Annials of the Royal College of Surgeons of England (1979) vol 6i ASPECTS OF TREATMENT*
PTFE (Goretex) femoropopliteal reconstruction for limb salvage Charles A C Clyne FRCSt J A McVeigh FRCR M J Fox MD FRCS§ G H Jantet FRCS C W Jamieson MS FRCS Departments of Surgery and Radiology, Hammersmith Hospital, London
Summary We present the results of the use of polytetrafluoroethylene (PTFE, Goretex) grafts for limb salvage in 20 cases of femoropopliteal or more distal arterial reconstruction. There appears to be no relationship between graft survival and 'run-off' or the overall disease state of the vessels. Cumulative graft patency was almost 50% at 6 months, which is in contrast with higher patency rates reported from other countries.
Introduction Long bypass of extensive occlusion of the femoropopliteal arterial segment is often the procedure of choice in limb salvage. Frequently the long saphenous vein is unsuitable or absent owing to previous surgery, or the time taken for its removal may jeopardise the success of the operation or the life of the patient. There is, however, no satisfactory vein substitute for use below the inguinal ligament, but there have been encouraging reports from other countries on the use of polytetrafluoroethylene (PTFE) for limb salvage'-4. Introduced into Britain in 1976, Goretex is a fibrillated PTFE prosthetic vascular graft which appears to be of low thrombogenicity' and whose thin and flexible fibres allow tissue ingrowth to occur and hence form a satisfactory neointima' 7. There are no reports of its use in Britain as a substitute for vein in femoro-
popliteal bypass so we therefore felt justified in carrying out a trial of PTFE grafts for limb salvage in cases in which rest pain and tissue necrosis predominated.
Patients and methods Twenty patients aged between 50 and 83 (mean 67.7) years underwent grafting from the common femoral to more distal vessels with PTFE. Twelve patients had rest pain with ulceration or gangrene and the remainder suffered claudication after a few paces. In I case a femoropopliteal graft above the knee was carried out and in 2 femorotibial grafts were inserted, but the remaining 17 operations were femoropopliteal grafts below the joint line. Only 2 patients were diabetic. In 3 cases aortoiliac reconstructions and in 4 lumbar sympathectomy were carried out simultaneously. Eight patients had already undergone sympathectomy and 6 had previously undergone reconstructions of either the common femoral or profunda femoris artery. Two of the grafts were tapered, but the remainder were straight with an internal diameter of 6 mm. Anastomoses were carried out with a continuous polypropylene stuture. All patients were followed up by personal interview, physical examination, and Doppler assessment of ankle pressures to confirm graft patency'. Results
tPresent address: Department of Surgery, South- There were no operative deaths. Three of the ampton General Hospital, Southampton §Present address: The Lonidon Hospital, White- 0o patients died from unrelated causes, with their grafts patent, at 6, 7, and I 5 weeks rechapel, London Ei The Editor would welcome any observations on this paper from readers *Fellows aind Members interested in submitting papers for consideration with a view to publication in this series should first write to the Editor
302
Charles A C Clyne, J A McVeigh, M J Fox, G H Jantet, and C W Jamieson 100 r
75 %
0
F
graft
patency
Cumulative graf t patency prepared by the life table method.
