TY - JOUR
T1 - Patient-reported quality of life and acceptance of the extravascular implantable cardioverter-defibrillator
T2 - Results from pivotal study
AU - Sears, Samuel F.
AU - Harrell, Rebecca
AU - Crozier, Ian
AU - Murgatroyd, Francis
AU - Boersma, Lucas V.A.
AU - Manlucu, Jaimie
AU - Knight, Bradley P.
AU - Leclercq, Christophe
AU - Birgersdotter-Green, Ulrika Maria
AU - Wiggenhorn, Christopher
AU - Hilleren, Gregory
AU - Friedman, Paul
N1 - Publisher Copyright:
© 2023 The Authors. Journal of Cardiovascular Electrophysiology published by Wiley Periodicals LLC.
PY - 2024/2
Y1 - 2024/2
N2 - Introduction: The 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. Methods: The 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. Results: From 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). Conclusion: The 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.
AB - Introduction: The 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. Methods: The 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. Results: From 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). Conclusion: The 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.
KW - device acceptance
KW - extravascular ICD
KW - patient reported outcomes
KW - quality of life
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U2 - 10.1111/jce.16151
DO - 10.1111/jce.16151
M3 - Article
C2 - 38047465
AN - SCOPUS:85178486762
SN - 1045-3873
VL - 35
SP - 240
EP - 246
JO - Journal of cardiovascular electrophysiology
JF - Journal of cardiovascular electrophysiology
IS - 2
ER -