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• W1969895980 abstract "PreambleThe membership of the Society of Interventional Radiology (SIR) Standards of Practice Committee represents experts in a broad spectrum of interventional procedures from both the private and academic sectors of medicine. Generally, Standards of Practice Committee members dedicate the vast majority of their professional time to performing interventional procedures; as such, they represent a valid broad expert constituency of the subject matter under consideration for standards production.Technical documents specifying the exact consensus and literature review methodologies as well as the institutional affiliations and professional credentials of the authors of this document are available upon request from SIR, 3975 Fair Ridge Dr., Suite 400 N., Fairfax, VA 22033.This standards document is a revision of the original one that first appeared in the Journal of Vascular and Interventional Radiology in 2005 (J Vasc Interv Radiol 2005; 16:585–595). This version contains new information, including modified definitions to best reflect the current state of the art.MethodologySIR produces its Standards of Practice documents using the following process. Standards documents of relevance and timeliness are conceptualized by the Standards of Practice Committee members. A recognized expert is identified to serve as the principal author for the standard. Additional authors may be assigned depending on the magnitude of the project.An in-depth literature search is performed by using electronic medical literature databases. Then, a critical review of peer-reviewed articles is performed with regard to the study methodology, results, and conclusions. The qualitative weight of these articles is assembled into an evidence table (1McNamara T.O. Fischer J.R. Thrombolysis of peripheral arterial and graft occlusions: improved results using high-dose urokinase.AJR Am J Roentgenol. 1985; 144: 769-775Crossref PubMed Scopus (295) Google Scholar, 2Berridge D.C. Makin G.S. Hopkinson B.R. Local low dose intra-arterial thrombolytic therapy: the risk of stroke or major haemorrhage.Br J Surg. 1989; 76: 1230-1233Crossref PubMed Scopus (86) Google Scholar, 3Durham J.D. Geller S.C. Abbott W.M. et al.Regional infusion of urokinase into occluded lower-extremity bypass grafts: long-term clinical results.Radiology. 1989; 172: 83-87PubMed Google Scholar, 4DeMaioribus C.A. Mills J.L. Fujitani R.M. Taylor S.M. Joseph A.E. A reevaluation of intraarterial thrombolytic therapy for acute lower extremity ischemia.J Vasc Surg. 1993; 17: 888-895Abstract Full Text Full Text PDF PubMed Scopus (49) Google Scholar, 5Clouse M.E. Stokes K.R. Perry L.J. Wheeler H.G. Percutaneous intraarterial thrombolysis: analysis of factors affecting outcome.J Vasc Interv Radiol. 1994; 5: 93-100Abstract Full Text PDF PubMed Scopus (36) Google Scholar, 6Schilling J.D. Pond G.D. Mulcahy M.M. McIntyre K.E. Hunter G.C. Bernhard V.M. Catheter-directed urokinase thrombolysis: an adjunct to PTA/surgery for management of lower extremity thromboembolic disease.Angiology. 1994; 45: 851-860Crossref PubMed Scopus (12) Google Scholar, 7Ouriel K. Shortell C.K. DeWeese J.A. et al.A comparison of thrombolytic therapy with operative revascularization in the initial treatment of acute peripheral arterial ischemia.J Vasc Surg. 1994; 19: 1021-1030Abstract Full Text Full Text PDF PubMed Scopus (462) Google Scholar, 8Ann Surg. 1994; 220 (Results of a prospective randomized trial evaluating surgery versus thrombolysis for ischemia of the lower extremity-the STILE trial): 251-266Crossref PubMed Scopus (624) Google Scholar, 9Faggioli G.L. Peer R.M. Pedrini L. et al.Failure of thrombolytic therapy to improve long-term vascular patency.J Vasc Surg. 1994; 19: 289-296Abstract Full Text Full Text PDF PubMed Scopus (51) Google Scholar, 10Ikeda Y. Rummel M.C. Field C.K. et al.Relationship of runoff vessels to results following thrombolysis and revascularization for synthetic graft occlusions.Am Surg. 1995; 61: 481-485PubMed Google Scholar, 11McNamara T.O. Gardner K.R. Bomberger R.A. Greaser L.E. Clinical and angiographic selection factors for thrombolysis as initial therapy for acute lower limb ischemia.J Vasc Interv Radiol. 