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Book SynopsisTRANSCATHETER MITRAL VALVE THERAPIES An essential survey of the advancing field of transcatheter mitral valve repair and replacementMinimally invasive transcatheter therapies have revolutionized the treatment of structural heart disease. Greatly improving outcomes for higher-risk patients, transcatheter aortic valve replacement is now established as a safe and effective alternative to invasive surgery. The mitral valve, however, poses further challenges. Contending with one of the heat's most anatomically and pathologically complex components, practitioners and engineers have yet to perfect a stream-lined, widely deliverable therapythough they are getting closer and closer to this goal. Transcatheter Mitral Valve Therapies provides a far-reaching survey of the field of mitral interventions in its current state. Highlighting the stumbling blocks preventing transcatheter mitral valve replacement's widespread adoption, the book's international group of contributors discuss the improveme
Table of ContentsList of Contributors xvii
Introduction—The Mitral Book xxiii
1 The Pathology of Mitral Valve Disease 1
Maria E. Romero, Sho Torii, and Renu Virmani
1.1 Introduction 1
1.2 General Anatomy of the Mitral Valve 1
1.2.1 Mitral Annulus 1
1.2.2 Leaflets 3
1.2.3 Chordae Tendineae and Papillary Muscles 5
1.2.4 Papillary Muscles and Left Ventricle 5
1.3 Pathology of Mitral Valve 5
1.3.1 Mitral Valve Stenosis 5
1.3.2 Aging Changes and Mitral Annulus Calcification (MAC) 6
1.3.3 Acute Mitral Regurgitation 8
1.3.4 Chronic Mitral Regurgitation 8
1.3.5 Degenerative MR; Myxomatous Degeneration of the Mitral Valve 8
1.3.6 Functional MR 10
References 11
2 The Importance of Minimally Invasive Approaches for Mitral Valve Repair 15
Bobby Yanagawa and Niv Ad
2.1 Introduction to Minimally Invasive Mitral Valve Surgery 15
2.2 The Importance of MICS MVS 16
2.3 Patient Selection 17
2.4 Surgical Setup—Fibrillating Heart MVS 18
2.5 Alternatives for Cannulation 19
2.6 Alternatives to Myocardial Protection 19
2.7 Mitral Valve Repair 20
2.8 Outcomes 20
2.9 Initiating Minimally Invasive Mitral Valve Repair Program 21
2.10 Conclusion 22
References 22
3 When to Intervene—Should Surgical Guidelines Apply to Transcatheter Techniques in Treating Mitral
Regurgitation? 25
Samir Kapadia, Rishi Puri, Kinjal Banerjee, and Lars G. Svensson
3.1 Introduction 25
3.2 Primary MR 25
3.2.1 Current Guideline Recommendations 25
3.2.2 Transcatheter Therapies—New Guideline Applications? 26
3.3 Secondary MR 29
3.3.1 Current Guideline Recommendations 29
3.4 Conclusions 31
References 32
4 Transcatheter Mitral Valve Therapies: A Three-Dimensional Echocardiographic View 35
Shmuel Schwartzenberg, Chaim Yosefy, and Alexander Sagie
4.1 Introduction 35
4.1.1 Mitral Valve Anatomy 35
4.1.2 Mitral Valve Structure and Function 35
4.1.3 Mitral Regurgitation Severity 36
4.1.4 Diagnosis of MR Severity: Proximal Isovelocity Surface Area Method 36
4.1.5 Diagnosis of MR Severity: Vena Contracta Method 37
4.1.6 Primary and Secondary MR 37
4.1.7 Mitral Regurgitation and Cardiovascular Death and Morbidity 38
4.1.8 Screening for MitraClip Suitability 40
4.1.9 MitraClip Procedure Guidance 41
4.1.10 Transseptal Puncture 41
4.1.11 MitraClip Delivery Guidance 42
4.1.12 Adequacy of MitraClip Implantation Assessment 43
4.1.13 Other Technologies 45
4.2 Conclusions 45
References 45
5 CMR Assessment of Mitral Regurgitation 51
Daniel Knight and Vivek Muthurangu
5.1 Introduction 51
5.2 Pulse Sequences Used in CMR 52
