- Email: [email protected]
The registry of the international society for heart and lung transplantation: introduction to the twentieth annual reports—2003
REGISTRY REPORTS
The Registry of the International Society for Heart and Lung Transplantation: Introduction to the Twentieth Annual Reports—2003 Marshall I. Hertz, MD,a Paul J. Mohacsi, MD,a David O. Taylor, MD,a Elbert P. Trulock, MD,a Mark M. Boucek, MD,a Mario C. Deng, MD,a Berkeley M. Keck, MPH,a Leah B. Edwards, PhD,a and Amanda W. Rowe, BAa
W
e 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 From the International Society for Heart and Lung Transplantation, Addison, Texas. Reprint requests: Marshall I. Hertz, MD, University of Minnesota, 420 Delaware Street SE, 276 MMC, Minneapolis, Minnesota 55455. Telephone: 612-624-0999. Fax: 612-625-2174. E-mail: [email protected] J Heart Lung Transplant 2003;22:610 – 615. Copyright © 2003 by the International Society for Heart and Lung Transplantation. 1053-2498/03/$–see front matter doi:10.1016/S1053-2498(03)00185-2
610
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.
INCREASING WORLDWIDE HEART AND LUNG TRANSPLANT REPORTING Widespread participation of thoracic transplant centers throughout the world is critical to maintaining the unique international nature of the Registry. In recent years, the number of non-U.S. heart transplant centers reporting to the Registry has decreased significantly (Figure 1), while the number of U.S. centers has remained constant. The number of non-U.S. lung transplant centers has also decreased, but not as dramatically (Figure 2). Although it is difficult to obtain accurate data regarding activity in centers that do not report to the Registry, it is likely that a significant proportion of transplants performed by non-U.S. centers are not currently reported (this will be discussed in more detailed in a separate report in a future issue of this journal). Therefore, improving the completeness of trans-
The Journal of Heart and Lung Transplantation Volume 22, Number 6
FIGURE 1 Number of centers reporting heart transplants by year of transplantation. plant reporting from centers outside the USA is clearly an important goal of the Registry. We are pursuing 2 main strategies to increase non-U.S. center reporting to the Registry. First, we are developing direct reporting relationships with more organ exchange organizations (OEOs), which can provide data regarding transplants at a number of centers within a country or region. In the USA, reporting to the United Network for Organ Sharing (UNOS) is mandatory and the data directly populates the Registry database. In the past several years, the Registry has established direct data downloads with Eurotransplant (which submits data from 42 thoracic organ transplant centers in Austria, Belgium, Germany, The Netherlands and Slovenia) and UK Transplant (which submits data from 10 thoracic organ transplant centers in Ireland and the UK). Altogether, reporting via OEO accounts for approximately 90% of the transplants included in the Registry database. Within the past year, we have established a new reporting relationship with ScandiaTransplant, representing 6 thoracic transplant centers in Denmark, Finland, Norway and Sweden, which will increase that proportion significantly.
FIGURE 2 Number of centers reporting lung transplants by year of transplantation.
Hertz et al.
611
In fact, data currently available from the ScandiaTransplant registry, the “Nordic Thorax Transplantation Registry,” will immediately add more than 2,000 heart and lung transplants to the Registry database. A second method to increase non-U.S. center reporting is facilitate the process for individual centers to report directly to the Registry. The development of an internet-based system of reporting has been a major effort of the Registry in the past 2 years, and, as of July 2003, all reporting to the Registry by individual centers will be online. Centers wishing to establish online reporting of their data should contact Linda Butler ([email protected]) or Kathryn Philibin (philibka@ unos.org). Although internet-based reporting will make reporting more efficient, some centers perceive that they will have difficulty reporting due to a large number of required data elements. In reality, however, although the Registry database contains 150 individual data elements, only 15 data elements are required to register a patient. Finally, we have sent letters of invitation to all thoracic organ transplant centers that are known to us but not currently submitting Registry data; ISHLT members whose institutions are not currently reporting to the Registry should ask their program directors to contact Linda Butler (butlerlp@ unos.org) or Kathryn Philibin ([email protected]) to establish a reporting agreement.
INITIATION OF THE MECHANICAL CIRCULATORY SUPPORT DEVICE DATABASE The past several years have brought explosive worldwide growth in the implantation of mechanical circulatory support devices for patients with heart failure. However, there has not previously been a central repository of data regarding these devices. In accord with its mission to study and promote therapies for failing hearts and lungs, the Scientific Council on Mechanical Circulatory Support of the ISHLT has established the international Mechanical Circulatory Support Device (MCSD) Database. The MCSD Database will generate critical data to advance knowledge about the efficacy and safety of mechanical circulatory support devices. Specifically, the goals of the MCSD Database are: (1) to capture worldwide data related to the implantation and outcome of patients receiving cardiac assist devices designed for use for 30 or more days; (2) to identify risk factors for complications; (3) to improve patient selection and management before and after device implantation; (4) to generate predictive models of outcome for given patient profiles; (5) to generate statistical analyses of the data that can be used as the underlying evidence/justification for government
612
Hertz et al.
