Preventable Chronic Disease and the Need for Organ Transplantation in the United States: A Descriptive Report –

By Richard A. Laeng, MPH, Gregory V. Fant, PhD, FRIPH, and Laura M. St. Martin MD, MPH, United States Department of Health and Human Services, Health Resources and Services Administration, Healthcare Systems Bureau, Division of Transplantation.

ABSTRACT

The burden of chronic disease has an impact on the supply and demand for solid organ transplantation in the United States. The findings in this report tend to support the March 2004 reminder published by the Joint Commission on Accreditation of Healthcare Organizations on the topic of organ donation and transplantation in the United States:

"Each individual in this society has an obligation to maintain and preserve his or her health to the fullest extent possible—an obligation to that individual and to this society—in order to forestall that time in life when an organ may be needed. In a country that largely gives lip service to the concepts of health promotion and disease prevention, the need for change will become apparent all too soon."

The objective of this report is to describe the presence of chronic disease conditions among those who were on the organ transplant waiting list and those who received a solid organ transplant in the United States from 1988 to 2004. This descriptive study uses publicly available data.

The results of the study show that among those on the organ transplant waiting list in 2004, 40.5 percent had chronic disease conditions as their primary diagnosis. And, the primary diagnoses of chronic disease conditions affected 30.7 percent of patients who received organ transplants from 1988 to 2004. One can conclude that chronic disease conditions have been and continue to impact the need for transplantation in the United States.

INTRODUCTION

Risk Factors, Chronic Disease, and the Demand for Organs

The presence of chronic diseases may affect organ donation and transplantation practices in the United States. Among the 15 leading causes of death in the United States, the onset or clinical course of 7 of these diseases (heart disease, cancer, cerebrovascular disease, chronic lower respiratory disorders, diabetes, cirrhosis, and hypertension)¹ are influenced by a complex combination of genetic and environmental factors, including social and physical components. While genetic variation may contribute to the risk of various chronic diseases, most of the solutions for chronic disease prevention involve changing environmental influences that may affect personal choices. Mokdad, et. al., have calculated cause-attributable fractions of preventable deaths for the year 2000. The results indicate that up to 48 percent (1.16 million) of the 2.4 million deaths in 2000 could be attributed to modifiable behavioral risk factors.² Of the detrimental individual behaviors, perhaps the most damaging are tobacco use, physical inactivity, and poor dietary choices.^{3, 4} The number of adults who smoke in the United States is dropping and currently numbers about 45 million.⁵ Since 1964, there have been 28 Surgeon General’s Reports on Smoking and Health, outlining the consequences of smoking.⁶ Poor diet and lack of exercise (leading to obesity or the excess accumulation of body fat as measured by body mass index [BMI]) have been identified as the second leading contributors to deaths in the United States and are the most rapidly rising threats to public health.^4,7 Obesity and inactivity rates have nearly doubled since 1980 and they are accelerating for children.⁸ The behavioral risk factors that lead to the onset and progression of chronic diseases may decrease the quality and quantity of organs available for transplantation along with increasing the demand for organ transplantation.

The Limited Source of Organs

In the United States, donated organs for transplantation are recovered from two sources, either deceased or living donors. Over the last decade, the number of deceased organ donors has steadily increased. As reported through the Organ Procurement and Transplantation Network (OPTN) from data collected by the Scientific Registry of Transplant Recipients (SRTR), there were 5,099 donors in 1994. This rose to 5,985 in 2000 and then to 6,455 in 2003. This is an increase of approximately 3 percent per year.⁹ OPTN donor data for 2004 indicate that there were 7,154 donors, which is an increase of approximately 10.8 percent over 2003, and primarily attributed to projects begun under the Secretary’s Organ Donation Initiative and the National Organ Donation Breakthrough Collaborative. The current level of donation allows approximately 20,000 transplants to be performed from the deceased donor pool (with an average of 3.0 organs per deceased donor). The number of living donors has significantly increased from just over 3,000 in 1994 to almost 7,000 in 2004. Deceased and living donors currently allow approximately 27,000 transplants to be performed each year. Although there have been some gains in the number of organ donors, additions to the transplant waiting list have increased more rapidly. Despite 7 percent annual growth in the total donor supply from 1996 to 2001, the waiting list grew by 11 percent over the same time period.¹⁰ Coupled with the number of candidates who continue to wait from the preceding year to the next, the total number of those waiting for a transplant increased to over 87,000 as of December 2004. From 1999 to 2004, about 6,500 patients died each year waiting for an organ without receiving a transplant.

