Comparative Assessment of Transvenous versus Subcutaneous Implantable Cardioverter-defibrillator Therapy Outcomes: An Updated Systematic Review and Meta-analysis

Nso, Nso; Nassar, Mahmoud; Lakhdar, Sofia; Enoru, Sostanie; Guzman, Laura; Rizzo, Vincent; Munira, Most Sirajum; Radparvar, Farshid; Thambidorai, Senthil

doi:10.1016/j.ijcard.2021.11.029

Cited by 12 publications

(15 citation statements)

References 40 publications

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“…1,2 Transvenous ICD implantation may be complicated by vascular injury, cardiac perforation, pneumothorax, hemothorax, and venous obstruction. [3][4][5] Transvenous leads are also subject to mechanical failure and serious infection resulting in lead extraction. 3,4 The subcutaneous ICD was developed to avoid the vascular risks of transvenous ICDs.…”

Section: Introductionmentioning

confidence: 99%

“…[3][4][5] Transvenous leads are also subject to mechanical failure and serious infection resulting in lead extraction. 3,4 The subcutaneous ICD was developed to avoid the vascular risks of transvenous ICDs. 6,7 In a recent comparison with transvenous ICDs, the subcutaneous ICD effectively prevented sudden arrhythmic death with fewer complications; however, it was associated with shocks for ventricular tachycardia that might have been avoided if antitachycardia pacing were available.…”

Section: Introductionmentioning

confidence: 99%

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Efficacy and Safety of an Extravascular Implantable Cardioverter–Defibrillator

et al. 2022

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BACKGROUNDThe extravascular implantable cardioverter-defibrillator (ICD) has a single lead implanted substernally to enable pause-prevention pacing, antitachycardia pacing, and defibrillation energy similar to that of transvenous ICDs. The safety and efficacy of extravascular ICDs are not yet known. METHODSWe conducted a prospective, single-group, nonrandomized, premarket global clinical study involving patients with a class I or IIa indication for an ICD, all of whom received an extravascular ICD system. The primary efficacy end point was successful defibrillation at implantation. The efficacy objective would be met if the lower boundary of the one-sided 97.5% confidence interval for the percentage of patients with successful defibrillation was greater than 88%. The primary safety end point was freedom from major system-or procedure-related complications at 6 months. The safety objective would be met if the lower boundary of the onesided 97.5% confidence interval for the percentage of patients free from such complications was greater than 79%.

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Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Efficacy and Safety of an Extravascular Implantable Cardioverter–Defibrillator

et al. 2022

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“…The authors concluded that for patients with an ICD indication without the need for pacing, TV‐ICD and S‐ICD are comparable in terms of the composite of clinically relevant device‐related complications and inappropriate shocks. Another systematic review and meta‐analysis from 2021 13 included 26 studies that examined 7542 patients with S‐ICD and 5400 patients with TV‐ICD. The results showed that patients with S‐ICD had a statistically significantly lower incidence of lead‐related complications.…”

Section: Discussionmentioning

confidence: 99%

“…The search was limited to the period December 2017 until December 2021, updating the existing SR from 2018, and to articles published in English or German. In addition, hand searches in reference lists of other SRs 13 , 14 , 15 were carried out. On 29 November 2021, three clinical trial registries ( ClinicalTrials.gov ; WHO‐ICTRP; EU Clinical Trials) were searched to identify ongoing and unpublished studies.…”

Section: Methodsmentioning

confidence: 99%

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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“…Subcutaneous implantable cardioverter-defibrillators (S-ICD) are an alternative treatment option for ventricular arrhythmias [ 2 ]. It eliminates complications associated with traditional transvenous ICDs (TV-ICDs) [ 3 ]. Due to subcutaneous electrodes, rhythm detection and discrimination are challenging.…”

Section: Introductionmentioning

confidence: 99%

Hyperkalemia Causing Inappropriate Subcutaneous Implantable Cardioverter Defibrillator Shocks in a Patient with End-Stage Renal Disease: A Case Report and Literature Review

Botrus¹,

Mahtani²,

Isber³

et al. 2022

Cureus

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Subcutaneous implantable cardioverter-defibrillators (S-ICD) provide an effective treatment option for ventricular arrhythmias. When compared to transvenous implantable cardioverter-defibrillators (TV-ICDs), S-ICDs have a lower infection rate but a higher rate of inappropriate shocks. In patients with end-stage renal disease (ESRD), significant electrolyte disturbances are commonly seen, such as hyperkalemia, which can cause an increase in T wave amplitude. We present a patient with ESRD on hemodialysis who experienced inappropriate shocks from an S-ICD during sinus rhythm due to hyperkalemia-induced T wave oversensing and highlight related cases in the current literature.

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Comparative Assessment of Transvenous versus Subcutaneous Implantable Cardioverter-defibrillator Therapy Outcomes: An Updated Systematic Review and Meta-analysis

Cited by 12 publications

References 40 publications

Efficacy and Safety of an Extravascular Implantable Cardioverter–Defibrillator

Efficacy and Safety of an Extravascular Implantable Cardioverter–Defibrillator

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

Hyperkalemia Causing Inappropriate Subcutaneous Implantable Cardioverter Defibrillator Shocks in a Patient with End-Stage Renal Disease: A Case Report and Literature Review

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