Pieter T. den Hoed

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.

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.

Reference value of transcutaneous oxygen measurement in diabetic patients compared with nondiabetic patients

PURPOSE This study evaluated the values of transcutaneous oxygen tension (TcPo(2)) measurement in diabetic patients compared with nondiabetic patients and assessed its reproducibility. METHODS In 60 diabetic patients (type 1 and type 2 diabetes mellitus) without signs of peripheral arterial disease or neuropathy, we measured TcPo(2) at the chest and foot and compared these measurements with 60 age- and sex-matched nondiabetic patients in a cross-sectional fashion. The reproducibility of TcPo(2) in terms of interobserver variability was also assessed. RESULTS Diabetic patients had a mean +/- SD TcPo(2) value at the foot of 50.02 +/- 8.92 mm Hg, which was significantly lower compared with 56.04 +/- 8.80 mm Hg in nondiabetic patients (P < .001). At the chest wall, values for TcPo(2) were 51.77 +/- 11.15 mm Hg, and 58.22 +/- 12.47 mm Hg for diabetic patients and nondiabetic patients, respectively (P = .003). Regression analysis showed that TcPo(2)was significantly associated with diabetes mellitus (coefficient = -0.258; P = .004), and with having a first-degree relative with diabetes mellitus (coefficient = -0.265; P = .003). Furthermore, the interobserver variability showed a substantial correlation for both measurements at the chest (P < .001; r = 0.654; intraclass correlation coefficient [ICC] = 0.79) and at the dorsum of the foot (P < .001; r = 0.426; ICC = 0.60). CONCLUSION Diabetic patients without signs of peripheral disease or neuropathy had significantly lower TcPo(2) values compared with age- and sex-matched nondiabetic patients. The influence of the examiner on the variance in TcPo(2) measurements was relatively small. We advocate the use of TcPo(2) measurement in diabetic patients to detect subclinical microvascular impairment as an additional tool to assess peripheral vascular disease.

The vascular nurse in practice: results of prescribed exercise training in patients with intermittent claudication

Intermittent claudication (IC) is a mild stage of peripheral arterial disease that affects between 3% and 7% of the population and up to 1 in 5 patients over the age of 75 years. Risk factors such as hypertension, hyperlipidemia, diabetes, smoking, and genetics increase the incidence of peripheral arterial disease. Patients with IC have limitations in functional capacity and can benefit from regular exercise. Walking is the preferred mode of exercise and improves the symptoms of claudication in several ways. Vascular nurses can play an important role during exercise therapy. A personalized, home-based exercise program can be developed, and nurses can assist and motivate patients during follow-up periods. Helping patients to quit smoking and control other risk-factor modifications (ie, high blood pressure and lipid levels) also has high priority in daily practice of the vascular nurse. This prospective study will illustrate the results of prescribed home-based exercise training by a vascular nurse on the maximum painless walking distance for patients with IC and will be applied to subgroups of vascular pathology.

Subfascial ligation of the incompetent short saphenous vein: technical success measured by duplex sonography

The aim of this prospective study was to assess the technical success of subfascial ligation of the short saphenous vein (SSV) in patients with SSV varices by postoperative duplex sonography. From January 1997 to October 2000, 28 patients (9 men and 19 women; mean age 56 years, range 32-72) underwent sapheno-popliteal ligation for incompetence of the sapheno-popliteal junction (SPJ). Four patients had operations on both limbs. Follow-up took place 3 months after the operation by using duplex sonography. In only 5 cases, the SSV was occluded completely. In 14 cases, there was no communication with the deep venous system, but a venous reflux via collaterals and epifascial veins still existed. In 13 cases, the SPJ still existed with tortuous development of the SPJ and sometimes with partial thrombosis. Postoperative duplex sonography showed that subfascial ligation of the SSV alone is not effective for the treatment of sapheno-popliteal reflux. Further prospective studies are necessary to find the best treatment for sapheno-popliteal reflux. Because of the immense progress in this treatment and the increased responsibility of nurses caring for these patients, the nurse must be thoroughly aware of the multifaceted problems of SSV varices.