Table 4.
Variable | Device Group (N = 1524) | Control Group (N = 778) | P Value |
---|---|---|---|
no. of participants with event (%) | |||
No. of total shocks | <0.001 | ||
0 | 1495 (98.1) | 777 (99.9) | |
1 | 20 (1.3) | 0 | |
≥2 | 9 (0.6) | 1 (0.1) | |
No. of appropriate shocks | 0.008 | ||
0 | 1504 (98.7) | 777 (99.9) | |
1 | 13 (0.9) | 0 | |
≥2 | 7 (0.5) | 1 (0.1) | |
No. of inappropriate shocks | 0.12 | ||
0 | 1515 (99.4) | 778 (100) | |
1 | 7 (0.5) | 0 | |
≥2 | 2 (0.1) | 0 | |
No. of shocks aborted by pressing response button† | <0.001 | ||
0 | 1455 (95.5) | 777 (99.9) | |
1 | 43 (2.8) | 1 (0.1) | |
2–5 | 11 (0.7) | 0 | |
>5 | 15 (1.0) | 0 | |
No. of alarms indicating arrhythmia | <0.001 | ||
0 | 432 (28.3) | 762 (97.9) | |
1 | 115 (7.5) | 1 (0.1) | |
2–5 | 252 (16.5) | 2 (0.3) | |
6–100 | 579 (38.0) | 12 (1.5) | |
>100 | 146 (9.6) | 1 (0.1) | |
No. of alarms indicating asystole | <0.001 | ||
0 | 1483 (97.3) | 777 (99.9) | |
1 | 22 (1.4)‡ | 0 | |
≥2 | 19 (1.2)‡ | 1 (0.1) |
Shown are the numbers of participants who had an event over the entire 90-day period. The wearable cardioverter– defibrillator was used by 20 participants in the control group, who received the device outside the protocol. Percentages may not total 100 because of rounding. P values were not corrected for multiple comparisons.
This analysis included arrhythmia alarms lasting more than 30 seconds that were aborted when the participant pressed the shock-suppression button.
Among 41 participants with an alarm indicating asystole, 6 events (all in the device group) were adjudicated as having had a true asystole event.