Mechanical Circulatory Support: A Companion to Braunwalds Heart Disease

Cover
Inside Front cover
Copyright
Dedication
Contributors
Preface
Braunwald’s Heart Disease Family of Books
Chapter 1: Historical Aspects of Mechanical Circulatory Support
Early mechanical circulatory support devices and technology development
Establishing the Concept
Clinical Application and Evolution of MCS
Ongoing technology developments and devices
Current state of MCS
Disclosure
Funding
References
Chapter 2: Advanced Heart Failure and Cardiogenic Shock
Introduction
Definition
Etiology of cardiogenic shock
Hemodynamic effects of cardiogenic shock
Reduced Cardiac Output
Hypotension
Increased Filling Pressures
Neurohormonal response to cardiogenic shock
Lactic Acidosis
Inflammatory pathways
Nitric Oxide
End organ injury
Conclusion
References
Chapter 3: Risk Stratification in Advanced Heart Failure
Introduction
Acute versus chronic heart failure
Hospitalization as a Prognostic Marker
Heart failure with preserved ejection fraction
Sudden cardiac death versus progressive heart failure
Elderly versus transplant referral populations
Renal dysfunction
Biomarkers
Natriuretic Peptides
Metabolic and Inflammatory Markers
Physical capacity and mortality risk in heart failure
Six-Minute Walk Test
Maximal Oxygen Uptake and Prognosis in Heart Failure
Exercise hemodynamics
Frailty
Multivariable risk stratification in heart failure
Models for Inpatients
Models for Outpatients
Conclusion
References
Chapter 4: Candidate Selection and Decision Making in Mechanical Circulatory Support
Introduction
Indications for mechanical circulatory support
Bridge to Transplant
Destination Therapy
Non-MCS Alternatives
Timing
Objective Measures of Disease Severity Warranting MCS
Heart Failure Risk Scores
Contraindications to MCS—medical, cardiac
Right Ventricular Dysfunction
Ventricular Arrhythmia
Cardiac Anatomy, Prior Surgery, and Valve Disease
Contraindications to MCS—Medical, Noncardiac
Hematologic, Gastrointestinal, and Anticoagulation Considerations
Renal Dysfunction
Pulmonary Disease
Peripheral Vascular Disease
Cancer
Infection
Diabetes
Malnutrition and Obesity
Neurologic Disease
Frailty
Contraindications to MCS—nonmedical
Psychosocial Considerations
Temporary support to assess candidacy
Formal evaluation protocols
Shared decision making
Summary
References
Chapter 5: Acute Circulatory Support
Introduction
The spectrum of cardiogenic shock
Short-term mechanical circulatory support devices
Intraaortic Balloon Pump Support
Percutaneous Ventricular Assist Devices: Left Ventricular Support
The TandemHeart Left Ventricular Support System
Impella Left Ventricular Support System
Percutaneous Ventricular Assist Devices: Right Ventricular Support
Impella RP Right Ventricular Support Device
Protek Duo Right Ventricular Support Device
Biventricular Support/Venoarterial Extracorporeal Membrane Oxygenation
Venoarterial Extracorporeal Membrane Oxygenation
Complication of temporary circulatory support
Clinical outcomes in shock patients supported with short-term mechanical circulatory support
Conclusions/summary
Disclosures
References
Chapter 6: The Role of Extracorporeal Membrane Oxygenation in Cardiac Support
Background
Current ecmo technologies used in cardiac support
Ecmo configurations and cannulation strategies for cardiac support
Characteristics of ecmo vs other temporary mechanical circulatory support systems
Indications for ecmo in patients with cardiac disease
Heart Failure and Cardiogenic Shock
Postcardiotomy Shock
Septic Shock
Extracorporeal CPR
Bridge to Heart Transplantation or Durable LVAD
Conclusion
References
Chapter 7: Understanding the Principles of Continuous-Flow Rotary Left Ventricular Assist Devices
Introduction
Historical perspective
General pump design
CF rotary pump design: axial versus centrifugal pumps
Bearing design/impeller suspension
Mechanical Bearing
Noncontact Bearing Designs
Hydrodynamic Bearing
Magnet Bearing
Hydrodynamic performance of CF pumps
Interaction of the CF rotary pump and native heart
Parallel and series circulation
Flow estimation
Limitations in flow control with cf rotary pumps
Conclusion
References
Chapter 8: Hemocompatibility in Mechanical Circulatory Support
Introduction
Biological Factors
Hemolysis
Thrombosis
High Shear
Coagulation/Low Shear
Hemocompatibility-Related Engineering Aspects
Pump Configurations
Pump Curves
Surface Preparation/Roughness
Flow Analysis (Device/Ventricle)
Material Science
Inflow/Outflow Cannula
Shear Stress
Speed Modulation
Conclusions
References
Chapter 9: The Biological Response to Ventricular Unloading
Introduction
Cardiac hypertrophy-atrophy
Contractile dysfunction, calcium handling, and cytoskeletal proteins
Cardiac metabolism and bioenergetics
