137 consecutive patients with known ankle pressures and diabetic status had attempted femoro-popliteal dilatation for lower limb ischaemia in an English provincial teaching hospital. All except one were followed until failure or death to assess survival and amputation rates. Non-diabetic patients with critical limb ischaemia had a 5 year survival rate of 62.2% (SE 17.1) compared to 50.5% (SE 7.0) for claudicants, with no significant difference on logrank testing. Diabetics had a relative risk of amputation of 11.2 compared to nondiabetics. Patients with pre-treatment ankle pressures of 50 mm or less had a relative risk of amputation of 2.6 compared to those with higher resting pressures. It is concluded that angioplasty should be the treatment of first choice in critical lower limb ischaemia whenever it is technically possible. Including patients with rest pain in the critical ischaemia group does not significantly affect cumulative patency rates.
Eight catheters from five manufacturers have been subjected to tests which combined bending and tension. Three failure mechanisms have been identified. These included separation of the balloon from its proximal attachment to the shaft, fracture of the shaft at its junction with the balloon, and undue ductility of the shaft. It is concluded that good catheter design should ensure that there is no sudden change in stiffness along the length of the catheter, and that the optimum relationship of ductility to stiffness has not yet been defined for catheters. Recommendations relating to these characteristics could be included in the British Standards relating to angioplasty balloon catheters.
The pathophysiological response to peripheral percutaneous transluminal balloon angioplasty in 20 patients was investigated using 111-Indium labelled platelets. Platelet deposition was quantified by measuring the degree of radioactivity uptake at angioplasty and control sites using a computer linked system and expressing the uptake as a ratio of angioplasty/control. Following platelet labelling, scans were performed before angioplasty and at 1, 24 and 48 h after angioplasty. To assess patency of the angioplasty, ankle brachial Doppler pressure indices were performed and supported by repeat angiograms if doubt of patency existed. All patients were followed-up at 1 week, 1 month and 6 months to correlate the degree of early platelet uptake with failure. The mean +/- sem platelet radioactivity ratio at the angioplasty site increased from 1.1 +/- 0.1 prior to the procedure to a peak of 2.1 +/- 0.3 at 1 h (p less than 0.01), 1.6 +/- 0.2 at 24 h (p less than 0.05), and 1.7 +/- 0.3 at 48 h (p less than 0.05). Angioplasties that failed within 6 months tended to have a higher maximum early platelet uptake (3.1 +/- 0.6) compared to successful angioplasties (1.9 +/- 0.3) but the difference was not significant in the numbers studied. This study provides a suitable model to assess the role of platelet accumulation in angioplasty failure and the influence of various antiplatelet regimes.
A prospective study of 370 patients who underwent 500 percutaneous transluminal angioplasties (PTAs) for lower-limb ischemia over a 7-year period was performed. A 97% follow-up rate was achieved. The first PTA was successful in 188 patients (51%). Of the failures, 31% were failed attempts at dilation and 73% occurred within 1 month of intervention. Of the patients with failed PTA, 39% underwent bypass surgery and 24% underwent amputation. The 30-day mortality rate was 3%, with 1% of the deaths attributed to PTA. The survival rate at 5 years for the successes was double that for the failures (P less than .0005). The best results were in femoropopliteal stenoses with two or three patent calf vessels (cumulative patency rate, 78% at 3 years) and the worst in femoropopliteal occlusions with one or no patent calf vessels (cumulative patency rate, 25% at 3 years). Log rank tests on the life-table data were used to show factors favoring a good outcome. It is concluded that PTA is the treatment of first choice in suitable patients and, although the failure of intervention in critical ischemia has a significant risk, it is a valuable addition to the therapeutic options in patients with little chance of surgical treatment.
A retrospective review of 63 patients undergoing duplex scanning and angiography for suspected carotid artery disease was performed to evaluate the need for routine angiography before carotid endarterectomy. A consultant surgeon (M.H.) made a simulated management decision on the basis of a clinical summary and a duplex scan report. Twenty-four patients were selected for surgery without angiography; duplex scanning had a sensitivity of 100 per cent and a specificity of 90 per cent in the detection of internal carotid artery stenosis. In two cases duplex scanning misdiagnosed a total occlusion as a critical stenosis. Eighteen patients failed to meet the criteria for surgery and were referred for angiography. Twenty-one patients were selected for conservative treatment on the basis of the duplex scan report. Combining the surgical and conservative groups (45 patients), duplex scanning had a sensitivity of 96 per cent and specificity of 95 per cent for the detection of stenosis greater than 50 per cent. In the identification of a total occlusion, duplex scanning had a poor sensitivity of 50 per cent. These results suggest that routine angiography before carotid endarterectomy is unnecessary in selected patients but that a suspected occlusion should be confirmed by angiography.
