Publication Information

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650, 742, 854, 1007, 1193, 1256, 1285, 1460, 1481, 1690, 1752, 1879, 1930, 1982, 2029, 2275, 2398, 2626, 2742, 3027, 3223, 3277, 3499, 3568], 'Birmingham,': [61, 3569], 'Birmingham.': [62], 'Originally': [63], 'published11': [64], 'Sep': [65], '2012https://doi.org/10.1161/CIRCULATIONAHA.112.097816Circulation.': [66], '2012;126:1401–1406IntroductionThe': [67], 'Interagency': [68, 992, 1721, 1796, 2907], 'is': [76, 653, 667, 729, 827, 1445, 1542, 1763, 1829, 1839, 2109, 2158, 2204, 2211, 2266, 2279, 2294, 2312, 2585, 2649, 2740, 2747, 2893, 2915, 3398, 3414], 'a': [77, 158, 189, 220, 224, 319, 340, 364, 434, 503, 567, 640, 660, 711, 773, 1038, 1042, 1206, 1293, 1335, 1370, 1416, 1564, 1734, 1780, 1812, 1880, 2133, 2322, 2464, 2564, 2600, 2671, 2750, 2760, 2858, 2877, 2919, 2968, 2979, 2993, 3045, 3075, 3131, 3365, 3481, 3525, 3551, 3735, 3759, 4071, 4178], 'North': [78, 3422], 'American': [79], 'national': [80, 2030], 'registry': [81, 341, 435, 663, 2432, 2466, 2868, 2980, 3305, 3429, 3764, 4042], 'mechanical': [83, 214, 444, 755, 972, 1363, 1429, 1510, 1536, 1709, 1912, 2170, 2730, 3433, 3440, 3446, 3452, 3666, 4140], 'circulatory': [84, 215, 445, 756, 973, 1364, 1430, 1511, 1537, 1710, 2171, 2357, 2731, 3434, 3441, 3447, 3453, 3626, 3667, 3732, 3799, 4078, 4141], 'support': [85, 360, 757, 974, 1365, 1431, 1512, 2108, 3435, 3442, 3448, 3454, 4113, 4142], 'devices': [86, 132, 243, 251, 265, 1376, 2331, 2866, 2984, 3797], '(MCSDs)': [87], 'that': [88, 98, 117, 237, 275, 334, 352, 516, 539, 580, 595, 657, 728, 760, 1006, 1408, 1449, 1496, 1758, 1773, 1878, 1923, 2034, 2265, 2296, 2367, 2445, 2460, 2489, 2530, 2634, 3058, 3092, 3116, 3195], 'are': [89, 110, 147, 155, 596, 618, 717, 988, 1015, 1352, 1390, 1501, 1506, 1748, 1928, 2035, 2131, 2180, 2231, 2239, 2446, 2472, 2490, 2497, 2523, 2542, 2559, 2624, 2659, 2684, 2718, 2850, 2939], 'used': [90, 832, 912, 1380, 1526, 1732, 1997, 2524, 2917], 'treat': [92], 'advanced': [93, 2726, 3845], 'heart': [94, 1129, 1173, 2727, 3846, 3898, 4185], 'failure.': [95, 4186], 'Durable': [96], 'MCSDs': [97, 116, 208, 236, 2112, 2289, 2319, 2444, 2488, 2528, 3425], 'have': [99, 1730, 1779, 2026, 3162, 3319], 'been': [100, 1525, 1599, 1731, 2027, 3394], 'approved': [101, 2455, 2483, 2493], 'by': [102, 196, 268, 369, 506, 887, 1355, 1399, 1414, 1553, 2242, 2290, 2484, 2494, 2561, 2587, 2720, 2749, 2829, 2956, 2964, 3003, 3336, 3357], 'US': [104, 3648], 'Food': [105], 'Drug': [107], 'Administration': [108], '(FDA)': [109], 'included': [111, 403, 1245, 1275, 1686, 3284], 'in': [112, 119, 286, 328, 375, 419, 440, 530, 659, 695, 751, 784, 839, 882, 894, 951, 1072, 1093, 1142, 1160, 1236, 1272, 1308, 1337, 1381, 1532, 1547, 1587, 1601, 1635, 1644, 1765, 1856, 1893, 1899, 1936, 1966, 2000, 2103, 2145, 2182, 2213, 2250, 2375, 2382, 2411, 2425, 2476, 2722, 2978, 3061, 3070, 3139, 3178, 3303, 3376, 3503, 3505, 3585, 3665, 3737, 3979], 'this': [113, 153, 284, 949, 1273, 1740, 1819, 2001, 2229, 2297, 2435, 2886, 2997, 3326], 'registry;': [114], 'however,': [115], 'remain': [118], 'FDA': [120, 282, 293, 379, 1035, 2191, 2496, 2823, 2837, 3090, 3114, 3193, 3389, 3691], 'trials': [121, 556, 767, 2442], 'pending': [122], 'initial': [123, 260, 471, 483, 815, 1197, 1637, 1767, 2736, 2744, 2998], 'approval': [124, 559, 1036, 2326, 2702, 2930, 3315, 3380], '(ie,': [125, 898, 1122, 1134, 2661, 2869, 3382], 'investigational': [126], 'device': [127, 143, 296, 648, 932, 1091, 1976, 2015, 2899, 2953, 3943, 4182, 4216], 'exemption': [128], '[IDE]': [129], 'trials)': [130, 3391], 'intended': [133, 647], 'short-term': [135], 'use': [136, 1074, 1291, 1329, 1339, 1426, 2053, 2410, 2418, 2430, 2807, 4176], '(eg,': [137, 172, 244, 697, 736, 758, 1432, 1478, 2478, 2638, 3144, 3183], 'Abiomed': [138, 3554], 'BVS': [139, 4110], '5000': [140, 4111], 'ventricular': [141, 249, 1790, 1834, 2013, 2897, 3590, 3600, 3904, 3941, 4180, 4214], 'assist': [142, 250, 1791, 1835, 2014, 2898, 3905, 3942, 4181, 4215, 4244], '[Abiomed,': [144], 'Danvers,': [145], 'MA])': [146], 'not': [148, 1353, 1368, 1502, 2569, 3067, 3246, 3393], 'included.': [149], 'The': [150, 257, 281, 348, 396, 533, 588, 870, 968, 1373, 1617, 2152, 