Supplementary Appendix -cdn.com



Supplementary AppendixTable of Contents:Online Table 1. Cohort Formation…….page 2Online Table 2. Medications used to define Guideline Directed Medical Therapy …….page 3Online Table 3. Complete Table of Patient Characteristics…….page 4Online Table 4. Mean Days of Guideline Directed Medical Therapy and 80% Medication Possession Ratio…….page 6Online Table 5. Poisson Regression Results: Patient Characteristics and Death at One Year…….page 8Online Table 1. Cohort Selection Criteria NDefibrillator Registry-Medicare 40% Denominator Sample Intersection 172,877Inclusion CriteriaICD Registry device Indication is “Primary Prevention” 136,879ICD Registry indicates no previous ICD (ie not a replacement of a prior generator) 93,649ICD Registry indicates most recent ejection fraction is 40% or less 90,460ICD Registry indicates diagnosis of heart failure (Meets Inclusion Criteria) 78,655 Exclusion CriteriaFFS Medicare Part A, B & D Enrollment -6 consecutive months before index date 26,116FFS Medicare Parts A and B for 12 months after index date or until death 25,113Age 65 or over as of ICD date 20,188Living in the 50 US states or Washington DC 20,173Filled at least one prescription using Part D benefit in 6 months prior to implant (Final cohort) 19,773 ICD - implantable cardioverter-defibrillatorOnline Table 2. Medications used to define Guideline Directed Medical TherapyAngiotensin receptor blocker (ARB)azilsartancandesartaneprosartanirbesartanlosartanolmesartantelmisartanvalsartanANGIOTENSIN CONVERTING ENZYME INHIBITOR (ACE-I)perindopriltrandolaprilmoexiprillisinoprilbenazeprilramiprilquinaprilfosinoprilenalaprilcaptoprilHEART FAILURE specific beta blockerscarvedilolmetoprolol tartrate and succinatebisoprololBETA BLOCKERS NOT SPECIFICALLY APPROVED FOR HEART FAILUREatenolollabetalolnadololpindololtimololbetaxololnebivololOnline Table 3. Full Patient Characteristics TotalNo GDMT Prescriptions FilledAny GDMT Prescription FilledAt least 80% days covered by GDMTN19,7737,70012,0735,590Age (mean, SD) - from Medicare74.9 (6.2)75.5 (6.3)74.5 (6.2)74.6 (6.1)Age (mean) - from ICD Registry74.975.574.574.6Race/Ethnicity - from Medicare (%) Black1941 (9.8)689 (9.0)1252 (10.4)503 (9.0)Hispanic1359 (6.9)477 (6.2)882 (7.3)347 (6.2) Other16473 (83.3)6534 (84.9)9939 (82.3)4740 (84.8)Female (%)6989 (35.4)2477 (32.2)4512 (37.4)2139 (38.3)Year (%)20072382 (12.1)991 (12.9)1391 (11.5)611 (10.9)20084601 (23.3)1787 (23.2)2814 (23.3)1321(23.6)20094634 (23.4)1760 (22.9)2874 (23.8)1271 (22.7)20104281 (21.7)1674 (21.7)2607 (21.6)1211 (21.7)20113875 (19.6)1488 (19.3)2387 (19.8)1176 (21.0)CABG during ICD Admission (%) 127 (0.6)81 (1.1)46 (0.4)18 (0.3)EP Study (%) 1429 (7.2)614 (8.0)815 (6.8)341 (6.1)Family History of Sudden Death (%)652 (3.3)255 (3.3)397 (3.3)190 (3.4)Prior Heart Failure Diagnosis (%)< 3 months 2684 (13.6)1229 (16.0)1455 (12.1)547 (9.8)>=3 months - 9 months 3104 (15.8)1111 (14.5)1993 (16.6)937 (16.8)> 9 months13917 (70.6)5341 (69.5)8576 (71.3)4083 (73.3)Ischemic heart disease (%)14689 (74.4)5897 (76.7)8792 (73.0)4039 (72.4)LVEF (mean)25.58 (6.6)25.69 (6.7)25.52 (6.5)25.93 (6.3)LVEF (% ) <202432 (12.4)967 (12.7)1465 (12.3)577 (10.4)20-258345 (42.6)3153 (41.4)5192 (43.4)2383 (43.0)26-305476 (28.0)2125 (27.9)3351 (28.0)1621 (29.3)31-352872 (14.7)1161 (15.3)1711 (14.3)863 (15.6)36-40449 (2.3)207 (2.7)242 (2.0)98 (1.8)LVEF assessed (%)19579 (99.0)7613 (98.9)11966 (99.1)5543 (99.2)Most Recent LVEF Time Frame (%) <1 month9552 (49.0)4186 (55.2)5366 (45.0)2331 (42.2)>1 month - <3months5409 (27.7)1805 (23.8)3604 (30.2)1655 (30.0)> 3 months - <6 months2236 (11.5)728 (9.6)1508 (12.7)774 (14.0) >6 months2318 (11.9)871 (11.5)1447 (12.1)760 (13.8)Non-Ischemic Dilated Cardiomyopathy (%)12238 (62.0)4336 (56.4)7902 (65.6)3744 (67.1)QRS duration (msec)132.8133.1132.6133.3NYHA Class (%)NYHA 1537 (2.7)188 (2.5)349 (2.9)180 (3.2) NYHA 25796 (29.4)2131 (27.8)3665 (30.4)1835 (32.9) NYHA 312519 (63.5)4963 (64.7)7556 (62.8)3375 (60.6) NYHA 4857 (4.4)388 (5.0)469 (3.9)183 (3.3)PCI during ICD Admission (%)323 (1.6)179 (2.3)144 (1.2)65 (1.2)Prior Ventricular Tachychardia (%)4553 (23.1)2093 (27.2)2460 (20.4)1017 (18.2)% of ZIP code population below poverty mean (sd) (2010 census)11.35 (8.6)11.05 (8.4)11.53 (8.7)11.02 (8.3)LIS status (%)6696 (33.9)2376 (30.9)4320 (35.8)1949 (34.9)Medicaid Dual eligibility (%)5071 (25.7)1785 (23.2)3286 (27.2)1453 (26.0)History of (%):Cerebrovascular disease 4690 (23.7)1910 (25.8)2780 (23.0)1153 (20.6)Chronic pulmonary disease 9016 (45.6)3647 (47.4)5369 (44.5)2293 (41.0)Congestive heart failure 19512 (98.7)7497 (97.4)12015 (99.5)5559 (99.5)Renal failure 6193 (31.3)2713 (35.2)3480 (28.8)1413 (25.3)Connective tissue disease 12268 (62.0)4899 (63.6)7369 (61.0)3239 (57.9)Dementia 508 (2.6)228 (3.0)280 (2.3)98 (1.8)Mild liver disease 344 (1.7)145 (1.9)199 (1.7)82 (1.5)Peripheral vascular disease 6431 (32.5)2601 (33.8)3830 (31.7)1636 (29.3)Ulcer disease 462 (2.3)178 (2.3)284 (2.4)107 (1.9)Myocardial infarction 6357 (32.2)2290 (29.7)4067 (33.7)1848 (33.1)Diabetes 10010 (50.6)3894 (50.6)6116 (50.7)2755 (49.3)Hemiplegia116 (0.6)52 (0.7)64 (0.5)23 (0.4)Metastatic solid tumor189 (1.0)81 (1.1)108 (0.9)40 (0.7)Charlson comborbidities Count (mean)3.03.12.92.7Count of acute care admissions in 6 months before ICD – mean (SD)1.9 (1.4)1.9 (1.4)2.0 (1.4)1.7 (1.1)Acute care admissions (% with any) – 90 days97.097.797.298.3Mean LOS in acute care (SD)8.5 (9.3)9.1 (9.7)8.1 (9.0)6.53 (7.0)Mean LOS in non-acute care institution (SD)26.3 (26.1)29.8 (29.5)23.8 (23.1)19.23 (21.7)GDMT – guideline directed medical therapy. ICD – implantable cardioverter defibrillator. CABG – coronary artery bypass graft. EP – electrophysiology. LVEF – left ventricular ejection fraction. NYHA – New York Heart Association class. PCI – Percutaneous coronary intervention. LIS – Part D low income subsidy, a marker of 150% of less than the federal poverty limit. LOS – length of stay.Online Table 4. Mean Days of Guideline Directed Medical Therapy (GDMT) and Medication Possession Ratio of 80%NMean days of GDMT (SD)Age in years65-75997151.9 (41.0)75-85844147.3 (42.1)>85136144.5 (42.5)Race/ethnicityBlack194150.6 (40.3)Hispanic135950.3 (40.2)Other1647349.2 (41.9)Year2007238247.3 (41.8)2008460149.4 (41.6)2009463449.9 (41.4)2010428149.3 (41.7)2011387550.3 (41.8)SexFemale684852.8 (41.0)Male1292547.6 (41.9)Low Income SubsidyYes669651.4 (40.7)No1307748.4 (42.1)Left Ventricular Ejection Fraction (LVEF)<20243247.0 (41.0)20-25834550.2 (41.4)26-30547650 .0(41.8)31-35287249.4 (42.4)36-4044943.6 (42.2)Most Recent LVEF Time Frame<1 month955244.6 (41.8)>1 month - <3months540954.3 (40.6) > 3 months - <6 months223656.1 (40.7)>6 months231851.7 (41.8)Nonischemic Dilated Cardiomyopathy Yes300951.0 (41.4)No1344948.2 (41.8)Ischemic Heart Disease Yes1287348.8 (41.7)No596251.3 (41.4)Chronic Renal Disease Yes619344.9 (41.7)No1358051.5 (41.5)CABG during Implantable Cardioverter Defibrillator admissionYes12727.1 (38.4)No1964049.6 (41.6)Duration of Prior Heart Failure Diagnosisprior CHF < 3 months 268442.0 (41.4)prior CHF >=3 months - 9 months 310452.0 (41.1)prior CHF > 9 months1391750.2 (41.7)New York Heart Association ClassNYHA 153753.5 (41.5)NYHA 2579651.7 (41.6)NYHA 31251948.7 (41.6)NYHA 485742.4 (41.2)GDMT – guideline directed medical therapy. ICD – implantable cardioverter defibrillator. CABG – coronary artery bypass graft. EP – electrophysiology. LVEF – left ventricular ejection fraction. NYHA – New York Heart Association class. PCI – Percutaneous coronary intervention. LIS – Part D low income subsidy, a marker of 150% of less than the federal poverty limit. LOS – length of stay.Online Table 5. Poisson Regression Results: Risk of Death within One Year of Implantable Cardioverter Defibrillator (ICD) Implant associated with Patient Characteristics and Prescription fill ParameterRR95% CIP-valueAge1.03(1.03,1.04)<0.0001Any GDMT in 90 days prior to ICD implant0.77(0.71,0.83)<0.0001Female0.88(0.81,0.96)0.002Black1.11(0.98,1.26)0.03Hispanic0.97(0.83,1.12)0.90Low income subsidy1.21(1.11,1.32)0.006Cerebrovascular disease1.13(1.04,1.23)0.002Chronic obstructive pulmonary disease1.42(1.31,1.54)<0.0001Renal disease1.73(1.59,1.88)<0.0001Dementia1.12(0.92,1.36)0.47Diabetes1.20(1.11,1.31)0.0005Number of admissions1.12(1.10,1.15)<0.0001Duration of heart failure compared with <3 months>=3 months – 9 months prior to implant0.95(0.85,1.06)0.38> 9 months0.87(0.77,0.98)0.03Ischemic heart disease1.05(0.91,1.20)0.95New York Heart Association class compared with Class INYHA Class II1.06(0.80,1.41)0.76NYHA Class III1.39(1.05,1.84)0.049NYHA Class IV1.95(1.43,2.64)0.001Left Ventricular Ejection Fraction (LVEF) compared with <20%20-25%0.85(0.77,0.95)0.00626-30%0.70(0.62,0.79)<0.000131-35%0.68(0.59,0.79)<0.000136-40%0.62(0.47,0.83)0.005Non-ischemic dilated cardiomyopathy0.86(0.75,0.98)0.04Ventricular tachycardia1.34(1.22,1.46)<0.0001Timing of most recent LVEF measurement compared with <1 Month prior to ICD>1 month - <3months0.80(0.72,0.88)<0.0001> 3 months - <6 months0.80(0.69,0.92)0.003>6 months0.92(0.81,1.05)0.13GDMT – guideline directed medical therapy. ICD – implantable cardioverter defibrillator. CABG – coronary artery bypass graft. EP – electrophysiology. LVEF – left ventricular ejection fraction. NYHA – New York Heart Association class. PCI – Percutaneous coronary intervention. LIS – Part D low income subsidy, a marker of 150% of less than the federal poverty limit. LOS – length of stay. ................
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