- Email: [email protected]
Other treatment modalities
IOURNAL OF VASCULAR SURGERY
Volume 31, Number 1, Part 2
D4 Treatment of Critical Limb Ischemia 8263
References
1. Moore WS. Carotid endarterectomy: is it safe in the community? J VaseSurg 1986;4:313-314. 2. Rich NM, Hughes CWo Vietnam vascular registry: a preliminary report. Surgery 1969;65:218-226. 3. Plecha FR, Avellone JC, Beven EG, DePalma RG, Hertzer NR. A computerized vascular registry: experience of the Cleveland Vascular Society. Surgery 1979;86:826-835. 4. Karmody AM, Blumenberg RM, Wall CA. Preliminary experience with a large scale vascularregistry. Am J Surg 1983;146:162-163. 5. Karmody AM, Fitzgerald K, Branagh M. Leather RP. Development of a computerized vascular registry for large scale use. J Vase Surg 1984;1:594-600. 6. Auditing Surgical Outcome: 10 years with the Swedish Vascular Registry (SWEDVASC). Eur J Surg 1998;164(suppl)581. 7. Jensen LP, Schroeder TV, Madsen PV, Lorentzen JE. Vascular registers in Denmark based on personal computers. Ann Chir GynaecoI1992;81:253-256. 8. Lepantalo M, Salenius JP, Alhack A, Ylonen K, Luther M. Frequency of repeated vascularsurgery. A survey of 7616 surgical and endovascular Finnvasc procedures. Pinnvasc Study Group. Eur J Surg 1996;162:279-285. 9. Lepantalo M, Salenius JP, Harjola PT. Trends in vascular surgery: an evaluation of operative activity in Finland 1976-1992. Ann Chir Gynecol 1996;85:225-229. 10. Salenius JP. National vascular registry in Finland-Finnvasc. Finnvasc STUDY GROUP. Ann Chit GynaecoI1992;81:257-260. 11. Elfstrom J, Stubberod A, Troeng T. Patients not included in medical audit have a worse outcome than those included. Int J of Quality Health Care 1996;8:153-157. 12. Jensen LP, Nielsen OM, Schroeder TV. The importance of complete follow-up for results after femoro-infrapopliteal vascular surgery. Eur J Vase Endovasc Surg 1996;12:282-286. 13. Zdanowski Z, Troeng T, Norgren L. Outcome and influence of age after infrainguinal revascularization in critcal limb ischemia. Swedish Vascular Registry (SWEDVASC). Eur J Vase Endovasc Surg 1998;16: 137-141. 14. Rutherford RB. Reporting standards for endovascular surgery: should existing standards be modified for newer procedures? Semin Vase Surg 1997;10:197-205. 15. Rutherford RB. Acute limb ischaemia: clinical assessment and standards for reporting. Semin VaseSurg 1986;4:80-94. 16. Rutherford RB, Flanigan PO, Gupta SK, et al. Suggested standards for reports dealing with lower extremity ischemia. Prepared by the Ad Hoc Committee on Reporting Standards, Society for Vascular SurgeryjNorth American Chapter, International Society fur Cardiovascular Surgery. J VaseSurg 1986;4:80-94. 17. Effects of perioperative iloprost on patency of femorodistal bypass grafts. The Iloprost Bypass International Study Group. Eur JVase Endovasc Surg 1996;12:363-371. 18. Reoperations, redo surgery and other site interventions constitute more than one third of vascularsurgery. A study from Swedvasc (the Swedish Vascular Registry). The Swedish Society for VascularSurgery. Eur J Vase Endovasc Surg 1997;14:244-251.
D 4.16
Other Treatment Modalities The treatment modalities considered here are not necessarily confined to sometimes also used in claudicants.
eLI patients but are
D 4.16.1 Transfusion of Ultraviolet Irradiated Autologous Blood This technique is widely used in patients with PAD in all stages, mostly in eastern countries of Europe and Russia. Photohemotherapy consists of ultraviolet radiation of autologous blood. Although a few uncontrolled studies showed an improvement of rheological properties of the blood, there is no controlled prospective study in patients with IC or CLI showing a clear clinical benefit for the treated patients.! D 4.16.2 Hyperbaric Oxygen The initial reports on the use of hyperbaric oxygen in patients with early gangrene of the legs were encouraging, because relief of pain was obtained and amputations could be postponed, even for several years.2,a In an uncontrolled study, 18% of diabetic patients with ulcers refractory to conventional treatment had complete healing, but all made at least a fair response. Seventyfive percent of atherosclerotic ulcers in nondiabetic patients improved sufficiently to allow patients to return home and resume daily activities.s The longest and largest experience was reported by Predenuccif who collected data on more than 2,000 patients treated in over 70,000 sessions between 1966 and 1983. Relief ofrest pain and healing of limiting ulcers was observed in one third of patients after 4 to 6 weeks of treatment. The therapy is cumbersome, and it is also unclear to what extent the clinical results can be attributed to concomitant therapy,
JOURNAL OF VASCULAR SURG ERY
S264 D4 Treatment of Critical Limb Ischemia
January
2000
including heparin infusion. All of the reponed studies were uncontrolled. This treatment cannot be recommended until prospective controlled trials have shown it to be beneficial.
Local treatment with hyperbaric oxygen Although local hyperbaric oxygen with topical hyperbaric OA-ygen chamber technique has undergone real waves of enthusiasm, its use for treatment of ulcers due to CLI or for stump healing problemss-? remains to be more clearly demonstrated by randomized clinical trials .
D 4.16.3 Ambulation, Intermittent Venous Compression, Negative Pressure Application Limited walking and intermittent compression of the foot, calf, or both have been shown to increase blood flow and foot TCP0 2 in limbs with PAD.8,9,lO,ll,12,13 Limited walking in patients with chronic CLI was suggested in the Second European Consensus Document on Chronic Critical Limb Ischernia.J? and Foley reported on the treatment of gangrene by walking .lf There is some evidence that increased blood flow in response to walking or intermittent venous compression may be contributed to further in some cases by the inhibition of veno arteriolar reflex vasoconstriction or by endothelium-mediated me chanisms. 1l,12 Similarly, application of external negative pressure to the leg increased skin blood flow in the foot of patients with PAD and incre ased walking distance in patients with IC. 16,1 7 These and similar approaches may be of benefit in the management of patients with PAD, especially when inre rventional treatment is not indicated, but their value needs to be assessed by properly designed clinical trials. Critical Issue 44: Limited walking) intermittent pneumatic compression) negative pressure application in peripheral arterial disease There is a need for properly designed studies to determine the benefit of limited walking, intermittent pneumatic compression, and negative pressure application in treatment of peripheral arterial disease.
D 4 .16.4 Epidural Spinal Cord Stimulation In some vascular centers in Europe, spinal cord stimulation (SCS ) has been used since the late 1960s in patients with intractable pain caused by CLI, as an alternative to amputation. The tech nique involves implantation of an electrode at the level of L3-L4 and a pulse generator subcutaneously. This method is used not only to relieve leg pain but also as a means of maintaining circulation in the leg. In one uncontrolled study, 94% of the 38 patients treated with SCS experienced pain relief, and in half of the patients, healing of ischemi c ulcers occurred.If In anothe r uncontrolled study, immediate relief of rest pain was seen in 18 of20 CLI patients. Of these, 12 patients had continued pain relief and healing of ischemic ulcers, with improved microcirculatory flow suggested by capillaroscopy.19 Nevertheless, the real mechanism of action of SCS is unknown, and the appropriate place for this form of therapy remains to be determined. Prospective studies are needed to show the value of SCS20,2I (see also D 4.2.1, Control of Pain , p 5193). Two controlled studies have been published on the efficacy of SCS in patients with inoperable severe CLI.22,23 In the first study, patients with inoperable severe CLI were randomized to either SCS or analgesic treatment only with 18 months' follow-up .R Long-term pain relief was o bserved only in the 5CS group. Limb salvage rates did not differ at the end of the follow-up period, although tissue loss was significantly less in the SCS group, and a subgroup analysis showed that patients without arterial hypertension had a lower amputation rate if treated with SCS.22 In the second study, patients with inoperable severe CLI were randomized to either SCS plus best medical treatment or best medical treatment on1y.23 Median follow-up was 605 days (interquartile range, 244-1,771). There was no difference in mortality between the two groups, and the major amputation rate was insignificantly lower in the SCS plus medical treatment group (42% vs 48%, p = 0.47).
JOURNAL or VASCULAR SURGERY Volume 31, Number 1, Part 2
D4 Treatment afCritical Limb Ischemia 8265
Recommendation 100: Spinal cord stimulation in critical limb ischemia On current evidence, spinal cord stimulation cannot be recommended in the treatment of critical limb ischemia. D 4.16.5 Chelation Therapy Chelation therapy has been promoted as a means to treat atherosclerosis and relieve symptoms of cardiovascular disease. However, there is no scientific basis to support these claims. Four randomized, double-blind, multicenter trials of ethylenediaminetetra-acetic acid (EDTA) in patients with PAD have been recently reviewed.ct The drug was not shown to be effective in treating the symptoms of c1auctication in any of these studies, nor in improving the ABPI. Furthermore, frequent infusions of EDTA may produce severe hypocalcemia and therefore actually may be dangerous. Recommendation 101: Chelation therapy in peripheral arterial disease There is no scientific basis for the use of chelation therapy in the treatment of peripheral arterial disease. D 4.16.6 Sympathectomy in the Management of Critical Limb Ischemia Among patients with atherosclerotic arterial occlusion or thromboangiitis obliterans, lumbar sympathectomy has been limited to patients with inoperable disease complicated by rest pain and tissue loss.
Sympathectomy to treat ischemic rest pain Symptom relief has been reported in 47% to 71% of unselected patients, with limb salvagein 60% to 94%.25 The best results were obtained by Persson-s among 37 patients who had an ABPI greater than 0.3, no evidence of neuropathy, and very limited tissue necrosis. In this series, 78% of patients had long-term relief of ischemic pain, and 11% required amputation. The worst results were noted by Fulton and Blakely-? in 17 unselected patients undergoing sympathectomy, with only 6% obtaining relief, whereas 70% required early amputation. Disappointing results therefore can be expected when limb-threatening ischemia is unselectively treated by sympathectomy. Sympathectomy to treat tissue loss Less impressive results than for rest pain are generally noted, with 35% to 62% of patients showing complete initial healing of the ischemic lesions. In addition, amputation rates were higher than in the rest pain group, with a range of 27 to 38%.25 Persson et al26 again reported the best results in 22 patients who had adequate inflow, no neuropathy, and no evidence of infection; 77% had ulcer healing, and only 22% required amputation. Sympathectomy as an adjunct for lower-extremity revascularization Because lumbar sympathectomy increases lower-extremity blood flow at least temporarily, it has been suggested as an adjunct during aortoiliac reconstruction in an attempt to improve outflow and graft patency. However, subsequent randomized trials failed to show any difference in clinical outcome or graft patency when sympathectomy was added during aortofemoral bypass.28,29 Thus, this technique is no longer practiced. There have not been trials of the effect of sympathectomy on infrainguinal bypass patency or efficacy, but the requirement for a separate incision discourages this approach. A benefit of temporary chemical sympathectomy provided by epidural anesthesia was suggested in one randomized trial that showed improved early infrainguinal graft patency. 3D However, two subsequent trials failed to show this effect.31,32 Currently, there is no established role for adjuvant surgical sympathectomy to improve bypass graft patency or efficacy.
