- Email: [email protected]
Percutaneous Balloon Angioplasty: Standing the Test of Time
18. Abbruzzese TA, Havens], Belkin M, Donaldson MC, Whittemore AD, Liao ]K, Conte MS. Statin therapy is associated with improved patency of autogenous infra inguinal bypass grafts. ] Vase Surg 2004; 39: 1178-1185. 19. Mann M], Whittemore AD, Donaldson MC, Belkin M, Conte MS, Polak], et al. Ex-vivo gene therapy of human vascular bypass grafts with E2F decoy; the PREVENT single-centre, randomized, controlled trial. Lancet 1999; 3544:1493-1498. 2:40 p.m.
Percutaneous Balloon Angioplasty: Standing the Test of Time Krishna Kandarpa, MD, PhD University ofMassachusetts Medical School Worcester, MIl Although percutaneous endoluminal procedures, such as SFA balloon angioplasty, are frequendy used to treat peripheral atherosclerotic lesions, their role in overall patient management is often not clearly established. The realities of current medical economics require that medical decision theorists integrate safety, efficacy, and cost data to establish the true cost-effectiveness of competing treatment modalities. Well-conducted controlled large multi-center comparative studies of transcathter therapy and surgelY are not available and quality of the literature on surgical management is also deficient. A prior published review (1) of the English language literature on transcatheter endovascular procedures for the lower extremity included reports (Medline: 19931999) providing a high quality of evidence (U.S. Preventive Services Task Force Quality of Evidence Ratings, QOE Level I: prospective randomized trials) for decisionmaking regarding such therapy. Percutaneous techniques generally yield lower patency results than surgelY and both are expensive. However, since the associated risks of periprocedural mortality and morbidity of percutaneous revascularization are low, even for early intermjttent claudication, PTA is a viable option. Trade-offs of chosen treatment options need to be understood to justify related costs (2-6). One randomized controlled trial (ReT) compared PTA with exercise demonstrating a larger improvement in walking distance with exercise in the short-term (6) but no significant differences in long-term outcome. A randomized-controlled comparison of PTA with surgery in patients demonstrated no difference in outcome (7,8). Yet, a third RCT comparing PTA with surgery was also unable to demonst.rate a difference in long-term outcome but showed a reduced length of hospital stay (LOS) in patients treated with PTA (9). A recent decisionanalysis study suggested that angioplasty was more effective than exercise for claudication (10). Given these mixed results, endovascular treatment had generally been reserved for focal disease. However, in recent years, the length of "focal disease" amenable to endo-
vascular procedures has increased with the inroduction of newer devices. Patients with symptomatic femoropopliteal atherosclerotic lesions will benefit from endovascular procedures if the proper selection criteria are used. A favorable outcome can be expected under the follOWing conditions: intermittent claudication, proXimal lesion location, short lesions, stenoses, good distal run-off, and lack of reSidual stenosis following treatment (11-15). A meta-analysis of the literature on femoropopliteal PTA (Table) showed that balloon angioplasty of stenoses and synthetic po!ytetrafluoroethylene (PTFE) bypass grafts share an equivalent risk of long-term failure, but have approximately twice the risk compared to venous bypass grafts (16). Another decision- and cost-effectiveness analysis of the literature suggested that PTA as initial treatment was both more effective and less costly for patients with focal femoropopliteal stenoses with either claudication or critical ischemia. Although the same is true for patients with a focal occlusion and claudication, a substantial propOltion still required a bypass graft for long-term failure of angioplasty (16). Two RCTs suggest that neither atherectomy nor stenting improve the patency rates of femoropopliteal PTA (14,15). Femoropopliteal stenting is useful when balloon angioplasty fails technically (17). Angioplasty is currently the recommended option for femoropopliteal disease in .patients with single stenoses or occlusions up to 5 em long, or multiple lesions each less than 3 em, not involving the distal popliteal artelY (16). For longer lesions, subintimal angioplasty may playa role (18). For patients with critical ischemia with occlusions less than 5 em in length, primalY stenting may have added benefit (19). Recent trials of percutaneous stent-graft (Viabahn self-expanding covered stents) placement for treating femoral arterial occlusive disease show promising early and midterm patencies (20). Coated stents may have role in prolonging patency in treated SFA lesions. The correction of prothrombotic factors prevalent in patients with infra-inguinal disease may also improve the outcomes of angioplasty (21). Considerable progress has been made in generating supporting evidence for the proper application of transcatheter treatment for peripheral atherosclerosis, but significant gaps remain. Quality of life is determined by preservation of mobility. For treatments such as lower extremity PTA, early medical decision models and costeffectiveness data are emerging and provide good evidence to recommend these therapies for the specific indications discussed above.