1995; 6: 36S-47SAbstract Full Text PDF PubMed Scopus (17) Google Scholar, 12Schweizer J. Altmann E. Stosslein F. Florek H.J. Kaulen R. Comparison of tissue plasminogen activator and urokinase in the local infiltration thrombolysis of peripheral arterial occlusions.Eur J Radiol. 1996; 22: 129-132Abstract Full Text PDF PubMed Scopus (46) Google Scholar, 13Ouriel K. Veith F.J. Sasahara A.A. Thrombolysis or peripheral arterial surgery: phase I results TOPAS Investigators.J Vasc Surg. 1996; 23: 64-73Abstract Full Text PDF PubMed Scopus (251) Google Scholar, 14Hess H. Mietaschk A. von Bilderling P. Neller P. Peripheral arterial occlusions: local low-dose thrombolytic therapy with recombinant tissue-type plasminogen activator (rt-PA).Eur J Vasc Endovasc Surg. 1996; 12: 97-104Abstract Full Text PDF PubMed Scopus (41) Google Scholar, 15Braithwaite B.D. Buckenham T.M. Galland R.B. Heather B.P. Earnshaw J.J. Prospective randomized trial of high-dose bolus versus low-dose tissue plasminogen activator infusion in the management of acute limb ischaemia—Thrombolysis Study Group.Br J Surg. 1997; 84: 646-650Crossref PubMed Scopus (77) Google Scholar, 16Spence L.D. Hartnell G.G. Reinking G. et al.Thrombolysis of infrapopliteal bypass grafts: efficacy and underlying angiographic pathology.AJR Am J Roentgenol. 1997; 169: 717-721Crossref PubMed Scopus (12) Google Scholar, 17Ouriel K. Veith F.J. Sasahara A.A. A comparison of recombinant urokinase with vascular surgery as initial treatment for acute arterial occlusion of the legs Thrombolysis or Peripheral Arterial Surgery (TOPAS) Investigators.N Engl J Med. 1998; 338: 1105-1111Crossref PubMed Scopus (609) Google Scholar, 18Wholey M.H. Maynar M.A. Pulido-Duque J.M. Reyes R. Jarmolowski C.R. Castaneda W.R. Comparison of thrombolytic therapy of lower-extremity acute, subacute, and chronic arterial occlusions.Cathet Cardiovasc Diagn. 1998; 44: 159-169Crossref PubMed Scopus (82) Google Scholar, 19Lambert A.W. Trkulja D. Fox A.D. Budd J.S. Chalmers A.H. Horrocks M. Age-related outcome for peripheral thrombolysis.Eur J Vasc Endovasc Surg. 1999; 17: 144-148Abstract Full Text PDF PubMed Scopus (12) Google Scholar, 20Ouriel K. Kandarpa K. Schuerr D.M. Hultquist M. Hodkinson G. Wallin B. Prourokinase versus urokinase for recanalization of peripheral occlusions, safety and efficacy: the PURPOSE trial.J Vasc Interv Radiol. 1999; 10: 1083-1091Abstract Full Text PDF PubMed Scopus (79) Google Scholar, 21Braithwaite B.D. Tomlinson M.A. Walker S.R. Davies B. Buckenham T.M. Earnshaw J.J. Peripheral thrombolysis for acute-onsetclaudication—Thrombolysis Study Group.Br J Surg. 1999; 86: 800-804Crossref PubMed Scopus (24) Google Scholar, 22Suggs W.D. Cynamon J. Martin B. et al.When is urokinase treatment an effective sole or adjunctive treatment for acute limb ischemia secondary to native artery occlusion?.Am J Surg. 1999; 178: 103-106Abstract Full Text Full Text PDF PubMed Scopus (22) Google Scholar, 23Ouriel K. Gray B. Clair D.G. Olin J. Complications associated with the use of urokinase and recombinant tissue plasminogen activator for catheter-directed peripheral arterial and venous thrombolysis.J Vasc Interv Radiol. 