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Quality of Life in Subcutaneous or Transvenous Implantable Cardioverter-Defibrillator Patients: A Secondary Analysis of the PRAETORIAN Trial

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. S...

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Main Authors: Knops, Reinoud E. (Author) , de Veld, Jolien A. (Author) , Ghani, Abdul (Author) , Boersma, Lucas V.A. (Author) , Kuschyk, Jürgen (Author) , El Chami, Mikhael F. (Author) , Bonnemeier, Hendrik (Author) , Behr, Elijah R. (Author) , Brouwer, Tom F. (Author) , Kääb, Stefan (Author) , Mittal, Suneet (Author) , Pepplinkhuizen, Shari (Author) , Quast, Anne-Floor B.E. (Author) , Smeding, Lonneke (Author) , van der Stuijt, Willeke (Author) , de Weger, Anouk (Author) , Bijsterveld, Nick R. (Author) , Richter, Sergio (Author) , Brouwer, Marc A. (Author) , de Groot, Joris R. (Author) , Kooiman, Kirsten M. (Author) , Lambiase, Pier D. (Author) , Neuzil, Petr (Author) , Vernooy, Kevin (Author) , Alings, Marco (Author) , Betts, Timothy R. (Author) , Bracke, Frank A.L.E. (Author) , Burke, Martin C. (Author) , de Jong, Jonas S.S.G. (Author) , Wright, David J. (Author) , Jansen, Ward P.J. (Author) , Whinnett, Zachary I. (Author) , Nordbeck, Peter (Author) , Knaut, Michael (Author) , Philbert, Berit T. (Author) , van Opstal, Jurren M. (Author) , Chicos, Alexandru B. (Author) , Allaart, Cornelis P. (Author) , Borger van der Burg, Alida E. (Author) , Dizon, Jose M. (Author) , Miller, Marc A. (Author) , Nemirovksy, Dmitry (Author) , Surber, Ralf (Author) , Upadhyay, Gaurav A. (Author) , Tijssen, Jan G.P. (Author) , Wilde, Arthur A.M. (Author) , Olde Nordkamp, Louise R.A. (Author)
Format: Article (Journal)
Language:English
Published: Nov 2024
In: Circulation. Cardiovascular quality and outcomes
Year: 2024, Volume: 17, Issue: 11, Pages: 1156-1165
ISSN:1941-7705
DOI:10.1161/CIRCOUTCOMES.124.010822
Online Access:Verlag, kostenfrei, Volltext: https://doi.org/10.1161/CIRCOUTCOMES.124.010822
Verlag, kostenfrei, Volltext: https://www.ahajournals.org/doi/10.1161/CIRCOUTCOMES.124.010822
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Author Notes:Reinoud E. Knops , MD, PhD; Jolien A. de Veld , MD; Abdul Ghani, MD, PhD; Lucas V.A. Boersma , MD, PhD; Juergen Kuschyk , MD; Mikhael F. El Chami , MD; Hendrik Bonnemeier , MD, PhD; Elijah R. Behr , MD; Tom F. Brouwer , MD, PhD; Stefan Kääb , MD, PhD; Suneet Mittal , MD; Shari Pepplinkhuizen , MD; Anne-Floor B.E. Quast , MD, PhD; Lonneke Smeding , PhD; Willeke van der Stuijt , MD, PhD; Anouk de Weger , MSc; Nick R. Bijsterveld , MD, PhD; Sergio Richter , MD; Marc A. Brouwer, MD, PhD; Joris R. de Groot , MD, PhD; Kirsten M. Kooiman , MPA; Pier D. Lambiase , MD, PhD; Petr Neuzil , MD, PhD; Kevin Vernooy , MD, PhD; Marco Alings , MD, PhD; Timothy R. Betts , MD; Frank A.L.E. Bracke , MD, PhD; Martin C. Burke , DO; Jonas S.S.G. de Jong , MD, PhD; David J. Wright , MD; Ward P.J. Jansen , MD, PhD; Zachary I. Whinnett , MD, PhD; Peter Nordbeck , MD; Michael Knaut , MD; Berit T. Philbert , MD; Jurren M. van Opstal , MD, PhD; Alexandru B. Chicos , MD; Cornelis P. Allaart , MD, PhD; Alida E. Borger van der Burg , MD, PhD; Jose M. Dizon , MD; Marc A. Miller, MD; Dmitry Nemirovksy, MD; Ralf Surber , MD; Gaurav A. Upadhyay , MD; Jan G.P. Tijssen , MD, PhD; Arthur A.M. Wilde , MD, PhD; Louise R.A. Olde Nordkamp , MD, PhD; on behalf of the PRAETORIAN Investigators
Description
Summary: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.
Item Description:Online veröffentlicht: 19. November 2024
Gesehen am 20.05.2025
Physical Description:Online Resource
ISSN:1941-7705
DOI:10.1161/CIRCOUTCOMES.124.010822

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