5.2.1 Cine Imaging 52
5.2.2 Phase Contrast Imaging 52
5.3 Assessment of MR Severity 52
5.3.1 Qualitative Assessment 52
5.3.2 Quantitative Assessment 55
5.3.3 Technical Considerations for the Quantitative Assessment of MR by CMR 56
5.4 Identification of MR Etiology 57
5.4.1 Primary MR 57
5.4.2 Secondary MR 57
5.5 The Role of CMR Assessment of MR in Clinical Practice 58
5.6 Conclusions 58
References 58
6 CT Planning for TMVR and Predicting LVOT Obstruction 63
Dee Dee Wang, Mayra Guerrero, Brian O’Neill, Pedro A. Villablanca Spinetto, James Lee, Tiberio Frisoli, Marvin Eng, and William O’Neill
6.1 Introduction 63
6.2 History of Imaging for Mitral Valve Disease 63
6.2.1 TAVR CT Planning 63
6.2.2 Surgical and Transcatheter Mitral Interventions 63
6.3 Concept of Aortic and Mitral Valve Technology Development 64
6.4 Basics of CT Imaging Acquisition 66
6.5 Definition of Mitral Valve and TMVR device Landing Zone 66
6.6 Definition of LVOT 66
6.7 CT Methods for Neo-LVOT prediction modeling 67
6.8 CT Validation of Neo-LVOT Prediction Modeling Post-TMVR 68
6.9 Correlation Between Pre- and Post-TMVR CT Neo-LVOT Prediction Modeling 69
6.10 What Else Has CT Planning for TMVR Taught Us? 70
Acknowledgments 72
References 72
7 General Principles and State-of-the-Art Echocardiographic Evaluation of the Mitral Valve 75
Federico M. Asch and Diego Medvedofsky
7.1 Introduction 75
7.2 Mechanism and Etiology of Chronic MR 75
7.2.1 Transthoracic Echocardiography 76
7.2.1.1 Assessment of MR Severity 76
7.2.2 Qualitative Assessment 76
7.2.2.1 Color Flow Doppler 76
7.3 Continuous Wave (CW) Density Jet 79
7.3.1 Semi-Quantitative Assessment 79
7.3.1.1 VC Width 79
7.4 Pulmonary Vein Flow/Mitral Inflow 79
7.4.1 Quantitative Assessment 80
7.5 Selection of Best Candidates for Interventions of the Mitral Valve 82
7.5.1 Echocardiographic Criteria of COAPT (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation) Trial 84
References 84
8 Intraprocedural Echocardiography for MitraClip 87
Philip Haines and Sumbal A. Janjua
8.1 Introduction 87
8.2 Pre-Procedure Evaluation 88
8.3 Importance of the Baseline Study – TEE 88
8.4 The Transseptal Puncture 95
8.5 Guiding MitraClip System to Mitral Valve 98
8.6 Intraprocedural Guidance of Clip within Mitral Valve and Leaflets 102
8.7 Post-Clip-Deployment Assessment of Mitral Valve Function 103
8.8 Assessment of Complications and Iatrogenic ASD 105
References 112
9 Intraprocedural Echocardiography for Transcatheter Mitral Valve Replacement 115
Patrick T. Gleason, John C. Lisko, and Stamatios Lerakis
9.1 Introduction 115
9.2 Baseline Mitral Valve Assessment 115
9.3 Access to the Left Atrium, Left Ventricle, and Mitral Valve 116
9.4 Predeployment and Deployment Monitoring 118
9.5 Postdeployment Evaluation 120
References 122
10 Transcatheter Repair: MitraClip for Degenerative Mitral Regurgitation 125
Ted Feldman
10.1 Surgery for Degenerative Mitral Regurgitation 125
10.2 Evidence Base for MitraClip 125
10.3 Challenges for the MitraClip Procedure 130
10.4 Evaluation of MitraClip for Less than Prohibitive-Risk DMR Patients 131
10.5 Future Directions for MitraClip and Alternative Approaches for Leaflet Repair 133
10.6 Summary 135
References 136
11 MitraClip™ for Secondary Mitral Regurgitation 139
Brian J. Forrestal and Toby Rogers
11.1 Introduction 139
11.2 European and US Clinical Practice Guidelines 139
11.3 The MitraClip System 140
11.4 MitraClip Preprocedural Planning 140
11.5 Surgical Outcomes Data 140
11.6 The COAPT and MITRA-FR Trials 141
11.7 Summary and Conclusions 144
References 144
