Role of Gritti-Stokes amputation in peripheral vascular disease.

The perigenicula lower limb amputations performed for peripheral vascular disease in Nottingham between April 1987 and September 1992 were reviewed. Of the 434 amputations, 173 were below-knee amputations (BKA), 144 Gritti-Stokes amputations (GSA) and 117 above-knee amputations (AKA). The 30-day mortality was significantly greater for AKA patients than either GSA or BKA patients. There was no difference in mortality within 30 days of amputation between GSA and BKA. Re-amputation rate to a more proximal level was significantly higher in BKA compared with GSA. Mobility after prosthetic rehabilitation was assessed using the Stanmore grading. A greater number of patients achieved mobility grade III and above in the GSA and BKA groups when compared with the AKA group, but there was no significant difference between GSA and BKA groups. At follow-up, a median of 23 months after amputation, there was a tendency for more patients to have given up using their limb prosthesis in the GSA group than either the BKA or AKA groups. However, there remained no significant difference between the BKA and GSA groups in the numbers of patients who remained successfully rehabilitated to Stanmore grade III or above. When a BKA is not possible, GSA offers a better prospect for rehabilitation compared with AKA in patients with occlusive arterial disease.

Assessment of wall structure and composition of varicose veins with reference to collagen, elastin and smooth muscle content.

OBJECTIVES: To compare collagen, elastin and smooth muscle contents of varicose and control long saphenous veins. DESIGN: Collagen, elastin and muscle were estimated stereologically using random sampling and histological staining. MATERIALS: Varicose vein samples were collected from nine patients (mean age 52 years, range 34-64 years) undergoing vein stripping, sample sites being saphenofemoral junction and knee. Control samples were taken from five patients (mean age 58 years, range 38-76 years) presenting for femoral-popliteal bypass at equivalent levels. METHODS: Veins were fixed, sectioned transversely, and stained with Picric Acid Sirius Red. Analysis of samples was performed using point and intersection counting on vertically projected images. RESULTS: Using two way analysis of variance tests, varicose saphenous veins had significantly larger wall areas (p < 0.01) and higher amounts of collagen (p < 0.01). Collagen content and wall area were significantly larger proximally compared to distally in both control and varicose veins (p < 0.05) with a higher content of smooth muscle and elastin in varicose veins proximally compared to distally (p < 0.05). There was no difference in wall thickness or elastin content between the two groups. CONCLUSIONS: This suggests that varicose veins are a dynamic response to venous hypertension and are not thin walled structures as previously thought.

Prospective randomised comparative study of pulse spray and conventional local thrombolysis.

OBJECTIVES: To compare the time required to achieve lysis with the pulse spray technique and the conventional slow continuous infusion technique. DESIGN: Prospective randomised open Study. METHODS: Eighteen patients suitable for intra-arterial thrombolytic therapy with conventional and pulse spray technique were randomised 1:1 to receive either pulse spray thrombolysis with 0.33 mg/ml rt-PA injected as a bolus of 0.2 ml or conventional thrombolysis with 0.05 mg/ml rt-PA infused at a rate of 10 ml/h. RESULTS: The age, duration of symptoms, length of occlusion and prethrombolysis ankle brachial pressure index were comparable in the two groups. The median duration of thrombolytic therapy in the pulse spray group was 195 min (range 90-1260) compared to 1390 min (range 300-2400) in the Conventional group. The difference between the two groups was significant, p < 0.002 (Mann-Whitney test). CONCLUSIONS: Significantly shorter time is required to achieve local thrombolysis with pulse spray compared to the conventional infusion method.

Carbon dioxide: an alternative to iodinated contrast media.

OBJECTIVES: To study the use of carbon dioxide as a contrast medium for arteriography. METHODS: Carbon dioxide was used as a contrast medium for intra-arterial digital subtraction lower limb angiography in 12 examinations on 11 patients. RESULTS: No complication was encountered and no significant changes occurred in the arterial pH, PaCO2 and PaO2. The quality of images as assessed by an independent observer was adequate for the majority of the vessels (77%). CONCLUSIONS: Carbon dioxide is a safe alternative in patients at an increased risk of adverse reaction to iodinated ionic or non-ionic contrast medium and is very cheap.

