NATIONAL HEART, LUNG AND BLOOD INSTITUTE NATIONAL INSTITUTES OF HEALTH SPECIAL EMPHASIS PANEL ON THE STANDARDIZED ASSESSMENT OF HEART FAILURE IN POPULATION STUDIES Minutes of Meeting May 7, 1997 A Special Emphasis Panel (SEP) on the Standardized Assessment of Heart Failure in Population Studies was convened by the National Heart, Lung, and Blood Institute (NHLBI) on May 7, 1997 at the Bethesda Marriott in Bethesda, Maryland. The purpose of the meeting was to develop a uniform definition of heart failure for use in epidemiologic studies. In accordance with Public Law 92-463, the meeting had been announced in the Federal Register and was open to the public. PANEL MEMBERS present: Dr. Russell Luepker, Chairperson; Dr. Emelia Benjamin; Dr. George Mensah; Dr. John O'Connell; Dr. Marc Pfeffer; and Dr. Bruce Psaty. NHLBI STAFF present: Dr. Robin Boineau, Executive Secretary; Dr. Lawton Cooper; Dr. Darrell Ellsworth; Dr. Richard Fabsitz; Dr. Sara Knox; Dr. Riitta Luotto; Dr. Teri Manolio; Mr. Chuke Nwachuku; Mr. Leslie Reinleib; Dr. Yves Rosenberg; Dr. Carolyn Voorhees; and Mr. Michael Wolz. OTHER INDIVIDUALS present: Dr. Jeff Probstfield; Dr. Michael Klibaner; Dr. David Haack; Ms. Beryl Carew; Ms. Carla Maffeo; and Dr. Brenda Lewis. OPEN MEETING I. Call to Order and Opening Remarks: Dr. Boineau welcomed the attendees and called the meeting to order. The purpose of the meeting was to develop a definition for congestive heart failure for use in epidemiologic studies. II. Review of Conflict of Interest Procedures: Dr. Manolio reviewed the policies and procedures regarding avoidance of conflict of interest situations. III. Other Agenda Items and Recommendations Developed by the Panel: The Panel reviewed: Current NHLBI cohort study definitions, Framingham criteria for CHF; selection of a definition of CHF; clinical heart failure trials; difficulties in assessment of CHF when relying on medical records (including review of International Classification of Disease Coding and questionnaire reproducibility); signs and symptoms of heart failure; noninvasive and invasive supporting tests; criteria for prevalent and incident CHF; telephone, interviewer or self-administered questionnaires ; physical exam findings; medical record abstraction; and future directions. Recommendations: Data to be collected: (1) Physical exams and interviews should continue to be used to obtain congestive heart failure (CHF) signs and symptoms of heart failure, since it is important to have an assessment of an individual's functional limitations which may vary greatly between persons with similar measures of cardiac function such as EF. (2) Data should be collected on both systolic and diastolic heart failure. (3) Electrocardiograms should be obtained. (4) Complete two dimensional, M-mode and Doppler echocardiography should be obtained. (5) Radionuclide ventriculography (RNV) does not appear feasible for population studies due to its associated invasiveness, radiation exposure, and participant and equipment burden, but RNV data in medical records should be recorded if available. (6) Medications used by the participants should be recorded. (7) A chest radiogram (CXR) would be useful for exclusion of lung processes as etiologies of signs and symptoms which may otherwise be attributed to CHF. As with RNV above, CXR data from medical records should be collected, but routine CXR probably is not feasible in population studies. Definition of Heart Failure: (8) Data necessary for the Framingham criteria should be collected in all studies, as this is considered to be the most comprehensive and accurate assessment currently available. (9) Evidence of active treatment for heart failure should be considered in defining CHF, to prevent inclusion of individuals incorrectly labeled as having CHF for the benefit of improving DRG reimbursements. (10) A