12 The Edwards PASCAL Transcatheter Valve Repair System 147
Mirjam Winkel, Stephan Windecker, and Fabien Praz
12.1 Introduction 147
12.2 The Edwards PASCAL™ Transcatheter Valve Repair System 147
12.3 Implantation Procedure 148
12.4 Compassionate-Use and Early Feasibility Data 150
12.5 Future Developments 151
References 152
13 The Development of a Novel Percutaneous Treatment for Secondary Mitral Regurgitation—The Carillon® Mitral Contour System® 153
Steven L. Goldberg
13.1 Introduction 153
13.2 REDUCE-FMR 157
13.3 The CARILLON Trial 160
13.4 Summary 161
References 161
14 A Fully Percutaneous Mitral Ring: The Cardioband System 163
Antonio Mangieri, Enrico Poletti, and Azeem Latib
14.1 Introduction 163
14.2 Mitral Annulus Anatomy 163
14.3 Pathophysiological Role of the Mitral Annulus in Mitral Regurgitation 164
14.3.1 Mitral Annulus in FMR 164
14.3.2 Mitral Annulus in DMR 164
14.4 Surgical Annuloplasty in Mitral Regurgitation 164
14.5 The Cardioband System: Description of the Device 165
14.6 Procedural Planning 165
14.7 Clinical Studies 168
14.8 Possible Complications Related to the Implantation of Cardioband 170
14.9 Recurrence of Mitral Regurgitation Following Cardioband Implantation 171
14.10 Cardioband in Combination with Other Devices 172
14.11 Conclusions 173
References 173
15 Transcatheter Mitral Cerclage Annuloplasty 175
Christopher Bruce, June-Hong Kim, Toby Rogers, and Robert J. Lederman
15.1 Introduction 175
15.2 Cerclage Anatomy and Function 175
15.3 Limitations of Coronary Sinus Annuloplasty 176
15.4 Cerclage Annuloplasty Device 177
15.5 The Cerclage Procedure 177
15.6 Preclinical Experiments 178
15.7 Initial Human Experience 178
15.8 Future Directions 180
15.9 Summary 182
Competing Interests 183
References 183
16 The Transapical Off-Pump Mitral Valve Repair with the NeoChord Implantation (TOP-MINI) 185
Stefan Bertog, Laura Vaskelyte, Nalan Schnelle, Iris Grunwald, Ilona Hofmann, Sameer Gafoor, Markus Reinartz, Predrag Matic, Bojan Jovanovic, Kolja Sievert, Michèle Jaqueline Lembens, and Horst Sievert
16.1 Introduction 185
16.2 Technology 185
16.3 Patient Selection 186
16.4 Procedure 186
16.5 Echocardiographic Guidance 191
16.6 Examples 191
16.6.1 Ideal Anatomy 191
16.6.2 Acceptable Anatomy 191
16.6.3 Challenging Anatomy 192
16.6.4 Data 192
16.7 Conclusion 194
References 195
17 AltaValve™—A Transcatheter Mitral Valve Regurgitation Treatment Technology 197
Katherine Kumar, PhD and Saravana Kumar, PhD
17.1 Clinical Need 197
17.2 Device Description 198
17.2.1 Principle of Operation 198
17.2.2 Device Construction 199
17.2.2.1 Stent 200
17.2.2.2 Stent Cap 200
17.2.2.3 Tissue Valve 200
17.2.2.4 Fabric Skirts and Sutures 200
17.2.3 Delivery Systems 200
17.3 Anatomical Imaging and Sizing 202
17.4 Preclinical and Clinical Experience 203
17.4.1 Animal Studies 203
17.5 Human Clinical Experience 204
17.6 Summary 205
References 206
18 The ARTO Transcatheter Mitral Valve Repair System 209
Andrejs Erglis, Inga Narbute, Agnese Strenge, and Samantha E. Greene
18.1 Device Description 209
18.2 Procedural Details 209
18.3 Clinical Experience with the ARTO System 212
18.4 Unique Features of the ARTO System 216
References 216
19 Transcatheter Mitral Annuloplasty: The Millipede Device 219
Jason H. Rogers and Steven F. Bolling
19.1 Background 219
19.2 The Millipede Device 219
19.3 Millipede Implantation Procedure 220
19.4 Surgical Millipede Implants 220
19.5 Millipede Clinical Results 222
19.6 Clinical Implications 223
19.7 Summary 226
Author Disclosures 226
References 226