How successful is varicose vein surgery? A patient outcome study following varicose vein surgery using the SF-36 Health Assessment Questionnaire.

OBJECTIVE: Assessment of outcome after varicose vein surgery. DESIGN: Prospective study using the Health Assessment Questionnaire (SF36) which considers different aspects of overall health. SETTING: University Hospital and Community. MATERIALS: 150 patients undergoing varicose vein surgery. CHIEF OUTCOME MEASURES: SF36 questionnaires were sent pre-operatively and at 1 and 6 months post surgery. MAIN RESULTS: Eighty-nine (59%) patients answered all three questionnaires. Pre-operatively their overall health was similar to that of the general population. The "cost" to the patient of the operation was demonstrated by an increased pain and reduced role function at 1 month post-operation (p < 0.01). By 6 months post-operation, when compared with preoperative values, all dimensions except social function and health perception were improved (p < 0.01). Overall symptoms improved (p < 0.01) by 1 month and were further improved at 6 months. CONCLUSIONS: The general good health of varicose vein patients may justify the low priority given to their treatment, but the improvement in symptoms and general health that relatively simple surgery provides should ensure its continued provision as a health care service.

Immediate and early follow-up results of purse spray thrombolysis in patients with peripheral ischaemia.

Pulse spray thrombolysis is a technique of accelerated peripheral thrombolysis which has been evaluated in 38 patients, 29 with threatened limb viability and nine with a viable but critically ischaemic limb. The median length of occlusion was 26.5 (range 3-65) cm. The lytic agent used was recombinant tissue plasminogen activator (rtPA), injected manually via a pulse spray catheter at a concentration of 0.33 mg/ml and a bolus size of 0.2 ml. The median total dose of rtPA was 18 (range 5-35)mg. Patency and flow were completely restored in 34 of 38 patients and clinical success at 30 days was maintained in 27 of 38. The median lysis time was 120 (range 35-1125) min, compared with a median duration of 1545 (range 42-5760) min in 120 consecutive patients previously treated with conventional low-dose infusion thrombolysis using rtPA. This represents a 12-fold reduction in lysis time (P < 0.001). The overall estimated cumulative limb salvage rate for the 38 patients who entered the study was 84 per cent and the cumulative patency rate for the 34 patients in whom patency was restored was 74 per cent at 18 months follow-up. Pulse spray thrombolysis rapidly restores patency with good limb salvage at 30 days; the benefit is sustained even in patients with limbs at immediate risk of irreversible ischaemic injury who are not considered suitable for conventional thrombolysis.

Experience with pulse-spray technique in peripheral thrombolysis.

Pulse-spray thrombolysis (PST) is a new technique of accelerated peripheral arterial thrombolysis. This technique has been evaluated on 24 patients with limb ischaemia. Severe acute limb-threatening ischaemia with sensory and motor deficit was present in 11/24 (45.8%) patients. The median dose of recombinant tissue plasminogen activator (rt-PA) used was 18 mg (10-35 mg) injected in a concentration of 0.33 mg/ml and bolus size of 0.2 ml. The median length of occlusions treated was 23 cm (range 4-55 cm). Complete initial lysis was achieved in 23/24 (95.8%) and limb salvage at 30 days was achieved in 18/24 (75%) of the cases. The overall 30-days mortality was 4/24 (16.6%) and 2/4 (50%) in those who required surgical intervention. The median duration of thrombolytic treatment was 137.5 minutes (range 35-1125 minutes) which is an 11-fold and significant reduction (p < 0.001, Mann-Whitney) in lysis time compared with the results of conventional low dose infusion of rt-PA at a rate of 0.5 mg/h in 120 consecutive patients in our unit. PST rapidly restores vascular patency and may become the treatment of choice for acute limb ischaemia including those at immediate risk of irreversible ischaemic injury which would not be considered suitable for conventional thrombolysis.

