Mechanical Circulatory Support: A Companion to Braunwald's Heart Disease Ebook

James K. Kirklin, Joseph G Rogers

• Publisher: Elsevier
• Year: 2019
• ISBN:
  9780323566971
• Edition: 2
• Topic: Médecine
• Subtopic: Cardiologie

Offering comprehensive, authoritative coverage of mechanical circulatory support (MCS), this fully revised companion to Braunwald's Heart Disease provides the clinically relevant information you need to effectively use this therapy to treat and manage end-stage heart failure. New editors and authors – experts in both cardiology and cardiovascular surgery – bring you fully up to date with the newest technology and devices, as well as basic science, clinical applications, adverse event monitoring and management, socioeconomic implications, future directions, and more.

• Covers all of the newest techniques, including new-generation devices.
• Discusses the management of common patient problems, highlighting cautions and outcomes, as well as pathophysiology and rationale for treatment.
• Brings you up to speed with the latest coverage of ventricular assist devices (VAD), extracorporeal membrane oxygenation (ECMO), next-generation centrifugal pumps, and total artificial hearts.
• Provides a complete clinical perspective of the latest scientific breakthroughs and analysis of the current literature.
• Includes coverage of the most recent guidelines and protocols, including MCS for pediatric and congenital heart disease; the Interagency Registry of Mechanically Assisted Circulatory Support (INTERMACS) as a tool to track and advance clinical practice; and cellular, molecular, genomic, and functional changes that occur in the failing heart in response to MCS.
• Presents practical evidence from the registry of thousands of cases to guide cardiologists, cardiovascular surgeons, emergency physicians, primary care physicians, and other team members on the best management course to follow for each particular patient.

1

Historical Aspects of Mechanical Circulatory Support

J. Timothy Baldwin; John T. Watson

Abstract

The mechanical circulatory support (MCS) devices of today trace their roots to ex-vivo studies in the 1930s, the clinical application for the heart-lung machine in the 1950s, and the advent of the National Institutes of Health Artificial Heart Program in the 1960s. Since then, MCS devices have evolved from large positive-displacement pumps with limited durability and large control consoles to battery-powered continuous-flow rotary pumps with compact smart controllers that are small enough to be implanted in infants. The progress made in these devices has occurred as a result of federal and private funding leading to various technological breakthroughs by talented and dedicated interdisciplinary teams of engineers, scientists, and clinicians. While the current devices provide a therapy for advanced stage heart failure patients to routinely live five years or longer with an MCS device with a better quality of life, adverse events such as strokes and infections are still common. Further progress on the devices with specific goals to overcome these issues is needed to benefit more heart failure patients and realize the full potential of MCS devices

Keywords

mechanical circulatory support; artificial heart; ventricular assist device; VAD

Key points

• Early Mechanical Circulatory Support Devices and Technology Development
• Ongoing Technology Developments and Devices
• Current State of MCS

Early mechanical circulatory support devices and technology development

Establishing the Concept

In the 1930s, Carrel and Lindbergh¹ developed an in vitro artificial heart-like apparatus for keeping organs alive outside the body. They removed the hearts, kidneys, ovaries, adrenal glands, thyroid glands, and spleens of small animals to watch them develop and function over the course of several days.² Acute animal studies in Russia and the United States followed in the 1940s. However, the meaningful origin of the modern era of mechanical circulation support (MCS) can be traced to the development of the heart-lung machine by Gibbon (Table 1.1) and its first successful clinical use in 1953.^3,4 The device was developed for cardiopulmonary bypass so that surgical cardiac procedures that require hours of circulatory support could be performed. The success of the device and the need for prolonged circulatory support for patients who could not be weaned from the heart-lung machine or whose hearts could recover with longer durations of support provided the initial impetus for developing devices that could provide long-term circulatory support. The optimism in the 1950s and 1960s that circulation could be successfully supported for extended periods by an artificial heart spurred its development by pioneers such as Kolff, Akutsu, DeBakey, Liotta, and Kantrowitz.⁵ In 1963, DeBakey and Lederberg testified before the US Congress on the need for an artificial heart in very different domains: for patients otherwise healthy except for their failed heart and for isolated travelers on long space journeys.⁶ These hearings coincided with the debate about the implications of the Russian Sputnik Program and unbridled national enthusiasm for taking on large technologic challenges such as the program to put the first man on the moon, which had begun just a few years earlier.