JOUR...'lAL OF VASCULAR SURGERY
8266 D4 Treatment of Critical Limb Ischemia
January 2000
Current indications for lumbar sympathectomy Primary indications for lumbar sympathectomy are limited to selected patients with inoperable distal arterial occlusive disease secondary to arteriosclerosis or thromboangiitis obliterans. Current determination of inoperability differs with expertise and availability of saphenous vein. In rare cases in which such revascularization procedures are not feasible because of inadequate run-off, lumbar sympathectomy may be considered in the patients with (1) ABPI greater than 0.3; (2) superficial tissue necrosis limited to digits; (3) absent neuropathy (diabetes); (4) symptom relief after lumbar sympathetic blockade, and (5) acceptable surgical risk for a retroperitoneal approach. The most common complications of lumbar sympathectomy are temporary neuralgia and inadequate clinical improvement. 26 Recommendation 102: Lumbar sympathectomy in critical limb ischemia There is currently insufficient scientific evidence for the selection of patients likely to benefit from lumbar sympathectomy for the treatment of critical limb ischemia. References 1. Karandashov VI, Petukhov EB, KaralkinAV. The regional hemodynamics in patients with chronic arterial insufficiency of the lower extremities after the transfusion ofUV-irradiated autologous blood. Vesrn Khir Irn II Grek 1996;155(2):76-78. 2. TIlingworth CFW. Treatment of arterial occlusion under oxygen at two atmospheres pressure. Br Med J 1962;2: 1272. 3. Koomen AR. The influence of hyperbaric oxygen in chronic arterial obstruction of the peripheral arteries. J Cardiovasc Surg 1967;8:335-337. 4. Hart GB, Strauss MB. Responses of ischemic conditions to OHP. In: Smith G, ed. Hyperbaric Medicine. Aberdeen: Aberdeen University Press, P312-314. 5. Fredenuccl P. Oxygenothcrapie hypcrbare et arteropathies. J Mal Vase 1985;10(Suppl A):166-172. 6. Fischer BH. Treatment of ulcers on the legs with hyperbaric oxygen. J Derrnatol Surg 1975;1:55-58. 7. Diamond E, Forst MB, Hyman SA, Rand SA. The effect of hyperbaric oxygen on lower extremity ulcerations. J Am Podiatry Assoc 1982;72: 180-185. S. Spacil J, Hlavova A, Linhart J, Prerovsky r. The effect of slow walking on the subcutaneous blood How in the leg in patients with ischemic disease of lower limbs. Vasa 1976;5:323-328. 9. Gaskell P, Parrott JC. The effect of a mechanical venous pump on the circulation of the feet in the presence of arterial obstructions. Surg Gynaecol Obstet 1978;146:583-592. 10. Carter SA. Effects of ambulation on foot oxygen tension in limbs with peripheral atherosclerosis. Clin Physiol 1996;16: 199-208. 11. Morgan RH, Carolan G, PsailaJV, Gardner AM, Fox RH, Woodcock JP. Arterial tlow enhancement by impulse compression. Vase Surg 1991;25:8-15. 12. van Bernrnclen PS, Mattos MA, Faught WE, Mansour MA, Barkmeier LO, Hodgson KJ, et al, Augmentation of blood flow in limbs with occlusive arterial disease by intermittent calf compression. J VaseSurg 1994;19:1052-1058. 13. Eze AR, Comcrora AJ, Cisek PL, Holland BS, Kerr RP, Veeramasuneni R, et al, Intermittent calf and foot compression increases lower extremity blood flow. Am J Surg 1996;172:130-134. 14. Second European Consensus Document on Chronic Critical Leg Ischaemia. European Working Group on Critical Leg Ischaemia. Em J Vasc Surg 1992;6(Suppl A):1-32. 15. Foley WT. Treatment of gangrene of the feet and legs by walking. Circulation 1957;15:689-700. 16. Agerskov K, Tofft HP, Jensen FB, Engel! HC. External negative thigh pressure: effect upon blood flow and pressure in the toot in patients with occlusivearterial disease. Dan Med Bull 1990;37:451-4. 17. Mehlsen J, Himmelstrup H, Himmelstrup B, Winther K, Trap-Jensen J. Beneficial effects of intermittent suction and pressure treatment in intermittent claudication. Angiology 1993;44:16-20. 18. Augustinson LE, Carlson CA, Holm I, Iivcgard L. Epidural electric stimulation in severe limb ischemia. Pain relief, increased blood flow and a possible limb-saving effect. Ann Surg 1985;202:104-110. 19. Jacobs MJ, Iorning PI, Beckers RCY, Ubbink OT, van Kleef M, SlafDW, et al, Foot salvage and improvement of microvascular blood flow as a result of epidural spinal cord electrical stimulation. J Vase Surg 1990;12:354-360. 20. Skinner JA, Cohen AT. Amputation for premature peripheral atherosclerosis: do young patients do better? Lancet 1996;348:1396. 21. Tallis R, Jacobs M, Miles J. Spinal cord stimulation in peripheral vascular disease. Br J Neurosurg 1992;6:101-105. 22. Iivegard LE, Augustinsson LE, Holm J, Risberg B, Ortenwall P. Effects of spinal cord stimulation (SCS) in patients with inoperable severe lower limb ischemia: a prospective, randomised, controlled study. Eur J Vase Endovasc Surg 1995;9(4)421-425. 23. Spincernaille GH, Steycrbcrg EW, Habbcrna JD, van Urk H, for the ESES Study. Spinal-cord stimulation in critical limb ischaemia: a randornised trial, ESES Study Group. Lancet 1999;353:1040-1044. 24. Ernst E. Chelation therapy for peripheral arterial occlusive disease: a systematic review. Circulation 1997;96;1031-1033. 25. Walker PM, Johnston KW: Predicting the success of a sympathectomy]: a prospective study using discriminant function and multiple regression analysis. Surgery 1980;87:216-221. 26. Persson AV, Anderson LA, Padberg FT. Selection of patients for lumbar sympathectomy. Surg Clin North Am 1985;65:393-403.
