Open heart · 2026
Subcutaneous versus transvenous implantable cardioverter-defibrillator therapy: an updated systematic review and meta-analysis.
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Muhammad Fahad, Jamileh Eyad, Farooq Omar, Abusheikha Mohammad, Hosseini Kaveh, Abdin Amr, Ng G André, Antoun Ibrahim
Аннотация
BACKGROUND: The subcutaneous implantable cardioverter-defibrillator (S-ICD) avoids intravascular leads but does not provide chronic bradycardia pacing or antitachycardia pacing. We performed an updated systematic review and meta-analysis comparing S-ICD with transvenous ICD therapy, prioritising contemporary randomised evidence and clinically relevant device trade-offs.
METHODS: Following Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) 2020 (PROSPERO: CRD420261328562), PubMed/MEDLINE, Embase and CENTRAL were searched from inception and rerun on 14 September 2026. Randomised evidence was prioritised, with non-randomised evidence analysed separately as supportive. Published time-to-event HRs were retained where available; sparse binary outcomes were analysed without blanket continuity correction, and incompatible endpoints or follow-up horizons were reported separately.
RESULTS: 23 reports representing 15 study/cohort families were included. In the published Prospective Randomized Comparison of Subcutaneous and Transvenous Implantable Cardioverter Defibrillator Therapy (PRAETORIAN)–Avoid Transvenous Leads in Appropriate Subjects (ATLAS) individual-participant-data analysis Transvenous Leads in Appropriate Subjects (ATLAS) individual-participant-data analysis, S-ICD was associated with a higher hazard of first inappropriate shock (HR 1.61, 95% CI 1.06 to 2.45). Trial-level analysis also showed a higher hazard of first appropriate shock (HR 1.54, 95% CI 1.14 to 2.09), although this finding was sensitive to the uncertainty method. Conversely, randomised evidence showed fewer lead-related complications with S-ICD in PRAETORIAN (HR 0.24, 95% CI 0.10 to 0.54) and fewer major lead-related perioperative complications in ATLAS (risk difference −4.4 percentage points, 95% CI −6.9 to −1.9). The two-trial all-cause mortality estimate was imprecise (HR 1.22, 95% CI 0.89 to 1.66). Infection, pneumothorax and tamponade outcomes were sparse and definition-dependent. PRAETORIAN-Extended Long-Term Follow-Up (XL) provided supportive extended follow-up but was not treated as an independent trial.
CONCLUSIONS: Randomised evidence suggests fewer lead-related and invasive device complications with S-ICD but a higher hazard of first inappropriate shock. First-appropriate-shock inference was method-sensitive, while mortality and rare-event comparisons remained uncertain. Device selection should therefore consider pacing and antitachycardia-pacing requirements, future procedures, infection severity and patient preferences without inferring equivalence from non-significant results.
PROSPERO REGISTRATION NUMBER: CRD420261328562.
METHODS: Following Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) 2020 (PROSPERO: CRD420261328562), PubMed/MEDLINE, Embase and CENTRAL were searched from inception and rerun on 14 September 2026. Randomised evidence was prioritised, with non-randomised evidence analysed separately as supportive. Published time-to-event HRs were retained where available; sparse binary outcomes were analysed without blanket continuity correction, and incompatible endpoints or follow-up horizons were reported separately.
RESULTS: 23 reports representing 15 study/cohort families were included. In the published Prospective Randomized Comparison of Subcutaneous and Transvenous Implantable Cardioverter Defibrillator Therapy (PRAETORIAN)–Avoid Transvenous Leads in Appropriate Subjects (ATLAS) individual-participant-data analysis Transvenous Leads in Appropriate Subjects (ATLAS) individual-participant-data analysis, S-ICD was associated with a higher hazard of first inappropriate shock (HR 1.61, 95% CI 1.06 to 2.45). Trial-level analysis also showed a higher hazard of first appropriate shock (HR 1.54, 95% CI 1.14 to 2.09), although this finding was sensitive to the uncertainty method. Conversely, randomised evidence showed fewer lead-related complications with S-ICD in PRAETORIAN (HR 0.24, 95% CI 0.10 to 0.54) and fewer major lead-related perioperative complications in ATLAS (risk difference −4.4 percentage points, 95% CI −6.9 to −1.9). The two-trial all-cause mortality estimate was imprecise (HR 1.22, 95% CI 0.89 to 1.66). Infection, pneumothorax and tamponade outcomes were sparse and definition-dependent. PRAETORIAN-Extended Long-Term Follow-Up (XL) provided supportive extended follow-up but was not treated as an independent trial.
CONCLUSIONS: Randomised evidence suggests fewer lead-related and invasive device complications with S-ICD but a higher hazard of first inappropriate shock. First-appropriate-shock inference was method-sensitive, while mortality and rare-event comparisons remained uncertain. Device selection should therefore consider pacing and antitachycardia-pacing requirements, future procedures, infection severity and patient preferences without inferring equivalence from non-significant results.
PROSPERO REGISTRATION NUMBER: CRD420261328562.