2499, 2555, 2772, 2836, 3007, 3039, 3713, 4006], 'purposes': [151], 'article': [154, 1541], 'present': [157, 188], 'developmental': [159], 'history': [160, 884], 'INTERMACS,': [162, 197, 797, 2485], 'outline': [164, 2854], 'collaboration': [166, 376, 420, 2508], 'INTERMACS': [168, 479, 620, 666, 696, 724, 770, 822, 886, 895, 958, 1031, 1057, 1085, 1123, 1135, 1156, 1168, 1190, 1202, 1239, 1298, 1347, 1356, 1383, 1419, 1457, 1522, 1697, 1824, 2040, 2178, 2201, 2203, 2263, 2343, 2397, 2419, 2459, 2477, 2522, 2562, 2567, 2657, 2683, 2754, 2787, 2809, 3001, 3037, 3088, 3141, 3221, 3230, 3273, 3312, 3335, 3358, 3375, 3751, 3793, 3811, 3842, 3858, 3933, 3971, 4008], 'with': [169, 232, 288, 377, 393, 421, 521, 786, 841, 865, 902, 980, 1021, 1034, 1162, 1424, 1469, 1513, 1669, 1917, 2121, 2149, 2218, 2440, 2544, 2670, 2688, 2793, 2889, 3000, 3101, 3172, 3360, 3473, 3901], 'various': [170], 'constituencies': [171], 'FDA,': [173], 'National': [174, 354, 371, 2220, 3722], 'Institutes': [175, 372, 2221], 'Health,': [177, 2223], 'Center': [178, 381, 670, 2591, 2800], 'Medicare': [180, 383, 672], '&': [181, 384, 673], 'Medicaid': [182, 385, 674], 'Services,': [183], 'industry,': [184, 2511], 'physicians),': [186], 'summary': [190], 'information': [192, 538, 727, 950, 2264, 2298, 2360, 2405], 'generated': [193, 726], 'date': [195], 'describe': [200, 573, 761], 'future': [202], 'directions': [203], 'INTERMACS.Developmental': [205], 'History': [206, 3678, 3692], 'INTERMACSThe': [210], 'concept': [211], 'using': [213, 2867], 'assistance': [216], 'more': [218, 1476, 1633, 3132, 3936], 'than': [219, 1516, 1643, 3137, 3177, 3937], 'brief': [221], 'time': [222, 856, 1081, 1195, 1258, 1287, 1462, 1483, 1618, 1647, 1883, 1968, 2628, 3279, 3406], 'after': [223, 867, 923, 1010, 1640, 1662, 1770, 1846, 1871, 1933, 2011, 4136, 4242], 'cardiac': [225, 1491, 3148, 3604], 'operation': [226], 'dates': [227], 'early': [230, 881, 1230, 2068], '1960s': [231], 'development': [234, 258, 2287, 2390, 2856, 3404], 'fit': [238], 'definitions': [240, 594, 2500, 2520], 'counterpulsation': [242], 'intra-aortic': [246], 'balloon': [247], 'pump),': [248], '(VADs),': [252], 'total': [254], 'artificial': [255, 3624], 'hearts.1–5': [256], 'clinical': [261, 562, 2426, 2441, 2874, 2961, 3175, 3197, 3368, 3767, 4106], 'evaluation': [262, 1361, 2284, 2863, 4107], 'these': [264, 474, 1103, 1382, 2369, 3474, 3478], 'were': [266, 863, 879, 1105, 1154, 1189, 1201, 1227, 1888, 1960, 1981, 2504, 3066, 3233], 'regulated': [267], 'individual': [269, 687, 743, 1403, 1746, 2706], 'academic': [270], 'medical': [271, 1132, 2330, 2378, 2450, 2865], 'center': [272, 4074], 'review': [273, 279, 2700, 2926], 'groups': [274, 309, 2416, 3200, 3475], 'evolved': [276], 'into': [277, 557, 1229, 3168, 3480, 3766], 'institutional': [278, 2699], 'boards.': [280], 'entered': [283, 2665], 'arena': [285], '1976': [287, 303], 'advent': [290], 'section': [294], 'regulation': [297], 'based': [298, 2036, 2784], 'on': [299, 431, 453, 928, 977, 1018, 1583, 1826, 1844, 1866, 1911, 2009, 2037, 2091, 2406, 2563, 2785, 2832, 3531, 4075], 'passage': [300], 'Medical': [304], 'Device': [305], 'Amendments.6': [306], 'By': [307, 1079], '1991,': [308], 'including': [310, 2708, 2715, 2967], 'Institute': [312, 330, 359, 3710], 'Medicine': [314, 332, 3700], 'foresaw': [315], 'need': [317], 'detailed': [320], 'longitudinal': [321], 'database': [322, 1523, 3436, 3794], 'patients': [324, 520, 840, 893, 918, 975, 1000, 1014, 1113, 1165, 1188, 1210, 1307, 1344, 1358, 1386, 1454, 1498, 1508, 1571, 1670, 1747, 1774, 1909, 1927, 1980, 2104, 2138, 2147, 2584, 3020, 3060, 3167, 3222, 4068], 'receiving': [325], 'MCSDs,': [326, 2387], 'stating': [327, 3004], 'an': [329, 686, 1402, 1543, 1853, 2454, 2650, 2816, 2822], 'report': [333, 781, 816, 1274, 1300, 1317, 1552, 2573, 3352], '"patients': [335], 'should': [336], 'be': [337, 526, 1412, 1632, 1996, 2482, 2534, 3208, 3322], 'followed': [338], 'through': [339, 626, 791, 1001, 2506], 'remainder': [344], 'their': [346, 1388, 1654, 1673], 'lives…."7': [347], 'committee': [349, 2790], 'further': [350, 2286, 3080], 'recommended': [351], 'Heart,': [355], 'Lung,': [356], 'Blood': [358], 'long-term': [361, 4065], 'follow-up': [362, 1882, 2582], 