| 1. |
- Nordanstig, Joakim, et al.
(författare)
-
Mortality with Paclitaxel-Coated Devices in Peripheral Artery Disease.
- 2020
-
Ingår i: The New England journal of medicine. - : Massachusetts Medical Society. - 1533-4406 .- 0028-4793. ; 383, s. 2538-46
-
Tidskriftsartikel (refereegranskat)abstract
- The results of a recent meta-analysis aroused concern about an increased risk of death associated with the use of paclitaxel-coated angioplasty balloons and stents in lower-limb endovascular interventions for symptomatic peripheral artery disease.We conducted an unplanned interim analysis of data from a multicenter, randomized, open-label, registry-based clinical trial. At the time of the analysis, 2289 patients had been randomly assigned to treatment with drug-coated devices (the drug-coated-device group, 1149 patients) or treatment with uncoated devices (the uncoated-device group, 1140 patients). Randomization was stratified according to disease severity on the basis of whether patients had chronic limb-threatening ischemia (1480 patients) or intermittent claudication (809 patients). The single end point for this interim analysis was all-cause mortality.No patients were lost to follow-up. Paclitaxel was used as the coating agent for all the drug-coated devices. During a mean follow-up of 2.49 years, 574 patients died, including 293 patients (25.5%) in the drug-coated-device group and 281 patients (24.6%) in the uncoated-device group (hazard ratio, 1.06; 95% confidence interval, 0.92 to 1.22). At 1 year, all-cause mortality was 10.2% (117 patients) in the drug-coated-device group and 9.9% (113 patients) in the uncoated-device group. During the entire follow-up period, there was no significant difference in the incidence of death between the treatment groups among patients with chronic limb-threatening ischemia (33.4% [249 patients] in the drug-coated-device group and 33.1% [243 patients] in the uncoated-device group) or among those with intermittent claudication (10.9% [44 patients] and 9.4% [38 patients], respectively).In this randomized trial in which patients with peripheral artery disease received treatment with paclitaxel-coated or uncoated endovascular devices, the results of an unplanned interim analysis of all-cause mortality did not show a difference between the groups in the incidence of death during 1 to 4 years of follow-up. (Funded by the Swedish Research Council and others; ClinicalTrials.gov number, NCT02051088.).
|
|
| 2. |
-
Allusions and Reflections : Greek and Roman Mythology in Renaissance Europe
- 2015
-
Samlingsverk (redaktörskap) (refereegranskat)abstract
- In June 2012, scholars from a number of disciplines and countries gathered in Stockholm to discuss the representation of ancient mythology in Renaissance Europe. This symposium was an opportunity for the participants to cross disciplinary borders and to problematize a well-researched field. The aim was to move beyond a view of mythology as mere propaganda in order to promote an understanding of ancient tales and fables as contemporary means to explain and comprehend the Early Modern world.With the Renaissance, pagan religion ceased to pose a threat to Christianity and its mythologies found a way to coexist with Christian doctrine. Old Greek and Roman tales came to play a crucial role in Renaissance culture, partly because the ancient sources, both literary and artistic, many of them recently uncovered, provided rich material for the writers and artists of the period. Mythology provided a network of allusions and references for contemporary poetry and art, reinforcing the possibilities of allegorical interpretation. Furthermore, it offered moral guidance since deities could easily be materialized into personifications of vices and virtues. All artistic expressions, visual and textual, whether they belonged to a secular or a religious tradition, made use of mythology. This volume exemplifies how Renaissance writers’ and artists’ acquaintance with mythological accounts from Homer to Apuleius was of utmost importance for their creative work, as it was for their readers and those contemporary patrons of art who saw themselves as the living embodiment of some remote ancient deity. By posing new questions and suggesting alternative answers to old ones, the contributors to this volume provide a better and more detailed understanding of the struggles and strategies of recycling, recuperating and transforming ancient mythology during the Renaissance. All chapters here have a common focus on the re-configuration of classical myths in Early Modern Europe, in political, erotic and ceremonial contexts. By returning to the classical world of cosmic strife and harmony, of gods and metamorphoses, Renaissance poets and artists were able to express their aesthetic ideals, personal preoccupations and moral attitudes. Ancient mythology offered them a full set of useful metaphors, which could take on new meanings in a new cultural context.
|
|
| 3. |
- Ederle, Joerg, et al.
(författare)
-
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
-
Ingår i: The Lancet. - 1474-547X. ; 375:9719, s. 985-997
-
Tidskriftsartikel (refereegranskat)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.
|
|
| 4. |
- Ersryd, Samuel, et al.
