Transcatheter Mitral Valve Therapies

Edited byRon 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.

• List of Contributors xviiIntroduction—The Mitral Book xxiii1 The Pathology of Mitral Valve Disease 1Maria E. Romero, Sho Torii, and Renu Virmani1.1 Introduction 11.2 General Anatomy of the Mitral Valve 11.2.1 Mitral Annulus 11.2.2 Leaflets 31.2.3 Chordae Tendineae and Papillary Muscles 51.2.4 Papillary Muscles and Left Ventricle 51.3 Pathology of Mitral Valve 51.3.1 Mitral Valve Stenosis 51.3.2 Aging Changes and Mitral Annulus Calcification (MAC) 61.3.3 Acute Mitral Regurgitation 81.3.4 Chronic Mitral Regurgitation 81.3.5 Degenerative MR; Myxomatous Degeneration of the Mitral Valve 81.3.6 Functional MR 10References 112 The Importance of Minimally Invasive Approaches for Mitral Valve Repair 15Bobby Yanagawa and Niv Ad2.1 Introduction to Minimally Invasive Mitral Valve Surgery 152.2 The Importance of MICS MVS 162.3 Patient Selection 172.4 Surgical Setup—Fibrillating Heart MVS 182.5 Alternatives for Cannulation 192.6 Alternatives to Myocardial Protection 192.7 Mitral Valve Repair 202.8 Outcomes 202.9 Initiating Minimally Invasive Mitral Valve Repair Program 212.10 Conclusion 22References 223 When to Intervene—Should Surgical Guidelines Apply to Transcatheter Techniques in Treating MitralRegurgitation? 25Samir Kapadia, Rishi Puri, Kinjal Banerjee, and Lars G. Svensson3.1 Introduction 253.2 Primary MR 253.2.1 Current Guideline Recommendations 253.2.2 Transcatheter Therapies—New Guideline Applications? 263.3 Secondary MR 293.3.1 Current Guideline Recommendations 293.4 Conclusions 31References 324 Transcatheter Mitral Valve Therapies: A Three-Dimensional Echocardiographic View 35Shmuel Schwartzenberg, Chaim Yosefy, and Alexander Sagie4.1 Introduction 354.1.1 Mitral Valve Anatomy 354.1.2 Mitral Valve Structure and Function 354.1.3 Mitral Regurgitation Severity 364.1.4 Diagnosis of MR Severity: Proximal Isovelocity Surface Area Method 364.1.5 Diagnosis of MR Severity: Vena Contracta Method 374.1.6 Primary and Secondary MR 374.1.7 Mitral Regurgitation and Cardiovascular Death and Morbidity 384.1.8 Screening for MitraClip Suitability 404.1.9 MitraClip Procedure Guidance 414.1.10 Transseptal Puncture 414.1.11 MitraClip Delivery Guidance 424.1.12 Adequacy of MitraClip Implantation Assessment 434.1.13 Other Technologies 454.2 Conclusions 45References 455 CMR Assessment of Mitral Regurgitation 51Daniel Knight and Vivek Muthurangu5.1 Introduction 515.2 Pulse Sequences Used in CMR 525.2.1 Cine Imaging 525.2.2 Phase Contrast Imaging 525.3 Assessment of MR Severity 525.3.1 Qualitative Assessment 525.3.2 Quantitative Assessment 555.3.3 Technical Considerations for the Quantitative Assessment of MR by CMR 565.4 Identification of MR Etiology 575.4.1 Primary MR 575.4.2 Secondary MR 575.5 The Role of CMR Assessment of MR in Clinical Practice 585.6 Conclusions 58References 586 CT Planning for TMVR and Predicting LVOT Obstruction 63Dee Dee Wang, Mayra Guerrero, Brian O’Neill, Pedro A. Villablanca Spinetto, James Lee, Tiberio Frisoli, Marvin Eng, and William O’Neill6.1 Introduction 636.2 History of Imaging for Mitral Valve Disease 636.2.1 TAVR CT Planning 636.2.2 Surgical and Transcatheter Mitral Interventions 636.3 Concept of Aortic and