This article reviews the development of the new U.S. lung allocation system that took effect in spring 2005. In 1998, the Health Resources and Services Administration of the U.S. Department of Health and Human Services published the Organ Procurement and Transplantation Network (OPTN) Final Rule. Under the rule, which became effective in 2000, the OPTN had to demonstrate that existing allocation policies met certain conditions or change the policies to meet a range of criteria, including broader geographic sharing of organs, reducing the use of waiting time as an allocation criterion and creating equitable organ allocation systems using objective medical criteria and medical urgency to allocate donor organs for transplant. This mandate resulted in reviews of all organ allocation policies, and led to the creation of the Lung Allocation Subcommittee of the OPTN Thoracic Organ Transplantation Committee. This paper reviews the deliberations of the Subcommittee in identifying priorities for a new lung allocation system, the analyses under-

and reported to the Registry. In addition to reporting key data for donor and recipient characteristics, transplant events and recipient treatments and outcomes, this year's report focuses on an overall theme of primary diagnostic indications for transplant. We present data on the distribution of diagnostic categories (see Figure 1), demographics of patients with the different lung disorders leading to the need for transplant, associations of the diagnoses with outcomes, and other data of interest related to this topic. The Registry's online slide sets show results from additional analyses and complementary information not included in this publication (see http:// ishlt.org/registries/slides.asp?slides=heartLungRegistry/). Data collection, conventions and statistical methods National and multinational organ/data exchange organizations and individual centers submit data to the ISHLT Registry. Since the Registry's inception, 457 heart transplant centers, 1,2 253 lung transplant centers 3 and 177 heart-lung transplant centers have reported data to the Registry. In our estimation, data submission to the Registry represents approximately two thirds of the worldwide thoracic transplant activity. This report presents an overview of donor and recipient characteristics and outcomes. Additional and extended analyses are presented in the aforementioned online slide sets (5 separate slide sets supplement the report data, including: "Introduction"; "Overall Lung Transplant"; "Overall Heart-Lung Transplant"; "Adult Lung Transplant"; and "Adult Heart-Lung Transplant"). The ISHLT website also contains slide sets for previous annual reports. This article refers to specific online eSlides when particular data are discussed but not presented due to space limitations; eSlide numbers refer to the online Adult Lung Transplant slides (e.g., eSlide LU 3) or Adult Heart-Lung Transplant slides (e.g., eSlide HL 3), unless otherwise specified. The Registry website also provides spreadsheets of the data elements collected in the Registry. Registry data quality depends on center reporting accuracy and completeness. The Registry uses various quality control measures to ensure acceptable data quality and completeness before including the data in the main data set and using the data for analyses. Analytical conventions Unless otherwise specified, analyses of lung transplants do not include heart-lung transplants. Retransplant includes those with a previously reported transplant of the same

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