Chapter VIII
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RESULTS OF COMPRESSION SCLEROTHERAPY
There is no universally accepted standard by which the results of any method of treating chronic venous insufficiency can be assessed and compared with those obtained by other techniques. This is due in part to the wide variations which occur from one series to another in the acceptance of clinical features other than dilated veins and ulceration as being due to venous insufficiency. Thus, selection of cases presents an initial problem which immediately affects the criteria by which the assessment is to be made. The early results following treatment are not of great value in those patients treated by compression sclerotherapy since patients are not discharged until they are considered to have been cured. The assessment of results after five or more years is complicated by the difficulty of distinguishing between recurrent and new varicosities. For simplicity, we consider all varicosities which appear subsequent to treatment as recurrences, and hence these patients are included as being unsatisfactory.
Some results reported by other workers have been assessed by signs and symptoms (Mathiesen, 1953; McElwee & Maisel, 1947), but more frequently by the presence or absence of dilated veins on the leg (Agrifolio & Edwards, 1961; Dodd & Cockett, 1956; Maisel, Herringman & Greenstone, 1957; Sherman, 1964; Sigg, 1952). Thus comparison with the results of other forms of treatment, as reported in the literature, is difficult.
Sherman (1964), reporting the results of a series of 214 patients, found a satisfactory rate of 54%. The assessment was measured by the time taken for reflux filling to occur. The observation for reflux filling suggests the presence of at least one untreated incompetent perforating vein (Fegan, FitzGerald & Beesley, 1964). Maisel et al., (1957) reported satisfactory results in 97% of 114 patients. The assessment was made on the appearance of the leg, an excellent result (52%) indicating the presence of a few varicosities. Mathiesen (1953) surveyed 293 patients and achieved complete cure in 38% of the group and unmistakable improvement in 44%, giving s satisfactory result in 82%. Agrifolio & Edwards (1961) classified 316 patients into three groups; uncomplicated, complicated and post-thrombotic. Their assessment was either excellent, good or poor. An excellent result was one which required a few follow-up injections during the first post-operative year, a good result was one which required two or three follow-up injections each year, and a poor result was one with many recurrences. Their results were reported as 71% excellent and 24% good. Dodd & Cockett (1956) applied assessment methods similar to those of Agrifolio and Edwards. An unsatisfactory result indicated the recurrence of complications, and a satisfactory result was one which might require post-operative injections either occasionally or at frequent intervals. Philips (1964), reporting on 168 patients, classified excellent results (47%) as those with no residual signs or symptoms, results (31%) as those with no signs and occasional symptoms, fair results (18.4%) as those with some signs and symptoms present, and a bad result as one with no relief. Sigg (1952), reporting on 100 patients after injection treatment for severe varicosities, obtained 32% cure rate, with a further 39% who did not require more treatment.
These reviewed reports cover a survey period of between eighteen months and eight years. The sizes of the groups mentioned varied from 100 patients to 416 patients. The satisfactory results obtained by these workers mostly fall between 70 and 90% and this percentage range appears to be the accepted level. The assessment standards, however, show very great variation. The most frequent standard used is the presence or absence of dilated veins on the leg (Agrifolio & Edwards, 1961; Dodd & Cockett, 1956; Sherman, 1964). Although these may be the most obvious clinical features, they are often a misleading indication of the severity of the condition. The necessity for follow-up injections after various surgical procedures has not been used to classify the results of operations as unsatisfactory by some authors even when injections are required on a number of post-operative visits (Agrifolio & Edwards, 1961; Dodd & Cockett, 1956).
In an attempt to overcome these problems a survey was carried out in 1963 of the patients who attended the clinic at Sir Patrick Dun's Hospital during the period 1951 to 1961. In all, 1171 patients attended for review out of a total of 1900 who has been treated.
In order to test if the 1171 patients formed a representative sample of the 1900 patients asked to attend, the first 100 patients attending the clinic for each of three consecutive years were questioned in their homes. Some of these patients included those who attended the hospital on request, and the others were those who had failed to keep their review appointment. The result of this questioning were so similar to the 1171 patients that the surveyed group was considered representative .