Mitral Valve Technology Development 646.4 Basics of CT Imaging Acquisition 666.5 Definition of Mitral Valve and TMVR device Landing Zone 666.6 Definition of LVOT 666.7 CT Methods for Neo-LVOT prediction modeling 676.8 CT Validation of Neo-LVOT Prediction Modeling Post-TMVR 686.9 Correlation Between Pre- and Post-TMVR CT Neo-LVOT Prediction Modeling 696.10 What Else Has CT Planning for TMVR Taught Us? 70Acknowledgments 72References 727 General Principles and State-of-the-Art Echocardiographic Evaluation of the Mitral Valve 75Federico M. Asch and Diego Medvedofsky7.1 Introduction 757.2 Mechanism and Etiology of Chronic MR 757.2.1 Transthoracic Echocardiography 767.2.1.1 Assessment of MR Severity 767.2.2 Qualitative Assessment 767.2.2.1 Color Flow Doppler 767.3 Continuous Wave (CW) Density Jet 797.3.1 Semi-Quantitative Assessment 797.3.1.1 VC Width 797.4 Pulmonary Vein Flow/Mitral Inflow 797.4.1 Quantitative Assessment 807.5 Selection of Best Candidates for Interventions of the Mitral Valve 827.5.1 Echocardiographic Criteria of COAPT (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation) Trial 84References 848 Intraprocedural Echocardiography for MitraClip 87Philip Haines and Sumbal A. Janjua8.1 Introduction 878.2 Pre-Procedure Evaluation 888.3 Importance of the Baseline Study – TEE 888.4 The Transseptal Puncture 958.5 Guiding MitraClip System to Mitral Valve 988.6 Intraprocedural Guidance of Clip within Mitral Valve and Leaflets 1028.7 Post-Clip-Deployment Assessment of Mitral Valve Function 1038.8 Assessment of Complications and Iatrogenic ASD 105References 1129 Intraprocedural Echocardiography for Transcatheter Mitral Valve Replacement 115Patrick T. Gleason, John C. Lisko, and Stamatios Lerakis9.1 Introduction 1159.2 Baseline Mitral Valve Assessment 1159.3 Access to the Left Atrium, Left Ventricle, and Mitral Valve 1169.4 Predeployment and Deployment Monitoring 1189.5 Postdeployment Evaluation 120References 12210 Transcatheter Repair: MitraClip for Degenerative Mitral Regurgitation 125Ted Feldman10.1 Surgery for Degenerative Mitral Regurgitation 12510.2 Evidence Base for MitraClip 12510.3 Challenges for the MitraClip Procedure 13010.4 Evaluation of MitraClip for Less than Prohibitive-Risk DMR Patients 13110.5 Future Directions for MitraClip and Alternative Approaches for Leaflet Repair 13310.6 Summary 135References 13611 MitraClip™ for Secondary Mitral Regurgitation 139Brian J. Forrestal and Toby Rogers11.1 Introduction 13911.2 European and US Clinical Practice Guidelines 13911.3 The MitraClip System 14011.4 MitraClip Preprocedural Planning 14011.5 Surgical Outcomes Data 14011.6 The COAPT and MITRA-FR Trials 14111.7 Summary and Conclusions 144References 14412 The Edwards PASCAL Transcatheter Valve Repair System 147Mirjam Winkel, Stephan Windecker, and Fabien Praz12.1 Introduction 14712.2 The Edwards PASCAL™ Transcatheter Valve Repair System 14712.3 Implantation Procedure 14812.4 Compassionate-Use and Early Feasibility Data 15012.5 Future Developments 151References 15213 The Development of a Novel Percutaneous Treatment for Secondary Mitral Regurgitation—The Carillon® Mitral Contour System® 153Steven L. Goldberg13.1 Introduction 15313.2 REDUCE-FMR 15713.3 The CARILLON Trial 16013.4 Summary 161References 16114 A Fully