| 1. |
- Ederle, Joerg, et al.
(author)
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Carotid artery stenting compared with endarterectomy in patients with symptomatic carotid stenosis (International Carotid Stenting Study): an interim analysis of a randomised controlled trial
- 2010
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In: The Lancet. - 1474-547X. ; 375:9719, s. 985-997
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Journal article (peer-reviewed)abstract
- Background Stents are an alternative treatment to carotid endarterectomy for symptomatic carotid stenosis, but previous trials have not established equivalent safety and efficacy. We compared the safety of carotid artery stenting with that of carotid endarterectomy. Methods The International Carotid Stenting Study (ICSS) is a multicentre, international, randomised controlled trial with blinded adjudication of outcomes. Patients with recently symptomatic carotid artery stenosis were randomly assigned in a 1:1 ratio to receive carotid artery stenting or carotid endarterectomy. Randomisation was by telephone call or fax to a central computerised service and was stratified by centre with minimisation for sex, age, contralateral occlusion, and side of the randomised artery. Patients and investigators were not masked to treatment assignment. Patients were followed up by independent clinicians not directly involved in delivering the randomised treatment. The primary outcome measure of the trial is the 3-year rate of fatal or disabling stroke in any territory, which has not been analysed yet. The main outcome measure for the interim safety analysis was the 120-day rate of stroke, death, or procedural myocardial infarction. Analysis was by intention to treat (ITT). This study is registered, number ISRCTN25337470. Findings The trial enrolled 1713 patients (stenting group, n=855; endarterectomy group, n=858). Two patients in the stenting group and one in the endarterectomy group withdrew immediately after randomisation, and were not included in the ITT analysis. Between randomisation and 120 days, there were 34 (Kaplan-Meier estimate 4.0%) events of disabling stroke or death in the stenting group compared with 27 (3.2%) events in the endarterectomy group (hazard ratio [HR] 1.28, 95% CI 0.77-2.11). The incidence of stroke, death, or procedural myocardial infarction was 8.5% in the stenting group compared with 5.2% in the endarterectomy group (72 vs 44 events; HR 1.69, 1.16-2.45, p=0.006), Risks of any stroke (65 vs 35 events; HR 1.92, 1.27-2.89) and all-cause death (19 vs seven events; HR 2.76, 1.16-6.56) were higher in the stenting group than in the endarterectomy group. Three procedural myocardial infarctions were recorded in the stenting group, all of which were fatal, compared with four, all non-fatal, in the endarterectomy group. There was one event of cranial nerve palsy in the stenting group compared with 45 in the endarterectomy group. There were also fewer haematomas of any severity in the stenting group than in the endarterectomy group (31 vs 50 events; p=0.0197). Interpretation Completion of long-term follow-up is needed to establish the efficacy of carotid artery stenting compared with endarterectomy. In the meantime, carotid endarterectomy should remain the treatment of choice for patients suitable for surgery.
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- Malmstedt, J, et al.
(author)
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Influence of perioperative blood glucose levels on outcome after infrainguinal bypass surgery in patients with diabetes
- 2006
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In: British Journal of Surgery. - : John Wiley & Sons. - 0007-1323 .- 1365-2168. ; 93:11, s. 1360-1367
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Journal article (peer-reviewed)abstract
- BACKGROUND: High glucose levels are associated with increased morbidity and mortality after coronary surgery and in intensive care. The influence of perioperative hyperglycaemia on the outcome after infrainguinal bypass surgery among diabetic patients is largely unknown. The aim was to determine whether high perioperative glucose levels were associated with increased morbidity after infrainguinal bypass surgery.METHODS: Ninety-one consecutive diabetic patients undergoing primary infrainguinal bypass surgery were identified from a prospective vascular registry. Risk factors, indication for surgery, operative details and outcome data were extracted from the medical records. Exposure to perioperative hyperglycaemia was measured using the area under the curve (AUC) method; the AUC was calculated using all blood glucose readings during the first 48 h after surgery.RESULTS: Multivariable analysis showed that the AUC for glucose (odds ratio (OR) 13.35, first versus fourth quartile), renal insufficiency (OR 4.77) and infected foot ulcer (OR 3.38) was significantly associated with poor outcome (death, major amputation or graft occlusion at 90 days). Similarly, the AUC for glucose (OR 14.45, first versus fourth quartile), female sex (OR 3.49) and tissue loss as indication (OR 3.30) was associated with surgical wound complications at 30 days.CONCLUSION: Poor perioperative glycaemic control was associated with an unfavourable outcome after infrainguinal bypass surgery in diabetic patients.
