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PERIPHERAL ARTERIAL DISEASE VOLUME II
Table of Contents
INTRODUCTION. 1
THE DISEASE . 1
SYMPTOMS AND CONSEQUENCES. 1
INTERMITTENT CLAUDICATION IS UNCOMMON . 2
MOBILITY IMPAIRMENT, MUSCLE AND NERVE DAMAGE. 3
MOBILITY IMPAIRMENT . 3 ISCHEMIA CAUSES MUSCLE AND NERVE DAMAGE . 3 ISCHEMIC DAMAGE—A FACTOR IN CARDIOVASCULAR MORTALITY?. 4 MORTALITY . 5
HEART ATTACK AND STROKE—THE MAIN CAUSES OF DEATH. 5 HIGH FIVE- AND 10-YEAR MORTALITY . 5 AN INDICATOR OF SILENT CARDIOVASCULAR AND
CEREBROVASCULAR DISEASE . 5
INITIAL DIAGNOSIS—ABI . 6
DISEASE SEVERITY ASSOCIATED WITH LOWER ABI . 6
PAD IS NOT BENIGN . 7
DISEASE PROGRESSION—RECENT RESEARCH . 8 TREATMENT OPTIONS. 8
REVASCULARIZATION . 9
DIAGNOSTIC MODALITIES. 10
Angiography—The Gold Standard . 10 Intravascular Ultrasound. 10 Duplex Ultrasound. 11 Magnetic Resonance Angiography (MRA) . 11 CT Angiography. 12 REVASCULARIZATION METHOD DEPENDS ON DISEASE SEVERITY,
LOCATION AND TYPE OF LESION. 12
TYPES OF ATHEROSCLEROSIS . 13
TYPE I—AORTOILIAC DISEASE. 13 TYPE II DISEASE . 13 SYSTEMS FOR CATEGORIZING DISEASE SEVERITY. 13
FONTAINE DISEASE CLASSIFICATION SYSTEM . 14 RUTHERFORD CLASSIFICATION SYSTEM . 14 INTERVENTIONAL GUIDELINES AND LESION CLASSIFICATION SYSTEMS
. 14
DEFINITION OF SUCCESS. 15
PROBLEMS COMPARING DIFFERENT REVASCULARIZATION METHODS
. 17
QUALITY OF LIFE . 17
NEW METHODS FOR MEASURING QUALITY OF LIFE. 17
LOWER EXTREMITY GRADING SCALE (LEGS) . 17 PERIPHERAL ARTERY QUESTIONNAIRE (PAQ) . 18 THE ALEVE REGISTRY . 18 BYPASS SURGERY. 19
THE GOLD STANDARD . 19 ADVANTAGES AND DISADVANTAGES OF BYPASS SURGERY . 19 INDICATIONS FOR BYPASS SURGERY. 20 TYPE OF DISEASE AND LESIONS DETERMINE USE OF SURGERY . 21 OUTCOME MEASUREMENTS . 22 Location of Surgery and Type of Graft Affect Patency. 22 RESTENOSIS—BYPASS . 24
GRAFTS . 24
BLOOD CLOTS . 25
Thrombolysis. 26 Thrombectomy Devices. 27 ENDOVASCULAR THERAPY . 27
INDICATIONS AND CONTRAINDICATIONS . 29 VARIABLES IN SUCCESSFUL PTA. 30 COMPLICATIONS . 30 PREVENTION OF BLOOD CLOTS. 32 Reduce Risk of Vascular Occlusion . 33 Protective Effect Against Heart Attack, Stroke and Death . 33 Plavix Reduces Risk of Adverse Events in Coronary Interventions. 33 Plavix Clinical Trials in PTA and Peripheral Bypass . 33 RESTENOSIS—PTA . 34
HIGHER AFTER PTA THAN BYPASS. 34 MECHANISMS OF RESTENOSIS. 35 Intimal Hyperplasia . 35 Elastic Recoil . 35 Arterial Remodeling. 35 PTA BALLOON CATHETERS AND RELATED ANGIOPLASTY PRODUCTS 36
STENTS . 36
BALLOON-EXPANDABLE . 36 SELF-EXPANDABLE . 37 COMPLICATIONS . 37 ATHERECTOMY . 38
ILIAC ARTERIES AND AORTOILIAC DISEASE . 40
ENDOVASCULAR HAS BECOME FIRST-LINE THERAPY . 41 GENERAL PRINCIPLES FOR CHOICE OF INTERVENTION. 42 TYPES OF LESIONS AND TREATMENT CHOICE . 42 PTA COMPARED TO BYPASS SURGERY. 44 PTA MORE COST-EFFECTIVE IN TREATMENT OF IC . 45 ILIAC STENTING . 45