Percutaneous Mitral Ring: The Cardioband System 163Antonio Mangieri, Enrico Poletti, and Azeem Latib14.1 Introduction 16314.2 Mitral Annulus Anatomy 16314.3 Pathophysiological Role of the Mitral Annulus in Mitral Regurgitation 16414.3.1 Mitral Annulus in FMR 16414.3.2 Mitral Annulus in DMR 16414.4 Surgical Annuloplasty in Mitral Regurgitation 16414.5 The Cardioband System: Description of the Device 16514.6 Procedural Planning 16514.7 Clinical Studies 16814.8 Possible Complications Related to the Implantation of Cardioband 17014.9 Recurrence of Mitral Regurgitation Following Cardioband Implantation 17114.10 Cardioband in Combination with Other Devices 17214.11 Conclusions 173References 17315 Transcatheter Mitral Cerclage Annuloplasty 175Christopher Bruce, June-Hong Kim, Toby Rogers, and Robert J. Lederman15.1 Introduction 17515.2 Cerclage Anatomy and Function 17515.3 Limitations of Coronary Sinus Annuloplasty 17615.4 Cerclage Annuloplasty Device 17715.5 The Cerclage Procedure 17715.6 Preclinical Experiments 17815.7 Initial Human Experience 17815.8 Future Directions 18015.9 Summary 182Competing Interests 183References 18316 The Transapical Off-Pump Mitral Valve Repair with the NeoChord Implantation (TOP-MINI) 185Stefan Bertog, Laura Vaskelyte, Nalan Schnelle, Iris Grunwald, Ilona Hofmann, Sameer Gafoor, Markus Reinartz, Predrag Matic, Bojan Jovanovic, Kolja Sievert, Michèle Jaqueline Lembens, and Horst Sievert16.1 Introduction 18516.2 Technology 18516.3 Patient Selection 18616.4 Procedure 18616.5 Echocardiographic Guidance 19116.6 Examples 19116.6.1 Ideal Anatomy 19116.6.2 Acceptable Anatomy 19116.6.3 Challenging Anatomy 19216.6.4 Data 19216.7 Conclusion 194References 19517 AltaValve™—A Transcatheter Mitral Valve Regurgitation Treatment Technology 197Katherine Kumar, PhD and Saravana Kumar, PhD17.1 Clinical Need 19717.2 Device Description 19817.2.1 Principle of Operation 19817.2.2 Device Construction 19917.2.2.1 Stent 20017.2.2.2 Stent Cap 20017.2.2.3 Tissue Valve 20017.2.2.4 Fabric Skirts and Sutures 20017.2.3 Delivery Systems 20017.3 Anatomical Imaging and Sizing 20217.4 Preclinical and Clinical Experience 20317.4.1 Animal Studies 20317.5 Human Clinical Experience 20417.6 Summary 205References 20618 The ARTO Transcatheter Mitral Valve Repair System 209Andrejs Erglis, Inga Narbute, Agnese Strenge, and Samantha E. Greene18.1 Device Description 20918.2 Procedural Details 20918.3 Clinical Experience with the ARTO System 21218.4 Unique Features of the ARTO System 216References 21619 Transcatheter Mitral Annuloplasty: The Millipede Device 219Jason H. Rogers and Steven F. Bolling19.1 Background 21919.2 The Millipede Device 21919.3 Millipede Implantation Procedure 22019.4 Surgical Millipede Implants 22019.5 Millipede Clinical Results 22219.6 Clinical Implications 22319.7 Summary 226Author Disclosures 226References 22620 Transapical and Transseptal Access for Transcatheter Mitral Valve Replacement: Techniques and Devices 227James Edelman and Vinod H. Thourani20.1 Introduction 22720.2 Transapical Approach 22720.2.1 Technique 22820.2.2 Devices in Active Clinical Trial Phase 23020.2.2.1 Tendyne 23020.2.2.2 Intrepid 23020.2.2.3 CardiAQ 23120.2.2.4 TIARA 23120.2.2.5 HighLife 23120.3 Transseptal Approach 23120.3.1 Technique 23120.3.2 