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• W2950668668 abstract "HomeCirculation: Cardiovascular InterventionsVol. 12, No. 5Putting Theory to the Test Free AccessEditorialPDF/EPUBAboutView PDFView EPUBSections ToolsAdd to favoritesDownload citationsTrack citationsPermissions ShareShare onFacebookTwitterLinked InMendeleyReddit Jump toFree AccessEditorialPDF/EPUBPutting Theory to the TestThe Validity of Using Real-World Data in Assessing Structural Heart Disease Outcomes Jordan B. Strom, MD, MSc and Robert W. Yeh, MD, MSc Jordan B. StromJordan B. Strom Richard A. and Susan F. Smith Center for Outcomes Research in Cardiology, Division of Cardiovascular Medicine, Beth Israel Deaconess Medical Center, Boston, MA. Search for more papers by this author and Robert W. YehRobert W. Yeh Robert W. Yeh, MD, MSc, Richard A. and Susan F. Smith Center for Outcomes Research in Cardiology, Beth Israel Deaconess Medical Center, 375 Longwood Ave, Fourth Floor, Boston, MA 02215. Email E-mail Address: [email protected] Richard A. and Susan F. Smith Center for Outcomes Research in Cardiology, Division of Cardiovascular Medicine, Beth Israel Deaconess Medical Center, Boston, MA. Search for more papers by this author Originally published14 May 2019https://doi.org/10.1161/CIRCINTERVENTIONS.119.007953Circulation: Cardiovascular Interventions. 2019;12:e007953This article is a commentary on the followingUse of Medicare Claims to Identify Adverse Clinical Outcomes After Mitral Valve RepairSee Article by Lowenstern et alWhile randomized trials have formed the bedrock for evidence generation over the last century, in part because of the robust clinical event adjudication process that standardizes end point definitions and is blind to treatment assignment, high costs limit the number and size of trials, in some cases preventing potentially beneficial therapies from reaching patients.1 Given these concerns, there has been increasing interest in the use of real-world evidence, including electronic health records, registries, and administrative billing data, collected during the routine process of care, to substitute for or augment rigorously adjudicated outcomes in trials. Indeed, understanding the need to efficiently generate evidence for regulatory decision making, the Food and Drug Administration has begun the process of building a National Evaluation System for Health Technology and a Cardiovascular Device-Coordinated Research Network to leverage observational real-world evidence in synthesizing evidence on device effectiveness and safety.2 However, concerns about the validity of using real-world evidence to substitute for traditional trial outcomes have limited their adoption. Motivated in part by a desire to understand the claims-based algorithms that best identify clinical events and the circumstances in which these algorithms are valid, the Food and Drug Administration commissioned a number of validation studies and literature reviews of Health Outcomes of Interest as part of the Sentinel Initiative, a program that uses real-world data to improve post-marketing surveillance of approved drugs and devices.3No prior study, however, has compared the validity of claims or other types of real-world data to clinical event committee-adjudication in a large structural heart disease study. Given the growing structural heart disease volumes and a need to efficiently understand the clinical impact and safety of devices developed for this field, this has represented a major gap in knowledge.4What This Study AddsIn this issue of Circulation: Cardiovascular Interventions, Lowenstern et al5 linked Medicare claims to registry data from individuals who underwent transcatheter mitral valve repair using MitraClip for severe mitral regurgitation from 2007 to 2013, included in the EVEREST II (Endovascular Valve Edge-to-Edge Repair Study II) High-Risk and REALISM (Real World Expanded Multicenter Study of the MitraClip System) Continued Access registries.6,7 As direct identifiers were not available to link Medicare and registry patients, deterministic linkage using procedure date, discharge date, patient sex, age, and site identifier was used to determine a match, and linkage success rates were high (72.3%). Adjudicated outcomes for mortality, heart failure hospitalization, mitral valve reintervention, renal failure, mechanical ventilation >48 hours, and bleeding/transfusion were compared between Medicare claims and registry data, with the latter as the criterion standard. A number of candidate International Classification of Diseases, Ninth Revision, Clinical Modification diagnosis and procedure codes, Current Procedural Terminology codes, and Medicare revenue center codes were identified based on literature review and clinical judgment. Subsequently, the agreement between claims and physician-adjudicated outcomes was assessed using a variety of diagnosis/procedure code sets, including secondary diagnoses, primary diagnoses and outpatient claims.As expected, the agreement between claims and registry data was near perfect for mortality, with a sensitivity, specificity, and positive and negative predictive values of 100%, 99%, 97%, and 100%, respectively with near perfect agreement (κ=0.98). For