STENTS IMPROVE PTA OUTCOMES . 45 OCCLUSIONS . 46 LOW RESTENOSIS RATES . 46 DISEASE PATTERN AND GENDER AFFECT OUTCOME AND COMPLICATIONS. 46 SELECTIVE STENTING IS MORE COST-EFFECTIVE THAN PTA ALONE . 46 PRIMARY STENTING IS THE NORM . 47 DEBATE OVER PRIMARY STENTING . 47 STENTS CURRENTLY EMPLOYED IN ILIAC DISEASE. 48
Comparison of SMART and WALLSTENT-CRISP US Study . 50 PERIPHERAL COVERED STENTS . 51
STENT-GRAFTS IN TREATMENT OF ILIAC OCCLUSIVE DISEASE. 52 Potential Complications and Costs. 52 Early Stent-Grafts Had Poor Patency and High Rate of Complications. 53 PROMISING RESULTS WITH NEW STENT-GRAFTS. 53 Viabahn Endoprothesis. 53 Early Results in Treatment of Diffuse Aortoiliac Disease—Wallgraft, Viabahn and aSpire . 54 FEMOROPOPLITEAL DISEASE . 55
THE ACHILLES HEEL OF THE VASCULAR SPECIALIST. 56 CHARACTERISTICS . 56 ANGIOPLASTY IN FEMOROPOPLITEAL DISEASE. 57 COMPARISON OF FEMOROPOPLITEAL AND AORTOILIAC PTA . 58 DISEASE DIFFUSION AND RUNOFF STATUS—KEYS TO SUCCESS . 59 COMPARISON OF FEMOROPOPLITEAL PTA AND BYPASS SURGERY. 60 Mode of Failure . 61 Cost-Effectiveness and Quality of Life. 62 PTA — Generally the Preferred Initial Treatment Strategy. 63 COMBINED REVASCULARIZATION APPROACH: PTA FOLLOWED BY SURGERY . 63 Total Patency—A Measure of the End Result of All Invasive Treatments. 64 Invasive Treatment Might Delay Development of CLI . 64 FEMOROPOPLITEAL STENTING. 65
Lesion Location Affects Restenosis. 66 VARIABLES IN SUCCESSFUL SFA STENTING . 66 Poor Patency with Stainless Steel Stents . 66 COMPARISON OF STENTING WITH BYPASS SURGERY . 68 Bypass—Higher Patency But Higher Morbidity and Mortality . 70 RESULTS OF OLDER SFA STENT STUDIES NOT COMPARABLE TO THOSE
OF RECENT STUDIES . 70
NEW DESIGNS AND MATERIALS. 71 ADVANCES IN DELIVERY TECHNOLOGY AND TECHNIQUE . 71 IMPACT OF ANTI-CLOTTING THERAPY. 71 STENTS EMPLOYED IN THE INFRAINGUINAL ARTERIES. 71
MOST ARE USED OFF-LABEL . 71 NITINOL STENTS . 72 Restenosis Rates Considerably Lower . 72 Excellent Patency May Change the Role of Stenting in Femoropopliteal Disease . 74 A NOTE OF CAUTION REGARDING ROLE OF CURRENT STENT TECHNOLOGY IN THE SFA. 75 STENT-GRAFTS IN THE FEMORAL ARTERIES . 77
DRUG ELUTING STENTS . 79
SIROCCO I . 79 SIROCCO II . 79 JOSTENT INFRAPOPLITEAL FEASIBILITY STUDY . 80 STENT FRACTURE AND LATE RESTENOSIS RATES RAISE QUESTIONS . 80 EXPECT SLOWER ADOPTION OF DES IN THE SFA. 81 NEW STENT CONCEPTS—MATERIALS, COATINGS AND ABSORBABLE
STENTS . 81
CRYOPLASTY—A NEW APPROACH TO TREATING SFA DISEASE . 81
TOTAL OCCLUSIONS . 82
Frontrunner. 83 Safe-Cross Radiofrequency Total Occlusion Crossing System . 84 CrossPoint TransAccess Catheter . 85 Excimer Laser in Total Occlusions. 86 TIBIOPERONEAL DISEASE. 88
LIMITED INDICATIONS FOR PTA . 88 AGE AND SERIOUS CO-MORBIDITIES COMPLICATE TREATMENT OF TIBIAL DISEASE . 89 PTA FOR LIMB SALVAGE AND PAIN RELIEF . 89 STENTS IN THE TIBIAL ARTERIES . 90 CRITICAL LIMB ISCHEMIA . 90
PTA AS PRIMARY THERAPY—RECENT EVIDENCE . 90 SURGERY AND LIMB SALVAGE IN CLI . 92 In Diabetic and Non-Diabetic Patients. 92 Pedal Bypass Grafting in Patients with Serious Co-Morbidities . 93 In ESRD and Non-ESRD Patients. 94 ENDOVASCULAR MAY BECOME PRIMARY THERAPY IN LIMB SALVAGE . 94 LIMB SALVAGE WITH CUTTING BALLOON AND EXCIMER LASER . 94
