Rate and impact on patient outcome and healthcare utilization of complications requiring surgical revision: Subcutaneous versus transvenous implantable defibrillator therapy

Palmisano, Pietro; Ziacchi, Matteo; Ammendola, Ernesto; D’Onofrio, Antonio; Dell’Era, Gabriele; Laffi, Mattia; Biffi, Mauro; Nigro, Gerardo; Bianchi, Walter; Prenna, Eleonora; Angeletti, Andrea; Guido, Alessandro; Stronati, Giulia; Gaggioli, Germano; Russo, Antonio Dello; Accogli, Michele; Guerra, Federico; Pacing, Cardiac

doi:10.1111/jce.15080

Cited by 17 publications

(27 citation statements)

References 27 publications

(75 reference statements)

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“…Among 5 studies 12 , 27 , 28 , 29 , 30 (2387 patients), S‐ICD had a similar rate of device‐related complications (Figure 2 ) at follow‐up compared with TV‐ICD (RR, 0.59 [95% CI, 0.33–1.04]; P =0.070; I 2 =75%). Of these, lead‐related complications (Figure 3 ) occurred significantly less with S‐ICD (RR, 0.14 [95% CI, 0.07–0.29]; P <0.0001; I 2 =0%).…”

Section: Resultsmentioning

confidence: 96%

“…A total of 504 duplicates were removed, and the remaining 832 studies were screened by title and abstract. A total of 9 studies were identified for full‐text review, and 1 RCT 12 and 4 PSMs 27 , 28 , 29 , 30 comprising 2387 patients were included in this study (Figure 1 ).…”

Section: Resultsmentioning

confidence: 99%

“…Loss to long‐term follow‐up among all studies meant that the divergence was not statistically significant, with only 333 (16.3%) of the original 2049 patients having 5‐year follow‐up data. Although Palmisano et al 29 did not provide a risk table for the Kaplan–Meier curve of freedom from device‐related complications for their matched cohort and hence it was not used in IPD analysis, their Kaplan–Meier analysis of the overall cohort significantly favored S‐ICD ( P =0.001). This significant favoring from a time‐to‐event perspective combined with the fact that this study exhibited the largest effect size in the comparative meta‐analysis (Figure 2 ) suggest that its exclusion from IPD analysis may account for the numerical discrepancy between the derived RR and HR.…”

Section: Discussionmentioning

confidence: 99%

“… 37 Crucially, infections in TV‐ICDs are generally more serious, with a high rate of systemic involvement, 38 , 39 compared with S‐ICD, where infections are much more likely to be local. 40 In the studies included in this analysis, Palmisano et al 29 discussed systemic versus local infection in depth in their nonmatched cohort. All 12 infections occurring in the TV‐ICD arm were systemic, whereas the sole infection in the S‐ICD arm was not.…”

Section: Discussionmentioning

confidence: 99%

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Subcutaneous Versus Transvenous Implantable Defibrillator Therapy: A Systematic Review and Meta‐Analysis of Randomized Trials and Propensity Score–Matched Studies