2000; 11: 295-298Abstract Full Text Full Text PDF PubMed Scopus (143) Google Scholar, 24Korn P. Khilnani N.M. Fellers J.C. et al.Thrombolysis for native arterial occlusions of the lower extremities: clinical outcome and cost.J Vasc Surg. 2001; 33: 1148-1157Abstract Full Text Full Text PDF PubMed Scopus (64) Google Scholar, 25Swischuk J.L. Fox P.F. Young K. et al.Transcatheter intraarterial infusion of rt-PA for acute lower limb ischemia: results and complications.J Vasc Interv Radiol. 2001; 12: 423-430Abstract Full Text Full Text PDF PubMed Scopus (63) Google Scholar, 26Nehler M.R. Mueller R.J. McLafferty R.B. et al.Outcome of catheter-directed thrombolysis for lower extremity arterial bypass occlusion.J Vasc Surg. 2003; 37: 72-78Abstract Full Text Full Text PDF PubMed Scopus (38) Google Scholar, 27Conrad M.F. Shepard A.D. Rubinfeld I.S. et al.Long-term results of catheter-directed thrombolysis to treat infrainguinal bypass graft occlusion: the urokinase era.J Vasc Surg. 2003; 37: 1009-1016Abstract Full Text Full Text PDF PubMed Scopus (33) Google Scholar, 28Castaneda F. Swischuk J.L. Li R. Young K. Smouse B. Brady T. Declining-dose study of reteplase treatment for lower extremity arterial occlusions.J Vasc Interv Radiol. 2002; 13: 1093-1098Abstract Full Text Full Text PDF PubMed Scopus (23) Google Scholar, 29Duda S.H. Tepe G. Luz O. et al.Peripheral artery occlusion: treatment with abciximab plus urokinase versus with urokinase alone--a randomized pilot trial (the PROMPT Study) Platelet Receptor Antibodies in Order to Manage Peripheral Artery Thrombosis.Radiology. 2001; 221: 689-696Crossref PubMed Scopus (67) Google Scholar, 30Drescher P. McGuckin J. Rilling W.S. Crain M.R. Catheter-directed thrombolytic therapy in peripheral artery occlusions: combining reteplase and abciximab.AJR Am J Roentgenol. 2003; 180: 1385-1391Crossref PubMed Scopus (19) Google Scholar, 31Ouriel K. Castaneda F. McNamara T. et al.Reteplase monotherapy and reteplase/abciximab combination therapy in peripheral arterial occlusive disease: results from the RELAX trial.J Vasc Interv Radiol. 2004; 15: 229-238Abstract Full Text Full Text PDF PubMed Scopus (47) Google Scholar, 32Earnshaw J.J. Whitman B. Foy C. National Audit of Thrombolysis for Acute Leg Ischemia (NATALI): clinical factors associated with early outcome.J Vasc Surg. 2004; 39: 1018-1025Abstract Full Text Full Text PDF PubMed Scopus (115) Google Scholar, 33Hopfner W. Vicol C. Bohndorf K. Loeprecht H. Shredding embolectomy thrombectomy catheter for treatment of acute lower-limb ischemia.Ann Vasc Surg. 1999; 13: 426-435Abstract Full Text PDF PubMed Scopus (25) Google Scholar, 34Muller-Hulsbeck S. Kalinowski M. Heller M. Wagner S.J. Rheolytic hydrodynamic thrombectomy for percutaneous treatment of acutely occluded infra-aortic native arteries and bypass grafts: midterm follow-up results.Invest Radiol. 2000; 35: 131-140Crossref PubMed Scopus (62) Google Scholar, 35Kasirajan K. Gray B. Beavers F.P. et al.Rheolytic thrombectomy in the management of acute and subacute limb-threatening ischemia.J Vasc Interv Radiol. 2001; 12: 413-421Abstract Full Text Full Text PDF PubMed Scopus (112) Google Scholar, 36Wagner H.J. Muller-Hulsbeck S. Pitton M.B. Weiss W. Wess M. Rapid thrombectomy with a hydrodynamic catheter: results from a prospective, multicenter trial.Radiology. 1997; 205: 675-681PubMed Google Scholar, 37Ansel G.M. George B.S. Botti C.F. et al.Rheolytic thrombectomy in the management of limb ischemia: 30-day results from a multicenter registry.J Endovasc Ther. 2002; 9: 395-402Crossref PubMed Scopus (83) Google Scholar, 38Han S.M. Weaver F.A. Comerota A.J. Perler B.A. Joing M. Efficacy and safety of alfimeprase in patients with acute peripheral arterial occlusion (PAO).J Vasc Surg. 2010; 51: 600-609Abstract Full Text Full Text PDF PubMed Scopus (38) Google Scholar, 39Hanover T.M. Kalbaugh C.A. Gray B.H. et al.Safety and efficacy of reteplase for the treatment of acute arterial occlusion: complexity of underlying lesion predicts outcome.Ann Vasc Surg. 2005; 19: 817-822Abstract Full Text Full Text PDF PubMed Scopus (14) Google Scholar, 40Ansel G.M. Botti Jr, C.F. Silver M.J. Treatment of acute limb ischemia with a percutaneous mechanical thrombectomy-based endovascular approach: 5-year limb salvage and survival results from a single center series.Cathet Cardiovasc Interv. 