RELEASE DATE:  December 4, 2003
NOTICE: NOT-HL-04-103 (see NOT-HL-04-104)

National Heart, Lung, and Blood Institute (NHLBI) 

RESPONSE DUE DATE: December 30, 2003

The NHLBI plans to release a Request for Proposals for a Clinical and Data 
Coordinating Center to establish a patient and device data registry to track 
patients receiving mechanical circulatory support for end-stage heart failure.  
The registry will also establish a tissue and blood repository.  The registry 
will benefit the research and practice communities as well as federal agencies 
concerned with patient safety and oversight.

The NHLBI would like information from academic institutions, professional groups 
and private industries that develop and apply mechanical circulatory support 
devices to identify optimum parameters to establishing a registry and ways to 
design and implement an effective program.  Specifically, NHLBI seeks advice 
concerning core information to be collected, concerns and solutions to protect 
rights of patients, facilities, providers and support teams and manufacturers.  
Also important are independence of data analysis, access to data and data 
sharing, and potential strategies for the registry to become at least partially 
self-supporting.  Ways to involve private industry without undermining the 
independence of the program governance are also sought.


Over the past two decades, mechanical circulatory support devices, such as 
ventricular assist devices and total artificial hearts, have been developed to 
augment or supplant failing myocardial performance.  This therapy has been used 
successfully as a bridge to heart transplantation, a bridge to recovery, and, 
most recently, as destination therapy for intractable heart failure.  Although 
cardiac transplantation offers life-saving therapy for selected patients, its 
use is limited by a supply of donor organs that currently meets less than one-
tenth the need, and which is steadily decreasing.  As a consequence, the number 
of mechanical circulatory support device implantations has increased from a 
cumulative total U.S. experience of 1,000 in 1990, to approximately 1,000 per 
year in 2000.  The latter figure is expected to increase greatly following the 
2002 Food and Drug Administration (FDA) approval of a destination therapy device 
and the October 1, 2003, CMS approval for reimbursement for this indication.  
Despite favorable survival and quality of life outcomes, mechanical devices have 
severe and sometimes life-threatening complications associated with infection, 
thrombosis, and device failure.  Development of new procedures and devices to 
reduce these complications would be expedited by a systematic, independent 
analysis of mechanical support device implantation procedures and outcomes.  
Cooperation among the federal agencies involved in the development, regulation, 
and use of circulatory support devices, including NHLBI, FDA and Center for 
Medicare and Medicaid Services (CMS), will permit development of standard 
reporting of patient characteristics, indications, implantation procedures, and 
adverse events.  Such cooperation will facilitate clinical evaluation and 
patient management and aid better device development. 

Heart failure is a malignant cardiac disorder affecting over 4.5 million people 
in the U.S.; it is the most common hospital discharge diagnosis, exacting 
substantial morbidity and mortality, and health care resources and costs.  
Current therapies improve symptoms, but have only a modest impact on long-term 
survival. The NHLBI-supported Randomized Evaluation of Mechanical Assistance for 
the Treatment of Congestive Heart Failure (REMATCH) study evaluated the 
implantation of left ventricular assist devices and optimal medical therapy, 
versus optimal medical therapy alone, in randomly assigned end-stage heart 
failure patients ineligible for cardiac transplantation.  REMATCH results 
demonstrated better survival and quality of life in patients who received the 
assist devices.  Because the cost of mechanical assistance in REMATCH was 
similar to transplantation, mechanical assistance offers an important 
therapeutic alternative to transplantation.  Nevertheless, device therapy can be 
improved.  Better patient selection, device design and patient management are 
possible, but require careful evaluation that would be facilitated by data 
centralization and independent analysis.  A tissue and blood repository would 
encourage studies of heart failure using cutting-edge approaches, such as 
genomics and proteomics, the response to mechanical assistance, and the 
mechanisms underlying the reported improvement in native heart function with 
these devices.  Information obtained by the registry will aid in the development 
of improved surgical implantation procedures and patient management paradigms, 
and also point the way for future research studies.

The registry will support a Clinical and Data Coordinating Center, a tissue and 
blood repository, and a scientific advisory group to develop protocols for 
standard procedures to collect patient and device data, tissue, and blood 
samples for genomic and proteomic investigations.  Registry data would be 
analyzed to permit understanding of clinical outcomes, complications, and 
associated therapies.  The registry would serve as a resource to encourage 
research investigations using centrally collected tissue or data, and would 
provide information critical to the design of clinical investigations or trials 
of specific therapeutic interventions.  The proposed registry would build on the 
progress of the existing registries, and facilitate transfer of federally 
required data sets without compromising confidentiality of proprietary 


NHLBI seeks comments and suggestions as requested below.

1. Patient outcomes are determined by patient characteristics, surgical provider 
and facilities support, and device performance.  Please suggest data elements 
you consider essential for collection by the registry.

2. Abstracting hospital and out-patient data and checking accuracy of submitted 
data will be required.  Please provide concerns you have about the registry 
collecting data on patients, devices, hospitals and medical providers.  Please 
suggest ways the NHLBI can design registry protocols to minimize those concerns.

3. Please identify ways for NHLBI to encourage industry to participate and 
support the registry.

4. Please suggest ways to design the registry so that participants do not have 
duplicate reporting requirements.

5. Please provide methods to ensure accuracy and security of data in the 

6. Please suggest strategies for the registry to become at least partially self-
7. We would appreciate any additional views or opinions that you think would be 
useful to develop a registry that will improve outcomes for patients receiving 
mechanical circulatory support.


Responses in any of the areas are welcome; respondents should not feel compelled 
to address all items.  Please respond no later than December 30, 2003.  We look 
forward to your thoughts, opinions and suggestions and hope that you will share 
this document with your colleagues.  All responses will be kept confidential.  
Thank you for your assistance.

To respond please link to the online form in the "What's New" section on the 
NHLBI home page ( or send a letter, 
fax or email to the following address:

Amanda Curto
Program Specialist
Clinical and Molecular Medicine Program
Division of Heart and Vascular Diseases
National Heart, Lung, and Blood Institute 
National Institutes of Health
6701 Rockledge Drive, Rm. 9153, MSC-7940
Bethesda, MD 20892-7940 (Courier 20817)
Tel. 301-435-0515 / Fax. 301-480-1336

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