Transcatheter Mitral Valve Therapies

An essential survey of the advancing field of transcatheter mitral valve repair and replacement

Minimally 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 therapy?though 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 improvements to be made in repair and replacement procedures, as well as the adjunctive use of imaging and pharmacologic therapies. This ground-breaking text:

Transcatheter Mitral Valve Therapies is an important, up-to-date resource for interventional cardiologists, as well as all clinical researchers and practitioners seeking information on this vital and developing treatment.

List 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

Edited by

Ron Waksman, MD, Director of Clinical Research and Advanced Education, MedStar Cardiovascular Research Network, Cleveland Clinic, Washington, DC, USA.

Toby Rogers, MD, PhD, Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC; Cardiovascular and Pulmonary Branch, Division of Intramural Research, National Heart Lung and Blood Institute, National Institutes of Health, Bethesda, MD, USA.