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D4 Treatmentof Critical Limb Ischemia 8267
27. Fulton RL, Blakeley WR. Lumbar sympathectomy: a procedure of questionable value in the treatment of arteriosclerosis obliterans of the legs. Am J Surg 1968;116:735-744. 28. Satiani B, Liapis CD, Hayes JP, Kimmins S, Evans WE. Prospective randomized study of concomitant lumbar sympathectomy with aortoiliac reconstruction. Air. J Surg 1982 Jun;143(6):755-760. 29. Barnes RW, Baker WH, Shanik G, Maixner W, Hayes AC, Lin R, Clarke W. Value of concomitant sympathectomy in acrtoiliac reconstruction: results of a prospective, randomized study. Arch Surg 1977 Nov;112( 11): 1325-1330. 30. Perler BA, Christopherson R, Rosenfeld BA, Norris E}, Frank S, Beattie C, et al, The influence of anesthetic method on infrainguinal bypass graft patency: a closer look.Am Surg 1995;61(9):784-789. 31. Schunn CD, Hertzer NR, O'Hara PJ, Krajewski LP, Sullivan TM, Beven EG. Epidural versus general anesthesia: does anesthetic management influence early infrainguinal graft thrombosis? AtU1 Vasc Surg 1998;J,\n 12(1):65-69. 32. Pierce ET, Pomposelli FB, Stanley GD, Lewis KP, Cass JL, LoGerfo FW, ct a!' Anesthesia type does not influence early graft patency or limb salvage rates of lower extremity arterial bypass. J Vase Surg 1997;Feb;25(2):226-232; discussion 232-233.
D 4.17
Amputation Because patients with severe lower extremity ischemia have a high incidence of coexisting myocardial, cerebrovascular and renal disease, their operative risk is significantly elevated. Therefore the indications for amputation, selection of the appropriate level and surgical management of these patients must clearly be established prior to the procedure to avoid the need for revision or re-amputation (see A 2.9.2, Risk Factors for Major Amputation, p 525).
D 4.17.1 Indications for Amputation
Primary amputation Primary amputation is defined as amputation of the ischemic lower extremity without an antecedent attempt at revascularization. Amputation is considered as primary therapy for lower limb ischemia only in selected cases. UnreconstructabJe arterial disease is generally due to the progressive nature of the underlying atherosclerotic occlusive disease. Newer imaging techniques, such as magnetic resonance angiography, duplex ultrasonography, and more recently, high-resolution digital angiography, have improved the ability of physicians to pre-operatively detect patent distal vessels that might serve as su.itable recipient sites for the construction of a bypass. 1 The complete absence of detectable distal vessels, using modern imaging techniques, especially in the setting of advanced distal ischemia associated with a low ABPI «0.30), suggests that vascular reconstruction is not possible and that major amputation' is inevitable.t-' These patients are best served by primary amputation.s Ulceration and necrosis of me weight-bearing surface of the foot are frequent causes of amputation. In a recent study of more than 200 patients requiring amputation loss of the foot pads at the level of the digits, metatarsophalangeal joints and the heel was the indication for amputation in more than 75% of cases.f Loss of the heel renders revascularization useless for preservation of ambulation.v The use of myocutaneous free flaps tor the replacement of necrotic muscle and skin has been reported as a technique for extending limb salvage in selected patients'? This aggressive vascular reconstructive effort, however, may be associated with multiple procedures, a recuperative period of more than 6 months and yields flap survival in the range of 50% to 62% and a functional foot in 50% to 86%, respective!y.8,9,10,11 As vascular reconstruction in these patients does not result in a functional extremity, primary amputation provides optimal therapy. Nonambulatory elderly patients represent a particularly challenging group. Peripheral arterial occlusive disease is often severe and associated with rest pain and tissue loss. These patients frequently have flexion contractures which form from the prolonged withdrawal response to the pain. Aggressive vascular reconstruction does not provide these patients with a stable and useful limb. The surgical endeavor is significantly complicated by the presence of the flexion contrac-
Volume 31, Number 1, Part 2
D4 Treatment of Critical Limb Ischemia 8263
References
