Arrhythmias & electrophysiology
Subcutaneous Implantable Cardioverter-Defibrillator: A Systematic Review of Comparative Effectiveness and Safety
Pooled result · Inappropriate shocks and device-related complications (RCT)Result — go to the resultHazard ratio 0.99 95% CI 0.71–1.39Authors' conclusion
The available evidence is insufficient to show the superiority of S-ICD compared with TV-ICD, hindering the widespread use of the technology.
Study context
- Population
- Patients at increased risk of SCD with an ICD indication for primary or secondary prevention1 RCT (n = 849) + 4 observational (n = 7149)
- Comparison
- S-ICD vs TV-ICD
- Outcome
- Primary composite endpoint of the RCT
- Follow-up
- 4 years
Methodological detailsGrading of Recommendations, Assessment, Development, and Evaluation (GRADE) evidence grading, Evidence graded low to very low, except moderate for the RCT primary composite endpoint
- GRADE evidence grading
- Evidence graded low to very low, except moderate for the RCT primary composite endpoint
Pooled result
As reported in the abstract
Inappropriate shocks and device-related complications (RCT)
Hazard ratio
0.99
95% CI 0.71–1.39
P = 0.001
Events by group
S-ICDvs TV-ICD
HR 0.99 (95% CI 0.71–1.39); P = 0.001
Further pooled results
| Outcome | S-ICD | TV-ICD | HR (95% CI) | P value | |
|---|---|---|---|---|---|
| Appropriate shocks (RCT) | 19.2% | 11.5% | 1.52 (1.08–2.12) | P = 0.02 | |
| 0.512Hazard ratio (log scale) |
| Outcome | S-ICD | TV-ICD | P value |
|---|---|---|---|
| Appropriate shocks (one observational study) | 9.9% (95% CI 7.0–13.9) | 13.9% (95% CI 10.8–17.8) | P = 0.003 |
Overall mortality and shock efficacy
- No significant difference in any included study
- P > 0.05
Safety
| Outcome | S-ICD | TV-ICD | HR (95% CI) | |
|---|---|---|---|---|
| Lead complications (RCT) · 4 years | 1.4% | 6.6% | 0.24 (0.10–0.54) | |
| 0.10.31310Hazard ratio (log scale) |
Lead complications (observational study) · 3 years
P = 0.03
Lead complications (observational study) · 5 years
P = 0.03
Inappropriate shocks (one observational study)
P = 0.007
- Inappropriate shocks (one observational study) — RCT and two other observational studies: no significant difference
- P > 0.05
Original publication
Subcutaneous Implantable Cardioverter-Defibrillator: A Systematic Review of Comparative Effectiveness and Safety. ESC Heart Fail. Published 29 November 2022. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →