The Fate of Patients with Intermittent Claudication Managed Nonoperatively Ferdinand F. McAllister, MD, New York, New York
Although we have performed reconstructive surgery for occlusive arterial disease for twenty-five years, our knowledge of the fate of patients managed nonoperatively is scanty. Boyd’s studies [I] of the natural course of arteriosclerosis of the lower extremities are an exception, but as recently as 1970 Kannel et al [2], reporting the Framingham experience with patients afflicted with intermittent claudication, stated “the natural history of peripheral occlusive disease needs to be better defined.” To add further to our knowledge, a study of patients with intermittent claudication followed from one to eighteen years is presented. By the end of the 1950s our early enthusiasm [3] for reconstructive surgery in segmental occlusive disease had become tempered by disappointing five year patency rates [4,5] and occasional but rare loss of leg after acute occlusion of a previously well functioning graft [6,7]. Additionally, some studies [8,9] suggested that obstruction might have a retardant effect on the progression of distal arteriosclerosis. Accordingly, stricter criteria for operation were established, and intermittent claudication alone without progressive disease, rest pain, threatened or actual gangrene, interference with ability to earn a living, or other grave cause was not considered an adequate indication for surgery. With such criteria, those who required operation usually came to surgery within one year. This left a number of patients whom we have followed for many years, and we have been concerned that our approach might have been overly conservative, perhaps causing us to miss opportunities for reconstruction and thus to have lost legs unnecessarily. With this in mind 100 consecutive cases from my private files were chosen for review. Material and Methods
Sixty-nine males and thirty-one females were followed from one to eighteen years with an average follow-up of six years. Eighty-nine of the patients had femoropopliteal occlusive lesions, of whom twenty-six had some evidence
From the Department of Surgery, Columbia University College of Physicians and Surgeons and the Presbyterian Hospital, New York, New York. Reprint requests should be ad&essed to Ferdinand F. McAllister. MD, 161 Fort Washington Avenue, New York, New York 10032.
Volume 132, November 1976
of aortoiliac disease as well. Eleven patients had primary aortoiliac disease. Fifteen of the 100 patients had evidence of associated coronary disease and six had evidence of carotid disease. For the most part, the patients had intermittent claudication only and operation was not considered indicated according to our established criteria. However, a few patients qualified but refused or had insufficient runoff to justify it. Thirteen had mild claudication (4 or more blocks), fifty-nine had moderate claudication (1 to 4 blocks), and twenty-eight had severe claudication (1 block or less). The majority of patients were in the sixth and seventh decade of age (1 patient, 20 to 40 years; 9,40 to 50 years; 28, 50 to 60 years; 44,60 to 70 years; and 17,70 to 80 years). Twenty per cent were heavy smokers and 30 per cent were moderate smokers, so that exactly half of the group smoked. However, many additional patients had been smokers in the past but had given up the habit at the time of the first visit. Thirteen per cent of the patients were diabetic. An impressive 33 per cent exhibited hypertension (blood pressure greater than 190/100); average blood pressure for the entire group was 170/90. Only 16 per cent could be described as heavy or fat although many additional patients showed excessive abdominal and buttock fat. Lipid studies were inadequate because of reliance on word of mouth assurance by the referring doctor that the cholesterol and triglyceride levels were within normal limits. When confirmed data were available, the serum cholesterol level proved to be elevated in 29 per cent of patients. The patients were seen at from two to twelve month intervals. A history of stroke, transient cerebral ischemia, angina pectoris, or myocardial infarction was noted together with the walking tolerance. On examination a record was made of all pulses, presence or absence of murmurs over arteries, the oscillometric readings at the calf, color and temperature of the feet, degree of blanching on elevation, and more recently, changes elicited with the Doppler. The patients were instructed in the importance of exercise as a stimulus to the development of collateral circulation and were told to try to increase the total distance walked from day to day. However, they were told not to force exercise once pain appeared but to rest until free of pain, then resume walking. During winter months the patients were encouraged to use a stationary bicycle with their toes on the pedals. If overweight, they were instructed in a 1,500 calorie diet, and if the lipids were elevated, the patients were instructed in a low fat, low cholesterol diet.
