Cardiac Rhythm Management Devices World Markets

• Publication date: October 2011

In the last five decades, electronic cardiac medicine has witnessed dramatic technological developments. The cardiac rhythm management products mainly marketed by a handful of global players are used to treat arrhythmias, specifically supraventricular arrhythmias (SVA) and ventricular arrhythmias (VA). The different types of SVA are premature atrial contractions (PAC), supraventricular tachycardia (SVT), sick sinus syndrome (SSS), atrial fibrilla...

In the last five decades, electronic cardiac medicine has witnessed dramatic technological developments. The cardiac rhythm management products mainly marketed by a handful of global players are used to treat arrhythmias, specifically supraventricular arrhythmias (SVA) and ventricular arrhythmias (VA). The different types of SVA are premature atrial contractions (PAC), supraventricular tachycardia (SVT), sick sinus syndrome (SSS), atrial fibrillation (A-fib) and atrial flutter (AFL). Varying forms of VA are premature ventricular complex (PVC), ventricular tachycardia (VT) and ventricular fibrillation (VF). These cardiac disorders are treated with the aid of different types of electronic cardiac devices. This TriMark Publications report focuses on the global and regional markets for all cardiac rhythm management (CRM) devices, and includes data on implant volumes, procedure costs and reimbursement coverage. This study also covers in detail important areas within CRM such as: implantable cardioverter-defibrillators (ICDs), cardiovascular implantable electronic devices (CIEDs), resynchronisation therapy (CRT), implantable loop recorders (ILRs) and implantable hemodynamic monitoring (IHM).

Cardiovascular Devices Industry in Spain

TABLE OF CONTENTS

1. Overview 13
1.1 Scope of This Report 13
1.2 Methodology 14
1.3 Executive Summary 15

2. Cardiac Rhythm Management: An Overview 18
2.1 Cardiac Rhythm Disorders 18
2.1.1 Premature Atrial Contractions (PACs) Sinus Tachycardia 19
2.1.2 Sinus Tachycardia 19
2.1.3 Sinus Bradycardia 20
2.2 Abnormal Rhythms 20
2.2.1 Tachycardia Ventricular Fibrillation (V Fib) 20
2.2.2 Ventricular Fibrillation (V Fib) 21
2.2.3 Ventricular Flutter 21
2.2.4 Paraxysmal Supraventricular Tachycardia (PSVT) 21
2.2.5 Atrial Fibrillation (A Fib) 22
2.3 Causes of Heart Rhythm Disorders 22
2.3.1 Symptoms of Heart Rhythm Disorders, Exams and Tests 23
2.3.1.1 Treatment for Heart Rhythm Disorders 23
2.4 Sudden Cardiac Death (SCD) 24
2.4.1 Incidence of SCD in the U.S. 24
2.5 Cardiac Rhythm Management Devices: An Overview 25
2.5.1 Cardiac Pacemakers 26
2.5.1.1 NBG Codes for Permanent Pacing 26
2.5.2 Pacemaker Components 27
2.5.2.1 Batteries in Pacemakers 27
2.5.2.2 Circuitry in Pacemakers 27
2.5.2.3 Connector Blocks of Pacemakers 30
2.5.2.4 Leads in Pacemakers 30
2.5.2.5 Electrodes in Pacemakers 31
2.5.2.6 Insulation in Pacemakers 32
2.5.2.7 Conductor Coils in Pacemakers 32
2.5.2.8 Fixation Mechanisms 32
2.5.2.9 Connectors in Pacemakers 33
2.5.2.10 Unipolar and Bipolar Pacing Systems 34
2.6 Basic Concepts and Terms in Pacemaker Procedures 35
2.6.1 Pacing Threshold 35
2.6.2 Sensing of Pacemakers 35
2.6.3 Slew Rate 36
2.6.4 Impedance in Pacing 37
2.6.5 Acute Implant Values in Pacing 37
2.6.6 Post-Implant Values 38
2.6.7 Pacing Intervals 38
2.6.8 Programmability 38
2.6.9 Magnetic Response in Pacing 39
2.7 Basic Single Chamber Pacing 40
2.7.1 Automatic Interval in Basic Single Chamber Pacing 40
2.7.2 Escape Interval 41
2.7.3 Refractory Period 41
2.8 Additional Concepts in Single Chamber Pacing 44
2.8.1 Hysteresis 44
2.8.2 Fusion and Pseudofusion in Single Chamber Pacing 44
2.8.3 Latency in Single Chamber Pacing 45
2.9 Concepts and Modes in Dual Chamber Pacing 46
2.9.1 AV Interval (AVI) 46
2.9.2 Differential AV Interval 46
2.9.3 Adaptive AVI 47
2.9.4 Atrial Escape Interval (AEI) 47
2.9.5 Post-Ventricular Atrial Refractory Period (PVARP) 48
2.9.6 Total Atrial Refractory Period (TARP) 49
2.9.7 Adaptive PVARP 49
2.9.8 Upper Rate Limit (URL) 49
2.9.9 Ventricular Blanking Period 50
2.9.10 Atrial-based Timing 50
2.9.11 DDD Mode 51
2.9.12 Totally Inhibited (PR) Pacing 51
2.9.13 Atrial Pace/Ventricular Inhibited (AR) 51
2.9.14 Atrial Inhibited Ventricular Pacing (PV) 52
2.9.15 Atrial Paced and Ventricular Paced (AV) 52
2.9.16 DVI Pacing 52
2.9.17 DDI Mode 53
2.9.18 VDD Mode 54
2.9.19 Upper Rate Behavior 54
2.9.20 Block (Multiblock) 55
2.9.21 Pseudo-Wenckebach 55
2.9.22 Rate Smoothing 56
2.9.23 Fallback Response 56
2.9.24 Sensor-driven Rate Smoothing 57
2.9.25 Sensor-driven Pacing in Dual Chamber Pacemakers 57
2.9.26 Activity/Vibration 58
2.10 Tips for Buying Cardiac Pacemakers 60
2.10.1 Comparison of Biotronik’s Cardiac Pacemakers 60
2.10.2 Comparison of Cardiac Pacemakers from Boston Scientific 62
2.10.3 Comparison of Cardiac Pacemakers from Medtronic 63
2.11 Implantable Cardioverter-Defibrillators (ICDs) 64
2.11.1 NBD Code for ICD 64
2.11.2 Basic Concepts of ICDs 65
2.11.3 Battery in ICDs 65
2.11.4 Capacitors in ICDs 66
2.11.5 Sensing in ICDs 66
2.11.6 Detection in ICDs 67
2.11.7 Defibrillation Waveform 68
2.11.8 Defibrillation Threshold 69
2.11.9 Anti Tachycardia Pacing (ATP) 69
2.12 Recommended Replacement Time for ICDs 70
2.13 Cardiac Resynchronization Therapy (CRT) 70
2.13.1 Clinical Benefits of CRT in Atrial Fibrillation 71
2.13.2 Differences between Pacemaker and CRT Device 71
2.13.3 CRT-P Implantation 71
2.13.4 CRT-D Implantation 72
2.13.5 CRT-D Implantation Procedure 73
2.14 Insertable Loop Recorder (ILR) 73
2.14.1 Implantation of ILR 73
2.15 External Cardioverter-Defibrillators 74
2.15.1 Types of Automatic External Defibrillators (AEDs) 74
2.15.2 External Defibrillation Procedure 74
2.15.3 Accuracy of an AED 75
2.15.4 Battery Core and Maintenance of an AED 75
2.15.5 Purchase Considerations for AEDs 75
2.16 Wearable Cardioverter-Defibrillators 81
2.17 Devices Interfering with Cardiac Implants 81
2.18 Future Applications for Pacemakers 82
2.19 Device Life of CRM Implants 82
2.20 Quality of Life with CRM Implants 83
2.21 Cost of CRM Implants 83