Chronic Disease, Organ Demand and Supply

Individual health status plays a substantial role in one's ability to become an organ donor. The presence or past history of chronic diseases could be a reason for a person to be removed from consideration as an organ donor. Of more than 2 million individuals who die in the United States each year¹¹, a relatively small number die under certain circumstances or with health histories that make them suitable to be considered for organ donation. Estimates of the size of the pool of potential organ donors in the United States vary. Some of the more recent studies provide a range of estimates from 10,000 -17,000 potential donors annually.^{12, 13} According to the 2004 Annual Report of the OPTN/SRTR, in 2002 and 2003 there were approximately 12,000 potential donors annually meeting eligible death criteria.¹⁴ Even if all suitable potential donors became actual donors, the demand for organs still would not be met. The ever-increasing demand for organ transplantation seems to necessitate broad strategies that not only increase the supply of organs, but also those that reduce demand by placing greater emphasis on preventing chronic disease and end-stage organ failure. This descriptive report has two specific aims: (1) To describe the types and amount of potentially preventable chronic disease conditions among those patients who were on the organ transplant waiting list as of May 2004; and (2) to describe the number of patients who received a solid organ transplant between 1988 and February 2004 and who had a primary diagnosis of a preventable chronic disease condition.

METHODS

The data for this descriptive study were obtained from the Organ Procurement and Transplantation Network Web site. The data were aggregate, cumulative frequency counts of data collected from 1988 to 2004^*. The data do not contain any information that could be used to identify an individual. In order to describe the impact of potentially preventable chronic disease on organ transplantation, a review of the data from the OPTN included the data from the "Current United States Wait List" as of May 21, 2004, and all "United States Transplants Performed" between January 1, 1988, and February 29, 2004. Both data sets included all organ transplants including kidney, liver, pancreas, kidney/pancreas, heart, heart/lung, lung, and intestine. The data analysis did not include a review of each specific organ system separately because this is beyond the scope of the study. Within each data set, "Primary Diagnosis" categories, as reported to the OPTN, were reviewed. These categories included approximately 220 separate diagnoses, which included genetic diseases, chronic diseases, trauma, and various idiopathic diseases.

The diagnoses that could be considered chronic in nature were separated from those diagnoses that were not related to a chronic condition (see Table 1). After review of the 220 categories of primary diagnoses, we determined that approximately 30 of those categories of diseases could be classified as "preventable" chronic diseases (as shown in Tables 2 and 3). We considered a potentially preventable chronic disease as one where the risk of onset and progression of the disease is largely influenced by lifestyle behaviors. Such diseases include type 2 diabetes, hypertension, chronic obstructive pulmonary disease (COPD), and certain types of heart, liver, and kidney disease. Lifestyle behaviors such as tobacco use, drug and alcohol abuse, poor diet, and lack of physical activity are recognized contributors to chronic disease and death.^{15, 16}

RESULTS

Table 1a, Frequency of Waitlist Candidates --May 21, 2004

Source: Organ Procurement Transplantation Network, data as of May 21, 2004

Table 1b, Frequency of Transplant Recipients, 1988 thru February, 2004

Overview of dataset

The overall number of persons waiting on the organ transplant list as of May 21, 2004 was 85,065 candidates (Table 1a). Of this number, 50,906 candidates (or 60 percent) were not considered in this study while 34,159 candidates with chronic conditions (or 40 percent) were included. Those candidates who were not included had primary diagnoses including “metabolic or genetic diagnoses”, “other or not reported reasons”, “re-transplants or graft failures”, and a small number of “idiopathic” diagnoses.

The overall number of persons who received transplants from January 1988 to February 2004 was 313,578 recipients (Table 1b). Of this number, 221,028 recipients (or 70 percent) were not considered in this study while 92,550 recipients (or 29 percent) were included. Those recipients who were not included fell into the same categories of candidates not considered identified in Table 1a. The percentages of candidates and recipients with preventable chronic conditions, while sizable, were substantially less than the percentages of candidates and recipients without preventable chronic conditions.