593
McAllister
TABLE
I
Fate of 100 Patients with Claudication Technic
Tabulated
Intermittent
by Life Table
over 10 Years Year of Follqw-Up
12345678910 Number of patients Percentage improved Percentage stable Percentage worse
100
94
79
65
54
44
36
23
16
11
52
54
56
58
56
55
53
48
44
27
26
28
25
25
24
25
28
30
44
55
22
18
19
17
20
20
19 22 ---___
12
18
The usual protective measures as regards appropriate dress and care of the feet were stressed. The diabetic patients were urged to control themselves as strictly as possible to avoid spillage. Patients who smoked were instructed to give up tobacco completely and were directed to special clinics for this on request. Although arteriographic studies were performed on many of these patients, the results were not reported because repetitive studies were considered impractical, uncomfortable, expensive, and unrevealing of lesions developing in the upper part of the body. Results Forty-one of the patients were improved at the time of their last follow-up visit. Eleven additional patients were improved as regards the original complaint of claudication but showed evidence of
progression of atherosclerosis by the appearance of other lesions. Thus, a total of fifty-two patients or more than half were improved. An additional nineteen were classified as stable and seven were stable with progression of disease elsewhere. Thus, a surprising 78 per cent were either improved or stabilized. There is no bias in these results, as shown in Table I. The percentage of those who worsened is remarkably consistent during a ten year period, varying with one exception from 17 to 22 per cent. Up to seven years the number of patients improved and stable is also consistent, but after the seventh year there is a progressive increase in the number stable with a corresponding decrease in the number improved. Seven of the eleven patients with aortoiliac disease improved and three remained stable. One patient worsened during a six year interval and died after efforts at reconstruction. He had polycythemia and
progressed from left iliac stenosis to complete aortic occlusion to the renal artery level and bilateral femoropopliteal artery occlusions, eventually dying of acute thrombotic occlusion of the superior mesenteric artery and the celiac axis.
594
A total of eleven patients died, all of complications of atherosclerosis. Of fifty-six patients with femoropopliteal occlusion in one leg, twenty-two (39 per cent) went on to have a similar occlusion in the opposite leg after two to six years. Thirty-nine patients in all showed evidence of progression of atherosclerosis, in some cases at more than one site. In twenty-two instances lesions appeared in the opposite leg, in eleven in the distal small vessels, in eight in the coronary arteries, in seven in the carotids, and in five in the aortoiliac system. Twenty-two patients worsened due to progression of disease as follows: eleven due to further occlusion of the tibia1 and pedal arteries; eight due to the development of a more restrictive occlusion in the opposite leg; one due to extension of the occlusion in the original leg; and two due to progression of aortoiliac lesions. Seven of those who worsened came to amputation. Six of these had severe diabetes and two came to bilateral amputation despite efforts to salvage the legs with bypass grafting and lumbar sympathectomy. Only one patient without diabetes underwent amputation, an elderly male with arteriosclerosis who first refused reconstructive surgery and ultimately became inoperable because of obliteration of his tibia1 arteries. Of the twenty-two patients who worsened, six had diabetes, seven smoked, twelve had hypertension (blood pressures greater than 190/100), and sixteen led sedentary inactive lives. Sixteen patients underwent sympathectomy one to four years after initial examination: three improved, four became stable, and nine worsened. Four of the latter had diabetes and underwent amputation, and sympathectomy did not alter the outcome. The data are too scant to have significance. Comments It is apparent that intermittent claudication resulting from either femoropopliteal occlusion or aortoiliac occlusion may be a relatively benign condition if none of the graver signs or symptoms exist. A surprising number of patients may actually improve with appropriate management over a period of years and additional numbers may be stabilized. It should be pointed out, however, that this is: a selected group since most of the patients with more serious and progressive disease underwent operation within a year and have not been included in this study.