1. Moore WS. Carotid endarterectomy: is it safe in the community? J VaseSurg 1986;4:313-314. 2. Rich NM, Hughes CWo Vietnam vascular registry: a preliminary report. Surgery 1969;65:218-226. 3. Plecha FR, Avellone JC, Beven EG, DePalma RG, Hertzer NR. A computerized vascular registry: experience of the Cleveland Vascular Society. Surgery 1979;86:826-835. 4. Karmody AM, Blumenberg RM, Wall CA. Preliminary experience with a large scale vascularregistry. Am J Surg 1983;146:162-163. 5. Karmody AM, Fitzgerald K, Branagh M. Leather RP. Development of a computerized vascular registry for large scale use. J Vase Surg 1984;1:594-600. 6. Auditing Surgical Outcome: 10 years with the Swedish Vascular Registry (SWEDVASC). Eur J Surg 1998;164(suppl)581. 7. Jensen LP, Schroeder TV, Madsen PV, Lorentzen JE. Vascular registers in Denmark based on personal computers. Ann Chir GynaecoI1992;81:253-256. 8. Lepantalo M, Salenius JP, Alhack A, Ylonen K, Luther M. Frequency of repeated vascularsurgery. A survey of 7616 surgical and endovascular Finnvasc procedures. Pinnvasc Study Group. Eur J Surg 1996;162:279-285. 9. Lepantalo M, Salenius JP, Harjola PT. Trends in vascular surgery: an evaluation of operative activity in Finland 1976-1992. Ann Chir Gynecol 1996;85:225-229. 10. Salenius JP. National vascular registry in Finland-Finnvasc. Finnvasc STUDY GROUP. Ann Chit GynaecoI1992;81:257-260. 11. Elfstrom J, Stubberod A, Troeng T. Patients not included in medical audit have a worse outcome than those included. Int J of Quality Health Care 1996;8:153-157. 12. Jensen LP, Nielsen OM, Schroeder TV. The importance of complete follow-up for results after femoro-infrapopliteal vascular surgery. Eur J Vase Endovasc Surg 1996;12:282-286. 13. Zdanowski Z, Troeng T, Norgren L. Outcome and influence of age after infrainguinal revascularization in critcal limb ischemia. Swedish Vascular Registry (SWEDVASC). Eur J Vase Endovasc Surg 1998;16: 137-141. 14. Rutherford RB. Reporting standards for endovascular surgery: should existing standards be modified for newer procedures? Semin Vase Surg 1997;10:197-205. 15. Rutherford RB. Acute limb ischaemia: clinical assessment and standards for reporting. Semin VaseSurg 1986;4:80-94. 16. Rutherford RB, Flanigan PO, Gupta SK, et al. Suggested standards for reports dealing with lower extremity ischemia. Prepared by the Ad Hoc Committee on Reporting Standards, Society for Vascular SurgeryjNorth American Chapter, International Society fur Cardiovascular Surgery. J VaseSurg 1986;4:80-94. 17. Effects of perioperative iloprost on patency of femorodistal bypass grafts. The Iloprost Bypass International Study Group. Eur JVase Endovasc Surg 1996;12:363-371. 18. Reoperations, redo surgery and other site interventions constitute more than one third of vascularsurgery. A study from Swedvasc (the Swedish Vascular Registry). The Swedish Society for VascularSurgery. Eur J Vase Endovasc Surg 1997;14:244-251.
D 4.16
Other Treatment Modalities The treatment modalities considered here are not necessarily confined to sometimes also used in claudicants.
eLI patients but are
D 4.16.1 Transfusion of Ultraviolet Irradiated Autologous Blood This technique is widely used in patients with PAD in all stages, mostly in eastern countries of Europe and Russia. Photohemotherapy consists of ultraviolet radiation of autologous blood. Although a few uncontrolled studies showed an improvement of rheological properties of the blood, there is no controlled prospective study in patients with IC or CLI showing a clear clinical benefit for the treated patients.! D 4.16.2 Hyperbaric Oxygen The initial reports on the use of hyperbaric oxygen in patients with early gangrene of the legs were encouraging, because relief of pain was obtained and amputations could be postponed, even for several years.2,a In an uncontrolled study, 18% of diabetic patients with ulcers refractory to conventional treatment had complete healing, but all made at least a fair response. Seventyfive percent of atherosclerotic ulcers in nondiabetic patients improved sufficiently to allow patients to return home and resume daily activities.s The longest and largest experience was reported by Predenuccif who collected data on more than 2,000 patients treated in over 70,000 sessions between 1966 and 1983. Relief ofrest pain and healing of limiting ulcers was observed in one third of patients after 4 to 6 weeks of treatment. The therapy is cumbersome, and it is also unclear to what extent the clinical results can be attributed to concomitant therapy,
JOURNAL OF VASCULAR SURG ERY
S264 D4 Treatment of Critical Limb Ischemia
January
2000
including heparin infusion. All of the reponed studies were uncontrolled. This treatment cannot be recommended until prospective controlled trials have shown it to be beneficial.
Local treatment with hyperbaric oxygen Although local hyperbaric oxygen with topical hyperbaric OA-ygen chamber technique has undergone real waves of enthusiasm, its use for treatment of ulcers due to CLI or for stump healing problemss-? remains to be more clearly demonstrated by randomized clinical trials .