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- Montan, C., et al.
(author)
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Massive Blood Transfusion in Patients with Ruptured Abdominal Aortic Aneurysm
- 2016
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In: European Journal of Vascular and Endovascular Surgery. - : Elsevier BV. - 1078-5884. ; 52:5, s. 597-603
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Journal article (peer-reviewed)abstract
- Objectives The aim was to study blood transfusions and blood product ratios in massively transfused patients treated for ruptured abdominal aortic aneurysms (rAAAs). Methods This was a registry based cohort study of rAAA patients repaired at three major vascular centres between 2008 and 2013. Data were collected from the Swedish Vascular Registry, hospitals medical records, and local transfusion registries. The transfusion data were analysed for the first 24 h of treatment. Massive transfusion (MT) was defined as 4 or more units of red blood cell (RBC) transfused within 1 h, or 10 or more RBC units within 24 h. Logistic regression was used to calculate the odds ratio of 30 day mortality associated with the ratios of blood products and timing of first units of platelets (PLTs) and fresh frozen plasma (FFP) transfused. Results Three hundred sixty nine rAAA patients were included: 80% men; 173 endovascular aneurysm repairs (EVARs) and 196 open repairs (ORs) with median RBC transfusion 8 units (Q1–Q3, 4–14) and 14 units (Q1–Q3, 8–28), respectively. A total of 261 (71%) patients required MT. EVAR patients with MT (n = 96) required less transfusion than OR patients (n = 165): median RBC 10 units (Q1–Q3, 6–16.5) vs. 15 units (Q1–Q3, 9–26) (p = .002), FFP 6 units (Q1–Q3, 2–14.5) vs. 13 units (Q1–Q3, 7–24) (p < .001), and PLT 0 units (Q1–Q3, 0–2) vs. 2 units (Q1–Q3, 0–4) (p = .01). Median blood product ratios in MT patients were FFP/RBC (EVAR group 0.59 [0.33–0.86], OR group 0.84 [0.67–1.2]; p < .001], and PLT/RBC (EVAR 0 [0–0.17], OR 0.12 (0–0.18); p < .001]. In patients repaired by OR a FFP/RBC ratio close to 1 was associated with reduced 30 day mortality (p = .003). The median PLT/RBC ratio was higher during the later part of the study period (p < .001, median test), whereas there was no significant difference in median FFP/RBC ratio (p = .101, median test). Conclusion The majority of rAAA patients undergoing EVAR required MT. EVAR patients treated with MT had lower FFP/RBC and PLT/RBC ratios than OR patients with MT. The mortality risk was lower with FFP/RBC ratio close to 1:1 in open repaired patients requiring MT. The 24 h PLT/RBC ratio increased over the study period.
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- Björck, M, et al.
(author)
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Twenty years with the Swedvasc Registry.
- 2008
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In: European journal of vascular and endovascular surgery : the official journal of the European Society for Vascular Surgery. - : Elsevier BV. - 1532-2165 .- 1078-5884. ; 35:2, s. 129-30
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Journal article (other academic/artistic)
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| 15. |
- Ekberg, NR, et al.