20 Transapical and Transseptal Access for Transcatheter Mitral Valve Replacement: Techniques and Devices 227
James Edelman and Vinod H. Thourani
20.1 Introduction 227
20.2 Transapical Approach 227
20.2.1 Technique 228
20.2.2 Devices in Active Clinical Trial Phase 230
20.2.2.1 Tendyne 230
20.2.2.2 Intrepid 230
20.2.2.3 CardiAQ 231
20.2.2.4 TIARA 231
20.2.2.5 HighLife 231
20.3 Transseptal Approach 231
20.3.1 Technique 231
20.3.2 Devices in Active Clinical Trial Phase 233
20.3.2.1 Sapien M3 233
20.3.2.2 EVOQUE 233
20.3.2.3 Caisson 233
20.4 Conclusions 233
References 233
21 Mitral Valve-in-Valve and Valve-in-Ring Therapies 235
Norihiko Kamioka, Peter C. Block, Adam B. Greenbaum, and Vasilis C. Babaliaros
21.1 Overview 235
21.2 Evidence 236
21.3 Procedure Planning 239
21.4 Procedure 243
21.5 Pitfalls and Solutions—POULEZ and LAMPOON 244
References 245
22 Edwards SAPIEN in Native Mitral Annular Calcification (MAC) 251
Mayra Guerrero, Dee Dee Wang, Mackram Eleid, Charanjit Rihal, William O’Neill, and Ted Feldman
22.1 Introduction 251
22.2 Anatomic Considerations and Sizing 251
22.3 Delivery Access Types 253
22.4 Preprocedural Planning 253
22.5 Valve Deployment Technique 253
22.6 Clinical Outcomes and Complications 255
22.7 LVOT Obstruction 256
22.8 TMVR in MAC Clinical Trials 256
22.9 Aortic THV versus Dedicated TMVR Devices for MAC 257
22.10 Conclusions 257
Disclosures 258
References 258
23 Transcatheter Mitral Valve Replacement: The Tendyne Device 261
Alison Duncan
23.1 Introduction 261
23.2 The Tendyne TMVI Device 261
23.2.1 Current Tendyne Device Design 262
23.3 Patient Screening and Preprocedural Imaging 262
23.3.1 Patient Selection 262
23.3.2 Anatomical Screening 263
23.4 Implantation Technique 264
23.4.1 Transapical Approach 264
23.4.2 Device Entry into Left Atrium 264
23.4.3 Intra-annular Device Deployment 264
23.4.4 Apical Pad Fixation and Adjustment of Tether Tension 264
23.4.5 Confirmation of Device Position and Function 267
23.5 Clinical Outcomes 267
23.6 Future Challenges 271
23.7 Conclusion 274
References 274
24 TIARA Transcatheter Mitral Replacement System 277
Anson Cheung
24.1 Introduction 277
24.2 Neovasc TIARA TMVR System 277
24.3 Candidacy for TIARA TMVR 278
24.4 Clinical Case and TIARA TMVR Implantation 278
24.5 Clinical Updates 281
24.6 Conclusions 281
Conflict of Interest 282
References 282
25 Caisson Transcatheter Mitral Valve Replacement System 283
Mathew R. Williams and Cezar S. Staniloae
25.1 Introduction 283
25.2 Caisson Transcatheter Mitral Valve Replacement System Components 283
25.2.1 Anchor 284
25.2.2 Valve 285
25.2.3 The Delivery System 285
25.2.4 Retrieval Accessories 285
25.3 Procedural Details 285
25.3.1 Role of Imaging on Valve Sizing and Procedural Guidance 287
25.3.1.1 Role of Gated CT 287
25.3.1.2 Role of TEE Guidance During the Procedure 288
25.4 Current Status of the Caisson Research Program 289
25.5 Conclusions 289
Reference 289
26 Transcatheter Mitral Valve Replacement with the CardiAQ-Edwards and EVOQUE Prostheses 291
Howard C. Herrmann, Wilson Y. Szeto, and Frank E. Silvestry
26.1 Introduction 291
26.2 Device Description 291
26.3 First-in-Human Transfemoral Case 292
26.4 Initial Experience via Transapical Approach 292
26.5 Second-Generation Transseptal Approach 293
26.6 Current CardiAQ Generation Design and Contemporary Case Example 293
26.6.1 Evolution to EVOQUE TMVR 295
26.7 Discussion 296
References 297
27 Intrepid 299
Eberhard Grube and Jan-Malte Sinning
27.1 Background 299
27.2 The Intrepid Valve Features 300
27.3 Clinical Experience 301
27.4 Discussion 304