D 4.16.3 Ambulation, Intermittent Venous Compression, Negative Pressure Application Limited walking and intermittent compression of the foot, calf, or both have been shown to increase blood flow and foot TCP0 2 in limbs with PAD.8,9,lO,ll,12,13 Limited walking in patients with chronic CLI was suggested in the Second European Consensus Document on Chronic Critical Limb Ischernia.J? and Foley reported on the treatment of gangrene by walking .lf There is some evidence that increased blood flow in response to walking or intermittent venous compression may be contributed to further in some cases by the inhibition of veno arteriolar reflex vasoconstriction or by endothelium-mediated me chanisms. 1l,12 Similarly, application of external negative pressure to the leg increased skin blood flow in the foot of patients with PAD and incre ased walking distance in patients with IC. 16,1 7 These and similar approaches may be of benefit in the management of patients with PAD, especially when inre rventional treatment is not indicated, but their value needs to be assessed by properly designed clinical trials. Critical Issue 44: Limited walking) intermittent pneumatic compression) negative pressure application in peripheral arterial disease There is a need for properly designed studies to determine the benefit of limited walking, intermittent pneumatic compression, and negative pressure application in treatment of peripheral arterial disease.
D 4 .16.4 Epidural Spinal Cord Stimulation In some vascular centers in Europe, spinal cord stimulation (SCS ) has been used since the late 1960s in patients with intractable pain caused by CLI, as an alternative to amputation. The tech nique involves implantation of an electrode at the level of L3-L4 and a pulse generator subcutaneously. This method is used not only to relieve leg pain but also as a means of maintaining circulation in the leg. In one uncontrolled study, 94% of the 38 patients treated with SCS experienced pain relief, and in half of the patients, healing of ischemi c ulcers occurred.If In anothe r uncontrolled study, immediate relief of rest pain was seen in 18 of20 CLI patients. Of these, 12 patients had continued pain relief and healing of ischemic ulcers, with improved microcirculatory flow suggested by capillaroscopy.19 Nevertheless, the real mechanism of action of SCS is unknown, and the appropriate place for this form of therapy remains to be determined. Prospective studies are needed to show the value of SCS20,2I (see also D 4.2.1, Control of Pain , p 5193). Two controlled studies have been published on the efficacy of SCS in patients with inoperable severe CLI.22,23 In the first study, patients with inoperable severe CLI were randomized to either SCS or analgesic treatment only with 18 months' follow-up .R Long-term pain relief was o bserved only in the 5CS group. Limb salvage rates did not differ at the end of the follow-up period, although tissue loss was significantly less in the SCS group, and a subgroup analysis showed that patients without arterial hypertension had a lower amputation rate if treated with SCS.22 In the second study, patients with inoperable severe CLI were randomized to either SCS plus best medical treatment or best medical treatment on1y.23 Median follow-up was 605 days (interquartile range, 244-1,771). There was no difference in mortality between the two groups, and the major amputation rate was insignificantly lower in the SCS plus medical treatment group (42% vs 48%, p = 0.47).
JOURNAL or VASCULAR SURGERY Volume 31, Number 1, Part 2
D4 Treatment afCritical Limb Ischemia 8265
Recommendation 100: Spinal cord stimulation in critical limb ischemia On current evidence, spinal cord stimulation cannot be recommended in the treatment of critical limb ischemia. D 4.16.5 Chelation Therapy Chelation therapy has been promoted as a means to treat atherosclerosis and relieve symptoms of cardiovascular disease. However, there is no scientific basis to support these claims. Four randomized, double-blind, multicenter trials of ethylenediaminetetra-acetic acid (EDTA) in patients with PAD have been recently reviewed.ct The drug was not shown to be effective in treating the symptoms of c1auctication in any of these studies, nor in improving the ABPI. Furthermore, frequent infusions of EDTA may produce severe hypocalcemia and therefore actually may be dangerous. Recommendation 101: Chelation therapy in peripheral arterial disease There is no scientific basis for the use of chelation therapy in the treatment of peripheral arterial disease. D 4.16.6 Sympathectomy in the Management of Critical Limb Ischemia Among patients with atherosclerotic arterial occlusion or thromboangiitis obliterans, lumbar sympathectomy has been limited to patients with inoperable disease complicated by rest pain and tissue loss.
Sympathectomy to treat ischemic rest pain Symptom relief has been reported in 47% to 71% of unselected patients, with limb salvagein 60% to 94%.25 The best results were obtained by Persson-s among 37 patients who had an ABPI greater than 0.3, no evidence of neuropathy, and very limited tissue necrosis. In this series, 78% of patients had long-term relief of ischemic pain, and 11% required amputation. The worst results were noted by Fulton and Blakely-? in 17 unselected patients undergoing sympathectomy, with only 6% obtaining relief, whereas 70% required early amputation. Disappointing results therefore can be expected when limb-threatening ischemia is unselectively treated by sympathectomy. Sympathectomy to treat tissue loss Less impressive results than for rest pain are generally noted, with 35% to 62% of patients showing complete initial healing of the ischemic lesions. In addition, amputation rates were higher than in the rest pain group, with a range of 27 to 38%.25 Persson et al26 again reported the best results in 22 patients who had adequate inflow, no neuropathy, and no evidence of infection; 77% had ulcer healing, and only 22% required amputation. Sympathectomy as an adjunct for lower-extremity revascularization Because lumbar sympathectomy increases lower-extremity blood flow at least temporarily, it has been suggested as an adjunct during aortoiliac reconstruction in an attempt to improve outflow and graft patency. However, subsequent randomized trials failed to show any difference in clinical outcome or graft patency when sympathectomy was added during aortofemoral bypass.28,29 Thus, this technique is no longer practiced. There have not been trials of the effect of sympathectomy on infrainguinal bypass patency or efficacy, but the requirement for a separate incision discourages this approach. A benefit of temporary chemical sympathectomy provided by epidural anesthesia was suggested in one randomized trial that showed improved early infrainguinal graft patency. 3D However, two subsequent trials failed to show this effect.31,32 Currently, there is no established role for adjuvant surgical sympathectomy to improve bypass graft patency or efficacy.
