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Title: Institutional and Patient Criteria for Heart-Lung Transplantation.
Agency: Agency for Health Care Policy and Research/Center for Health Care Technology
(Formerly, the Office of Health Technology Assessment).
Contact: Ira Green, M.D., Medical Officer; Thomas V. Holohan, M.D., Director, CHCT.
Status: Technology Assessment: Published, 1994.
Primary Objective: To identify which patients would benefit from, and be suitable candidates for
HLT and to select criteria for institutions that will ensure optimal success in the performance of
Methods Used: Literature review and consultation with U.S. Public Health Service NIH and
FDA. In addition, expert opinion was sought from institutions and individuals performing HLT.
Data Identification: MEDLINE search of articles published between 1978-1992. Key words
used were "heart-lung transplantation" and "human." Two hundred and twenty-seven articles
Study Selection: Forty-seven articles were selected that specifically described the results of HLT
in humans and the types of institutions performing HLT.
Data Extraction: Papers were examined for the trial design, patient selection criteria, and how
survival of the patients was described. Papers were also examined for a variety of institutional
facilities, staff, and numbers of procedures performed as related to patient survival.
Key Findings: Objective validated and reliable patient criteria cannot be obtained from the
current published literature. In the absence of such data, criteria recommended by the National
Institutes of Health (NIH) should form the basis for patient selection until the time that better
objective data are available. Information regarding institutional criteria is also incomplete. Until
better data are available, it would seem reasonable that institutions performing HLT be subject to
the same facility requirement as those mandated by HCFA and CHAMPUS for HT. In addition,
those institutions should have personnel with previous experience with HLT, pulmonary medicine,
and pathology. Institutional criteria recommended by the NIH could also be used until more
objective data is obtained.
Conclusions: Objective and reliable information regarding patient and institutional criteria cannot
be obtained from the published literature. Expert opinion from the NIH could be used until such
information is available from the literature.