Effects of spinal cord stimulation (SCS) in patients with inoperable severe lower limb ischaemia: a prospective randomised controlled study. Spinal cord stimulation in the treatment of non-reconstructable stable critical leg ischaemia: results of the European Peripheral Vascular Disease Outcome Study (SCS-EPOS). Design issues of a randomised controlled clinical trial on spinal cord stimulation in critical limb ischaemia. ESES Study Group. [Spinal cord electric stimulation vs. femoro-distal bypass in critical ischemia of the legs. Preliminary results in a randomized prospective study]. Early surgery versus initial conservative treatment in patients with spontaneous supratentorial intracerebral haematomas in the International Surgical Trial in Intracerebral Haemorrhage (STICH): a randomised trial. Influence of coumarin treatment on patency and limb salvage after peripheral arterial reconstructive surgery. The treatment of spontaneous intracerebral hemorrhage. A prospective randomized trial of surgical and conservative treatment. Evaluation of the clinical efficacy of conservative treatment in the management of carpal tunnel syndrome. Autologous transplantation of granulocyte colony-stimulating factor-mobilized peripheral blood mononuclear cells improves critical limb ischemia in diabetes.
This study was designed to test the hypothesis that spinal cord stimulation (SCS) improves limb salvage in patients with inoperable severe leg ischaemia.
                Prospective randomised controlled study with 18 months follow-up.
                Vascular surgical units in two university hospitals.
                Atherosclerotic (n = 41) and diabetic (n = 10) patients having chronic leg ischaemia with rest pain and/or ischaemic ulcerations due to technically inoperable arterial occlusions.
                Limb salvage and amount of tissue loss within 18 months, pain relief.
                Twenty-five patients were randomized to SCS and 26 to analgesic (control) treatment. Macrocirculatory parameters were not different in the two groups during follow-up. Long-term pain relief was observed only in the SCS group. At 18 months, limb salvage rates in the SCS and control groups were 62% and 45% (N.S.). Tissue loss was less (p = 0.05) in the SCS group. A subgroup analysis of patients without arterial hypertension showed a significantly lower amputation rate in the SCS vs the control group.
                SCS provided long-term pain relief but limb salvage at 18 months was not significantly improved by SCS in this rather small study. The results suggest that SCS may reduce amputation levels in patients with severe inoperable leg ischaemia and be most effective in patients without arterial hypertension. To determine the effect of spinal cord stimulation (SCS) on limb survival in patients with non-reconstructable critical leg ischaemia, and the value of patient selection on the basis of transcutaneous oxygen pressure (TcpO2) measurements and trial screening.
                A prospective, controlled, European multicentre study.
                Non-reconstructable patients with stable critical leg ischaemia were divided into three groups. The SCS-Match group comprised patients with a baseline forefoot TcpO2 of < 30 mmHg and both sufficient pain relief and sufficient paraesthesia coverage (> 75%) after a test stimulation period of at least 72 h. If baseline TcpO2 was < 10 mmHg, the TcpO2 should have exceeded 20 mmHg after test stimulation. The SCS-Match group was compared with patients not meeting these criteria, who were treated either with SCS (SCS-No-Match) or without SCS (No-SCS).
                At baseline, the mean (+/- SD) supine TcpO2 was 14.9 +/- 8.3 mmHg in the SCS-Match group (n = 41), 11.3 +/- 13.3 mmHg in the SCS-No-Match group (n = 32) and 15.3 +/- 17.1 mmHg in the No-SCS group (n = 39). In the SCS-Match group a significant improvement in pain relief (p < 0.005) and TcpO2 (p < 0.001) was seen. After 12 months, cumulative limb survival of patients treated with SCS was significantly better than that of patients not treated with SCS (p < 0.03), and limb survival in the SCS-Match group was significantly higher (p < 0.03) than that in the SCS-No-Match and No-SCS groups (78, 55 and 45%, respectively).
                SCS treatment of non-reconstructable critical leg ischaemia provides a significantly better limb survival rate compared with conservative treatment. Patient selection based on TcpO2 and the results of trial screening further increase the probability of limb survival after SCS therapy. Review of the design of a clinical study to evaluate of the efficacy of epidural spinal cord electrical stimulation (ESES) as compared to best medical treatment in patients with nonreconstructible critical limb ischaemia.
                Randomised controlled clinical trial of pragmatic type, which will be analysed according to the intention-to-treat principle. The treatment strategies are ESES, in addition to best medical treatment, and best medical treatment alone. Patients are followed-up for at least 18 months.
                The ESES-trial is an ongoing multicentre trial in 17 hospitals in The Netherlands.