50
25
4
8
12
20
16
24
28
32
time (weeks)
spectively. One patient has had a mild stroke and in another the graft became occluded while he was lying unconscious after an overdose. Two of the grafts failed within I4 days and review of the operative arteriograms suggests that technical problems may have existed at the distal anastomoses. Re-exploration failed to restore patency in either case. The accompanying figure shows the projected graft patency curve prepared by the life table method9. The mean duration of patency for the whole group is 30.7 weeks, but at the present time only 4 grafts are still patent in the I7 patients still alive. The longest period of patency is I28 weeks in a patient who has received continuous warfarin treatment since a deep vein thrombosis was diagnosed days after surgery. As the graft has remained patent and as he has had no complications from treatment we have maintained his anticoagulation. (Experimental evidence suggests that anticoagulation may lead to increased PTFE graft patency'0.) We have analysed the results of the 20 grafts using data from the preoperative arteriograms. Each of the arteriograms was assessed io
by a radiologist (JAM) who had no knowledge of the outcome of surgery. A simple scoring system was then used to assess aortoiliac disease, profunda disease, and disease below the popliteal artery-that is, the 'run-off'. Little or no radiological disease scored i, moderate disease scored 2, and very severe disease or blocks scored 3. The scores also took into account the number of vessels blocked in the case of the 'run-off' from the popliteal artery. The patients were then divided into four groups according to the duration of graft patency (see table). Prolonged graft patency was not associated with less disease of the popliteal artery and its trifurcation. Even the sum of the overall disease did not appear to be a bad prognostic factor, being similar in all groups. Scoring those 3 patients who underwent simultaneous iliac reconstructions as having no iliac disease, a good 'run-in' suggests a trend towards longer graft patency. Outcome of graft failure Three patients have died and 4 grafts are patent at the time of writing. Of the I3 patients with occluded grafts, only have avoided 2
Radiological assessment of disease Patency of graft
No of cases Mean aortoiliac Mean distal vessel disease disease
(weeks)
Mean total
disease
score
score
score
2,15,40
5 4
1.0
2.2
0.5
2.3
4.8 4.8
3.4
PTFE (Goretex) femoropopliteal reconstruction for limb salvage
further surgery. One patient underwent an 'elective' profundaplasty for claudication after Io months and another developed rest pain and a false aneurysm at 48 weeks following infection in the groin but successfully underwent profunda femoris reconstruction; the remainder required amputation-7 above and 2 below the knee.
Discussion In contrast with other reports our overall patency rate of approximately 5070 at 6 months is disappointing. This must, however, include our 'learning curve', but even those grafts that survived the initial postoperative period of 'technical failure' did not necessarily remain patent for long periods. Although a good 'runoff' is thought to be important in conventional graft survival, our small series shows no correlation between this and prolonged patency. The quality of 'run-in', which was improved in 3 cases by simultaneous aortoiliac reconstructions, may favour longer patency. All our patients underwent peroperative arteriography to try to exclude technical problems, but in spite of this our 2 early failures appeared to have been due to stenosed distal anastomoses. All those patients whose grafts failed after 3 months had continued to smoke more than 20 cigarettes each day".
303
In view of the probably high annual mortality rate in this group of advanced arteriopaths (3 out of 20 patients have already died in our 2-year trial period) combined with the high mortality of amputation"2 we feel that a continued cautious trial of this graft in limb salvage is probably justified"3.
References I Campbell, C D, et al (1976) Surgery, 79, 485. 2 Johnson, J M, Goldfarb, D, and Baker, C D (I976) American Journal of Surgery, I32, 723. 3 Bumham, S J, et al. (I978) Surgery, 84, 417. 4 Haimov, M, Giron, F, and Jacobson, J H (1978) Abstracts of the European Society of Cardiovascular Surgery, Lyon, I978, p 70. 5 Hamlin, G W, et al. (I978) British Journal of Surgery, 65, 272. 6 Campbell, C D, Goldfarb, D, and Roe, R (I975) Annals of Surgery, 182, I38. 7 Florian, A, et al. (1976) Archives of Surgery, iiI,
267.
8 Yao, S T, Hobbs, J T, and Irvine, W T (I968) British Journal of Surgery, 55, 859. 9 Hill, A Bradford (I96I) Principles of Medical Statistics, 7th edn, p. 220. London, Lancet Ltd. io Oblath, R W, et al. (1978) Surgery, 84, 37. ii Myers, K A, et al. (I978) British Journal of Surgery, 65, 267. I2 Jarnieson, C W, and Hill, D A (1976) British Journal of Surgery, 63, 683. 13 Myers, K A, et al. (1978) British Journal of Surgery, 65, 460.