2008; 72: 325-330Crossref PubMed Scopus (38) Google Scholar), which is used to write the document such that it contains evidence-based data with respect to content, rates, and thresholds.When the evidence of literature is weak, conflicting, or contradictory, consensus for the parameter is reached by a minimum of 12 Standards of Practice Committee members by using a Modified Delphi Consensus Method (Appendix A) (41Fink A. Kosecoff J. Chassin M. Brook R.H. Consensus methods: characteristics and guidelines for use.Am J Public Health. 1984; 74: 979-983Crossref PubMed Scopus (1358) Google Scholar). For purposes of these documents, consensus is defined as 80% Delphi participant agreement on a value or parameter. In addition, for the specific purpose of this document, studies with fewer than 50 patients were not included for the purpose of defining the parameters established here later. Generic terms for United States Food and Drug Administration–approved thrombolytic agents accepted by the the United States Adopted Names Council, a consortium sponsored by the United States Pharmacopeial Council, are listed in Table 1, Table 2 (42Semba C.P. Tam I. Blaney M. Re: catheter-directed thrombolytic therapy for limb ischemia: current status and controversies.J Vasc Interv Radiol. 2004; 15: 517Abstract Full Text Full Text PDF PubMed Scopus (3) Google Scholar).Table 1Thrombolytic Agents: Background InformationGeneric NameBrand Name(s)ManufacturerAbbreviationStreptokinaseStreptase; KabikinaseDexa Medica/CSL Behring, Marburg, GermanySKAnistreplaseEminaseGlaxoSmithKline, London, UKAPSACHuman-derived urokinaseKinlytic; AbbokinaseMicrobix Biosystems, Mississauga, ON, CanadaUKRecombinant urokinaseUrokinase AlfaAbbott Laboratories, Abbott Park, ILr-UKRecombinant prourokinaseProlyseAbbott Laboratories, Abbott Park, ILpro-UKAlteplaseActivaseGenentech, San Francisco, CATPAReteplaseRetavaseCentocor, Malvern, PARPATenecteplaseTNKaseGenentech, San Francisco, CATNK Open table in a new tab Table 2Thrombolytic Agents: Pharmacologic InformationAgentAbbreviationMolecular Weight (Da)Plasma Half-life (min)Fibrin SpecificityFibrin AffinityStreptokinaseSK48,00016/90LowLowAnistreplaseAPSAC131,00070–120 (mean, 90)LowIntermediateUrokinaseUK32,000-54,00014LowLowRecombinant urokinaser-UK54,0007LowLowRecombinant prourokinasepro-UK49,0007HighLowAlteplaseTPA68,0003.5HighHighReteplaseRPA39,00014ModerateLowTenecteplaseTNK65,00015Very highHigh Open table in a new tab The draft document is critically reviewed by the Standards of Practice Committee members by telephone conference calling or face-to-face meeting. The finalized draft from the Committee is sent to the SIR membership for further input/criticism during a 30-day comment period. These comments are discussed by the Standards of Practice Committee, and appropriate revisions are made to create the finished standards document. Before its publication, the document is endorsed by the SIR Executive Council.Acute limb ischemiaAcute limb ischemia (ALI), defined as any sudden decrease in, or worsening of, limb perfusion causing a threat to extremity mobility and viability that has been present for less than 14 days, is one sequela of peripheral arterial disease (PAD). It is one of the most common vascular