other outcomes, however, claims were less reliable. Claims performed best for heart failure hospitalizations, with quoted sensitivities/specificities between 82% to 94% and 62% to 94%, respectively. Bleeding and renal failure claims had much lower positive predictive values (27%–40% for bleeding and 11%–19% for renal failure), demonstrating significant overidentification of events in claims.With regard to timing of nonfatal events, the 1-year cumulative incidence of heart failure hospitalizations and renal failure events was similar when only the first position diagnosis code was considered, but was nearly 3-fold higher than physician adjudication for heart failure, and 7- to 8-fold higher for renal failure, when all secondary diagnosis codes were considered. The timing and event rates for other events, including bleeding and mechanical ventilation, were discordant. Overall, 90% of recorded first event dates in claims occurred within a week of the event date in the registry.The results of this study imply that Medicare claims under the International Classification of Diseases,Ninth Revision, Clinical Modification framework can be validly used to track mortality outcomes. Whether they could also be used to evaluate heart failure hospitalizations and renal failure events under certain circumstances is a bit murkier. Consistent with prior comparisons of real-world evidence to physician-adjudicated events, claims had a low accuracy for detection of bleeding events.8These conclusions importantly define the circumstances under which claims might or might not be considered valid substitutes for adjudicated outcomes with several important caveats. First, the enrollment period of the registries (2007–2013) did not overlap with the transition to the International Classification of Diseases, Tenth Revision, Clinical Modification framework on October 1, 2015. Therefore, it remains unknown whether or not the authors’ observations about Medicare claims extend to the International Classification of Diseases, Tenth Revision, Clinical Modification classification, the system that would be used in any prospectively designed study. Second, as rates of stroke and new-onset atrial fibrillation events were low, the number of events was insufficient to evaluate concordance between claims and registry data for these outcomes. Third, definitions used to define bleeding and renal failure outcomes differed from those currently used as part of the VARC-2 criteria (Valve Academic Research Consortium-2),9 and thus may overestimate or underestimate event rates. Despite these unavoidable limitations, the article by Lowenstern et al5 adds significantly to the existing literature on this subject and opens the possibility for broadening the use of real-world data to support device evaluation in a regulatory context.Next StepsWhile the current article by Lowenstern et al5 highlights a number of limitations of using real-world data to track certain outcomes, such as bleeding, it overall provides cautious optimism about the use of such data types in evidence generation. The overarching message is that certain outcomes such as death or heart failure hospitalizations may be reliably tracked through claims. As technological advancements permit the evolution of transcatheter therapies for the mitral and tricuspid valves, understanding how these novel therapies compare to traditional therapeutic approaches, and the individuals who stand most to benefit from these new therapies will be vital. The findings by Lowenstern et al5 may suggest that claims could be used to efficiently gather information on death and heart failure hospitalizations that could improve the efficiency of evaluation of these new devices and evaluate their use in practice.Still, much work needs to be done before the use of real-world data for regulatory decision making is considered a mature science. First, despite the promising results of the current study, it is difficult to generalize about the use of claims based on one study alone, and failure to confirm these findings could inject a dose of reality in an area of science with much hype but little productivity. Second, it will be important to ensure that these findings hold under the International Classification of Diseases,Tenth Revision classification system. Third, many more critically important outcomes, such as stroke, transient ischemic attack, vascular complications, and new conduction disturbance and arrhythmia require evaluation.9 Fourth, more data are needed on the use of nonclaims information such as registry and electronic health record data to substitute for adjudicated outcomes. Fifth, and finally, more data are needed for other cardiovascular devices and settings in which real-world evidence could be used in the regulatory process.10ConclusionsWhile randomized trials have been a cornerstone of evidence generation in cardiovascular disease for the last century, high expenses and a need for efficient data generation have spawned a burgeoning interest in leveraging the abundant data collected during routine care to inform regulatory decisions. The painstaking work of validating such approaches is a necessary step before they can become widely used, particularly