Berkeley M. Keck

The registry of the international society for heart and lung transplantation: eighteenth official report—2001

In this last report of the Registry’s current administration, it is appropriate to review the changes and growth of the Registry during our 7-year stewardship. The total number of thoracic transplant recipients listed in the Registry has grown from 35,972 to more than 73,000 (see Table I). In addition to the increase in sheer volume of data, the breadth and sophistication of the analyses increased, from descriptive and univariate survival analyses to complex multivariate, risk-stratified data that investigate mortality as well as morbidity end-points. In 1993, the number of slides showing thoracic transplant data offered as a service to the members of the International Society for Heart and Lung Transplantation (ISHLT) was in the mid-30s. This year’s slide set offered free as a PowerPointTM file on the ISHLT website will contain 65 data slides. The health of the Registry will continue with a smooth transition to the new directorship.

The Registry of the International Society for Heart and Lung Transplantation: Seventeenth Official Report—2000

The Registry of the International Society for Heart and Lung Transplantation has grown substantially during the past 5 years, from a little more than 43,000 registered procedures at the end of 1994 to almost 70,000 registered procedures by the end of 1999 (see Table I). The substantial increase during this 5-year period occurred despite overall annual transplant numbers that were flat or that declined. We attribute this increase to obtaining more complete data from national and multinational registries, from capturing new centers that did not previously report, and finally, from direct Internetbased data reporting by individual centers. During this same 5-year period, excluding the annual reports, the Registry has peer reviewed 23 publications, reviews, and book chapters. J Heart Lung Transplant 2000;19:909.

The Registry of the International Society for Heart and Lung Transplantation : Sixteenth Official Report-1999

Over the past 12 months, The Registry of the International Society for Heart and Lung Transplantation added a total of 3673 additional thoracic organ recipients, the smallest number over the past 5 years. In addition, we added 10 new transplant programs to those reporting data. We continue to be in sharing discussions with 4 newer national/ regional databases, and electronic data submission via the Internet has been instituted with approximately 25% of the non-US centers submitting data using the new system. We continue to use the entire data set to calculate multivariate risks rather than the U.S. data set alone, and we have continued to extend the time frame for both univariate and multivariate analyses.

The Registry of the International Society for Heart and Lung Transplantation: Fifteenth Official Report—1998

Over the past 12 months, The Registry of the International Society for Heart and Lung Transplantation added 20 new transplantation programs and a total of 7073 additional thoracic organ recipients. All of the national and multinational registries are now fully integrated into our registry, and electronic data submission via the Internet will be instituted by mid 1998 for those centers not participating in larger registries. For the first time, the entire data set was used to calculate multivariate risks rather than the U.S. data set alone, and we have continued to extend the time frame for both univariate and multivariate analyses. For this report, risk factors for 5-year outcome and morbidity at 3 years are presented.

The registry of the international society for heart and lung transplantation: twentieth official adult heart transplant report—2003

Although only a small number of lung and heart– lung transplantation procedures were performed between 1963 and 1973, the current eras of heart–lung and lung transplantation, which began in 1981 and 1983, respectively, are now entering their third decades. The optimism of the considerable success of these modalities has been tempered by limitations, such as the shortage of donor organs, and by problems, such as chronic allograft dysfunction. This portion of the Twentieth Official Report summarizes the current status of adult heart–lung and lung transplantation from data submitted to the Registry from centers around the world. The Registry now contains information on more than 2000 adult heart–lung recipients and almost 14,000 adult lung recipients, and provides a robust database for analysis.

THE RESULTS OF CARDIAC RETRANSPLANTATION: AN ANALYSIS OF THE JOINT INTERNATIONAL SOCIETY FOR HEART AND LUNG TRANSPLANTATION/UNITED NETWORK FOR ORGAN SHARING THORACIC REGISTRY

Background. It is well established that repeat heart transplantation has a significantly worse outcome when compared with primary (first time) transplantation. Defining the risk factors for mortality within this group has been difficult due to small numbers of patients at individual centers. Methods. All cardiac retransplants performed in the United States and registered in the Joint International Society for Heart and Lung Transplantation (ISHLT)/United Network for Organ Sharing (UNOS) Thoracic Registry were analyzed for demographics, morbidity posttransplantation, immunosuppression, and risk factors for mortality. Results. The study cohort included 514 patients of which 81% were male with a mean age of 47±12 years. Time from primary transplant to retransplantation ranged from 1 day to 15.5 years and more than 50% of the patients underwent retransplantation for chronic rejection. More than 60% of patients were in the intensive care unit at the time of retransplantation and more than 40% of the patients were reported to be on some form of life support (ventricular assist device, ventilator, and/or inotropic therapy). Survival for the entire retransplant cohort was 65, 59, and 55% for 1, 2, and 3 years, respectively, but was substantially lower when the intertransplant interval was short. Conversely, when the interval between primary and retransplantation was more than 2 years, 1 year survival postretransplantation approached that of primary transplantation. Additional independent risk factors for mortality for the retransplant cohort included overall cardiac transplant center volume, the use of a ventricular assist device or ventilator, the patient being in the intensive care unit, and recipient age. The four most common causes of death were infection, primary/nonspecific graft failure, chronic rejection (allograft vasculopathy), and acute rejection. Conclusions. The data confirm that repeat heart transplantation is a higher risk procedure than primary transplantation, especially early after the primary heart transplant.