3. Market Analysis for CRM Products 84
3.1 Global Cardiac Devices Market 84
3.1.1 North American Market for Cardiac Medical Devices 84
3.1.2 European Market for Cardiac Medical Devices 85
3.1.3 Cardiac Medical Devices Market in Asia-Pacific 86
3.1.4 Global market for Interventional Cardiac Devices 88
3.1.5 Global Market for Peripheral Vascular Devices 88
3.1.6 Global Peripheral Vascular Device Market by Vendor 89
3.1.7 Global market for Cardiac Electrophysiology Market 90
3.1.8 Global Market for Cardiac Prosthetic Devices (CPD) 90
3.2 Global Market for Cardiac Rhythm Management (CRM) Devices 91
3.2.1 Market for CRM Devices in BRICSS Countries 92
3.2.2 Market for CRM Devices in China 93
3.2.3 Leading Global CRM Device Vendors 93
3.2.4 Global Market for Cardiac Monitoring and Diagnostic Devices 94
3.3 Global Market for Cardiac Pacemakers 95
3.3.1 North American Market for Cardiac Pacemakers 96
3.3.2 European Cardiac Pacemaker Market 96
3.4 Global Market for ICDs 97
3.4.1 North American Market for ICDs 98
3.4.2 European Market for ICDs 99
3.4.3 Asia-Pacific Market for ICDs 99