'studies.Eventually,': [363], 'competitive': [365], 'contract': [366, 402], 'was': [367, 436, 480, 502, 535, 570, 581, 782, 831, 911, 1032, 1097, 1323, 1585, 1625, 1629, 2401, 2819, 3010, 3056, 3128, 3138, 3550], 'issued': [368], 'Health': [374, 3651], 'Services': [386, 675], 'record': [388], 'analyze': [390], 'patient': [391, 579, 613, 637, 904, 1409, 1417, 1471, 1804, 2093, 2114, 2162, 2352, 2407, 2531, 3135], 'outcomes': [392, 518, 737, 909, 922, 970, 1389, 1993, 2144, 2408, 2532], 'durable': [394, 523, 1341, 1371, 1849, 2122, 2491, 3796], 'MCSDs.8,9': [395], 'group': [397, 491, 641, 1876, 2257, 3387], 'chosen': [398], 'fill': [400], '3': [404, 1638, 1768], 'coprincipal': [405], 'investigators—James': [406], 'K.': [407], 'Kirklin,': [408], 'MD,': [409, 413, 3561], 'James': [410, 3466], 'B.': [411], 'Young,': [412], 'Robert': [415], 'Kormos,': [417], 'MD—working': [418], 'United': [423, 1095, 3981], 'Network': [424], 'Organ': [426], 'Sharing': [427], 'others.': [429, 3457], 'Advice': [430], 'constructing': [432], 'such': [433, 664, 825, 1540, 2332], 'requested': [437], 'from': [438, 554, 1118, 1145, 1327, 1418, 2200, 2208, 2234, 2463, 2546, 2557, 2621, 2711, 2905, 3035, 4219], 'experts': [439, 2721, 2734], 'field': [442, 753, 1534, 2167, 2338, 2724], 'support,': [446, 930, 1711, 1913, 2172], 'many': [447], 'whom': [449], 'had': [450, 1597, 1664, 1672], 'previously': [451, 1598], 'worked': [452], 'similar': [454, 565, 3068], 'projects': [455, 2783], 'under': [456, 3462], 'auspices': [458], 'International': [461, 3680], 'Society': [462], 'Heart': [464, 602, 631, 1613, 3635, 3681, 3740, 3805, 3852, 3946, 3984, 4016, 4222], 'Lung': [466, 3683, 3806, 3853, 3947, 3985, 4017], 'Transplantation': [467], '(ISHLT).': [468], 'During': [469, 1311], 'meetings': [472, 484, 2033], 'MCSD': [475, 524, 586, 678, 868, 924, 929, 1260, 1548, 1570, 1641, 2303, 2340, 2540, 3412], 'experts,': [476], 'name': [478], 'chosen.': [481], 'These': [482, 610, 2042, 2943], 'also': [485], 'outlined': [486], 'organization': [488], 'established': [493, 880], 'goals': [495], 'INTERMACS.10For': [497], 'first': [499, 779, 794, 845, 1621, 1655, 1674, 1970, 2806, 2895, 3801], 'time,': [500, 3327], 'there': [501, 1322, 1887, 1959, 2130, 2648, 2739, 3397], 'concerted': [504], 'effort': [505, 3484], 'physicians': [507, 1505, 2051], 'industry': [509, 1400], 'partners': [510, 2247, 2792], 'define': [512, 834, 2873], 'adverse': [513, 871, 1567, 1579, 1623, 1657, 1676, 1684, 1816, 1869, 1957, 1973, 1987, 2070, 2502, 2518, 2716, 3252], 'events': [514, 1685, 1744, 1870, 2071, 2503, 3231, 3253, 3289, 3302], 'so': [515, 2529], 'any': [522, 3248, 3261], 'would': [525], 'gathered': [527], 'adjudicated': [529, 2719], 'uniform': [531], 'fashion.11': [532], 'goal': [534, 2395], 'provide': [537, 2403, 2735], 'allows': [540], 'optimal': [541], 'MCSD-patient': [542], 'matching': [543], 'objective': [545], 'quantitative': [546], 'evaluations': [547], 'blood': [549, 1250, 1714], 'pumps': [550], 'as': [551, 665, 680, 1041, 1167, 1346, 1450, 1456, 1563, 1750, 1811, 2333, 2421, 2685, 2759, 2811, 2918, 2954, 3384], 'they': [552, 2853], 'move': [553], 'IDE': [555, 766, 2192, 2817, 3008, 3390], 'postmarket': [558, 2325, 2929, 3317], 'surveillance': [560, 2317, 2327, 3318], 'use.': [563], 'In': [564, 843, 1175, 1739, 1818, 1852, 3458], 'fashion,': [566], 'classification': [568, 589], 'system': [569, 590], 'created': [571], 'preoperative': [575], 'condition': [576], 'relevant': [582], 'selection': [584], 'therapy.12': [587], 'provides': [591, 746, 2321, 2768], 'meaningful': [592], 'operational': [593], 'essentially': [597], 'subclassifications': [598], 'New': [600, 629], 'York': [601, 630], 'Association': [603, 632], 'class': [604, 633], 'III': [605, 634], 'IV': [607], 'functional': [608], 'status.': [609], 'profiles': [611, 3843], 'disease': [614], 'severity': [615], 'implantation': [617, 1092, 1116, 1485, 1642, 1663, 1771, 4137], 'designated': [619], 'levels': [621, 1136, 1807], '1': [622, 897, 1008, 1158, 1192, 1385, 1421, 1459, 1660, 1699, 3337], '(critical': [623], 'cardiogenic': [624, 874, 899, 1120, 1247, 1520], 'shock)': [625, 900, 1161], '7': [627, 1885], '(advanced': [628], 'symptoms).': [635], 'Other': [636, 1679], 'descriptors': [638], 'include': [639, 2062, 2373, 2467, 2945, 3331, 3426], 'demographic': [643], 'variables': [644], 'strategy': [649], 'implantation.8,13': [651], 'It': [652, 1444], 'important': [654, 1530, 1837, 2046, 2281, 2313, 3210], 'note': [656, 1448], 'participation': [658, 694, 2704], 'recognized': [661, 3081], 'multi-institutional': [662], 'mandatory': [668], 'funding': [676, 2226], 'implants': [679, 1104, 1153, 2541, 4012], 'destination': [681, 3977], 'therapy.': [682], 'Moreover,': [683, 1577, 3370], 'failure': [684, 1130, 2728, 3899], 'site': [688, 713, 2480, 2606, 2620, 2695], 'adhere': [690], 'requirements': [692, 2681], 'timely': [698, 961, 2404], 'accurate': [700], 'data': [701, 738, 1351, 1729, 2157, 2207, 2344, 2420, 2433, 2578, 2658, 2676, 2810, 2871, 2904, 2977, 3002, 3232, 3363, 3765], 'entry,': [702], 'prompt': [703], 'query': [704], 'response)': [705], 'can': [706, 1411, 1995, 2533, 2614], 'lead': [707, 2300, 2615], 'exclusion': [709, 3112], 'participating': [712, 3513], 'until': [714, 1619], 'deficiencies': [716], 'rectified.13INTERMACS:': [718], 'Accomplishments': [719], 'DateSince': [721], 'its': [722, 732, 2214, 2399, 2971, 3005], 'inception,': [723], 'has': [725, 771, 1524, 2072, 2437, 3392, 3529], 'useful': [730], 'community': [733, 2049], 'collaborators': [735], 'quality': [740, 2269, 2272], 'improvement': [741, 2273], 'programs)': [744], 'perspective': [747], 'other': [749, 903, 1466, 1515, 2329], 'publications': [750, 759, 2199], 'results': [763, 2189, 2958], 'multicenter': [765, 1396], 'VADs14).': [769], 'published': [772, 783, 1855, 2188], 'series': [774], 'annual': [776, 780, 846, 1058, 1086, 1240, 1299, 2651, 3802, 3934, 3972, 4009], 'reports;': [777], '2008': [785], 'reports': [787, 1059, 2556], 'every': [788, 2667], 'year': [789, 795, 1009, 1029], 'thereafter': [790], '2012.10,15–17During': [792], 'enrollment': [798, 3165], 'actually': [799], 'spanned': [800], 'June': [801, 1146, 1183, 1319], '23,': [802], '2006,': [803], 'December': [805, 1149], '31,': [806, 1003], '2007,': [807], 'statistical': [810, 3041], 'methods': [811, 2366, 3286], 'developed': [812, 2505], 'became': [817, 1218, 1475], 'template': [819], 'subsequent': [821, 1177, 1646], 'reports.': [823], 'One': [824, 1539], 'method': [826], 'multivariate': [828], 'analysis,': [829, 910], 'which': [830, 1596, 2196, 2903, 2937], 'risk': [835, 1216, 1223, 1243, 1472, 1680, 1813, 1984, 2115, 2349, 2974], 'factors': [836, 1224, 1244, 1467, 1681, 2350], 'death': [838, 866, 1226, 1271, 1474], 'MCSDs.': [842, 2151, 2414, 2537], 'report,10': [847], 'older': [848, 1276, 1479, 1687], 'age,': [849, 1277], 'presence': [851, 1488, 1560, 2153], 'ascites': [853], 'implantation,': [858, 1011, 1198, 1261, 1289], 'increased': [860, 1470, 1983, 2302], 'serum': [861, 1283, 2639], 'bilirubin': [862], 'associated': [864, 1468], 'placement.': [869, 2016], 'effects': [872, 2083], 'shock': [875, 1121], 'hemodynamic': [877, 1517], 'instability': [878, 1518], 'showing': [888], 'substantially': [889], 'diminished': [890], 'survival': [891, 1410, 1584, 1667, 1867, 1894, 2101, 4066], 'level': [896, 1124, 1157, 1169, 1191, 1203, 1348, 1384, 1420, 1458, 1698, 1825], 'compared': [901, 1668, 2439, 2535, 2543, 3359], 'classifications.18': [905], 'Another': [906, 2095], 'method,': [907], 'competing': [908, 969], 'depict': [914], 'proportions': [916], 'experiencing': [919], 'following': [921, 2469], 'implantation:': [925], 'alive': [926, 1016, 1910, 1929], 'dead,': [931], 'explanted': [933, 3024], 'because': [934, 2202, 2852], 'recovery': [936, 3026], 'native': [939], 'heart,': [940], 'or': [941, 1026, 1377, 1395, 1438, 1593, 1902, 1975, 2113, 2261, 2452, 3023, 3259], 'status': [942, 1700], 'post–cardiac': [943], 'transplantation': [944, 1045], '(Figure': [945, 1649, 1703], '1).': [946], 'Publication': [947, 2777], 'quarterly': [952, 2565], 'reports13': [953], 'reinforces': [954], 'message': [956], 'gives': [960], 'updates': [962], 'participants.Download': [964], 'figureDownload': [965, 1718, 1793, 1989], 'PowerPointFigure': [966, 1719, 1794, 1990], '1.': [967, 1349], '(alive': [976, 1017], 'device,': [978, 984, 1019, 1025], 'recovered': [979, 1020, 1916], 'removal': [981, 1022], 'transplanted,': [985, 1914, 3022], 'dead)': [987], 