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

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

doi:10.1161/CIRCOUTCOMES.124.010822

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

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

^*Corresponding author for this work

Research output: Contribution to journal › Article › Academic › peer-review

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.

Original language	English
Article number	e010822
Pages (from-to)	e010822
Journal	Circulation : Cardiovascular Quality and Outcomes
Volume	17
Issue number	11
DOIs	https://doi.org/10.1161/CIRCOUTCOMES.124.010822
Publication status	Published - 1 Nov 2024

Keywords

arrhythmias, cardiac
defibrillators, implantable
mental health
quality of life
Humans
Defibrillators, Implantable
Quality of Life
Female
Male
Middle Aged
Aged
Prospective Studies
Treatment Outcome
Electric Countershock/instrumentation adverse effects
Time Factors
Mental Health
Prosthesis Design
Surveys and Questionnaires
Health Status
Arrhythmias, Cardiac/therapy diagnosis physiopathology
Functional Status
Risk Factors
Death, Sudden, Cardiac/prevention & control

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10.1161/CIRCOUTCOMES.124.010822

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11575910Licence: Other

Cite this

Knops, R. E., de Veld, J. A., Ghani, A., Boersma, L. V. A., Kuschyk, J., El Chami, M. F., Bonnemeier, H., Behr, E. R., Brouwer, T. F., Kääb, S., Mittal, S., Pepplinkhuizen, S., Quast, A.-F. B. E., Smeding, L., van der Stuijt, W., de Weger, A., Bijsterveld, N. R., Richter, S., Brouwer, M. A., ... PRAETORIAN Investigators (2024). Quality of Life in Subcutaneous or Transvenous Implantable Cardioverter-Defibrillator Patients: A Secondary Analysis of the PRAETORIAN Trial. Circulation : Cardiovascular Quality and Outcomes, 17(11), e010822. Article e010822. https://doi.org/10.1161/CIRCOUTCOMES.124.010822

@article{6fc0573651654b6aa4e6233c9c6fffa3,

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

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.",

keywords = "arrhythmias, cardiac, defibrillators, implantable, mental health, quality of life, Humans, Defibrillators, Implantable, Quality of Life, Female, Male, Middle Aged, Aged, Prospective Studies, Treatment Outcome, Electric Countershock/instrumentation adverse effects, Time Factors, Mental Health, Prosthesis Design, Surveys and Questionnaires, Health Status, Arrhythmias, Cardiac/therapy diagnosis physiopathology, Functional Status, Risk Factors, Death, Sudden, Cardiac/prevention & control",

author = "Knops, {Reinoud E} and {de Veld}, {Jolien A} and Abdul Ghani and Boersma, {Lucas V A} and Juergen Kuschyk and {El Chami}, {Mikhael F} and Hendrik Bonnemeier and Behr, {Elijah R} and Brouwer, {Tom F} and Stefan K{\"a}{\"a}b and Suneet Mittal and Shari Pepplinkhuizen and Quast, {Anne-Floor B E} and Lonneke Smeding and {van der Stuijt}, Willeke and {de Weger}, Anouk and Bijsterveld, {Nick R} and Sergio Richter and Brouwer, {Marc A} and {de Groot}, {Joris R} and Kooiman, {Kirsten M} and Lambiase, {Pier D} and Petr Neuzil and Kevin Vernooy and Marco Alings and Betts, {Timothy R} and Bracke, {Frank A L E} and Burke, {Martin C} and {de Jong}, {Jonas S S G} and Wright, {David J} and Jansen, {Ward P J} and Whinnett, {Zachary I} and Peter Nordbeck and Michael Knaut and Philbert, {Berit T} and {van Opstal}, {Jurren M} and Chicos, {Alexandru B} and Allaart, {Cornelis P} and {Borger van der Burg}, {Alida E} and Dizon, {Jose M} and Miller, {Marc A} and Dmitry Nemirovksy and Ralf Surber and Upadhyay, {Gaurav A} and Tijssen, {Jan G P} and Wilde, {Arthur A M} and {Olde Nordkamp}, {Louise R A} and {PRAETORIAN Investigators}",

year = "2024",

month = nov,

day = "1",

doi = "10.1161/CIRCOUTCOMES.124.010822",

language = "English",

volume = "17",

pages = "e010822",

journal = "Circulation : Cardiovascular Quality and Outcomes",

issn = "1941-7705",

publisher = "Lippincott Williams & Wilkins",

number = "11",

}

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', Circulation : Cardiovascular Quality and Outcomes, vol. 17, no. 11, e010822, pp. e010822. https://doi.org/10.1161/CIRCOUTCOMES.124.010822