4. The U.S. and European Scenario of Cardiac Rhythm Management 101
4.1 U.S. Opportunities in Cardiovascular Segment 101
4.1.1 U.S. Cardiovascular Devices Market 102
4.2 Data from U.S. ICD Registry 104
4.2.1 Demographics and ICD Indications in the U.S. 105
4.2.2 Physician Training and ICD Implant Volume in the U.S. 106
4.2.3 ICD Types and Adverse Events in the U.S. 106
4.2.4 ICD Implants in the U.S. 107
4.2.5 Single Chamber, Dual Chamber and Biventricular Implants in the U.S. 108
4.2.6 Proportion of ICD Utilization for Primary and Secondary Prevention in the U.S. 108
4.2.7 Proportion of ICD/CRT-D by Type in the U.S. 109
4.2.8 Characteristics of ICD Patients in the U.S. 110
4.3 Cardiac Implants in 45 Californian Hospitals 111
4.3.1 Annual Volume of Pacemaker Procedures in California 111
4.3.2 Procedure and Average Implant Costs 111
4.3.3 Best Cardiology Hospitals in California 112
4.3.4 Pacemaker Procedure Costs in 42 Californian Hospitals 113
4.3.5 Cost as a Percentage of Total Reimbursement 113
4.3.6 Pacemaker Cost as a Percentage of Total Reimbursement 114
4.4 Future of Pacemaker Implantation in the U.S. 115
4.5 ICD Complication Rates in the U.S. 116
4.6 Cost of CRT-D Therapy in the U.S. 117
4.6.1 Cost of ICDs in the U.S. 117
4.6.2 Cost for Pacemakers in the U.S. 118
4.6.3 Options for Negotiating the Costs 119
4.7 Reimbursement Guide for ICD Implants 121
4.7.1 Coverage for ICD Therapy 122
4.7.2 Coverage with Non-Medicare Patients 122
4.7.3 Coding for ICD Therapy 122
4.7.4 Hospital Inpatients Procedure Codes 123
4.7.5 Hospital Outpatient Procedure Codes 123
4.7.6 C-Codes for ICD Implants 124
4.7.7 ICD-9-CM Diagnosis Codes 124
4.7.8 Inpatient Hospital Medicare Payment for ICD Therapy 127
4.8 ICD Implants in South America 127
4.9 Pacemaker Implant Rate in Europe 128
4.10 CRT-D Implants in Europe 129
4.11 ICD Implants in Europe 130
4.12 ICD and CRT-D Implants in Europe 131
4.13 All CRT-P Implants in Europe 132
4.14 Implanted CRM Devices in Europe by Type and Country 133
4.15 Comparison between U.S. and European Implant Rates 135
4.16 Comparison of CRT-D and CRT-P Implant Rates between the U.S. and Europe 135
4.17 Proportions of Pacing Modes Used in Europe 136
4.18 Geographic Variations in ICD Implantation in Europe 137
4.19 ICD Utilization in Europe 138
4.20 Rates of ICD Implants in Select Countries of Europe 139
4.21 ICD Implantation and Economic Factors in Europe 139
4.22 Penetration of Dual Chamber ICDs in Europe 140
4.23 Number of ICD Implanting Centers in Europe 141
4.24 Healthcare Factors and ICD Implantation in Europe 142
4.25 Potential ICD Implant Recipients in Europe 142
4.26 Status of Cardiac Electrophysiology in ESC Member Countries 142
4.27 U.K. National Survey on CRM Devices 153
4.27.1 New Pacemaker Implant Rates in U.K. 153
4.27.2 New ICD Implant Rate in U.K. 153
4.27.3 New CRT Implant Rates in U.K. 154
4.27.4 Total (New and Replacements) CRT Implant Rates in U.K. 155
4.27.5 Physiological Pacing and Age in U.K. 155
4.27.6 Projected Pacemaker Sales in U.K., 2008-2016 156
4.27.7 Projected ICD Sales in U.K. 157
4.27.8 Projected CRT Device Sales in U.K. 158
4.27.9 Top Ten CRM Device Implanting Hospitals in U.K. 158
4.28 U.K.: ICD Registry 159
4.28.1 CRT Activity in U.K. 159
4.28.2 Over-Performance of ICD and CRT-D Activity Compared to Plan 160
4.28.3 CRT Activity in U.K. 161
4.28.4 Pacemaker Activity 161
4.28.5 Increasing Role of CRT in England 162
4.28.6 High-Energy Implants for Primary Prevention in U.K. 163
4.28.7 High-Energy Implants for Secondary Prevention in U.K., 2009 164
4.28.8 Increasing Role of CRT in U.K. 164
4.28.9 CRT-P and CRT-D 165
4.28.10 Survival after CRM Device Implants in U.K. 166
4.28.11 Pacemaker Implantation Rate in U.K.’s Anglia Network Region 166
4.28.12 New ICD Implant Rate in Anglia Network 167
4.28.13 CRT Implant Rate in Anglia Network 168
4.29 CRM Device Implants in Switzerland 168
4.30 CRM Device Implants in Italy 170
4.31 ICD Implants in Spain 171
4.31.1 Total Number of Implantations in Spain 171
4.31.2 New Implants vs. Replacements in Spain 172
4.31.3 Age and Gender of Device Recipients in Spain 172
4.31.4 Underlying Heart Diseases in Spain Requiring CRM Device 172
4.31.5 LVEF Patients in Spanish Registry 173
4.31.6 Clinical Arrhythmias Requiring ICD Implants in Spain 174
4.31.7 Clinical Presentations of Arrhythmias in Spanish Patient 174
4.31.8 Cardiovascular Diseases in Serbia 175
4.31.9 CRM Devices Implants in Serbia, 2009 175
4.32 ICD Implants by Type in Israel 177
4.32.1 Initial and Replacement ICD Implants in Israel, 2010 178
4.32.2 ICD Implants in Israel by Age and Ethnicity 178
4.32.3 Doubling of ICD Implants in Israel, 2011 179
4.32.4 Off-Label ICD Implants in Israel 184