physician review should be required for a diagnosis of heart failure when using medical record review to determine presence of heart failure. (11) Signs and symptoms must be present to diagnosis CHF, it is not a laboratory diagnosis. Future research: (12) A set number of cases of possible CHF should be adjudicated by the events committees for the Atherosclerosis and Risk in Communities (ARIC) Study, the Strong Heart Study, FHS and CHS for comparison across studies of the various protocols currently in use. (13) A variety of questions on self-report of CHF should be verified in one of the ongoing cohort studies. (14) Published data discussing heart failure should include the specific definition used for congestive heart failure and the results should list CHF disease rates by age, race and gender. (15) Circulating markers for CHF should be investigated, such as pro-atrial natriuretic peptide (pro-ANP) or brain natriuretic peptide (BNP) as a screening tool and as a method for identifying asymptomatic individuals with CHF. (16) Currently the Framingham criteria include these symptoms: paroxysmal nocturnal dyspnea, orthopnea, dyspnea on ordinary exertion, dyspnea at rest and night cough. Consideration should be given to developing questions on fatigue which might be sensitive to early CHF. (17) A questionnaire directed at functional assessment should be considered, including how the subject has modified their lifestyle. (i.e. Are there activities which the subject is no longer doing due to shortness of breath?) These questions should be sensitive (at the cost of specificity) to ensure early changes can be detected. (18) Better congestive heart failure trend analysis should be developed. Because of their wide availability, major (428.0- 428.9, Congestive Heart Failure and 425.0- 425.9, Cardiomyopathies) and minor (more than ten possible ) International Classification of Disease (ICD) codes should be included as part of this analysis. The only way to eliminate bias induced by shifting Diagnostic Related Groups or other coding practices is to use consistent definitions over time, relying on event adjudication for difficult cases. ADJOURNMENT The meeting was adjourned at 4:00 pm on May 7, 1997. CERTIFICATION I hereby certify that, to the best of my knowledge, the foregoing minutes are accurate and complete. Russell V. Luepker, M.D. Date Chair Standardized Assessment of Heart Failure in Population Studies Robin Boineau, M.D. Date Executive Secretary Standardized Assessment of Heart Failure in Population Studies Attachment: Panel Roster National Heart, Lung, and Blood Institute Special Emphasis Panel on Standardized Assessment of Heart Failure in Population Studies May 7, 1997 - Roster Emelia Benjamin, M.D., Sc.M. Director of Echocardiography Lab Framingham Heart Study 5 Thurber Street Framingham, MA 01701 CHAIR Russell V. Luepker, M.D. Professor and Head Division of Epidemiology School of Public Health University of Minnesota 1300 South Second Street, Suite 300 Minneapolis, MN 55454-1015 George Mensah, M.D., F.A.C.P., F.A.C.C. Associate Professor of Medicine Section of Cardiology Medical College of Georgia 1120 15th Street Augusta, GA 30912-3105 John O'Connell, M.D. Professor and Chairman Department of Internal Medicine Wayne State University Physician in Chief, Detroit Medical Center Harper Hospital 3990 John R., 1 WS Detroit, MI 48201 Marc Pfeffer, M.D., Ph.D. Associate Professor of Medicine Harvard Medical School Director of the Heart Failure/Transplant Center Physician, Cardiovascular Division Brigham & Women's Hospital 75 Francis Street Boston, MA 02115 Bruce Psaty, M.D., Ph.D., M.P.H. Co-Director, Cardiovascular Health Research Unit Professor University of Washington Metropolitan Park, East Tower 1730 Minor Avenue, Suite 1360 Seattle, WA 98101 EXECUTIVE SECRETARY Robin Boineau, M.D. Medical Officer (Cardiology) Epidemiology and Biometry Program Division of Epidemiology and Clinical Applications National Heart, Lung, and Blood Institute II Rockledge Center, MSC 7934 6701 Rockledge Drive, Room 8158 Bethesda, MD 20892-7934 CONGESTIVE HEART FAILURE Date of Review __/__/__ Data entry date __/__/__ NAME______________________________ ID__-______ EXAM_____ DATE___/___/_____ CLINICAL CRITERIA FOR CHF MAJOR CRITERIA MINOR CRITERIA PND - paroxysmal nocturnal dyspnea, or 0 1 9 Dyspnea on ordinary exertion 0 1 9 Orthopnea (either or both = 1 major) 0 1 9 Night cough 0 1 9 Distended neck veins (not supine) 0 1 9 Tachycardia (120+) 0 1 9 Hepatojugular reflux 0 1 9 Hepatomegaly 0 1 9 Rales 0 1 9 Bilateral ankle edema 0 1 9 S3 gallop 0 1 9 Decrease in vital capacity by 1/3 0 1 9 Enlarging heart by X-ray 0 1 9 Pleural effusion by X-ray 0 1 9 Acute pulmonary edema on CXR 0 1 9 Pulmonary vascular engorgement on CXR 0 1 9 Weight loss on CHF Rx: 10 lbs./5days 0 1 9 0=no 1=yes 9=unknown or not done Increased venous pressure >16 cm H2O 0 1 9 Pulmonary edema, visceral congestion, cardiomegaly on autopsy 0 1 9 CHF INITIAL CLINICAL REVIEW SUMMARY SOE 40 CHF not hospitalized (NH) 40 & 41: CHF = (1 major plus 2 minor; or 2 major criteria) 42 & 43: MAYBE CHF includes categories 1 & 2 below (which were previously noted by the registrar, but were not coded on the sequence of events) and a new category, 3, partial criteria for CHF (which was coded no CHF before) 1 = PROBABLE CHF: strongly suspect CHF, but insufficient information to meet criteria 2 = QUESTION CHF: criteria for CHF are met but reviewers suspect a noncardiac etiology to symptoms (specify____________________) 3 = PARTIAL CRITERIA CHF: some criteria for CHF (1 major + 1 minor; or 2 minors) but not enough criteria for definite CHF SOE 41 CHF hospitalized (H) SOE 42 1 2 3 9 Maybe CHF NH (circle category) SOE 43 1 2 3 9 Maybe CHF H (circle category) CHF LABORATORY TESTS LVEF CI (CI = CO/BSA)  Filling Pressure (FP) Valvular Disease LVH (not by ECG only) TEST Echo/GBPS/LV gram Swan/right cath PCWP/PAd/LVEDP Echo / Cath Echo / MRI/ autopsy MAJOR ó 35%/severe < 2.0 ò 20 Severe Severe (>15 mm.) MINOR 36-45%/mild-mod. 2.0-2.3 16-19 Moderate Mild-mod. (12-15mm) NORMAL ò 55% ò 2.5 ó 12 ó trace valvular dis. Normal FINDING DATE (mo/day/yr) (1/1/40=unknown) CRITERIA 0=normal; 1=major; 2=minor; 3=borderline; 9=unknown Reduced LVEF ____/____/________ 0 1 2 3 9 Decreased CI ____/____/________ 0 1 2 3 9  Filling Pressure (FP) ____/____/________ 0 1 2 3 9 Valvular Heart Disease ____/____/_________ AI 0 1 2 3 9 AS 0 1 2 3 9 MR 0 1 2 3 9 MS 0 1 2 3 9 other 0 1 2 3 9 (specify)__________________________________ Diastolic CHF/LVH ____/____/________ 0 1 2 3 9 0=nl; 1=maj.; 2=min.; 3=borderline; 9=unk Other evidence of CHF ____/____/________ 0 1 2 9 0=no; 1=yes; 2=maybe; 9=unknown Specify: CHF CODING GUIDELINES, FINAL DIAGNOSTIC IMPRESSIONS SOE 44-45 & other=2 or 3, some criteria MUST come from the lab and some from the clinical section 1 major plus 2 minor; or 2 majors DEFINITE CHF = SOE 44 1 major plus 1 minor; or 2 minors MAYBE CHF = SOE 45 test performed at inappropriate time; the test wasn't normal but didn't meet minor criteria; &/or nondiagnostic lab, suspect diastolic CHF LAB DATA NONCONTRIBUTORY = OTHER 2 appropriate lab tests performed, at appropriate time, no lab evidence of CHF NO CHF= OTHER 3 CHF FINAL DIAGNOSTIC (CLINICAL & LAB) REVIEW SUMMARY (code only one) SOE 44 Final impression (clinical + lab) DEFINITE CHF SOE 45 Final impression (clinical + lab) MAYBE CHF OTHER CHF 1 CHF laboratory tests not performed OTHER CHF 2 Final clinical impression unchanged; lab noncontributory OTHER CHF 3 Final impression (clinical + lab) NO CHF If coding guidelines are overridden by clinical judgement, please note why ____________________________________________ SOE REVIEW FHS 6-5-95 .