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Online Appendix for the following February 23 JACC article TITLE: Evaluation of Early Complications Related to De Novo Cardioverter Defibrillator Implantation: Insights From the Ontario ICD Database AUTHORS: Douglas S. Lee, Andrew D. Krahn, Jeffrey S. Healey, David Birnie, Eugene Crystal, Paul Dorian, Christopher S. Simpson, Yaariv Khaykin, Douglas Cameron, Amir Janmohamed, Raymond Yee, Peter C. Austin, Zhongliang Chen, Judy Hardy, Jack V. Tu _____________________________________________________________________ APPENDIX 1. Participating Hospitals and Investigators in the Ontario ICD Database Defibrillator Implantation and Follow-up Sites: Hamilton Health Sciences Centre (J.S. Healey), Kingston General Hospital (C.S. Simpson), London Health Sciences Centre (A.D. Krahn, R. Yee), Rouge Valley Health System (A. Janmohammed), St. Michael’s Hospital (I. Mangat, P. Dorian), Southlake Regional Health Centre (Y. Khaykin), Sunnybrook Health Sciences Centre (E. Crystal), Toronto General Hospital (D. Cameron), Trillium Health Centre (C. LeFeuvre), University of Ottawa Heart Institute (D. Birnie) Non-Implanting Defibrillator Follow-up Sites: Credit Valley Hospital (J. Cyriac), Grey Bruce Health Services (M. Newton), Hotel Dieu Grace Hospital (A. Glanz), Kawartha Cardiology Clinic (W. Hughes), St. Mary’s General Hospital (C. Rinne), Scarborough General Hospital (E.G. Davies), Sudbury Regional Hospital (R. Labonte), Thunder Bay Regional Health Sciences Centre (C. Lai) APPENDIX 2. Univariate analysis for major complications Major Complications Age 61-80 vs. 60 yr Age >80 vs. 60 yr Women Secondary vs. Primary prevention Nonischemic vs. Ischemic CM Other cardiac disease vs. Ischemic CM Prior myocardial infarction Prior PCI or CABG Heart failure NYHA class III-IV vs. I-II Pre-existing pacemaker system Atrial fibrillation Diabetes Hypertension Chronic obstructive lung disease ACE inhibitor or ARB Beta-adrenoreceptor blocker Loop diuretic Anticoagulation, Aspirin or Clopidogrel vs. None Amiodarone vs. None Class 1 or Other Class 3 AAD vs. None QRS duration >140 vs. 140 msec LVESD 45 vs. <45 mm LVEDD 60 vs. <60 mm LVEF 21-35 vs. >35% LVEF 20 vs. >35% LA size 45 vs. <45 mm Serum creatinine >2.49 vs. 1.24 mg/dL Serum creatinine 1.25-2.49 vs. 1.24 mg/dL Serum Sodium 135 vs. >135 mEq/L Hemoglobin >12.0 vs. 10.0 g/dL Hemoglobin 10.1-12.0 vs. 10.0 g/dL eGFR <30 vs. 90 mL/min/1.73 m2 eGFR 30-59 vs. 90 mL/min/1.73 m2, eGFR 60-89 vs. 90 mL/min/1.73 m2, Weight (per 10 lb) New leads 2 vs. 1 or none New leads 3 vs. 1 or none Passive vs. active fixation RV lead Dual vs. single coil RV lead Dual-chamber ICD vs. Single-chamber CRT-D vs. Single-chamber Hazard Ratio 1.01 0.97 1.57 1.23 1.93 1.49 0.95 0.70 1.14 1.47 1.39 0.93 1.11 1.08 1.05 0.69 0.91 1.13 95% CI 0.71 - 1.44 0.44 - 2.15 1.09 - 2.26 0.86 - 1.75 1.14 - 3.27 0.92 - 2.41 0.68 - 1.33 0.49 - 0.99 0.81 - 1.61 1.04 - 2.08 0.77 - 2.52 0.64 - 1.35 0.77 - 1.61 0.77 - 1.51 0.63 - 1.77 0.46 - 1.03 0.58 - 1.44 0.80 - 1.59 p-value 0.96 0.95 0.016 0.25 0.015 0.11 0.76 0.04 0.45 0.029 0.27 0.71 0.57 0.66 0.84 0.071 0.68 0.48 1.43 1.07 3.34 1.44 1.57 0.99 1.07 0.98 1.03 1.14 0.88 - 2.30 0.70 - 1.62 1.06 - 10.53 1.03 - 2.02 1.12 -2.21 0.68 - 1.44 0.69 - 1.66 0.56 - 1.71 0.70 – 1.50 0.57 - 3.48 0.15 0.75 0.039 0.035 0.009 0.96 0.77 0.95 0.89 0.45 1.12 1.09 0.71 0.58 1.79 1.21 0.85 1.01 1.78 2.17 1.29 0.67 1.96 2.33 0.78 - 1.61 0.59 - 2.02 0.38 -1.32 0.28 -1.22 0.89 - 