The American Journal of Surgery
Intermittent
This tendency to improve through the development of increased collateral circulation may explain the fact that some patients have appeared to do well or improve after grafting even though the graft has obviously thrombosed. It is probable that they would show improvement had no surgery been performed. It is also probable that in such individuals the grafts became occluded slowly so that previously established collateral circulation had time to redevelop. It has been suggested that after a functioning graft has been in place, it somehow causes lasting improvement in the distal circulation. However, this is contrary to our data which indicate that: (1) collateral circulation exists in response to need and rapidly regresses after a functioning graft is inserted [5]; (2) the caliber of the arteries distal to an occlusion decreases [6], which would be the case when the graft becomes occluded; and (3) there is no evidence, other than the contrary, that the presence of a functioning graft arrests or stabilizes distal disease [6,8]. Thus, it is probably no specific effect of the graft but the progressive expansion of the collateral in response to need which accounts for improvement. The fact that this group of patients has done reasonably well is reassuring for it does not appear that we have caused individuals to lose legs by withholding operation. Regarding quality of life, the majority have not seemed too unhappy with their limitation and many have found that the discipline of enforced diet and of regular exercise has made them feel generally healthier. However, since our recently recorded series [IO] of femoropopliteal bypass grafts shows that in only 3 per cent have we caused individuals to lose legs after graft failure, it is probable that we could liberalize our indications to include more patients with claudication exhibiting negligible improvement on conservative management. The amputation rate of 7 per cent is the same as that of Boyd [I], but he did not record the incidence of diabetes. Our study suggests that in the absence of diabetes the amputation rate is closer to 1 per cent. Our incidence of progression of atherosclerosis during an average six year observation period was 39 per cent, which is again similar to that of Boyd [I] who claimed 20 per cent incidence of additional thromboses within five years and 40 per cent within ten years. It is reasonable to wonder why operation was withheld in the twenty-two patients who worsened. In the eight patients in whom more restrictive occlusion developed in the opposite leg, operation was
Vohmm 132. Novombu 1970
Claudication
still not deemed necessary because of the absence of grave signs. In the eleven in whom further occlusion of the tibia1 and pedal arteries developed, the runoff was unfavorable, but two patients had unsuccessful efforts at bypass grafting. Nine patients had lumbar sympathectomy. One patient with progressive aortoiliac disease died in the course of efforts at operative correction. The remaining two patients elected to continue on a nonoperative basis. Summary
Of 100 patients with intermittent claudication, followed an average of six years, a surprising 78 per cent either showed improvement or remained stable regarding the presenting complaint. However, 39 per cent showed evidence of further progression of atherosclerosis. In patients with femoropopliteal occlusion in one leg, almost 40 per cent had occlusion in the other leg after two to six years. The amputation rate was 7 per cent but six of these seven patients had severe diabetes. This study suggests that we are not causing limb loss by adhering to stringent criteria for bypass grafting. It also suggests that the patient with intermittent claudication without associated grave signs has a better than 50 per cent chance of improving and a better than 60 per cent chance that his disease will not show evidence of significant progression during a five to six year period. Such data should be taken into consideration when patients are considered for arterial reconstruction. References 7. Boyd AM: Natural course of arteriosclerosis of the lower extremities. Proc R Sot Med 55: 591, 7962. 2. Kant@ WB, Skinner JJ Jr, Schwartz MJ, Shurtliff D: Intermittent claudication-incidence in Framingham study. Circulation 47: 875, 7970. 3. McAllister FF: Experiences with replacement of diseased femoral and popliteal arteries. Surgery 38: 964, 7955. 4. Hoye SJ, Warren R: Follow-up studies of ileofemoral arterial reconstruction in arteriosclerosis obliterans. N Engl J Med 254: 102, 1956. 5. Dye WS, Grove WJ, Olwin JH, Julian OC: Two to four year behavior of vein grafts in the lower extremities. Arch Surg 72: 64, 7956. 6. Jacobson JH, McAllister FF: The harmful effect of grafting on existing collateral circulation. Surgery 42: 148, 7957. 7. Thompson RC Jr, Delbanco TL, McAllister FF: Complications following lower extremity amputation. Surg Gynecol Obsfef 720: 307, 7965. 8. McAllister FF: The effect of arterial occlusion on experimental atherogenesis. J Cardiovas Surg 7: 63, 7966. 9. Warren R, Gomez RL, Marston JAP, Cos JST: Femoro-popliteal arteriosclerosis obliterans. Surgery 55: 135, 7964. 70. Buda JA, Weber CJ, McAllister FF, Voorhees AB Jr: Factors influencing patency of femoropopliteal arterial bypass grafts. Am J Surg 732: 6, 7976.
