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Background: The fact that a high prevalence of asymptomatic peripheral arterial disease (PAD) in the population has repeatedly been noted in recent years, without there being data as to how often asymptomatic PAD has to be anticipated in inpatients treated for divergent internal diseases led us now to performing a screening study in a general-care hospital., Patients and Methods: The study population consisted of 990 patients (51.8% women, 48.2% men) with a mean age of 65.2 years (40-93 years) who had to be treated in a hospital for various internal diseases in the period from January 1994 to January 1995. Their case histories were taken, and their clinical findings and the ankle/brachial indices as calculated from Doppler ultrasonographic measurements of the systolic pressures in the malleolar and brachial arteries were used to ascertain how many of the patients presented with asymptomatic and symptomatic PAD. Further the frequency of risk factors (smoking, hypertension, diabetes mellitus, lipid disorders) was recorded for either patient group., Results: The study showed that 6% of the 990 patients suffered from symptomatic PAD and that of the remaining 931 patients, 43.7% were diagnosed, on the basis of the ankle/brachial index (ABI) (< or = 0.9), to have asymptomatic PAD, while 56.3% showed no indication of PAD., Conclusions: The high number of cases of asymptomatic PAD among inpatients who underwent internal treatment--a percentage well above the figures published so far for outpatients--allows the conclusion that the determination of the ABI is well suited to screen patients older than 50 years even in a hospital setting so that early secondary prophylaxis can be initiated.

Unlabelled: DRG-based cost analysis of inpatient conservative treatment of PAD stage III/IV BACKGROUND: In a prospective study carried out by the German Society of Angiology and the DRG Competence Center, Munich, the question was investigated whether the costs of conservative treatment of patients with PAOD stage III/IV (DRG F65) are adequately represented within the current G-DRG system. METHODS UND PATIENTS: Between September 1 and December 16, 2002, a total of 704 patients with DRG F65 (peripheral vascular diseases) were evaluated at 8 angiologic centers in Germany. Apart from the length of hospital stay, the total costs (cost equivalents) were calculated using a method developed by the DRG Research Group at the University of Münster. Moreover, the study population was compared with a German calculation sample for the DRGs F65A/B, as published by InEK., Results: As it turned out, conservatively treated patients with PAOD stage III or IV (DRGs F65A/B) cause significantly (p < 0.001) higher costs and have significantly (p < 0.001) greater lengths of hospital stay than patients who were also assigned to DRG F65 because of other vascular diseases. At the same time it became clear that angiologic centers treat twice as many patients with critical limb ischemia in comparison with the German average. The reimbursement hitherto estimated by InEK covers not even half the cost actually produced by conservative treatment of PAD stage III/IV., Conclusion: To ensure a performance-related reimbursement, a new basis DRG for patients with PAD stage III/IV has to be created, as has ben proposed by the German Society of Angiology. Otherwise, adequate conservative therapy in accordance with existing guidelines, of patients who cannot be treated surgically or interventionally will not be possible any more in the future.

Background: Intravenous iloprost, titrated from 0.5 up to 2.0 ng/kg/min has been shown in patients with PAOD III/IV to significantly improve healing of trophic lesions, relief of rest pain, and reduce the rate of major amputation or death at 6 months as compared to placebo. The effect is considered related to improvement of the microcirculation. The aim of the present trial was to identify an optimum dose regarding treatment response and tolerability, by studying 4 doses of 25, 50, 75 and 100 micrograms iloprost daily., Patients and Methods: 302 patients with PAOD IV were randomised via a double-blind fashion to one of the 4 doses. The primary endpoint was the responder rate at end of treatment. Responders were defined as patients with very good or good global efficacy, as judged by lesion healing and pain relief. Side effects were documented and a pre-defined benefit/risk index was calculated., Results: No dose-dependency of iloprost regarding primary or secondary endpoints was observed. The rate of responders ranged between 48.7-53.5%. Side effects, mainly related to vasodilation, increased dose-dependently (p < 0.001, chi 2-test), with a significant decrease of the benefit/risk index from 2.19 +/- 1.19 to 1.64 +/- 0.97 (p = 0.012, ANOVA). Responders had a better outcome at 6 months than non-responders (2.6 fold higher rate of major amputation or death; life table analysis)., Conclusions: It is concluded that iloprost should be titrated to the optimum rather than maximum tolerated dose, since a higher incidence of side effects not associated with an increased treatment response was observed at higher doses.

Background: Many physiological processes are subjected to circadian variation. We tested if circadian changes of skin perfusion can be detected by measuring laser Doppler flux (LDF) in the foot and if such variations are different in patients with peripheral arterial occlusive disease (PAOD)., Patients and Methods: LDF was recorded hourly during a 24-hour period in 10 healthy subjects and in 19 PAOD patients, 9 presenting with claudication (stage II according to Fontaine, ankle artery pressures (AP) 80 +/- 11 mmHg) and 10 with skin necrosis (stage IV, AP 42 +/- 29 mmHg)., Results: Circadian variability of LDF was significantly reduced in stage IV patients compared both with stage II patients and controls (p < 0.01). An increase in LDF could be observed early in the afternoon and, more pronounced, during the night, occurring to the same extent in healthy and PAOD patients in stage II (p < 0.001). In stage IV the increase in LDF was not significant and a decrease was observed in two patients. LDF and local skin temperature were correlated in controls and stage II patients (mean r = 0.69 +/- 0.12 and 0.7 +/- 0.14, respectively), but not in stage IV (mean r = 0.23 +/- 0.18). A further limitation of LDF variability and nocturnal increase was seen in the presence of diabetes., Conclusion: Circadian variations of skin blood flow are comparable in controls and patients with claudication but markedly reduced in patients with severe PAOD presenting with ulcers, in whom skin perfusion seems uncoupled from temperature regulation, possibly due to local factors causing continuous arteriolar vasodilation.

