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Results of surgery and angioplasty for the treatment of chronic severe lower limb ischaemia
Eur J VascEndovascSurg 16, 159-163 (1998)
Results of Surgery and Angioplasty for the Treatment of Chronic Severe Lower Limb Ischaemia K. Varty*, S. Nydahl, A. Nasim, A. Bolia, P. R. F. Bell and N. J. M. London Department of Surgery, Clinical Sciences Building, Leicester Royal Infirmary, Leicester, LE2 7LX, U.K. Objective: The aim of this study was to assess and compare the efficacy of PTA and surgery in the treatment of severe lower limb ischaemia. Design" Prospective 12-month study of 180 consecutive patients with severe chronic lower limb ischaemia. Methods: PTA was used as first line therapy whenever possible and appropriate. Surgical revascularisation, primary amputation and conservative therapy were used in the remaining patients. Patient survival and limb salvage were derived using life table analysis. Results: Revascularisation was attempted in 135 (75%) patients, with PTA in 82 (46%), surgery in 49 (27%) and a combination of both in four (2%). Overall 12-month survival and limb salvage was 75% and 71%, respectively. Surgery and PTA had significantly higher survival rates (91% and 78%) than primary amputation or conservative therapy (57% and 52%) (p
of 76%. Conclusion: A large proportion of patients with severe chronic lower limb ischaemia can be managed by PTA. This management strategy produces a clinically effective outcome at 1-year.
Introduction
prospective 12-month observational study in our unit where the policy was to use PTA as first line therapy Chronic severe lower limb ischaemia is a common whenever possible. The purpose of the study was to problem facing the vascular surgeon with considerable determine the consequences of this treatment strategy implications for the organisation of vascular services. 1'2 and establish whether this policy was justified. Although it is generally accepted that revascularisation should be attempted wherever possible and apPatients and Methods propriate, 2 the role of percutaneous transluminal angioplasty (PTA) and surgery in achieving this goal has recently been the source of controversy.3 Doubts about All patients presenting during 1994 to our vascular the technical success rate and long-term patency of unit with chronic severe leg ischaemia (rest pain, infrainguinal and infrapopliteal PTA have been raised, ulceration or gangrene present for greater than 2 leading to calls for randomised controlled trials. 3'4 weeks) were prospectively entered into the study. Although such pleas are laudable they are arguably The intention was to recruit "all comers", including misplaced in this context, since the two available treat- outlying referrals on medical, rehabilitation and derment options are not mutually exclusive. In order to matological wards. The details of the original 188 achieve limb salvage PTA represents a "minimally patients and their initial management have previously invasive" first line of treatment that does not preclude been reported. 6 In appropriate cases, duplex scanning subsequent surgery if required3 Providing PTA can or angiography was used to characterise the arterial be shown to be an effective therapy when used in this lesions and a joint decision taken between the vascular surgeon and radiologist regarding the suitability of way, its use can be justified. In order to evaluate the efficacy of PTA for the PTA as the first line of therapy. Intervention with PTA was considered whenever treatment of severe limb ischaemia we undertook a possible, including iliac occlusions, flush superficial femoral artery occlusions, and crural vessel lesions. *Please address all correspondence to: K. Varty, Department of Very extensive multi-level disease and heavy calSurgery, Box201, Addenbrookes'Hospital,Hills Road, Cambridge, CB2 2QQ, U.K. cification were the only relative contraindications to 1078-5884/98/080159+05 $12.00/0 © 1998 W.B.Saunders CompanyLtd.