The Journal of Heart and Lung Transplantation June 2003
TABLE I Summary of the 3 levels of Registry data request
Level 1: Simple inquiries/clarification Level 2: New analyses of existing data Level 3: Complex analyses of existing data/new data collection
Analysis time required
Usual turnaround time
⬍1 hour ⬍5 hours ⬎5 hours
⬍14 days 4 to 6 weeks Variable
agency- and industry-funded studies and clinical trials; and (6) to identify overall and best practices with the aim of improving current practices. The MCSD Database consists of 3 tiers of data: Tier 1 includes basic data that focus on the specifics of the device type, surgical implant procedure and indications for implant, and outcome; Tier 2 includes details regarding the specific patient-related complications and events subsequent to device implantation; and Tier 3 consists of device-related events compatible with FDA post-marketing surveillance requirements. As of March 2003, data had been submitted to the MCSD Database from 15 centers regarding 94 patients and 117 devices; the first report of the MCSD Database consists of information regarding these implants.
FACILITATATION OF ACCESS TO DATA FOR CLINICAL INQUIRIES AND RESEARCH PROJECTS As in past years, all of the data figures and tables included in the Registry reports are also available for viewing and downloading on the ISHLT web site (www.ishlt.org/registries) in PowerPoint (Microsoft) format. The web site also contains many additional data slides that are not included in the published reports. In addition, individuals wishing to view the published heart, lung and heart–lung, pediatric and MCSD reports online may do so by contacting www.cardiosource.com. In addition to the information available in the published Registry reports and slide sets, continentspecific and center-specific data reports can be obtained from the secure section of the ISHLT web site (www.ishlt.org). These include transplant counts; tabulations of recipient, transplant and donor demographics; and survival rates stratified by demographic parameters. Continent-specific reports are available to everyone and allow comparison of continent-specific transplant and outcome data with that of all transplants submitted to the Registry. Center-specific reports allow comparison of one’s own individual center with that of all transplants submitted to the Registry. These reports are available to all actively participating centers, including those submitting data via OEO. Because we only want staff members affiliated with each center to access center-specific reports from their
Requirements Available to all ISHLT members only ISHLT members only; reviewed by Executive Committee (February, June, October)
own center, the center-specific reports require a user name and password, which can be obtained from Linda Butler ([email protected]) or Kathryn Philibin ([email protected]). ISHLT members and non-members frequently request Registry data not readily available in the slide set or in the continent- or center-specific reports. To facilitate and expedite these data queries, we developed a uniform process by which they will be handled. All requests will be submitted to the ISHLT headquarters office accompanied by a data request form (available at www.ishlt.org). ISHLT staff will determine the number of hours each request will require, which will allow each request to be assigned to a specific level, as described in Table I. For approved data requests, ISHLT members may be granted a specific number of hours of data analysis and biostatistical support for publication of new information regarding heart and lung transplantation. At present, the ISHLT is not using all of the analysis time that we have purchased; therefore, we encourage members to submit Level 2 and 3 data requests that will form the basis for scientific reports.
CONCLUSIONS The ISHLT Registry is a valuable resource that represents a core activity of the Society. On this twentieth anniversary of the Transplant Registry, we should re-dedicate the Society to serving the transplant community by maintaining and continuously improving this critical function. The developing MCSD Database will provide a critical resource as the field of cardiac assist and replacement continues to evolve rapidly in coming years. We encourage ISHLT members to participate actively in the Registry, both by ensuring that their centers’ transplants are included in the database, and by requesting analyses that are not included in the core Registry reports, particularly those that result in manuscript submissions to The Journal of Heart and Lung Transplantation. The authors wish to acknowledge the contributions of UNOS staff members Jude Maghirang, Denise Wise, and Kelly Balagtas, without whose diligent efforts this report would not be possible.
The Journal of Heart and Lung Transplantation Volume 22, Number 6
Hertz et al.
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APPENDIX List of thoracic transplant centers reporting transplants to the ISHLT Registry in 2000 –2002
Center Argentina Fundacion Favaloro Australia St. Vincent The Prince Charles Hospital The Alfred Hospital Royal Perth Hospital Austria University of Vienna Innsbruck University Hospital University Klinik fur Chirurgie (Graz) Belgium Erasme University Hospital (Brussels) University Hospital Gasthuisberg (Leuven) University Hospital Antwerp OLV Hospital (Aalst) University Hospital Gent Centre Hospitalier Universitaire de Liege, CHU Sart-Tilman Canada Royal Victoria Hospital Montreal Heart Institute The Toronto General Hospital Quebec Heart Institute–Laval Hospital Ottawa Heart Institute University of Alberta Hospitals/ Walter C. Mackenzie Health Sciences St. Paul Vancouver General Hospital The Hospital for Sick Children Chile Hospital DIPRECA Clinica Las Condes Denmark Skejby University Hospital Rigshospitalet, National University Hospital Finland Helsinki University Central Hospital Children’s Hospital, University of Helsinki France Hopital Cardiolgique (Lille) Hopital La Pitie Germany Organisationsbuero des K.F.H. (Homburg/Saar) Martin-Luther Universitaet Halle Technischen Universitaet Dresden German Heart Institute (Berlin) Universitat Hamburg
Transplants Transplants performed performed 1/2001 to in 2000 and 6/2002 reported to and reported ISHLT to ISHLT x
x
x x x
x x x x
x x x
x x x
x x
x x
x x x x
x x x x
x x x x
x x x x
x x
x x
x x x
x x x
x
x x
x x
x x
x x
x x
x x
x x
x
x
x x x x
x x x x
Center
Transplants performed in 2000 and reported to ISHLT
Universitaetsklinik (Koeln) University of Leipzig–Heart Center Kerckoff-Klinik der Max-PlanckGesellschaft zur Forderung der Wissenschaften e. V. (Bad Nauheim) Klinikum der Universitaet (Heidelberg) Herz-und Diabetesentrum Nordrhein-Westfalen (Bad Oeynhausen) Chirurgische Universitaetsklinik/ Univ. Rostock (Freiburg lm Breisgau) Essen University Medical School I. Med. Klinik J. Gutenberg (Mainz) der Heinrich-Heine-Universitat Dusseldorf Klinikum Grosshadern, LudwigMaximilians-Universitat Munchen Klinikum der Universitat Kaiserslautern Chirurgische Universitatsklinik Heidelberg Medizinische Hochschule Hannover Universitatsklinik Gottingen Klinikum der Rheinisch-Westfalischen Technischen Hochschule Aachen Fulda Medical Center Klinikum der J.W. Goethe University (Frankfurt am Main) Klinikum Der Christian-AlbrechtsUniverstat zu Kiel Transplantations-Zentrum (Frankfurt) Friedrich Schiller Universitaet (Jena) Klinikum Karlsburg Klinik fuer Herzchirurgie Karlsruhe Medizinische Einrichtupgen der Universitat, Nurenberg Chirurgische Univ. Klinik/Julius Maxmillians Universitet (Wurzburg) Greece Onassis Cardiac Surgery Center Ireland Mater Hospital Israel Sheba Medical Center Hadassah University Hospital Italy Policlinico S. Orsola–Universita degli Studi Japan Tohoku University, IDAC Hospital
Transplants performed 1/2001 to 6/2002 and reported to ISHLT
x x x
x x x
x
x
x
x
x
x
x x x
x x x
x
x
x x
x
x x
x x
x x x
x x x
x
x
x
x
x
x
x x x
x x
x x
x
x
x
x x
x
x x
x
614
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The Journal of Heart and Lung Transplantation June 2003
APPENDIX Cont’d
Center Osaka University Hospital National Cardiovascular Center The Netherlands Heart–Lung Institute, University Hospital Utrecht Thoraxcenter–University Hospital Rotterdam University Hospital Groningen New Zealand Green Lane Hospital Norway Rikshospitalet–National Hospital of Norway Singapore National Heart Centre Slovenia University Medical Center Ljubljana Sweden University Hospital of Lund Sahlgrenska University Hospital Switzerland Bern University Hospital United Kingdom Great Ormand Street Hospital for Children University of Glasgow/Glasgow Royal Infirmary Northern General Hospital The Freeman Hospital Harefield Hosp Wythenshawe Hospital St. George’s Hospital Queen Elizabeth Hospital Papworth Hospital United States University of Alabama Hospital Baptist Medical Center, Little Rock Arkansas Children’s Hospital The University Hospital of Arkansas University Medical Center, University of Arizona Children’s Hospital Los Angeles Cedars Sinai Medical Center Loma Linda University Medical Center California Pacific Medical Center UCSD Medical Center University of California, San Francisco Medical Center Sutter Memorial Hospital Sharp Memorial Hospital UC Davis Medical Center Stanford University Medical Center St Vincent Medical Center
Transplants Transplants performed performed 1/2001 to in 2000 and 6/2002 reported to and reported ISHLT to ISHLT x x
x x
x
x
x
x
x
x
x
x
x
x
x x
x
x x
x x
x
x
x
x
x
x
x x x x x x x
x x x x
x x x x x
x x x x x
x x x
x x x
x x x
x x x
x x x x x
x x
x x
x x
Center
Transplants performed in 2000 and reported to ISHLT
