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Important Information About the
International Society for Heart and Lung Transplantation’s (ISHLT)’s
Mechanical Circulatory Support Device Database
ISHLT is a non-profit medical subspecialty society, which has been in existence since 1981, and
which is headquartered in Dallas, TX. Our society is dedicated to the science and treatment of endstage heart and lung disease. We currently have approximately 2300 individual members worldwide.
ISHLT has recently created a database of demographic and medical data for all recipients of
mechanical circulatory support devices (MCSDs). The database collects data related to implantation,
adverse events, and outcomes. The Transplant Informatics Institute (TII), in Richmond, Virginia, is
the contractor which maintains the database and computer systems. TII is a subsidiary of the United
Network for Organ Sharing (UNOS), which is the contactor for the United States Government’s Organ
Procurement and Transplantation Network.
PURPOSES OF DATABASE
The purposes of the Mechanical Circulatory Support Device Database are:
1) to capture worldwide data relating to the implantation and outcome of patients receiving cardiac
assist devices designed for and capable of use for 30 or more days
2) to identify risk factors for complications
3) to improve patient selection and management before and after device implantation
4) to generate predictive models of outcome for given patient profiles
5) to generate statistical analyses of the data that can be used as the underlying evidence/
justification for government agency funded studies and clinical trials
6) to identify overall and best practices with the aim of improving current practices
The primary objective of the database is the analysis of a large ongoing combined experience
focusing on outcomes after device implantation and identification of associated risk factors.
This database involves a retrospective chart review and materials (data, documents, records) that
have been collected or will be collected solely for non-research purposes.
This database will involve all patients at various institutions worldwide who have received a cardiac
assist device designed for and capable of use for 30 or more days. There are no control populations.
NATURE AND QUANTITY OF DATA TO BE COLLECTED
The database consists of two tiers of data. First tier data (see Attachment A) includes information on
device implantation and early postoperative course, preimplant condition and intention to treat, and
the recording of the incidence of any post-implant event. Second tier data includes details regarding
the specific complications and events subsequent to device implantation.
Centers who agree to participate in this database are required to submit first tier data on all device
recipients at their center. Centers which agree to participate in this database are not required to
submit second tier data. However, centers who chose to submit second tier data will be required to
do so on all device recipients at their center.
CONFIDENTIALITY/SECURITY
ISHLT/TII/UNOS is committed to the protection of confidential patient information and has
implemented a variety of security procedures to ensure privacy of information is maintained:
Data Entry - Participating institutions worldwide submit data via a web-based data collection system.
Data is then encrypted and sent to UNOS/TII for validity checking, inclusion in the database, and
analysis.
Institution Personnel - Access to the data entry process and to an institution’s data is available only to
TII/UNOS personnel and to personnel designated in writing by the center. All approved access is via
a protected password login. All those having access to the database are required to sign
confidentiality agreements. Each center controls which of its personnel receives a login and
password
TII/UNOS Personnel –TII/UNOS personnel are exposed to various levels of sensitive data related to
transplantation. They routinely handle center and patient specific data. In conjunction with our
government contract to support the Organ Procurement and Transplantation Network, each TII/UNOS
employee must pass a sensitive data clearance administered by the Department of Health and
Human Services. For employees that have modification rights to transplant data, this clearance may
involve a 10-year background check.
Systems – TII/UNOS has a secured network. All access outside of the prescribed Internet application
is highly restricted. To insure data security, the systems are protected by a series of routers and
firewalls that proved roadblocks to any potential hacker.
Backup – TII/UNOS provides a sophisticated level of backup. Data stored in TII/UNOS databases is
copied to DLT tape on a nightly basis. These tapes are rotated to offsite storage for potential disaster
recovery. Off site storage is provided by Database of Virginia Inc., which has constructed an
environmentally stable series of vaults in an underground facility.
Data Transmission – TII/UNOS applications utilize security features found in the Internet Explorer
Browser. This browser includes built-in SSL (Secure Socket Layer) security technology currently
utilized to transfer credit card transactions over the Internet. Additional security coded into the ISHLT
system includes a requirement for registry assigned user names and passwords to access data.
Access to the web applications will be controlled by the Hospital's designated program director. To
obtain additional logins, a written request from the program director on letterhead must be submitted
to the TII/UNOS ISHLT/MCSD coordinator.
Analyses - Analytical results will be reported on the database as a whole. Each institution will have
access to its own center-specific results, but these will not be published or distributed.
When responding to data requests UNOS will not provide center-specific or patient-specific
information in either an identified or encrypted format, except to the center that submitted the data.
Adherence to this policy will encourage accurate data submission and will protect the confidentiality of
the patients and centers.
SELECTION OF SUBJECTS
The racial, gender, and ethnic characteristics of the proposed population reflects the demographics of
patients with end-stage congestive heart failure referred for cardiac treatment. There are no exclusion
criteria and there are no control groups.
PATIENT PRIVACY
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The following patient identifiers are collected by the database but are optional fields. Institutions are
not required to enter this data if their IRB does not approve or if patient consents are not obtained or if
the institution does not wish to submit identifiable data: first name, last name, social security number,
date of birth.
RISK/BENEFIT RATIO
The only risk associated with participation in the database is possible breach of patient confidentiality.
However, ISHLT/TII/UNOS have extensive precautions in place as described above to maintain
subject confidentiality.
The benefits of participation in this registry include:
* rapid access to postmarket data and outcomes (particularly rapid identification and evaluation of
device problems) will likely lead to improved patient selection and management
* this database serves as a valuable source of data for assessing device performance, may potentially
expedite time to market for devices, and offers assurance of a system for vigilance once a device
enters the marketplace
* this database provides an opportunity to identify device performance trends, inappropriate off-label
use, and hypotheses for follow-up studies
* this database will offer long term data on significant post-implant events, quality of life, functionality,
and quality of care
* a centralized database ensures confidentiality of patient and physician data and enhances data
consistency, reliability, and accuracy
* currently, a number of devices are in use, and overall results achieved with these devices are
unknown and comparisons are impossible. This database should make comparisons possible and
make overall results available to all
* this database will enable practitioners to identify the populations of patient who would benefit the
most from device technology; identify the type of adverse events associated with the use of these
devices; identify complications rates for various devices; make reliability determinations for the
various devices; and generate predictive models of outcome based on factors relating to patient
selection, degree of preoperative illness, or timing of implantation
COSTS AND PAYMENT
Subjects participating in the database will receive no compensation. No costs will be incurred by
either the subject or the institution for their participation in the database. The database is funded by
the International Society for Heart and Lung Transplantation.
CONCLUSION
Mechanical Circulatory Support Device (MCSD) implantation provides a viable bridge to cardiac
transplantation while waiting for scarce organs to become available. It may well prove to offer a viable
alternative to cardiac transplantation or death from end-stage congestive heart failure. MCSD
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implantation, and soon perhaps Total Artificial Heart (TAH) implantation, will experience dramatic
growth over the next 5 years, and will soon become vital programs at many cardiac care institutions.
It is important that your institution be an active contributor to this database, in order that your
institution’s experience can be captured and included and so that your institution can have access to
its data and to the aggregate data of all institutions.
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