Johanna L. Bosch

Randomised comparison of primary stent placement versus primary angioplasty followed by selective stent placement in patients with iliac-artery occlusive disease

BACKGROUND Percutaneous transluminal angioplasty (PTA) is a safe, simple, and successful treatment for intermittent claudication caused by iliac-artery occlusive disease. Primary stent placement has been proposed as more effective than PTA. We compared the technical results and clinical outcomes of two treatment strategies-primary placement of a stent across the stenotic segment of the iliac artery, or primary PTA followed by selective stent placement when haemodynamic results were inadequate. METHODS We randomly assigned 279 patients with intermittent claudication, recruited from departments of vascular surgery, either to direct stent placement (group I, n=143) or primary angioplasty (group II, n=136), with subsequent stent placement in case of a residual mean pressure gradient greater than 10 mm Hg across the treated site. The main inclusion criterion was intermittent claudication on the basis of iliac-artery stenosis of more than 50%, proven by angiography. All patients had a clinical assessment before intervention and at 3, 12, and 24 months. Clinical success was defined as improvement of at least one clinical category. Secondary endpoints were initial technical results, procedural complications, cumulative patency as assessed by duplex ultrasonography, and quality of life. FINDINGS In group II, selective stent placement was done in 59 (43%) of the 136 patients. The mean follow-up was 9.3 months (range 3-24). Initial haemodynamic success and complication rates were 119 (81%) of 149 limbs and 6 (4%) of 143 limbs (group I) versus 103 (82%) of 126 limbs and 10 (7%) of 136 limbs (group II), respectively. Clinical success rates at 2 years were 29 (78%) of 37 patients and 26 (77%) of 34 patients in groups I and II, respectively (p=0.6); however, 43% and 35% of the patients, respectively, still had symptoms. Quality of life improved significantly after intervention (p<0.05) but we found no difference between the groups during follow-up. 2-year cumulative patency rates were similar at 71% versus 70% (p=0.2), respectively, as were reintervention rates at 7% versus 4%, respectively (95% CI -2% to 9%). INTERPRETATION There were no substantial differences in technical results and clinical outcomes of the two treatment strategies both at short-term and long-term follow-up. Since angioplasty followed by selective stent placement is less expensive than direct placement of a stent, the former seems to be the treatment of choice for lifestyle-limiting intermittent claudication caused by iliac artery occlusive disease.

Correlates of health-related quality of life in type 2 diabetes

Aims/hypothesisWe assessed the impact of medical comorbidities, depression, and treatment intensity on quality of life in a large primary care cohort of patients with type 2 diabetes.MethodsWe used the Health Utilities Index-III, an instrument that measures health-related quality of life based on community preferences in units of health utility (scaled from 0=death to 1.0=perfect health), in 909 primary care patients with type 2 diabetes. Demographic and clinical correlates of health-related quality of life were assessed.ResultsThe median health utility score for this population was 0.70 (interquartile range 0.39–0.88). In univariate analyses, older age, female sex, low socioeconomic status, cardiovascular disease, microvascular complications, congestive heart failure, peripheral vascular disease, chronic lung disease, depression, insulin use and number of medications correlated with decreased quality of life, while obesity, hypertension and hypercholesterolaemia did not. In multiple regression analyses, microvascular complications, heart failure and depression were most strongly related to decreased health-related quality of life, independently of duration of diabetes; in these models, diabetes patients with depression had a utility of 0.59, while patients without symptomatic comorbidities did not have a significantly reduced quality of life. Treatment intensity remained a significant negative correlate of quality of life in multivariable models.Conclusions/interpretationPatients with type 2 diabetes have a substantially decreased quality of life in association with symptomatic complications. The data suggest that treatment of depression and prevention of complications have the greatest potential to improve health-related quality of life in type 2 diabetes.

Association of diabetes‐related emotional distress with diabetes treatment in primary care patients with Type 2 diabetes

Aims  To characterize the determinants of diabetes‐related emotional distress by treatment modality (diet only, oral medication only, or insulin).

Health-related quality of life after angioplasty and stent placement in patients with iliac artery occlusive disease: Results of a randomized controlled clinical trial

Backround —To assess the quality of life in patients with iliac artery occlusive disease, we compared primary stent placement versus primary angioplasty followed by selective stent placement in a multicenter randomized controlled trial. Methods and Results —Quality-of-life assessments were completed by 254 patients in a telephone interview. Assessment measures consisted of the RAND 36-Item Health Survey 1.0, time tradeoff, standard gamble, rating scale, health utilities index, and EuroQol-5D. The interviews were performed before treatment and after 1, 3, 12, and 24 months. When the 2 treatments were compared, no significant difference was observed ( P >0.05). All measurements showed a significant improvement in the quality of life after treatment ( P Conclusions —Health-related quality of life improves equally after primary stent placement and primary angioplasty with selective stent placement in the treatment of intermittent claudication caused by iliac artery occlusive disease.