emergencies interventional radiologists and vascular surgeons are asked to evaluate and treat. The treatment options for ALI fall into three broad categories: (i) medical management, (ii) surgical management, and (iii) image-guided minimally invasive therapies. Medical management entails systemic anticoagulation with continued observation, surgical management entails thrombectomy, and image-guided minimally invasive therapies entail percutaneous endovascular removal of the clot. Often, more than one is needed to achieve optimum results. Their relative merit depends on the clinical history and physical findings. Nonetheless, if removal of the clot by any method is chosen, the underlying causative abnormality must be addressed.There are diverse etiologies for ALI, with the two most common etiologies being embolus and thrombosis in situ secondary to underlying disease such as atherosclerosis (43O’Connell J.B. Quinones-Baldrich W.J. Proper evaluation and management of acute embolic versus thrombotic limb ischemia.Semin Vasc Surg. 2009; 22: 10-16Abstract Full Text Full Text PDF PubMed Scopus (57) Google Scholar). Differentiation between the two can sometimes be difficult; the latter is far more common in occluded bypass grafts. ALI is usually caused by atherosclerotic disease but can also arise from other etiologies (eg, dissection, intimal hyperplasia, in situ thrombosis secondary to a hypercoagulable state, trauma, vasculitis, aneurysm thrombosis). Outcomes and prognosis of ALI largely depend on the rapid diagnosis and initiation of appropriate and effective therapy. The 30-day mortality rate is approximately 15%, and there are variable reported amputation rates of 10%–30% (44Dormandy J. Heeck L. Vig S. Acute limb ischemia.Semin Vasc Surg. 1999; 12: 148-153PubMed Google Scholar). For many years, primary surgical intervention was performed, but entailed significant morbidity and mortality (45Ouriel K. Shortell C.K. Azodo M.V. Guiterrez O.H. Marder V.J. Acute peripheral arterial occlusion: predictors of success in catheter-directed thrombolytic therapy.Radiology. 1994; 193: 561-566PubMed Google Scholar, 46Yeager R.A. Moneta G.L. Taylor Jr, L.M. Hamre D.W. McConnell D.B. Porter J.M. Surgical management of severe acute lower extremity ischemia.J Vasc Surg. 1992; 15: 385-391Abstract Full Text Full Text PDF PubMed Scopus (109) Google Scholar, 47Blaisdell F.W. Steele M. Allen R.E. Management of acute lower extremity arterial ischemia due to embolism and thrombosis.Surgery. 1978; 84: 822-834PubMed Google Scholar).Systemic administration of a thrombolytic agent to treat ALI carries a high morbidity and mortality risk with poor clinical outcomes, and is not recommended (48Am J Cardiol. 1998; 81 (Thrombolysis in the management of lower limb peripheral arterial occlusion-a consensus document. Working Party on Thrombolysis in the Management of Limb Ischemia): 207-218Abstract Full Text Full Text PDF PubMed Scopus (132) Google Scholar, 49Patel N. Sacks D. Patel R.I. et al.SIR reporting standards for the treatment of acute limb ischemia with use of transluminal removal of arterial thrombus.J Vasc Interv Radiol. 2003; 14: S453-S465Abstract Full Text Full Text PDF PubMed Scopus (59) Google Scholar, 50Berridge D.C. Gregson R.H. Hopkinson B.R. Makin G.S. Randomized trial of intra-arterial recombinant tissue plasminogen activator, intravenous recombinant tissue plasminogen activator and intra-arterial streptokinase in peripheral arterial thrombolysis.Br J Surg. 1991; 78: 988-995Crossref PubMed Scopus (116) Google Scholar). In 1974, Dotter et al (51Rosch C.T. Seaman J. AJ. Selective clot lysis with low-dose streptokinase.Radiology. 