PTFE (Goretex) femoropopliteal reconstruction for limb salvage Charles A C Clyne FRCSt J A McVeigh FRCR M J Fox MD FRCS§ G H Jantet FRCS C W Jamieson MS FRCS Departments of Surgery and Radiology, Hammersmith Hospital, London
Summary We present the results of the use of polytetrafluoroethylene (PTFE, Goretex) grafts for limb salvage in 20 cases of femoropopliteal or more distal arterial reconstruction. There appears to be no relationship between graft survival and 'run-off' or the overall disease state of the vessels. Cumulative graft patency was almost 50% at 6 months, which is in contrast with higher patency rates reported from other countries.
Introduction Long bypass of extensive occlusion of the femoropopliteal arterial segment is often the procedure of choice in limb salvage. Frequently the long saphenous vein is unsuitable or absent owing to previous surgery, or the time taken for its removal may jeopardise the success of the operation or the life of the patient. There is, however, no satisfactory vein substitute for use below the inguinal ligament, but there have been encouraging reports from other countries on the use of polytetrafluoroethylene (PTFE) for limb salvage'-4. Introduced into Britain in 1976, Goretex is a fibrillated PTFE prosthetic vascular graft which appears to be of low thrombogenicity' and whose thin and flexible fibres allow tissue ingrowth to occur and hence form a satisfactory neointima' 7. There are no reports of its use in Britain as a substitute for vein in femoro-
popliteal bypass so we therefore felt justified in carrying out a trial of PTFE grafts for limb salvage in cases in which rest pain and tissue necrosis predominated.
Patients and methods Twenty patients aged between 50 and 83 (mean 67.7) years underwent grafting from the common femoral to more distal vessels with PTFE. Twelve patients had rest pain with ulceration or gangrene and the remainder suffered claudication after a few paces. In I case a femoropopliteal graft above the knee was carried out and in 2 femorotibial grafts were inserted, but the remaining 17 operations were femoropopliteal grafts below the joint line. Only 2 patients were diabetic. In 3 cases aortoiliac reconstructions and in 4 lumbar sympathectomy were carried out simultaneously. Eight patients had already undergone sympathectomy and 6 had previously undergone reconstructions of either the common femoral or profunda femoris artery. Two of the grafts were tapered, but the remainder were straight with an internal diameter of 6 mm. Anastomoses were carried out with a continuous polypropylene stuture. All patients were followed up by personal interview, physical examination, and Doppler assessment of ankle pressures to confirm graft patency'. Results
tPresent address: Department of Surgery, South- There were no operative deaths. Three of the ampton General Hospital, Southampton §Present address: The Lonidon Hospital, White- 0o patients died from unrelated causes, with their grafts patent, at 6, 7, and I 5 weeks rechapel, London Ei The Editor would welcome any observations on this paper from readers *Fellows aind Members interested in submitting papers for consideration with a view to publication in this series should first write to the Editor
302
Charles A C Clyne, J A McVeigh, M J Fox, G H Jantet, and C W Jamieson 100 r
75 %
0
F
graft
patency
Cumulative graf t patency prepared by the life table method.