References 1. Kandarpa K, Becker G], Hunink MGM, et al. Image-
guided Transcatheter Interventions for the Treatment of Peripheral Atherosclerotic Lesions. Parts I: Peripheral Vascular Interventions. ]VIR 2001; 12: 683-695.
P57
2. Coffman ]D. Intermittent claudication - be conservative. N Engl] Med. 1991;325:577-578. 3. Gold, MR, editor. Cost-effectiveness in health and medicine. New York: Oxford University Press; 1996. 4. Lundgren F, Dahllof AG, Lundholm K, Schersten T, Volkmann R. Intermittent claudication - surgical reconstruction or physical training? Ann Surg. 1989; 209(3): 346-355. 5. Creasy TS, McMillan P], Fletcher EW, Collin], Morris PJ. Is percutaneous transluminal angioplasty better than exercise for claudication? Preliminary results from a prospective randomized trial. Eur] Vase Surg. 1990; 4:135-140.
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6. Perkins ]M, Collin], Creasy TS, Fletcher EW, Morris PJ. Exercise training versus angioplasty for stable claudication. Long and medium term results of a prospective, randomized trial. Eur] Vase Endovasc Surg. 1996; 11:409-413. 7. Wilson SE, Wolf GL, Cross AP. Percutaneous transluminal angioplasty versus operation for peripheral arteriosclerosis. Report of a prospective randomized trial in a selected group of patients. ] Vase Surg. 1989;9:1-9. 8. Wolf GL, Wilson SE, Cross AP, Deupree RH, Stason WE. Surgery or balloon angioplasty for peripheral vascular disease: a randomized clinical trial. Principal investigators and their Associates of Veterans Administration Cooperative Study Number 199. ] Vase Interv Radiol. 1993;4:639-648. 9. Holm], Arfvidsson B,]ivegard L, et al. Chronic lower limb ischaemia. A prospective randomised controlled study comparing the I-year results of vascular surgety and percutaneous transluminal angioplasty (PTA). Eur] Vase Surg. 1991;5:517-522. 10. De Vries SO, Vissier K, De Vries]A, et al. Intermittent claudication: cost-effectiveness of revascularization versus exercise therapy. Radiology 2002; 222:25-36. 11. Hunink MG, Wong ]B, Donaldson MC, Meyerovitz MF, Harrington DP. Patency results of percutaneous and surgical revascularization for femoropopliteal arterial disease. Med Decis Making. 1994;14:71-81. 12. Matsi P], Manninen HI, Vanninen RL, et al. Femoropopliteal angioplasty in patients with claudication: primary and secondary patency in 140 limbs with 1-3-year follow-up. Radiology. 1994;191:727-733. 13. Hunink MG, Donaldson MC, Meyerovitz MF, et al. Risks and benefits of femoropopliteal percutaneous balloon angioplasty.] Vase Surg. 1993;17:183-194.
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14. Tielbeek AV, Vroegindeweij D, Buth ], Landman GH. Comparison of balloon angioplasty and Simpson atherectomy for lesions in the femoropopliteal artery: angiographic and clinical results of a prospective randomized trial. ] Vase Interv Radiol. 1996;7: 837-844.
15. Vroegindeweij D, Vos LD, Tielbeek AV, Buth J, v.d. Bosch He. Balloon angioplasty combined with primary stenting versus balloon angioplasty alone in femoropopliteal obstructions: a comparative randomized study. Cardiovasc Intervent Radiol. 1997; 20:420-425.
Why not just amputate? Be ready to answer these questions. ii. 40% of CCLI patients will be dead in three years e. Surgical back-up? i. You will need a plan if "things go badly"
16. Hunink MG, Wong JB, Donaldson MC, Meyerovitz MF, de Vries JA, Harrington DP. Revascularization for femoropopliteal disease. A decision and costeffectiveness analysis. JAMA. 1995;274: 165-171.
1. Role of anticoagulation a. Try to avoid full anticoagulation and subintimal tract balloon dilatation until you re-enter the distal true lumen..this limits bleeding should you perforate the subintimal channel prior to re-entry into the true lumen
17. TransAtlantic Inter-Society Consensus (TASC) Working Group. Management of peripheral arterial occlusive disease: TASC document. 18. Spinosa DJ, Leung DA, Matsumoto AH, et al. Percutaneous intentional extraluminal recanalization in patients with chronic critical limb ischemia. Radiology 2004; 232: 499-507. 19. Muradin GSR, Bosch JL, Stijnen T, Hunink MGM. Balloon dilation and stent implantation for treatment of femoropopliteal artelial disease: meta-analysis. Radiology 2001;221:137-145. 20. Jahnke T, Muller-Hulsbeck S. Current and future strategies in the treatment of PVD. Plenary Session: 14.2. CIRSE 2004, Barcelona, Spain. 21. Caldwell S, Martin G, Reid S, et al. Prothrombotic abnormalities in patients undergoing infrainguinal angioplasty. B]S 1999 (suppl); 86: 25-26.
