CARDIOVASCULAR DISABILITY

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CARDIOVASCULAR DISABILITY Updating the Social Security Listings Committee on Social Security Cardiovascular Disability Criteria Board on the Health of Select Populations

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THE NATIONAL ACADEMIES PRESS 500 Fifth Street, N.W. Washington, DC 20001 NOTICE: The project that is the subject of this report was approved by the Govern- ing Board of the National Research Council, whose members are drawn from the councils of the National Academy of Sciences, the National Academy of Engineer- ing, and the Institute of Medicine. The members of the committee responsible for the report were chosen for their special competences and with regard for appropri- ate balance. This study was supported by Contract No. SS-00-08-60149 between the National Academy of Sciences and the Social Security Administration. Any opinions, find- ings, conclusions, or recommendations expressed in this publication are those of the author(s) and do not necessarily reflect the view of the organizations or agencies that provided support for this project. International Standard Book Number-13: 978-0-309-15698-1 International Standard Book Number-10: 0-309-15698-X Additional copies of this report are available from The National Academies Press, 500 Fifth Street, N.W., Lockbox 285, Washington, DC 20055; (800) 624-6242 or (202) 334-3313 (in the Washington metropolitan area); Internet, http://www.nap. edu. For more information about the Institute of Medicine, visit the IOM home page at: www.iom.edu. Copyright 2010 by the National Academy of Sciences. All rights reserved. Printed in the United States of America The serpent has been a symbol of long life, healing, and knowledge among almost all cultures and religions since the beginning of recorded history. The serpent adopted as a logotype by the Institute of Medicine is a relief carving from ancient Greece, now held by the Staatliche Museen in Berlin. Suggested citation: IOM (Institute of Medicine). 2010. Cardiovascular disability: Updating the Social Security listings. Washington, DC: The National Academies Press.

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“Knowing is not enough; we must apply. Willing is not enough; we must do.” — Goethe Advising the Nation. Improving Health.

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The National Academy of Sciences is a private, nonprofit, self-perpetuating society of distinguished scholars engaged in scientific and engineering research, dedicated to the furtherance of science and technology and to their use for the general welfare. Upon the authority of the charter granted to it by the Congress in 1863, the Acad- emy has a mandate that requires it to advise the federal government on scientific and technical matters. Dr. Ralph J. Cicerone is president of the National Academy of Sciences. The National Academy of Engineering was established in 1964, under the charter of the National Academy of Sciences, as a parallel organization of outstanding en- gineers. It is autonomous in its administration and in the selection of its members, sharing with the National Academy of Sciences the responsibility for advising the federal government. The National Academy of Engineering also sponsors engineer- ing programs aimed at meeting national needs, encourages education and research, and recognizes the superior achievements of engineers. Dr. Charles M. Vest is presi- dent of the National Academy of Engineering. The Institute of Medicine was established in 1970 by the National Academy of Sciences to secure the services of eminent members of appropriate professions in the examination of policy matters pertaining to the health of the public. The Insti- tute acts under the responsibility given to the National Academy of Sciences by its congressional charter to be an adviser to the federal government and, upon its own initiative, to identify issues of medical care, research, and education. Dr. Harvey V. Fineberg is president of the Institute of Medicine. The National Research Council was organized by the National Academy of Sci- ences in 1916 to associate the broad community of science and technology with the Academy’s purposes of furthering knowledge and advising the federal government. Functioning in accordance with general policies determined by the Academy, the Council has become the principal operating agency of both the National Academy of Sciences and the National Academy of Engineering in providing services to the government, the public, and the scientific and engineering communities. The Council is administered jointly by both Academies and the Institute of Medicine. Dr. Ralph J. Cicerone and Dr. Charles M. Vest are chair and vice chair, respectively, of the National Research Council. www.national-academies.org

