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The importance of the mechanical circulatory support database: a plea for commitment
EDITORIAL
The Importance of the Mechanical Circulatory Support Database: A Plea for Commitment James K. Kirklin, MD
D
uring the International Society for Heart and Lung Transplantation (ISHLT) presidency of Dr. Robert Kormos, an initiative was established to form an international database to track the use and outcomes of mechanical circulatory support devices. Subsequently, a Mechanical Circulatory Support Council of the ISHLT was established to promote this endeavor. The Society and its leadership are to be congratulated for this extremely important initiative in high-quality, multi-institutional outcomes research. We are indebted to the United Network of Organ Sharing (UNOS) for providing the personnel and expertise to manage the database. This organization has paved the way for such efforts by establishing required data submission, analysis, and reporting for the entire field of organ transplantation within the United States. Of note, our Society has spawned other highly successful registries and databases, beginning soon after its inception in 1981 with the establishment of the Registry for the International Society for Heart and Lung Transplantation. The Cardiac Transplant Research Database, organized by members of this society in 1990, embraces more than 40 institutions in which outcomes data in adult heart transplantation are collected and analyzed. Subsequently, a similar database, the Pediatric Heart Transplant Study, was established in pediatric transplantation in 1992. As we enter an era of expanded invasive options for the treatment of end-stage heart disease, selection of the best therapy for each patient will depend largely on outcome information generated by multi-institutional trials and clinical databases, not only for transplantation, but for other therapies as well. One can imagine the future of advanced heart failure therapy when an array of medical, surgical,
and replacement options are available. When appropriate, accurate data are provided from large patient populations, techniques of multivariable analysis can be applied to identify risk factors for adverse outcomes. Available parametric methodology could then generate patient-specific survival predictions for each intervention. With such patient-specific equations available to predict the early and midterm survival of patients treated with each option, one could imagine the construction of a “computer printout” for each patient that lists the early (1-year) and midterm (5-year) or longer predicted survival for each therapy. Eventually, expected outcomes for sequential interventions (e.g., a ventricular assist device for 5 years followed by heart transplantation or specific medical heart failure therapy for 2 years followed by chronic circulatory support) could be generated. Such a printout on the front of each patient’s hospital or clinic record could immensely facilitate decision-making. For such patient-specific predictions to materialize, 3 conditions must be met: (1) large numbers of patients with diverse characteristics (usually from multiple institutions) must be analyzed; (2) the variables selected for analysis must be collected with scrupulous attention to accuracy and the generated risk factors must reflect true risk factors for specific outcome events; and (3) the databases must be frequently updated to reflect current practices with relevant patient sub-sets. In the realm of mechanical circulatory support, only the rigorous analysis of properly selected and accurately collected outcome data for a variety of mechanical circulatory support devices can ultimately provide the individual patient with the best choice of support for long-term quality and duration of life, whether through cardiac transplantation, a 803
804
Kirklin
pulsatile implantable ventricular assist device, an axial-flow ventricular augmentation device, the total artificial heart, or other evolving technology for cardiac assistance. Occasionally, an uninformed clinician or investigator will inquire about the beauty of a computer system that could generate any desired analysis with “a simple push of a button.” Such a fantasy could not be further from the truth. If endeavors in outcomes research such as the ISHLT Mechanical Circulatory Support Database are to succeed in generating useful information about
The Journal of Heart and Lung Transplantation August 2001
the expected outcomes with one or another chronic assist device (or, better yet, provide patient-specific predictions with a particular device or therapy), the integrity of the data will form the foundation of the project. The care, commitment, and accuracy of the data collected by each participating institution will determine the success or failure of this venture. Therefore, I implore each institution that participates in this critical study to dedicate itself and its personnel to accurate and complete data collection.
The Importance of the Mechanical Circulatory Support Database: A Plea for Commitment James K. Kirklin, MD
D
uring the International Society for Heart and Lung Transplantation (ISHLT) presidency of Dr. Robert Kormos, an initiative was established to form an international database to track the use and outcomes of mechanical circulatory support devices. Subsequently, a Mechanical Circulatory Support Council of the ISHLT was established to promote this endeavor. The Society and its leadership are to be congratulated for this extremely important initiative in high-quality, multi-institutional outcomes research. We are indebted to the United Network of Organ Sharing (UNOS) for providing the personnel and expertise to manage the database. This organization has paved the way for such efforts by establishing required data submission, analysis, and reporting for the entire field of organ transplantation within the United States. Of note, our Society has spawned other highly successful registries and databases, beginning soon after its inception in 1981 with the establishment of the Registry for the International Society for Heart and Lung Transplantation. The Cardiac Transplant Research Database, organized by members of this society in 1990, embraces more than 40 institutions in which outcomes data in adult heart transplantation are collected and analyzed. Subsequently, a similar database, the Pediatric Heart Transplant Study, was established in pediatric transplantation in 1992. As we enter an era of expanded invasive options for the treatment of end-stage heart disease, selection of the best therapy for each patient will depend largely on outcome information generated by multi-institutional trials and clinical databases, not only for transplantation, but for other therapies as well. One can imagine the future of advanced heart failure therapy when an array of medical, surgical,
and replacement options are available. When appropriate, accurate data are provided from large patient populations, techniques of multivariable analysis can be applied to identify risk factors for adverse outcomes. Available parametric methodology could then generate patient-specific survival predictions for each intervention. With such patient-specific equations available to predict the early and midterm survival of patients treated with each option, one could imagine the construction of a “computer printout” for each patient that lists the early (1-year) and midterm (5-year) or longer predicted survival for each therapy. Eventually, expected outcomes for sequential interventions (e.g., a ventricular assist device for 5 years followed by heart transplantation or specific medical heart failure therapy for 2 years followed by chronic circulatory support) could be generated. Such a printout on the front of each patient’s hospital or clinic record could immensely facilitate decision-making. For such patient-specific predictions to materialize, 3 conditions must be met: (1) large numbers of patients with diverse characteristics (usually from multiple institutions) must be analyzed; (2) the variables selected for analysis must be collected with scrupulous attention to accuracy and the generated risk factors must reflect true risk factors for specific outcome events; and (3) the databases must be frequently updated to reflect current practices with relevant patient sub-sets. In the realm of mechanical circulatory support, only the rigorous analysis of properly selected and accurately collected outcome data for a variety of mechanical circulatory support devices can ultimately provide the individual patient with the best choice of support for long-term quality and duration of life, whether through cardiac transplantation, a 803
804
Kirklin
pulsatile implantable ventricular assist device, an axial-flow ventricular augmentation device, the total artificial heart, or other evolving technology for cardiac assistance. Occasionally, an uninformed clinician or investigator will inquire about the beauty of a computer system that could generate any desired analysis with “a simple push of a button.” Such a fantasy could not be further from the truth. If endeavors in outcomes research such as the ISHLT Mechanical Circulatory Support Database are to succeed in generating useful information about
The Journal of Heart and Lung Transplantation August 2001
the expected outcomes with one or another chronic assist device (or, better yet, provide patient-specific predictions with a particular device or therapy), the integrity of the data will form the foundation of the project. The care, commitment, and accuracy of the data collected by each participating institution will determine the success or failure of this venture. Therefore, I implore each institution that participates in this critical study to dedicate itself and its personnel to accurate and complete data collection.