ࡱ> 36./012 }bjbj xx";T& & iiiiid}|t3xm<wwwwwww{e~`wQiwii`wiirw2CFr{D.rx03xD&A\FFiK'ww3x& /: Online Appendix for the following JACC article TITLE: Incremental Prognostic Significance of Peripheral Endothelial Dysfunction in Patients With Heart Failure With Normal Left Ventricular Ejection Fraction AUTHORS: Eiichi Akiyama, MD, Seigo Sugiyama, MD, PhD, Yasushi Matsuzawa, MD, Masaaki Konishi, MD, PhD, Hiroyuki Suzuki, MD, Toshimitsu Nozaki, MD, PhD, Keisuke Ohba, MD, Junichi Matsubara, MD, PhD, Hirofumi Maeda, MD, Yoko Horibata, MD, Kenji Sakamoto, MD, PhD, Koichi Sugamura, MD, PhD, Megumi Yamamuro, MD, PhD, Hitoshi Sumida, MD, PhD, Koichi Kaikita, MD, PhD, Satomi Iwashita, MT, Kunihiko Matsui, MD, MPH, Kazuo Kimura, MD, PhD, Satoshi Umemura, MD, PhD, Hisao Ogawa, MD, PhD Contents Online Methods Online References Online Table Online Figure Legends Online Figure Online Methods Diagnosis of HF We applied the following diagnostic criteria of the European Working Group to HFNEF  ADDIN EN.CITE  ADDIN EN.CITE.DATA (1): (i) signs or symptoms of HF, (ii) normal or mildly abnormal systolic LV function (LVEF>50% and LV end-diastolic volume index<97mL/m2), and (iii) evidence of LVDD. In this study, we defined LVDD as (i) the ratio of early transmitral flow velocity to tissue Doppler early diastolic mitral annular (medial) velocity (E/e )e"15 or (ii) 8<E/e <15 and B-type natriuretic peptide (BNP)>200 pg/ml. Signs or symptoms of HF include rales, pulmonary edema, leg edema, hepatomegaly, dyspnea on exertion, fatigue, and impaired exercise capacity as assessed by exercise tests. RH-PAT measurement As described previously ADDIN EN.CITE Matsuzawa201012401240124017Matsuzawa, Y.Sugiyama, S.Sugamura, K.Nozaki, T.Ohba, K.Konishi, M.Matsubara, J.Sumida, H.Kaikita, K.Kojima, S.Nagayoshi, Y.Yamamuro, M.Izumiya, Y.Iwashita, S.Matsui, K.Jinnouchi, H.Kimura, K.Umemura, S.Ogawa, H.Department of Cardiovascular Medicine, Faculty of Life Sciences, Kumamoto University, Kumamoto, Japan.Digital assessment of endothelial function and ischemic heart disease in womenJ Am Coll CardiolJ Am Coll Cardiol1688-9655162010/04/172010Apr 201558-3597 (Electronic) 0735-1097 (Linking)20394872S0735-1097(10)00594-2 [pii] 10.1016/j.jacc.2009.10.073 [doi]Nlmeng(2), a blood pressure cuff was placed on the study arm, while the opposite arm served as a control. After a 10 minute acclimatization period in a temperature and light-controlled room, baseline pulse amplitude was measured from each fingertip for 5 minutes. The blood pressure cuff was inflated to 60 mmHg plus systolic blood pressure or 200 mmHg for 5 minutes. After cuff deflation, PAT recording was continued for 10 minutes. The RH-PAT data were automatically analyzed in real-time in an operator-independent manner (Endo-PAT2000 software, version 3.0.4). Repeatability of RH-PAT measurement Repeatability of RH-PAT measurement was assessed in 31 patients on two different days during run-in phase in the present study. These data were analyzed according to the method by Bland and Altman (Online Figure-1)  ADDIN EN.CITE  ADDIN EN.CITE.DATA (3,4). Biochemical measurements To measure biochemical parameters, blood samples were obtained in the early morning following an overnight fast. BNP was measured using a commercially available assay (Abbott Japan Co., Matsudo, Japan). Renal function was determined from the estimated glomerular filtration rate (eGFR, mL/min/1.73m2), which was calculated using the equation recommended by the Japanese Society of Nephrology  ADDIN EN.CITE  ADDIN EN.CITE.DATA (5). Echocardiography Two-dimensional transthoracic echocardiography with standard M-mode, color Doppler imaging, pulsed-wave Doppler examination of mitral inflow, and tissue Doppler imaging of medial mitral annulus were performed in stable condition after medical therapy for HF by experienced, blinded sonographers according to the current guidelines  ADDIN EN.CITE  ADDIN EN.CITE.DATA (6) and interpreted by blinded cardiologists. We used commercially available ultrasound systems (Vivid 7 (GE-Vingmed Ultrasound, Horton, Norway) and Aplio XG (Toshiba, Tokyo, Japan)). LVEF was measured by the biplane modified Simpson method. For the assessment of LV diastolic function, the E/e ratio (septal) was calculated as described previously  ADDIN EN.CITE Nagueh200912001200120017Nagueh, S. F.Appleton, C. P.Gillebert, T. C.Marino, P. N.Oh, J. K.Smiseth, O. A.Waggoner, A. D.Flachskampf, F. A.Pellikka, P. A.Evangelisa, A.Methodist DeBakey Heart and Vascular Center, Houston, TX, USA.Recommendations for the evaluation of left ventricular diastolic