Cell death and stress
Natriuretic peptides and neurohormones
Inflammatory markers
Extracellular matrix and fibrosis
Gene expression, rna, and proteomic profiling
Endothelium and vasculature
Studies on angiogenesis
Future directions
Summary
References
Chapter 10: Current Types of Devices for Durable Mechanical Circulatory Support
Development of mechanical circulatory support systems
Durable left ventricular assist devices
HeartMate II LVAS
HeartMate 3 LVAS
HeartWare HVAD
Jarvik 2000
Berlin Heart INCOR
Berlin Heart EXCOR Pediatric Ventricular Assist Device
Evaheart LVAS
SynCardia Total Artificial Heart
Future directions of mechanical circulatory support
Summary
References
Chapter 11: Operative Techniques and Intraoperative Management
Historical note
Principles of device selection
Preoperative assessment and preparation
Implant operation
Intraoperative considerations
Valvular Incompetence and Repair
Tricuspid Regurgitation
Mitral Regurgitation
Aortic Valve
Patent Foramen Ovale
Ventricular Arrhythmias
Management of Weaning From Cardiopulmonary Bypass
Management of the Right Ventricle
Right Heart Failure
Decisions About Right Ventricular Support
Pump Selection for Right Heart Support
Intraoperative Bleeding
Sternal Reentry
Postoperative care
References
Chapter 12: Postoperative VAD Management: Operating Room to Discharge and Beyond
Surgical and Medical Considerations
Perioperative management
Considerations in the operating room relevant to subsequent ICU care
Early postimplantation ICU care
Early postimplantation medical management in the ICU
Pharmacologic management in the ICU
Preparing for home discharge
Standard outpatient visit
References
Chapter 13: Adverse Events and Mitigation Strategies
Introduction
Definitions
Time-related occurrence, contributing factors, and causation
Risk Factors
Adverse event burden and era effect
Adverse events contributing to death
Perioperative bleeding
Surgical wound infections
Pump-related infection
Percutaneous Driveline Infection
Pump Pocket Infections
Infections of Blood Contacting Pump Components (Pump Endocarditis)
Gastrointestinal bleeding
Neurologic dysfunction
Renal failure
Device failure
Pump thrombosis
Other thromboembolic events
Right Heart Failure
Aortic Insufficiency
Arrhythmias
References
Chapter 14: Right Heart Failure in Patients With Mechanical Circulatory Support
Introduction
Physiology and anatomy of the right ventricle
Right ventricular failure in patients with chronic heart failure after lvad
Definition of Right Ventricular Failure
Pathophysiology of Right Ventricular Failure After LVAD Placement
Right venticular afterload sensitivity and adaptation
Preoperative evaluation and predictive risk scores
Pulmonary artery pulsatility index
Perioperative management of right ventricular function
Mechanical circulatory support for right ventricular dysfunction
Delayed right ventricular failure
References
Chapter 15: Clinical Trial Results in Mechanical Circulatory Support
Disclosure
Overview of Clinical Trials of Mechanical Circulatory Support Devices
Pulsatile Flow
HeartMate IP1000
HeartMate VE/XVE
Novacor
Continuous Flow—Axial
HeartMate II
Jarvik 2000
MicroMed DeBakey/HeartAssist 5
Continuous Flow—Centrifugal
HVAD
VentrAssist
DuraHeart
HeartMate 3
Quality of Life, Functional Status, and Adverse Events
Elective LVAD Therapy
Total Artificial Hearts
Conclusion
References
Chapter 16: Psychosocial and Quality of Life Issues in Mechanical Circulatory Support
Preimplantation considerations
Disparities in Access to Mechanical Circulatory Support
Informed Consent
Decision-Making Capacity
Informing Patients, Caregivers, and Families About Treatment Options
Understanding of Treatment Options
Agreement to Treatment Options
Patient and Family Preferences and Decision-Making
Psychosocial Evaluation for Mechanical Circulatory Support
Psychosocial outcomes during mechanical circulatory support
Patient Health-Related Quality of Life
Physical Functional Health-Related Quality of Life
Psychological Health-Related Quality of Life
Social Health-Related Quality of Life
Global Health-Related Quality of Life
Patient Medical Adherence and Self-Care
Family Caregiver Well-Being and Quality of Life
Economic Burdens for the Patient and Family
Psychosocial predictors of clinical outcomes during mechanical circulatory support
Postimplantation and end-of-life considerations
Postimplantation Outcomes
Patient Health-Related Quality of Life After Heart Transplantation
Patient Health-Related Quality of Life After Recovery From Mechanical Circulatory Support
Palliative Care, Hospice, and End-of-Life Considerations
Palliative Care and Hospice Consultation
Discontinuation of Mechanical Circulatory Support
Conclusions and future clinical and research directions
References