The relationship between descriptive and valuational quality-of-life measures in patients with intermittent claudication

The study objective was to assess the relationship between descriptive and valuational quality-of-life measures in patients with intermittent claudication. In telephone inter views, 68 patients completed a questionnaire consisting of a descriptive health status measure (RAND 36-Item Health Survey 1.0), and several valuational measures (stan dard gamble, time tradeoff, rating scale, and McMaster health utility index). All mea sures demonstrated reduced quality of life in the patients. Scores on the RAND-36 dimensions correlated moderately well with the rating scale and McMaster health utility index (R = 0.37-0.67) but less well with the standard gamble and the time tradeoff (R = 0.10-0.46). Multiple regression analysis demonstrated that 28% of the variance in the time-tradeoff values and 14% of the variance of the standard-gamble utilities could be explained by the best combination of RAND dimensions. These results suggest that answers to descriptive health-status questions cannot reliably predict standard-gamble utilities or time-tradeoff values. Key words: quality of life; health status; utility assess ment ; peripheral vascular diseases; intermittent claudication. (Med Decis Making 1996;16:217-225)

Preference-Based Quality of Life of Patients on Renal Replacement Therapy : A Systematic Review and Meta-Analysis

OBJECTIVES Various utility measures have been used to assess preference-based quality of life of patients with end-stage renal disease (ESRD). The purposes of this study were to summarize the literature on utilities of hemodialysis (HD), peritoneal dialysis (PD), and renal transplantation (RTx) patients, to compare utilities between these patient groups, and to obtain estimates for quality-of-life adjustment in economic analyses. METHODS We searched the English literature for studies that reported visual analog scale (VAS), time trade-off (TTO), standard gamble (SG), EuroQol-5D (EQ-5D), and health utilities index (HUI) values of ESRD patients. We extracted patient characteristics and utilities and calculated mean utilities and 95% confidence intervals (CIs) for categories defined by utility measure and treatment modality using random-effects models. RESULTS We identified 27 articles that met the inclusion criteria. VAS articles were too heterogeneous to summarize quantitatively and we found only one study reporting HUI values. Thus, we summarized utilities from TTO, SG, and EQ-5D studies. Mean TTO and EQ-5D-index values were lower for dialysis compared to RTx patients, though not statistically significant for TTO values (TTO values: HD 0.61, 95% CI 0.54-0.68; PD 0.73, 95% CI 0.61-0.85; RTx 0.78, 95% CI 0.63-0.93; EQ-5D-index values: HD 0.56, 95% CI 0.49-0.62; PD 0.58, 95% CI 0.50-0.67; RTx 0.81, 95% CI 0.72-0.90). Mean HD versus PD associated TTO, EQ-5D-index and EQ-VAS values were not statistically significantly different. CONCLUSION RTx patients tended to have a higher utility than dialysis patients. Among HD and PD patients, there were no statistically significant differences in utility.

Intermittent Claudication: Clinical Effectiveness of Endovascular Revascularization versus Supervised Hospital-based Exercise Training—Randomized Controlled Trial

PURPOSE To compare clinical success, functional capacity, and quality of life during 12 months after revascularization or supervised exercise training in patients with intermittent claudication. MATERIALS AND METHODS This study had institutional review board approval, and all patients gave written informed consent. Between September 2002 and September 2005, 151 consecutive patients who presented with symptoms of intermittent claudication were randomly assigned to undergo either endovascular revascularization (angioplasty-first approach) (n = 76) or hospital-based supervised exercise (n = 75). The outcome measures were clinical success, functional capacity, and quality of life after 6 and 12 months. Clinical success was defined as improvement in at least one category in the Rutherford scale above the pretreatment level. Significance of differences between the groups was assessed with the unpaired t test, chi(2) test, or Mann-Whitney U test. To adjust outcomes for imbalances of baseline values, multivariable regression analysis was performed. RESULTS Immediately after the start of treatment, patients who underwent revascularization improved more than patients who performed exercise in terms of clinical success (adjusted odds ratio [OR], 39; 99% confidence interval [CI]: 11, 131; P < .001), but this advantage was lost after 6 (adjusted OR, 0.9; 99% CI: 0.3, 2.3; P = .70) and 12 (adjusted OR, 1.1; 99% CI: 0.5, 2.8; P = .73) months. After revascularization, fewer patients showed signs of ipsilateral symptoms at 6 months compared with patients in the exercise group (adjusted OR, 0.4; 99% CI: 0.2, 0.9; P < .001), but no significant differences were demonstrated at 12 months. After both treatments, functional capacity and quality of life scores increased after 6 and 12 months, but no significant differences between the groups were demonstrated. CONCLUSION After 6 and 12 months, patients with intermittent claudication benefited equally from either endovascular revascularization or supervised exercise. Improvement was, however, more immediate after revascularization.