function by echocardiographyEur J EchocardiogrEur J Echocardiogr165-931022009/03/102009Mar1532-2114 (Electronic) 1532-2114 (Linking)19270053jep007 [pii] 10.1093/ejechocard/jep007 [doi]Nlmeng(7). The E/e ratio has been shown to correlate with LV filling pressures and abnormal LV relaxation in patients with preserved LVEF  ADDIN EN.CITE  ADDIN EN.CITE.DATA (8,9). LV end-diastolic volume, left atrial diameter and LV mass were measured as reported previously  ADDIN EN.CITE  ADDIN EN.CITE.DATA (6). LV mass was expressed relative to body surface area (LV mass index). The definition of cardiovascular events A diagnosis of myocardial infarction was made by the detection of rise or fall of cardiac biomarkers (plasma creatine kinase-MB or cardiac troponin-T) above the 99th percentile of the upper limit of normal together with evidence of myocardial ischemia with at least one of the following, symptom, ECG changes (new ST-T changes, left bundle branch block, or pathological Q wave) or imaging evidence of new loss of viable myocardium or new regional wall motion abnormality  ADDIN EN.CITE  ADDIN EN.CITE.DATA (10). A diagnosis of unstable angina pectoris was made by new or accelerating symptoms of myocardial ischemia accompanied by new ischemic ST-T-wave changes. A diagnosis of ischemic stroke was based on both of neurological symptoms and radiological evidence excluding intracranial hemorrhage. A diagnosis of hospitalization for HF decompensation was made if the patient was admitted with symptoms typical of HF and had objective signs of worsening HF requiring intravenous drug administration. Statistical analysis The distribution of the continuous variables was tested for normality by the Kolmogorov-Smirnov test. Statistical analysis was performed using the unpaired t-test or Mann-Whitney test for continuous variables and the chi-square test for categorical variables. Logistic regression analysis was used to evaluate the association between the presence of HFNEF and clinical variables, including RHI. Variables not normally distributed were log transformed before regression analysis. Associations between groups and all other parameters were first analyzed by univariate logistic regression followed by stepwise backward multivariate logistic regression (P <0.10 for stay), and Hosmer-Lemeshow goodness-of-fit was calculated. We also used multivariate logistic regression analyses for the presence of HFNEF in the forced inclusion models. Survival data were analyzed by the Kaplan-Meier method and assessed with the log-rank test. The predictive value for cardiovascular events was assessed by Cox proportional hazards regression analysis. Associations between groups and all other parameters were first analyzed by univariate analysis followed by stepwise backward multivariate analysis (P<0.10 for stay). We also prepared five forced inclusion multivariate models to determine the significance of RHI for the prediction of the future cardiovascular events; Model-1: age, DM, NYHA class, HF hospitalization, LVEF, RHI as clinically important variables in patients with HFNEF Although age and DM were clinically important variables, age and DM were not significant factors for cardiovascular events in the present study. Thus, we excluded age and DM from the following analyses. We prepared the following combination of significant factors in the univariate Cox analysis to avoid the over-fit problem with limited outcomes (59 events) in the present study. Model-2: NYHA class, HF hospitalization, BNP, E/e, RHI Model-3: NYHA class, HF hospitalization, AF, BNP, E/e, RHI Model-4: NYHA class, HF hospitalization, HR, BNP, E/e, RHI Model-5: NYHA class, HF hospitalization, LVEF, BNP, E/e, RHI The incremental effect of adding RHI to the PF5 for predicting future cardiovascular events was also evaluated with using the net classification index (NRI) as previously described  ADDIN EN.CITE  ADDIN EN.CITE.DATA (11,12). First, we stratified patients into one of 3 risk categories on the basis of PF5 during follow-up period, 20 months: low risk (0 to <10%), intermediate risk (10 to 20%), or high risk (>20%). Then, we used RHI to reclassify the risk category ascertaining whether there would be improvement in the NRI. The NRI was calculated by following equation: NRI= ([number of events reclassified higher - number of events reclassified lower] / number of events) - ([number of non-events reclassified lower - number of non-events reclassified higher] / number of non-events). The analyses were performed with PASW Statistics 18 (SPSS Japan Inc., an IBM company, Tokyo, Japan), STATA version 11 (Stata Corporation, College Station, Texas), and SAS version 9.1.3 (SAS Institute Inc., Cary, North Carolina). Online References  ADDIN EN.REFLIST 1. Paulus WJ, Tschope C, Sanderson JE, et al. How to diagnose diastolic heart failure: a consensus statement on the diagnosis of heart failure with normal left ventricular ejection fraction by the Heart Failure and Echocardiography Associations of the European Society of Cardiology. Eur Heart J 2007;28:2539-50. 