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COMMITTEE ON SOCIAL SECURITY CARDIOVASCULAR DISABILITY CRITERIA NANETTE K. WENGER (Chair), Emory University School of Medicine and Grady Memorial Hospital, Atlanta, Georgia WILLIAM E. BODEN, University at Buffalo Schools of Medicine and Public Health and Kaleida Health, New York BLASE A. CARABELLO, Michael E. DeBakey Veterans Affairs Medical Center, Houston, Texas ROBERT M. CARNEY, Washington University School of Medicine, St. Louis, Missouri MANUEL D. CERqUEIRA, Cleveland Clinic Lerner College of Medicine of Case Western Reserve University, Ohio MICHAEL H. CRIqUI, University of California, San Diego ANDREW E. EPSTEIN, University of Pennsylvania and Philadelphia Veterans Affairs Medical Center ERIKA S. FROELICHER, University of California, San Francisco GARY H. GIBBONS, Morehouse School of Medicine, Atlanta, Georgia MARK A. HLATKY, Stanford University, California ALICE K. JACOBS, Boston University School of Medicine and Boston Medical Center, Massachusetts KAREN S. KUEHL, George Washington University, Children’s National Medical Center, and Washington Hospital Center, Washington, DC TODD D. MILLER, Mayo Clinic, Rochester, Minnesota LYNNE W. STEVENSON, Harvard Medical School and Brigham and Women’s Hospital, Boston, Massachusetts Consultant HOWARD H. GOLDMAN, University of Maryland School of Medicine, Baltimore Study Staff FREDERICK (RICK) ERDTMANN, Director, Board on the Health of Select Populations MICHAEL McGEARY, Study Director SUSAN R. McCUTCHEN, Senior Program Associate ERIN E. WILHELM, Research Associate LAVITA D. COATES-FOGLE, Senior Program Assistant PAMELA RAMEY-McCRAY, Administrative Assistant SAMANTHA CHAO, Program Officer JOI WASHINGTON, Senior Program Assistant ANDREA COHEN, Financial Associate WILLIAM McLEOD, Senior Librarian v

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Reviewers This report has been reviewed in draft form by individuals chosen for their diverse perspectives and technical expertise, in accordance with procedures approved by the National Research Council’s Report Review Committee. The purpose of this independent review is to provide candid and critical comments that will assist the institution in making its published report as sound as possible and to ensure that the report meets institutional standards for objectivity, evidence, and responsiveness to the study charge. The review comments and draft manuscript remain confidential to protect the integrity of the deliberative process. We wish to thank the following individuals for their review of this report: James A. Blumenthal, Duke University Medical Center, Durham, North Carolina Robert O. Bonow, Northwestern University Feinberg School of Medicine and Northwestern Memorial Hospital, Chicago, Illinois Deborah Chyun, New York University David P. Faxon, Brigham and Women’s Hospital, Boston, Massachusetts Gary S. Francis, Cleveland Clinic and Case Western Reserve University, Minneapolis, Minnesota William L. Henrich, University of Texas Health Science at San Antonio William R. Hiatt, University of Colorado, Denver Stuart Rich, University of Chicago Medical Center, Illinois Roberta G. Williams, University of Southern California and Childrens Hospital, Los Angeles vii

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viii REVIEWERS Although the reviewers listed above have provided many constructive comments and suggestions, they were not asked to endorse the conclusions or recommendations nor did they see the final draft of the report before its release. The review of this report was overseen by Harlan M. Krumholz, Yale University, and Johanna T. Dwyer, Tufts University. Appointed by the National Research Council and Institute of Medicine, they were responsible for making certain that an independent examination of this report was carried out in accordance with institutional procedures and that all review comments were carefully considered. Responsibility for the final content of this report rests entirely with the authoring committee and the institution.

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Preface The Committee on Social Security Cardiovascular Disability Criteria, an ad hoc committee of medical experts appointed by the Institute of Medi- cine (IOM), was charged to conduct a study to assist the Social Security Administration (SSA) with revising its criteria for cardiovascular disability in its Listing of Impairments (“the Listings”). The committee reviewed the current cardiovascular disability criteria in the Listings and identified areas in which the committee believed the cardiovascular listings should be revised and updated based on current medical knowledge and practice. Specifically, the committee (1) conducted a comprehensive review of the relevant research literature and current professional practice guidelines de- veloped jointly by the American Heart Association and the American Col- lege of Cardiology; (2) assessed the current cardiovascular listings in light of current research knowledge and evidence-based medical practice; and (3) produced a concise report with specific recommendations for revision of the cardiovascular listings based on evidence (to the extent possible) and on professional judgment (where evidence was lacking). SSA uses the Listings to expedite the approval of claims from individuals who are so obviously disabled that they have a high probability of being found disabled if SSA went through the full disability determination process. The primary pur- pose of the consensus committee was to make concrete recommendations designed to improve the utility of the cardiovascular listings for evaluating disability claims by improving the sensitivity and specificity of the listing criteria to identify individuals who meet SSA’s definition of disability, that is, those who are no longer able to engage in substantial work activities. ix

