Complications of Percutaneous Coronary Interventions (eBook)

Foreword I 6
Foreword II 7
Preface 9
Table of Contents 11
Contributors 13
1 Introduction 15
References 18
2 Complications of the Medications 20
1. Case 1. An Unusual Bleeding Complication 20
2. Bleeding Complications 20
3. Treatment of Major Hemorrhage 22
4. Case 2. Acute Stent Thrombosis: Possible Role of Suboptimal Pharmacological Therapy 22
5. Case 3. Thrombocytopenia 24
5.1. Pseudothrombocytopenia 24
5.2. True Thrombocytopenia 25
6. Contrast-Induced Nephropathy 25
7. Treatment of the No-Reflow Phenomenon 26
7.1. Nitroprusside 26
7.2. Adenosine 26
7.3. Calcium Channel Blockers 27
8. Agents Used to Produce Conscious Sedation 27
8.1. Benzodiazepines 27
8.2. Opioid Analgesics 27
9. Conclusions 27
References 28
3 Groin Complications 35
1. Case 35
2. Local Bleeding and Hematoma 35
3. Pseudoaneurysm 37
4. Retroperitoneal Hemorrhage 38
5. Arteriovenous Fistula 38
6. Groin Infection 39
7. Thrombotic Occlusion 40
8. Arterial Laceration and Perforation 40
9. Arterial Dissection 41
10. Femoral Neuropathy 42
References 43
4 Complications of Plain Old Balloon Angioplasty 46
1. Case 1:A Coronary Dissection after Percutaneous Transluminal Coronary Angioplasty 46
2. Case 2: Arterial Rupture after Percutaneous Transluminal Coronary Angioplasty 46
3. Introduction 46
4. Complications 48
4.1. Coronary Dissection 48
4.2. Vessel Perforation/Rupture 49
4.3. The No-Reflew Phenomenon 50
4.4. Balloon Rupture 50
4.5. Acute Closure 51
5. Summary 51
References 51
5 Coronary Guidewire Complications 53
1. Guidewire Structure and Characteristics 54
2. Coronary Perforation by Guidewire 54
2.1. Mechanism 54
2.2. Prevention and Management 57
3. Pseudolesions 60
3.1. Mechanism 60
3.2. Prevention and Management 61
4. Treating In-Stent Lesions: Guidewire Passage through Stent Struts 61
4.1. Mechanism 61
4.2. Prevention and Management 61
5. Wire Kinking, Entanglement, and Entrapment 63
5.1. Mechanism 63
5.2. Prevention and Management 66
6. Coronary Guidewire Fracture 67
6.1. Mechanism 67
6.2. Prevention and Management 67
7. Coronary Guidewire-Induced Dissection 67
7.1. Mechanism 67
7.2. Prevention and Management 68
8. Conclusions 70
References 71
6 Complications Related to Coronary Stenting 74
1. Case 74
2. Introduction 74
2. The Early Problems 76
2.1. Stent Loss 76
2.2. Stent Damage 76
3. Issues with Stent Delivery 78
3.1. Multiple Stents 78
3.2. Stent Migration and Damage 79
3.3. Side Branch Intervention Risks 79
3.4. Balloon Rupture 80
3.5. Fracture of the Delivery Balloon Shaft 80
4. Damage to the Coronary Artery 80
4.1. Coronary Artery Aneurysm, Rupture 81
4.2. Coronary Artery Fistula Formation 81
4.3. Device Entrapment 81
4.4. Acute and Subacute Stent Thrombosis 81
4.5. Coronary Artery and Other Infections 82
4.6. Cardiac Tamponade 82
5. Treating the Problems That Arise 82
6. Noncardiac Surgery after Stent Implantation 83
References 83
7 Complications of Atherectomy Devices 85
1. Case 85
2. Introduction 85
3. Cutting Balloon Atherectomy 86
4. Rotational Atherectomy 87
5. Directional Atherectomy 89
6. Transluminal Extractional Atherectomy 92
7. Laser Angioplasty 92
8. Conclusions 94
References 94
8 The No-Reflow Phenomenon 96
1. Definition and Historical Aspects 96
2. Angiographic Diagnosis and Assessment of No-Reflow 97
3. Incidence and Predisposing Factors 98
4. Clinical Manifestations and Outcomes 99
5. Pathophysiology of Coronary No-Reflow 99
6. Management of No-Reflow 100
6.1. General Measures 100
6.2. Specific Measures 101
6.2.1. Calcium Channel Antagonists 101
6.2.2. Adenosine 101
6.2.3. Nitrovasodilators 102
6.2.4. Papaverine 102
6.2.5. Epinephrine 102
6.2.6. Nicorandil 103
6.2.7. Glycoprotein lIb/IlIa Antagonists 103
6.2.8. Other Agents 103
6.2.9. Intraaortic Balloon Counterpulsation 103
7. Prevention of No-Reflow 103
7.1. Pharmacologic Strategies 103
7.2. Direct Stenting 104
7.3. Intracoronary Thrombectomy 104
7.4. Embolic Protection 104
8. Conclusion 106
References 106
9 Early versus Late Complications 110
1. Case 110
2. Introduction 110
3. Complications with Arterial Access 110
3.1. Specific Complications Involving the Access Site 113
3.1.1. Hematoma, Retroperitoneal Bleeding, and Pseudoaneurysm 113
3.1.2. Arterial Dissection 114
3.1.3. Infections 114
4. Coronary Perforation 114
4.1. Predictors of Coronary Perforation 118
4.1.1. Patient Factors 118
4.1.2. Device Selection 118
4.2. Management of Coronary Perforation 120
5. Acute, Subacute, and Late Stent Thrombosis 121
5.1. Incidence and Risk Factors 121
5.2. Prevention and Management 121
6. Renal Function Deterioration after Catheterization 124