Obesity as a risk factor in major reconstructive vascular surgery.

In a prospective analysis of 150 consecutive major vascular reconstructions, 104 patients were of normal weight (NW), 33 were overweight (OW) and 13 were obese (OB), as defined by body mass index calculations (BMI = kg/m2). Wound infections were more common in OW than NW patients (10/33 versus 10/104, p < 0.01) and in the OB compared to the NW group (4/13 versus 10/104, p < 0.05). Wound dehiscence was more common in the combined OW and OB groups than the NW patients (3/46 versus 0/104, p < 0.01). Chest infections were more common in OB (4/13) than NW (9/104) patients (p < 0.02). Median (interquartile range) in-patient stay was longer in OB patients [34 (15-41) days] compared to OW [14 (10-19) days, p < 0.001] and NW [11 (8-15) days; p < 0.001] patients. Nonetheless, there were no significant differences in the rates of more major complications or operative mortality between the three groups and early infrainguinal graft patency and limb salvage rates were not different. Only one prosthetic graft infection occurred in this series. In conclusion, despite the higher risk of infective complications, major vascular reconstruction can be performed safely in overweight and obese patients.

Peripheral arterial thrombolysis: intermediate-term results.

To determine the intermediate-term results of intra-arterial thrombolysis, 127 consecutive patients receiving 129 courses of treatment were reviewed at a median follow-up of 3 years. At initial review, 30 days after treatment, thrombolysis was successful in 63 cases (49 per cent). Of these patients, 16 were lost to follow-up: 15 died without further vascular symptoms and one moved from the area. Some 35 patients were alive and asymptomatic, of whom 33 had either angiographic or clinical evidence of continued arterial patency. Symptomatic reocclusion occurred in 12 cases; a further two patients remained asymptomatic and reocclusion was detected at follow-up. Two of the 12 symptomatic patients required amputation. Estimated patency rates were 80 per cent at 1 year, 72 per cent at 2 years and 70 per cent at 3 years. The intermediate-term results in the 66 cases in which lysis was unsuccessful were worse, only 16 patients (24 per cent) surviving to follow-up with the treated limb intact. It is concluded that, if thrombolysis is successful at 30 days, the intermediate-term results are good.

Postoperative limb compression in reduction of haemorrhage after varicose vein surgery.

In varicose vein surgery, significant postoperative morbidity results from subcutaneous haematoma formation and limb swelling after saphenous vein stripping. We investigated the effectiveness of a high-compression short-stretch adhesive bandage compared with non-adhesive crêpe in reducing haemorrhage after stripping of varicose veins. Using 99mTc-labelled red blood cells, the degree of postoperative bleeding was assessed in 10 patients with bilateral varicose veins allocated for stripping and ligation. High-compression adhesive bandaging was applied to the experimental limb and a non-adhesive bandage to the contralateral control limb. Results show that adequate compression bandaging can decrease subcutaneous haematoma formation after stripping of varicose veins.

A study of the use of the thromboxane A2 antagonist, sulotroban, in combination with streptokinase for local thrombolysis in patients with recent peripheral arterial occlusions: clinical effects, platelet function and fibrinolytic parameters.

