Arrhythmias & electrophysiology
Inappropriate Therapy and Shock Rates Between the Subcutaneous and Transvenous Implantable Cardiac Defibrillator: A Secondary Analysis of the PRAETORIAN Trial
Primary result · Inappropriate therapyResult — go to the resultHazard ratio 0.99 95% CI 0.65–1.52Authors' conclusion
There was no significant difference in IAT and IAS rates between the S-ICD and TV-ICD in a conventional ICD population, but causes and predictors for IAT differed between the devices. After the first IAS, an intervention significantly reduced the recurrence rate of IAS.
Study context
- Population
- Patients with an indication for implantable cardiac defibrillator (ICD) therapymodified ITT
- Participants
- 849 patients
- Comparison
- Subcutaneous ICD (S-ICD) vs transvenous ICD (TV-ICD)
- S-ICDn = 426
- TV-ICDn = 423reference
- Primary endpoint
- Inappropriate therapy (IAT)
- Follow-up
- 48 months
Methodological detailsinternational, multicentre, ICD programming mandated by protocol
- International
- Multicentre
- ICD programming mandated by protocol
Primary result
Inappropriate therapy · 48-month Kaplan-Meier cumulative incidence
Hazard ratio
0.99
95% CI 0.65–1.52
P = 0.97
Events by treatment group
As reported in the abstract
Further findings
Independent predictors of inappropriate therapy (IAT) (TV-ICD)
| HR (95% CI) | P value | ||
|---|---|---|---|
| Baseline heart rate >80 bpm | 1.99 (1.05–3.76) | P = 0.03 | |
| History of AF | 2.66 (1.41–5.02) | P = 0.003 | |
| Smoking | 2.46 (1.31–4.09) | P = 0.005 | |
| 0.20.5125Hazard ratio (log scale) |
Predictor of IAT by cardiac oversensing (S-ICD)
| HR (95% CI) | P value | ||
|---|---|---|---|
| QRS duration >120 ms | 3.13 (1.34–7.31) | P = 0.008 | |
| 0.10.31310Hazard ratio (log scale) |
| Outcome | S-ICD | TV-ICD |
|---|---|---|
| IAT episodes, IAS and inappropriate ATP | ||
| IAT episodes | 81 | 89 |
| IAS | 124 | 130 |
| Inappropriate ATP | 1 | 124 |
| Main cause of IAT episodes | 40/81 | 83/89 |
| Cause | cardiac oversensing | supraventricular tachycardias |
Inappropriate shock (patients)
- No significant difference between groups
- P = 0.14
Inappropriate shock (IAS) recurrence after post-IAS intervention
- Post-IAS interventions significantly reduced IAS recurrence in both groups
- P = 0.046
Original publication
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