6.1. Contrast-Induced Nephropathy 124
6.2. Atheroembolism 125
7. Future Perspectives 125
References 126
10 Complications of Radiation Exposure and Therapy 131
1. Introduction 131
2. Therapeutic Use of Radiation 131
3. Diagnostic Use of Radiation 131
4. External Beam Radiation 132
5. Intravascular Brachytherapy 132
5.1. Coronary Spasm 133
5.2. Coronary Thrombosis 133
5.3. The "Edge" Effect 135
6. Diagnostic and Interventional Complications of X-Rays 135
6.1. Patient Issues 135
6.2. Staff Issues 137
7. Conclusions 138
References 138
11 Complications of Closure Devices 141
1. Introduction 141
1.2. Case 141
2. Suture-Mediated Closure Device 143
3. Collagen-Assisted Sealing Devices 143
3.1. Case 143
3.2. Case 145
4. Vacular Closure Devices versus Manual Compression 145
5. Comparison of the Vascular Closure Devices 146
6. Risk of Infection with Vascular Closure Devices 146
7. Closure Devices in Conjunction with Glycoprotein lIb/IlIa Receptor Blockers 146
References 147
12 Legal Complications of Percutaneous Coronary Procedures 150
1. Introduction 150
2. General Principles of Medical Malpractice Law 150
2.1. Medical Negligence 150
2.1.1. Standard of Care 151
2.2. Informed Consent and Battery 151
2.3. The Doctor-Patient Relationship 151
3. Case Studies Involving Percutaneous Procedures 152
3.1. The Doctor-Patient Relationship in Percutaneous Procedures 152
3.1.1. Percutaneous Procedures Where the Physician Never Sees or Examines the Patient 152
3.1.2. The Need for Som e Contact 153
3.2. Informed Consent Cases 153
3.2.1. Failure to Obtain a Signed Form 153
3.2.2. Failure to Use Specific Language 153
3.2.3. Known Risks 153
3.2.4. Failure to Offer a Risky Option 154
3.3. Alleged Poor Technique 154
3.3.1. Stent Sizing 154
3.3.2. Balloon Rupture/Stent Release into Bloodstream 154
3.3.3. Broken Guidewire 154
3.3.4. The Kissing Balloon Technique 155
3.4. Timing Cases 155
3.4.1. Delay in Performing the Procedure 155
3.4.2. Failure to Recognize Signs and Symptoms Resulting in Delay 155
3.5. Infections 155
3.6. Delay in Giving Adrenaline 156
3.7. Femoral Nerve Damage 156
3.8. Complications of Anticoagulation 156
3.9. Sexual Abuse Allegations 156
3.10. Radiation Exposure 157
4. Strategies to Minimize Malpractice Claims 157
4.1. Complete, Accurate, and Detailed Medical Records 157
4.2. Complete, Detailed, and Timely Informed Consent 157
4.3. The Informal Consult 157
4.4. Timely Action Based upon Diagnostic Information 158
4.5. Adherence to or Knowledge of Current Recommendations 158
13 Cardiac Arrest and Resuscitation During Percutaneous Coronary Interventions 159
1. Death Associated with Percutaneous Coronary Intervention 160
2. Cardiac Arrest Associated with Percutaneous Coronary Intervention 160
3. Prevention of Cardiac Arrest During Percutaneous Coronary Intervention 161
4. Treatment of Cardiac Arrest During Percutaneous Coronary Intervention 161
4.1. Acute Hemodynamic Collapse 161
4.2. Ventricular Fibrillation Cardiac Arrest 162
4.3. Defibrillation in the Percutaneous Coronary Intervention Suite 162
4.4. Performing Cardiopulmonary Resuscitation in the Percutaneous Coronary Intervention Suite 162
4.5. Fixing the Cause of Cardiac Arrest 165
4.6. Intra-Aortic Balloon Counterpulsation During Cardiac Arrest 165
4.7. Percutaneous Cardiopulmonary Bypass During Refractory Cardiac Arrest 165
4.8. Technique for Using Percutaneous Cardiopulmonary Bypass in the Percutaneous Coronary Intervention Suite for Refactory Cardiac Arrest 166
5. Non-Ventricular Fibrillation Cardiac Arrest 166
5.1. Brady-Asystole or Pulseless Electrical Activity 166
6. Postresuscitation Care 167
7. Summary 167
References 167
14 Adverse Event Reporting: Physicians, Manufacturers, and the Food and Drug Administration 170
1. A Serious Injury Report 170
2. MedWatch 170
3. Device Expectations 170
4. Instructions for Use 174
5. Common User Errors 175
5.1. Examples of Common User Errors 175
5.1.1. Use of Device after Damage Has Been Observed 175
5.1.2. Incorrect Device Preparation 176
5.1.3. Application of Excessive Force 176
6. Medical Device Reporting 176
7. Health Insurance Portability and Accountability Act Privacy Rules and MedWatch 177
8. The Reporting Process 177
8.1. The Complaint 177
8.2. Processing the Complaint 177
8.3. Determining Reportability 178
9. The Adverse Events: Death, Serious Injury, and Malfunction of a Device 179
9.1. Serious Injury 179
9.2. Malfunction 179
10. Injury Without Device Malfunction 180
11. Global Reporting Requirements 180
12. Clinical Trial Event Reporting 180
13. Conclusions 180
References 181
Index 182