(författare)
-
Risk Factors for Abdominal Compartment Syndrome After Endovascular Repair for Ruptured Abdominal Aortic Aneurysm : A Case Control Study
- 2021
-
Ingår i: European Journal of Vascular and Endovascular Surgery. - : Elsevier. - 1078-5884 .- 1532-2165. ; 62:3, s. 400-407
-
Tidskriftsartikel (refereegranskat)abstract
- Objective: Ruptured abdominal aortic aneurysms (rAAA) are treated by endovascular aneurysm repair (rEVAR) increasingly often. Despite rEVAR being a minimally invasive method, abdominal compartment syndrome (ACS) remains a significant post-operative threat. The aim of this study was to investigate risk factors for ACS after rEVAR, including aortic morphological features. Methods: The Swedish vascular registry (Swedvasc) was assessed for ACS after rEVAR in the period 2008 - 2015. All patients identified were compared with controls (i.e., patients who did not develop ACS after rEVAR), matched by centre and repair date. Case records were reviewed, and radiology images analysed in a core laboratory. Comparisons were performed with respect to physiological and radiological risk factors. Results: The study population consisted of 40 patients with ACS and 68 controls. Pre-operatively, patients with ACS had a lower blood pressure (BP) than controls (median 70 mmHg vs. 97 mmHg; p <.001). Intra-operatively, they had aortic balloon occlusion more often (55.0% vs. 10.3%; p <.001) and received more transfusions than controls (median nine units of packed red blood cells [pRBC] vs. two units; p <.001). Ninety-seven per cent of those who developed ACS had a pre-operative BP < 70 mmHg, aortic balloon occlusion, or received more than five pRBC unit transfusions. Treatment outside the instructions for use did not differ between patients and controls (57.5% vs. 54.4%; p=.84), and neither did the pre-operative patency of the inferior mesenteric artery (57.1% vs. 63.9%; p=.52) nor the number of visible lumbar arteries on pre-operative imaging (2 vs. 4; p=.014). In multivariable logistic regression, the number of intra-operative transfusions were predictive of ACS (p <.001), while pre-operative hypotension (p=.32) and aortic balloon occlusion (p=.018) were not. Conclusion: ACS after rEVAR is mainly associated with physiological factors and is unlikely to develop without the presence of a pre-operative BP < 70 mmHg, the need for an aortic occlusion balloon, or more than five intraoperative pRBC unit transfusions. Treatment outside the IFU or any other morphological factor were not associated with a risk of ACS.
|
|
| 5. |
- Ersryd, Samuel, 1978-, et al.
(författare)
-
Risk factors for abdominal compartment syndrome after endovascular repair for ruptured abdominal aortic aneurysm: A case-control study
-
Annan publikation (övrigt vetenskapligt/konstnärligt)abstract
- Objectives: Ruptured abdominal aortic aneurysms (rAAA) are increasingly often treated by endovascular aneurysm repair (rEVAR). Despite rEVAR being a minimal invasive method, abdominal compartment syndrome (ACS) remains a significant postoperative threat. The aim was to investigate risk factors for ACS after rEVAR, including aortic morphological features.Methods: The Swedish vascular registry (Swedvasc) was assessed for ACS after rEVAR during 2008-2015. All patients identified were compared with controls, i.e. patients who did not develop ACS after rEVAR, matched by centre and repair date. Case records were reviewed, and radiologic images were analysed in a core-lab. Comparisons were performed with respect to physiological and radiological risk factors.Results: After data validation the final study population consisted of 40 patients with ACS after rEVAR and 68 controls. Preoperatively, ACS patients had lower blood pressure (BP) than controls (median 70mmHg vs 97mmHg, p<.001). Intraoperatively, they had aortic balloon occlusion more often (55.0% vs 10.3%, p<.001) and received more transfusions than controls (median 9 packed red blood cells (pRBC) vs 2 pRBC, p<.001). Postoperatively, they received more transfusions than controls (5 pRBC vs 0 pRBC, p<.001). Ninety-seven percent of those who developed ACS had either preoperative BP <70mmHg, aortic balloon occlusion or received >5 intraoperative pRBC transfusions. Neither treatment outside instructions for use (IFU) nor preoperative patency of the inferior mesenteric artery differed between cases and controls (57.5% vs 54.4%, p=.842 and 57.1% vs 63.9%, p=.522 respectively), while the number of visible lumbar arteries on preoperative imaging were fewer among ACS patients (2 vs 4, p=.014).Conclusions: ACS after rEVAR is mainly associated with physiologic factors and is unlikely to develop without the presence of either preoperative BP <70mmHg, need for aortic occlusion balloon, or >5 intraoperative pRBC transfusions. Neither treatment outside IFU nor any other morphological factor could be associated with risk for ACS.
|
|
| 6. |
- Gavali, Hamid, et al.