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x PREfaCE The contemporary approach to patient-centered care is designed to achieve optimal outcomes, including disease outcomes. This is the approach that the committee extended to tailor a process for disability evaluation that would ensure optimal outcomes. The committee is grateful for the contributions of many individuals who expanded our knowledge and understanding of cardiovascular disabil- ity and suggested improvements in the disability evaluation process. They are listed in the Acknowledgments section of this report. The committee acknowledges with deepest appreciation the expert support and collegial relationship of the IOM staff. They are Michael McGeary (study director), Susan McCutchen (senior program associate), Erin Wilhelm (research asso- ciate), LaVita Coates-Fogle (senior program assistant), and Frederick (Rick) Erdtmann (director, Board on the Health of Select Populations). The cardiovascular community has a tradition of evidence-based clini- cal practice guidelines that address a number of cardiovascular disease states. These guidelines are updated periodically to reflect current knowl- edge. A specific and uniform grading system identifies the level of evidence and the robustness of the database supporting this evidence. However, a review of the currently applicable clinical practice guidelines, although with abundant recommendations for diagnostic and prognostic testing, clinical management, and resultant outcomes, clearly shows (as viewed by the committee) an unmet need for a research base for the evaluation of cardiovascular disability. The approach of the committee is its unique contribution. Careful re- view of the scientific literature from both primary and secondary sources was undertaken to identify tests or procedures that would quantify functional capacity and, furthermore, be generally available either in the claimants’ medical records or for purchase in the assessment of potential claimants. With this in mind, we sought to apply the best available knowledge and to recommend new practices and perspectives to ensure the optimal outcomes for disability claimants who meet SSA’s definition of disability. Highlighted in the committee deliberations was that a large number of recently available cardiovascular test procedures precisely delineate anat- omy or pathoanatomy, but that there is no consistent relationship between anatomy and functional capacity. The committee therefore concluded that the tests delineating anatomy should be used to define the presence and severity of disease, but that the disability process usually requires addi- tional information on the functional limitations imposed by the disease. The committee recommended revisions in most of the current listings and suggested new listings for certain cardiovascular problems, including hyper- trophic cardiomyopathy, right heart failure, and pulmonary hypertension. We developed flowcharts for decision making for most of the cardiovascu- lar listings to assist the adjudicator in the definition of disease and levels

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xi PREfaCE of functional limitations required to meet those listings. We also reviewed important comorbidities that the adjudicator should consider in assessing whether a claimant’s cardiovascular condition equals a listing. Finally, we delineated four areas of research that SSA could pursue to improve the dis- ability decision process, including the listings. The committee first met in December 2009, with three subsequent for- mal sessions in February, April, and June 2010 (and numerous conference calls), during which we categorized and evaluated cardiovascular medically determinable physical and mental impairments that could be expected to result in death or that have lasted or can be expected to last for a continu- ous period of not less than 12 months. I would like to express my personal gratitude for the skills and dedica- tion of the individual committee members and for their expertise, enthu- siasm, and energy. On behalf of the committee, I would also like to thank Howard Goldman, who chairs IOM’s standing committee of medical ex- perts to assist SSA, for his participation and advice. The intellectual content is evidence based and objective. The conclu- sions were reached by consensus and are the combined judgment of the committee. Our emphasis in this report is on consistency, quality, and appropriateness criteria. Future covariables that should influence disability determination and guide its research agenda include the impact of changes in the national and regional economy, changes in health insurance and access to health care and disease evaluation, and the expansion of the evidence base en- abled by open government, among others. All are likely to alter cardio- vascular disease outcomes and inform consequent cardiovascular disability determinations. Nanette K. Wenger Chair, Committee on Social Security Cardiovascular Disability Criteria

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xvi ContEntS 4 APPROACHES TO REVISING THE CARDIOVASCULAR 63 LISTINGS Issues in Revising the Listings, 63 Summary, 73 References, 74 5 HEART FAILURE, CARDIOMYOPATHY, AND RIGHT 77 HEART FAILURE Description, 77 Epidemiology, 78 Types of Heart Failure, 79 Diagnosis of Heart Failure, 81 Treatment, 82 Disability, 83 Conclusions and Recommendations, 88 References, 95 6 HEART TRANSPLANTATION 97 Description, 97 Epidemiology, 98 Conclusions and Recommendations, 98 References, 99 7 ISCHEMIC HEART DISEASE 101 Description, 102 Epidemiology, 104 Diagnostic Criteria and Methods, 104 Treatment, 109 Disability, 112 Current Listing, 117 Concluding Concepts, 117 Final Conclusions and Recommendations, 120 References, 124 8 PERIPHERAL ARTERY DISEASE 133 Description, 133 Epidemiology, 134 Diagnostic Criteria and Methods, 135 Treatment, 139 Disability, 141 Current Listing, 143 Conclusions and Recommendations, 145 References, 152