160
K. Varty et al.
PTA where reconstructive surgery was used as the first option. Patients who were wheelchair bound, had extensive necrosis or joint contractures preventing walking were treated with primary major amputation. Conservative therapies were adopted for the remaining patients, including sympathectomy, analgesia, antibiotics, ulcer dressings and subsequent rehabilitation. Spinal cord stimulation and pharmacological therapy (i.e. iloprost) were not in routine use in our unit during this study. A minimum of 12 months follow-up was undertaken for each patient in order to determine limb salvage and survival. Patients were reviewed in the vascular clinic or vascular studies unit (VSU). The clinical status of the leg was recorded and for those attending VSU, usually for graft surveillance, a colour duplex graft scan performed. In those patients discharged from follow up before 12 months where the outcome was unknown (n =21) the general practitioner was sent a brief questionnaire including a request to contact the patient directly if necessary. Four patients were contacted directly by phone. Complete 12-month followup data was obtained for 180 patients (187 legs), eight of the original cohort moved out of the area or were distant tertiary referrals and could not be traced. The following event details were recorded; death, with particular note of deaths directly due to limb ischaemia; limb salvage; on-going limb ischaemia at 12 months or at time of death; requirement of further vascular interventions. The principal study end points were patient survival and limb salvage rates. In 11 cases PTA failed within 30 days and surgery was used to achieve limb salvage. These were classified as primary PTA procedural failures in the analysis.
The details of these procedures are shown in Table 1. Subintimal PTA 7 was used to recanalise 42 of the 51 occlusions in the PTA group. Primary amputation was carried out in 14 (8%) patients and conservative therapy in 31 (17%).
Survival The overall 12-month patient survival was 75%. The survival rate for each treatment group is shown in Fig. 1. Patients undergoing revascularisation with either surgery or PTA had significantly higher 12-month survival rates (91% and 78%) than those treated with primary amputation or conservatively (57% and 52%) (p<0.0001 log rank test). A high proportion (66%) of the deaths in the conservatively treated group resulted from on-going limb ischaemia.
Limb salvage The overall 12-month limb salvage rate was 71%. The limb salvage rate for patients treated with either PTA or surgery was 76% (Fig. 2). Although many patients in the conservatively treated group did not actually come to amputation they did have on-going limb ischaemia at the time of death or at 12 months. Only 10 (32%) had resolution of their rest pain or tissue necrosis. Overall, at the end of the study, 89 patients (49% of the total) were alive with a useful, nonischaemic, leg.
Further vascular procedures Data analysis Data were entered onto a computer software database (Statistical Package for the Social Sciences for Windows release 6, Chicago, Illinois, U.S.A.). The Chi-squared test with a continuity correction was used for comparison of proportions. Survival and limb salvage were calculated using life table analysis with the log rank test to compare survival probabilities.
Seven surgical revascularisations were required during the first year following failed PTA, and five emergency procedures were performed for PTA complicated by embolism/thrombosis. All of these were successful except for one case where extensive distal atheroembolisation during PTA was not salvageable by surgery. Two failed PTA procedures were managed successfully by a repeat procedure. Fifteen grafts with stenoses, inflow and run-off disease were treated by PTA to maintain assisted primary patency. Nine failed or failing grafts were revised or replaced surgically.
Results
Discussion
Revascularisation was attempted initially in 135 (75%) patients with PTA in 82 (46%) and surgery in 53 (29%).
The overall 75% 1-year survival rate from this study is in keeping with the findings of previous series 8'9
Eur J Vasc Endovasc Surg Vol 16, August 1998
Results of Surgery and Angioplasty for the Treatment of Chronic Severe Lower Limb Ischaemia
Table 1.
Summary
of surgical
procedures
performed
and the site and nature
161
of PTA lesions.
PTA procedure
No.
Surgical procedure
No.
Iliac occlusion Iliac stenosis Femoropopliteal occlusion Femoropopliteal stenoses Crural occlusion Crural stenoses
2 8 30 28 19 18
Femorocrural bypass graft Femoropopliteal bypass graft Aortic bifurcated graft Femoral endarterectomy Iliopopliteal bypass graft Iliofem bypass graft Thrombectomy Extra-anatomic bypass graft
24 19 4 2 4 3 3 4
1.00 -
0.90 -
-
~
=
~7
0.80 0.70
~--
- -O-- - -- 1
~---~---"• - - ' - - - ' - - ' - - -
0
I 1
I 2
= Surgery • PTA
L--.-- I
6-'-~--
~- - - * - - *-- - - - . - - *-- ---* A m p u t a t i o n •- - - - . - - - ~ - - - . - - - - - - - . Conservative
0.50 0.40
:
i
i
0.60 -
=
I 3
I 4
I 5
I I 6 7 Months
I 8
i 9
I I I F 10 11 12 13
N u m b e r at risk 53 51 51 49 49 49 49 49 48 48 48 48 48 S u r g e r y 82 77 77 76 74 72 68 67 65 65 65 65 6 4 P T A 31 22 22 18 18 17 17 16 16 16 16 16 16 Conservative 14 11 11 11 10
8
8
7
7
7
7
7
7 Amputation
Fig. 1. Life table showing cumulative proportion surviving for surgery ( i - - n ) ; PTA (A . . . . &); amputation ( , - - - - ~ ) ; conservative therapy ( O - - - - - O ) . Log rank statistic for all g r o u p s = 2 3 , p<0.0001. Inter-group comparisons s h o w e d a significaant difference for both surgery and PTA over amputation and conservative therapy. Other inter-group comparisons were non-significant including PTA vs. Surgery. Standard error <10% at all time points except for amputation group, >10% from 1 month.