595
Although we have performed reconstructive surgery for occlusive arterial disease for twenty-five years, our knowledge of the fate of patients managed nonoperatively is scanty. Boyd’s studies [I] of the natural course of arteriosclerosis of the lower extremities are an exception, but as recently as 1970 Kannel et al [2], reporting the Framingham experience with patients afflicted with intermittent claudication, stated “the natural history of peripheral occlusive disease needs to be better defined.” To add further to our knowledge, a study of patients with intermittent claudication followed from one to eighteen years is presented. By the end of the 1950s our early enthusiasm [3] for reconstructive surgery in segmental occlusive disease had become tempered by disappointing five year patency rates [4,5] and occasional but rare loss of leg after acute occlusion of a previously well functioning graft [6,7]. Additionally, some studies [8,9] suggested that obstruction might have a retardant effect on the progression of distal arteriosclerosis. Accordingly, stricter criteria for operation were established, and intermittent claudication alone without progressive disease, rest pain, threatened or actual gangrene, interference with ability to earn a living, or other grave cause was not considered an adequate indication for surgery. With such criteria, those who required operation usually came to surgery within one year. This left a number of patients whom we have followed for many years, and we have been concerned that our approach might have been overly conservative, perhaps causing us to miss opportunities for reconstruction and thus to have lost legs unnecessarily. With this in mind 100 consecutive cases from my private files were chosen for review. Material and Methods
Sixty-nine males and thirty-one females were followed from one to eighteen years with an average follow-up of six years. Eighty-nine of the patients had femoropopliteal occlusive lesions, of whom twenty-six had some evidence
From the Department of Surgery, Columbia University College of Physicians and Surgeons and the Presbyterian Hospital, New York, New York. Reprint requests should be ad&essed to Ferdinand F. McAllister. MD, 161 Fort Washington Avenue, New York, New York 10032.
Volume 132, November 1976
of aortoiliac disease as well. Eleven patients had primary aortoiliac disease. Fifteen of the 100 patients had evidence of associated coronary disease and six had evidence of carotid disease. For the most part, the patients had intermittent claudication only and operation was not considered indicated according to our established criteria. However, a few patients qualified but refused or had insufficient runoff to justify it. Thirteen had mild claudication (4 or more blocks), fifty-nine had moderate claudication (1 to 4 blocks), and twenty-eight had severe claudication (1 block or less). The majority of patients were in the sixth and seventh decade of age (1 patient, 20 to 40 years; 9,40 to 50 years; 28, 50 to 60 years; 44,60 to 70 years; and 17,70 to 80 years). Twenty per cent were heavy smokers and 30 per cent were moderate smokers, so that exactly half of the group smoked. However, many additional patients had been smokers in the past but had given up the habit at the time of the first visit. Thirteen per cent of the patients were diabetic. An impressive 33 per cent exhibited hypertension (blood pressure greater than 190/100); average blood pressure for the entire group was 170/90. Only 16 per cent could be described as heavy or fat although many additional patients showed excessive abdominal and buttock fat. Lipid studies were inadequate because of reliance on word of mouth assurance by the referring doctor that the cholesterol and triglyceride levels were within normal limits. When confirmed data were available, the serum cholesterol level proved to be elevated in 29 per cent of patients. The patients were seen at from two to twelve month intervals. A history of stroke, transient cerebral ischemia, angina pectoris, or myocardial infarction was noted together with the walking tolerance. On examination a record was made of all pulses, presence or absence of murmurs over arteries, the oscillometric readings at the calf, color and temperature of the feet, degree of blanching on elevation, and more recently, changes elicited with the Doppler. The patients were instructed in the importance of exercise as a stimulus to the development of collateral circulation and were told to try to increase the total distance walked from day to day. However, they were told not to force exercise once pain appeared but to rest until free of pain, then resume walking. During winter months the patients were encouraged to use a stationary bicycle with their toes on the pedals. If overweight, they were instructed in a 1,500 calorie diet, and if the lipids were elevated, the patients were instructed in a low fat, low cholesterol diet.