Table 2: Preventable Chronic Disease Diagnoses of Waitlist Candidates -- May 21, 2004

Source: Organ Procurement Transplantation Network, data as of May 21, 2004

Waitlist data

Table 2 presents the preventable chronic disease diagnoses reported as primary diagnoses among candidates on the organ transplant waitlist. The largest disease categories reported included Diabetes-Type II with 12,034 candidates (or 35 percent), and Hypertensive nephrosclerosis with 9,762 candidates (or 28 percent). These two groups accounted for 63 percent of the waiting candidates with a primary diagnosis of a preventable chronic disease. The next group of 5 diseases: Cirrhosis-postnecrotic (all types of hepatitis) with 5,644 candidates (or 16 percent), Laennec’s cirrhosis (alcoholic) with 2,596 candidates (or 7 percent), Dilated myopathy-ischemic with 1,204 candidates (or 3 percent), COPD/Emphysema with 1,153 candidates (or 3 percent), and Laennec’s cirrhosis and post-necrotic cirrhosis with 990 candidates (or 2 percent), accounted for about 31 percent of those waiting for a transplant. These two clusters of seven diagnoses accounted for 94 percent of those with a primary diagnosis of a preventable chronic disease who were waiting for transplants.

Table 3: Preventable Chronic Disease Diagnoses of Transplant Recipients, From 1988 to February 2004

Source: Organ Procurement Transplantation Network, data as of May 21, 2004

Recipient data

Table 3 presents the chronic disease diagnoses among those who received an organ transplant from 1988 to February 2004. The 3 largest chronic disease categories reported included Hypertensive nephrosclerosis with 25,836 transplants (or 27 percent), Cirrhosis-postnecrotic (all types of hepatitis) with 17,081 transplants (or 18 percent), and Diabetes-Type II with 16,511 transplants (or 18 percent). These three groups accounted for 62 percent of the recipients. The next 5 groups -Dilated myopathy-ischemic with 8,096 transplants (or 8 percent), Laennec’s cirrhosis (alcoholic) with 7,943 transplants (or 8 percent), Coronary artery disease with 7,301 transplants (or 7 percent), COPD/Emphysema with 4,337 transplants (or 4 percent), and Laennec’s cirrhosis and post-necrotic cirrhosis with 2,925 transplants (or 3 percent), accounted for 30 percent of the transplants received by candidates with a chronic disease as the primary diagnosis and these 2 clusters of 8 diagnoses accounted for 92 percent of those chronic disease candidates transplanted.

DISCUSSION

Most individuals who were on the organ transplant waiting list, along with those who eventually became organ transplant recipients in the dataset that we examined, did not have a primary diagnosis of a preventable chronic condition. However, we found that 40 percent of the candidates on the waitlist for organ transplantation and 30 percent of the recipients had a primary diagnosis of a preventable chronic condition. The preventable chronic conditions that we identified were the following: Diabetes-Type II, Hypertensive nephrosclerosis, Cirrhosispostnecrotic (all types of hepatitis), Laennec’s cirrhosis (alcoholic), Dilated myopathy-ischemic, COPD/Emphysema, and Laennec’s cirrhosis and post-necrotic cirrhosis.

Nearly two thirds of the adult population in the United States is either overweight or obese.¹⁷ Sedentary lifestyles and poor dietary habits are primary contributors to obesity. Body weight and genetic makeup of the individual are risk factors that can influence the onset and progression of various chronic diseases. Obesity increases the risk for developing type 2 diabetes, high blood pressure, high cholesterol, heart disease, stroke, some cancers, arthritis, and other chronic conditions. The obesity/disease link is strikingly apparent when looking at the rates of type 2 diabetes. About 17 million Americans have diabetes and rates are highest among Black women. ¹⁸ For both waiting list candidates and recipients, the presence of type 2 diabetes and hypertension played significant roles in the need for organs. Our findings suggest that the sizable number of candidates waiting for an organ, in addition to those who had received an organ transplant and who were classified with a primary diagnosis of a preventable chronic condition, may illuminate a significant public health issue.