1.00 0.90 -
=
0.80
.... ,___.__'_..__.__.__,___,___,_','__,
.
Surgery
0.70 0.60 0.50 I 3
I 4
] 5
N u m b e r at risk 84 65 64 62
60
56
53
57
43
43
43
0.40 0
I 1
48
I 2
48
47
] / 6 7 Months
F 8
] 9
] 10
] 11
] 12
50
49
49
49
49
47 PTA
42
40
40
40
40
40 S u r g e r y
Fig. 2. Life table showing cumulative proportion, limb salvage for surgery ( i - - i ) points.
13
and PTA ( A - - - A ) standard error <10% at all time
Eur J Vasc Endovasc Surg Vol 16, August 1998
162
K. Varty e t al.
and reflects an elderly p o p u l a t i o n w i t h a d v a n c e d atherosclerosis. Failure to revascularise the limb, for w h a t e v e r reason, w a s associated with a particularly high mortality, a p p r o a c h i n g 50%. Lep~intalo and Matzke report a similar experience f r o m Finland w i t h a 12-month survival of only 46% for unreconstructed CLI) ° The policy to a t t e m p t PTA w h e n e v e r possible enabled 46% of the patients in this s t u d y to be revascularised b y this m o d a l i t y c o m p a r e d to a national average of 22%. 1 Furthermore, the limb salvage rates for PTA c o m p a r e v e r y f a v o u r a b l y with surgery. There h a v e b e e n two r a n d o m i s e d trials of PTA versus surgery for chronic leg ischaemia principally dealing w i t h claudicants rather than CLI. 11'12As in the present s t u d y these trials s h o w e d c o m p a r a b l e limb salvage for PTA and surgery. In a retrospective c o m p a r i s o n of PTA and surgery for severe limb ischaemia Blair a n d colleagues reported an u n u s u a l l y high PTA failure rate at 1m o n t h of 59% and not surprisingly concluded that surgery w a s the m o r e durable option. I3 The r e p o r t e d results of PTA, however, suggest that i m p r o v e m e n t s h a v e b e e n m a d e over the last decade and such a high early failure rate is no longer representative. In two series collected d u r i n g the 1980s Currie 14and Treiman 15 describe a p o o r o u t c o m e for PTA b u t m o r e recent series describe m o r e favourable results, particularly for infrapopliteal P T A ) 6-1s The true durability of infrapopliteal PTA for limb salvage remains to be established since m a n y of the reported series include p r o c e d u r e s p e r f o r m e d for claudication. 19'2° In selected patients, however, the results f r o m m o r e recent series a p p e a r favourable. The e m e r g i n g evidence therefore suggests that with i m p r o v e d PTA in the 1990s there is a role for the use of this m o d a l i t y in the t r e a t m e n t of limb threatening ischaemia. In the present series a p p r o x i m a t e l y equal n u m b e r s of further vascular p r o c e d u r e s w e r e necessary to "salv a g e " failing grafts a n d failed PTAs d u r i n g the 12 m o n t h s follow-up. In this regard a c o m p l i m e n t a r y role b e t w e e n surgery a n d PTA w a s seen to exist. Importantly, there w a s no evidence that a failed PTA c o m p r o m i s e d s u b s e q u e n t surgery t h o u g h e m bolisation complicating PTA w a s prejudicial to one surgical procedure. A similar conclusion w a s m a d e in b o t h the r a n d o m i s e d trials of PTA versus surgery. I1'12 A s t u d y of PTA failures a n d complications b y S a m s o n and coworkers also failed to identify a n y detrimental effect of PTA on later s u r g e r y ) In conclusion, the data f r o m this s t u d y strongly s u p p o r t s the use of PTA as first line treatment for severe limb ischaemia w i t h no major evidence that PTA is detrimental to later surgery if required. It has Eur J Vasc Endovasc Surg Vol 16, August 1998
b e e n suggested that longer t e r m outcomes m a y be i m p o r t a n t in order to fully evaluate the value of PTA. 3 H o w e v e r , in the context of a 12-month survival of 75% and a 3-year survival of only 50--60% 9'2I'22 a long-term solution is not w h a t m a n y of these elderly frail patients require. This s t u d y highlights that as a m i n i m a l l y invasive p r o c e d u r e PTA serves the majority of patients v e r y well, w i t h a short hospital stay, 6 and 12-month limb salvage rates that equate with those achieved b y surgery.
