| 1. |
- 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.
|
|
| 2. |
- Berger, P., et al.
(författare)
-
Validation of the Simulator for Testing and Rating Endovascular SkillS (STRESS)-machine in a setting of competence testing
- 2010
-
Ingår i: Journal of Cardiovascular Surgery. - 0021-9509 .- 1827-191X. ; 51:2, s. 253-256
-
Tidskriftsartikel (refereegranskat)abstract
- AIM: Endovascular skills are an integral part of modern-day vascular surgery. The STRESS machine has been developed to test these skills in vascular surgeons. This study aims to define an optimal pass/fail cutoff value for the STRESS test score. METHODS: The STRESS machine consists of a dry glass model of the abdominal aorta and its tributaries with various stenotic lesions, elongations, and tortuosities. A camera and computer software are used to simulate plain fluoroscopy-mode. The test subjects are given two assignments after which two reviewers use a combination of the ICEPS and MRS to produce the final total score; 43 subjects were tested. According to previous endovascular experience, subjects were classified into four groups: novice-low (no experience, less than 11 performed procedures, less than 50 assisted procedures), novice-high (11-25 performed procedures, more than 50 assisted procedures), intermediate (1-10 performed and >11-25 assisted procedures, 11-25 performed and >1-10 assisted procedures or 25-50 performed procedures) and advanced (more than 50 performed procedures). RESULTS: Test-score and noted experience showed a correlation of 0.794. All intermediate and advanced test subjects scored more than 50 points compared to 4 out of 15 novices. CONCLUSION: We demonstrated that it is possible to determine an optimal cut-off value for competence testing with the STRESS machine.
|
|
| 3. |
- Willems, M. C. M., et al.
(författare)
-
Assessing endovascular skills using the Simulator for Testing and Rating Endovascular Skills (STRESS) machine
- 2009
-
Ingår i: European Journal of Vascular and Endovascular Surgery. - : Elsevier BV. - 1078-5884 .- 1532-2165. ; 37:4, s. 431-6
-
Tidskriftsartikel (refereegranskat)abstract
- OBJECTIVES: Endovascular techniques are an integral part of modern-day vascular surgery practice and training. Nevertheless, validated in vitro assessment tools for these skills are scarce. This study describes the development and pilot testing of the Simulator for Testing and Rating Endovascular Skills (STRESS machine). DESIGN: The design was kept straightforward and compact, without the need for contrast or fluoroscopy. A specific technical skill score was designed analogous to the Imperial College Evaluation of Procedural Skill (ICEPS), an assessment score for open surgical skill. This score was combined with an already validated global rating assessment to form the total score (TS). METHODS: A pilot study was carried out on 18 candidates of varying levels of expertise: novice, intermediate and expert, who were assessed by two independent observers to test inter-observer reliability. RESULTS: Inter-observer reliability was excellent, Cronbach's alpha coefficient of the TS was 0.94 (95% confidence interval: 0.84-0.97). A one-way analysis of variance (ANOVA) showed a significant difference between the novice and expert groups (p<0.001), between the novice and intermediate groups (p<0.01) and between the intermediate and expert groups (p<0.05). CONCLUSION: The STRESS machine, in combination with the specific technical skill score and global rating assessment, provides a reliable method of discriminating between the novice, intermediate and expert candidates with excellent inter-observer variability.
|
|