593
McAllister
TABLE
I
Fate of 100 Patients with Claudication Technic
Tabulated
Intermittent
by Life Table
over 10 Years Year of Follqw-Up
12345678910 Number of patients Percentage improved Percentage stable Percentage worse
100
94
79
65
54
44
36
23
16
11
52
54
56
58
56
55
53
48
44
27
26
28
25
25
24
25
28
30
44
55
22
18
19
17
20
20
19 22 ---___
12
18
The usual protective measures as regards appropriate dress and care of the feet were stressed. The diabetic patients were urged to control themselves as strictly as possible to avoid spillage. Patients who smoked were instructed to give up tobacco completely and were directed to special clinics for this on request. Although arteriographic studies were performed on many of these patients, the results were not reported because repetitive studies were considered impractical, uncomfortable, expensive, and unrevealing of lesions developing in the upper part of the body. Results Forty-one of the patients were improved at the time of their last follow-up visit. Eleven additional patients were improved as regards the original complaint of claudication but showed evidence of
progression of atherosclerosis by the appearance of other lesions. Thus, a total of fifty-two patients or more than half were improved. An additional nineteen were classified as stable and seven were stable with progression of disease elsewhere. Thus, a surprising 78 per cent were either improved or stabilized. There is no bias in these results, as shown in Table I. The percentage of those who worsened is remarkably consistent during a ten year period, varying with one exception from 17 to 22 per cent. Up to seven years the number of patients improved and stable is also consistent, but after the seventh year there is a progressive increase in the number stable with a corresponding decrease in the number improved. Seven of the eleven patients with aortoiliac disease improved and three remained stable. One patient worsened during a six year interval and died after efforts at reconstruction. He had polycythemia and
progressed from left iliac stenosis to complete aortic occlusion to the renal artery level and bilateral femoropopliteal artery occlusions, eventually dying of acute thrombotic occlusion of the superior mesenteric artery and the celiac axis.
594
A total of eleven patients died, all of complications of atherosclerosis. Of fifty-six patients with femoropopliteal occlusion in one leg, twenty-two (39 per cent) went on to have a similar occlusion in the opposite leg after two to six years. Thirty-nine patients in all showed evidence of progression of atherosclerosis, in some cases at more than one site. In twenty-two instances lesions appeared in the opposite leg, in eleven in the distal small vessels, in eight in the coronary arteries, in seven in the carotids, and in five in the aortoiliac system. Twenty-two patients worsened due to progression of disease as follows: eleven due to further occlusion of the tibia1 and pedal arteries; eight due to the development of a more restrictive occlusion in the opposite leg; one due to extension of the occlusion in the original leg; and two due to progression of aortoiliac lesions. Seven of those who worsened came to amputation. Six of these had severe diabetes and two came to bilateral amputation despite efforts to salvage the legs with bypass grafting and lumbar sympathectomy. Only one patient without diabetes underwent amputation, an elderly male with arteriosclerosis who first refused reconstructive surgery and ultimately became inoperable because of obliteration of his tibia1 arteries. Of the twenty-two patients who worsened, six had diabetes, seven smoked, twelve had hypertension (blood pressures greater than 190/100), and sixteen led sedentary inactive lives. Sixteen patients underwent sympathectomy one to four years after initial examination: three improved, four became stable, and nine worsened. Four of the latter had diabetes and underwent amputation, and sympathectomy did not alter the outcome. The data are too scant to have significance. Comments It is apparent that intermittent claudication resulting from either femoropopliteal occlusion or aortoiliac occlusion may be a relatively benign condition if none of the graver signs or symptoms exist. A surprising number of patients may actually improve with appropriate management over a period of years and additional numbers may be stabilized. It should be pointed out, however, that this is: a selected group since most of the patients with more serious and progressive disease underwent operation within a year and have not been included in this study.