3.60 0.75 - 1.95 0.53 - 1.36 0.95 -1.07 1.21 - 2.63 1.38 - 3.40 0.68 - 2.46 0.21 - 2.10 1.29 - 2.98 1.51 - 3.59 0.55 0.78 0.27 0.15 0.10 0.43 0.51 0.70 0.004 <0.001 0.44 0.49 0.002 <0.001 AAD=antiarrhythmic drug, ACE=angiotensin converting enzyme, ARB=angiotensin receptor blocker, CABG=coronary artery bypass graft surgery, CM=cardiomyopathy, CRT-D=cardiac resynchronization defibrillator, eGFR=estimated glomerular filtration rate, ICD=implantable cardioverter defibrillator, LA=left atrium, LVEDD=left ventricular end-diastolic dimension, LVEF=left ventricular ejection fraction, LVESD=left ventricular end-systolic dimension, NYHA=New York Heart Association, PCI=percutaneous coronary intervention; To convert serum creatinine to SI units (mol/L), multiply by 88.4 APPENDIX 3. Univariate analysis for minor complications Minor Complications Age 61-80 vs. 60 yr Age >80 vs. 60 yr Women Secondary vs. Primary prevention Nonischemic vs. Ischemic CM Other cardiac disease vs. Ischemic CM Prior myocardial infarction Prior PCI or CABG Heart failure NYHA class III-IV vs. I-II Pre-existing pacemaker system Atrial fibrillation Diabetes Hypertension Chronic obstructive lung disease ACE inhibitor or ARB Beta-adrenoreceptor blocker Loop diuretic Anticoagulation, Aspirin or Clopidogrel vs. None Amiodarone vs. None Class 1 or Other Class 3 AAD vs. None QRS duration >140 vs. 140 msec LVESD 45 vs. <45 mm LVEDD 60 vs. <60 mm LVEF 21-35 vs. >35% LVEF 20 vs. >35% LA size 45 vs. <45 mm Serum creatinine >2.49 vs. 1.24 mg/dL Serum creatinine 1.25-2.49 vs. 1.24 mg/dL Serum Sodium 135 vs. >135 mEq/L Hemoglobin >12.0 vs. 10.0 g/dL Hemoglobin 10.1-12.0 vs. 10.0 g/dL eGFR <30 vs. 90 mL/min/1.73 m2 eGFR 30-59 vs. 90 mL/min/1.73 m2, eGFR 60-89 vs. 90 mL/min/1.73 m2, Weight (per 10 lb) New leads 2 vs. 1 or none New leads 3 vs. 1 or none Passive vs. active fixation RV lead Dual vs. single coil RV lead Dual-chamber ICD vs. Single-chamber CRT-D vs. Single-chamber Hazard Ratio 1.29 1.64 1.40 0.84 2.21 1.74 0.84 0.75 1.23 1.73 1.52 1.19 1.06 1.21 1.33 0.84 1.31 1.24 95% CI 0.92 - 1.80 0.88 - 3.08 1.00 - 1.96 0.60 - 1.18 1.35 - 3.61 1.10 - 2.74 0.62 - 1.14 0.55 - 1.03 0.90 - 1.67 1.27 - 2.35 0.91 - 2.54 0.86 - 1.63 0.76 - 1.48 0.89 - 1.64 0.86 - 2.04 0.58 - 1.23 0.82 - 2.09 0.91 - 1.68 p-value 0.13 0.12 0.051 0.32 0.002 0.017 0.26 0.073 0.20 <0.001 0.11 0.29 0.74 0.23 0.20 0.38 0.26 0.17 1.40 1.32 1.82 1.36 1.25 1.04 1.07 0.98 0.97 1.04 0.91 - 2.15 0.93 - 1.87 0.45 - 7.36 1.01 - 1.85 0.93 -1.69 0.73 -1.47 0.72 - 1.59 0.59 - 1.63 0.69-1.37 0.75 -1.45 0.12 0.13 0.40 0.046 0.14 0.83 0.75 0.95 0.88 0.80 1.09 1.07 0.91 0.64 2.01 1.09 1.11 0.95 1.64 2.36 1.61 1.71 1.51 2.42 0.45 -2.68 0.62 -1.86 0.49 -1.68 0.31 -1.32 1.07 - 3.78 0.69 - 1.71 0.73 - 1.69 0.87-1.03 1.12 - 2.39 1.62 - 3.43 0.95 - 2.73 0.87 - 3.35 1.06 - 2.15 1.64 - 3.56 0.84 0.80 0.76 0.22 0.030 0.71 0.62 0.19 0.010 <0.001 0.079 0.12 0.023 <0.001 AAD=antiarrhythmic drug, ACE=angiotensin converting enzyme, ARB=angiotensin receptor blocker, CABG=coronary artery bypass graft surgery, CM=cardiomyopathy, CRT-D=cardiac resynchronization defibrillator, eGFR=estimated glomerular filtration rate, ICD=implantable cardioverter defibrillator, LA=left atrium, LVEDD=left ventricular end-diastolic dimension, LVEF=left ventricular ejection fraction, LVESD=left ventricular end-systolic dimension, NYHA=New York Heart Association, PCI=percutaneous coronary intervention; To convert serum creatinine to SI units (mol/L), multiply by 88.4