The Registry of the International Society for Heart and Lung Transplantation: Fifth Official Pediatric Report-2001 to 2002.

Pediatric thoracic organ transplant recipients are an important and biologically unique component of the overall experience in thoracic organ transplantation. Issues of immunologic naivete, growth and development make the pediatric recipient an important biologic model to aid in our understanding of overall thoracic organ transplantation. This report documents stability in the number of pediatric recipients and notes the continued trend of markedly improved survival for heart recipients in the most recent years. Despite improved survival, the overall number of reported pediatric recipients has remained stable, underlining the rate-limiting step of donor organ availability. Compared with previous years, this report offers an expanded analysis of donor and recipient characteristics. Risk factor analysis for mortality is expanded to include parameters important for 5-year survival. A more thorough description of immunosuppressive medication usage and actuarial freedom from morbidity curves represent new analyses of the pediatric data. These data are intended to analyze our experience to date and also to highlight areas where our experience and knowledge base need expansion in the future. HEART TRANSPLANTION Transplant Volumes and Indications

The registry of the international society for heart and lung transplantation: introduction to the twentieth annual reports—2003

We are pleased to present the Twentieth Annual Reports of the Scientific Registry of the International Society for Heart and Lung Transplantation (the Registry). The mission of the Registry is to advance the state of knowledge and patient care regarding therapies for the failing heart and lung by: analyzing outcomes and treatment modalities for advanced heart and lung failure and transplantation; serving as a resource for health-care providers, governmental agencies, patient-related organizations and pharmaceutical companies seeking information regarding patient care and outcomes; and providing benchmark aggregate data for use by individual centers to assess their center-specific practices and outcomes. For the first time, all of the Registry reports are being published in a single issue of this journal; these include reports on the Adult Heart, Adult Lung and Heart–Lung, Pediatric Heart and Lung, and Mechanical Circulatory Support Device (MCSD) Database. The Registry remains the world’s most comprehensive record of heart and lung transplant activity, practices and outcomes. At present, the Registry contains data regarding 62,851 heart transplants, 2,955 heart–lung transplants and 15,199 lung transplants. More than 220 centers from 24 countries submit data to the Registry (Appendix), and participation in the Registry is open to any center in the world performing heart or lung transplantation. We wish to extend our sincere thanks to the many thoracic transplant surgeons, physicians and data coordinators in transplant programs throughout the world, whose timely and accurate submission of data has made these analyses possible. In what follows, we relate information regarding progress made toward reaching our 2002–2003 goals: (1) increasing worldwide heart and lung transplant reporting; (2) initiation of the MCSD Database; and (3) facilitation of access to data for clinical inquiries and research projects.

Outcomes in Patients Who Are Hepatitis B Surface Antigen-Positive Before Transplantation: An Analysis and Study Using the Joint ISHLT/ UNOS Thoracic Registry

BACKGROUND Hepatitis B surface antigenemia (HBsAg) has been considered at least a relative contraindication for heart transplantation, yet patients have undergone liver transplantation for hepatitis B-induced chronic liver disease, albeit with poorer results than for other liver diseases. The impact of asymptomatic hepatitis B infection on heart transplant outcome is not known. METHODS To examine this question, we queried the Joint International Society for Heart and Lung Transplantation/United Network of Organ Sharing Thoracic Registry for all patients undergoing heart transplantation who had been identified as positive for HBsAg before transplantation. We then sent a 4-question data instrument to the centers responsible for the identified patients. Seventy-eight patients were identified. Of the 78 data forms sent, 53 forms were returned with the requested data. Of the 53 data forms returned, the centers incorrectly identified 23 patients as positive for HBsAg, resulting in 30 patients who were confirmed as HBsAg positive and who served as the final cohort for this analysis. RESULTS The cohort included 24 males and 6 females, with a mean age of 46 +/- 16 years (range 0 to 68 years). Eleven patients had coronary artery disease, 14 had dilated cardiomyopathy, and 5 patients had a variety of other cardiac diseases. Of those tested at most recent follow-up, 20 of 25 patients continued to be positive for HBsAg, whereas 7 of 21 patients studied had converted and were hepatitis B serum antibody-positive. Approximately 37% of the patients had evidence of active hepatic inflammation or cirrhosis. We found a statistically significant correlation between positivity for hepatitis C antibodies and clinical liver disease (p = 0.0105). No difference in survival could be demonstrated between the study cohort and a reference heart transplant cohort, yet 5 of the 9 deaths were considered to be related to hepatitis B. CONCLUSIONS These data demonstrate that clinical liver disease is common post-transplantation in HBsAg+ patients who presumably have no overt liver disease at the time of transplantation. Despite the inability to show a survival difference in this cohort, the fact that the majority of deaths were related to hepatitis B should suggest caution in accepting HBsAg+ patients for cardiac transplantation.