Table 2:
Trials of Pacemakers for NCS
Study | Type of Study | Inclusion Criteria | Number of Patients (Intervention/Control) | Intervention/Control | Mean Follow-up | Syncope Recurrence (Intervention/Control) |
---|---|---|---|---|---|---|
Connolly et al. 199933 | Nonblinded RCT | ≥ six episodes of syncope plus HUT with relative bradycardia | 54 (27/27) | DDD with rate-drop response/standard treatment | 1 year | 22%/70% (p < 0.0001) |
Sutton et al. 200034 | Nonblinded RCT | ≥ three episodes of syncope in two years; VASIS IIa or IIb on HUT |
42 (19/23) | DDI with hysteresis/no therapy | 3.7 years | 5%/61% (p = 0.0006) |
Ammirati et al. 200135 | Nonblinded RCT | ≥ three episodes of syncope in two years plus HUT with relative bradycardia | 93 (46/47) | DDD with rate-drop response/atenolol | 520 days | 4.3%/25.5% (p = 0.004) |
Connolly et al. 200336 | Double-blinded RCT | ≥ six total episodes of syncope or ≥ three episodes in two years plus HUT with heart rate × blood pressure < 6,000 bpm × mmHg | 94 (42/52) | DDD with rate-drop response/sensing only (ODO) | 6 months | 33%/42% (p = 0.14) |
Raviele et al. 200437 | Double-blinded RCT | ≥ six episodes of syncope plus HUT with asystolic or mixed response | 29 (16/13) | DDD with rate-drop response/no pacing (OOO) | 715 days | 50%/33% (p = not reported) |
Brignole et al. 200639 | Observational | ≥ three episodes of syncope in two years | 392 | Implantable loop recorder- based specific therapy (pacemaker, anti-tachycardia therapy)/no therapy | 9 months | 11%/35% (p = 0.002) |
Brignole et al. 201440 | Double-blinded RCT | ≥ three episodes of syncope in two years; ILR-documented asystolic response | 77 (38/39) | DDD with rate-drop response/sensing only (ODO) | 2 years | 25%/57% (p = 0.039) |
Flammang et al. 201241 | SIngle-blinded RCT | Isolated or recurrent syncope; > 10-second pause on ATP test | 80 (39/41) | DDD/backup pacing (AAI) | 16 months | 66%/21% (p = not reported) |
NCS: neurocardiogenic syncope; RCT: randomized controlled trial; HUT: head-up tilt test; ILR: implantable loop recorder; ATP: adenosine triphosphate.