Registry report
Registry of the International Society for Heart and Lung Transplantation: Eleventh Official Pediatric Heart Transplantation Report—2008

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Registry Data Source and Statistical Methods

The International Society for Heart and Lung Transplantation (ISHLT) Registry data are provided either by individual centers or a data-sharing arrangement with a national or regional organ procurement or exchange organization. Around 400 transplants are reported to the Registry each year with the majority of the data provided from North American centers (79% for the Years 2000 to 2007), but there are significant contributions from centers in Europe (19%) and the rest of the world (2%). The

Centers and Activity

The total number of pediatric (age <18 years) heart transplants reported to the Registry is 7,765, with an annual transplant rate of around 400. This is about one-eighth of the 3,000 adult heart transplants per annum.1 The number of centers reporting transplant activity in the 1980s and early 1990s increased rapidly to a peak of 106 in 1994. It has decreased slightly since then, and has now plateaued at 80 centers.

Over the last 10 years there has been a gradual trend toward centers undertaking

Transplant Demographics

Approximately 25% of all pediatric heart transplants are undertaken in infancy (first year of life), with the remainder split almost equally between the 1- to 10-year and >10-year age groups (Figure 5). There has been little change over time, but in North America the proportion transplanted as infants (27%) has been higher than in the rest of the world (9%) (Figure 6). In Europe, >43% of heart transplant donors for pediatric recipients were from the adult pool (age >18 years), with the figure

Induction

Over the past 6 years, there has been an increasing tendency for induction utilization, with 37% of patients receiving induction in 2001 and 67% in 2007 (Figure 9). This can mainly be accounted for by use of polyclonal antibodies (anti-lymphocyte/thymocyte globulin), which has increased from 23% to 46%, although the use of interleukin-2 receptor antagonists has also increased, from 12% to 20%. The overall use of induction agents in the adult population is similar, although there was greater use

Survival

The transplant half-life (the time at which 50% of recipients remain alive) has varied with the age of the recipient at transplant. For those transplanted as teenagers, the half-life was 11.3 years, whereas for infants it was 15.8 years (Figure 12). The highest risk of dying was in the first 6 months post-transplant. By estimating survival for those who have lived beyond this high-risk period—for example, including only those who survived at >1 year post-transplant (conditional

Transplant Morbidity

Functional status in the Registry is available on 554 patients at 10 years post-transplant. Of these patients, 92% had no limitations on physical activity and only 1% required total assistance. The need for hospitalization in the first year post-transplant was significant (50%), with 13% for rejection and 18% for infection. By their tenth year, hospitalization was much less frequent, with just under 25% hospitalized (3% for rejection and 8% for rejection, 1% for both and 10% for other reasons) (

Rejection

Despite the increasing use of induction agents, they do not appear to result in a reduction in rejection episodes. In fact, overall, more patients had rejection after receiving induction therapy (37%) compared with those who received no induction therapy (30%) (Figure 20). This detrimental effect was not due to an OKT3 effect, as these patients were removed from the analysis. Rejection episodes are more marked if an interleukin-2 receptor antagonist was used (47%). Rejection episodes were only

Cardiac Allograft Vasculopathy

Overall, nearly 75% of patients have remained free of cardiac allograft vasculopathy (CAV) at 8 years post-transplant. Age at transplant has an influence, with patients transplanted in infancy or early childhood having a reduced incidence of CAV (78% freedom from CAV) compared with those transplanted at >10 years of age (58% freedom from CAV) (Figure 23). Neither ischemic time nor the use of induction therapy had a clinically significant influence on the development of CAV. Once CAV occurred,

Renal Dysfunction

Severe renal dysfunction (defined as a patient requiring renal dialysis, transplant or with a serum creatinine of >2.5 mg/dl [221 μmol/liter]) according to Kaplan–Meier assessment showed a linear decline after transplantation, occurring in 11% of pediatric recipients at 10 years after transplant. This contrasts with adults, among whom 40% had severe renal dysfunction by 10 years.

Malignancy

A malignancy will have occurred in 8% of patients by 10 years (Table 2). In the pediatric age range almost all malignancies have been lymphomas. This contrasts with adults, among whom malignancy was more common (33% by 10 years), with the majority of these cancers being of the skin.

Hypertension

Approximately 69% of patients surviving to 8 years with complete reporting on hypertension had developed hypertension. In the adult population, 94% developed hypertension by 5 years post-transplant.

Cause of Death

Nearly half of all deaths in the first 30 days after transplant occurred due to graft failure—either primary or secondary to rejection, technical factors, etc. (Table 3). Acute rejection, infection and multiple-organ failure each accounted for around 10% of deaths. Acute rejection has remained an ever present threat, accounting for about 20% of all deaths through to 3 years with a gradual decline thereafter. Graft failure has remained constant at around 20% of deaths from the time of

Conclusion

This Registry report has continued to document the outcome in pediatric heart transplant recipients. It is a registry report and not a double-blind, randomized trial of treatment options and outcomes. The information is therefore imperfect and often poses more questions than answers. The report will have achieved its objective if it stimulates discussion and suggests areas fruitful for research.

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    Table 2 shows hazard ratios on known risk factors and D-R age differences. Similar to the 2014 ISHLT Pediatric Report,8 we found increasing D-R difference and donor age to be continuous risk factors for 10- and 15-year mortality. However, the findings require context.

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All figures and tables from this report, and a more comprehensive set of Registry slides are available at www.ishlt.org/registries.

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