50
25
4
8
12
20
16
24
28
32
time (weeks)
spectively. One patient has had a mild stroke and in another the graft became occluded while he was lying unconscious after an overdose. Two of the grafts failed within I4 days and review of the operative arteriograms suggests that technical problems may have existed at the distal anastomoses. Re-exploration failed to restore patency in either case. The accompanying figure shows the projected graft patency curve prepared by the life table method9. The mean duration of patency for the whole group is 30.7 weeks, but at the present time only 4 grafts are still patent in the I7 patients still alive. The longest period of patency is I28 weeks in a patient who has received continuous warfarin treatment since a deep vein thrombosis was diagnosed days after surgery. As the graft has remained patent and as he has had no complications from treatment we have maintained his anticoagulation. (Experimental evidence suggests that anticoagulation may lead to increased PTFE graft patency'0.) We have analysed the results of the 20 grafts using data from the preoperative arteriograms. Each of the arteriograms was assessed io
by a radiologist (JAM) who had no knowledge of the outcome of surgery. A simple scoring system was then used to assess aortoiliac disease, profunda disease, and disease below the popliteal artery-that is, the 'run-off'. Little or no radiological disease scored i, moderate disease scored 2, and very severe disease or blocks scored 3. The scores also took into account the number of vessels blocked in the case of the 'run-off' from the popliteal artery. The patients were then divided into four groups according to the duration of graft patency (see table). Prolonged graft patency was not associated with less disease of the popliteal artery and its trifurcation. Even the sum of the overall disease did not appear to be a bad prognostic factor, being similar in all groups. Scoring those 3 patients who underwent simultaneous iliac reconstructions as having no iliac disease, a good 'run-in' suggests a trend towards longer graft patency. Outcome of graft failure Three patients have died and 4 grafts are patent at the time of writing. Of the I3 patients with occluded grafts, only have avoided 2
Radiological assessment of disease Patency of graft
No of cases Mean aortoiliac Mean distal vessel disease disease
(weeks)
Mean total
disease
score
score
score
2,15,40
5 4
1.0
2.2
0.5
2.3
4.8 4.8
3.4
PTFE (Goretex) femoropopliteal reconstruction for limb salvage
further surgery. One patient underwent an 'elective' profundaplasty for claudication after Io months and another developed rest pain and a false aneurysm at 48 weeks following infection in the groin but successfully underwent profunda femoris reconstruction; the remainder required amputation-7 above and 2 below the knee.
Discussion In contrast with other reports our overall patency rate of approximately 5070 at 6 months is disappointing. This must, however, include our 'learning curve', but even those grafts that survived the initial postoperative period of 'technical failure' did not necessarily remain patent for long periods. Although a good 'runoff' is thought to be important in conventional graft survival, our small series shows no correlation between this and prolonged patency. The quality of 'run-in', which was improved in 3 cases by simultaneous aortoiliac reconstructions, may favour longer patency. All our patients underwent peroperative arteriography to try to exclude technical problems, but in spite of this our 2 early failures appeared to have been due to stenosed distal anastomoses. All those patients whose grafts failed after 3 months had continued to smoke more than 20 cigarettes each day".
303
In view of the probably high annual mortality rate in this group of advanced arteriopaths (3 out of 20 patients have already died in our 2-year trial period) combined with the high mortality of amputation"2 we feel that a continued cautious trial of this graft in limb salvage is probably justified"3.
References I Campbell, C D, et al (1976) Surgery, 79, 485. 2 Johnson, J M, Goldfarb, D, and Baker, C D (I976) American Journal of Surgery, I32, 723. 3 Bumham, S J, et al. (I978) Surgery, 84, 417. 4 Haimov, M, Giron, F, and Jacobson, J H (1978) Abstracts of the European Society of Cardiovascular Surgery, Lyon, I978, p 70. 5 Hamlin, G W, et al. (I978) British Journal of Surgery, 65, 272. 6 Campbell, C D, Goldfarb, D, and Roe, R (I975) Annals of Surgery, 182, I38. 7 Florian, A, et al. (1976) Archives of Surgery, iiI,
267.
8 Yao, S T, Hobbs, J T, and Irvine, W T (I968) British Journal of Surgery, 55, 859. 9 Hill, A Bradford (I96I) Principles of Medical Statistics, 7th edn, p. 220. London, Lancet Ltd. io Oblath, R W, et al. (1978) Surgery, 84, 37. ii Myers, K A, et al. (I978) British Journal of Surgery, 65, 267. I2 Jarnieson, C W, and Hill, D A (1976) British Journal of Surgery, 63, 683. 13 Myers, K A, et al. (1978) British Journal of Surgery, 65, 460.
