A Randomized Trial of Decision-Making in Asymptomatic Carotid StenosisSilver B, Zaman IF, Ashraf K, et al. Neurology 2012;78:315-21. Conclusion: Presentation format (information framing) has a strong influence on patient decision making with regard to management of asymptomatic carotid stenosis.Summary: Randomized trials of asymptomatic carotid stenosis have shown a modest reduction in stroke risk when surgery is added to best medical therapy. One can express, when discussing with patients, this difference in multiple ways. The difference can be expressed as overall absolute risk reduction (11% vs 5% over 5 years), relative risk reduction (50% over 5 years), annualized absolute risk reduction (2% vs 1% per year over 5 years), absolute disease free survival (89% vs 95% over 5 years), or qualitative description of benefit, such as significantly less strokes with surgery vs medical therapy alone. There are also variables that may determine how patients respond to proposed alternative treatments, including patient age, sex, or race, as well as presenter age, sex, or race and how the information is presented (so-called information framing, Nikolajevic-Sarunac J et al, J Gen Intern Med 1999;14:591-8). This study sought to evaluate whether different presentation formats, presenter factors, and patient factors affected decision making regarding management of asymptomatic carotid stenosis. Subjects were recruited through a neurology clinic. All subjects were aged Ͼ18 years, without known carotid stenosis. Once recruited, subjects were randomized to a 30-second video with one of five presentation formats (absolute risk, absolute event-free survival, annualized absolute risk, relative risk, and qualitative description). Presentations were delivered by one of four presenter physicians (black women, white women, black men, and white men). After the presentation, subjects completed a 1-page form regarding background demographics and their decision regarding treatment choice. The video was watched and the survey completed by 409 subjects; overall, 48.4% chose surgery. The format of presentation strongly predicted choice of surgery (qualitative [64%], relative risk [63%], absolute risk [43%], absolute event-free survival [37%], and annualized absolute risk [35%]; P Ͻ .001). There was a trend for younger age (mean age 52 vs 55 years; P ϭ .054), male sex (53% vs 45%; P ϭ .08), and advanced education (42% for high school education or less vs 52% for more than high school education; P ϭ .052) to predict a choice for surgery. Sex and race of presenter and race of subject had no influence of the choice of treatment.Comment: The basic message is that it matters how you talk to patients. There are, however, multiple limitations to this study. The authors point out that the participants were only given information for 30 seconds and were not given the opportunity to ask questions to clarify information. It is therefore unclear whether the participants actually understood the message transmitted. Also, the subjects were not actual pat...
Objective: To compare the clinical efficacy and safety of endovenous laser treatment (EVLT) with high ligation and stripping (HLS) as standard treatment for great saphenous vein (GSV) insufficiency. Design: Two-center randomized controlled trial with 2-year follow-up. Setting: Interventions were performed on ambulatory and hospitalized patients at 2 vein centers, a university dermatology department (EVLT-treated group), and a specialized vein clinic (HLS-treated group). Patients: Random sample of 400 patients with GSV insufficiency. Interventions: Patients were assigned (1:1) to EVLT or HLS of the GSV from September 2004 through March 2007; 185 and 161 patients (limbs), respectively, were treated per protocol. Main Outcome Measures: Clinically recurrent varicose veins after surgery (REVAS classification, primary study objective), duplex-detected saphenofemoral recurrence, clinical venous severity scoring (Homburg Varicose Vein Severity Score), hemodynamics (venous refilling time), quality of life (Chronic Venous Insufficiency Questionnaire 2), adverse effects, and visual analog scalebased evaluations of patients' satisfaction. Results: Clinically recurrent varicose veins after surgery were similarly observed in both groups: 16.2% (EVLTtreated group) vs 23.1% (HLS-treated group); P=.15. Duplex-detected saphenofemoral refluxes occurred significantly more frequently after EVLT (17.8% vs 1.3%; PϽ.001). Both treatments equally improved medical condition (Homburg Varicose Vein Severity Score) and diseaserelated quality of life. Endovenous laser treatment caused more adverse effects (phlebitic reaction, tightness, dyspigmentation) but revealed advantages concerning hemodynamics, recovery, and cosmetic outcome. Conclusions: Both EVLT and HLS are comparably safe and effective procedures to treat GSV incompetence. The significantly higher rate and the course of duplexdetected saphenofemoral recurrences after EVLT remain a matter of further investigations.
The complication rate in varicose vein surgery has not been viewed separately for the sapheno-femoral and the saphenopopliteal junction. From 1.10.1988 to 31.12.99 we prospectively registered the major vascular and neural complication rate. A total of 31,838 ligations of the saphenofemoral junction and 6,152 ligations of the saphenopopliteal junction were performed. There were seven major vascular injuries (0.017%) and three major neural injuries (0.0074%). The specific risk at the saphenofemoral junction amounts to: major venous injury n = 4 (0.013%) without development of a postthrombotic syndrome (PTS); no arterial injury and no major neural injury. At the saphenopopliteal junction we found three major venous injuries (0.049%) with development of PTS in all cases. There were three major neural injuries (0.049%) with complete regeneration in two cases and one permanent paresis of digit V. Since operations on the saphenopopliteal junction show a higher risk of major vascular und major neural injury, flush ligation of the saphenopopliteal junction should not be forced in every case.
A meticulous dissection of the sapheno-femoral junction (SFJ) at the time of primary surgery is regarded as best protection against the development of recurrences from this area. However, despite correct ligation of the junction recurrences may occur. In a prospective randomised trial, which has been started in 1998, we want to find out, whether this regrowth might be inhibited by the use of different ligation technics of the SFJ: Group 1: Ligation of the SFJ with resorbable Vicryl Group 2: Ligation with Vicryl and continuous non-resorbable stitching over (Prolene) the saphenous stump which precludes contact between free stump endothelium and the surrounding subcutaneous tissue Group 3: Non-resorbable ligation of the SFJ (Ethibond) Group 4: Ethibond ligation with Prolene stitching over the saphenous stump. The first follow-up examinations, which have been done by color-dupley-scan are presented. In each group about n = 100 groins could be examined. We found slight inguinal insufficiency due to a small branch of the femoral vein in group one: n = 10; group two: n = 6; group three: n = 3; group four: n = 1. Our hypothesis that the use of the suture material or the free lying stump endothelium might be influencing the development of the neovascularisation, seems to be supported by these results. We found the lowest rate of postoperative inguinal refluxes in the Ethibond-Prolene group, where the contact between free stump endothelium and the surrounding subcutaneous tissue is precluded. However, definite reliable data will be presented not before the third follow-up (24 months after the operation).
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