Patient acceptance of subcutaneous versus transvenous defibrillator systems: A multi‐center experience

Vicentini, Alessandro; Bisignani, Giovanni; Vivo, Stefano De; Viani, Stefano; Savarese, Gianluca; Francia, Pietro; Celentano, E.; Checchi, Luca; Carreras, Giovanni; Santini, Luca; Lamberti, Filippo; Ottaviano, Luca; Scalone, Antonio; Giorgi, Davide; Lovecchio, Mariolina; Valsecchi, Sergio; Rordorf, Roberto; Investigators, “S-Icd Rhythm Detect”

doi:10.1111/jce.15297

Cited by 15 publications

(15 citation statements)

References 38 publications

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“…8 Patient acceptance scores of the EV ICD patients were statistically significantly better than those reported by S-ICD and TV-ICD patients using historical norms. 4 Subscale comparisons indicated that EV ICD patients reported less device-related distress and less body image concerns than patients with S-ICD and TV-ICDs. Moreover, the EV ICD patients reported more positive appraisal of the ICD than TV-ICD patients.…”

Section: Discussionmentioning

confidence: 93%

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Patient‐reported quality of life and acceptance of the extravascular implantable cardioverter‐defibrillator: Results from pivotal study

Sears,

Harrell,

Crozier

et al. 2023

Cardiovasc electrophysiol

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IntroductionThe pivotal study of the extravascular implantable cardioverter‐defibrillator (EV ICD) recently demonstrated primary efficacy and safety endpoints comparable to previous ICD systems. Patient experience with this novel device has not been reported. The current study examined the standardized patient‐reported outcome (PRO) metrics of quality of life (QOL) and patient acceptance of the device.MethodsThe EV ICD Pivotal Study was a prospective, single‐arm, nonrandomized, global, premarket approval trial. Patients completed the 12‐Item Short Form Survey (SF‐12) QOL surveys at baseline and at 6 months following implant. Additionally, patients completed the Florida Patient Acceptance Survey (FPAS) QOL survey at 6 months.ResultsFrom baseline to 6 months, patients within the EV ICD Pivotal Study (n = 247) reported statistically significant SF‐12 improvements in physical QOL (45.4 ± 9.4 vs. 46.8 ± 9.1 respectively, p = .020) and no changes in mental QOL (49.3 ± 10.4 vs. 50.5 ± 9.7, p = .061). No differences were noted by sex, atrial fibrillation, or the experience of ICD shock. EV ICD patients reported better total FPAS patient acceptance of their ICD than TV‐ICD or S‐ICD patients using historical norms comparisons (80.4 ± 15.7 vs. 70.2 ± 17.8, p < .0001 for S‐ICD and 73.0 ± 17.4, p = .004 for TV‐ICD).ConclusionThe initial PROs for EV ICD patients indicated that patients had improvements in physical QOL from baseline to 6‐month follow‐up and markedly better overall acceptance of their ICD compared to a previous study with S‐ICD and TV‐ICD data. These initial results suggest that the EV ICD is evaluated positively by patients.

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Section: Discussionmentioning

confidence: 93%

“…Additionally, a retrospective comparison to historical data from a previous study 4 that included FPAS survey results for patients with S‐ICD and TV‐ICD systems was performed by extracting data points from the published dot plots.…”

Section: Methodsmentioning

confidence: 99%

Patient‐reported quality of life and acceptance of the extravascular implantable cardioverter‐defibrillator: Results from pivotal study

Sears,

Harrell,

Crozier

et al. 2023

Cardiovasc electrophysiol

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show abstract

“…Furthermore, we have recently demonstrated positive patient acceptance of the S-ICD, even in groups at risk of psychological distress, such as females or those with a smaller body habitus, independent of the generator positioning. 22 Patients with inherited cardiac arrhythmias and cardiomyopathies are usually younger and could be considered suitable for S-ICD therapy. Nevertheless, data from the literature in these scenarios are still scarce and debatable.…”

Section: Tv-icd Study or Subgroupmentioning

confidence: 99%

“…5 Moreover, it must be recognised that, despite the initial concern about the size of the current S-ICD, patient acceptance is positive and its use is sometimes associated with better positive appraisal in comparison with the TV-ICD. 22…”

Section: Tv-icd Study or Subgroupmentioning

confidence: 99%

The ATLAS Randomised Clinical Trial: What do the Superiority Results Mean for Subcutaneous ICD Therapy and Sudden Cardiac Death Prevention as a Whole?

Rordorf

2022

Arrhythm Electrophysiol Rev

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This review sets out the key evidence comparing subcutaneous ICDs (S-ICDs) and transvenous ICDs and uses it to empower clinical cardiologists and those who implant ICDs to make optimum patient selections for S-ICD use. The evidence demonstrates that clinical trials performed until recently have proven the performance of S-ICDs. However, the latest data now available from the ATLAS randomised controlled trial have added new insights to this body of evidence. ATLAS demonstrates the superiority of S-ICDs over transvenous ICDs regarding lead-related complications, findings that point to promising opportunities for patients who are at risk of sudden cardiac death.

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“…In contrast, previous reviews with subcutaneous ICDs (S-ICD) in pediatric populations 4 has suggested only minor implant modifications may need to be considered, and Vincentini et al did not find any differences in device acceptance by body habitus. 5 The size of the EV-ICD may also be a consideration for shared decision making with respect to the decision of which ICD to implant in which patient. Specifically, the EV-ICD compares favorably in size…”

mentioning

confidence: 99%

Patient reported QOL and EV‐ICD: Response to letter from Kataoka and Imamura (2024)

Sears,

Harrell,

Crozier

et al. 2024

Cardiovasc electrophysiol

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The subscale of Device-Related Distress directly queries feelings of disfigurement from the device and this may account for the differences.Finally, the question was raised of selection bias related to the possibility of patients at risk for decreased QOL or patients with smaller body habitus leading to possible avoidance of being enrolled in this study. We do not have any data to refute or accept this limitation as this is the initial sample of patients considering EV-ICDs.However, as noted in the paper, 3 we do acknowledge that the process of agreeing to a novel device may induce a degree of positive acceptance bias in patients and in their reporting of outcomes. As a result, we indicated that cautious interpretation of this data is needed until full randomized studies could disentangle these common psychological processes.

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Patient acceptance of subcutaneous versus transvenous defibrillator systems: A multi‐center experience

Cited by 15 publications

References 38 publications

Patient‐reported quality of life and acceptance of the extravascular implantable cardioverter‐defibrillator: Results from pivotal study

Patient‐reported quality of life and acceptance of the extravascular implantable cardioverter‐defibrillator: Results from pivotal study

The ATLAS Randomised Clinical Trial: What do the Superiority Results Mean for Subcutaneous ICD Therapy and Sudden Cardiac Death Prevention as a Whole?

Patient reported QOL and EV‐ICD: Response to letter from Kataoka and Imamura (2024)

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