A randomized trial was carried out in patients with occlusions of the femoro-popliteal artery to compare the passage of metal-tipped optical fibres with guide wires and catheters through the occlusions, prior to balloon angioplasty. The study was in a provincial English teaching hospital providing a vascular service for the area. Fifty patients were entered; 25 into the "laser" group and 25 into the "control" group. End points were (a) the success in passage through the occlusion and (b) the outcome 1 month after passage. Comparison of the groups showed no appreciable difference between the two methods with regard to age, sex, symptoms, incidence of diabetes, or previous myocardial infarctions. Successful passage through the occlusion followed by dilatation was achieved in 18 (72%) patients in the laser group and 20 (80%) in the control group. After 1 month, 13 (52%) arteries in the laser group were patent compared to 13 (57%) in the control group. Confidence limits for the difference in success of passage are -15% to +31%, and -24% to +33% for patency after 1 month. Since these limits include zero, it is unlikely that a longer trial would alter the difference between the two methods. The results suggest that the laser system currently in use is no better than conventional methods.
Eight millimetre diameter angioplasty balloon catheters of both the Gruntzig and Olbert types from five manufacturers have been tested in vitro to establish bursting pressures and the changes in maximum and deflated diameters following repeated inflations, both when free and within a restraining sleeve. Maximum inflated diameters were within 10% of that stated and all types of balloon except one burst at a pressure greater than the recommended value. Deflated diameters were approximately 1 mm greater than insertion diameters, which are much smaller in the Olbert type. All balloons became a little larger with each of the first few distensions, and became stiffer. The maximum diameter was reached and remained constant after 10-15 distensions. Distension within a latex sleeve did not change bursting pressures, and it is considered that results from unconstrained testing can be extrapolated to behaviour in vivo. Computer modelling and calculation of maximum stress resultants also showed that calculated longitudinal and circumferential stresses are unaffected by applied restrictions. It is concluded that balloon technology is steadily improving and it is suggested that British Standards should be established for dilatation balloon catheters. Amongst other factors these Standards should include maximum recommended inflation pressures that are at least 2 atm less than bursting pressures, whilst the stated maximum diameter should be for fully extended balloons, and should have a tolerance of more than +/- 10%.
Gruntzig balloon catheters from three manufacturers have been tested in vitro to establish a method of assessing the diameters and bursting pressures of inflated balloons. The method of testing and of measuring the inflated balloons is described. It was found that there were considerable variations in the behaviour of different balloons, and the relevance of this to arterial rupture is discussed. There were significant associations between the manufacturer and premature rupture of the balloon (p less than 0.01), and between co-axial construction of the catheter and overdistension of the balloon by more than 20% (p less than 0.01). The balloon length and the stated maximum diameter were not associated with either premature failure or overdistension.
The assessment of lesions involving the internal auditory canals and cerebellopontine angle has come to rely heavily on computed tomography (CT). The resolution of modern CT scanners is now comparable to that of complex movement conventional tomography, and CT has the advantage of demonstrating the soft tissue lesion and its intracranial extent, as well as any abnormality of the bone. The most common reason for radiography and CT scanning of this region is to look for an acoustic neurinoma in patients with sensineural hearing loss. Radiographs of the internal auditory canals should be requested before moving on to CT, since it is unusual to find an abnormality on CT if plain films are normal. Films are normally requested only when there is audiological evidence of sensineural hearing loss.
Digital subtraction angiography (DSA) allows the degree of arterial patency or stenosis to be rapidly quantified. We have assessed the accuracy with which a single-plane DSA system is able to quantify area patency by densitometric and geometric methods. Arterial phantoms were designed to test for systematic error; intra-arterial DSA images of critical lesions of the carotid bifurcation and the lower abdominal and peripheral vessels were used to determine intra- and interobserver reproducibility. The densitometric method, which was more accurate than the geometric method, had a mean systematic error of up to 4% and a mean intra-observer variability of about 15% (coefficient of variation). We have identified the principal sources of inaccuracy and ways in which it may be reduced.
Three hundred and twenty-three angioplasties (159 iliac; 164 femoro-popliteal) were performed for lower limb ischaemia on 253 consecutive patients from 1980-86. The mean resting ankle/brachial pressure index (ABPI) was increased at one month in open angioplasties as follows: Femoro-popliteal 0.56-0.82; iliac with open superficial femoral artery (SFA) 0.7-0.95; iliac with occluded SFA 0.52-0.63. Successful angioplasty virtually abolished the post-exercise fall in ABPI except for patients having iliac dilations when multisegment disease was present. At 5 years, cumulative patency was 72% for iliac angioplasty and 53% for femoro-popliteal angioplasty. The results of angioplasty were compared with operative arterial reconstructions during 1985. Eighty-eight (91%) of 96 surgical bypasses were alive and patent at hospital discharge and 44 (71%) of 62 angioplasties were patent at 1 month. There were many fewer complications with angioplasty which involved a much shorter hospital stay (2 days vs 16 days).