Table 2.
Primary and secondary outcomes analysis
| Outcome events | Total (N = 106) | HeartMate 3 (N = 36; 34%) | HeartWare (N = 70; 66%) | P‐value |
|---|---|---|---|---|
| Follow‐up time (days) | 541.0 [246.0, 879.0] | 530.0 [326.0, 894.5] | 544.5 [219.0, 873.0] | 0.739 |
| Death | ||||
| Death overall | 28 (26.4%) | 12 (33.3%) | 16 (22.9%) | 0.247 |
| Death within 30 days | 6 (21.4%) | 4 (33.3%) | 2 (12.5%) | |
| Death after 30 days | 22 (78.6%) | 8 (66.7%) | 14 (87.5%) | |
| Days to death | 384.0 [58.0, 541.5] | 259.5 [13.0, 530.0] | 391.5 [214.5, 632.0] | 0.227 |
| Heart transplant | ||||
| Heart transplant overall | 47 (44.3%) | 4 (11.1%) | 43 (61.4%) | <0.001 |
| Heart transplant within 30 days | 0 (0%) | 0 (0%) | 0 (0%) | |
| Heart transplant after 30 days | 47 (100%) | 4 (100%) | 43 (100%) | |
| Days to heart transplant | 551.0 [219.0, 786.0] | 566.5 [372.5, 695.5] | 551.0 [209.0, 799.0] | 0.900 |
| MACCE | ||||
| MACCE overall | 67 (63.2%) | 21 (58.3%) | 46 (65.7%) | 0.456 |
| MACCE within 30 days | 32 (47.8%) | 12 (57.1%) | 20 (43.5%) | |
| MACCE after 30 days | 35 (52.2%) | 9 (42.9%) | 26 (56.5%) | |
| Days to MACCE | 115.0 [1.0, 260.0] | 19.0 [1.0, 301.0] | 123.5 [3.0, 254.0] | 0.750 |
| Major neurological dysfunction > 24 h | ||||
| Major neurological dysfunction overall | 22 (20.8%) | 5 (13.9%) | 17 (24.3%) | 0.211 |
| Major neurological dysfunction within 30 days | 10 (45.5%) | 4 (80.0%) | 6 (35.3%) | |
| Major neurological dysfunction after 30 days | 12 (54.6%) | 1 (20.0%) | 11 (64.7%) | |
| Days to major neurological dysfunction | 112.5 [1.0, 282.0] | 1.0 [1.0, 7.0] | 167.0 [1.0, 282.0] | 0.411 |
| Major bleeding | ||||
| Major bleeding overall | 44 (41.5%) | 16 (44.4%) | 28 (40.0%) | 0.660 |
| Major bleeding within 30 days | 22 (50.0%) | 10 (62.5%) | 12 (42.9%) | |
| Major bleeding after 30 days | 22 (50.0%) | 6 (37.5%) | 16 (57.1%) | |
| Days to major bleeding | 35.5 [3.5, 259.5] | 14.5 [1.0, 268.0] | 118.0 [5.5, 259.5] | 0.464 |
| Major device‐related infection excluding driveline | ||||
| Major device‐related infection excluding driveline overall | 5 (4.7%) | 2 (5.6%) | 3 (4.3%) | >0.99 |
| Major device‐related infection excluding driveline within 30 days | 1 (20.0%) | 0 (0%) | 1 (33.3%) | |
| Major device‐related infection excluding driveline after 30 days | 4 (80.0%) | 2 (100%) | 2 (66.7%) | |
| Days to major device‐related infection excluding driveline | 519.0 [354.0, 521.0] | 268.0 [354.0, 519.0] | 521.0 [10.0, 1977.0] | 0.800 |
| Major device malfunction, excluding pump thrombosis | ||||
| Major device malfunction overall | 23 (21.7%) | 3 (8.3%) | 20 (28.6%) | 0.017 |
| Major device malfunction within 30 days | 1 (4.4%) | 0 (0%) | 1 (5.0%) | |
| Major device malfunction after 30 days | 22 (95.7%) | 3 (100%) | 19 (95.0%) | |
| Days to major device malfunction | 391.0 [172.0, 784.0] | 612.0 [202.0, 784.0] | 328.0 [163.5, 863.5] | 0.635 |
| Pump thrombosis | ||||
| Pump thrombosis overall | 9 (8.5%) | 1 (2.8%) | 8 (11.4%) | 0.130 |