In peripheral thrombolysis adjuvant anti-platelet therapy may help to lyse otherwise resistant thrombus, thereby increasing the number of patients successfully treated and reducing the "time to lysis". If continued after lysis it may help to prevent early rethrombosis. In this pilot study 21 patients undergoing peripheral thrombolysis with streptokinase were randomised to receive the thromboxane receptor antagonist sulotroban or placebo. The dose of sulotroban given was 2 mg/min (four patients), 4 mg/min (five patients) or 8 mg/min (four patients), eight patients received placebo. The clinical and laboratory effects of the treatment were monitored. Thrombolysis was achieved more quickly in patients receiving sulotroban, however, there was no difference between groups in the number of patients in whom recanalisation was achieved (six of eight receiving placebo and eight of 13 receiving sulotroban) or in the number of cases of early rethrombosis. During lysis there was an increase in plasma beta-thromboglobulin with similar levels being found in patients receiving sulotroban and streptokinase and those receiving streptokinase alone. No other major changes in platelet function during lysis were seen in patients receiving streptokinase alone. Sulotroban significantly reduced platelet aggregation and 14C-5HT release in response to several platelet agonists. With the thromboxane mimetic U46619 the degree of inhibition of aggregation and 14C-5HT release depended on the dose of sulotroban used. High levels of inhibition were associated with an excess of haemorrhagic complications especially in combination with a low plasma fibrinogen level. We conclude that the use of low dose sulotroban in combination with streptokinase merits further study and may hve a role in accelerating lysis.(ABSTRACT TRUNCATED AT 250 WORDS)

Recombinant tissue-type plasminogen activator is superior to streptokinase for local intra-arterial thrombolysis.

The results of local intra-arterial thrombolysis in 98 patients treated with streptokinase and 69 patients treated with recombinant tissue plasminogen activator (rtPA) have been compared. The two groups of patients were well matched and their treatment protocols were identical except with regard to the thrombolytic agent used. Strict criteria for defining successful thrombolysis were used. Successful lysis was achieved in 40 of 98 patients (41 per cent) receiving streptokinase and 40 of 69 patients (58 per cent) receiving rtPA (P less than 0.05). The time to lysis was significantly shorter with rtPA, median time 22 h, than with streptokinase, median time 40 h (P less than 0.002). There was no difference in the incidence of haemorrhagic complications. These results suggest that rtPA is superior to streptokinase for local intra-arterial thrombolysis.

Detection of left heart thrombus by echocardiography is not essential before peripheral arterial thrombolysis.

Left heart thrombus has been regarded as a contraindication to thrombolysis. In this prospective study the role of echocardiography before thrombolysis in the cardiac assessment of 51 patients undergoing thrombolysis for a peripheral arterial occlusion was evaluated. Ten patients with positive echocardiograms were identified. Echocardiography contributed to the diagnosis of embolus in one patient. All eight patients with embolic arterial occlusions were successfully recanalized, comparing favourably with a success rate of 58% in patients with thrombotic occlusions. There were no embolic complications during thrombolytic treatment or in the subsequent 30 days. We conclude that thrombolysis can be performed safely despite the presence of left heart thrombus.

Fibrinolytic enhancement with a prostaglandin analogue iloprost.

Earlier workers have suggested a possible fibrinolytic effect using prostaglandin or prostaglandin analogues. Despite using maximum tolerated doses of the prostaglandin analogue Iloprost, we have been unable to demonstrate any significant effect on fibrinolysis in patients with stage IV peripheral vascular disease (Fontaine classification).

Detection and characterization of arterial thromboses using a platelet-specific monoclonal antibody (P256 Fab').

Arteriography does not reliably distinguish between acute and chronic arterial occlusions. Seventeen patients with acute lower limb ischaemia were investigated by arteriography and by imaging with a platelet-specific monoclonal antibody (P256 Fab'); 20 MBq 111In-labelled P256 Fab' was administered intravenously and patients were imaged at intervals of between 20 min and 24 h. Thirteen patients were subsequently treated with intra-arterial thrombolysis. In six the images showed foci of increased uptake of 111In-labelled P256 Fab' and the corresponding arterial segment was recanalized. Patency to 30 days was maintained in four cases. Seven patients had negative scans, only four of whom achieved lysis, and two of these suffered early rethrombosis. The remaining four patients were excluded from thrombolysis by the arteriographic appearances. 111In-labelled P256 Fab' imaging can identify sites of acute arterial thrombosis and may have clinical applications in the management of peripheral vascular disease. Further studies are required to test whether the technique has a role to play in patient selection for thrombolysis.

Randomized trial of intra-arterial recombinant tissue plasminogen activator, intravenous recombinant tissue plasminogen activator and intra-arterial streptokinase in peripheral arterial thrombolysis.