'shown': [989, 1600, 1630, 1749], 'all': [991, 2527, 2553], 'March': [1002], '2011.': [1004], 'Note': [1005, 1757], '81%': [1012], 'transplanted).The': [1027], 'second': [1028, 2215], 'contemporaneous': [1033, 2920], 'continuous-flow': [1039, 1065, 1106, 2078, 3902], 'pump': [1040, 1077, 1918, 3338, 3602], 'bridge': [1043], '(HeartMate': [1046, 3340], 'II': [1047, 3341], 'left': [1048, 1107, 1295, 1435, 1789, 1833, 1850, 1872, 2012, 2054, 2896, 3342, 3589, 3903, 3940, 4179, 4213], 'VAD;': [1049, 3343], 'Thoratec': [1050], 'Corp,': [1051], 'Pleasanton,': [1052], 'CA;': [1053], 'April': [1054, 2833, 3506], '2008).': [1055], 'Subsequent': [1056], 'documented': [1060, 1557], 'rapid': [1062], 'adoption': [1063], 'technology': [1066, 1333, 2079], 'concomitant': [1069, 1254], 'marked': [1070], 'decrease': [1071, 1336], 'pulsatile': [1076, 1331, 4139], 'designs.': [1078], 'third': [1084, 1238, 2761], 'report,16': [1087], 'rate': [1089, 1760, 2102], 'States': [1096], 'accelerating,': [1098], 'majority': [1101, 1925], 'VADs.': [1108, 1851], 'Importantly,': [1109, 2516], 'profile': [1111, 1805, 2950, 2975], 'undergoing': [1114], 'VAD': [1115, 1332, 1436, 1873, 1934, 2107], 'shifted': [1117], 'critical': [1119, 1246], '1)': [1125], 'progressively': [1127], 'declining': [1128, 1172], 'despite': [1131, 1572], 'therapy': [1133, 2451, 3736, 3978], '2': [1137, 1170, 1423], '3).': [1139], 'For': [1140, 1220], 'example,': [1141, 1221, 1741], 'period': [1144, 1178, 1648, 2217, 2674], '2006': [1147], '2008,': [1150], '34.7%': [1151], '(patients': [1159], '40%': [1163], 'categorized': [1166], '(progressively': [1171], 'failure).': [1174], 'January': [1180], '2009': [1181], '2010,': [1184], 'only': [1185, 2487], '17.3%': [1186], 'whereas': [1199], '45.2%': [1200], '2.': [1204, 1720], 'With': [1205, 1954], 'larger': [1207], 'number': [1208, 1783, 2117, 2135], 'longer': [1212], 'follow-up,': [1213], 'refinement': [1214], 'modeling': [1217], 'possible.': [1219], 'divided': [1228], 'hazard': [1231, 1234], 'constant': [1233], 'phases': [1235], 'report.16': [1241], 'Early-phase': [1242], 'shock,': [1248], 'higher': [1249, 1713, 1764, 1782], 'urea': [1251, 1715], 'nitrogen': [1252, 1716], 'level,': [1253], 'surgery': [1255, 1702], 'requirement': [1263, 1706], 'biventricular': [1265, 1708, 2106, 4112, 4243], 'assistance.': [1266, 3591, 3605], 'Constant': [1267], '(late)-phase': [1268], 'risks': [1269, 1514], 'diabetes': [1278], 'mellitus,': [1279], 'pulmonary': [1280, 3152, 3190], 'hypertension,': [1281], 'lower': [1282, 2100], 'sodium': [1284], 'pulsatile-flow': [1294], 'VAD.The': [1296], 'fourth': [1297, 1316], 'passed': [1301], 'milestone': [1303], 'enrolling': [1305], '>4000': [1306], 'database.17': [1310], 'era': [1313], 'ending': [1318], '30,': [1320], '2011,': [1321, 3459], 'persistent': [1324], 'migration': [1325], 'away': [1326, 2233], 'VADs': [1342, 2055, 2123], 'classified': [1345, 1455], 'Unfortunately,': [1350], 'collected': [1354, 3234], 'who': [1359, 1652, 1671, 2052, 2058], 'undergo': [1360], 'but': [1366], 'do': [1367], 'receive': [1369, 2259], 'MCSD.': [1372, 2456], 'types': [1374], 'management': [1378, 2379], 'strategies': [1379], 'unknown': [1391], 'beyond': [1392], 'single-institution': [1393, 2185], 'reports19': [1394], 'studies': [1397, 2043, 2186], 'supported': [1398, 2120, 2148], 'MCSD.20': [1404], 'Furthermore,': [1405, 3154], 'hypothesis': [1407], 'improved': [1413], 'converting': [1415], 'temporary': [1428, 4076], 'Impella': [1433], '5.0': [1434], '[Abiomed]': [1437], 'extracorporeal': [1439, 4077], 'membrane': [1440], 'oxygenation)': [1441], 'remains': [1442, 2124], 'untested.': [1443], 'interesting': [1446, 2851], 'prevalence': [1452], 'implant': [1464], 'decreased,': [1465], 'common': [1477, 1634], 'age': [1480, 1688, 1778], 'prior': [1490], 'surgery).': [1492], 'Thus,': [1493], 'it': [1494, 1920, 2293, 2462, 2746, 3055], 'appears': [1495, 1810], 'high-risk': [1497], 'per': [1499], 'se': [1500], 'avoided.': [1503], 'Rather,': [1504], 'accepting': [1507], 'shock.The': [1521], 'address': [1528], 'several': [1529], 'questions': [1531, 2045], 'support.': [1538, 2358, 2732, 3668, 4079], 'assessment': [1544, 2270], 'infection': [1546, 1562, 1582, 1622, 1628, 1656, 1675, 1683, 