"9 Early versus Late Complications (p. 92-93)

Albert W. Chan and Christopher White

One stitch in time saves nine

1. Case

A 70-year-old woman had acute onset of groin pain and hypotension about 3 hours after removal of an arterial sheath. The patient was brought to the catheterization laboratory and ante grade contrast injection via the contralateral access identified the location of the bleeding (Figure 9-1A, arrow). After the advancement of the stiffangled guidewire and the insertion of a crossover sheath, balloon inflation was performed across the extravasation site (Figure 9-1B).

A total of 3000U of diluted 1: 10,000 thrombin was injected percutaneously while the balloon was inflated within the artery (Figure 9-1C, blocked arrow). Repeat angiography revealed minimal residual leak (Figure 9-1D, arrow), but an intra-arterial thrombus was identified in the common femoral artery and part of it migrated distally to the superficial femoral artery (Figure 9-1E, arrowhead) and to the tibioperoneal trunk (Figure 9-1F, arrowhead).

Angiojet, Percusurge Guardwire, and Filterwire were used sequentially in both the anterior and posterior tibial artery to reduce the thrombus burden (Figures 9-1G,H). Tissue plasminogen activator and papaverine were given through a Transit catheter. Because of residual thrombotic occlusion in the infrapopliteal arteries (Figure 9-1I), intra-arterial thrombolysis was administered overnight. To avoid bleeding in the common femoral artery, a Wallgraft was placed to seal the original extravasation site in the common femoral artery. The patient was discharged on the next day after an uneventful recovery.

2. Introduction

Patients who have undergone a successful percutaneous coronary intervention (PCI) are conventionally observed in the hospital overnight. However, procedure-related complications do happen beyond the hospitalization period (Table 9-1). Appropriate selections of arterial access, antithrombotic regimen, guide catheters, guidewires, and balloon and stent catheters, combined with meticulous techniques, contribute to the lowering of the periprocedural risk and late complications.

Indeed, with a routine stent strategy and improved antiplatelet and anticoagulation regimens, complications associated with PCI are much less common in recent years; and when combined with the use of vascular closure devices, same-day discharge has become possible, and even advocated by some for low-risk patients.1-7 The objective of this chapter is to discuss and contrast several major early and late complications of PCI, and include possible preventive measures as well as management strategies for their resolution.

3. Complications with Arterial Access

Arterial access-site complications are the most common complications of PCI, occurring in -3%-5% of all cases," Dissection, hematoma, pseudoaneurysm, and retroperitoneal hemorrhage represent examples of the early arterial access complications, while pseudoaneurysm and infection may sometimes be noted only days after the index procedure. Arterial access complications may cause major morbidity, prolongation of hospital stay, increased cost, and even mortality. "