STEVENSON AND KORMOS, ET AL., MECHANICAL CARDIAC SUPPORT
2000
JACC Vol. 37, No. 1, January 2001:340-70
American College of Cardiology Consensus Conference
Report:
Mechanical Cardiac Support 2000:
Current Applications and Future Trial Design
Steering
Committee Members
Robert
C. Bourge, MD, FACC, Annetine Gelijns, PhD, Bartley P.
Griffith, MD, Ray E. Hershberger, MD, FACC, Sharon Hunt,
MD, FACC, James Kirklin, MD, FACC, Leslie W. Miller, MD,
FACC, Walter E. Pae, JR., MD, FACC, George Pantalos, PhD
D., Glenn Pennington, MD, FACC, Eric A. Rose, MD, FACC,
John T. Watson, PhD, James T. Willerson, MD, FACC, James
B. Young, MD, FACC.
Writing
Group Participants
Mark
L. Barr, MD, Maria Rosa Costanzo, MD, FACC, Patrice Desvigne-Nickens,
MD, Arthur Michael Feldman, MD, PhD,
FACC, O. Howard (Bud) Frazier, MD, FACC, Lawrence Friedman,
MD, J. Donald Hill, MD, FACC, Marvin A. Konstam, MD, FACC,
Patrick McGuane McCarthy, MD, Robert E. Michler, MD, FACC,
Mehmet C. Oz, MD, FACC, Bruce R. Rosengard, MD, Wolf Sapirstein,
MD, Rhona Shanker, Craig R. Smith, MD, Randall C. Starling,
MD, MPH, FACC, David O. Taylor, MD, FACC, Alison Wichman,
MD.
Invited Representatives of Industry
Dallas
W. Anderson, Ken Charhut, Laura Damme, RN, MPH, Michael
R. Devries, Lorenzo DiCarlo, MD, FACC, David J. Farrar,
PhD, Leonard A. R. Golding, MD, FACC, Steven
A. Kolenik, Tim Krauskopf, Douglas McNair,
MD, PhD, Tofy Mussivand, PhD, Chisato
Nojiri, MD, PhD, George P. Noon, MD, Steven
J. Phillips, MD, FACC, Peer M. Portner, PhD,
FACC, Eric Schorsch, Joseph J. Schwoebel, MBA, Winston
Umemura, Robert L. Whalen, PhD, Helene Zintak,
PA.
Sponsoring Organizations
The
conference was conducted with financial and other support
from the following organizations: American College of
Cardiology, American Heart Association, International
Society for Heart and Lung Transplantation, American Society
of Transplantation, Heart Failure Society of America,
American Association for Thoracic Surgery, the Society
of Thoracic Surgeons, and the American Society of Transplant
Surgeons.* Additionally,
participants included members of these agencies: Food
and Drug Administration, National Institutes of Health,
and the American Society for Artificial Internal Organs.
Contents:
Impact
Statement
Introduction
Executive
Summary
I.
Current Status of Mechanical Cardiac Support
II.
Evolution of Therapies for Heart Failure
A.
Medical Therapies for Heart Failure
B.
Surgical Therapies for Heart Failure
C.
Downshifting of Risk for New Surgical Therapies
III.
Target Populations and End Points for Mechanical Circulatory
Support
A.
Indications for Device Support
1.
Cardiogenic shock
2.
Heart failure dependent on intravenous inotropic
support
3.
Outpatients with symptomatic heart failure—
who is at intermediate risk?
4.
Uncontrollable ventricular arrhythmias
5.
Cardiac allograft dysfunction and/or cardiac allograft
vasculopathy
B.
Evaluation for Exclusion Criteria
C.
Selection of Devices
D.
End Points for Outcomes
1.
The end points for critical populations
2.
Ambulatory heart failure on oral therapy
IV.
Establishing Efficacy for Devices: Ethical and Practical
Challenges
A.
Therapies for Life-threatening Illness
B.
Differences Between Development of Drugs and Devices
C.
The Potential for “Breakthrough” Devices
D.
Ethical Considerations Governing Trials of Mechanical
Circulatory Support
1.
Requirement for clinical equipoise
2.
Ethical issues in patient selection for mechanical
circulatory support
3.
Ethical issues surrounding randomization
4.
Ethical issues after randomization
5.
Future ethical issues for equipoise
E.
Design of Clinical Trials for Mechanical Circulatory
Support
1.
Randomized clinical trials
2.
The REMATCH trial
3.
Modifications of the randomized controlled trial
for mechanical circulatory support devices
4.
Comparison of non-randomized cohorts
F.
The Vital Importance of Registries
1.
Outcomes database for advanced heart failure
2.
Registries for implantable devices
V.
Future Devices Entering Clinical Development
A.
Existing Minimum Standards for Pre-Clinical Device
Evaluation
B.
Devices Currently in Clinical Development
1.
Continuous flow left ventricular assist devices
2.
Pulsatile flow devices
3.
Total artificial hearts
4.
Devices without blood contact
C.
Conclusions
*The
recommendations set forth in this report are those of
the conference participants and do not necessarily reflect
the official position of the American College of Cardiology.
The full text document will be published in the Journal
of the American College of Cardiology, and the
executive summary will be published in Circulation,
the Journal of Heart and Lung Transplantation,
and the Journal of Thoracic and Cardiovascular
Surgery. This document is available on the World
Wide Web site of the American College of Cardiology (www.acc.org).
Reprints of this document are available for $5.00 each
by calling 800-253-4636 (U.S. only) or by writing the
Resource Center, American College of Cardiology, 9111
Old Georgetown Road, Bethesda, Maryland 20814.
©
2000 by The American Heart Association, Inc. and
The American College of Cardiology
Published by Elsevier
Science Inc.
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