References 1 HARRIS PL. For THE VASCULARSURGICAL SOCIETY OF GREAT
BRITAINANDIRELAND.Critical limb ischaemia: management and outcome, report of a national survey. Eur J Vasc Endovasc Surg 1995; 10: 108-113. 2 AUDITCOMMITTEEOFTHE VASCULARSURGICALSOCIETYOFGREAT
BRITAINAND IRELAND.Recommendations for the management of chronic critical lower limb ischaemia. Eur J Vasc Endovasc Surg 1996; 12: 131-135. 3 BRADBURYAW, VAUGHANRUCKLEYC. Angioplasty for lowerlimb ischaemia: time for randomised controlled trials. Lancet 1996; 347: 277. 4 PORTERJM. Endovascular arterial intervention: expression of concern. J Vasc Surg 1995; 21: 995-957. 5 SAMSON RH, SPRAYGREENS, VEITH FJ, SCHER LA, GUPTA SK,
6 7
8 9
ASCER E. Management of angioplasty complications, unsuccessful procedures and early and late failure. Ann Surg 1984; 199: 234-240. VARTYK, NYDAHLS, BUTTERWORTHPet al. Changes in the management of critical limb ischaemia. Br J Surg 1996; 83: 953-956. BOLIAA, MILESKA, BRENNANJ, BELLPRF. Percutaneous transluminal angioplasty of occlusions of the femoral and popliteal arteries by subintimal dissection. Cardiovasc Intervent Radio11990; 13: 357-363. WOLFEJHN. Defining the outcome of critical limb ischaemia: a 1-year prospective study. Br J Surg 1986; 73: 321. HOLDSWORTHRJ, McCOLLUM PT. Results and resource implications of treating end-stage limb ischaemia. Eur J Vasc Endovasc Surg 1997; 13: 164-173.
10 LEPXNTALOM, M2KTZKES. Outcome of unreconstructed chronic
critical leg ischaemia. Eur J Vasc Endovasc Surg 1996; 11: 153-157. 11 HOLMJ, ARFVIDSSONB, JIVEGARD Let al. Chronic lower limb ischaemia. A prospective randomised controlled study comparing the 1-year result of vascular surgery and PTA. Eur J Vasc Surg 1991; 5: 517-522. 12 WILSONSE, WOLF GL, CROSS AP. Percutaneous transluminal angioplasty versus operation for peripheral arteriosclerosis. J Vasc Surg 1989; 9: 1-9. 13 BLAIRJM, GEWERTZBL, MOOSA H, Lu C, ZARINS CK. Percutaneous transluminal angioplasty versus surgery for limb threatening ischaemia. J Vasc Surg 1989; 9: 698-703. 14 CURRIEIC, WAKELEYCJ, COLESE, WYATTMG, SCOTTDJ, BAIRD RN. Femoropopliteal angioplasty for severe limb ischaemia. Br J Surg 1994; 81: 191-193. 15 TREIMAN GS, TREIMAN RL, ICmKAWAL, VAN ALLEN R. Should
percutaneous transluminal angioplasty be recommended for treatment of infrageniculate popliteal artery or tibioperoneal trunk stenosis. J Vasc Surg 1995; 22: 457-465. 16 BUCKENHAMTM, LOH A, DORMANDYJA, TAYLORRS. Infrapopliteal angioplasty for limb salvage. Eur J Vasc Surg 1993; 7: 21-25.