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xvii ContEntS 9 CHRONIC VENOUS INSUFFICIENCY 157 Description, 157 Epidemiology, 158 Diagnostic Criteria and Methods, 158 Treatment, 159 Disability, 159 Current Listing, 160 Conclusions and Recommendation, 160 References, 162 10 CONGENITAL HEART DISEASE 165 Description, 165 Epidemiology, 166 Diagnostic Criteria and Methods, 167 Consideration of Noncardiac Congenital Anomalies, 167 Treatment, 167 Disability, 168 Current Listings, 170 Conclusions and Recommendations, 172 References, 179 11 PULMONARY HYPERTENSION 183 Description, 183 Epidemiology, 184 Diagnostic Criteria and Methods, 184 Treatment, 185 Disability, 186 Current Listing, 186 Conclusions and Recommendation, 187 References, 189 12 VALVULAR HEART DISEASE 191 Description, 191 Diagnostic Criteria and Methods, 192 Treatment, 194 Disability, 194 Conclusions and Recommendations, 195 Reference, 197 13 ARRHYTHMIAS 199 Description, 199 Epidemiology, 201 Diagnostic Criteria and Methods, 202

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xviii ContEntS Treatment, 202 Disability, 203 Conclusions and Recommendation, 205 References, 205 14 ANEURYSM OR DISSECTION OF THE AORTA AND 209 PERIPHERAL ARTERIES Description, 209 Epidemiology, Natural History, and Types of Aortic Aneurysms, 210 Diagnostic Criteria and Methods, 213 Treatment, 213 Disability, 214 Conclusions and Recommendations, 214 References, 217 15 COMORBIDITIES 219 Extent of Comorbidities, 219 Evaluating Comorbidities at the Listings Step, 225 Conclusion, 226 References, 227 16 FUTURE DIRECTIONS FOR IMPROVING THE LISTINGS 231 Policy Issues, 231 Programmatic Issues, 231 Correlation of Impairments and Functional Limitations, 233 True Prevalence of and Trends in Impairments That Meet the Social Security Definition of Disability or Meet the Listings, 233 Conclusions and Recommendation, 233 References, 234 APPENDIXES A Biographical Sketches of Committee Members and Staff 235 B Literature Review 247 C Review of ACC/AHA Clinical Practice Guidelines 269

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Tables, Figures, and Boxes TABLES O-1 Current Adult and Child Cardiovascular Listings, 10 2-1 Numbers of Disability Program Beneficiaries and Benefit Amounts, 2008, 43 6-1 Survival Rates After Heart Transplantation, by Sex, 98 7-1 Canadian Cardiovascular Society Functional Classification of Angina, 103 7-2 Other Variables Associated with Multivessel CHD or Worse Prognosis, 106 7-3 Criteria to Meet a Listing Through the Use of an Exercise Stress Test, 108 7-4 Optimal Pharmacologic Therapy Based on the COURAGE Trial, 121 9-1 Clinical Classification of Chronic Venous Disease (CVD), 159 12-1 Characterization of Severe Valve Disease, 193 14-1 Normal Adult Thoracic Aortic Diameters, 215 B-1 Literature Table of Cardiovascular Employment and Disability Articles, 250 FIGURES O-1 Five-step sequential evaluation process for adults, 8 2-1 Five-step sequential evaluation process for adults, 41 2-2 Disability evaluation process for Supplemental Security Income children, 45 xix

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xx tablES, fIgURES, and boxES 3-1 Annual number of initial adult cardiovascular claims, 1990–2008, 56 3-2 Annual allowance rate for initial adult cardiovascular claims, 1990–2008, 57 3-3 Annual percentage of initial adult allowances made on the basis of the cardiovascular listings, 1990–2008, 58 3-4 Annual number of initial adult allowances based on the cardiovascular listings, 1999–2009, 59 3-5 Percentage of adult initial allowances based on the cardiovascular listings, by selected impairment code, 1989–2008, 60 5-1 Recommended listing-level criteria for systolic and diastolic heart failure, 89 5-2 Recommended listing-level criteria for hypertrophic cardiomyopathy, 91 5-3 Recommended listing-level criteria for right heart failure, 92 7-1 Coronary heart disease listings, 122 7-2 Coronary heart disease listings: Ischemic heart disease ladder flow diagram, 123 10-1 Documentation of congenital heart defect likely to require surgery, diagnosis of significant heart disease in infancy or childhood, 171 10-2 Documentation of congenital heart defect likely to require surgery, disabled by Groups A and B, birth to age 12, 171 10-3 Documentation of congenital heart defect, disabled by Group C, ages 12 to 18, 172 10-4 Documentation of congenital heart defect disabled as adults, ages 18 and over, 173 11-1 Meeting criteria for disability due to pulmonary hypertension, 187 12-1 Determining listing-level disability for claimants with valvular heart disease, 192 BOXES 1-1 Cardiovascular Committee’s Statement of Work, 37 4-1 Committee’s Approach to Revising the Listings, 65 5-1 Current Listing for Chronic Heart Failure, 86 6-1 Current Listing for Heart Transplant, 98 7-1 Current Adult Listing for Ischemic Heart Disease, 118 7-2 Current Childhood Listing for Ischemic Heart Disease, 119 8-1 Current Listing for Peripheral Arterial Disease, 144 8-2 1.00 Musculoskeletal System, 150 9-1 Current Listing for Chronic Venous Insufficiency, 160