(författare)
-
Outcome of Radical Surgical Treatment of Abdominal Aortic Graft and Endograft Infections Comparing Extra-anatomic Bypass with In Situ Reconstruction : A Nationwide Multicentre Study
- 2021
-
Ingår i: European Journal of Vascular and Endovascular Surgery. - : Saunders Elsevier. - 1078-5884 .- 1532-2165. ; 62:6, s. 918-926
-
Tidskriftsartikel (refereegranskat)abstract
- Objective: Abdominal aortic graft and endograft infection (AGI) is primarily treated by resection of the infected graft and restoration of distal perfusion through extra-anatomic bypass (EAB) or in situ reconstruction/repair (ISR). The aim of this study was to compare these surgical strategies in a nationwide multicentre retrospective cohort study.Methods: The Swedish Vascular Registry (Swedvasc) was used to identify surgically treated abdominal AGIs in Sweden between January 1995 and May 2017. The primary aim was to compare short and long term survival, as well as complications for EAB and ISR.Results: Some 126 radically surgically treated AGI patients were identified – 102 graft infections and 24 endograft infections – treated by EAB: 71 and ISR: 55 (23 neo-aorto-iliac systems, NAISs). No differences in early 30 day (EAB 81.7% vs. ISR 76.4%, p =.46), or long term five year survival (48.2% vs. 49.9%, p =.87) were identified. There was no survival difference comparing NAIS to other ISR strategies. The frequency of recurrent graft infection during follow up was similar: EAB 20.3% vs. ISR 17.0% (p =.56). Survival and re-infection rates of the new conduit did not differ between NAIS and other ISR strategies. Age ≥ 75 years (odds ratio [OR] 4.0, confidence interval [CI] 1.1 – 14.8), coronary artery disease (OR 4.2, CI 1.2 – 15.1) and post-operative circulatory complications (OR 5.2, CI 1.2 – 22.5) were associated with early death. Prolonged antimicrobial therapy (> 3 months) was associated with reduced long term mortality (HR 0.3, CI 0.1 – 0.9).Conclusion: In this nationwide multicentre study comparing outcomes of radically treated AGI, no differences in survival or re-infection rate could be identified comparing EAB and ISR.
|
|
| 7. |
- Gavali, Hamid, et al.
(författare)
-
Semi-Conservative Treatment Versus Radical Surgery in Abdominal Aortic Graft and Endograft Infections
- 2023
-
Ingår i: European Journal of Vascular and Endovascular Surgery. - : Elsevier. - 1078-5884 .- 1532-2165. ; 66:3, s. 397-406
-
Tidskriftsartikel (refereegranskat)abstract
- Objective: Abdominal aortic graft and endograft infections (AGIs) are rare complications following aortic surgery. Radical surgery (RS) with resection of the infected graft and reconstruction with extra-anatomical bypass or in situ reconstruction is the preferred therapy. For patients unfit for RS, a semi-conservative (SC), graft preserving strategy is possible. This paper aimed to compare survival and infection outcomes between RS and SC treatment for AGI in a nationwide cohort.Methods: Patients with abdominal AGI related surgery in Sweden between January 1995 and May 2017 were identified. The Management of Aortic Graft Infection Collaboration (MAGIC) criteria were used for the definition of AGI. Multivariable regression was performed to identify factors associated with mortality.Results: One hundred and sixty-nine patients with surgically treated abdominal AGI were identified, comprising 43 SC (14 endografts; 53% with a graft enteric fistula [GEF] in total) and 126 RS (26 endografts; 50% with a GEF in total). The SC cohort was older and had a higher frequency of cardiac comorbidities. There was a non-significant trend towards lower Kaplan -Meier estimated five year survival for SC vs. RS (30.2% vs. 48.4%; p = .066). A non-significant trend was identified towards worse Kaplan -Meier estimated five year survival for SC patients with a GEF vs. without a GEF (21.7% vs. 40.1%; p = .097). There were significantly more recurrent graft infections comparing SC with RS (45.4% vs. 19.3%; p < .001). In a Cox regression model adjusting for confounders, there was no difference in five year survival comparing SC vs. RS (HR 1.0, 95% CI 0.6 -1.5).Conclusion: In this national AGI cohort, there was no mortality difference comparing SC and RS for AGI when adjusting for comorbidities. Presence of GEF probably negatively impacts survival outcomes of SC patients. Rates of recurrent infection remain high for SC treated patients.
|
|
| 8. |
- Gavali, Hamid, et al.