Results of Surgery and Angioplasty for the Treatment of Chronic '~evere Lower Limb Ischaemia
17 PELL JP, WHYMAN MR, DURHAM JR, HOROWITZ JD, WRmH:r
JG, SMEAD WL. Percutaneous transluminal angioplasty of tibial arteries for limb salvage in the high-risk diabetic patient. Ann Vasc Surg 1994; 8: 48-53. 18 VARTY K, BOLIA A, NAYLOR AR, BELL PRF, LONDON NJM. Infrapopliteal percutaneous transluminal angioplasty: a safe and successful procedure. Eur J Vasc Endovasc Surg 1995; 9: 341-345. 19 FRASER SA, AL-KUTOUBI MA, WOLFE JHN, Percutaneous transluminal angioplasty of the infrapopliteal vessels: the evidence. Radiology 1996; 200: 33-36.
163
20 BAKaL CW, CYNAMON J, SPRAYGREEN S. Infrapopliteal percutaneous transluminal angioplasty: what we know. Radiology 1996; 200: 36-43. 21 HUMPHREYS~vVV,EVANS ~r WATKIN G, WILLIAMS T. Critical limb ischaemia in patients over 80 years of age: options in a district general hospital. Br J Surg 1995; 82: 1361-1363. 22 TROi~NG T, BERGQVIST D, JANSON L. Incidence and causes of adverse outcomes of operation for chronic ischaemia of the leg. Eur J Surg 1994; 160: 17-25.
Accepted 16 April 1998
Eur J Vasc Endovasc Surg Vol 16, August 1998
Results of Surgery and Angioplasty for the Treatment of Chronic Severe Lower Limb Ischaemia K. Varty*, S. Nydahl, A. Nasim, A. Bolia, P. R. F. Bell and N. J. M. London Department of Surgery, Clinical Sciences Building, Leicester Royal Infirmary, Leicester, LE2 7LX, U.K. Objective: The aim of this study was to assess and compare the efficacy of PTA and surgery in the treatment of severe lower limb ischaemia. Design" Prospective 12-month study of 180 consecutive patients with severe chronic lower limb ischaemia. Methods: PTA was used as first line therapy whenever possible and appropriate. Surgical revascularisation, primary amputation and conservative therapy were used in the remaining patients. Patient survival and limb salvage were derived using life table analysis. Results: Revascularisation was attempted in 135 (75%) patients, with PTA in 82 (46%), surgery in 49 (27%) and a combination of both in four (2%). Overall 12-month survival and limb salvage was 75% and 71%, respectively. Surgery and PTA had significantly higher survival rates (91% and 78%) than primary amputation or conservative therapy (57% and 52%) (p
of 76%. Conclusion: A large proportion of patients with severe chronic lower limb ischaemia can be managed by PTA. This management strategy produces a clinically effective outcome at 1-year.
Introduction
prospective 12-month observational study in our unit where the policy was to use PTA as first line therapy Chronic severe lower limb ischaemia is a common whenever possible. The purpose of the study was to problem facing the vascular surgeon with considerable determine the consequences of this treatment strategy implications for the organisation of vascular services. 1'2 and establish whether this policy was justified. Although it is generally accepted that revascularisation should be attempted wherever possible and apPatients and Methods propriate, 2 the role of percutaneous transluminal angioplasty (PTA) and surgery in achieving this goal has recently been the source of controversy.3 Doubts about All patients presenting during 1994 to our vascular the technical success rate and long-term patency of unit with chronic severe leg ischaemia (rest pain, infrainguinal and infrapopliteal PTA have been raised, ulceration or gangrene present for greater than 2 leading to calls for randomised controlled trials. 3'4 weeks) were prospectively entered into the study. Although such pleas are laudable they are arguably The intention was to recruit "all comers", including misplaced in this context, since the two available treat- outlying referrals on medical, rehabilitation and derment options are not mutually exclusive. In order to matological wards. The details of the original 188 achieve limb salvage PTA represents a "minimally patients and their initial management have previously invasive" first line of treatment that does not preclude been reported. 6 In appropriate cases, duplex scanning subsequent surgery if required3 Providing PTA can or angiography was used to characterise the arterial be shown to be an effective therapy when used in this lesions and a joint decision taken between the vascular surgeon and radiologist regarding the suitability of way, its use can be justified. In order to evaluate the efficacy of PTA for the PTA as the first line of therapy. Intervention with PTA was considered whenever treatment of severe limb ischaemia we undertook a possible, including iliac occlusions, flush superficial femoral artery occlusions, and crural vessel lesions. *Please address all correspondence to: K. Varty, Department of Very extensive multi-level disease and heavy calSurgery, Box201, Addenbrookes'Hospital,Hills Road, Cambridge, CB2 2QQ, U.K. cification were the only relative contraindications to 1078-5884/98/080159+05 $12.00/0 © 1998 W.B.Saunders CompanyLtd.