Fong

Wang

et al. 2022

JAHA

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Background Subcutaneous implantable cardioverter‐defibrillators (S‐ICDs) have been of great interest as an alternative to transvenous implantable cardioverter‐defibrillators (TV‐ICDs). No meta‐analyses synthesizing data from high‐quality studies have yet been published. Methods and Results An electronic literature search was conducted to retrieve randomized controlled trials or propensity score–matched studies comparing S‐ICD against TV‐ICD in patients with an implantable cardioverter‐defibrillator indication. The primary outcomes were device‐related complications and lead‐related complications. Secondary outcomes were inappropriate shocks, appropriate shock, all‐cause mortality, and infection. All outcomes were pooled under random‐effects meta‐analyses and reported as risk ratios (RRs) and 95% CIs. Kaplan–Meier curves of device‐related complications were digitized to retrieve individual patient data and pooled under a 1‐stage meta‐analysis using Cox models to determine hazard ratios (HRs) of patients undergoing S‐ICD versus TV‐ICD. A total of 5 studies (2387 patients) were retrieved. S‐ICD had a similar rate of device‐related complications compared with TV‐ICD (RR, 0.59 [95% CI, 0.33–1.04]; P =0.070), but a significantly lower lead‐related complication rate (RR, 0.14 [95% CI, 0.07–0.29]; P <0.0001). The individual patient data–based 1‐stage stratified Cox model for device‐related complications across 4 studies yielded no significant difference (shared‐frailty HR, 0.82 [95% CI, 0.61–1.09]; P =0.167), but visual inspection of pooled Kaplan–Meier curves suggested a divergence favoring S‐ICD. Secondary outcomes did not differ significantly between both modalities. Conclusions S‐ICD is clinically superior to TV‐ICD in terms of lead‐related complications while demonstrating comparable efficacy and safety. For device‐related complications, S‐ICD may be beneficial over TV‐ICD in the long term. These indicate that S‐ICD is likely a suitable substitute for TV‐ICD in patients requiring implantable cardioverter‐defibrillator implantation without a pacing indication.

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Section: Resultsmentioning

confidence: 96%

Section: Resultsmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

See 2 more Smart Citations

Subcutaneous Versus Transvenous Implantable Defibrillator Therapy: A Systematic Review and Meta‐Analysis of Randomized Trials and Propensity Score–Matched Studies

Fong

Wang

et al. 2022

JAHA

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“…To date, there is no clinical study evaluating survival in S-ICD patients as a primary outcome (13,(32)(33)(34)(35). In the randomized controlled PRAETORIAN trial, Knops and colleagues described death from any cause as secondary outcome demonstrating no statistically significant difference between patients with S-ICD and TV-ICD (HR = 1.23; 95 % CI.…”

Section: Survivalmentioning

confidence: 99%

Clinical outcomes of subcutaneous vs. transvenous implantable defibrillator therapy in a polymorbid patient cohort

Kattih

Operhalski

Boeckling

et al. 2022

Front. Cardiovasc. Med.

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BackgroundThe subcutaneous implantable cardioverter-defibrillator (S-ICD) has been designed to overcome lead-related complications and device endocarditis. Lacking the ability for pacing or resynchronization therapy its usage is limited to selected patients at risk for sudden cardiac death (SCD).ObjectiveThe aim of this single-center study was to assess clinical outcomes of S-ICD and single-chamber transvenous (TV)-ICD in an all-comers population.MethodsThe study cohort comprised a total of 119 ICD patients who underwent either S-ICD (n = 35) or TV-ICD (n = 84) implantation at the University Hospital Frankfurt from 2009 to 2017. By applying an inverse probability-weighting (IPW) analysis based on the propensity score including the Charlson Comorbidity Index (CCI) to adjust for potential extracardiac comorbidities, we aimed for head-to-head comparison on the study composite endpoint: overall survival, hospitalization, and device-associated events (including appropriate and inappropriate shocks or system-related complications).ResultsThe median age of the study population was 66.0 years, 22.7% of the patients were female. The underlying heart disease was ischemic cardiomyopathy (61.4%) with a median LVEF of 30%. Only 52.9% had received an ICD for primary prevention, most of the patients (67.3%) had advanced heart failure (NYHA class II–III) and 16.8% were in atrial fibrillation. CCI was 5 points in TV-ICD patients vs. 4 points for patients with S-ICD (p = 0.209) indicating increased morbidity. The composite endpoint occurred in 38 patients (31.9 %), revealing no significant difference between patients implanted with an S-ICD or TV-ICD (unweighted HR 1.50, 95 % confidence interval (CI) 0.78–2.90; p = 0.229, weighted HR 0.94, 95% CI, 0.61–1.50, p = 0.777). Furthermore, we observed no difference in any single clinical endpoint or device-associated outcome, neither in the unweighted cohort nor following inverse probability-weighting.ConclusionClinical outcomes of the S-ICD and TV-ICD revealed no differences in the composite endpoint including survival, freedom of hospitalization and device-associated events, even after careful adjustment for potential confounders. Moreover, the CCI was evaluated in a S-ICD cohort demonstrating higher survival rates than predicted by the CCI in young, polymorbid (S-)ICD patients.

