Reprinted article "Prospective randomised study of endovenous radiofrequency obliteration (closure) versus ligation and vein stripping (EVOLVeS): two-year follow-up".

PURPOSE: To study intermediate clinical outcomes, rates of recurrent varicosities and neovascularisation, ultrasound changes of the GSV, and the quality of life changes in patients from EVOLVeS trial. METHODS: Forty five patients were re-examined 1 year and 65 two years after treatment. Follow-up visits included clinical examination with CEAP classification and calculation of venous clinical severity score (VCSS), ultrasound examination, and a quality of life questionnaire. RESULTS: The clinical course of the disease (CEAP, VCSS) was similar in the two treatment groups. 51% of the GSV trunks occluded by RFO underwent progressive shrinkage with the external diameter decreased from 6.3 SD 1.4 mm at 72 h after treatment to 2.9 SD 1.5 mm at 2 years. An additional 41% of the GSV became undetectable by ultrasound at 2-year follow up. In two patients we observed re-opening of an initially closed GSV lumen. Neovascularisation was found in one RFO case and in four S and L cases. Cumulative rates of recurrent varicose veins at combined 1 and 2 years follow-up were 14% for RFO and 21% for S and L (NS). The difference in global QOL score in favour of RFO re-appeared at 1 year and remained significant at 2 years after treatment. CONCLUSION: The 2-year clinical results of radiofrequency obliteration are at least equal to those after high ligation and stripping of the GSV. In the vast majority of RFO patients the GSV remained permanently closed, and underwent progressive shrinkage to eventual sonographic disappearance. Recurrence and neovascularisation rates were similar in the two groups although limited patient numbers prevent reliable statistical analysis. Improved quality of life scores persisted through the 2-year observations in the RFO group compared to the S and L group.

Blood-pancreatic juice barrier to antibiotic excretion.

Antibiotics were given intravenously to dogs with chronic pancreatic fistulas, and serum and pancreatic juice levels were measured. Despite adequate serum values, gentamicin, tetracycline, clindamycin, and moxalactam did not appear in the pancreatic juice, which suggested a barrier to their excretion. In contrast, chloramphenicol reached a peak concentration in the pancreatic juice that amounted to 36 percent of the peak serum value. In the pancreatic juice, ampicillin, cefoxitin, and cefamandole reached only 5 percent of the peak serum values but were still within the therapeutic range. We have concluded that there is a blood-pancreatic juice barrier to some antibiotics, which leads to selective excretion.

Inequalities of health insurance guidelines for the treatment of symptomatic varicose veins.

OBJECTIVES: The emerging model of US health-care delivery is aimed at reducing costs, standardizing care, and improving outcomes. Although it is necessary for health-care providers and insurance carriers to work together to achieve those goals, insurers have the added duty of assuring physicians and patients that they comprehend the medical evidence and, based on that understanding, construct policies. Are US insurers meeting that responsibility or are they simply creating policies to serve their own needs? METHODS: The medical policies of several US health insurers were analysed. The goal was to see whether it could readily be determined if these carriers used evidence-based medicine consistently to create uniform policies for the treatment of patients with symptomatic varicose veins. The literature was also reviewed to determine whether increased insurance documentation requirements have affected cost reduction, standardization of care and/or improvement of outcomes related to chronic vein disease management. RESULTS: There is a dramatic lack of uniformity among the insurance policies reviewed. Insurers appear to not choose important papers to create policy but use carefully chosen articles to reinforce what they want their policies to say. In so doing, conflicting policy criteria are being created. Complicating this inconsistency, rules for medical necessity are modified frequently, raising frustration levels among vein providers and their patients. What is clear is that costs are not being lowered, care is not being standardized and little is being done to prevent potential complications resulting from chronic vein disease. CONCLUSIONS: Patients and physicians are increasingly ill-served by, and frustrated with, the clear lack of consistency in the medical policy criteria being created by US insurance carriers in covering the treatment of patients with symptomatic varicose veins. The contradictory coverage requirements, seemingly based on no understanding of evidence-based medicine guidelines, and total variability in reimbursement for various types of treatment options is particularly worrisome. Collaboration between venous treatment providers and insurance carriers, to create evidence-based standards of care, would be timely and beneficial in creating guidelines for optimal patient care.

Prospective randomised study of endovenous radiofrequency obliteration (closure) versus ligation and vein stripping (EVOLVeS): two-year follow-up.