1974; 111 (Dotter): 31-37PubMed Google Scholar) reported the feasibility of use of transcatheter streptokinase (SK) infusions for the treatment of arterial and graft occlusions. Since that time, there have been a number of advances in endovascular thrombolytic therapy. Current methods include catheter-directed methods for local delivery of thrombolytic agent, aspiration thrombectomy, mechanical thromboembolectomy, and pharmacomechanical thrombolysis. Successful management of ALI requires optimal patient selection with astute and timely clinical assessment.Randomized prospective trials have shown that patients with acute leg ischemia (ie,<14 d) have improved survival and long-term benefit compared with surgery when thrombolysis is used alone or to reduce the magnitude of surgery (8Ann Surg. 1994; 220 (Results of a prospective randomized trial evaluating surgery versus thrombolysis for ischemia of the lower extremity-the STILE trial): 251-266Crossref PubMed Scopus (624) Google Scholar, 17Ouriel K. Veith F.J. Sasahara A.A. A comparison of recombinant urokinase with vascular surgery as initial treatment for acute arterial occlusion of the legs Thrombolysis or Peripheral Arterial Surgery (TOPAS) Investigators.N Engl J Med. 1998; 338: 1105-1111Crossref PubMed Scopus (609) Google Scholar, 52Comerota A.J. Weaver F.A. Hosking J.D. et al.Results of a prospective, randomized trial of surgery versus thrombolysis for occluded lower extremity bypass grafts.Am J Surg. 1996; 172: 105-112Abstract Full Text PDF PubMed Scopus (158) Google Scholar). Intraarterial catheter-directed administration of thrombolytic agents can achieve thrombolysis of the thrombosed segments and unmask a causative lesion in most cases. This lesion can then often be treated with endovascular techniques. In many patients, thrombolysis with adjunctive procedures can reduce the scope of or even eliminate the need for surgical intervention. Surgical reperfusion therapy is a very high-risk procedure in elderly patients, with surgical mortality rates as high as 29% in high-risk populations (53Diffin D.C. Kandarpa K. Assessment of peripheral intraarterial thrombolysis versus surgical revascularization in acute lower-limb ischemia: a review of limb-salvage and mortality statistics.J Vasc Interv Radiol. 1996; 7: 57-63Abstract Full Text PDF PubMed Scopus (60) Google Scholar).Recommending a single uniform treatment protocol from the numerous clinical studies is not possible because of the wide variability in reporting. Several independent variables have been identified, including (i) acute versus chronic limb ischemia; (ii) target site treated, ie, native vessel or graft; (iii) dosing regimen of the thrombolytic drug and duration of therapy; (iv) method of infusion, ie, continuous infusion versus bolus infusion or other methods; (v) postthrombolytic anticoagulation therapy, eg, heparin or aspirin; and (vi) clinical endpoints, eg, technically successful thrombolysis versus clinically useful thrombolysis versus amputation-free survival. For instance, the Rochester study (7Ouriel K. Shortell C.K. DeWeese J.A. et al.A comparison of thrombolytic therapy with operative revascularization in the initial treatment of acute peripheral arterial ischemia.J Vasc Surg. 1994; 19: 1021-1030Abstract Full Text Full Text PDF PubMed Scopus (462) Google Scholar) used “event-free survival,” the Surgery versus Thrombolysis for Ischemia of the Lower Extremity (STILE) trial (8Ann Surg. 1994; 220 (Results of a prospective randomized trial evaluating surgery versus thrombolysis for ischemia of the lower extremity-the STILE trial): 251-266Crossref PubMed Scopus (624) Google Scholar) used “composite clinical outcome,” and the Thrombolysis or Peripheral Arterial Surgery (TOPAS) study (17Ouriel K. Veith F.J. Sasahara A.A. A comparison of recombinant urokinase with vascular surgery as initial