                Patients with critical limb ischaemia, nonsuitable for either primary intervention or reintervention after failing reconstructions.
                Limb survival, patient survival, quality of life and cost-effectiveness.
                From November 1991 until May 1994 120 patients had been enrolled. Using life-table analysis, at one year 76% of these randomised patients were alive: 41% without amputation and 35% with amputation. Quality of life of the trial patients was low, even compared to other severely ill patient groups, such as liver and heart transplant candidates.
                Considering the high incidence of death and amputation, 18 months of follow-up seems adequate to detect a clinically relevant outcome improvement from ESES-treatment, if present. We hope to present the results of this study at the end of 1995. In the last few years the development of new and improved surgical procedures caused a more aggressive approach, by femoro-distal bypass, to the limb affected by critical ischaemia. A good surgical result is related to the crural vessel patency, the presence of an adequate autologous vein and the possibility to visualize inframalleolar and foot arteries by selective angiograms. Should all these conditions not be present, an outflow procedure might be at high risk for failure. On the other hand, several studies show that SCS relieves rest pain and improves trophic lesion healing although there is no evident increase in peripheral blood flow, but these studies refer to heterogeneous non-randomized patients. In order to evaluate the effectiveness of SCS compared to distal arterial reconstruction, we started this prospective and randomized study. In a period of 15 months, 12 patients affected by critical limb ischaemia at 4th stage of Fontaine with angiographic multilevel distal lesions were randomised for SCS (7 cases: group A) and distal bypass (5 cases: group B). The result of the therapy was judged as good or fair when either complete or evident pain regression and trophic lesion healing were obtained; otherwise the result was considered as poor. Actually the study is in progress, the follow-up is partial (3-12 months), the results are preliminary. In the patients of group A the results were good or fair in 5 cases (72%) and poor in 2 (28%). In the patients of group B the results were good or fair in 2 cases (40%) and poor in 3 (60%).(ABSTRACT TRUNCATED AT 250 WORDS) Spontaneous supratentorial intracerebral haemorrhage accounts for 20% of all stroke-related sudden neurological deficits, has the highest morbidity and mortality of all stroke, and the role of surgery remains controversial. We undertook a prospective randomised trial to compare early surgery with initial conservative treatment for patients with intracerebral haemorrhage.
                A parallel-group trial design was used. Early surgery combined haematoma evacuation (within 24 h of randomisation) with medical treatment. Initial conservative treatment used medical treatment, although later evacuation was allowed if necessary. We used the eight-point Glasgow outcome scale obtained by postal questionnaires sent directly to patients at 6 months follow-up as the primary outcome measure. We divided the patients into good and poor prognosis groups on the basis of their clinical status at randomisation. For the good prognosis group, a favourable outcome was defined as good recovery or moderate disability on the Glasgow outcome scale. For the poor prognosis group, a favourable outcome also included the upper level of severe disability. Analysis was by intention to treat.
                1033 patients from 83 centres in 27 countries were randomised to early surgery (503) or initial conservative treatment (530). At 6 months, 51 patients were lost to follow-up, and 17 were alive with unknown status. Of 468 patients randomised to early surgery, 122 (26%) had a favourable outcome compared with 118 (24%) of 496 randomised to initial conservative treatment (odds ratio 0.89 [95% CI 0.66-1.19], p=0.414); absolute benefit 2.3% (-3.2 to 7.7), relative benefit 10% (-13 to 33).