Table 1.1

Mechanical Circulatory Support Milestones

Year	Event
1953	First successful use of heart-lung machine for cardiopulmonary bypass (Gibbon)
1958	First successful use TAH in a dog (Kolff and Akutso)
1963	First successful use of LVAD in human (DeBakey)
1964	Artificial Heart Program established at NIH Six contracts awarded to analyze issues and need for program
1968	First clinical use of intraaortic balloon pump (Kantrowitz)
1969	First artificial heart implant in humans (Cooley)
1977	NHLBI RFPs for blood pumps, energy converters, and energy transmission NHLBI RFA on blood-material interactions
1980	NHLBI RFP for integration of blood pumps designed for 2-year use
1982	Barney Clark received first TAH implant for destination therapy (DeVries)
1984	NHLBI RFP for 2-year reliability studies First use of Pierce-Donachy VAD (Thoratec PVAD) as BTT (Hill) First implant of Novacor VAD First use of electromechanical VAD (Oyer)
1985	First use of CardioWest TAH as BTT (Copeland)
1988	First use of hemopump in humans (Rich Wampler)—first rotary blood pump used (Frazier) NHLBI awards four contracts to develop portable, durable TAHs
1989	Manual of operations for Novacor VAD NHLBI clinical trial completed
1991	First HeartMate VE implant (Frazier)
1994	FDA approval for pneumatic HeartMate VE as BTT
1996	NHLBI IVAS contracts awarded for Jarvik 2000, HeartMate II, CorAide VADS Pilot trial (PREMATCH) for destination therapy begins NHLBI awards two contracts for TAH Clinical Readiness Program (Abiomed, Penn State)
1998	FDA approval for HeartMate XVE as BTT FDA approval for Novacor as BTT REMATCH trial begins First DeBakey VAD implant (Wieselthaler)
1999	First human implant Arrow LionHeart VAD (first use of TETS) (Korfer)
2000	First HeartMate II implant (Lavee) First Jarvik 2000 implant (Frazier)
2001	REMATCH trial completed First implant of the AbioCor TAH (Dowling)
2002	FDA approval of HeartMate XVE as destination therapy
2003	CMS coverage decision for destination therapy
2004	NHLBI pediatric mechanical circulatory support program launched First implant of DuraHeart VAD (Korfer)
2006	First implant of HeartWare HVAD (Wieselthaler) First implant of Levacor VAD (Long) FDA approval of AbioCor TAH (Humanitarian Device Exemption) INTERMACS registry launched (PI: Kirklin )
2007	First implant of Circulite Synergy device (Meyns); advent of miniature VADs Peter Houghton dies after a record 2714 days of VAD support
2008	HeartMate II BTT clinical trial completed
2009	FDA approval of HeartMate II for BTT HeartMate II destination therapy clinical trial completed 850th implant of the CardioWest TAH
2010	FDA approval of HeartMate II for destination therapy
2012	FDA approval of HVAD centrifugal flow pump for bridge-to-transplant therapy
2014	First implant of HM3 (Schmitto)
2017	FDA approval of HVAD for destination therapy FDA approval of HM3 centrifugal flow pump for bridge-to-transplant and bridge-to-recovery therapy

BTT, Bridge-to-transplant; CMS, Centers for Medicare and Medicaid Services; FDA, Food and Drug Administration; HM3, HeartMate; INTERMACS, Interagency Registry of Mechanically Assisted Circulatory Support for End-Stage Heart Failure; IVAS, Innovative Ventricular Assist System; LVAD, left ventricul...