Devices in Active Clinical Trial Phase 23320.3.2.1 Sapien M3 23320.3.2.2 EVOQUE 23320.3.2.3 Caisson 23320.4 Conclusions 233References 23321 Mitral Valve-in-Valve and Valve-in-Ring Therapies 235Norihiko Kamioka, Peter C. Block, Adam B. Greenbaum, and Vasilis C. Babaliaros21.1 Overview 23521.2 Evidence 23621.3 Procedure Planning 23921.4 Procedure 24321.5 Pitfalls and Solutions—POULEZ and LAMPOON 244References 24522 Edwards SAPIEN in Native Mitral Annular Calcification (MAC) 251Mayra Guerrero, Dee Dee Wang, Mackram Eleid, Charanjit Rihal, William O’Neill, and Ted Feldman22.1 Introduction 25122.2 Anatomic Considerations and Sizing 25122.3 Delivery Access Types 25322.4 Preprocedural Planning 25322.5 Valve Deployment Technique 25322.6 Clinical Outcomes and Complications 25522.7 LVOT Obstruction 25622.8 TMVR in MAC Clinical Trials 25622.9 Aortic THV versus Dedicated TMVR Devices for MAC 25722.10 Conclusions 257Disclosures 258References 25823 Transcatheter Mitral Valve Replacement: The Tendyne Device 261Alison Duncan23.1 Introduction 26123.2 The Tendyne TMVI Device 26123.2.1 Current Tendyne Device Design 26223.3 Patient Screening and Preprocedural Imaging 26223.3.1 Patient Selection 26223.3.2 Anatomical Screening 26323.4 Implantation Technique 26423.4.1 Transapical Approach 26423.4.2 Device Entry into Left Atrium 26423.4.3 Intra-annular Device Deployment 26423.4.4 Apical Pad Fixation and Adjustment of Tether Tension 26423.4.5 Confirmation of Device Position and Function 26723.5 Clinical Outcomes 26723.6 Future Challenges 27123.7 Conclusion 274References 27424 TIARA Transcatheter Mitral Replacement System 277Anson Cheung24.1 Introduction 27724.2 Neovasc TIARA TMVR System 27724.3 Candidacy for TIARA TMVR 27824.4 Clinical Case and TIARA TMVR Implantation 27824.5 Clinical Updates 28124.6 Conclusions 281Conflict of Interest 282References 28225 Caisson Transcatheter Mitral Valve Replacement System 283Mathew R. Williams and Cezar S. Staniloae25.1 Introduction 28325.2 Caisson Transcatheter Mitral Valve Replacement System Components 28325.2.1 Anchor 28425.2.2 Valve 28525.2.3 The Delivery System 28525.2.4 Retrieval Accessories 28525.3 Procedural Details 28525.3.1 Role of Imaging on Valve Sizing and Procedural Guidance 28725.3.1.1 Role of Gated CT 28725.3.1.2 Role of TEE Guidance During the Procedure 28825.4 Current Status of the Caisson Research Program 28925.5 Conclusions 289Reference 28926 Transcatheter Mitral Valve Replacement with the CardiAQ-Edwards and EVOQUE Prostheses 291Howard C. Herrmann, Wilson Y. Szeto, and Frank E. Silvestry26.1 Introduction 29126.2 Device Description 29126.3 First-in-Human Transfemoral Case 29226.4 Initial Experience via Transapical Approach 29226.5 Second-Generation Transseptal Approach 29326.6 Current CardiAQ Generation Design and Contemporary Case Example 29326.6.1 Evolution to EVOQUE TMVR 29526.7 Discussion 296References 29727 Intrepid 299Eberhard Grube and Jan-Malte Sinning27.1 Background 29927.2 The Intrepid Valve Features 30027.3 Clinical Experience 30127.4 Discussion 304References 30628 Laceration of the Anterior Mitral Leaflet to Prevent Outflow Obstruction (LAMPOON) 309Jaffar M. Khan and Vasilis C. Babaliaros28.1 Introduction 30928.1.1 Mechanism of LVOT Obstruction from TMVR 30928.1.2 Prediction