Nerve management during open hernia repair

Peroperative identification and subsequent division or preservation of the inguinal nerves during open hernia repair may influence the incidence of chronic postoperative pain.

Cost-effectiveness of endovascular revascularization compared to supervised hospital-based exercise training in patients with intermittent claudication: A randomized controlled trial

BACKGROUND The optimal first-line treatment for intermittent claudication is currently unclear. OBJECTIVE To compare the cost-effectiveness of endovascular revascularization vs supervised hospital-based exercise in patients with intermittent claudication during a 12-month follow-up period. DESIGN Randomized controlled trial with patient recruitment between September 2002-September 2006 and a 12-month follow-up per patient. SETTING A large community hospital. PARTICIPANTS Patients with symptoms of intermittent claudication due to an iliac or femoro-popliteal arterial lesion (293) who fulfilled the inclusion criteria (151) were recruited. Excluded were, for example, patients with lesions unsuitable for revascularization (iliac or femoropopliteal TASC-type D and some TASC type-B/C. INTERVENTION Participants were randomly assigned to endovascular revascularization (76 patients) or supervised hospital-based exercise (75 patients). MEASUREMENTS Mean improvement of health-related quality-of-life and functional capacity over a 12-month period, cumulative 12-month costs, and incremental costs per quality-adjusted life year (QALY) were assessed from the societal perspective. RESULTS In the endovascular revascularization group, 73% (55 patients) had iliac disease vs 27% (20 patients) femoral disease. Stents were used in 46/71 iliac lesions (34 patients) and in 20/40 femoral lesions (16 patients). In the supervised hospital-based exercise group, 68% (51 patients) had iliac disease vs 32% (24 patients) with femoral disease. There was a non-significant difference in the adjusted 6- and 12-month EuroQol, rating scale, and SF36-physical functioning values between the treatment groups. The gain in total mean QALYs accumulated during 12 months, adjusted for baseline values, was not statistically different between the groups (mean difference revascularization versus exercise 0.01; 99% CI -0.05, 0.07; P = .73). The total mean cumulative costs per patient was significantly higher in the revascularization group (mean difference euro2318; 99% CI 2130 euros, 2506 euros; P < .001) and the incremental cost per QALY was 231 800 euro/QALY adjusted for the baseline variables. One-way sensitivity analysis demonstrated improved effectiveness after revascularization (mean difference 0.03; CI 0.02, 0.05; P < .001), making the incremental costs 75 208 euro/QALY. CONCLUSION In conclusion, there was no significant difference in effectiveness between endovascular revascularization compared to supervised hospital-based exercise during 12-months follow-up, any gains with endovascular revascularization found were non-significant, and endovascular revascularization costs more than the generally accepted threshold willingness-to-pay value, which favors exercise.

Comparison of the Health Utilities Index Mark 3 (HUI3) and the EuroQol EQ-5D in patients treated for intermittent claudication

The Health Utilities Index Mark 3 (HUI3) and the EuroQol EQ-5D (EQ-5D) were compared to each other and to other quality-of-life (QoL) measures in patients treated for intermittent claudication. A total of 88 patients with intermittent claudication completed the HUI3, EQ-5D, RAND 36-Item Health Survey 1.0, time tradeoff, standard gamble, and rating scale before revascularization and at follow-up at 1 month, 3 months, and 1 year. The effect of treatment on the HUI3 and EQ-5D dimensions and the overall scores, calculated using published formulas based on societal preferences, were compared. After 1 month of treatment, the majority of patients showed improvement on the HUI3 dimensions ambulation and pain and on the EQ-5D dimensions mobility, usual activities, and pain/discomfort. The mean HUI3 score was significantly higher than the mean EQ-5D score (0.66 and 0.57, respectively, p < 0.01) before treatment. After treatment, however, they were not significantly different from each other (e.g., 12 months after treatment: 0.77 and 0.75, respectively (p > 0.05). After 1 month, the scores did not change significantly over time (p > 0.05). The intraclass correlation coefficient between changes over time in the HUI3 and EQ-5D scores was 0.30, with other health-related quality-of-life (HRQoL) measures the correlations for HUI3 and EQ-5D were very similar. In conclusion, both the HUI3 and EQ-5D demonstrated an effect of treatment in patients with intermittent claudication; in addition, they showed similar relationships with other (HRQoL) measures. To demonstrate the effect of revascularization in patients with intermittent claudication, however, clinicians and researchers should be aware of the differences in the mean HUI3 and EQ-5D scores.