Trends in Disease Prevalence Over Two Decades

The 10 leading causes of death among the population in the United States changed somewhat during the last part of the 20th Century. Even though the top 3 categories of death remained the same (i.e., heart disease, cancer, and cerebrovascular disease), some chronic diseases either changed order within the top 10 or were newly added to the top-10 list. In 1980, chronic obstructive pulmonary disease was fifth on the top-10 list and accounted for over 56,000 deaths. In 2002, chronic lower respiratory disease moved to fourth place and accounted for nearly 125,000 deaths. In 1980, diabetes mellitus accounted for nearly 35,000 deaths and was ranked seventh. In 2002, diabetes caused over 73,000 deaths and was ranked in sixth place.¹⁹

By the end of 2004, there were over 87,000 patients waiting for organs and over 60,000 of those patients were waiting for kidneys.²⁰ With the increasing rates of obesity and its associated chronic diseases, such as type 2 diabetes and hypertension, it is likely that rates of end-stage organ failure will continue to increase. Our descriptive study found that among those on the waitlist, transplant candidates with primary diagnoses of type 2 diabetes or hypertensive nephrosclerosis accounted for over 63 percent of the total.

Transplants are no panacea

In many cases, transplants represent the last hope to save a life. However, transplantation carries with it all of the inherent risks of major surgery and, for most recipients, a lifelong regimen of immunosuppressive drug therapy, with drug-related health risks. Consequently, a worthy goal would be to reduce the overall number of patients who require organ transplants. This is consistent with the preventive health focus that has traditionally been the hallmark of the discipline and practice of public health. The data that we have examined suggest that the number of candidates and recipients who have chronic disease as a primary diagnosis may serve as a reference point for future prevention strategies designed to reduce preventable chronic disease in the population. Moreover, the role that preventable chronic disease may play in end-stage organ failure may need to be explored in future public health studies.

Limitations of the Report

There are at least three limitations to this descriptive report. First, the OPTN data that we examined represent the segment of the general population listed for transplant. Since this is a biased subset of the population with chronic disease, it may, in fact, underestimate the potential impact of chronic disease on end-stage organ failure. Second, the identification of "preventable" chronic disease diagnoses in this dataset was somewhat arbitrary. An established and recognized list of preventable, chronic disease diagnoses would have been helpful. Third, the data available did not provide information on the link between a patient’s behavior and the development of a preventable chronic condition. However, it is well known that personal behavior and lifestyle choices play a major role in the cause of many preventable chronic diseases²¹, but the link between chronic disease and end-stage organ failure leading to the need for transplantation, as well as reducing the number of available suitable donors, are issues that have not been fully studied. This knowledge would be of interest to the public health community and aid in public health decision-making.

Conclusion

Our findings suggest that the number of individuals diagnosed with a potentially preventable chronic disease condition represented a sizable percentage of those waiting for an organ and those who have received a transplant. Unhealthy lifestyle behaviors such as tobacco use, poor diet, and lack of physical activity may lead to the presence of chronic illness, which if left unmanaged, could ultimately impair organ function, leading to organ failure and the need for organ transplantation. Furthermore, a genetic predisposition along with environmental influences leading to unhealthy behaviors can interact to accelerate and exacerbate the process. The findings in this descriptive report tend to support the recommendations and conclusions of a national independent organization linking the burden of chronic disease to the demand for organ transplantation. In March 2004, the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) offered several conclusions from their roundtable discussion on "Strategies for Narrowing the Organ Donation Gap and Protecting Patients." The most noteworthy conclusion related to chronic disease and organ donation was the acknowledgement that the prevalence of some of the conditions that lead to the need for transplantation ― morbid obesity, hypertension, and diabetes ― continues to escalate across America. Unless more resources are invested in curbing these epidemics, the demand for organs will continue to spiral.²²

REFERENCES

¹ National Vital Statistics Reports, Vol. 52, No. 3, p. 8, 2003 Sept 18; National Center for Health Statistics, CDC, HHS; http://www.cdc.gov/nchs/fastats/deaths.htm.

² Mokdad AH, Marks JS, Stroup DF, Gerberding JL, Actual Causes of Death in the United States, 2000, JAMA. 2004;291:1238-45.

³ CDC At A Glance -Targeting Tobacco Use: The Nation's Leading Cause of Death 2004; U.S Department of Health and Human Services, Centers for Disease Control and Prevention; http://www.cdc.gov/nccdphp/aag/pdf/aag_osh2004.pdf.

⁴ CDC At A Glance -Physical Activity and Good Nutrition: Essential Elements to Prevent Chronic Diseases and Obesity 2004; U.S. Department of Health and Human Services, Centers for Disease Control and Prevention; http://www.cdc.gov/nccdphp/aag/aag_dnpa.htm.