160
K. Varty et al.
PTA where reconstructive surgery was used as the first option. Patients who were wheelchair bound, had extensive necrosis or joint contractures preventing walking were treated with primary major amputation. Conservative therapies were adopted for the remaining patients, including sympathectomy, analgesia, antibiotics, ulcer dressings and subsequent rehabilitation. Spinal cord stimulation and pharmacological therapy (i.e. iloprost) were not in routine use in our unit during this study. A minimum of 12 months follow-up was undertaken for each patient in order to determine limb salvage and survival. Patients were reviewed in the vascular clinic or vascular studies unit (VSU). The clinical status of the leg was recorded and for those attending VSU, usually for graft surveillance, a colour duplex graft scan performed. In those patients discharged from follow up before 12 months where the outcome was unknown (n =21) the general practitioner was sent a brief questionnaire including a request to contact the patient directly if necessary. Four patients were contacted directly by phone. Complete 12-month followup data was obtained for 180 patients (187 legs), eight of the original cohort moved out of the area or were distant tertiary referrals and could not be traced. The following event details were recorded; death, with particular note of deaths directly due to limb ischaemia; limb salvage; on-going limb ischaemia at 12 months or at time of death; requirement of further vascular interventions. The principal study end points were patient survival and limb salvage rates. In 11 cases PTA failed within 30 days and surgery was used to achieve limb salvage. These were classified as primary PTA procedural failures in the analysis.
The details of these procedures are shown in Table 1. Subintimal PTA 7 was used to recanalise 42 of the 51 occlusions in the PTA group. Primary amputation was carried out in 14 (8%) patients and conservative therapy in 31 (17%).
Survival The overall 12-month patient survival was 75%. The survival rate for each treatment group is shown in Fig. 1. Patients undergoing revascularisation with either surgery or PTA had significantly higher 12-month survival rates (91% and 78%) than those treated with primary amputation or conservatively (57% and 52%) (p<0.0001 log rank test). A high proportion (66%) of the deaths in the conservatively treated group resulted from on-going limb ischaemia.
Limb salvage The overall 12-month limb salvage rate was 71%. The limb salvage rate for patients treated with either PTA or surgery was 76% (Fig. 2). Although many patients in the conservatively treated group did not actually come to amputation they did have on-going limb ischaemia at the time of death or at 12 months. Only 10 (32%) had resolution of their rest pain or tissue necrosis. Overall, at the end of the study, 89 patients (49% of the total) were alive with a useful, nonischaemic, leg.
Further vascular procedures Data analysis Data were entered onto a computer software database (Statistical Package for the Social Sciences for Windows release 6, Chicago, Illinois, U.S.A.). The Chi-squared test with a continuity correction was used for comparison of proportions. Survival and limb salvage were calculated using life table analysis with the log rank test to compare survival probabilities.
Seven surgical revascularisations were required during the first year following failed PTA, and five emergency procedures were performed for PTA complicated by embolism/thrombosis. All of these were successful except for one case where extensive distal atheroembolisation during PTA was not salvageable by surgery. Two failed PTA procedures were managed successfully by a repeat procedure. Fifteen grafts with stenoses, inflow and run-off disease were treated by PTA to maintain assisted primary patency. Nine failed or failing grafts were revised or replaced surgically.