(författare)
-
Semi-Conservative Treatment Versus Surgery in Abdominal Aortic Graft and Endograft Infections
- 2023
-
Ingår i: European Journal of Vascular and Endovascular Surgery. - : Elsevier. - 1078-5884 .- 1532-2165. ; 66:3, s. 397-406
-
Tidskriftsartikel (refereegranskat)abstract
- OBJECTIVE: Abdominal aortic graft and endograft infections (AGIs) are rare complications following aortic surgery. Radical surgery (RS) with resection of the infected graft and reconstruction with extra-anatomical bypass or in situ reconstruction is the preferred therapy. For patients unfit for RS, a semi-conservative (SC), graft-preserving strategy is possible. This paper aimed to compare survival and infection outcomes between RS and SC treatment for AGI in a nationwide cohort.METHODS: Patients with abdominal AGI-related surgery in Sweden between January 1995 and May 2017 were identified. The Management of Aortic Graft Infection Collaboration (MAGIC) criteria were used for definition of AGI. Multivariable regression was performed to identify factors associated with mortality.RESULTS: A total of 169 patients with surgically treated abdominal AGI were identified, comprising 43 SC [14 endografts; 53% with a graft-enteric fistula (GEF) in total] and 126 RS [26 endografts; 50% with a GEF in total]. The SC cohort was older and had a higher frequency of cardiac comorbidities. There was a non-significant trend towards lower Kaplan-Meier estimated 5-year survival for SC versus RS (30.2% vs. 48.4%; p = .066). A non-significant trend was identified towards worse Kaplan-Meier estimated 5-year survival for SC patients with a GEF versus without a GEF (21.7% vs. 40.1%; p = .097). There were significantly more recurrent graft infections comparing SC versus RS (45.4% vs. 19.3%; p < .001). In a Cox regression model adjusting for confounders, there was no difference in 5-year survival comparing SC versus RS (HR 1.0, 95% CI 0.6 - 1.5).CONCLUSION: In this national AGI cohort, we could not identify any mortality difference comparing SC versus RS for AGI when adjusting for comorbidities. Presence of GEF likely negatively impacts survival outcomes of SC patients. Rates of recurrent infection remain high for SC-treated patients.
|
|
| 9. |
- Gillgren, Peter, et al.
(författare)
-
2-cm versus 4-cm surgical excision margins for primary cutaneous melanoma thicker than 2 mm: a randomised, multicentre trial
- 2011
-
Ingår i: The Lancet. - 1474-547X. ; 378:9803, s. 1635-1642
-
Tidskriftsartikel (refereegranskat)abstract
- Background Optimum surgical resection margins for patients with clinical stage IIA-C cutaneous melanoma thicker than 2 mm are controversial. The aim of the study was to test whether survival was different for a wide local excision margin of 2 cm compared with a 4-cm excision margin. Methods We undertook a randomised controlled trial in nine European centres. Patients with cutaneous melanoma thicker than 2 mm, at clinical stage IIA-C, were allocated to have either a 2-cm or a 4-cm surgical resection margin. Patients were randomised in a 1:1 allocation to one of the two groups and stratified by geographic region. Randomisation was done by sealed envelope or by computer generated lists with permuted blocks. Our primary endpoint was overall survival. The trial was not masked at any stage. Analyses were by intention to treat. Adverse events were not systematically recorded. The study is registered with ClinicalTrials.gov, number NCT01183936. Findings 936 patients were enrolled from Jan 22, 1992, to May 19, 2004; 465 were randomly allocated to treatment with a 2-cm resection margin, and 471 to receive treatment with a 4-cm resection margin. One patient in each group was lost to follow-up but included in the analysis. After a median follow-up of 6.7 years (IQR 4.3-9.5) 181 patients in the 2-cm margin group and 177 in the 4-cm group had died (hazard ratio 1.05, 95% CI 0.85-1.29; p=0.64). 5-year overall survival was 65% (95% CI 60-69) in the 2-cm group and 65% (60-70) in the 4-cm group (p=0.69). Interpretation Our findings suggest that a 2-cm resection margin is sufficient and safe for patients with cutaneous melanoma thicker than 2 mm.
|
|
| 10. |
|
|