1743, 1762], 'patients.21': [1549], 'A': [1550], '2010': [1551], 'et': [1555], 'al21': [1556], 'continued': [1559, 3498], 'relatively': [1565, 3173], 'frequent': [1566], 'event': [1568, 1624, 1658, 1677, 2519, 3265], 'attempts': [1573], 'prevent': [1575], 'it.': [1576], 'influence': [1580, 1822, 1841, 1863, 2006], 'demonstrated': [1586, 2955], 'absence': [1589], 'full-blown': [1591], 'sepsis': [1592, 1594], 'syndrome,': [1595], 'Randomized': [1603], 'Evaluation': [1604], 'Mechanical': [1606, 3488, 3731], 'Assistance': [1607], 'Treatment': [1610], 'Congestive': [1612], 'Failure': [1614], '(REMATCH)': [1615], 'Trial.22': [1616], 'examined,': [1626], 'months': [1639, 1769, 1932, 2669], '2).': [1650], 'Patients': [1651], 'suffered': [1653], 'before': [1659, 1701, 2198, 2678], 'month': [1661], 'significantly': [1665, 1781], 'worse': [1666, 3174], 'later.': [1678], '(dichotomized': [1689], '60': [1691, 1753], 'years': [1692, 1754, 1776], 'age;': [1694], 'Figure': [1695, 1950], '2),': [1696], '3),': [1704], 'levels.21Download': [1717], 'wide': [1735], 'range': [1736], 'analyses.': [1738, 1904], 'cumulative': [1742, 1785, 1827], 'dichotomized': [1751], 'age.': [1756], '>60': [1775], 'infections.': [1786], 'LVAD': [1787, 1831], 'indicates': [1788, 1832], 'device.Download': [1792], '3.': [1795], '(INTERMACS': [1806], '1–7)': [1808], 'consistently': [1809], 'factor': [1814], 'events.': [1817], 'depiction,': [1820], 'infections': [1828], 'shown.': [1830], 'device.Another': [1836], 'question': [1838], 'sex': [1843, 1865, 1942, 2008], 'outcome': [1845, 2010, 2156], 'placement': [1847, 1935], 'analysis': [1854, 1994, 3053, 4040], '2012,': [1857], 'Hsich': [1858, 4194], 'coauthors23': [1860], 'examined': [1861], 'implantation.': [1874], 'This': [1875, 2359, 2892, 2922], 'found': [1877], 'mean': [1881], 'months,': [1886], 'no': [1889, 1961, 2662], 'statistically': [1890, 1962], 'significant': [1891, 1963], 'differences': [1892, 1965], 'men': [1896], 'women': [1898, 1945, 4211], 'either': [1900], 'nonadjusted': [1901], 'risk-adjusted': [1903], 'When': [1905], 'one': [1906], 'summates': [1907], 'removal,': [1919], 'becomes': [1921], 'apparent': [1922], '6': [1931, 2668], 'current': [1938, 3849], 'era,': [1939], 'regardless': [1940], '(77%': [1943], '83%': [1947], 'men;': [1949], '4A': [1951], 'B).': [1953], 'regard': [1955, 3102], 'events,': [1958, 1974, 2717, 3149], 'sex-based': [1964], 'infection,': [1971], 'bleeding': [1972], 'malfunction.': [1977], 'However,': [1978, 2129], 'female': [1979], 'neurological': [1986, 2069], 'events.Download': [1988], '4.': [1991], 'Competing': [1992], 'comparisons,': [1999], 'case': [2002, 2572, 3351], 'determine': [2004], 'A,': [2017], 'Survival': [2018, 2022, 4241], 'women.': [2020], 'B,': [2021, 3882], 'men.Several': [2024], 'abstracts': [2025], 'presented': [2028, 2820], 'international': [2032], 'analyses': [2038, 2142, 2179], 'data.': [2041, 2788, 4043], 'addressed': [2044], 'engineers': [2057], 'design': [2059, 3095, 3283, 3339], 'them.': [2060], 'Examples': [2061], 'determining': [2063], 'whether': [2064, 2098], 'incidence': [2066], 'changed': [2073], 'since': [2074], 'introduction': [2076, 3587], 'quantifying': [2081], 'preimplantation': [2085], 'nutritional': [2086], 'state': [2087], 'hepatic': [2089], 'function': [2090], 'postimplantation': [2092], 'outcome.': [2094], 'presentation': [2096, 3176], 'determined': [2097, 3057], 'requiring': [2105], 'related': [2110], 'factors.24The': [2116], 'children': [2119], 'low': [2125], 'relative': [2126], 'adults.': [2128], 'now': [2132, 2212, 2240, 2417], 'sufficient': [2134], 'pediatric': [2137, 2146, 2169], 'initiate': [2140], 'INTERMACS-based': [2141], 'pediatric-specific': [2150, 2176], 'robust': [2155], 'essential': [2159], 'measuring': [2161], 'outcomes,': [2163], 'reviewing': [2164], 'emerging': [2166], 'evaluating': [2174, 2412], 'novel': [2175, 2365, 2393], 'devices.25': [2177], 'evaluated': [2181], 'light': [2183], 'trials,': [2193, 2427], 'both': [2194, 3236], 'appear': [2197], 'limited': [2205], 'FDA-approved': [2209], 'MCSDs.INTERMACS': [2210], 'contractual': [2216], 'sources': [2227], 'work': [2230], 'evolving': [2232], 'governmental': [2235], 'agencies.': [2236], 'Specifically,': [2237], 'fees': [2238, 