5. Selected Company Profiles 185
5.1 Biotronik, Inc. 185
5.1.1 Selected CRM Products from Biotronik 185
5.1.1.1 Evia DR-T 185
5.1.1.2 Estella DR-T 185
5.1.1.3 Effecta DR 186
5.1.1.4 Cyclos 990 DR-T 186
5.1.1.5 Philos II DR-T 187
5.1.1.6 Talos DR 187
5.1.1.7 Axios-S 188
5.1.2 Biotronik’s ICDs for Tachyarrhythmia 188
5.1.2.1 Lumax 540 VR-T DX 188
5.1.2.2 Lumax 540 VR-T 189
5.1.3 Biotronik’s CRT Products 189
5.1.3.1 Lumax 540 HF-T 189
5.1.3.2 Stratos LV-T 190
5.1.3.3 Lumax 340 HF-T 190
5.2 Boston Scientific Corporation 191
5.2.1 Selected CRM Products from Boston 191
5.2.1.1 PeriVac Pericardiocentesis Kits 191
5.2.1.2 COGNIS (CRT-D) 192
5.2.1.3 Contak Renewal 3 RF 192
5.2.1.4 Contak Renewal TR 192
5.2.1.5 Livian CRT-DS 193
5.2.1.6 Confient ICD 193
5.2.1.7 Teligen ICD 193
5.2.1.8 Vitality ICD 194
5.2.1.9 The Altrua Pacemaker Family 194
5.3 Cardiac Science Corporation 194
5.3.1 Powerheart AED G3 Plus 195
5.3.2 Powerheart AED G3 Pro 195
5.3.3 Powerheart AED G3 195
5.3.4 Powerheart AED G3 Trainer 196
5.4 Esaote S.p.A 196
5.4.1 P80 196
5.4.2 P8000 196
5.5 Fukuda Denshi, Co., Ltd. 197
5.5.1 CardiMax FCP-7101 197
5.5.2 CardiMax FX-7102 197
5.5.3 CardiMax FX-7202 198
5.5.4 CardiMax FX-7402 198
5.6 Laerdal Medical AS 199
5.6.1 Defibrillation Products from Laerdal 199
5.6.1.1 HeartStart HSI First Aid Defibrillator 199
5.6.1.2 HeartStart FR2 Automated External Defibrillator 199
5.6.1.3 HeartStart FRx 200
5.6.1.4 HeartStart MRx 200
5.7 Medtronic, Inc. 201
5.7.1 Medtronic’s CRM Products 201
5.7.1.1 Reveal DX and Reveal XT Insertable Cardiac Monitors 204
5.7.1.2 Protecta XT (CRT-D) 204
5.7.1.3 Protecta (CRT-D) 204
5.7.1.4 Consulta (CRT-D) 205
5.7.1.5 Maximo II (CRT-D) 205
5.7.1.6 Historical CRT Devices 205
5.7.2 Medtronic’s CRT-P Devices 206
5.7.2.1 Syncra CRT-P 206
5.7.3 Medtronic’s ICDs 206
5.7.3.1 Protecta XT DR and VR 206
5.7.3.2 Secura DR and VR 207
5.8 Nihon Kohden Corporation 207
5.8.1 Cardiofax ECG 9620 208
5.8.2 Cardiofax C ECG 1150 208
5.8.3 CardiofaxS ECG -1250 209
5.8.4 Cardiofax M ECG-1350 209
5.8.5 Cardiofax V ECG-1500 Series 209
5.9 Philips Healthcare 210
5.9.1 Selected CRM Products from Philips 210
5.9.1.1 HeartStart FR2+ 210
5.9.1.2 HeartStart FRx Defibrillator 211
5.9.1.3 HeartStart OnSite (HIS) 212
5.9.1.4 HeartStart MRx ALS Monitor/Defibrillator 212
5.9.1.5 HeartStart XL Defibrillator/Monitor 213
5.9.1.6 Q-CPR Measurement and Feedback Tool 213
5.9.1.7 HeartStart Telemedicine System 213
5.9.1.8 HeartStart Event Review Pro—EMS 214
5.9.1.9 HeartStart Event Review Pro—Hospitals 214
5.9.1.10 HeartStart Data Messenger 215
5.9.1.11 HeartStart Event Review for AEDs 215
5.9.1.12 HeartStart Configure 216
5.9.1.13 HeartStart Event Review Pro—Hospitals 216
5.10 Schiller AG 216
5.10.1 Schiller’s Public Access Defibrillators 217
5.10.1.1 FRED easy (Automatic) 217
5.10.1.2 FRED easyport 217
5.11 Sorin Group USA, Inc. 217
5.11.1 Selected CRM Products from Sorin 218
5.11.1.1 Paradym (CRT) 218
5.11.1.2 Ovatio (CRT) 218
5.11.1.3 Paradym DR 219
5.11.1.4 Paradym VR 219
5.11.1.5 Esprit DR 219
5.12 St. Jude Medical, Inc. 220
5.12.1 Accent Pacemakers 220
5.12.2 Affinity Pacemakers 220
5.12.3 Entity Pacemakers 220
5.12.4 Identity ADx Pacemakers 220
5.12.5 Integrity Pacemakers 221
5.12.6 Microny Pacemakers 221
5.12.7 Regency Pacemakers 221
5.12.8 Temporary Pacemakers 221
5.12.9 Verity ADx Pacemakers 222
5.12.10 Victory Pacemakers 222
5.12.11 Zephyr Pacemakers 223
5.12.12 Anthem CRT-P 223
5.12.13 Atlas II HF CRT-D 223
5.12.14 Epic HF CRT-D 224
5.12.15 Epic II HF CRT-D 224
5.12.16 Frontier II CRT-P 225
5.12.17 Promote Accel CRT-D 225
5.12.18 Promote Plus CRT-D 225
5.12.19 Unify CRT-D 226
5.12.20 Atlas ICD Family 226
5.12.21 Atlas II ICD Family 227
5.12.22 Current Accel ICD 227
5.12.23 Current Plus ICD 228
5.12.24 Epic ICD 228
5.12.25 Epic II ICD Family 229
5.13 Welch Allyn, Inc. 229
5.13.1 AED10 Defibrillator 230
5.14 Zoll Medical Corporation 230
5.14.1 Selected Zoll’s CRM Products 231
5.14.1.1 AED Plus Automated External Defibrillator 231
5.14.1.2 AED Plus Automated External Defibrillator 231
5.14.1.3 Auto-Pulse Non-Invasive Cardiac Support Pump 232
5.14.1.4 CodeNet Resusciation Data Management System 232
5.14.1.5 Defibrillator Dashboard Software 232
5.14.1.6 E Series Defibrillators 233
5.14.1.7 Zoll Life Vest 233
5.14.1.8 M Series CCT Defibrillators 233
5.14.1.9 M Series Defibrillators 234
5.14.1.10 Propaq MD 235
5.14.1.11 R Series Monitor Defibrillator 235