                Patients with spontaneous supratentorial intracerebral haemorrhage in neurosurgical units show no overall benefit from early surgery when compared with initial conservative treatment. The effect of coumarin on patency, limb salvage, and survival after primary femoro-popliteal and femoro-distal reconstructions was studied in 116 randomized patients (61 in the study group and 55 in the control group). All patients were treated postoperatively with heparin. Patients allocated to the study group received dicumarol (a coumarin derivative) orally postoperatively. The overall patency after 1 year was 75 +/- 6%, compared with 74 +/- 6%, after 2 years 65 +/- 9 compared with 57 +/- 8%, and after 3 years 46 +/- 11% compared with 42 +/- 9% (mean +/- SE) in the study and control groups, respectively. There were no statistically significant differences in limb salvage or survival rates between the two groups. In contrast, coumarin treatment was associated with serious bleeding complications in 4% to 5% of the study patients. As expected, limb salvage was lower in patients with critical ischemia (p less than 0.03), and this was also true for survival (p less than 0.04), which was also influenced by the level of the reconstruction; survival was lower in patients with femoro-distal reconstructions (p less than 0.001). Our results demonstrate that coumarin treatment does not improve outcome in routine femoro-popliteal and femoro-distal reconstructive surgery. In a prospective study, 52 patients with a spontaneous supratentorial intracerebral hematoma (ICH) were randomly assigned to receive emergency surgery or conservative treatment within 48 hours after the bleed. Patients with a decreased level of consciousness and/or a severe neurological deficit were admitted to the study. The overall mortality rate at 6 months was 42%: 10 (38%) of the 26 patients in the conservative group and 12 (46%) of the 26 in the surgical group. Six (20%) of the 30 survivors at 6 months were able to conduct their activities of daily living independently: five (31%) of the 16 patients in the conservative group and one (7%) of the 14 in the operative group. These differences are not statistically significant. The mortality rate of semicomatose or stuporous patients (Glasgow Coma Scale score 7 to 10) was statistically significantly lower in the surgical group (none of the four patients) than in the conservative group (four of five patients) (p less than 0.05); however, all surviving patients in this subgroup were severely disabled. The study suggests that surgical treatment of this category of patients with ICH does not offer any definite advantage over conservative treatment. In semicomatose or stuporous patients, surgery may improve the length of survival, but the quality of life remains poor. Carpal tunnel syndrome (CTS) is impingement of the median nerve at the wrist. The aim of this study was to compare the effectiveness of tendon and nerve gliding exercises with standard conservative treatment (SCT), which consists of splinting and local steroid injections, in the treatment of CTS.
                This study was a prospective, randomized, single-blind trial. Patients were randomized into three groups: treatment with SCT (Group 1); SCT and tendon and nerve gliding exercises (Group 2); tendon and nerve gliding exercises only (Group 3). A symptom total point score was obtained from five symptoms: hand pain, tingling, numbness, nocturnal numbness, and interrupted sleep. The functional status of the hand was determined by assessing seven daily living activities: writing, buttoning clothes, gripping a telephone receiver, opening jars, doing housework, carrying grocery bags, and bathing. Standard physical examinations (Tinel's test, Phalen's test, reverse Phalen's test, and the compression test) were also performed.
                A total of 111 patients who were diagnosed with intermediate-stage CTS were included in the study. At the end of treatment, significant improvements in symptoms and functionality were detected in all groups. However, the recovery of patients in Groups 1 (n=41) and 2 (n=35) were found to be significantly greater than that of patients in Group 3 (n=35; P<0.001). Patient satisfaction was investigated a mean of 11 months after treatment. Percentages of asymptomatic patients in Group 1 and Group 2 were significantly higher than in Group 3 (P=0.02 and P=0.04, respectively).
                In the intermediate stage of CTS, SCT was an effective treatment to improve symptoms and functional status. Tendon and nerve gliding exercises alone were inferior to either SCT alone or SCT in combination with gliding exercises. To assess the application of autologous transplantation of granulocyte colony-stimulating factor (G-CSF)-mobilized peripheral blood mononuclear cells (PBMNCs) in the treatment of critical limb ischemia (CLI) of diabetic patients and to evaluate the safety, efficacy, and feasibility of this novel therapeutic approach.
                Twenty-eight diabetic patients with CLI were enrolled and randomized to either the transplant group or the control group. In the transplant group, the patients received subcutaneous injections of recombinant human G-CSF (600 microg/day) for 5 days to mobilize stem/progenitor cells, and their PBMNCs were collected and transplanted by multiple intramuscular injections into ischemic limbs. All of the patients were followed up after at least 3 months.
                At the end of the 3-month follow-up, the main manifestations, including lower limb pain and ulcers, were significantly improved in the patients of the transplant group. Their laser Doppler blood perfusion of lower limbs increased from 0.44 +/- 0.11 to 0.57 +/- 0.14 perfusion units (P < 0.001). Mean ankle-brachial pressure index increased from 0.50 +/- 0.21 to 0.63 +/- 0.25 (P < 0.001). A total of 14 of 18 limb ulcers (77.8%) of transplanted patients were completely healed after cell transplantation, whereas only 38.9% of limb ulcers (7 of 18) were healed in the control patients (P = 0.016 vs. the transplant group). No adverse effects specifically due to cell transplantation were observed, and no lower limb amputation occurred in the transplanted patients. In contrast, five control patients had to receive a lower limb amputation (P = 0.007, transplant vs. control group). Angiographic scores were significantly improved in the transplant group when compared with the control group (P = 0.003).
                These results provide pilot evidence indicating that the autologous transplantation of G-CSF-mobilized PBMNCs represents a simple, safe, effective, and novel therapeutic approach for diabetic CLI.
There is evidence to favour SCS over standard conservative treatment alone to improve limb salvage and clinical situations in patients with NR-CCLI. The benefits of SCS must be considered against the possible harm of relatively mild complications and the costs.