Results
Discussion
Revascularisation was attempted initially in 135 (75%) patients with PTA in 82 (46%) and surgery in 53 (29%).
The overall 75% 1-year survival rate from this study is in keeping with the findings of previous series 8'9
Eur J Vasc Endovasc Surg Vol 16, August 1998
Results of Surgery and Angioplasty for the Treatment of Chronic Severe Lower Limb Ischaemia
Table 1.
Summary
of surgical
procedures
performed
and the site and nature
161
of PTA lesions.
PTA procedure
No.
Surgical procedure
No.
Iliac occlusion Iliac stenosis Femoropopliteal occlusion Femoropopliteal stenoses Crural occlusion Crural stenoses
2 8 30 28 19 18
Femorocrural bypass graft Femoropopliteal bypass graft Aortic bifurcated graft Femoral endarterectomy Iliopopliteal bypass graft Iliofem bypass graft Thrombectomy Extra-anatomic bypass graft
24 19 4 2 4 3 3 4
1.00 -
0.90 -
-
~
=
~7
0.80 0.70
~--
- -O-- - -- 1
~---~---"• - - ' - - - ' - - ' - - -
0
I 1
I 2
= Surgery • PTA
L--.-- I
6-'-~--
~- - - * - - *-- - - - . - - *-- ---* A m p u t a t i o n •- - - - . - - - ~ - - - . - - - - - - - . Conservative
0.50 0.40
:
i
i
0.60 -
=
I 3
I 4
I 5
I I 6 7 Months
I 8
i 9
I I I F 10 11 12 13
N u m b e r at risk 53 51 51 49 49 49 49 49 48 48 48 48 48 S u r g e r y 82 77 77 76 74 72 68 67 65 65 65 65 6 4 P T A 31 22 22 18 18 17 17 16 16 16 16 16 16 Conservative 14 11 11 11 10
8
8
7
7
7
7
7
7 Amputation
Fig. 1. Life table showing cumulative proportion surviving for surgery ( i - - n ) ; PTA (A . . . . &); amputation ( , - - - - ~ ) ; conservative therapy ( O - - - - - O ) . Log rank statistic for all g r o u p s = 2 3 , p<0.0001. Inter-group comparisons s h o w e d a significaant difference for both surgery and PTA over amputation and conservative therapy. Other inter-group comparisons were non-significant including PTA vs. Surgery. Standard error <10% at all time points except for amputation group, >10% from 1 month.
1.00 0.90 -
=
0.80
.... ,___.__'_..__.__.__,___,___,_','__,
.
Surgery
0.70 0.60 0.50 I 3
I 4
] 5
N u m b e r at risk 84 65 64 62
60
56
53
57
43
43
43
0.40 0
I 1
48
I 2
48
47
] / 6 7 Months
F 8
] 9
] 10
] 11
] 12
50
49
49
49
49
47 PTA
42
40
40
40
40
40 S u r g e r y
Fig. 2. Life table showing cumulative proportion, limb salvage for surgery ( i - - i ) points.
13
and PTA ( A - - - A ) standard error <10% at all time
Eur J Vasc Endovasc Surg Vol 16, August 1998
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K. Varty e t al.