2254], 'paid': [2241], 'implanting': [2243, 2276], 'sites': [2244, 2277], 'industrial': [2246], 'participate': [2249], 'INTERMACS.': [2251, 2593, 2622, 2771, 4220], 'Payment': [2252], 'entitles': [2255], 'each': [2256, 2479, 2655], 'site-specific': [2260], 'device-specific': [2262], 'crucial': [2267], 'efforts': [2274], 'similarly': [2280], 'industry.': [2291], 'Ultimately,': [2292], 'expected': [2295], 'will': [2299, 2345, 2361], 'effectiveness': [2304, 2949], 'safety.INTERMACS:': [2306], 'Future': [2310], 'Hold?INTERMACS': [2311], 'postmarketing': [2316], 'paradigm': [2323, 2860, 3761], 'internal': [2334], 'cardioverter-defibrillators.26,27': [2335], 'As': [2336], 'moves': [2341], 'forward,': [2342], 'continue': [2346], 'identify': [2348], 'mortality': [2353], 'morbidity': [2355], 'during': [2356], 'help': [2362], 'formulate': [2364], 'nullify': [2368], 'risks.': [2370], 'Possible': [2371], 'approaches': [2372], 'changes': [2374, 2381], 'surgical': [2376], 'techniques,': [2380], 'engineering': [2384], 'existing': [2386], 'completely': [2392], 'MCSDs.One': [2394], 'inception': [2400], 'new': [2413, 2859, 2887, 3760], 'Some': [2415], 'comparison': [2423, 2813, 2969, 3263, 3386], 'arm': [2424, 2814, 3124, 3143, 3171, 3182, 3241, 3258, 3296], 'although': [2428, 3227, 3396], 'purpose': [2436], 'limitations': [2438], 'prospectively': [2447], 'randomized': [2448, 3367], 'Aspects': [2457], 'distinguish': [2461], 'typical': [2465], 'items.': [2470], 'There': [2471], 'criteria': [2473, 3159], 'inclusion': [2475, 3110], 'must': [2481], 'included).': [2498], 'physicians,': [2510, 3514], 'regulatory': [2514, 3522], 'community.': [2515], 'uniformly': [2525], 'between': [2536, 3199, 3267], 'Entries': [2538], 'records': [2545], 'manufacturers': [2547, 2558], 'ensure': [2549], 'complete': [2550, 2577], 'reporting': [2551], 'cases.': [2554], 'received': [2560], 'basis.': [2566], 'does': [2568], 'accept': [2570], 'incomplete': [2571], 'forms,': [2574], 'thereby': [2575], 'ensuring': [2576], 'entry.': [2579], 'Completeness': [2580], 'monitored': [2586], 'Data': [2589, 2623, 2773, 2798, 3532], 'Coordinating': [2590, 2799], 'Form': [2594], 'completion': [2595, 2677], 'rates': [2596, 3254, 3266], '<90%': [2598], 'trigger': [2599], 'phone': [2601], 'call': [2602], 'local': [2605, 2698], 'investigators': [2607, 2795], 'improve': [2609], 'follow-up.': [2610], 'Lack': [2611], 'remediation': [2613], 'expulsion': [2617], 'screened': [2625], 'entry': [2630], 'detect': [2632], 'outliers': [2633], 'may': [2635], 'represent': [2636], 'mistakes': [2637], 'creatinine': [2640], '17': [2642], 'instead': [2643], '1.7': [2645], 'mg%),': [2646], 'telephone': [2652], 'audit': [2653], 'site.': [2656], 'frozen': [2660], 'modification': [2663], 'data)': [2666], '1-month': [2672], 'grace': [2673], 'freezing.': [2679], 'Regulatory': [2680], 'follows:': [2686], 'compliance': [2687], 'HIPPA': [2689], 'regulations,': [2690], 'human': [2691], 'subjects': [2692], 'training': [2693], 'investigators,': [2696], 'board': [2701], 'sites,': [2707], 'informed': [2709], 'consent': [2710], 'patient.': [2713], 'Outcomes,': [2714], 'Two': [2733], 'adjudication.': [2737], 'If': [2738], 'disagreement': [2741], 'review,': [2745], 'resolved': [2748], 'member': [2751], 'Adverse': [2755, 3812], 'Event': [2756, 3813], 'Committee': [2757, 2778], 'acting': [2758], 'reviewer.': [2762], 'An': [2763], 'Observational': [2764], 'Study': [2765], 'Monitoring': [2766, 3535], 'Board': [2767, 2848], 'oversight': [2769], 'Access,': [2774], 'Analysis,': [2775], 'reviews': [2779], 'requests': [2780], 'research': [2782], 'That': [2789], 'then': [2791], 'study': [2794, 2962, 3009, 3019, 3064], 'perform': [2802], 'thoughtfully': [2803], 'planned': [2804], 'analyses.The': [2805], 'trial': [2818, 2901, 3094, 3127], 'System': [2825, 2845], 'Devices': [2826, 2846, 3697], 'Advisory': [2827, 2847], 'Panel': [2828], 'HeartWare,': [2830, 3541], 'Inc': [2831, 3542], '25,': [2834], '2012.28': [2835], 'Executive': [2838, 2880, 2990, 3078], 'Summary29': [2839], 'Questions': [2841], 'Panel30': [2849], 'INTERMACS)': [2870], 'expectations': [2875], 'noninferiority': [2878, 3014], 'trial.31The': [2879], 'Summary': [2881, 2991, 3079], 'set': [2882], 'agenda': [2884], 