Knops, RE;
de Veld, JA;
Ghani, A;
Boersma, LVA;
Kuschyk, J;
El Chami, MF;
Bonnemeier, H;
Behr, ER;
Brouwer, TF;
Kääb, S;
et al.
Knops, RE; de Veld, JA; Ghani, A; Boersma, LVA; Kuschyk, J; El Chami, MF; Bonnemeier, H; Behr, ER; Brouwer, TF; Kääb, S; Mittal, S; Pepplinkhuizen, S; Quast, A-FBE; Smeding, L; van der Stuijt, W; de Weger, A; Bijsterveld, NR; Richter, S; Brouwer, MA; de Groot, JR; Kooiman, KM; Lambiase, PD; Neuzil, P; Vernooy, K; Alings, M; Betts, TR; Bracke, FALE; Burke, MC; de Jong, JSSG; Wright, DJ; Jansen, WPJ; Whinnett, ZI; Nordbeck, P; Knaut, M; Philbert, BT; van Opstal, JM; Chicos, AB; Allaart, CP; Borger van der Burg, AE; Dizon, JM; Miller, MA; Nemirovksy, D; Surber, R; Upadhyay, GA; Tijssen, JGP; Wilde, AAM; Olde Nordkamp, LRA; PRAETORIAN Investigators
(2024)
Quality of Life in Subcutaneous or Transvenous Implantable Cardioverter-Defibrillator Patients: A Secondary Analysis of the PRAETORIAN Trial.
Circ Cardiovasc Qual Outcomes, 17 (11).
e010822.
ISSN 1941-7705
https://doi.org/10.1161/CIRCOUTCOMES.124.010822
SGUL Authors: Behr, Elijah Raphael
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Abstract
BACKGROUND: The subcutaneous implantable cardioverter-defibrillator (S-ICD) was developed to overcome the risk of lead-related complications associated with the transvenous implantable cardioverter-defibrillator (TV-ICD). In contrast to the TV-ICD, the S-ICD is a completely extrathoracic device. Subsequently, complications differ between these 2 implantable cardioverter-defibrillators, which might impact patient perceptions of the therapies. This prespecified secondary analysis of the PRAETORIAN trial evaluates differences in quality of life. METHODS: The PRAETORIAN trial (A Prospective, Randomized Comparison of Subcutaneous and Transvenous Implantable Cardioverter Defibrillator Therapy) randomized patients with an implantable cardioverter-defibrillator indication, without the need for pacing to S-ICD or TV-ICD therapy. Two questionnaires were collected at baseline, discharge, 12 months, and 30 months. The Duke Activity Status Index measures cardiac-specific physical functioning, and the 36-Item Short Form Health Survey measures physical and mental well-being, with the subscales bodily pain and mental health being of interest in this analysis. Mann-Whitney U tests were used to compare study arms, and a mixed model was used to describe the questionnaire outcomes over time. RESULTS: Patients were randomized to S-ICD (n=426) and TV-ICD (n=423). In the S-ICD group, 20% were women versus 19% in the TV-ICD group. The median age was 63 (interquartile range, 54-69) years in the S-ICD group versus 64 (interquartile range, 56-69) years in the TV-ICD group. There were no significant differences in the Duke Activity Status Index and 36-Item Short Form Health Survey subscales for bodily pain and mental health between the groups at any time point. Patients with a shock in the last 90 days had significantly lower scores for social functioning (P=0.008) and role limitations due to emotional problems (P=0.001) than patients without a shock, but this effect did not differ between treatment arms. CONCLUSIONS: In a large randomized cohort of patients with an S-ICD or TV-ICD, no difference in overall quality of life was observed. However, implantable cardioverter-defibrillator shocks resulted in a reduction in quality of life, regardless of the device type or appropriateness. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT01296022.
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