2. Matsuzawa Y, Sugiyama S, Sugamura K, et al. Digital assessment of endothelial function and ischemic heart disease in women. J Am Coll Cardiol 2010;55:1688-96. 3. Bland JM, Altman DG. Statistical methods for assessing agreement between two methods of clinical measurement. Lancet 1986;1:307-10. 4. Bonetti PO, Barsness GW, Keelan PC, et al. Enhanced external counterpulsation improves endothelial function in patients with symptomatic coronary artery disease. J Am Coll Cardiol 2003;41:1761-8. 5. Matsuo S, Imai E, Horio M, et al. Revised equations for estimated GFR from serum creatinine in Japan. Am J Kidney Dis 2009;53:982-92. 6. Lang RM, Bierig M, Devereux RB, et al. Recommendations for chamber quantification: a report from the American Society of Echocardiography's Guidelines and Standards Committee and the Chamber Quantification Writing Group, developed in conjunction with the European Association of Echocardiography, a branch of the European Society of Cardiology. J Am Soc Echocardiogr 2005;18:1440-63. 7. Nagueh SF, Appleton CP, Gillebert TC, et al. Recommendations for the evaluation of left ventricular diastolic function by echocardiography. Eur J Echocardiogr 2009;10:165-93. 8. Ommen SR, Nishimura RA, Appleton CP, et al. Clinical utility of Doppler echocardiography and tissue Doppler imaging in the estimation of left ventricular filling pressures: A comparative simultaneous Doppler-catheterization study. Circulation 2000;102:1788-94. 9. Dokainish H, Zoghbi WA, Lakkis NM, et al. Optimal noninvasive assessment of left ventricular filling pressures: a comparison of tissue Doppler echocardiography and B-type natriuretic peptide in patients with pulmonary artery catheters. Circulation 2004;109:2432-9. 10. Thygesen K, Alpert JS, White HD, et al. Universal definition of myocardial infarction. Circulation 2007;116:2634-53. 11. Pencina MJ, D'Agostino RB, Sr., D'Agostino RB, Jr., Vasan RS. Evaluating the added predictive ability of a new marker: from area under the ROC curve to reclassification and beyond. Stat Med 2008;27:157-72; discussion 207-12. 12. Uppsala Clinical Research Center. NRI & IDI. Available at:  HYPERLINK "http://www.ucr.uu.se/en/index.php/epistat/program-code" http://www.ucr.uu.se/en/index.php/epistat/program-code. Accessed April 27, 2012.  Online Table. Online Table 1. Simple logistic regression analysis for low-RHI group in HFNEF patients. Simple RegressionOdds ratio95% CIP blocker1.240.80-1.920.34ACEIs or ARBs0.960.61-1.530.88Ca channel blockers0.890.58-1.390.62Nitrates1.050.59-1.860.86Diuretics1.550.97-2.490.07Spironolactone1.340.73-2.460.34Statins1.100.70-1.700.69Aspirin1.160.74-1.810.52 RHI: reactive hyperemia-peripheral arterial tonometry index, HFNEF: heart failure with normal left ventricular ejection fraction, CI: confidence interval, ACEI: angiotensin converting enzyme inhibitors, ARB: angiotensin II receptor blocker. Online Figure Legends Figure 1. Bland-Altman plot of RH-PAT repeatability data RH-PAT measurements were performed on two different days among 31 patients. 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The average difference and upper and lower limits of agreement (2-SDs of differences) are indicated. RHI: reactive hyperemia-peripheral arterial tonometry index, RH-PAT: reactive hyperemia-peripheral arterial tonometry. Online Figure Figure-1      Akiyama et al., Online Appendix, Page  PAGE \* MERGEFORMAT 10 .}7}:}<}=}?}@}B}C}E}F}}}}}}}}$a$ $]a$gdf$1$3$5$7$8$a$gdgdSgdU 1$3$5$7$8$gdC;A}C}D}F}V}\}]}g}l}m}}}}}}}}}軰hC4hC;KHaJho(hIhC4mHnHsHuhC4hImHsHjhIU%hC4hI5KHaJhmHo(sH"hC4hIKHaJhmHo(sHhC4hImHo(sHjh[Uh[G0P&P 0p 1Z/R :p4. A!"#$%p G0P&P 0p 1Z/R :p4. A!"#$%p G0P&P 0p 1Z/R :p4. A!"#$%p G0P&P 0p 1Z/R :p4. A!"#$%p G0P&P 0p 1Z/R :p4. A!"#$%p G0P&P 0p 1Z/R :p4. A!"#$%p 8 DPaulus200711991199119917Paulus, W. J.Tschope, C.Sanderson, J. E.Rusconi, C.Flachskampf, F. A.Rademakers, F. E.Marino, P.Smiseth, O. A.De Keulenaer, G.Leite-Moreira, A. F.Borbely, A.Edes, I.Handoko, M. L.Heymans, S.Pezzali, N.Pieske, B.Dickstein, K.Fraser, A. G.Brutsaert, D. 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