Long-term clinical effectiveness of supervised exercise therapy versus endovascular revascularization for intermittent claudication from a randomized clinical trial.

BACKGROUND: Long-term comparisons of supervised exercise therapy (SET) and endovascular revascularization (ER) for patients with intermittent claudication are scarce. The long-term clinical effectiveness of SET and ER was assessed in patients from a randomized trial. METHODS: Consenting patients with intermittent claudication were assigned randomly to either SET or ER. Outcome measures on functional performance (pain-free and maximum walking distance, ankle : brachial pressure index), quality of life (QoL) and number of secondary interventions were measured at baseline and after approximately 7 years of follow-up. Repeated-measurement and Kaplan-Meier methods were used to analyse the data on an intention-to treat-basis. RESULTS: A total of 151 patients were randomized initially to either SET or ER. After 7 years, functional performance (P < 0.001) and QoL (P ≤ 0.005) had improved after both SET and ER. Long-term comparison showed no differences between the two treatments, except in the secondary intervention rate, which was significantly higher after SET (P = 0.001). Nevertheless, the total number of endovascular and surgical interventions (primary and secondary) remained higher after ER (P < 0.001). CONCLUSION: In the longer term, SET-first or ER-first treatment strategies were equally effective in improving functional performance and QoL in patients with intermittent claudication. The substantially higher number of invasive interventions in the ER-first group supports a SET-first treatment strategy for intermittent claudication. REGISTRATION NUMBER: NTR199 (http://www.trialregister.nl).

Meta-analysis of laparoscopic versus open cholecystectomy for patients with liver cirrhosis and symptomatic cholecystolithiasis.

BACKGROUND: Open cholecystectomy (OC) is often preferred over laparoscopic cholecystectomy (LC) in patients with liver cirrhosis and portal hypertension, but evidence is lacking to support this practice. This meta-analysis aimed to clarify which surgical technique is preferable for symptomatic cholecystolithiasis in patients with liver cirrhosis. METHODS: A meta-analysis was conducted according to the PRISMA guidelines. Articles published between January 1990 and October 2011 were identified from MEDLINE, Embase and the Cochrane Library. Randomized clinical trials (RCTs) comparing outcomes of OC versus LC for cholecystolithiasis in patients with liver cirrhosis were included. The quality of the RCTs was assessed using the Jadad criteria. RESULTS: Following review of 1422 papers by title and abstract, a meta-analysis was conducted of four RCTs comprising 234 surgical patients. They provided evidence of at least level 2b on the Oxford Level of Evidence Scale, but scored poorly according to the Jadad criteria. Some 97·0 per cent of the patients had Child-Turcotte-Pugh (CTP) grade A or B liver cirrhosis. In all, 96·6 per cent underwent elective surgery. No postoperative deaths were reported. LC was associated with fewer postoperative complications (risk ratio 0·52, 95 per cent confidence interval (c.i.) 0·29 to 0·92; P = 0·03), a shorter hospital stay (mean difference -3·05 (95 per cent c.i. -4·09 to -2·01) days; P < 0·001) and quicker resumption of a normal diet (mean difference -27·48 (-30·96 to -23·99) h; P < 0·001). CONCLUSION: Patients with CTP grade A or B liver cirrhosis who undergo LC for symptomatic cholecystolithiasis have fewer overall postoperative complications, a shorter hospital stay and resume a normal diet more quickly than those who undergo OC.

Percutaneous transhepatic biliary drainage in patients with postsurgical bile leakage and nondilated intrahepatic bile ducts.

OBJECTIVE AND BACKGROUND: Bile leakage is a serious postoperative complication and percutaneous transhepatic biliary drainage (PTBD) may be an option when endoscopic treatment is not feasible. In this retrospective study, we established technical and clinical success rates as well as the complication rates of PTBD in a large group of patients with postoperative bile leakage. METHODS: Data on all patients with nondilated intrahepatic bile ducts who underwent a PTBD procedure for the treatment of bile leakage between January 2000 and August 2012 were retrospectively assessed. Data included type of surgery, site of bile leak, previous attempts of bile leak repair, interval between surgery and PTBD placement. Outcome measures were the technical and clinical success rates, the procedure-related complications, and mortality rate. RESULTS: A total of 63 patients were identified; PTBD placement was technically successful in 90.5% (57/63) after one to three attempts. The clinical success rate was 69.8% (44/63). Four major complications were documented (4/63; 6.3%): liver laceration, pneumothorax, pleural empyema, and prolonged hemobilia. One minor complication involved pain. CONCLUSIONS: PTBD is an effective treatment with low complication rates for the management of postsurgical bile leaks in patients with nondilated bile ducts.