UCLA Medical Center USC University Hospital The Children’s Hospital, Denver University Hospital, Denver Hartford Hospital Yale New Haven Hospital Children’s National Medical Center Washington Hospital Center All Children’s Hospital Jackson Memorial Hospital St. Luke’s Hospital, Jacksonville Tampa General Hospital Tallahassee Memorial Hospital Shands Hospital at University of Florida Egleston Children’s Hospital Emory University Hospital St. Joseph Hospital of Atlanta St. Francis Medical Center, Honolulu University of Iowa Hospital and Clinics Children’s Memorial Hospital Loyola University Medical Center Northwestern Memorial Hospital Rush–Presbyterian–St. Luke’s Medical Center OSF St. Francis Medical Center St. John’s Hospital University of Chicago Medical Center University of Illinois Hospital Clarian Health–Methodist/IU/Riley Indiana University Medical Center Lutheran Hospital of Fort Wayne St. Vincent Hospital and Health Care Center Via Christi Regional Medical Center Jewish Hospital Kosair Children’s Hospital University of Kentucky Medical Center Ochsner Foundation Hospital Tulane University Medical Center Willis Knighton Medical Center Children’s Hospital, Boston Massachusetts General Hospital New England Medical Center Brigham and Women’s Hospital UMass Memorial Medical Center Johns Hopkins Hospital University of Maryland Medical System Children’s Hospital of Michigan
x x x x x x x x x x
Transplants performed 1/2001 to 6/2002 and reported to ISHLT x x x x x x
x x x
x x x x x x x
x x x x
x x x x
x
x
x x x x
x x x
x x x
x
x x x x x
x x x x x
x x x x
x x
x x x x x x x
x
x
x x
x x x x x x x x x x
x
x
The Journal of Heart and Lung Transplantation Volume 22, Number 6
Hertz et al.
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APPENDIX Cont’d
Center Henry Ford Hospital University of Michigan Medical Center Abbott Northwestern Hospital St. Mary’s Hospital, Rochester Fairview University Medical Center Barnes–Jewish Hospital Cardinal Glennon Children’s Hospital St. Louis Children’s Hospital St. Louis Hospital of Kansas City St. Louis University Hospital University of Missouri Hospital and Clinic University of Mississippi Medical Center North Carolina Baptist Hospital Carolinas Medical Center Duke University Medical Center University of North Carolina Hospitals Bryan LGH Medical Center East Newark Beth Israel Medical Center Robert Wood Johnson University Hosp Presbyterian Hospital, Albuquerque Albany Medical Center Hospital The Presbyterian Hospital, NYC Strong Memorial Hospital Montefiore Medical Center Mt. Sinai Medical Center New York University Medical Center Westchester County Medical Center Cleveland Clinic Foundation Children’s Hospital Medical Center, Cincinnati Medical College Hospital, Toledo Ohio State University Hospital University of Cincinnati Medical Center University Hospital of Cleveland Integris Baptist Medical Center St. Francis Hospital, Tulsa Providence Portland Medical Center Oregon Health Sciences University Hosp Allegheny General Hospital Children’s Hospital of Pittsburgh Children’s Hospital of Philadelphia Penn State Milton S. Hershey Med Center
Transplants Transplants performed performed 1/2001 to in 2000 and 6/2002 reported to and reported ISHLT to ISHLT x x
x x
x x x x x x x x x
x x x x x x x x x
x
x
x x x x
x x x x
x x x
x x x
x x x
x x
x x x x x x x x x x
x x x
x x x
x x x x x
x x x x x
x x x x
x x x x
x
Center
Transplants performed in 2000 and reported to ISHLT
Hahnemann University Hospital Tenet University of Pittsburgh Medical Center Temple University Hospital The Hospital of the University of Pennsylvania Cardiovascular Center of Puerto Rico Medical University of South Carolina Baptist Memorial Hospital, Memphis St. Thomas Hospital Vanderbilt University Medical Center Brooke Army Medical Center University Hospital, San Antonio Children’s Medical Center of Dallas Seton Medical Center Columbia Hospital at Medical City Dallas St. Luke’s Episcopal Hospital Methodist Specialty and Transplant Hospital University of Texas Medical Branch The Methodist Hospital, Houston Christus Santa Rosa Medical Center St. Paul University Hospital Baylor University Medical Center LDS Hospital University of Utah Medical Center Primary Children’s Medical Center Inova Fairfax Hospital Henrico Doctors Hospital MCV Hospitals McGuire VA Medical Center Sentara Norfolk General Hospital University of Virginia HSC Children’s Hosp Medical Center, Seattle Sacred Heart Medical Center University of Washington Medical Center Children’s Hospital of Wisconsin Froedtert Memorial Lutheran Hospital St. Luke’s Medical Center University of Wisconsin Hospital and Clinics
Transplants performed 1/2001 to 6/2002 and reported to ISHLT
x
x
x
x
x x
x x
x
x
x x x x
x x x x
x x x x x
x x x x x
x x
x x
x x x x x x x x x x x x x x x
x x x x x x x x x x x x x x x
x x
x x
x x
x x
x x
x x
The Registry of the International Society for Heart and Lung Transplantation: Introduction to the Twentieth Annual Reports—2003 Marshall I. Hertz, MD,a Paul J. Mohacsi, MD,a David O. Taylor, MD,a Elbert P. Trulock, MD,a Mark M. Boucek, MD,a Mario C. Deng, MD,a Berkeley M. Keck, MPH,a Leah B. Edwards, PhD,a and Amanda W. Rowe, BAa
W
e 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 From the International Society for Heart and Lung Transplantation, Addison, Texas. Reprint requests: Marshall I. Hertz, MD, University of Minnesota, 420 Delaware Street SE, 276 MMC, Minneapolis, Minnesota 55455. Telephone: 612-624-0999. Fax: 612-625-2174. E-mail: [email protected] J Heart Lung Transplant 2003;22:610 – 615. Copyright © 2003 by the International Society for Heart and Lung Transplantation. 1053-2498/03/$–see front matter doi:10.1016/S1053-2498(03)00185-2
610
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.