and reflects an elderly p o p u l a t i o n w i t h a d v a n c e d atherosclerosis. Failure to revascularise the limb, for w h a t e v e r reason, w a s associated with a particularly high mortality, a p p r o a c h i n g 50%. Lep~intalo and Matzke report a similar experience f r o m Finland w i t h a 12-month survival of only 46% for unreconstructed CLI) ° The policy to a t t e m p t PTA w h e n e v e r possible enabled 46% of the patients in this s t u d y to be revascularised b y this m o d a l i t y c o m p a r e d to a national average of 22%. 1 Furthermore, the limb salvage rates for PTA c o m p a r e v e r y f a v o u r a b l y with surgery. There h a v e b e e n two r a n d o m i s e d trials of PTA versus surgery for chronic leg ischaemia principally dealing w i t h claudicants rather than CLI. 11'12As in the present s t u d y these trials s h o w e d c o m p a r a b l e limb salvage for PTA and surgery. In a retrospective c o m p a r i s o n of PTA and surgery for severe limb ischaemia Blair a n d colleagues reported an u n u s u a l l y high PTA failure rate at 1m o n t h of 59% and not surprisingly concluded that surgery w a s the m o r e durable option. I3 The r e p o r t e d results of PTA, however, suggest that i m p r o v e m e n t s h a v e b e e n m a d e over the last decade and such a high early failure rate is no longer representative. In two series collected d u r i n g the 1980s Currie 14and Treiman 15 describe a p o o r o u t c o m e for PTA b u t m o r e recent series describe m o r e favourable results, particularly for infrapopliteal P T A ) 6-1s The true durability of infrapopliteal PTA for limb salvage remains to be established since m a n y of the reported series include p r o c e d u r e s p e r f o r m e d for claudication. 19'2° In selected patients, however, the results f r o m m o r e recent series a p p e a r favourable. The e m e r g i n g evidence therefore suggests that with i m p r o v e d PTA in the 1990s there is a role for the use of this m o d a l i t y in the t r e a t m e n t of limb threatening ischaemia. In the present series a p p r o x i m a t e l y equal n u m b e r s of further vascular p r o c e d u r e s w e r e necessary to "salv a g e " failing grafts a n d failed PTAs d u r i n g the 12 m o n t h s follow-up. In this regard a c o m p l i m e n t a r y role b e t w e e n surgery a n d PTA w a s seen to exist. Importantly, there w a s no evidence that a failed PTA c o m p r o m i s e d s u b s e q u e n t surgery t h o u g h e m bolisation complicating PTA w a s prejudicial to one surgical procedure. A similar conclusion w a s m a d e in b o t h the r a n d o m i s e d trials of PTA versus surgery. I1'12 A s t u d y of PTA failures a n d complications b y S a m s o n and coworkers also failed to identify a n y detrimental effect of PTA on later s u r g e r y ) In conclusion, the data f r o m this s t u d y strongly s u p p o r t s the use of PTA as first line treatment for severe limb ischaemia w i t h no major evidence that PTA is detrimental to later surgery if required. It has Eur J Vasc Endovasc Surg Vol 16, August 1998
b e e n suggested that longer t e r m outcomes m a y be i m p o r t a n t in order to fully evaluate the value of PTA. 3 H o w e v e r , in the context of a 12-month survival of 75% and a 3-year survival of only 50--60% 9'2I'22 a long-term solution is not w h a t m a n y of these elderly frail patients require. This s t u d y highlights that as a m i n i m a l l y invasive p r o c e d u r e PTA serves the majority of patients v e r y well, w i t h a short hospital stay, 6 and 12-month limb salvage rates that equate with those achieved b y surgery.
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17 PELL JP, WHYMAN MR, DURHAM JR, HOROWITZ JD, WRmH:r
JG, SMEAD WL. Percutaneous transluminal angioplasty of tibial arteries for limb salvage in the high-risk diabetic patient. Ann Vasc Surg 1994; 8: 48-53. 18 VARTY K, BOLIA A, NAYLOR AR, BELL PRF, LONDON NJM. Infrapopliteal percutaneous transluminal angioplasty: a safe and successful procedure. Eur J Vasc Endovasc Surg 1995; 9: 341-345. 19 FRASER SA, AL-KUTOUBI MA, WOLFE JHN, Percutaneous transluminal angioplasty of the infrapopliteal vessels: the evidence. Radiology 1996; 200: 33-36.
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20 BAKaL CW, CYNAMON J, SPRAYGREEN S. Infrapopliteal percutaneous transluminal angioplasty: what we know. Radiology 1996; 200: 36-43. 21 HUMPHREYS~vVV,EVANS ~r WATKIN G, WILLIAMS T. Critical limb ischaemia in patients over 80 years of age: options in a district general hospital. Br J Surg 1995; 82: 1361-1363. 22 TROi~NG T, BERGQVIST D, JANSON L. Incidence and causes of adverse outcomes of operation for chronic ischaemia of the leg. Eur J Surg 1994; 160: 17-25.
Accepted 16 April 1998
Eur J Vasc Endovasc Surg Vol 16, August 1998