of LVOT Obstruction 30928.1.3 Prevention and Treatment of LVOT Obstruction 30928.2 The LAMPOON Technique 31028.2.1 CT Planning for TMVR and LAMPOON 31128.2.2 LAMPOON Equipment 31228.2.3 Step 1: Positioning the Snare System 31228.2.4 Step 2: Leaflet Traversal 31228.2.5 Step 3: Leaflet Laceration 31228.3 Alternative LAMPOON Techniques 31328.3.1 Antegrade Transseptal LAMPOON 31328.3.2 Antegrade Apical LAMPOON 31328.3.3 “Rescue” LAMPOON 31428.4 Evidence for LAMPOON-Assisted TMVR 31528.5 Future Directions 31528.6 Conclusions 315References 31529 Use of Alcohol Septal Reduction Therapy to Facilitate Transcatheter Mitral Valve Replacement 317Marvin H. Eng, Tiberio Frisoli, Dee Dee Wang, James C. Lee, Pedro A. Villablanca Spinetto, Janet Wyman, and William W. O’Neill29.1 Introduction 31729.2 Technique 31929.3 Safety 32129.4 Efficacy 32129.5 Conclusion 323References 32330 Direct Transatrial Approach with Resection of the Anterior Mitral Leaflet to Prevent Outflow TractObstruction 325Fabien Praz and Isaac George30.1 Introduction 32530.2 Advantages of the Direct Transatrial Access 32530.3 Patients Selection and THV Sizing 32630.3.1 Mitral Annulus Sizing 32630.3.2 Assessment of the Risk of LVOTO Using Valve Simulation 32630.4 Implantation Techniques 32830.4.1 First-in-Human and Early Experience 32830.4.2 Strategies to Prevent Paravalvular Leakage 32930.5 Surgical Access 32930.6 Early Outcomes Data 33030.7 Conclusions 331References 33131 Transcatheter Closure of Mitral Paravalvular Leak 333Tilak K. R. Pasala, Vladimir Jelnin, and Carlos E. Ruiz31.1 Introduction 33331.2 Prevalence and Clinical Presentation 33331.3 Assessment of Mitral PVL 33431.3.1 Grading of Severity 33431.3.2 Complexity of Mitral PVL 33431.3.3 Adjunctive Imaging 33431.4 Timing of Intervention 33531.5 Preplanning 33631.5.1 Location 33631.5.2 Virtual Planning 33731.6 Devices Used for PVL Closure 33831.6.1 Transcatheter Procedure 33831.6.2 Procedural Guidance 34031.6.3 Access 34031.6.4 Procedural Techniques 34131.6.4.1 Crossing the PVLs 34131.6.4.2 Catheter and Device Delivery 34331.6.4.3 Device Deployment 34431.6.4.4 Hopscotch Technique 34531.7 Procedural Complications 34531.8 Follow-Up 34631.9 Future 34631.10 Conclusion 346Disclosures 346References 34632 Management of Iatrogenic Interatrial Septal Defect—To Close or not to Close? 349Christina Tan and James M. McCabe32.1 Introduction 34932.2 Hemodynamics and iASDs 34932.3 Incidence of Persistent Iatrogenic Atrial Septal Defects 35032.4 Evaluation of Iatrogenic Atrial Septal Defect 35132.5 Closure 35232.6 ASD Closure Procedure 35232.7 Management 353References 35533 Antithrombotic Therapy in Transcatheter Mitral Valve Intervention 359Yuefeng Chen and Ron Waksman33.1 Introduction 35933.2 MitraClip System 35933.2.1 Before the Procedure 35933.2.2 During the Procedure 36033.2.3 After the Procedure 36133.2.4 Thromboembolic and Bleeding Risk 36133.3 Transcatheter Mitral Valve Replacement 36233.3.1 Before the Procedure 36233.3.2 During the Procedure 36233.3.3 After the Procedure 36233.3.4 Thromboembolic and Bleeding Risk 36333.4 Patients with Atrial Fibrillation 36533.5 Antithrombotic Therapy for Other Mitral Valve Interventions 36533.6 Conclusions 365References 366Index 371

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