The effect of intravenous therapy with iloprost (average duration 6 weeks) on the prognosis of leg-preserving local surgical treatment and on the transcutaneously measured oxygen pressure (tcPO2) in patients with ischaemic lesions was investigated in a prospective, open, controlled, randomized study. All of the 30 patients recruited to the study suffered from a peripheral arterial occlusive disease Fontaine stage IV with progressive symptoms and arterial occlusions below the knee. 15 patients received iloprost intravenously for 6 hours per day in an individual tolerable dose (mean dose: 1.7 ng/kg/min). 15 patients in the control group received no trial therapy. During the treatment period each patient underwent minor amputation or skin grafting. Wound healing after surgery and tcPO2 were assessed. The long-term efficacy of iloprost was assessed by following the patients for one year. The iloprost treatment was in general well tolerated and all patients completed the study in accordance with the trial protocol. Primary postoperative wound healing as the responder-criterion was observed in 9 patients (60%) of the iloprost group and in 4 patients (27%) of the control group. Patients with iloprost therapy were especially likely to show wound healing if they received the operation approximately in the mid of the treatment phase. The effect of therapy lasted for one year after the end of the treatment in 7 of 9 classified responders of the iloprost group. After one year the responder rate of 47% in the iloprost group was still 20% higher than in the control group. Surgical revisions were necessary in 7 patients (47%) of each group. 2 patients (13%) treated with iloprost and 4 control patients (27%) underwent major amputation. The mortality was 13% = 2 of 15 patients (iloprost) and 7% = 1 of 15 patients (control). Transcutaneous PO2-measurements were very reproducible over a long-term period under standardized conditions. A significant effect of iloprost on the tcPO2 was shown. There was a mean increase of 8.1 mmHg +/- 11.2 (mean +/- SD) in the foot of the affected limb after an average 6-week therapy (p < 0.05). At the same time a significant difference in the tcPO2-changes between responders and nonresponders was demonstrated (p < 0.05). Patients with primary wound healing had a greater increase in tcPO2 than patients whose wounds did not heal. An increase of at least 10 mmHg (6 patients) in tcPO2 during the infusion after 3 weeks of therapy predicted primary post-operative wound healing.

121 patients with multilevel, lower extremity arterial occlusive disease were treated by aortofemoral reconstruction and extended profundoplasty. Early and late results of 201 limbs were analyzed according to their preoperative grade of ischemia. In the case of moderate claudication the success rate was 43% postoperatively and 81% after 5 years. When having severe claudication the success rate was 62% and 79% after 5 years. The revascularisation of the deep femoral artery helps developing the collateral arteries, responsible for an improvement after a considerable period of time. In limbs with rest pain we got a success rate of 78% postoperatively and 76% after 5 years. In the case of gangrene the primary success rate was 40% and 68% after 5 years. Angiographically, severe arteriosclerotic lesions were documented in the deep femoral artery and popliteal artery when limb-threatening ischemia was present. Nevertheless, the combined aortofemoral and extended deep femoral artery reconstruction was efficient in treating the multilevel occlusive disease; subsequent femoro-distal bypass was necessary only in case of threatening ischemia for 9.3% of limbs. Our findings show there is no indication for simultaneous aortofemoral and femoro-distal bypass grafting in the treatment of the multilevel disease.

In an open, randomized study in patients with peripheral arterial occlusive disease in state IIb according to Fontaine the clinical efficacy and tolerability of Actovegin upon intravenous and intraarterial application was examined compared to vascular training. 30 patients were included in each of the three therapy groups. Over a period of four weeks each patient received daily therapy--except for weekends. Patients of group I received a daily intravenous infusion of 250 ml Actovegin 20% p.i. the patients in group II received this medication by the intraarterial route. The third patient group received standardized vascular training. From a total of 90 patients 73 completed the study according to the study protocol. In all three groups the therapy resulted in the improvement of pain-free and pain-limited walking distances. Upon comparison of relative changes in the intraarterial and intravenous group significant differences turned out: whereas patients in the intravenous group achieved a mean increase in pain-free walking distance of 37.8%, a mean increase in walking distance of 44.9% in the intraarterial group was observed. With respect to maximum walking distances the relative improvements amounted to a mean of 44.0% in the intravenous group, and 64.3% in the intraarterial group. After training over four weeks in the vascular-training group the patients achieved a mean increase in pain-free walking distance of 69.6% and 53.5% in pain-limited walking distance. This meant a significantly greater improvement in pain-free walking distance compared to the intravenous group; the difference compared to the intraarterial group was not significant; however the mean values indicated that the vascular-training group showed greater improvements in pain-free walking distance, and more moderate improvements in maximum walking distance than the intraarterial group. However, these results were significantly modified, if a differentiation was made in the vascular-training group between patients with high and low compliance. In the patients' rating all three therapies were described as throughout beneficial, however, less positive for the intravenous therapy, which is in accordance to the results of changes in walking-distance. The results of the present study are discussed having in mind physical therapy being limited through contraindications and insufficient patient compliance.