Quality of Life in Subcutaneous or Transvenous Implantable Cardioverter-Defibrillator Patients: A Secondary Analysis of the PRAETORIAN Trial
Authors: Knops Reinoud E. , de Veld Jolien A. , Ghani Abdul , Boersma Lucas V.A. , Kuschyk Juergen , El Chami Mikhael F. , Bonnemeier Hendrik , Behr Elijah R. , Brouwer Tom F. , Kääb Stefan , Mittal Suneet , Pepplinkhuizen Shari , Quast Anne-Floor B.E. , Smeding Lonneke , van der Stuijt Willeke , de Weger Anouk , Bijsterveld Nick R. , Richter Sergio , Brouwer Marc A. , de Groot Joris R. , Kooiman Kirsten M. , Lambiase Pier D. , Neuzil Petr , Vernooy Kevin , Alings Marco , Betts Timothy R. , Bracke Frank A.L.E. , Burke Martin C. , de Jong Jonas S.S.G. , Wright David J. , Jansen Ward P.J. , Whinnett Zachary I. , Nordbeck Peter , Knaut Michael , Philbert Berit T. , van Opstal Jurren M. , Chicos Alexandru B. , Allaart Cornelis P. , Borger van der Burg Alida E. , Dizon Jose M. , Miller Marc A. , Nemirovksy Dmitry , Surber Ralf , Upadhyay Gaurav A. , Tijssen Jan G.P. , Wilde Arthur A.M. , Olde Nordkamp Louise R.A. ,   on behalf of the PRAETORIAN Investigators
Published: November 2024

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.