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xxi tablES, fIgURES, and boxES 10-1 Current Congenital Heart Disease Listing for Children, 174 10-2 Current Congenital Heart Disease Listing for Adults, 175 13-1 Current Listing for Recurrent Arrhythmias, 204 14-1 Current Listing for Aneurysm of Aorta or Major Branches, 215 B-1 Definition of Tiers, 249 C-1 American College of Cardiology/American Heart Association (ACC/AHA Guidelines), 271

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Abbreviations and Acronyms AAA abdominal aortic aneurysm ABI ankle-brachial index ACC American College of Cardiology ACE angiotensin-converting enzyme ACS acute coronary syndrome ADLs activities of daily living AHA American Heart Association ALJ administrative law judge AR aortic regurgitation AVNRT atrioventricular nodal reentrant tachycardia AVRT atrioventricular reentrant tachycardia BMI body mass index BMS bare metal stents BNP brain natriuretic peptide BP blood pressure BRFSS Behavioral Risk Factor Surveillance System CABG coronary artery bypass graft CAD coronary artery disease CCB calcium channel blocker CCS Canadian Cardiovascular Society CDC Centers for Disease Control and Prevention CDR continuing disability review CE consultative examination xxiii

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xxiv abbREVIatIonS and aCRonymS CHD chronic heart disease cm centimeter COPD chronic obstructive pulmonary disease CPX cardiopulmonary exercise CT computed tomography CTA computed tomography angiography CVD cardiovascular disease; chronic venous disease CVI chronic venous insufficiency CXR chest x-ray DDS disability determination services DES drug-eluting stent DM diabetes mellitus Dx diagnosis ECG electrocardiogram EECP enhanced external counterpulsation EF ejection fraction ESV end systolic volume ETT exercise tolerance test EVAR endovascular aneurysm repair FDA Food and Drug Administration HDL high-density lipoprotein cholesterol HF heart failure HFpEF heart failure with preserved ejection fraction IADLs instrumental activities of daily living ICD implantable cardioverter-defibrillator ICD International Classification of Diseases IHD ischemic heart disease IOM Institute of Medicine kg kilogram LA left atrial/atrium LDL low-density lipoprotein cholesterol LED lower extremity disease LV left ventricle LVDD left ventricular diastolic dysfunction LVEF left ventricular ejection fraction LVOT left ventricular outflow tract

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xxv abbREVIatIonS and aCRonymS m meter MER medical evidence of record MESA Multi-Ethnic Study of Atherosclerosis METs metabolic equivalents of task MI myocardial infarction MIE medical improvement expected min minute MINE medical improvement not expected MIP medical improvement possible ml milliliter mm millimeter mm Hg millimeters of mercury mph miles per hour MR mitral regurgitation MRA magnetic resonance angiography MRI magnetic resonance imaging NHANES National Health and Nutrition Examination Survey NHLBI National Heart, Lung, and Blood Institute NPRM Notice of Proposed Rulemaking NRC National Research Council NT-proBNP N-terminal prohormone brain natriuretic peptide O2 oxygen PAD peripheral artery disease PCI percutaneous coronary intervention PET positron emission tomography PO2 partial pressure of oxygen POMS Program Operations Manual System proBNP prohormone brain natriuretic peptide PVC premature ventricular contraction PVD peripheral vascular disease RER respiratory exchange ratio RFC residual functional capacity SD standard deviation sec second SGA substantial gainful activity SIP Sickness Impact Profile SPECT single-photon emission computerized tomography SRS summed reversibility score

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xxvi abbREVIatIonS and aCRonymS SSA Social Security Administration SSDI Social Security Disability Insurance SSI Supplemental Security Income SSS summed stress score TA thoracic aorta TBI toe-brachial index TG triglycerides TID transient ischemic dilatation Torr Torricelli U.S. United States VHD valvular heart disease VO2 oxygen consumption WHO World Health Organization WMA wall motion abnormality WMI wall motion index