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