The patients were interviewed by an independent worker with regard to the following points:
1. Cramp in the legs at night.
2. Swelling of the legs or ankles.
3. The presence of large distended veins on the leg.
4. Tiredness or heaviness of the legs.
5. Pain in the legs.
6. Ulceration of the legs.
7. The presence of a rash on the legs.
8.The presence of thrombophlebitis.
The history of the patient at the time of treatment was referred to at each interview in relation to these signs and symptoms.
The results of the interviews were subsequently programmed and analysed by a computed. This analysis resulted in forty combination groups. The results of the computer analysis were submitted to statistical testing to show the results of the treatment, and the importance of two of the factors, compression and ambulation.
The patients were asked for an opinion about the general condition of their legs and the replies recorded as above. The patients were asked if they had worn their bandages continuously during treatment until told to remove them, whether they had found difficulty due to loosening or slipping in keeping these on, and if they had worn an elastic stocking over the bandages. The female patients were also asked if they had been pregnant at the time of treatment, whether they had had any subsequent pregnancies, and if so, how many.
TABLE 4 - Available on request, E-mail: fegan@fegan.com
Table 4 shows the results of treatment on all patients, both male and female, classified by signs and symptoms. The total for 'numbers treated' (4519) differs from the total number of patients surveyed (1171), since most of them suffered from at least two of the signs or symptoms. The average cure rate for sign or symptom groups is statistically weighted by the number of patients in that particular group. The overall satisfactory result assessed by this method for 1171 patients, both male and female, was 79.7%.
TABLE 5 - Available on request, E-mail: fegan@fegan.com
Table 5 illustrates the overall scores for each of the years surveyed. In the years 1958 and 1959 the unsatisfactory rate was raised, and this was believed to be due to the increase in size of the clinic. In 1960 the employment of extra staff improved the situation. It can be seen that there was no increase in the unsatisfactory rate over the years; the failure rate was similar for each year.
The name of the therapy, continuous compression sclerotherapy, implies the fundamental importance of adequate compression of the leg during treatment. The sample was divided into those patients who maintained 'good compression', and those who had 'bad compression'. Those who kept on their bandages and elastic stockings continuously until told to remove them were classified as having had good compression. It was found that good compression produced a significant improvement in the overall score.
In general, the difference in the results of treatment between patients who had good rather than bad compression was greater than between good and bad walkers, though the overall difference was statistically significant in both cases. The individual signs and symptoms most affected by difference in compression are oedema, the presence of large distended veins on the leg, and tiredness of the legs.
The results reported in this survey cover a large group of patients (1171) over a period of seven years. They have all been treated by the same method, and assessed by the overall results of treatment on individual signs and symptoms.
By these assessment standards, compression sclerotherapy gave an overall average satisfactory score of 79.7% of signs and symptoms for the whole group of patients, 85.1% of signs and symptoms in those who maintained good compression and walked regularly. Altogether 81.8% of the patients reviewed were satisfied with the results of treatment and considered themselves to be cured. Thus it is clear that, provided the technique is carefully carried out, compression sclerotherapy as practised in the Dublin Clinics produces a clinical result which compares favourably with any other method of treating chronic venous insufficiency.
References
Agrifolio, G. & Edwards, E. A. (1961). J.A.M.A. 178, 906.
Dodd & Cockett, F. B. (1956). The Pathology and Surgery of the Veins of the Lower Limb. London: Livingstone.
Fegan, W. G., FitzGerald, D. E., & Beesley, W. H. (1964). Amer. Heart Jour. 68, 757.
Massell, T. B., Heringman, E. C. & Greenstone, S. (1957). Arch. Surg. 74, 112.
Mathiesen, F. R. (1953). Acta. Chir. Scand. 105, 376.
McElwee, R. S. & Maisel, B. (1947). Ann. Surg. 126, 350.
Phillips, R. S. (1964). Scot. Med. J. 9, 335.
Sherman, R. S. (1964). Ann. Surg. 120, 772.