2:55 p.m. Subintimal Recanalization Techniques David j. Spinosa, MD
1. "Cowboy up" a. Can YQ1llive "on the front of the wave" i. Time to be honest with yourself about your skills and your environment ii. Match your skill level to the level of difficulty of the procedure 2. Patient selection: "pick your battles"
a. Chronic critical limb ischemia (CCLI) vs claudication i. Greater "satisfaction" in CCLI patients even with limited patency? b. Heal ulcers i. Treating large heal ulcers (>4 cm) can be a set-up for failure even when re-establishing good circulation. c. Medical and surgical risk factors i. Patients "too sick" for surgery will require support from your medical collegues...get them involved early d. Treatment goals: i. Have a realistic goal for both the patient and family. Will this patient walk? Will treating this patient be good utilization of resources?
2. Role of coil embolization a. Bleeding almost always stopS if you pelforate the subintimal channel before exiting into the true distal vessel lumen when you pull out the catheter from the subintimal space... if it doesn't because you have anticoagulated or balloon dilated the subintimal tract prior to distal lumen re-entry ---? coil embolize the tract. 3. Role of emergency surgery a. Usually not necessary unless you aggressively "strip" the distal colaterals due to prolonged and repetitive attempts to re-enter the true lumen, or you cause a compartment syndrome in the lower leg due to excessive bleeding.
3. Have "the talk" with the patient and their family upfront a. The "a" word: amputation i. 75-95% of patients with CCLI will have an amputation in one year if no treatment is provided. b. Advantages/disadvantages of surgery vs. plain old PTA vs. SIR i. Surgery results depend on: 1. The surgeon 2. Level of the distal anastomosis 3. Amount of run-off 4. Bypass material: vein vs. synthetic 5. Indication: CCLI vs. claudication ii. PTA: still has a role 1. Relatively short «10 cm) lengths of disease (stenoses or occlusions) that when treated result in "straight-line flow" to the foot. iii. SIR: the alternative 1. Patients who are poor surgical risk, and/or have no vein conduit, have roo much disease for PTA. And have a distal target to create "straight-line flow" to tbe foot.
P59
Percutaneous Balloon Angioplasty: Standing the Test of Time Krishna Kandarpa, MD, PhD University ofMassachusetts Medical School Worcester, MIl Although percutaneous endoluminal procedures, such as SFA balloon angioplasty, are frequendy used to treat peripheral atherosclerotic lesions, their role in overall patient management is often not clearly established. The realities of current medical economics require that medical decision theorists integrate safety, efficacy, and cost data to establish the true cost-effectiveness of competing treatment modalities. Well-conducted controlled large multi-center comparative studies of transcathter therapy and surgelY are not available and quality of the literature on surgical management is also deficient. A prior published review (1) of the English language literature on transcatheter endovascular procedures for the lower extremity included reports (Medline: 19931999) providing a high quality of evidence (U.S. Preventive Services Task Force Quality of Evidence Ratings, QOE Level I: prospective randomized trials) for decisionmaking regarding such therapy. Percutaneous techniques generally yield lower patency results than surgelY and both are expensive. However, since the associated risks of periprocedural mortality and morbidity of percutaneous revascularization are low, even for early intermjttent claudication, PTA is a viable option. Trade-offs of chosen treatment options need to be understood to justify related costs (2-6). One randomized controlled trial (ReT) compared PTA with exercise demonstrating a larger improvement in walking distance with exercise in the short-term (6) but no significant differences in long-term outcome. A randomized-controlled comparison of PTA with surgery in patients demonstrated no difference in outcome (7,8). Yet, a third RCT comparing PTA with surgery was also unable to demonst.rate a difference in long-term outcome but showed a reduced length of hospital stay (LOS) in patients treated with PTA (9). A recent decisionanalysis study suggested that angioplasty was more effective than exercise for claudication (10). Given these mixed results, endovascular treatment had generally been reserved for focal disease. However, in recent years, the length of "focal disease" amenable to endo-