in rapidly evolving fields such as the treatment of structural heart disease. Until then, the use of traditional clinical trial machinery will continue to be the norm for the generation of any evidence that truly matters.Sources of FundingDr Strom is funded by a grant from the American Heart Association (18CDA34110627) outside of the submitted work. Dr Yeh is funded by the National Heart, Lung, and Blood Institute (1R01 HL136708).DisclosuresDr Yeh has received consulting fees from Abbott Vascular, Boston Scientific and Medtronic and has research grants from Abbott Vascular and Boston Scientific. The other author reports no conflicts.FootnotesThe opinions expressed in this article are not necessarily those of the editors or of the American Heart Association.https://www.ahajournals.org/journal/circinterventionsRobert W. Yeh, MD, MSc, Richard A. and Susan F. Smith Center for Outcomes Research in Cardiology, Beth Israel Deaconess Medical Center, 375 Longwood Ave, Fourth Floor, Boston, MA 02215. Email [email protected]harvard.eduReferences1. Moses H, Matheson DH, Cairns-Smith S, George BP, Palisch C, Dorsey ER. The anatomy of medical research: US and international comparisons.JAMA.2015; 313:174–189. doi: 10.1001/jama.2014.15939CrossrefMedlineGoogle Scholar2. Food and Drug Administration. National Evaluation System for Health Technology (NEST).https://www.fda.gov/aboutfda/centersoffices/officeofmedicalproductsandtobacco/cdrh/cdrhreports/ucm301912.htm. Accessed March 1, 2019.Google Scholar3. Carnahan RM, Moores KG. Mini-Sentinel’s systematic reviews of validated methods for identifying health outcomes using administrative and claims data: methods and lessons learned.Pharmacoepidemiol Drug Saf.2012; 21(suppl 1):82–89. doi: 10.1002/pds.2321CrossrefMedlineGoogle Scholar4. Grover FL, Vemulapalli S, Carroll JD, Edwards FH, Mack MJ, Thourani VH, Brindis RG, Shahian DM, Ruiz CE, Jacobs JP, Hanzel G, Bavaria JE, Tuzcu EM, Peterson ED, Fitzgerald S, Kourtis M, Michaels J, Chirstensen B, Seward WF, Hewitt K, Holmes DR; STS/ACC TVT Registry. 2016 Annual report of the society of thoracic surgeons/american college of cardiology transcatheter valve therapy registry.J Am Coll Cardiol. 2017; 69:1215–1230. doi: 10.1016/j.athoracsur.2016.12.001CrossrefMedlineGoogle Scholar5. Lowenstern A, Steven L, Brennan JM, Wang TY, Curtis LH, Feldman T, Glower DD, Hammill BG, Vemulapalli S. Use of medicare claims to identify adverse clinical outcomes after mitral valve repair.Circ Cardiovasc Interv. 2019; 12:e007451. doi: 10.1161/CIRCINTERVENTIONS.118.007451LinkGoogle Scholar6. Glower DD, Kar S, Trento A, Lim DS, Bajwa T, Quesada R, Whitlow PL, Rinaldi MJ, Grayburn P, Mack MJ, Mauri L, McCarthy PM, Feldman T. Percutaneous mitral valve repair for mitral regurgitation in high-risk patients: results of the EVEREST II study.J Am Coll Cardiol.2014; 64:172–181. doi: 10.1016/j.jacc.2013.12.062CrossrefMedlineGoogle Scholar7. Lim DS, Reynolds MR, Feldman T, Kar S, Herrmann HC, Wang A, Whitlow PL, Gray WA, Grayburn P, Mack MJ, Glower DD. Improved functional status and quality of life in prohibitive surgical risk patients with degenerative mitral regurgitation after transcatheter mitral valve repair.J Am Coll Cardiol.2014; 64:182–192. doi: 10.1016/j.jacc.2013.10.021CrossrefMedlineGoogle Scholar8. Guimaraes PO, Krishnamoorthy A, Kaltenbach LA, Anstrom KJ, Effron MB, Mark DB, McCollam PL, Davidson-Ray L, Peterson ED, Wang TY, Accuracy of medical claims for identifying cardiovascular and bleeding events after myocardial infarction: a secondary analysis of the TRANSLATE-ACS Study.JAMA Cardiology. 2017; 2:750–757. doi: 10.1001/jamacardio.2017.1460CrossrefMedlineGoogle Scholar9. Kappetein AP, Head SJ, Généreux P, Piazza N, van Mieghem NM, Blackstone EH, Brott TG, Cohen DJ, Cutlip DE, van Es GA, Hahn RT, Kirtane AJ, Krucoff MW, Kodali S, Mack MJ, Mehran R, Rodés-Cabau J, Vranckx P, Webb JG, Windecker S, Serruys PW, Leon MB. Updated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium-2 consensus document.Eur Heart J.2012; 33:2403–2418. doi: 10.1093/eurheartj/ehs255CrossrefMedlineGoogle Scholar10. Strom JB, Tamez H, Zhao Y, Valsdottir LR, Curtis J, Brennan JM, Shen C, Popma JJ, Mauri L, Yeh RW. Validating the use of registries and claims data to support randomized trials: rationale and design of the Extending Trial-Based Evaluations of Medical Therapies Using Novel Sources of Data (EXTEND) Study.Am Heart J. 2019; 212:64–71. doi: 10.1016/j.ahj.2019.02.007CrossrefMedlineGoogle Scholar Previous Back to top Next FiguresReferencesRelatedDetailsRelated articlesUse of Medicare Claims to Identify Adverse Clinical Outcomes After Mitral Valve RepairAngela Lowenstern, et al. Circulation: Cardiovascular Interventions. 2019;12 May 2019Vol 12, Issue 5 Advertisement Article InformationMetrics © 2019 American Heart Association, Inc.https://doi.org/10.1161/CIRCINTERVENTIONS.119.007953PMID: 31084240 Originally publishedMay 14, 2019 Keywordsalgorithmsheart diseasesdecision makingmarketingelectronic health recordsEditorialsPDF download Advertisement SubjectsCatheter-Based Coronary and Valvular InterventionsClinical StudiesDigital HealthHealth Services" @default.
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