| Pump thrombosis within 30 days | 2 (22.2%) | 0 (0%) | 2 (25.0%) | |
| Pump thrombosis after 30 days | 7 (77.8%) | 1 (100%) | 6 (75.0%) | |
| Days to pump thrombosis | 233.0 [103.0, 526.0] | 1126.0 | 179.5 [53.0, 402.5] | 0.222 |
| Right heart failure | ||||
| RHF overall | 28 (26.4%) | 13 (36.1%) | 15 (21.4%) | 0.104 |
| RHF within 30 days | 5 (17.9%) | 2 (15.4%) | 3 (20.0%) | |
| RHF after 30 days | 23 (82.1%) | 11 (84.6%) | 12 (80.0%) | |
| Days to RHF | 199.0 [68.5, 331.0] | 223.0 [72.0, 330.0] | 189.0 [65.0, 332.0] | 0.892 |
| RHF‐related rehospitalization overall | 23 (21.7%) | 11 (30.6%) | 12 (17.1%) | 0.113 |
| RHF‐related rehospitalization within 30 days | 0 (0%) | 0 (0%) | 0 (0%) | |
| RHF‐related rehospitalization after 30 days | 23 (100%) | 11 (100%) | 12 (100%) | |
| Days to RHF‐related rehospitalizations | 223.0 [133.0, 350.0] | 252.0 [133.0, 350.0] | 212.0 [132.0, 473.5] | 0.976 |
| Driveline infection | ||||
| Driveline infection overall | 40 (37.7%) | 17 (47.2%) | 23 (32.9%) | 0.148 |
| Driveline infection within 30 days | 2 (5%) | 2 (11.8%) | 0 (0%) | |
| Driveline infection after 30 days | 38 (95%) | 15 (88.2%) | 23 (100%) | |
| Time to driveline infection | 198.0 [73.0, 325.5] | 131.0 [96.0, 250.0] | 199.0 [71.0, 339.0] | 0.665 |
| Driveline infection‐related surgical re‐interventions overall | 20 (18.9%) | 12 (33.3%) | 8 (11.4%) | 0.006 |
| Driveline infection‐related surgical re‐interventions within 30 days | 0 (0%) | 0 (0%) | 0 (0%) | |
| Driveline infection‐related surgical re‐intervention after 30 days | 20 (100%) | 12 (100%) | 8 (100%) | |
| Days to driveline infection‐related surgical re‐interventions | 226.5 [110.5, 458.5] | 233.5 [89.0, 512.0] | 187.0 [110.5, 423.0] | 0.851 |
| Gastrointestinal bleeding | ||||
| Major GI bleeding overall | 22 (20.8%) | 7 (19.4%) | 15 (21.4%) | 0.811 |
| GI bleeding within 30 days | 1 (4.6%) | 1 (14.3%) | 0 (0%) | |
| GI bleeding after 30 days | 21 (95.5%) | 6 (85.7%) | 15 (100%) | |
| Days to GI bleeding | 274.5 [159.0, 381.0] | 235.0 [36.0, 381.0] | 289.0 [161.0, 693.0] | 0.458 |
GI, gastrointestinal; MACCE, major device‐related adverse cardiac and cerebrovascular events; RHF, right heart failure.
Numeric variables are presented as median [quartiles] and were compared with Mann–Whitney U tests. Categorical variables are presented as numbers and percentages and were compared with Pearson's χ 2 test or Fisher's exact test as appropriate. Days to the respective endpoint, as well as the percentage within or after 30 days, are calculated only among those patients who actually had experienced the event. For outcomes in which multiple events are possible, numbers refer to the first episode. Percentages may not necessarily add up to 100% due to rounding error. MACCE: composite endpoint including any of the following events: (1) major neurological dysfunction > 24 h, (2) major bleeding, (3) major device‐related infection excluding driveline infections, (4) major device malfunction, and (5) pump thrombosis.