JOUR...'lAL OF VASCULAR SURGERY
8266 D4 Treatment of Critical Limb Ischemia
January 2000
Current indications for lumbar sympathectomy Primary indications for lumbar sympathectomy are limited to selected patients with inoperable distal arterial occlusive disease secondary to arteriosclerosis or thromboangiitis obliterans. Current determination of inoperability differs with expertise and availability of saphenous vein. In rare cases in which such revascularization procedures are not feasible because of inadequate run-off, lumbar sympathectomy may be considered in the patients with (1) ABPI greater than 0.3; (2) superficial tissue necrosis limited to digits; (3) absent neuropathy (diabetes); (4) symptom relief after lumbar sympathetic blockade, and (5) acceptable surgical risk for a retroperitoneal approach. The most common complications of lumbar sympathectomy are temporary neuralgia and inadequate clinical improvement. 26 Recommendation 102: Lumbar sympathectomy in critical limb ischemia There is currently insufficient scientific evidence for the selection of patients likely to benefit from lumbar sympathectomy for the treatment of critical limb ischemia. References 1. Karandashov VI, Petukhov EB, KaralkinAV. The regional hemodynamics in patients with chronic arterial insufficiency of the lower extremities after the transfusion ofUV-irradiated autologous blood. Vesrn Khir Irn II Grek 1996;155(2):76-78. 2. TIlingworth CFW. Treatment of arterial occlusion under oxygen at two atmospheres pressure. Br Med J 1962;2: 1272. 3. Koomen AR. The influence of hyperbaric oxygen in chronic arterial obstruction of the peripheral arteries. J Cardiovasc Surg 1967;8:335-337. 4. Hart GB, Strauss MB. Responses of ischemic conditions to OHP. In: Smith G, ed. Hyperbaric Medicine. Aberdeen: Aberdeen University Press, P312-314. 5. Fredenuccl P. Oxygenothcrapie hypcrbare et arteropathies. J Mal Vase 1985;10(Suppl A):166-172. 6. Fischer BH. Treatment of ulcers on the legs with hyperbaric oxygen. J Derrnatol Surg 1975;1:55-58. 7. Diamond E, Forst MB, Hyman SA, Rand SA. The effect of hyperbaric oxygen on lower extremity ulcerations. J Am Podiatry Assoc 1982;72: 180-185. S. Spacil J, Hlavova A, Linhart J, Prerovsky r. The effect of slow walking on the subcutaneous blood How in the leg in patients with ischemic disease of lower limbs. Vasa 1976;5:323-328. 9. Gaskell P, Parrott JC. The effect of a mechanical venous pump on the circulation of the feet in the presence of arterial obstructions. Surg Gynaecol Obstet 1978;146:583-592. 10. Carter SA. Effects of ambulation on foot oxygen tension in limbs with peripheral atherosclerosis. Clin Physiol 1996;16: 199-208. 11. Morgan RH, Carolan G, PsailaJV, Gardner AM, Fox RH, Woodcock JP. Arterial tlow enhancement by impulse compression. Vase Surg 1991;25:8-15. 12. van Bernrnclen PS, Mattos MA, Faught WE, Mansour MA, Barkmeier LO, Hodgson KJ, et al, Augmentation of blood flow in limbs with occlusive arterial disease by intermittent calf compression. J VaseSurg 1994;19:1052-1058. 13. Eze AR, Comcrora AJ, Cisek PL, Holland BS, Kerr RP, Veeramasuneni R, et al, Intermittent calf and foot compression increases lower extremity blood flow. Am J Surg 1996;172:130-134. 14. Second European Consensus Document on Chronic Critical Leg Ischaemia. European Working Group on Critical Leg Ischaemia. Em J Vasc Surg 1992;6(Suppl A):1-32. 15. Foley WT. Treatment of gangrene of the feet and legs by walking. Circulation 1957;15:689-700. 16. Agerskov K, Tofft HP, Jensen FB, Engel! HC. External negative thigh pressure: effect upon blood flow and pressure in the toot in patients with occlusivearterial disease. Dan Med Bull 1990;37:451-4. 17. Mehlsen J, Himmelstrup H, Himmelstrup B, Winther K, Trap-Jensen J. Beneficial effects of intermittent suction and pressure treatment in intermittent claudication. Angiology 1993;44:16-20. 18. Augustinson LE, Carlson CA, Holm I, Iivcgard L. Epidural electric stimulation in severe limb ischemia. Pain relief, increased blood flow and a possible limb-saving effect. Ann Surg 1985;202:104-110. 19. Jacobs MJ, Iorning PI, Beckers RCY, Ubbink OT, van Kleef M, SlafDW, et al, Foot salvage and improvement of microvascular blood flow as a result of epidural spinal cord electrical stimulation. J Vase Surg 1990;12:354-360. 20. Skinner JA, Cohen AT. Amputation for premature peripheral atherosclerosis: do young patients do better? Lancet 1996;348:1396. 21. Tallis R, Jacobs M, Miles J. Spinal cord stimulation in peripheral vascular disease. Br J Neurosurg 1992;6:101-105. 22. Iivegard LE, Augustinsson LE, Holm J, Risberg B, Ortenwall P. Effects of spinal cord stimulation (SCS) in patients with inoperable severe lower limb ischemia: a prospective, randomised, controlled study. Eur J Vase Endovasc Surg 1995;9(4)421-425. 23. Spincernaille GH, Steycrbcrg EW, Habbcrna JD, van Urk H, for the ESES Study. Spinal-cord stimulation in critical limb ischaemia: a randornised trial, ESES Study Group. Lancet 1999;353:1040-1044. 24. Ernst E. Chelation therapy for peripheral arterial occlusive disease: a systematic review. Circulation 1997;96;1031-1033. 25. Walker PM, Johnston KW: Predicting the success of a sympathectomy]: a prospective study using discriminant function and multiple regression analysis. Surgery 1980;87:216-221. 26. Persson AV, Anderson LA, Padberg FT. Selection of patients for lumbar sympathectomy. Surg Clin North Am 1985;65:393-403.