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Subcutaneous implantable cardioverter‐defibrillator: a systematic review of comparative effectiveness and safety

et al. 2022

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This systematic review evaluated the clinical effectiveness and safety of subcutaneous implantable cardioverter‐defibrillator (S‐ICD) in patients at an increased risk of sudden cardiac death and with an ICD indication for primary or secondary prevention. A systematic literature search was conducted in four databases (Medline via Ovid, Embase, the Cochrane Library, and HTA‐INAHTA). Randomized controlled trials (RCTs) and controlled observational studies with ≥100 S‐ICD patients and a low to moderate risk of bias were eligible for inclusion. The studies' quality and the available evidence's strength were assessed using the Cochrane risk of bias tool, the ROBINS‐I tool, and the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) approach. One RCT, a post hoc analysis of the RCT ( n = 849) and four controlled observational studies ( n = 7149) were included. The quality of the available evidence was graded as low to very low, except for the primary composite endpoint of the RCT, which was rated as moderate quality. After 4 years, the RCT showed that S‐ICD was non‐inferior to TV‐ICD regarding the composite endpoint of inappropriate shocks and device‐related complications (68 [15.1%] vs. 68 [15.7%], hazard ratio [HR] 0.99, 95% confidence interval [CI] [0.71, 1.39], non‐inferiority margin 1.45, P = 0.001). The RCT and two observational studies reported statistically significantly fewer lead complications in S‐ICD patients (after 4 years: 1.4% vs. 6.6%, HR 0.24, 95% CI [0.10, 0.54]; after 3 years: 0.3% vs. 2.3%, P = 0.03; and after 5 years: 0.8% vs. 11.5%, P = 0.03). Identified evidence about appropriate and inappropriate shocks was inconclusive: The RCT detected statistically significantly more appropriate shocks in patients with S‐ICD (83 [19.2%] vs. 57 [11.5%], HR 1.52, 95% CI [1.08, 2.12], P = 0.02), whereas one observational study showed a statistically significantly lower rate in the S‐ICD group (9.9%, 95% CI [7.0, 13.9], vs. 13.9%, 95% CI [10.8, 17.8], P = 0.003). Regarding inappropriate shocks, one observational study reported statistically significantly higher rates in the S‐ICD cohort (11.9% vs. 7.5%, P = 0.007), whereas the RCT and two other observational studies did not detect a statistically significant difference between the treatment groups ( P > 0.05). None of the included studies showed a statistically significant difference in overall mortality and shock efficacy between patients with S‐ICD and TV‐ICD ( P > 0.05). The available evidence is insufficient to show the superiority of S‐ICD compared with TV‐ICD, hindering the widespread use of the technology. Results of the recently completed ATLAS trial are to be awaited, and the anticipated role of the S‐ICD needs to be clearly formulated.

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Rate and impact on patient outcome and healthcare utilization of complications requiring surgical revision: Subcutaneous versus transvenous implantable defibrillator therapy

Cited by 17 publications

References 27 publications

Subcutaneous Versus Transvenous Implantable Defibrillator Therapy: A Systematic Review and Meta‐Analysis of Randomized Trials and Propensity Score–Matched Studies

Subcutaneous Versus Transvenous Implantable Defibrillator Therapy: A Systematic Review and Meta‐Analysis of Randomized Trials and Propensity Score–Matched Studies

Clinical outcomes of subcutaneous vs. transvenous implantable defibrillator therapy in a polymorbid patient cohort

Subcutaneous implantable cardioverter‐defibrillator: a systematic review of comparative effectiveness and safety

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