treatment for acute arterial occlusion of the legs Thrombolysis or Peripheral Arterial Surgery (TOPAS) Investigators.N Engl J Med. 1998; 338: 1105-1111Crossref PubMed Scopus (609) Google Scholar) used “arterial recanalization and extent of lysis.”Although outcome measures in published studies focus on amputation-free survival, for the purposes of quality assurance, a definition of greater clinical relevance was sought. The outcome measures examined in this document are overall clinical success and major complications.These guidelines were written to be used in quality improvement programs to assess the outcome of percutaneous management of ALI. The most important processes of care are (i) appropriate patient selection, (ii) performance of the procedure, and (iii) monitoring of the patient. Outcome measures are assigned threshold levels.DefinitionsALI is defined as any sudden decrease in or worsening of limb perfusion causing a threat to extremity mobility and viability that has been present for less than 14 days (49Patel N. Sacks D. Patel R.I. et al.SIR reporting standards for the treatment of acute limb ischemia with use of transluminal removal of arterial thrombus.J Vasc Interv Radiol. 2003; 14: S453-S465Abstract Full Text Full Text PDF PubMed Scopus (59) Google Scholar, 54Dormandy J.A. Rutherford R.B. Management of peripheral arterial disease (PAD)—TASC Working Group TransAtlantic Inter-Society Concensus (TASC).J Vasc Surg. 2000; 31: S1-S296PubMed Google Scholar). Thrombolysis is defined for the purposes of this document as the percutaneous treatment of the thrombus with pharmacologic therapy, mechanical therapy, or a combination of the two.Guide Wire Traversal TestIn the guide wire traversal test, a guide wire is passed through the length of the thrombus before initiation of prolonged infusion. If a wire is passed, thrombolysis for acute (<7 d) occlusion is thought to be more likely (1McNamara T.O. Fischer J.R. Thrombolysis of peripheral arterial and graft occlusions: improved results using high-dose urokinase.AJR Am J Roentgenol. 1985; 144: 769-775Crossref PubMed Scopus (295) Google Scholar, 46Yeager R.A. Moneta G.L. Taylor Jr, L.M. Hamre D.W. McConnell D.B. Porter J.M. Surgical management of severe acute lower extremity ischemia.J Vasc Surg. 1992; 15: 385-391Abstract Full Text Full Text PDF PubMed Scopus (109) Google Scholar, 55Shortell C.K. Ouriel K. Thrombolysis in acute peripheral arterial occlusion: predictors of immediate success.Ann Vasc Surg. 1994; 8: 59-65Abstract Full Text PDF PubMed Scopus (43) Google Scholar). McNamara and Fisher (1McNamara T.O. Fischer J.R. Thrombolysis of peripheral arterial and graft occlusions: improved results using high-dose urokinase.AJR Am J Roentgenol. 1985; 144: 769-775Crossref PubMed Scopus (295) Google Scholar) showed that initial successful thrombolysis was more likely with positive guide wire traversal (100% vs 10%; P< .01). This was also observed (89% vs 16%; P = .003) by Ouriel et al (45Ouriel K. Shortell C.K. Azodo M.V. Guiterrez O.H. Marder V.J. Acute peripheral arterial occlusion: predictors of success in catheter-directed thrombolytic therapy.Radiology. 1994; 193: 561-566PubMed Google Scholar). Failure to pass a guide wire is not an absolute contraindication to thrombolytic therapy, but rather a predictor of poorer outcome.Regional Intraarterial InfusionIn nonselective regional intraarterial infusion, the catheter through which the thrombolytic agent is delivered is positioned proximal to the occluded vessel. In selective regional intraarterial infusion, the catheter tip or its infusion segment is embedded in the thrombotic occlusion.Infusion MethodsIntrathrombus InfusionIn intrathrombus infusion, the thrombolytic agent is delivered by an intraarterial catheter