INCREASING WORLDWIDE HEART AND LUNG TRANSPLANT REPORTING Widespread participation of thoracic transplant centers throughout the world is critical to maintaining the unique international nature of the Registry. In recent years, the number of non-U.S. heart transplant centers reporting to the Registry has decreased significantly (Figure 1), while the number of U.S. centers has remained constant. The number of non-U.S. lung transplant centers has also decreased, but not as dramatically (Figure 2). Although it is difficult to obtain accurate data regarding activity in centers that do not report to the Registry, it is likely that a significant proportion of transplants performed by non-U.S. centers are not currently reported (this will be discussed in more detailed in a separate report in a future issue of this journal). Therefore, improving the completeness of trans-
The Journal of Heart and Lung Transplantation Volume 22, Number 6
FIGURE 1 Number of centers reporting heart transplants by year of transplantation. plant reporting from centers outside the USA is clearly an important goal of the Registry. We are pursuing 2 main strategies to increase non-U.S. center reporting to the Registry. First, we are developing direct reporting relationships with more organ exchange organizations (OEOs), which can provide data regarding transplants at a number of centers within a country or region. In the USA, reporting to the United Network for Organ Sharing (UNOS) is mandatory and the data directly populates the Registry database. In the past several years, the Registry has established direct data downloads with Eurotransplant (which submits data from 42 thoracic organ transplant centers in Austria, Belgium, Germany, The Netherlands and Slovenia) and UK Transplant (which submits data from 10 thoracic organ transplant centers in Ireland and the UK). Altogether, reporting via OEO accounts for approximately 90% of the transplants included in the Registry database. Within the past year, we have established a new reporting relationship with ScandiaTransplant, representing 6 thoracic transplant centers in Denmark, Finland, Norway and Sweden, which will increase that proportion significantly.
FIGURE 2 Number of centers reporting lung transplants by year of transplantation.
Hertz et al.
611
In fact, data currently available from the ScandiaTransplant registry, the “Nordic Thorax Transplantation Registry,” will immediately add more than 2,000 heart and lung transplants to the Registry database. A second method to increase non-U.S. center reporting is facilitate the process for individual centers to report directly to the Registry. The development of an internet-based system of reporting has been a major effort of the Registry in the past 2 years, and, as of July 2003, all reporting to the Registry by individual centers will be online. Centers wishing to establish online reporting of their data should contact Linda Butler ([email protected]) or Kathryn Philibin (philibka@ unos.org). Although internet-based reporting will make reporting more efficient, some centers perceive that they will have difficulty reporting due to a large number of required data elements. In reality, however, although the Registry database contains 150 individual data elements, only 15 data elements are required to register a patient. Finally, we have sent letters of invitation to all thoracic organ transplant centers that are known to us but not currently submitting Registry data; ISHLT members whose institutions are not currently reporting to the Registry should ask their program directors to contact Linda Butler (butlerlp@ unos.org) or Kathryn Philibin ([email protected]) to establish a reporting agreement.
INITIATION OF THE MECHANICAL CIRCULATORY SUPPORT DEVICE DATABASE The past several years have brought explosive worldwide growth in the implantation of mechanical circulatory support devices for patients with heart failure. However, there has not previously been a central repository of data regarding these devices. In accord with its mission to study and promote therapies for failing hearts and lungs, the Scientific Council on Mechanical Circulatory Support of the ISHLT has established the international Mechanical Circulatory Support Device (MCSD) Database. The MCSD Database will generate critical data to advance knowledge about the efficacy and safety of mechanical circulatory support devices. Specifically, the goals of the MCSD Database are: (1) to capture worldwide data related to the implantation and outcome of patients receiving cardiac assist devices designed for use for 30 or more days; (2) to identify risk factors for complications; (3) to improve patient selection and management before and after device implantation; (4) to generate predictive models of outcome for given patient profiles; (5) to generate statistical analyses of the data that can be used as the underlying evidence/justification for government
612
Hertz et al.