Appendix 1: The Evolution of Pacemakers: An Electronics Perspective 236
Appendix 1.1: Excitation and Conducting System in Heart 236
Appendix 1.2: Cardiac Signals 237
Appendix 1.2.1: Surface Electrocardiogram 237
Appendix 1.2.2: Intracardiac Electrogram (IECG) 238
Appendix 1.2.3: Arrhythmia 238
Appendix 1.3: History and Development of Cardiac Pacing 239
Appendix 1.3.1: Hyman’s Pacemaker 240
Appendix 1.3.2: Dawn of Modern Era: Implantable Pacemakers 241
Appendix 1.3.3: Demand Pacemaker 242
Appendix 1.3.4: Dual-Chamber Pacemaker 244
Appendix 1.3.5: Rate-Responsive Pacemaker 245
Appendix 1.3.6: New Features in Modern Pacemakers 245
Appendix 2: Glossary of Terms: Cardiac Rhythm Disorders 247


INDEX OF FIGURES

Figure 2.1: Incidence of SCD in the U.S. by Age and Gender 25
Figure 2.2: Radiograph of a Nuclear Pacemaker 27
Figure 2.3: Photograph of an Older Pacemaker Showing the Discrete Components 27
Figure 2.4: Radiograph of a Current Model of Pacemaker of Microprocessor-based Design 28
Figure 2.5: Print-out of a Pacemaker Telemetry Data 29
Figure 2.6: Intracardiac Electrogram from a Pacemaker 29
Figure 2.7: Connector Block Types in Pacemakers 30
Figure 2.8: Diagram of a Typical Bipolar Pacing Lead 30
Figure 2.9: The Five Basic Types of Leads in Pacemakers 31
Figure 2.10: Diagram of a Steroid-eluting Lead Design in Pacemaker 31
Figure 2.11: Conductor Coil Types in Pacemakers 32
Figure 2.12: Fixation Types in Pacemakers 33
Figure 2.13: Connector Types in Pacemakers 33
Figure 2.14: Unipolar and Bipolar Pacing Systems 34
Figure 2.15: Strength Duration Curve 35
Figure 2.16: Comparison of Surface Cardiogram Recordings 36
Figure 2.17: Raw and Filtered Electrograms as Transmetered from a Pacemaker 37
Figure 2.18: Comparison of a Signal with a Good Slew Rate and Poor Slew Rate 37
Figure 2.19: Capture Threshold vs. Time Plot in Pacing 38
Figure 2.20: Pacing Strip Showing Magnetic Response 40
Figure 2.21: Automatic Interval in Single Chamber Pacing 40
Figure 2.22: Escape Interval in Single Chamber Pacing 41
Figure 2.23: Refractory Period in Single Chamber Pacing 41
Figure 2.24: VVI Mode in Single Chamber Pacing 42
Figure 2.25: VVT Mode in Single Chamber Pacing 42
Figure 2.26: VOO Mode in Single Chamber Pacing 42
Figure 2.27: AAT Mode in Single Chamber Pacing 43
Figure 2.28: AAI Mode in Single Chamber Pacing 43
Figure 2.29: AAT Mode in Single Chamber Pacing 43
Figure 2.30: Hysteresis in Single Chamber Pacing 44
Figure 2.31: Fusion in Single Chamber Pacing 45
Figure 2.32: Pseudofusion in Single Chamber Pacing 45
Figure 2.33: Latency in Single Chamber Pacing 46
Figure 2.34: AV Interval in Dual Chamber Pacing 46
Figure 2.35: Differential AV Interval in Dual Chamber Pacing 47
Figure 2.36: Adaptive AVI in Dual Chamber Pacing 47
Figure 2.37: Atrial Escape Interval in Dual Chamber Pacing 48
Figure 2.38: PVARP in Dual Chamber Pacing 48
Figure 2.39: URL in Dual Chamber Pacing 49
Figure 2.40: Relationship between the Major Timing Cycles in Dual Chamber Pacing 50
Figure 2.41: Ventricular-based Timing at Low and High Rates 50
Figure 2.42: Totally Inhibited Pacing in Dual Chamber Pacemaker 51
Figure 2.43: AR Pacing in Dual Chamber Pacing 52
Figure 2.44: Atrial Inhibited Ventricular Pace (PV) 52
Figure 2.45: AV Pacing in Dual Chamber Pacemaker 52
Figure 2.46: DVI-C (Committed) Mode in Dual Chamber Pacing 53
Figure 2.47: DVI-NC (Non-Committed) Mode in Dual Chamber Pacing 53
Figure 2.48: Sensing of Both Atrium and Ventricle by DDI Mode 53
Figure 2.49: Comparison of DDD, DDI and DVI in Dual Chamber Pacing 54
Figure 2.50: VDD Mode in Dual Chamber Pacing 54