⁵ Fewer Adults Smoke in the UNITED STATES and the Number is Dropping; Medical Study News; 2005 May 29; http://www.news-medical.net/print_article.asp?id+10472 .

⁶ National Center for Chronic Disease Prevention and Health Promotion; Tobacco Information and Prevention Source (TIPS); The Health Consequences of Smoking - A Report of the Surgeon General; http://www.cdc.gov/tobacco/sgr/sgr_2004/Factsheets/11.htm

⁷ Washingtonpost.com: CDC Study Overestimated Deaths from Obesity; by Rob Stein, 2004 Nov 24; p. A-11.

⁸ Manson JE, Skerrett PJ, Greenland P, Vanltallie TB, The Escalating Pandemics of Obesity and Sedentary Lifestyle: A Call to Action for Clinicians. Archives of Internal Medicine, 2004;164:249-58.

⁹ The OPTN/SRTR Annual Report 2004; http://www.optn.org/AR2004/Chapter_III_AR_CD.htm?cp=4

¹⁰ Nathan HM, Conrad SL, Held PJ, McCullough KP, Pietroski RE, Siminoff LA, Ojo AO, Organ Donation in the United States, Am J Transplant. 2003; 3 (Suppl. 4):29-40.

¹¹ Health United States, 2004; Table 32, Leading Causes of Death and Numbers of Deaths, According to Age: United States, 1980 and 2002, p. 158-159.

¹² Sheehy E, Conrad SL, Brigham LE, et al. Estimating the number of potential organ donors in the United States. N Engl J Med. 2003 Aug 14;349:667-674.

¹³ Ibid; Gortmaker, Beasley, Brigham, Critical Care Medicine, 1996; 24:432-439; Guadagnoli, E Harvard Medical School, 2003 Sept 9; Siminoff, et al JAMA. 2001;286:71-77

¹⁴ The OPTN/SRTR Annual Report 2004; Chapter III; Table III-1, Eligible, Actual and Additional Donors 2002-2003.

¹⁵ Morbidity and Mortality Weekly Report; Sept 10, 2004/53(RR11);1-6; National Center for Chronic Disease Prevention and Health Promotion; Centers for Disease Control and Prevention.

¹⁶ Northern Territory Government (Australia), Department of Health and Community Services, Preventable Chronic Diseases Strategy; http://www.nt.gov.au/health/cdc/prevntable/pcds.shtml.

¹⁷ National Center for Health Statistics; Prevalence of Overweight and Obesity Among Adults: United States, 1999-2002; http://www.cdc.gov/nchs/products/pubs/pubd/hestats/obese/obse99.htm

¹⁸ Weight-control Information Network (WIN) Notes: Winter 2002/2003;
http://win.niddk.nih.gov/notes/winter03notes/winter0203.htm

¹⁹ Health United States, 2004; Table 31, Leading Causes of Death and Numbers of Deaths, According to Sex, Race, Age and Hispanic Origin: United States, 1980 and 2002, p. 154.

²⁰ OPTN Data; based on Web site access 12/28/04; http://www.optn.org/data/.

²¹ Behavioral Risk Factor Surveillance System (BRFSS); About the BFRSS; Overview; http://www.cdc.gov/brfss/about.htm .

²² Joint Commission on Accreditation of Healthcare Organizations (JCAHO) Report 2004 -Health Care at the Crossroads: Strategies for Narrowing the Organ Donation Gap; p. 33.

*FOOTNOTE: The OPTN waiting list and transplant recipient data that were selected for analysis were the most current available data at the beginning of the study period.

Disclaimer Statement: The views expressed herein are those of the authors and not necessarily those of the United States Government. This is a United States Government-sponsored work. There are no restrictions on its use.

Ethics Approval
Since this study did not contain any information that could be used to identify an individual patient, no ethics committee review was necessary for this study.

Acknowledgements
The authors wish to acknowledge the support and encouragement provided by our colleagues in the Division of Transplantation, Healthcare Systems Bureau, Health Resources and Services Administration, U.S. Department of Health and Human Services.

Keywords: prevention, chronic disease, end stage organ failure, organ transplantation.

Corresponding Author:
Richard A. Laeng 5600 Fishers Lane Parklawn Bldg. - Room 12C-06 Rockville, Maryland 20857 e-mail:RLaeng@hrsa.gov Telephone: 301 443-5410 FAX: 301 594-6095