embedded within the thrombus. This position maximizes the concentration of the drug within the thrombus and delivers the drug to the region of thrombus-bound plasminogen. The thrombolytic agent is delivered via a catheter embedded in the clot. The thrombolytic agent exits the catheter via multiple side holes or through the pores of a low-pressure balloon (eg, ClearWay OTW; Atrium Medical, Hudson, New Hampshire).Intrathrombus “Bolusing” or “Lacing”The term “bolusing” has been used interchangeably with “lacing.” These terms refer to the initial intrathrombic delivery of a concentrated thrombolytic agent with a view toward saturating the thrombus with the plasminogen activator before infusion. During this portion of the procedure, a catheter (with an end hole or multiple side holes with or without a tip-occluding wire) is positioned in the most distal part of the thrombus. It is retracted proximally as the thrombolytic agent is delivered along the entire length of the thrombotic occlusion.Stepwise InfusionStepwise infusion entails placement of the tip of the catheter within the proximal thrombus and infusion of a fixed dose of thrombolytic agent over a short period of time. As thrombus dissolves, the catheter is advanced.Continuous InfusionContinuous infusion is infusion of thrombolytic agent by using a constant rate (ie, steady flow).Graded InfusionGraded infusion entails periodic tapering of the infusion rates, with the highest doses given within the first few hours.Forced Periodic InfusionForced periodic infusion (ie, pulse spray) entails forceful injection of the thrombolytic agent into the thrombus to fragment it and/or create deep crevices/fissures, thereby increasing the surface area available for thrombolytic action.Pharmacomechanical ThrombolysisPharmacomechanical thrombolysis is the combination of mechanical thrombus disruption with concomitant infiltration of a thrombolytic agent with the use of a device (ie, AngioJet; Medrad, Warrendale, Pennsylvania). Isolated thrombolysis is a specific type of pharmacomechanical thrombolysis that entails the use of a device (ie, Trellis, Covidien, Manfield, Massachusetts) with balloons that are inflated—one proximal to the thrombus and the other distal to the thrombus—with infusion and mechanical dispersion of the thrombolytic agent in the isolated arterial segment.Technical SuccessTechnical success is defined as restoration of antegrade flow with relief of the acute ischemic symptoms at rest.Time to ThrombolysisTime to thrombolysis is measured from onset of thrombolytic infusion to complete recanalization or maximal radiologic thrombolysis (15Braithwaite B.D. Buckenham T.M. Galland R.B. Heather B.P. Earnshaw J.J. Prospective randomized trial of high-dose bolus versus low-dose tissue plasminogen activator infusion in the management of acute limb ischaemia—Thrombolysis Study Group.Br J Surg. 1997; 84: 646-650Crossref PubMed Scopus (77) Google Scholar).Complete ThrombolysisComplete thrombolysis entails clearance of an occluded vessel by thrombolytic therapy with complete angiographic clearance of thrombus from an occluded vessel by thrombolytic therapy as determined by follow-up angiography. The underlying lesion may still be present (15Braithwaite B.D. Buckenham T.M. Galland R.B. Heather B.P. Earnshaw J.J. Prospective randomized trial of high-dose bolus versus low-dose tissue plasminogen activator infusion in the management of acute limb ischaemia—Thrombolysis Study Group.Br J Surg. 1997; 84: 646-650Crossref PubMed Scopus (" @default.
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• W1969895980 title "Quality Improvement Guidelines for Percutaneous Management of Acute Lower-extremity Ischemia" @default.
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