Figure 2.51: Block (Multiblock) in Dual Chamber Pacing 55
Figure 2.52: Pseudo-Wenckebach Behavior in Dual Mode Pacing 56
Figure 2.53: Rate Smoothing in Dual Chamber Pacing 56
Figure 2.54: Sensor Output in Relation to Activity 58
Figure 2.55: Diagram Showing Signals from a Piezoelectric Sensor 59
Figure 2.56: The Slope Values and Determination of Target Heart Rate 59
Figure 2.57: Reaction/Acceleration Time and Recovery/Deceleration Time 60
Figure 2.58: True Bipolar and Integrated Bipolar Sensing in ICDs 66
Figure 2.59: Detection of Arrhythmia Using Rate Stability Criterion 67
Figure 2.60: Sudden Onset Criteria to Differentiate VT from Sinus Tachycardia 68
Figure 2.61: Truncated Exponential Monophasic Waveform 68
Figure 2.62: DFT Probability Curve 69
Figure 2.63: Success of ATP 70
Figure 3.1: Global Cardiac Devices Market, 2010-2017 84
Figure 3.2: North American Market for Cardiac Medical Devices, 2010-2017 85
Figure 3.3: European Market for Cardiac Medical Devices, 2010-2017 86
Figure 3.4: Asia-Pacific Market for Cardiac Devices, 2010-2017 87
Figure 3.5: Global Market for Interventional Cardiac Devices, 2010-2017 88
Figure 3.6: Global Market for Peripheral Vascular Devices, 2010-2017 89
Figure 3.7: Global Peripheral Vascular Device Market Share by Company, 2010 89
Figure 3.8: Global Market for Electrophysiology Devices (EP), 2010-2017 90
Figure 3.9: Global Market for Cardiac Prosthetic Devices, 2010-2017 91
Figure 3.10: Global Market for Cardiac Rhythm Management (CRM) Devices, 2010-2017 92
Figure 3.11: CRM Devices Market in BRICSS Countries, 2010-2017 92
Figure 3.12: Chinese Market for CRM Devices, 2010-2017 93
Figure 3.13: Global Share of CRM Products by Vendor 94
Figure 3.14: Global Market for Cardiac Monitoring and Diagnostic Devices (CM&D), 2010-2017 95
Figure 3.15: Global Market for Cardiac Pacemakers, 2010-2017 95
Figure 3.16: North American Pacemaker Market, 2010-2017 96
Figure 3.17: European Pacemaker Market, 2010-2017 97
Figure 3.18: Global Market for ICDs, 2010-2017 98
Figure 3.19: North American Market for ICDs, 2010-2017 98
Figure 3.20: European Market for ICDs, 2010-2017 99
Figure 3.21: Asia-Pacific Market for ICDs, 2010-2017 100
Figure 4.1: Percentage of Deaths from Cardiovascular Diseases in the U.S. 101
Figure 4.2: ICD Implants in the U.S., 2006-2009 107
Figure 4.3: Implanted ICD Types in the U.S., 2006-2009 108
Figure 4.4: First ICD/CRT-D Implantation by Indication in the U.S. 109
Figure 4.5: Distribution of ICD Implants by Type in the U.S. 110
Figure 4.6: Annual Volume of Pacemaker Procedures in 42 Hospitals in California 111
Figure 4.7: Average Implant Cost in 34 Californian Hospitals 112
Figure 4.8: Total Pacemaker Procedure Costs in 42 Californian Hospitals 113
Figure 4.9: Defibrillator Cost as a Percentage of Total Reimbursement for Medicare FFS Patients 114
Figure 4.10: Pacemaker Cost as a Percentage of Total Reimbursement for Commercial HMO and PPO Patients 115
Figure 4.11: Future Demand for Pacemaker Implants in the U.S. by Type of Device, 2010-2028 116
Figure 4.12: Comparison of ICD Implants between Latin America, the U.S. and Europe 127
Figure 4.13: All Pacemaker Implants in Europe, 2009 128
Figure 4.14: All CRT-D Implants in Europe, 2009 129
Figure 4.15: All ICD Implants in Europe, 2009 130
Figure 4.16: All ICD and CRT-D Implants in Europe, 2009 131
Figure 4.17: All CRT-P Implants in Europe, 2009 132
Figure 4.18: Comparison between U.S. and European Implant Rates 135
Figure 4.19: Comparison between CRT-D and CRT-P Implant Rates in the U.S. and Europe 136
Figure 4.20: Pacing Modes Used in Europe by Percentage 137