(author)
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Analyte flux at a biomaterial-tissue interface over time: implications for sensors for type 1 and 2 diabetes mellitus
- 2010
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In: Journal of diabetes science and technology. - : SAGE Publications. - 1932-2968. ; 4:5, s. 1063-72
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Journal article (peer-reviewed)abstract
- The very presence of an implanted sensor (a foreign body) causes changes in the adjacent tissue that may alter the analytes being sensed. The objective of this study was to investigate changes in glucose availability and local tissue metabolism at the sensor-tissue interface in patients with type 1 diabetes mellitus (T1DM) and type 2 diabetes mellitus (T2DM). Method: Microdialysis was used to model implanted sensors. Capillary glucose and subcutaneous (sc) microdialysate analytes were monitored in five T1DM and five T2DM patients. Analytes included glucose, glycolysis metabolites (lactate, pyruvate), a lipolysis metabolite (glycerol), and a protein degradation byproduct (urea). On eight consecutive days, four measurements were taken during a period of steady state blood glucose. Results: Microdialysate glucose and microdialysate-to-blood-glucose ratio increased over the first several days in all patients. Although glucose recovery eventually stabilized, the lactate levels continued to rise. These trends were explained by local inflammatory and microvascular changes observed in histological analysis of biopsy samples. Urea concentrations mirrored glucose trends. Urea is neither produced nor consumed in sc tissue, and so the initially increasing urea trend is explained by increased local capillary presence during the inflammatory process. Pyruvate in T2DM microdialysate was significantly higher than in T1DM, an observation that is possibly explained by mitochondrial dysfunction in T2DM. Glycerol in T2DM microdialysate (but not in T1DM) was higher than in healthy volunteers, which is likely explained by sc insulin resistance (insulin is a potent antilipolytic hormone). Urea was also higher in microdialysate of patients with diabetes mellitus compared to healthy volunteers. Urea is a byproduct of protein degradation, which is known to be inhibited by insulin. Therefore, insulin deficiency or resistance may explain the higher urea levels. To our knowledge, this is the first histological evaluation of a human tissue biopsy containing an implanted glucose monitoring device. Conclusions: Monitoring metabolic changes at a material-tissue interface combined with biopsy histology helped to formulate an understanding of physiological changes adjacent to implanted glucose sensors. Microdialysate glucose trends were similar over 1-week in T1DM and T2DM; however, differences in other analytes indicated wound healing and metabolic activities in the two patient groups differ. We propose explanations for the specific observed differences based on differential insulin insufficiency/resistance and mitochondrial dysfunction in T1DM versus T2DM.
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| 16. |
- Gillgren, P, et al.
(author)
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Pseudoxanthoma Elasticum and Isolated Iliac Artery Occlusion
- 2020
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In: European journal of vascular and endovascular surgery : the official journal of the European Society for Vascular Surgery. - : Elsevier BV. - 1532-2165. ; 60:3, s. 409-409
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Journal article (other academic/artistic)
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- Nielsen, Niels Erik, et al.
(author)
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Plasma levels of cyclic GMP and endothelin in postmenopausal women with unstable coronary artery disease
- 1999
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In: Scandinavian Journal of Clinical and Laboratory Investigation. - : Informa UK Limited. - 0036-5513 .- 1502-7686. ; 59:5, s. 325-334
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Journal article (peer-reviewed)abstract
- Many women with typical anginal chest pain have normal coronary angiograms, which may be due to altered endothelial function. We evaluated the endothelial markers cyclic GMP (cGMP) and immunoreactive endothelin (ir-ET) regarding presence of coronary atherosclerosis in women with clinical signs of unstable coronary artery disease (CAD). Plasma levels of cGMP and ir-ET were determined in 118 patients and 84 controls. Ischaemia was evaluated at an exercise test. Of the patients 20% had normal vessels, 14% insignificant CAD and 66% significant stenosis at coronary angiography. Mean (95% CI) concentration of cGMP (nmol/l) was higher in patients than in controls (5.05 (4.53; 5.58) vs. 3.79 (3.34; 4.23)). Separating patients according to daily intake of nitroglycerin, only patients with this medication had significantly higher cGMP level (5.73 (4.88; 6.58)), whereas the difference between those without (4.35 (3.76; 4.94)) and controls disappeared. Patients with ischaemia at exercise test had higher cGMP level than those without (6.01 (5.13; 6.88) vs. 4.30 (3.66; 4.94)), even after adjusting for nitroglycerin treatment. ir-ET (pmol/l) was lower in patients with normal vessels than patients with coronary atherosclerosis (0.83 (0.78; 0.88) vs. 0.98 (0.92; 1.04)) and than the control group (0.91 (0.87; 0.94)). The difference between the control group and patients with atherosclerosis was also significant. Patients with unstable CAD and long-term nitroglycerin treatment have increased cGMP level. Patients with exercise-induced ischaemia have higher cGMP level than those without, irrespective of nitroglycerin treatment, which may reflect a general compensatory mechanism. Patients with normal vessels have low level of ir-ET, indicating different mechanisms for ischaemia/angina in these patients compared with patients with atherosclerosis.
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| 24. |
- Troëng, Thomas, et al.