Quality of Life in Subcutaneous or Transvenous Implantable Cardioverter-Defibrillator Patients: A Secondary Analysis of the PRAETORIAN Trial. / Knops, Reinoud E; de Veld, Jolien A; Ghani, Abdul et al.
In: Circulation : Cardiovascular Quality and Outcomes, Vol. 17, No. 11, e010822, 01.11.2024, p. e010822.

Research output: Contribution to journal › Article › Academic › peer-review

TY - JOUR

T1 - Quality of Life in Subcutaneous or Transvenous Implantable Cardioverter-Defibrillator Patients

T2 - A Secondary Analysis of the PRAETORIAN Trial

AU - Knops, Reinoud E

AU - de Veld, Jolien A

AU - Ghani, Abdul

AU - Boersma, Lucas V A

AU - Kuschyk, Juergen

AU - El Chami, Mikhael F

AU - Bonnemeier, Hendrik

AU - Behr, Elijah R

AU - Brouwer, Tom F

AU - Kääb, Stefan

AU - Mittal, Suneet

AU - Pepplinkhuizen, Shari

AU - Quast, Anne-Floor B E

AU - Smeding, Lonneke

AU - van der Stuijt, Willeke

AU - de Weger, Anouk

AU - Bijsterveld, Nick R

AU - Richter, Sergio

AU - Brouwer, Marc A

AU - de Groot, Joris R

AU - Kooiman, Kirsten M

AU - Lambiase, Pier D

AU - Neuzil, Petr

AU - Vernooy, Kevin

AU - Alings, Marco

AU - Betts, Timothy R

AU - Bracke, Frank A L E

AU - Burke, Martin C

AU - de Jong, Jonas S S G

AU - Wright, David J

AU - Jansen, Ward P J

AU - Whinnett, Zachary I

AU - Nordbeck, Peter

AU - Knaut, Michael

AU - Philbert, Berit T

AU - van Opstal, Jurren M

AU - Chicos, Alexandru B

AU - Allaart, Cornelis P

AU - Borger van der Burg, Alida E

AU - Dizon, Jose M

AU - Miller, Marc A

AU - Nemirovksy, Dmitry

AU - Surber, Ralf

AU - Upadhyay, Gaurav A

AU - Tijssen, Jan G P

AU - Wilde, Arthur A M

AU - Olde Nordkamp, Louise R A

AU - PRAETORIAN Investigators

PY - 2024/11/1

Y1 - 2024/11/1

N2 - 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.

AB - 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.

KW - arrhythmias, cardiac

KW - defibrillators, implantable

KW - mental health

KW - quality of life

KW - Humans

KW - Defibrillators, Implantable

KW - Quality of Life

KW - Female

KW - Male

KW - Middle Aged

KW - Aged

KW - Prospective Studies

KW - Treatment Outcome

KW - Electric Countershock/instrumentation adverse effects

KW - Time Factors

KW - Mental Health

KW - Prosthesis Design

KW - Surveys and Questionnaires

KW - Health Status

KW - Arrhythmias, Cardiac/therapy diagnosis physiopathology

KW - Functional Status

KW - Risk Factors

KW - Death, Sudden, Cardiac/prevention & control

U2 - 10.1161/CIRCOUTCOMES.124.010822

DO - 10.1161/CIRCOUTCOMES.124.010822

M3 - Article

SN - 1941-7705

VL - 17

SP - e010822

JO - Circulation : Cardiovascular Quality and Outcomes

JF - Circulation : Cardiovascular Quality and Outcomes

IS - 11

M1 - e010822

ER -

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

Abstract

Keywords

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