Figure 4.21: Number of ICDs Per Million Inhabitants in Select Countries of Europe, 2006-2008 139
Figure 4.22: Percentage of Single vs. Dual Chambered ICDs in Europe, 2008 140
Figure 4.23: New Implant Rates in U.K., 1999-2009 153
Figure 4.24: New ICD Implant Rates in U.K., 1999-2009 154
Figure 4.25: New CRT Implant Rates in U.K., 1999-2009 154
Figure 4.26: Total CRT Implant Rate in U.K., 1999-2009 155
Figure 4.27: Pacing as Percentage of Total New Implants in England and Wales, 2009 156
Figure 4.28: Projected Pacemaker Sales in U.K., 2008-2016 157
Figure 4.29: Projected ICD Sales in U.K., 2008-2016 157
Figure 4.30: Projected CRT Implant Sales in U.K., 2008-2016 158
Figure 4.31: Top Ten CRM Device Implanting Hospitals in U.K, 2007 and 2008 159
Figure 4.32: ICD and CRT Activity in NW London for April to July 2010 160
Figure 4.33: New, Planned and Projected Activity for CRTP in 2010-2011 161
Figure 4.34: Actual New and Changed Device in 2010 and Projected Pacemaker Activity in 2011 162
Figure 4.35: Increasing Role of CRT in England, 2000-2009 163
Figure 4.36: High-Energy Implants for Primary Prevention in U.K., 2009 163
Figure 4.37: High-Energy Implants for Secondary Prevention in U.K., 2009 164
Figure 4.38: Increasing Role of CRT Devices (New) in U.K., 2009 165
Figure 4.39: CRT Type and Symptom Indication Percentage in U.K., 2009 165
Figure 4.40: Pacemaker New Implant Rate in Anglia Network, 2003-2009 166
Figure 4.41: ICD New Implant Rate in Anglia Network, 2003-2009 167
Figure 4.42: CRT Implant Rate in Anglia Network, 2003-2009 168
Figure 4.43: Pacemaker and ICD Implants in Switzerland, 1998-2008 169
Figure 4.44: ICD Implantations Reported to the Registry and Estimated by EUCOMED, 2003-2009 171
Figure 4.45: ICD Implantation per Million People Reported to the Registry and Estimated by EUCOMED, 2003-2009 172
Figure 4.46: Types of Heart Devices Reported for Total Implantations in Spain 173
Figure 4.47: Left Ventricular Ejection Fraction (LVEF) of Patients in the Spanish Registry 173
Figure 4.48: Clinical Arrhythmias Requiring ICD Implants in Spain 174
Figure 4.49: Clinical Presentations of Arrhythmias in Spanish Patients 175
Figure 4.50: CRM Device Implants by Type in Serbia, 2008 and 2009 176
Figure 4.51: Total Number of CRM Device Implants in Serbia, 2000-2009 177
Figure 4.52: New ICD Implants by Type in Israel 177
Figure 4.53: Number of ICD Implants in Israel from July 2010 to February 2011 178
Figure 4.54: ICD Implantations in Israel by Age and Ethnicity 179
Figure 4.55: New ICD Implants in Israel, 2010-2011 180
Figure 4.56: Number of New ICD Implants in Israel by Month, 2010-2011 181
Figure 4.57: ICD Implantation by Age and Gender in Israel, 2010-2011 181
Figure 4.58: ICD Implantation Percentage by Gender in Israel vs. the U.S. 182
Figure 4.59: New ICD and CRT-D Implantation by Indication in Israel 183
Figure 4.60: Distribution of Implantations by Type of Devices in Israel 183
Figure 4.61: Off-Label ICD Implants in Israel 184
Figure A1.1: The Cardiac Conducting System 237
Figure A1.2: A Typical Electrocardiogram (ECD) 238
Figure A1.3: Basic Pacemaker Functional Block Diagram 239
Figure A1.4: The First Artificial Pacemaker 240
Figure A1.5: Block Diagram of Hyman’s Pacemaker 240
Figure A1.6: Schematic of First Implanted Pacemaker 241
Figure A1.7: Block Diagram of Demand Pacemaker 242
Figure A1.8: Schematic of the Pulse Generator of the First Demand Pacemaker 242
Figure A1.9: Schematic of Dual-Chamber Demand Pacemaker 244
Figure A1.10: Block Diagram of a Rate-Responsive Pacemaker 245
Figure A1.11: Block Diagram of a Typical Modern Pulse Generator 246