References 306
28 Laceration of the Anterior Mitral Leaflet to Prevent Outflow Obstruction (LAMPOON) 309
Jaffar M. Khan and Vasilis C. Babaliaros
28.1 Introduction 309
28.1.1 Mechanism of LVOT Obstruction from TMVR 309
28.1.2 Prediction of LVOT Obstruction 309
28.1.3 Prevention and Treatment of LVOT Obstruction 309
28.2 The LAMPOON Technique 310
28.2.1 CT Planning for TMVR and LAMPOON 311
28.2.2 LAMPOON Equipment 312
28.2.3 Step 1: Positioning the Snare System 312
28.2.4 Step 2: Leaflet Traversal 312
28.2.5 Step 3: Leaflet Laceration 312
28.3 Alternative LAMPOON Techniques 313
28.3.1 Antegrade Transseptal LAMPOON 313
28.3.2 Antegrade Apical LAMPOON 313
28.3.3 “Rescue” LAMPOON 314
28.4 Evidence for LAMPOON-Assisted TMVR 315
28.5 Future Directions 315
28.6 Conclusions 315
References 315
29 Use of Alcohol Septal Reduction Therapy to Facilitate Transcatheter Mitral Valve Replacement 317
Marvin H. Eng, Tiberio Frisoli, Dee Dee Wang, James C. Lee, Pedro A. Villablanca Spinetto, Janet Wyman, and William W. O’Neill
29.1 Introduction 317
29.2 Technique 319
29.3 Safety 321
29.4 Efficacy 321
29.5 Conclusion 323
References 323
30 Direct Transatrial Approach with Resection of the Anterior Mitral Leaflet to Prevent Outflow Tract
Obstruction 325
Fabien Praz and Isaac George
30.1 Introduction 325
30.2 Advantages of the Direct Transatrial Access 325
30.3 Patients Selection and THV Sizing 326
30.3.1 Mitral Annulus Sizing 326
30.3.2 Assessment of the Risk of LVOTO Using Valve Simulation 326
30.4 Implantation Techniques 328
30.4.1 First-in-Human and Early Experience 328
30.4.2 Strategies to Prevent Paravalvular Leakage 329
30.5 Surgical Access 329
30.6 Early Outcomes Data 330
30.7 Conclusions 331
References 331
31 Transcatheter Closure of Mitral Paravalvular Leak 333
Tilak K. R. Pasala, Vladimir Jelnin, and Carlos E. Ruiz
31.1 Introduction 333
31.2 Prevalence and Clinical Presentation 333
31.3 Assessment of Mitral PVL 334
31.3.1 Grading of Severity 334
31.3.2 Complexity of Mitral PVL 334
31.3.3 Adjunctive Imaging 334
31.4 Timing of Intervention 335
31.5 Preplanning 336
31.5.1 Location 336
31.5.2 Virtual Planning 337
31.6 Devices Used for PVL Closure 338
31.6.1 Transcatheter Procedure 338
31.6.2 Procedural Guidance 340
31.6.3 Access 340
31.6.4 Procedural Techniques 341
31.6.4.1 Crossing the PVLs 341
31.6.4.2 Catheter and Device Delivery 343
31.6.4.3 Device Deployment 344
31.6.4.4 Hopscotch Technique 345
31.7 Procedural Complications 345
31.8 Follow-Up 346
31.9 Future 346
31.10 Conclusion 346
Disclosures 346
References 346
32 Management of Iatrogenic Interatrial Septal Defect—To Close or not to Close? 349
Christina Tan and James M. McCabe
32.1 Introduction 349
32.2 Hemodynamics and iASDs 349
32.3 Incidence of Persistent Iatrogenic Atrial Septal Defects 350
32.4 Evaluation of Iatrogenic Atrial Septal Defect 351
32.5 Closure 352
32.6 ASD Closure Procedure 352
32.7 Management 353
References 355
33 Antithrombotic Therapy in Transcatheter Mitral Valve Intervention 359
Yuefeng Chen and Ron Waksman
33.1 Introduction 359
33.2 MitraClip System 359
33.2.1 Before the Procedure 359
33.2.2 During the Procedure 360
33.2.3 After the Procedure 361
33.2.4 Thromboembolic and Bleeding Risk 361
33.3 Transcatheter Mitral Valve Replacement 362
33.3.1 Before the Procedure 362
33.3.2 During the Procedure 362
33.3.3 After the Procedure 362
33.3.4 Thromboembolic and Bleeding Risk 363
33.4 Patients with Atrial Fibrillation 365
33.5 Antithrombotic Therapy for Other Mitral Valve Interventions 365
33.6 Conclusions 365
References 366
Index 371
