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

Abstract

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.

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

“…Kataoka and Imamura question whether there was equitable QOL outcomes by patients with smaller physiques with possible considerations for Asian populations. As we reported, 3 BMI scores were significantly different with the smallest BMI group (BMI < 25) reporting a lower mental score on average. Moreover, body image concerns were the highest in the lowest BMI group (BMI < 25) and the youngest (age < 50 years).…”

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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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“…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.…”

How to assess patients' quality of life after receiving extravascular implantable cardioverter‐defibrillation

“…2 Was there equitable quality of life experienced between individuals with smaller physiques and those with larger physiques among the patient cohort? Concerns regarding body image were notably more pronounced in the subcutaneous ICD cohort compared to the EV-ICD cohort, 1 potentially attributed to the placement of the supra-sternal subcutaneous lead. Could the authors expound upon why device-related distress was also heightened in the subcutaneous ICD group as opposed to the EV-ICD group, 1 given that the size and placement of the implanted generator were similar between the two groups?…”

“…A predominant number of participants underwent EV-ICD implantation for primary prevention. 1 It is imperative to note that instances of appropriate defibrillation therapy may manifest more frequently in cases of secondary prevention. The assessment of patients' QOL in clinical scenarios involving frequent defibrillation therapies warrants significant attention.…”