The Journal of Heart and Lung Transplantation June 2003
TABLE I Summary of the 3 levels of Registry data request
Level 1: Simple inquiries/clarification Level 2: New analyses of existing data Level 3: Complex analyses of existing data/new data collection
Analysis time required
Usual turnaround time
⬍1 hour ⬍5 hours ⬎5 hours
⬍14 days 4 to 6 weeks Variable
agency- and industry-funded studies and clinical trials; and (6) to identify overall and best practices with the aim of improving current practices. The MCSD Database consists of 3 tiers of data: Tier 1 includes basic data that focus on the specifics of the device type, surgical implant procedure and indications for implant, and outcome; Tier 2 includes details regarding the specific patient-related complications and events subsequent to device implantation; and Tier 3 consists of device-related events compatible with FDA post-marketing surveillance requirements. As of March 2003, data had been submitted to the MCSD Database from 15 centers regarding 94 patients and 117 devices; the first report of the MCSD Database consists of information regarding these implants.
FACILITATATION OF ACCESS TO DATA FOR CLINICAL INQUIRIES AND RESEARCH PROJECTS As in past years, all of the data figures and tables included in the Registry reports are also available for viewing and downloading on the ISHLT web site (www.ishlt.org/registries) in PowerPoint (Microsoft) format. The web site also contains many additional data slides that are not included in the published reports. In addition, individuals wishing to view the published heart, lung and heart–lung, pediatric and MCSD reports online may do so by contacting www.cardiosource.com. In addition to the information available in the published Registry reports and slide sets, continentspecific and center-specific data reports can be obtained from the secure section of the ISHLT web site (www.ishlt.org). These include transplant counts; tabulations of recipient, transplant and donor demographics; and survival rates stratified by demographic parameters. Continent-specific reports are available to everyone and allow comparison of continent-specific transplant and outcome data with that of all transplants submitted to the Registry. Center-specific reports allow comparison of one’s own individual center with that of all transplants submitted to the Registry. These reports are available to all actively participating centers, including those submitting data via OEO. Because we only want staff members affiliated with each center to access center-specific reports from their
Requirements Available to all ISHLT members only ISHLT members only; reviewed by Executive Committee (February, June, October)
own center, the center-specific reports require a user name and password, which can be obtained from Linda Butler ([email protected]) or Kathryn Philibin ([email protected]). ISHLT members and non-members frequently request Registry data not readily available in the slide set or in the continent- or center-specific reports. To facilitate and expedite these data queries, we developed a uniform process by which they will be handled. All requests will be submitted to the ISHLT headquarters office accompanied by a data request form (available at www.ishlt.org). ISHLT staff will determine the number of hours each request will require, which will allow each request to be assigned to a specific level, as described in Table I. For approved data requests, ISHLT members may be granted a specific number of hours of data analysis and biostatistical support for publication of new information regarding heart and lung transplantation. At present, the ISHLT is not using all of the analysis time that we have purchased; therefore, we encourage members to submit Level 2 and 3 data requests that will form the basis for scientific reports.
CONCLUSIONS The ISHLT Registry is a valuable resource that represents a core activity of the Society. On this twentieth anniversary of the Transplant Registry, we should re-dedicate the Society to serving the transplant community by maintaining and continuously improving this critical function. The developing MCSD Database will provide a critical resource as the field of cardiac assist and replacement continues to evolve rapidly in coming years. We encourage ISHLT members to participate actively in the Registry, both by ensuring that their centers’ transplants are included in the database, and by requesting analyses that are not included in the core Registry reports, particularly those that result in manuscript submissions to The Journal of Heart and Lung Transplantation. The authors wish to acknowledge the contributions of UNOS staff members Jude Maghirang, Denise Wise, and Kelly Balagtas, without whose diligent efforts this report would not be possible.