PURPOSE: To study intermediate clinical outcomes, rates of recurrent varicosities and neovascularisation, ultrasound changes of the GSV, and the quality of life changes in patients from EVOLVeS trial. METHODS: Forty five patients were re-examined 1 year and 65 two years after treatment. Follow-up visits included clinical examination with CEAP classification and calculation of venous clinical severity score (VCSS), ultrasound examination, and a quality of life questionnaire. RESULTS: The clinical course of the disease (CEAP, VCSS) was similar in the two treatment groups. 51% of the GSV trunks occluded by RFO underwent progressive shrinkage with the external diameter decreased from 6.3 SD 1.4 mm at 72 h after treatment to 2.9 SD 1.5 mm at 2 years. An additional 41% of the GSV became undetectable by ultrasound at 2-year follow up. In two patients we observed re-opening of an initially closed GSV lumen. Neovascularisation was found in one RFO case and in four S and L cases. Cumulative rates of recurrent varicose veins at combined 1 and 2 years follow-up were 14% for RFO and 21% for S and L (NS). The difference in global QOL score in favour of RFO re-appeared at 1 year and remained significant at 2 years after treatment. CONCLUSION: The 2-year clinical results of radiofrequency obliteration are at least equal to those after high ligation and stripping of the GSV. In the vast majority of RFO patients the GSV remained permanently closed, and underwent progressive shrinkage to eventual sonographic disappearance. Recurrence and neovascularisation rates were similar in the two groups although limited patient numbers prevent reliable statistical analysis. Improved quality of life scores persisted through the 2-year observations in the RFO group compared to the S and L group.

Indium-111 leukocyte accumulation in intramuscular injection sites.

We report four cases of indium-111 leukocyte concentration in previous intramuscular injection sites. Three patterns were observed: small, discrete, and round; linear; irregular and large. The scintigraphic appearance did not necessarily correlate with the number of injections that the patient had received.

Scoring system to aid in diagnoses of appendicitis.

Problems related to the diagnosis of appendicitis are evidenced by the significant negative laparotomy rate. The present study sought to assess the feasibility of decreasing this diagnostic error by studying two groups of patients and identifying and weighing details of history, physical examination and laboratory findings utilizing 23 predictive factors. One hundred consecutive cases of proven appendicitis (AAp) were retrospectively reviewed and compared with 100 consecutive cases that had normal appendices removed because of erroneous preoperative diagnosis of appendicitis (NAp). Rates of occurrence for each predictive factor were determined separately for both groups. These were converted into weights which were then added to yield a diagnostic score for each patient. A cutoff point established the score which designated one group for observation and the other for surgery. Scores were assessed at three different points by balancing risks of missed diagnoses against benefits of avoiding unnecessary operations. Seven predictive factors had differentiating weights and reached statistical significance (p less than or equal to 0.05):-sex, age, duration of symptoms, GU symptoms, involuntary right lower quadrant muscle spasm, right-sided rectal mass, and white blood cell count. Using these seven predictors, at a "-3" cutoff, 38% NAPs would have been spared laparotomy and about 5% of the AAps would have been indicated for observation. Analysis indicated little risk in observing the 5% AAp (5/7 history less than or equal to 1 day), and progressive improvement for NAps with increasing time. This simple scoring system could have eliminated over one third of the unnecessary laparotomies in the present sample, indicating potential value as an aid in surgical decision-making.

Prospective randomized study of endovenous radiofrequency obliteration (closure procedure) versus ligation and stripping in a selected patient population (EVOLVeS Study).

PURPOSE: This study was designed as a prospective multicenter randomized comparison of procedure-related complications, patient recuperation, and quality-of-life outcomes between patients undergoing vein stripping with high ligation and patients undergoing great saphenous vein (GSV) obliteration with temperature-controlled radiofrequency ablation without adjunctive high ligation (Closure procedure). METHODS: Eighty-five patients (86 limbs) from five sites (France, 2; Austria, 1; United States, 2) were randomly allocated to undergo radiofrequency obliteration (RFO) or stripping and high ligation (S&L). Final analysis included data for 44 limbs in the RFO group and 36 limbs in the S&L group. Follow-up examinations were performed at 72 hours, 1 week, 3 weeks, and 4 months. All patients completed the CIVIQ2 quality-of-life (QOL) questionnaire and underwent clinical and ultrasound examinations at each follow-up visit. RESULTS: Immediate success on the day of treatment was reported for 95% (42 of 44) of limbs in the RFO group and 100% (36 of 36) of limbs in the S&L group. In seven RFO limbs (16.3%) a scan obtained 72 hours after the procedure showed flow in the proximal GSV. Five of these segments had reflux in the open segment. At 1 week two of these closed, and an additional segment closed at 3 weeks. In no cases did flow reappear after complete occlusion of the GSV. Time to return to normal activities was significantly less in the RFO group (mean, 1.15 days; 95% confidence interval [CI], 0.05-2.34) compared with the S&L group (mean, 3.89 days; CI, 2.67-5.12; P =.02). In the RFO group, 80.5% of patients returned to routine activities of daily living within 1 day, compared with 46.9% of patients in the S&L group (P <.01). Patients in the RFO group were able to return to work in 4.7 days (CI, 1.16-8.17), compared with 12.4 days (CI, 8.66-16.23) for the S&L group (P <.05). Analysis of the QOL surveys showed statistically significant differences in favor of the RFO group for global score and pain score during follow-up. The magnitude of the difference, however, progressively decreased between 1 week and 4 months. CONCLUSIONS: In the absence of significant complications, such as deep vein thrombosis and pulmonary embolism, severe neuritic sequelae, and skin burns, there are significant early advantages to endovascular obliteration of the GSV compared with conventional vein stripping.