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D4 Treatmentof Critical Limb Ischemia 8267
27. Fulton RL, Blakeley WR. Lumbar sympathectomy: a procedure of questionable value in the treatment of arteriosclerosis obliterans of the legs. Am J Surg 1968;116:735-744. 28. Satiani B, Liapis CD, Hayes JP, Kimmins S, Evans WE. Prospective randomized study of concomitant lumbar sympathectomy with aortoiliac reconstruction. Air. J Surg 1982 Jun;143(6):755-760. 29. Barnes RW, Baker WH, Shanik G, Maixner W, Hayes AC, Lin R, Clarke W. Value of concomitant sympathectomy in acrtoiliac reconstruction: results of a prospective, randomized study. Arch Surg 1977 Nov;112( 11): 1325-1330. 30. Perler BA, Christopherson R, Rosenfeld BA, Norris E}, Frank S, Beattie C, et al, The influence of anesthetic method on infrainguinal bypass graft patency: a closer look.Am Surg 1995;61(9):784-789. 31. Schunn CD, Hertzer NR, O'Hara PJ, Krajewski LP, Sullivan TM, Beven EG. Epidural versus general anesthesia: does anesthetic management influence early infrainguinal graft thrombosis? AtU1 Vasc Surg 1998;J,\n 12(1):65-69. 32. Pierce ET, Pomposelli FB, Stanley GD, Lewis KP, Cass JL, LoGerfo FW, ct a!' Anesthesia type does not influence early graft patency or limb salvage rates of lower extremity arterial bypass. J Vase Surg 1997;Feb;25(2):226-232; discussion 232-233.
D 4.17
Amputation Because patients with severe lower extremity ischemia have a high incidence of coexisting myocardial, cerebrovascular and renal disease, their operative risk is significantly elevated. Therefore the indications for amputation, selection of the appropriate level and surgical management of these patients must clearly be established prior to the procedure to avoid the need for revision or re-amputation (see A 2.9.2, Risk Factors for Major Amputation, p 525).
D 4.17.1 Indications for Amputation
Primary amputation Primary amputation is defined as amputation of the ischemic lower extremity without an antecedent attempt at revascularization. Amputation is considered as primary therapy for lower limb ischemia only in selected cases. UnreconstructabJe arterial disease is generally due to the progressive nature of the underlying atherosclerotic occlusive disease. Newer imaging techniques, such as magnetic resonance angiography, duplex ultrasonography, and more recently, high-resolution digital angiography, have improved the ability of physicians to pre-operatively detect patent distal vessels that might serve as su.itable recipient sites for the construction of a bypass. 1 The complete absence of detectable distal vessels, using modern imaging techniques, especially in the setting of advanced distal ischemia associated with a low ABPI «0.30), suggests that vascular reconstruction is not possible and that major amputation' is inevitable.t-' These patients are best served by primary amputation.s Ulceration and necrosis of me weight-bearing surface of the foot are frequent causes of amputation. In a recent study of more than 200 patients requiring amputation loss of the foot pads at the level of the digits, metatarsophalangeal joints and the heel was the indication for amputation in more than 75% of cases.f Loss of the heel renders revascularization useless for preservation of ambulation.v The use of myocutaneous free flaps tor the replacement of necrotic muscle and skin has been reported as a technique for extending limb salvage in selected patients'? This aggressive vascular reconstructive effort, however, may be associated with multiple procedures, a recuperative period of more than 6 months and yields flap survival in the range of 50% to 62% and a functional foot in 50% to 86%, respective!y.8,9,10,11 As vascular reconstruction in these patients does not result in a functional extremity, primary amputation provides optimal therapy. Nonambulatory elderly patients represent a particularly challenging group. Peripheral arterial occlusive disease is often severe and associated with rest pain and tissue loss. These patients frequently have flexion contractures which form from the prolonged withdrawal response to the pain. Aggressive vascular reconstruction does not provide these patients with a stable and useful limb. The surgical endeavor is significantly complicated by the presence of the flexion contrac-