STEVENSON AND KORMOS, ET AL., MECHANICAL CARDIAC SUPPORT
2000
JACC Vol. 37, No. 1, January 2001:340-70
Introduction
Over
the past five years, mechanical circulatory support
devices have evolved from the earlier investigational
stages to become standard therapy for bridging to transplantation,
in some cases extending beyond original indications.
As the first randomized controlled trial of mechanical
circulatory support, the Randomized Evaluation of Mechanical
Assistance in the Treatment of Congestive Heart Failure
(REMATCH) trial began in 1998 and has undergone regular
protocol modifications resulting from experiences gained
with the patient population and the devices themselves.
In 1999, an expert review panel for the National Heart,
Lung and Blood Institute (NHLBI) recommended continued
support for the development of total artificial heart
programs. Refinement of currently available left ventricular
(LV) devices continues steadily, and many new types
of support devices are in or approaching clinical trials.
Ethical and practical issues have emerged regarding
the design and funding of these future clinical trials.
Challenges for optimal application are being compounded
as the separation between indications for recovery,
bridge to transplantation and permanent use is becoming
less distinct.
As
in the original conference on trial design for mechanical
circulatory support led by Pae in 1995, the goals of
investigators, governmental agencies and industry remain
the establishment of clinical trials that are “scientifically
sound, clinically meaningful and achievable in a finite
time frame at reasonable expense.” With
the rapid increase in experience with populations of
advanced heart failure, broader clinical application
of available devices and the promise of new technology
for future support, members of the steering group for
the NHLBI, the Food and Drug Administration (FDA), the
American College of Cardiology Committee on End-Stage
Heart Failure and the International Society for Heart
and Lung Transplantation sought broad representation
from professional societies and industry to address
the issues involved in trial design for mechanical circulatory
support looking ahead from 2000.
The
professional societies with significant interest in
this field were invited to co-sponsor this conference
and to select delegates to participate in the discussion
and writing of the draft document. The writing groups
established the basis of their conclusions for discussion
and subsequent revision by all participants during the
conference at the Heart House in Bethesda, Maryland,
to which representatives of industry were also invited.
The published document represents the consensus of the
participants, as approved by the Steering Committee,
and does not imply formal acceptance by any of the societies
represented. New developments will render the specifics
of this document obsolete, but it is hoped that the
fundamental considerations established here will help
to guide trial design and clinical decisions for the
near future.
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