INDEX OF TABLES

Table 2.1: NASPE/BPEG (NBG) Codes 26
Table 2.2: Medication Effects of Sensing in a Pacemaker 36
Table 2.3: Programmable Features of a Single Chamber Pacemaker 39
Table 2.4: Comparison of Two Models of Cardiac Pacemakers from Biotronik 61
Table 2.5: Comparison of Two Models of Pacemakers from Boston Scientific 62
Table 2.6: Comparison of Two Models of Pacemakers from Medtronic 63
Table 2.7: NBD Codes for ICDs 64
Table 2.8: Product Comparison Chart for External Defibrillators from Burdick 76
Table 2.9: Product Comparison Chart for External Defibrillators from Cardiac Science 77
Table 2.10: Product Comparison Chart for External Defibrillators from Medtronic 79
Table 4.1: Cardiovascular Medical Procedures in the U.S., 2009 102
Table 4.2: Estimated Direct Cost of Cardiovascular Disease and Stroke in the U.S., 2009 102
Table 4.3: U.S. Cardiovascular Devices Market, 2008-2012 103
Table 4.4: National ICD Registry (2006-2009): Medical History and Baseline Tests 105
Table 4.5: Demographics and ICD Indications in the U.S. 105
Table 4.6: Physician Training and ICD Implant Volume in the U.S. 106
Table 4.7: ICD Types and Adverse Events in the U.S., 2006-2009 107
Table 4.8: Characteristics of Patients with ICD Implants in the U.S. and Canadian Registries 110
Table 4.9: Comprehensive Calculator for CRT-D 119
Table 4.10: Comprehensive Calculator for Single Channel ICD 120
Table 4.11: Comprehensive Calculator for Pacemaker 120
Table 4.12: Physician Procedure Codes 122
Table 4.13: ICD-9-CM Procedure Codes 123
Table 4.14: ICD-9-CM Code for an Electrophysiology Study and Non-Invasive Programmed Stimulation 123
Table 4.15: Hospital Outpatient Procedure Codes 123
Table 4.16: C-Codes for ICD Implants 124
Table 4.17: ICD-9-CM Diagnosis Codes 125
Table 4.18: Heart Failure Diagnosis Codes and Medicare’s Classification 125
Table 4.19: Codes for Myocardial Infarction 126
Table 4.20: Inpatient Hospital Medicare Payment for ICD Therapy 127
Table 4.21: ICD Implants in Latin America by Country, 2006 and 2007 128
Table 4.22: Implanted CRM Devices in Europe by Type and Country 133
Table 4.23: Demographic, Economic and Insurance Data for Europe 137
Table 4.24: Number of ICD Implanting Centers in Europe 141
Table 4.25: Status of Cardiac Electrophysiology in ESC Member Countries, 2008 and 2009 143
Table 2.26: Current Activity Rate Compared to National Target and National Average 160
Table 4.27: Survival after High-Energy Implants in U.K., 2009 166
Table 4.28: Pacemaker and ICD Implant Rate in Anglia Network, 2006-2009 167
Table 4.29: New CRT and Total CRT Implant Rate in Anglia Network, 2006-2009 168
Table 4.30: Number of CRM Device Implantations in Switzerland and Neighboring Countries, 2007 170
Table 5.1: Medtronic’s Ablation Products for Arrhythmia 201
Table 5.2: Medtronic’s Cardiac CryoAblation System 202
Table 5.3: Medtronic’s Surgical Ablation Products 203
Table 5.4: Medtronic’s Pacemakers 207