vascular procedures has increased with the inroduction of newer devices. Patients with symptomatic femoropopliteal atherosclerotic lesions will benefit from endovascular procedures if the proper selection criteria are used. A favorable outcome can be expected under the follOWing conditions: intermittent claudication, proXimal lesion location, short lesions, stenoses, good distal run-off, and lack of reSidual stenosis following treatment (11-15). A meta-analysis of the literature on femoropopliteal PTA (Table) showed that balloon angioplasty of stenoses and synthetic po!ytetrafluoroethylene (PTFE) bypass grafts share an equivalent risk of long-term failure, but have approximately twice the risk compared to venous bypass grafts (16). Another decision- and cost-effectiveness analysis of the literature suggested that PTA as initial treatment was both more effective and less costly for patients with focal femoropopliteal stenoses with either claudication or critical ischemia. Although the same is true for patients with a focal occlusion and claudication, a substantial propOltion still required a bypass graft for long-term failure of angioplasty (16). Two RCTs suggest that neither atherectomy nor stenting improve the patency rates of femoropopliteal PTA (14,15). Femoropopliteal stenting is useful when balloon angioplasty fails technically (17). Angioplasty is currently the recommended option for femoropopliteal disease in .patients with single stenoses or occlusions up to 5 em long, or multiple lesions each less than 3 em, not involving the distal popliteal artelY (16). For longer lesions, subintimal angioplasty may playa role (18). For patients with critical ischemia with occlusions less than 5 em in length, primalY stenting may have added benefit (19). Recent trials of percutaneous stent-graft (Viabahn self-expanding covered stents) placement for treating femoral arterial occlusive disease show promising early and midterm patencies (20). Coated stents may have role in prolonging patency in treated SFA lesions. The correction of prothrombotic factors prevalent in patients with infra-inguinal disease may also improve the outcomes of angioplasty (21). Considerable progress has been made in generating supporting evidence for the proper application of transcatheter treatment for peripheral atherosclerosis, but significant gaps remain. Quality of life is determined by preservation of mobility. For treatments such as lower extremity PTA, early medical decision models and costeffectiveness data are emerging and provide good evidence to recommend these therapies for the specific indications discussed above.
References 1. Kandarpa K, Becker G], Hunink MGM, et al. Image-
guided Transcatheter Interventions for the Treatment of Peripheral Atherosclerotic Lesions. Parts I: Peripheral Vascular Interventions. ]VIR 2001; 12: 683-695.
P57
2. Coffman ]D. Intermittent claudication - be conservative. N Engl] Med. 1991;325:577-578. 3. Gold, MR, editor. Cost-effectiveness in health and medicine. New York: Oxford University Press; 1996. 4. Lundgren F, Dahllof AG, Lundholm K, Schersten T, Volkmann R. Intermittent claudication - surgical reconstruction or physical training? Ann Surg. 1989; 209(3): 346-355. 5. Creasy TS, McMillan P], Fletcher EW, Collin], Morris PJ. Is percutaneous transluminal angioplasty better than exercise for claudication? Preliminary results from a prospective randomized trial. Eur] Vase Surg. 1990; 4:135-140.
°
Lrl r--.. 0' 0' 00
I I I
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I I Or--..I 2.
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6. Perkins ]M, Collin], Creasy TS, Fletcher EW, Morris PJ. Exercise training versus angioplasty for stable claudication. Long and medium term results of a prospective, randomized trial. Eur] Vase Endovasc Surg. 1996; 11:409-413. 7. Wilson SE, Wolf GL, Cross AP. Percutaneous transluminal angioplasty versus operation for peripheral arteriosclerosis. Report of a prospective randomized trial in a selected group of patients. ] Vase Surg. 1989;9:1-9. 8. Wolf GL, Wilson SE, Cross AP, Deupree RH, Stason WE. Surgery or balloon angioplasty for peripheral vascular disease: a randomized clinical trial. Principal investigators and their Associates of Veterans Administration Cooperative Study Number 199. ] Vase Interv Radiol. 1993;4:639-648. 9. Holm], Arfvidsson B,]ivegard L, et al. Chronic lower limb ischaemia. A prospective randomised controlled study comparing the I-year results of vascular surgety and percutaneous transluminal angioplasty (PTA). Eur] Vase Surg. 1991;5:517-522. 10. De Vries SO, Vissier K, De Vries]A, et al. Intermittent claudication: cost-effectiveness of revascularization versus exercise therapy. Radiology 2002; 222:25-36. 11. Hunink MG, Wong ]B, Donaldson MC, Meyerovitz MF, Harrington DP. Patency results of percutaneous and surgical revascularization for femoropopliteal arterial disease. Med Decis Making. 1994;14:71-81. 12. Matsi P], Manninen HI, Vanninen RL, et al. Femoropopliteal angioplasty in patients with claudication: primary and secondary patency in 140 limbs with 1-3-year follow-up. Radiology. 1994;191:727-733. 13. Hunink MG, Donaldson MC, Meyerovitz MF, et al. Risks and benefits of femoropopliteal percutaneous balloon angioplasty.] Vase Surg. 1993;17:183-194.