'approach': [2888, 2995], 'statement:': [2891], '(LVAD)': [2900], 'being': [2916], 'control.': [2921], 'memorandum': [2923], 'summarizes': [2924], "FDA's": [2925], 'highlights': [2932], 'particular': [2934], 'areas': [2935], 'we': [2938], 'seeking': [2940], 'your': [2941], 'input.': [2942], 'topics': [2944], 'safety': [2947], 'conducted': [2963], 'Sponsor,': [2966], 'benefit': [2972, 3402], 'currently': [2982], 'marketed': [2983], 'same': [2987, 3032], 'indication.29Moreover,': [2988], 'described': [2992], 'conservative': [2994], 'venture': [2999], 'limitations:': [3006], 'designed': [3011], 'evaluate': [3013], 'proportion': [3017, 3033], 'alive,': [3021], '180': [3028], 'days': [3029], 'obtained': [3034], 'cohort.': [3038], "study's": [3040], 'plan': [3042], 'allowed': [3043, 3163], 'traditional,': [3046], 'PG': [3047], '(performance': [3048], 'goal)-based': [3049], 'primary': [3050, 3939], 'end': [3051], 'point': [3052], 'if': [3054], 'two': [3063, 3108], 'arms': [3065], 'enough': [3069], 'baseline': [3071], 'characteristics': [3072], 'justify': [3074], 'treatment-control': [3076], 'comparison.29The': [3077], 'potential': [3082, 3400], 'pitfalls': [3083], 'comparisons': [3085], 'population:': [3089], 'accepted': [3091], 'incorporated': [3096], 'differing': [3097, 3285], 'degrees': [3098], 'specificity': [3100], 'characterization': [3105], "arms'": [3109], 'criteria.': [3113], 'believes': [3115, 3194], 'HeartWare': [3118, 3180, 3218, 3269], 'VAS': [3119, 3181, 3219, 3270], '(Ventricular': [3120], 'Assist': [3121, 3637], 'System)': [3122], 'treatment': [3123, 3238, 3271, 3295], 'comprised': [3129], 'narrowly': [3133], 'defined': [3134, 3229], 'population': [3136], 'control': [3142, 3170, 3240, 3257, 3274, 3306], 'lack': [3145], 'recent': [3147], 'designation': [3150], 'hypertension).': [3153], 'some': [3155], 'analogous': [3158], 'could': [3160], 'conceivably': [3161], 'degree': [3184, 3188], 'renal': [3186], 'impairment,': [3187], 'impairment).': [3191], 'Accordingly,': [3192], 'appropriate': [3196], 'balance': [3198], 'eight': [3203], 'prespecified': [3204], 'propensity': [3205], 'score': [3206], 'covariates…may': [3207], 'quite': [3209], 'when': [3211], 'considering': [3212], 'overall': [3214], 'comparability': [3215], 'baseline.As': [3224], 'mentioned': [3225], 'previously,': [3226], 'identically': [3228], 'patients,': [3242], 'protocol': [3244, 3282], 'did': [3245], 'prespecify': [3247], 'consideration': [3249], 'consequently': [3260], 'direct': [3262], 'arms.': [3275], 'Justification': [3276], 'handling': [3288], '(monitoring': [3290], 'adjudication': [3292, 3300], 'versus': [3297], 'auditing': [3298], 'arm).29The': [3307], 'advantages': [3308], 'disadvantages': [3310, 3330], 'premarket': [3314, 3379], 'yet': [3320], 'fully': [3323], 'defined.': [3324], 'At': [3325], 'perceived': [3329], 'dominance': [3333], 'Thoratec)': [3344], 'less': [3347], 'rigorous': [3348], 'monitoring': [3349, 3361], 'forms': [3353], 'source': [3355], 'documents': [3356], 'prospective': [3366], 'trial.': [3369], 'putative': [3372], 'advantage': [3373], 'expediting': [3377], 'process': [3381], 'serving': [3383], 'proven,': [3395], 'cycle': [3405], 'MCSDs.The': [3408], 'final': [3409], 'frontier': [3410], 'registries': [3413, 3479], 'cross': [3416], 'geographic': [3417], 'borders.': [3418], 'Databases': [3419], 'outside': [3420], 'America': [3423], 'European': [3428], '(EuroMACS),': [3430], 'Japanese': [3432], '(J-MACS),': [3437], 'French': [3439], 'database,': [3443, 3449, 3455], 'British': [3445], 'Belgian': [3451], 'ISHLT': [3461, 3487, 3501], 'leadership': [3464], 'Kirklin': [3467, 3671, 3727, 3776, 3840, 3914, 3952, 3990, 4036, 4123, 4239], 'David': [3469], 'Naftel': [3470, 3729, 3778, 3834, 3916, 3954, 3992, 4030, 4125, 4196, 4229], 'began': [3471], 'talks': [3472], 'consolidate': [3477], 'single': [3482], 'global': [3483, 3526], 'called': [3485], '(IMACS).': [3493], 'Talks': [3494], 'establish': [3496], 'IMACS': [3497], 'meeting': [3502], 'Prague': [3504], '2012': [3507], 'expand': [3509], 'reach': [3511], 'engineers,': [3515], 'members': [3517], 'business': [3520], 'communities': [3523], 'level.32DisclosuresDr': [3527], 'served': [3530], 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