The American Journal of Surgery
Intermittent
This tendency to improve through the development of increased collateral circulation may explain the fact that some patients have appeared to do well or improve after grafting even though the graft has obviously thrombosed. It is probable that they would show improvement had no surgery been performed. It is also probable that in such individuals the grafts became occluded slowly so that previously established collateral circulation had time to redevelop. It has been suggested that after a functioning graft has been in place, it somehow causes lasting improvement in the distal circulation. However, this is contrary to our data which indicate that: (1) collateral circulation exists in response to need and rapidly regresses after a functioning graft is inserted [5]; (2) the caliber of the arteries distal to an occlusion decreases [6], which would be the case when the graft becomes occluded; and (3) there is no evidence, other than the contrary, that the presence of a functioning graft arrests or stabilizes distal disease [6,8]. Thus, it is probably no specific effect of the graft but the progressive expansion of the collateral in response to need which accounts for improvement. The fact that this group of patients has done reasonably well is reassuring for it does not appear that we have caused individuals to lose legs by withholding operation. Regarding quality of life, the majority have not seemed too unhappy with their limitation and many have found that the discipline of enforced diet and of regular exercise has made them feel generally healthier. However, since our recently recorded series [IO] of femoropopliteal bypass grafts shows that in only 3 per cent have we caused individuals to lose legs after graft failure, it is probable that we could liberalize our indications to include more patients with claudication exhibiting negligible improvement on conservative management. The amputation rate of 7 per cent is the same as that of Boyd [I], but he did not record the incidence of diabetes. Our study suggests that in the absence of diabetes the amputation rate is closer to 1 per cent. Our incidence of progression of atherosclerosis during an average six year observation period was 39 per cent, which is again similar to that of Boyd [I] who claimed 20 per cent incidence of additional thromboses within five years and 40 per cent within ten years. It is reasonable to wonder why operation was withheld in the twenty-two patients who worsened. In the eight patients in whom more restrictive occlusion developed in the opposite leg, operation was
Vohmm 132. Novombu 1970
Claudication
still not deemed necessary because of the absence of grave signs. In the eleven in whom further occlusion of the tibia1 and pedal arteries developed, the runoff was unfavorable, but two patients had unsuccessful efforts at bypass grafting. Nine patients had lumbar sympathectomy. One patient with progressive aortoiliac disease died in the course of efforts at operative correction. The remaining two patients elected to continue on a nonoperative basis. Summary
Of 100 patients with intermittent claudication, followed an average of six years, a surprising 78 per cent either showed improvement or remained stable regarding the presenting complaint. However, 39 per cent showed evidence of further progression of atherosclerosis. In patients with femoropopliteal occlusion in one leg, almost 40 per cent had occlusion in the other leg after two to six years. The amputation rate was 7 per cent but six of these seven patients had severe diabetes. This study suggests that we are not causing limb loss by adhering to stringent criteria for bypass grafting. It also suggests that the patient with intermittent claudication without associated grave signs has a better than 50 per cent chance of improving and a better than 60 per cent chance that his disease will not show evidence of significant progression during a five to six year period. Such data should be taken into consideration when patients are considered for arterial reconstruction. References 7. Boyd AM: Natural course of arteriosclerosis of the lower extremities. Proc R Sot Med 55: 591, 7962. 2. Kant@ WB, Skinner JJ Jr, Schwartz MJ, Shurtliff D: Intermittent claudication-incidence in Framingham study. Circulation 47: 875, 7970. 3. McAllister FF: Experiences with replacement of diseased femoral and popliteal arteries. Surgery 38: 964, 7955. 4. Hoye SJ, Warren R: Follow-up studies of ileofemoral arterial reconstruction in arteriosclerosis obliterans. N Engl J Med 254: 102, 1956. 5. Dye WS, Grove WJ, Olwin JH, Julian OC: Two to four year behavior of vein grafts in the lower extremities. Arch Surg 72: 64, 7956. 6. Jacobson JH, McAllister FF: The harmful effect of grafting on existing collateral circulation. Surgery 42: 148, 7957. 7. Thompson RC Jr, Delbanco TL, McAllister FF: Complications following lower extremity amputation. Surg Gynecol Obsfef 720: 307, 7965. 8. McAllister FF: The effect of arterial occlusion on experimental atherogenesis. J Cardiovas Surg 7: 63, 7966. 9. Warren R, Gomez RL, Marston JAP, Cos JST: Femoro-popliteal arteriosclerosis obliterans. Surgery 55: 135, 7964. 70. Buda JA, Weber CJ, McAllister FF, Voorhees AB Jr: Factors influencing patency of femoropopliteal arterial bypass grafts. Am J Surg 732: 6, 7976.
595