The Journal of Heart and Lung Transplantation Volume 22, Number 6
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APPENDIX List of thoracic transplant centers reporting transplants to the ISHLT Registry in 2000 –2002
Center Argentina Fundacion Favaloro Australia St. Vincent The Prince Charles Hospital The Alfred Hospital Royal Perth Hospital Austria University of Vienna Innsbruck University Hospital University Klinik fur Chirurgie (Graz) Belgium Erasme University Hospital (Brussels) University Hospital Gasthuisberg (Leuven) University Hospital Antwerp OLV Hospital (Aalst) University Hospital Gent Centre Hospitalier Universitaire de Liege, CHU Sart-Tilman Canada Royal Victoria Hospital Montreal Heart Institute The Toronto General Hospital Quebec Heart Institute–Laval Hospital Ottawa Heart Institute University of Alberta Hospitals/ Walter C. Mackenzie Health Sciences St. Paul Vancouver General Hospital The Hospital for Sick Children Chile Hospital DIPRECA Clinica Las Condes Denmark Skejby University Hospital Rigshospitalet, National University Hospital Finland Helsinki University Central Hospital Children’s Hospital, University of Helsinki France Hopital Cardiolgique (Lille) Hopital La Pitie Germany Organisationsbuero des K.F.H. (Homburg/Saar) Martin-Luther Universitaet Halle Technischen Universitaet Dresden German Heart Institute (Berlin) Universitat Hamburg
Transplants Transplants performed performed 1/2001 to in 2000 and 6/2002 reported to and reported ISHLT to ISHLT x
x
x x x
x x x x
x x x
x x x
x x
x x
x x x x
x x x x
x x x x
x x x x
x x
x x
x x x
x x x
x
x x
x x
x x
x x
x x
x x
x x
x
x
x x x x
x x x x
Center
Transplants performed in 2000 and reported to ISHLT
Universitaetsklinik (Koeln) University of Leipzig–Heart Center Kerckoff-Klinik der Max-PlanckGesellschaft zur Forderung der Wissenschaften e. V. (Bad Nauheim) Klinikum der Universitaet (Heidelberg) Herz-und Diabetesentrum Nordrhein-Westfalen (Bad Oeynhausen) Chirurgische Universitaetsklinik/ Univ. Rostock (Freiburg lm Breisgau) Essen University Medical School I. Med. Klinik J. Gutenberg (Mainz) der Heinrich-Heine-Universitat Dusseldorf Klinikum Grosshadern, LudwigMaximilians-Universitat Munchen Klinikum der Universitat Kaiserslautern Chirurgische Universitatsklinik Heidelberg Medizinische Hochschule Hannover Universitatsklinik Gottingen Klinikum der Rheinisch-Westfalischen Technischen Hochschule Aachen Fulda Medical Center Klinikum der J.W. Goethe University (Frankfurt am Main) Klinikum Der Christian-AlbrechtsUniverstat zu Kiel Transplantations-Zentrum (Frankfurt) Friedrich Schiller Universitaet (Jena) Klinikum Karlsburg Klinik fuer Herzchirurgie Karlsruhe Medizinische Einrichtupgen der Universitat, Nurenberg Chirurgische Univ. Klinik/Julius Maxmillians Universitet (Wurzburg) Greece Onassis Cardiac Surgery Center Ireland Mater Hospital Israel Sheba Medical Center Hadassah University Hospital Italy Policlinico S. Orsola–Universita degli Studi Japan Tohoku University, IDAC Hospital
Transplants performed 1/2001 to 6/2002 and reported to ISHLT
x x x
x x x
x
x
x
x
x
x
x x x
x x x
x
x
x x
x
x x
x x
x x x
x x x
x
x
x
x
x
x
x x x
x x
x x
x
x
x
x x
x
x x
x
614
Hertz et al.
The Journal of Heart and Lung Transplantation June 2003
APPENDIX Cont’d
Center Osaka University Hospital National Cardiovascular Center The Netherlands Heart–Lung Institute, University Hospital Utrecht Thoraxcenter–University Hospital Rotterdam University Hospital Groningen New Zealand Green Lane Hospital Norway Rikshospitalet–National Hospital of Norway Singapore National Heart Centre Slovenia University Medical Center Ljubljana Sweden University Hospital of Lund Sahlgrenska University Hospital Switzerland Bern University Hospital United Kingdom Great Ormand Street Hospital for Children University of Glasgow/Glasgow Royal Infirmary Northern General Hospital The Freeman Hospital Harefield Hosp Wythenshawe Hospital St. George’s Hospital Queen Elizabeth Hospital Papworth Hospital United States University of Alabama Hospital Baptist Medical Center, Little Rock Arkansas Children’s Hospital The University Hospital of Arkansas University Medical Center, University of Arizona Children’s Hospital Los Angeles Cedars Sinai Medical Center Loma Linda University Medical Center California Pacific Medical Center UCSD Medical Center University of California, San Francisco Medical Center Sutter Memorial Hospital Sharp Memorial Hospital UC Davis Medical Center Stanford University Medical Center St Vincent Medical Center
Transplants Transplants performed performed 1/2001 to in 2000 and 6/2002 reported to and reported ISHLT to ISHLT x x
x x
x
x
x
x
x
x
x
x
x
x
x x
x
x x
x x
x
x
x
x
x
x
x x x x x x x
x x x x
x x x x x
x x x x x
x x x
x x x
x x x
x x x
x x x x x
x x
x x
x x
Center
Transplants performed in 2000 and reported to ISHLT