(author)
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External validation of the Swedvasc registry : a first-time individual cross-matching with the unique personal identity number
- 2008
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In: European Journal of Vascular and Endovascular Surgery. - : Elsevier BV. - 1078-5884 .- 1532-2165. ; 36:6, s. 705-712
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Journal article (peer-reviewed)abstract
- OBJECTIVE: To study external validity of the Swedvasc registry concerning numbers of procedures and mortality. MATERIALS AND METHODS: Vascular registry data for carotid, infrainguinal bypass and aortic aneurysm (AAA) procedures were compared to the Swedish Hospital Discharge Register (SHDR) data, and the National Population Registry (for mortality) by matching every individual patient using the unique personal identity numbers (PINs). The time-period studied was 2000-2004 (5 years) for carotid and infrainguinal procedures. A separate analysis was performed for AAA-surgery in 2006. RESULTS: The external validity for carotid, infrainguinal bypass and AAA repair was 93.4%, 93.0% and 93.1%, respectively. The 30-day mortality was 0.86% after carotid and 2.9% after infrainguinal bypass procedures. Mortality was 2.6% after planned and 25.9% after unplanned AAA repair. Although there was a general trend towards inferior outcomes after procedures not registered in the Swedvasc, those procedures were so few that in none of the analyses did the inclusion of non-registered procedures affect general outcomes significantly. Combining data from both registries, the incidence for carotid, infrainguinal bypass and AAA procedures was 7.8, 15.2 and 13.6 per 100,000 person-years, respectively. In the hospital-specific analysis for 2006 it was shown that the non-registered procedures for AAA were localized to one non-compliant county hospital, and small district hospitals not performing elective AAA-surgery but only rare emergency operations. CONCLUSION: The external and internal validity of the Swedvasc registry allows to confidently assess volumes of, and mortality after, vascular surgery in Sweden.
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| 25. |
- Utjés, Deborah, et al.
(author)
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2-cm versus 4-cm surgical excision margins for primary cutaneous melanoma thicker than 2 mm : long-term follow-up of a multicentre, randomised trial
- 2019
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In: The Lancet. - 0140-6736. ; 394:10197, s. 471-477
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Journal article (peer-reviewed)abstract
- Background: The optimal surgical excision margins are uncertain for patients with thick (>2 mm) localised cutaneous melanomas. In our previous report of this multicentre, randomised controlled trial, with a median follow-up of 6·7 years, we showed that a narrow excision margin (2 cm vs 4 cm) did not affect melanoma-specific nor overall survival. Here, we present extended follow-up of this cohort. Methods: In this open-label, multicentre randomised controlled trial, we recruited patients from 53 hospitals in Sweden, Denmark, Estonia, and Norway. We enrolled clinically staged patients aged 75 years or younger diagnosed with localised cutaneous melanoma thicker than 2 mm, and with primary site on the trunk or upper or lower extremities. Patients were randomly allocated (1:1) to treatment either with a 2-cm or a 4-cm excision margin. A physician enrolled the patients after histological confirmation of a cutaneous melanoma thicker than 2 mm. Some patients were enrolled by a physician acting as responsible for clinical care and as a trial investigator (follow-up, data collection, and manuscript writing). In other cases physicians not involved in running the trial enrolled patients. Randomisation was done by telephone call to a randomisation office, by sealed envelope, or by computer generated lists using permuted blocks. Patients were stratified according to geographical region. No part of the trial was masked. The primary outcome in this extended follow-up study was overall survival and the co-primary outcome was melanoma-specific survival. All analyses were done on an intention-to-treat basis. The study is registered with ClinicalTrials.gov, number NCT03638492. Findings: Between Jan 22, 1992, and May 19, 2004, 936 clinically staged patients were recruited and randomly assigned to a 4-cm excision margin (n=465) or a 2-cm excision margin (n=471). At a median overall follow-up of 19·6 years (235 months, IQR 200–260), 621 deaths were reported—304 (49%) in the 2-cm group and 317 (51%) in the 4-cm group (unadjusted HR 0·98, 95% CI 0·83–1·14; p=0·75). 397 deaths were attributed to cutaneous melanoma—192 (48%) in the 2-cm excision margin group and 205 (52%) in the 4-cm excision margin group (unadjusted HR 0·95, 95% CI 0·78–1·16, p=0·61). Interpretation: A 2-cm excision margin was safe for patients with thick (>2 mm) localised cutaneous melanoma at a follow-up of median 19·6 years. These findings support the use of 2-cm excision margins in current clinical practice. Funding: The Swedish Cancer Society, Stockholm Cancer Society, the Swedish Society for Medical Research, Radiumhemmet Research funds, Stockholm County Council, Wallström funds.
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