Promising Early Evidence in Limb Salvage . 95 Restenosis in Bypass Grafts . 96 TRADITIONAL REVASCULARIZATION STRATEGIES COMPARED WITH CUTTING BALLOON AND LASER . 97 LACI Equivalent Study. 98 Ansel Cutting Balloon Study . 98 AMPUTATION. 99
MORBIDITY AND MORTALITY . 99 HIGH COST TO SOCIETY . 99 AMPUTATION COMPARED WITH REVASCULARIZATION—MORBIDITY, MORTALITY AND COST . 99 ARGUMENT FOR EARLIER AND MORE FREQUENT INTERVENTIONS . 100
PAD A SIGNIFICANT MARKET OPPORTUNITY . 101
MARKET TO INCREASE WITH THE GRAYING OF AMERICA . 101 PAD UNDERDIAGNOSED AND UNDERTREATED. 101
LESS THAN 20% OF PAD PATIENTS ESTIMATED TO HAVE BEEN DIAGNOSED . 102 CATALYSTS FOR CHANGE . 102 NHLBI and Coalition of Professional and Nonprofit Vascular Groups. 102 AHA Launches First PAD Program . 103 INTERVENTIONAL PROCEDURES 1983-2000. 103
PERIPHERAL BYPASS PROCEDURES. 103 INCREASING UTILIZATION OF ENDOVASCULAR PROCEDURES. 104 CHANGING PRACTICE—ENDOVASCULAR NOW PRIMARY TREATMENT FOR IC . 105 THE NUMBER OF PAD-RELATED AMPUTATIONS REMAINS HIGH . 106 Disease Often Not Diagnosed Until the Advanced Stages. 107 UNTAPPED MARKET FOR INTERVENTIONAL THERAPY. 107
ESTIMATED MARKET FOR INTERVENTIONAL THERAPY BY DISEASE
SEVERITY—2000 . 107
ESTIMATED MARKET FOR BYPASS AND ENDOVASCULAR THERAPY BY
DISEASE SEVERITY—2000 . 108
ESTIMATED BYPASS MARKET POTENTIAL IN MILLIONS OF LIMBS BY
DISEASE SEVERITY—2000 . 109
ESTIMATED ENDOVASCULAR MARKET POTENTIAL IN MILLIONS OF
LIMBS BY DISEASE SEVERITY—2000. 110
MARKET POTENTIAL FOR INTERVENTIONAL THERAPY 2000-2020. 111
COMPARISON OF CURRENT MARKET FOR PRIMARY BYPASS SURGERY
WITH POTENTIAL MARKET—2003. 112
COMPARISON OF BYPASS MARKET GROWTH PROJECTIONS 2000-2010 112
CURRENT BYPASS MARKET AND POTENTIAL MARKET AS PERCENTAGE OF PAD PATIENTS DIAGNOSED INCREASES TO 30%. 112 CURRENT BYPASS MARKET AND POTENTIAL MARKET AS PERCENTAGE OF PAD PATIENTS DIAGNOSED INCREASES TO 35%. 113 COMPARISON OF CURRENT MARKET FOR PRIMARY ENDOVASCULAR
THERAPY WITH POTENTIAL MARKET—2003 . 113
COMPARISON OF ENDOVASCULAR MARKET GROWTH PROJECTIONS 114
2000-2010 . 114
CURRENT ENDOVASCULAR MARKET AND POTENTIAL MARKET AS PERCENTAGE OF PAD PATIENTS DIAGNOSED INCREASES TO 30%. 114 CURRENT ENDOVASCULAR MARKET AND POTENTIAL MARKET AS PERCENTAGE OF PAD PATIENTS DIAGNOSED INCREASES TO 35%. 114 PAD MARKET POTENTIAL FOR PRIMARY AND REDO BYPASS
SURGERY—2003 . 114
PAD MARKET POTENTIAL FOR PRIMARY AND REDO BYPASS
SURGERY—2000-2020. 115
PAD MARKET POTENTIAL FOR PRIMARY AND REDO ENDOVASCULAR
THERAPY—2003 . 115
PAD MARKET POTENTIAL FOR PRIMARY AND REDO ENDOVASCULAR
THERAPY—2000-2020. 116
COMPANY INFORMATION. 116
REFERENCES. 116
LIST OF STUDIES/ACRONYMS . 116
INDEX OF TABLES AND FIGURES. 116
GLOSSARY. 116
TRADEMARKS. 116
DISCLOSURE STATEMENT . 116
CONTACT INFORMATION. 116

Source: http://www.thesagegroup.us/Volume%20II/VII%20TOC.pdf