Cost-effectiveness of screening for abdominal aortic aneurysm in the Netherlands and Norway.

BACKGROUND: The aim of this study was to determine the cost-effectiveness of ultrasound screening for abdominal aortic aneurysm (AAA) in men aged 65 years, for both the Netherlands and Norway. METHODS: A Markov model was developed to simulate life expectancy, quality-adjusted life-years, net health benefits, lifetime costs and incremental cost-effectiveness ratios for both screening and no screening for AAA. The best available evidence was retrieved from the literature and combined with primary data from the two countries separately, and analysed from a national perspective. A threshold willingness-to-pay (WTP) of €20,000 and €62,500 was used for data from the Netherlands and Norway respectively. RESULTS: The additional costs of the screening strategy compared with no screening were €421 (95 per cent confidence interval 33 to 806) per person in the Netherlands, and the additional life-years were 0·097 (-0·180 to 0·365), representing €4340 per life-year. For Norway, the values were €562 (59 to 1078), 0·057 (-0·135 to 0·253) life-years and €9860 per life-year respectively. In Norway the results were sensitive to a decrease in the prevalence of AAA in 65-year-old men to 1 per cent, or lower. Probabilistic sensitivity analyses indicated that AAA screening has a 70 per cent probability of being cost-effective in the Netherlands with a WTP threshold of €20,000, and 70 per cent in Norway with a threshold of €62,500. CONCLUSION: Using this model, screening for AAA in 65-year-old men would be highly cost-effective in both the Netherlands and Norway.

Distensibility of forearm veins in haemodialysis patients on duplex ultrasound testing using three provocation methods.

OBJECTIVE: It is well-known that vasodilatator function is affected in patients with renal failure. We hypothesized impaired venous forearm distensibility in haemodialysis patients. The purpose of this study was to investigate which provocation method generated 'maximal' venous distensibility in the forearm of haemodialysis patients compared to healthy volunteers by using duplex ultrasound. DESIGN: The study group consisted of haemodialysis patients (n=30) and healthy volunteers (n=30). In each participant ultrasound measurements of the venous diameter were performed by using 3 different provocation methods. METHODS: The applied provocation methods were: 1) hydrostatic pressure, 2) venous congestion and 3) hydrostatic pressure and warmth. Significance of differences in mean diameter changes within the groups was assessed with the paired t-test. Significance of differences in mean diameter changes between the groups was compared by using multivariate regression analysis. RESULTS: In haemodialysis patients, the increase in mean diameter after the different methods was: 29% after methods 2 versus 1, 23% after methods 3 versus 2 and 59% after methods 3 versus 1. In healthy volunteers, the mean diameter increase was: 27% after methods 2 versus 1, 29% after methods 3 versus 2 and 64% after methods 3 versus 1. The greatest increase in the mean internal venous diameter among the haemodialysis patients and the healthy volunteers was after the provocation method which combined hydrostatic pressure with warmth (mean difference: 1mm, 95% CI: .57, 1.36; P<.001 and mean difference: 1.4mm, 95% CI: .88, 1.78; P<.001, respectively). After adjustment for the baseline variables, both groups demonstrated a non-significant mean diameter difference for each of the provocation methods. CONCLUSION: Hydrostatic pressure combined with warmth generates the greatest venous distensibility in the lower arm in haemodialysis patients in a sitting position and is not significantly different compared to healthy volunteers. Without the superior provocation method, venous diameters of haemodialysis patients can be assessed as false-negatives yielding that a primary radio cephalic arteriovenous fistula (RCAVF) at wrist level (the first choice) in these patients will be withheld.

The vascular laboratory in practice: a national survey in the Netherlands.

OBJECTIVES: to overview Dutch vascular laboratory practice and specifically the variation in duplex criteria. METHODS: a questionnaire was sent to all vascular laboratories in The Netherlands (n=140). RESULTS: the response rate of the inquiry was 64% (n=89). There is no consensus on interpretation of outcome. In 22% of the clinics (n=20) a diagnostic angiography will be omitted when a percutaneous angioplasty is advised on account of duplex ultrasound. Only 5% (n=4) relies upon duplex ultrasound for operation without diagnostic angiography. In 44% (n=39) a PSV (peak systolic velocity) of 125 cm/s is used to identify a>70% or internal carotid artery stenosis. In 44% (n=39) a PSV of 210 cm/s and 10% (n=9) a PSV > or =150 cm/s is used. For grading a relevant stenosis in the femoro-politeal arteries a PSV ratio > or =2.5 is chosen in 75% (n=67). Criteria used for graft surveillance shows also a wide variation. CONCLUSIONS: a commission for the accreditation of vascular laboratories should be established with the goal of creating standards and performing quality control.