Sixty patients were recruited into a randomized parallel group comparison of three thrombolytic regimens for acute or subacute peripheral arterial thrombosis. There were no significant differences in age, duration of history, length of occlusion or presence of neurosensory deficit between the groups. Initially successful lysis was significantly greater with intra-arterial (IA) recombinant tissue plasminogen activator (rt-PA) than with either streptokinase (Sk) (P less than 0.04) or intravenous (IV) rt-PA (P less than 0.01). The duration of therapy varied from a median of 35 h with IA rt-PA to 40 h with Sk (P greater than 0.5). The median (confidence interval) increase in ankle:brachial pressure index following IA rt-PA of 0.57 (0.33-0.82) was significantly higher than for either Sk of 0.24 (0-0.57) or for IV rt-PA of 0.18 (0-0.41). Limb salvage at 30 days was achieved in 80, 60 and 45 per cent respectively for IA rt-PA, Sk and IV rt-PA. Haemorrhagic complications occurred in six patients following Sk and in 13 following IV rt-PA; only one minor haemorrhage occurred following a catheter perforation in a patient who received IA rt-PA (P less than 0.05). IA rt-PA provides a more effective, safer fibrinolytic regimen than conventional therapy with Sk. IV rt-PA has not been as successful and carries a significantly higher risk of haemorrhagic complications.

Double-blind randomized trial of perioperative fibrinolytic enhancement for femoropopliteal bypass.

Patients with rest pain or acute peripheral arterial thrombosis are known to have impaired endogenous fibrinolysis, which is associated with an increased risk of early vascular graft thrombosis. This risk is exacerbated by the fibrinolytic shutdown which is known to occur after major surgery. Stanozolol, which has been demonstrated to enhance endogenous fibrinolysis, was therefore used in an attempt to prevent this perioperative fibrinolytic shutdown and so enhance graft patency. Twenty-seven patients were randomized to receive either 50 mg stanozolol or placebo intramuscularly 24 h before operation, followed by a 6 week course of either 5 mg stanozolol or placebo orally, twice daily. On the second day after operation, 10-11 MBq of autologous 111indium-labelled platelets were injected, with scanning over the graft on the 3 following days. Despite using a large depot of stanozolol, significant effects, such as raised plasminogen (P less than 0.001), reduced fibrinogen (P less than 0.001) and reduced euglobulin lysis time (P less than 0.001), were not seen until the seventh day after operation, with maximum benefit at 6 weeks. This was reflected in the 111indium-labelled platelet deposition studies. The placebo group had a progressive increase in platelet deposition on all 3 days. In contrast, those receiving stanozolol showed a lower, static picture of deposition. However, these changes did not attain statistical significance. Three patients experienced early graft thrombosis, two in the placebo group and one in the stanozolol group. Only an incomplete inhibition of the perioperative fibrinolytic shutdown was achieved. Much longer preoperative courses are thus required to allow the maximum effect to be present at the most crucial time. At present, perioperative fibrinolytic enhancement does not appear to be a practical proposition, and we must await the development of new safer and more potent agents.

Acute critical ischaemia of the limb: a prospective evaluation.

A total of 119 patients with acute peripheral arterial ischaemia were studied prospectively to validate the definition of acute critical ischaemia suggested by the working party of the International Vascular Symposium. The majority of the patients had primary treatment using thrombolytic therapy. Overall limb salvage after 30 days was achieved in 56% of the patients, 19% required amputations and 25% died. Comparisons of the outcome in patients with or without a distal neurosensory deficit (limb salvage 30% vs. 72%, P = 0.0001) and those with absent or audible Doppler ankle blood flow (limb salvage 37% vs. 78%, P = 0.0001) confirmed that the severity of the initial ischaemia was a significant indicator of prognosis. The definition of acute critical ischaemia as assessed by objective measurement of Doppler pressures has been validated and can be used to divide patients into groups with critical and sub-critical ischaemia with different prognoses.