Mechanical Circulatory Support: A Companion to Braunwalds Heart Disease

Cover
Inside Front cover
MECHANICAL
CIRCULATORY
SUPPORT:
A COMPANION TO BRAUNWALD’S HEART DISEASE
Copyright
Dedication
Contributors
Preface
Braunwald’s Heart Disease Family of Books
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
	A
	B
	C
	D
	E
	F
	G
	H
	I
	J
	K
	L
	M
	N
	O
	P
	Q
	R
	S
	T
	U
	V
	W
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