~
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14. Tielbeek AV, Vroegindeweij D, Buth ], Landman GH. Comparison of balloon angioplasty and Simpson atherectomy for lesions in the femoropopliteal artery: angiographic and clinical results of a prospective randomized trial. ] Vase Interv Radiol. 1996;7: 837-844.
15. Vroegindeweij D, Vos LD, Tielbeek AV, Buth J, v.d. Bosch He. Balloon angioplasty combined with primary stenting versus balloon angioplasty alone in femoropopliteal obstructions: a comparative randomized study. Cardiovasc Intervent Radiol. 1997; 20:420-425.
Why not just amputate? Be ready to answer these questions. ii. 40% of CCLI patients will be dead in three years e. Surgical back-up? i. You will need a plan if "things go badly"
16. Hunink MG, Wong JB, Donaldson MC, Meyerovitz MF, de Vries JA, Harrington DP. Revascularization for femoropopliteal disease. A decision and costeffectiveness analysis. JAMA. 1995;274: 165-171.
1. Role of anticoagulation a. Try to avoid full anticoagulation and subintimal tract balloon dilatation until you re-enter the distal true lumen..this limits bleeding should you perforate the subintimal channel prior to re-entry into the true lumen
17. TransAtlantic Inter-Society Consensus (TASC) Working Group. Management of peripheral arterial occlusive disease: TASC document. 18. Spinosa DJ, Leung DA, Matsumoto AH, et al. Percutaneous intentional extraluminal recanalization in patients with chronic critical limb ischemia. Radiology 2004; 232: 499-507. 19. Muradin GSR, Bosch JL, Stijnen T, Hunink MGM. Balloon dilation and stent implantation for treatment of femoropopliteal artelial disease: meta-analysis. Radiology 2001;221:137-145. 20. Jahnke T, Muller-Hulsbeck S. Current and future strategies in the treatment of PVD. Plenary Session: 14.2. CIRSE 2004, Barcelona, Spain. 21. Caldwell S, Martin G, Reid S, et al. Prothrombotic abnormalities in patients undergoing infrainguinal angioplasty. B]S 1999 (suppl); 86: 25-26.
2:55 p.m. Subintimal Recanalization Techniques David j. Spinosa, MD
1. "Cowboy up" a. Can YQ1llive "on the front of the wave" i. Time to be honest with yourself about your skills and your environment ii. Match your skill level to the level of difficulty of the procedure 2. Patient selection: "pick your battles"
a. Chronic critical limb ischemia (CCLI) vs claudication i. Greater "satisfaction" in CCLI patients even with limited patency? b. Heal ulcers i. Treating large heal ulcers (>4 cm) can be a set-up for failure even when re-establishing good circulation. c. Medical and surgical risk factors i. Patients "too sick" for surgery will require support from your medical collegues...get them involved early d. Treatment goals: i. Have a realistic goal for both the patient and family. Will this patient walk? Will treating this patient be good utilization of resources?
2. Role of coil embolization a. Bleeding almost always stopS if you pelforate the subintimal channel before exiting into the true distal vessel lumen when you pull out the catheter from the subintimal space... if it doesn't because you have anticoagulated or balloon dilated the subintimal tract prior to distal lumen re-entry ---? coil embolize the tract. 3. Role of emergency surgery a. Usually not necessary unless you aggressively "strip" the distal colaterals due to prolonged and repetitive attempts to re-enter the true lumen, or you cause a compartment syndrome in the lower leg due to excessive bleeding.
3. Have "the talk" with the patient and their family upfront a. The "a" word: amputation i. 75-95% of patients with CCLI will have an amputation in one year if no treatment is provided. b. Advantages/disadvantages of surgery vs. plain old PTA vs. SIR i. Surgery results depend on: 1. The surgeon 2. Level of the distal anastomosis 3. Amount of run-off 4. Bypass material: vein vs. synthetic 5. Indication: CCLI vs. claudication ii. PTA: still has a role 1. Relatively short «10 cm) lengths of disease (stenoses or occlusions) that when treated result in "straight-line flow" to the foot. iii. SIR: the alternative 1. Patients who are poor surgical risk, and/or have no vein conduit, have roo much disease for PTA. And have a distal target to create "straight-line flow" to tbe foot.
P59