Chapter 17: Left Ventricular Assist Device in Special Population of Patients
Case presentation
Introduction
Modification in surgical technique
Left Ventricular Assist Device Pump Speed Management
Potential patient population
Summary
References
Chapter 18: Mechanical Circulatory Support in Pediatrics
Introduction
Heart failure in children
Current devices for pediatric cardiac support
Extracorporeal Membrane Oxygenation
Left Ventricular Assist Devices
Temporary Support Strategies
Durable Strategies
Continuous-flow devices
Pulsatile devices
Pediatric Device Initiatives
Bridge-to-transplantation
Management of pediatric patients receiving cardiac assist device therapy
Indications for Mechanical Circulatory Support in Children
Timing of Support and Device Selection
Other topics in pediatric mechanical circulatory support
Biventricular Assist Device Support
Congenital Heart Disease
Single-Ventricle Support
Adult Congenital Heart Disease
Adverse Events
Anticoagulation
Conclusion
References
Chapter 19: Facilitating Myocardial Recovery
History of recovery and device explantation
Possible explanations of the low rate of myocardial recovery
Assessment of Myocardial Recovery
Optimizing myocardial recovery
Harefield protocol
Harefield Protocol—Phase 1
Harefield Protocol—Phase 2
Harefield Protocol Prospective Trial—Pulsatile Pump
Harefield Protocol Prospective Trial—Continuous-Flow Pump
U.S. Harefield Recovery Protocol Study
Remission From Stage D Heart Failure Study
Surgery for myocardial recovery
Insertion
Explantation
Quality of life after left ventricular assist device explantation
Summary and next steps to enhance rate of recovery
Using the Left Ventricular Assist Device as Myocardial Therapy
Using the Left Ventricular Assist Device as a Platform for Adjuvant Therapy
Left Ventricular Assist Devices in the Future
References
Chapter 20: The Critical Role of MCS Registries
Origins of Intermacs/Pedimacs
Intermacs Patient profiles
Intermacs Profile definitions
Relationship of Intermacs Profiles to Outcomes
Evolving intent of durable mcs placement
Overall outcomes
Survival
Quality of Life
Adverse events
Early Versus Late Adverse Events
Freedom From Adverse Events and Patient Profile
Registry comparison to alternative therapies
Heart Transplant
Investigational Device Therapy and Registry Data
Contemporary Medical Therapy
MedaMACS
REVIVAL
Impact of registry data on clinical use of vads
Globalization of mcs registries
References
Chapter 21: Regulatory and Reimbursement Landscape for Mechanical Circulatory Support
Introduction
History of medical device regulations
History of Reimbursement in the United States
European Medical Device Regulations
Medical Device Regulations in Rest of World Markets
Global reimbursement
Regulatory pathways for mechanical circulatory support devices
Reimbursement pathways for mechanical circulatory support devices
Where Will It Fit?
Mechanical circulatory support device total product life cycle
Design
Preclinical Testing
Clinical Testing
Premarket Approval
Creating reimbursement for left ventricular assist devices
Pathways to Payment
Cost-effectiveness
Postmarket studies/surveillance
Device tracking
Mechanical circulatory support device registries
Mechanical circulatory support device corrections and removals (recalls)
Obsolescence
Lessons learned
Conclusions
References
Chapter 22: The Future of Mechanical Circulatory Support
I. The trail blazed and the pathway ahead
II. The future is leveraging the past
Early Goals of Life, and then Life Outside the Hospital
Exploring Long-Term Life with ‘Destination Therapy’
The Pathway to Improvement
TECHNOLOGY Breakthroughs
MANAGEMENT Improvements and Guidelines
PATIENT Selection and Risk Mitigation
The Era of Improving Survival
III. The future is optimizing the present
RECOGNIZING the OPPORTUNITIES
MAPPING the Pathway to OPTIMIZATION
OPTIMIZING TECHNOLOGY
Improving HEMOCOMPATIBILITY
The emerging science of hemocompatibility applied to device design
Improving BIOCOMPATIBILITY
Eliminating the need for ANTICOAGULATION
Reducing INFECTION
Extending Device DURABILITY
Expanding FUNCTIONALITY
Right Heart Support
Bi-ventricular Support
Smart Controllers
Pulsatility
Extending INDICATIONS
Recovery
Heart failure with preserved ejection fraction
Enhancing QUALITY OF LIFE
Facilitating IMPLANTATION
Easing Device USE
Remote Monitoring and Management
Optimizing Management
Optimizing SURGICAL Management
Optimizing MEDICAL Management
Optimizing LIFE-LONG Management
OPTIMIZING PATIENTS
Movement to EARLIER-STAGE PATIENTS
Addressing PATIENT-SPECIFIC Characteristics
IV. The future requires organization
Heart Failure Networks
Field-wide Collaboration
V. The future is now
References
Index
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