention rates. A Cox proportional hazards regression model was used to investigate risk factors for amputation and death. Results: AFS at 2 years was 59% in the endovascular group and 76% in the bypass group (P =.020). Kaplan-Meier survival analysis confirmed a significant difference in AFS, with mortality rate as the main driver for the observed intergroup AFS difference. In sequential multivariable regression analysis, the observed difference in AFS between the groups favored bypass surgery and remained significant after controlling for covariates of known prognostic importance (hazard ratio, 2.38; 95% confidence interval, 1.14-4.96). At 2 years, a higher proportion of patients subjected to bypass surgery remained free from ischemic rest pain, wounds, and gangrene (65% vs 45%; P =.009). The proportions of patients who underwent reintervention within 2 years were similar in the two groups (38% vs 39%; P =.90), but repeated reinterventions were more frequent in the bypass group. Conclusions: At 2 years, bypass surgery was associated with higher AFS than endovascular intervention, a finding that could not be explained only by differences in case mix. More patients who had bypass surgery were free from CLTI symptoms at both 1 year and 2 years after revascularization. Reinterventions to maintain patency were equally common after bypass and endovascular intervention. © 2020 Society for Vascular Surgery
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| 7. |
- Rådberg, Göran, 1945, et al.
(author)
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Relationship between gallbladder histopathology and ability to concentrate biliary lipids and bilirubin. A study on gallstone patients with functioning gallbladder.
- 1988
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In: Acta chirurgica Scandinavica. - 0001-5482. ; 154:10, s. 581-4
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Journal article (peer-reviewed)abstract
- Biliary lipids and bilirubin were measured in hepatic and gallbladder bile obtained at routine cholecystectomy in 35 gallstone patients. The gallbladders had opacified at cholecystography and the cystic ducts were patent at operation. The histologic changes in the gallbladder wall were evaluated by an independent pathologist. Increasing abnormality of the gallbladder wall was shown to be associated with reduced gallbladder contents/hepatic bile ratio of biliary lipids and of bilirubin. The concentrating function of the human gallbladder thus appears to be impaired in proportion to the severity of histologic lesions in its wall. Taken together with earlier findings in vitro, this relationship suggests impaired absorption of electrolytes and water by the gallbladder mucosa, or diffusion of biliary constituents from the lumen of the inflamed gallbladder.
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| 8. |
- Wennerholm, Ulla-Britt, 1948, et al.
(author)
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Timing of umbilical cord clamping for neonatal and maternal outcomes
- 2012
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In: Health Technology Assessment, HTA center Region Västra Götaland. ; :48, s. 1-51
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Research review (peer-reviewed)abstract
- Method and patient group Late versus early clamping of the umbilical cord- maternal and infant effects Question at issue Is early umbilical cord clamping not different from or better than late umbilical cord clamping regarding postpartum infant iron deficiency and iron deficiency anaemia variables, long-term cognitive function, loss of stem cells, maternal postpartum haemorrhage, manual removal of retained placenta and correct sampling for blood gas analysis? Studied risks and benefits for patients of the new health technology Level of evidence: The literature search identified four studies that fulfilled the selection criteria; a systematic review (SR) and three subsequently published randomised controlled trials (RCTs). The definition of early cord clamping varied from within 10 to < 60 sec between studies. The SR was methodologically of high quality but included mainly studies with high risk of bias. One of the RCTs was of high and the others of low quality. Infant outcomes O1 No studies evaluated cognitive function or loss of stem cells. Conclusions: There is some support for an increased risk of immediate anaemia (6.3% vs 1.2%) (GRADE ⊕⊕) and support for lower immediate Hb (mean difference 18g/l) and haematocrit (GRADE ⊕⊕⊕) with early as compared with late clamping. There is support for little or no difference regarding these outcomes at long-term (at 2 to 6 months of age) (GRADE ⊕⊕⊕). There is some support for an increased risk of long-term iron deficiency (5.7% vs. 0.6%) (GRADE ⊕⊕) and support for lower long-term ferritin levels (GRADE ⊕⊕⊕). There is some support for little or no difference regarding jaundice requiring phototherapy and a low Apgar score (<7 at 5 min) (GRADE⊕⊕) and insufficient support for an effect on the need for admittance to special baby care nursery or neonatal intensive care unit (GRADE ⊕) ). Maternal outcomes O2 There is some support for little or no difference regarding severe postpartum bleeding (GRADE ⊕⊕) and insufficient support for an effect on the need for manual removal of placenta (GRADE ⊕ ).. Methodological outcome O3 There is insufficient scientific documentation to evaluate the rate of correct sampling for cord blood acid-base and gas analysis after early versus late clamping. Ethical questions Is early cord clamping of the healthy term neonate ethically acceptable in view of unknown long-term infant risks regarding cognitive function? Presently, late cord clamping does not allow cord blood collection. Future research may identify optimal timing of cord clamping, to resolve these ethical issues. Economical aspects There are no reasons to believe that initial costs are different.
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