UCLA Medical Center USC University Hospital The Children’s Hospital, Denver University Hospital, Denver Hartford Hospital Yale New Haven Hospital Children’s National Medical Center Washington Hospital Center All Children’s Hospital Jackson Memorial Hospital St. Luke’s Hospital, Jacksonville Tampa General Hospital Tallahassee Memorial Hospital Shands Hospital at University of Florida Egleston Children’s Hospital Emory University Hospital St. Joseph Hospital of Atlanta St. Francis Medical Center, Honolulu University of Iowa Hospital and Clinics Children’s Memorial Hospital Loyola University Medical Center Northwestern Memorial Hospital Rush–Presbyterian–St. Luke’s Medical Center OSF St. Francis Medical Center St. John’s Hospital University of Chicago Medical Center University of Illinois Hospital Clarian Health–Methodist/IU/Riley Indiana University Medical Center Lutheran Hospital of Fort Wayne St. Vincent Hospital and Health Care Center Via Christi Regional Medical Center Jewish Hospital Kosair Children’s Hospital University of Kentucky Medical Center Ochsner Foundation Hospital Tulane University Medical Center Willis Knighton Medical Center Children’s Hospital, Boston Massachusetts General Hospital New England Medical Center Brigham and Women’s Hospital UMass Memorial Medical Center Johns Hopkins Hospital University of Maryland Medical System Children’s Hospital of Michigan
x x x x x x x x x x
Transplants performed 1/2001 to 6/2002 and reported to ISHLT x x x x x x
x x x
x x x x x x x
x x x x
x x x x
x
x
x x x x
x x x
x x x
x
x x x x x
x x x x x
x x x x
x x
x x x x x x x
x
x
x x
x x x x x x x x x x
x
x
The Journal of Heart and Lung Transplantation Volume 22, Number 6
Hertz et al.
615
APPENDIX Cont’d
Center Henry Ford Hospital University of Michigan Medical Center Abbott Northwestern Hospital St. Mary’s Hospital, Rochester Fairview University Medical Center Barnes–Jewish Hospital Cardinal Glennon Children’s Hospital St. Louis Children’s Hospital St. Louis Hospital of Kansas City St. Louis University Hospital University of Missouri Hospital and Clinic University of Mississippi Medical Center North Carolina Baptist Hospital Carolinas Medical Center Duke University Medical Center University of North Carolina Hospitals Bryan LGH Medical Center East Newark Beth Israel Medical Center Robert Wood Johnson University Hosp Presbyterian Hospital, Albuquerque Albany Medical Center Hospital The Presbyterian Hospital, NYC Strong Memorial Hospital Montefiore Medical Center Mt. Sinai Medical Center New York University Medical Center Westchester County Medical Center Cleveland Clinic Foundation Children’s Hospital Medical Center, Cincinnati Medical College Hospital, Toledo Ohio State University Hospital University of Cincinnati Medical Center University Hospital of Cleveland Integris Baptist Medical Center St. Francis Hospital, Tulsa Providence Portland Medical Center Oregon Health Sciences University Hosp Allegheny General Hospital Children’s Hospital of Pittsburgh Children’s Hospital of Philadelphia Penn State Milton S. Hershey Med Center
Transplants Transplants performed performed 1/2001 to in 2000 and 6/2002 reported to and reported ISHLT to ISHLT x x
x x
x x x x x x x x x
x x x x x x x x x
x
x
x x x x
x x x x
x x x
x x x
x x x
x x
x x x x x x x x x x
x x x
x x x
x x x x x
x x x x x
x x x x
x x x x
x
Center
Transplants performed in 2000 and reported to ISHLT
Hahnemann University Hospital Tenet University of Pittsburgh Medical Center Temple University Hospital The Hospital of the University of Pennsylvania Cardiovascular Center of Puerto Rico Medical University of South Carolina Baptist Memorial Hospital, Memphis St. Thomas Hospital Vanderbilt University Medical Center Brooke Army Medical Center University Hospital, San Antonio Children’s Medical Center of Dallas Seton Medical Center Columbia Hospital at Medical City Dallas St. Luke’s Episcopal Hospital Methodist Specialty and Transplant Hospital University of Texas Medical Branch The Methodist Hospital, Houston Christus Santa Rosa Medical Center St. Paul University Hospital Baylor University Medical Center LDS Hospital University of Utah Medical Center Primary Children’s Medical Center Inova Fairfax Hospital Henrico Doctors Hospital MCV Hospitals McGuire VA Medical Center Sentara Norfolk General Hospital University of Virginia HSC Children’s Hosp Medical Center, Seattle Sacred Heart Medical Center University of Washington Medical Center Children’s Hospital of Wisconsin Froedtert Memorial Lutheran Hospital St. Luke’s Medical Center University of Wisconsin Hospital and Clinics
Transplants performed 1/2001 to 6/2002 and reported to ISHLT
x
x
x
x
x x
x x
x
x
x x x x
x x x x
x x x x x
x x x x x
x x
x x
x x x x x x x x x x x x x x x
x x x x x x x x x x x x x x x
x x
x x
x x
x x
x x
x x