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| AATS/NHLBI: Cardiothoracic Surgery Exploring Collaborative Clinical Research Opportunities |
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Title and Author A National Registry of Outcomes for the Management of Aortic StenosisMichael Mack, M.D. Abstract Outcomes of disease management can be assessed using both clinical and administrative databases. The advantage of clinical data is that it yields intent to treat analyses and sophisticated risk-adjustment. The disadvantage is that only short-term follow-up, usually 30 days, is available. Administrative data provides information on long-term outcomes such as death, readmission diagnoses, procedures, medications, and cost. Recently the ability to link clinical and administrative databases has become a reality allowing the advantages of both clinical databases with risk adjustment and of administrative databases with long-term outcomes (1) This newfound ability to link short-term clinical data with long-term administrative data has opened up important new ways to conduct medical research. The Society of Thoracic Surgeons (STS) and The American College of Cardiology Foundation (ACCF) maintain large, mature, well-respected national registries of clinical information that can be readily applied to observational studies. Both registries have used probabilistic matching to link this clinical data with CMS MedPAR information to obtain longitudinal outcome data for patients having undergone a wide array of procedures. In conjunction with Duke Clinical Research Institute, STS and ACCF have undertaken funded research studies using this data link as the central feature of the analysis. The largest of these is the ASCERT Study, which is funded by NIH to study the comparative effectiveness of percutaneous coronary intervention (PCI) versus conventional coronary artery bypass graft (CABG) surgery (2). In this study, STS has linked its clinical data with 2004-2008 MedPAR data. Data from the ACCF is linked to this same MedPAR data in a similar fashion, with the individual linkages permitting a link between STS and ACC-NCDR data as well. Propensity scoring is being used to compare like populations differing only in the treatment received. It is important to note that the patients studied are typical, "real-world" patients and that the number of patients in this study is approximately 10 times the total combined number of all previous RCTs comparing these treatment options. Recently a new therapy for the management of aortic stenosis, transcatheter aortic valve replacement (TAVR) has completed its initial U. S. pivotal clinical trials. Pending regulatory approval and commercial release there will now be another option to surgical aortic valve replacement and medical therapy for the management of patients with severe aortic stenosis. This provides a perfect opportunity to link clinical and administrative databases to provide post market surveillance, long term outcomes, cost and comparative effectiveness research. The proposed research opportunity would capture all patients with aortic stenosis in the STS and ACCF inpatient and outpatient databases. Continuous linkage with the Social Security Death Master File and CMS MedPAR data would then be established. This would enable a national registry of patients with aortic stenosis that would be able to be followed long-term for the assessment of disease management. Long-term mortality, hospital readmission, device surveillance, cost and comparative effectiveness measurement would all be possible. Ultimately even compliance with guideline directed therapy may be possible. Precedents for this national registry have been established. The NHLBI funded INTERMACS registry tracks long-term outcomes of patients receiving ventricular assist devices (3). A national registry in Great Britain is capable of assessing long-term outcomes of all patients undergoing cardiac surgery. The German national registry of cardiac surgery provides short-term results of all patients undergoing surgical and catheter delivered aortic valve replacement in Germany. By establishment of a continuous linkage between two robust clinical databases and two administrative databases in a specific disease such as aortic stenosis, the feasibility of a national registry can be established. Ultimately this registry could then be expanded to the management of all patients with cardiovascular disease that currently is responsible for 43% of healthcare spending in the United States. Once feasibility has been established then expansion to other disease states and other medical specialties would be possible. Key Research Gap Requiring NHLBI Leadership Establishment of a national registry for the management of aortic stenosis by developing the continuous linkage of the STS and ACCF clinical databases with the Social Security Death Master File (SSDMF) and CMS MedPAR data Key Citations 1: Jacobs JP, Edwards FH, Shahian DM, et al., Successful Linking of The Society of Thoracic Surgeons Adult Cardiac Surgery Database to Centers for Medicare and Medicaid Services Medicare Data Ann. Thorac. Surg., October 2010; 90: 1150 � 11572: Klein LW, Edwards FH, DeLong ER, Ritzenthaler L, Dangas GJD, and Weintraub WS, ASCERT: The American College of Cardiology Foundation The Society of Thoracic Surgeons Collaboration on the Comparative Effectiveness of Revascularization Strategies Am. Coll. Cardiol. Intv. 2010;3;124-126 3: Kirklin JK, Naftel DC, Kormos RL, et al., Third INTERMACS Annual Report: The evolution of destination therapy in the United States. J Heart Lung Transplant 2011;30:115�23 |
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Copyright © 2012 American Association for Thoracic Surgery
All rights reserved. IMPORTANT REMINDER: The preceding information is intended only to provide
general guidance and not as a definitive basis for diagnosis or treatment in any particular case.
It is very important that you consult a doctor about any specific medical problem or question.
All rights reserved. IMPORTANT REMINDER: The preceding information is intended only to provide
general guidance and not as a definitive basis for diagnosis or treatment in any particular case.
It is very important that you consult a doctor about any specific medical problem or question.