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

被引：0

作者：

Knops, Reinoud E. ^{[1
]}

de Veld, Jolien A. ^{[1
]}

Ghani, Abdul ^{[2
]}

Boersma, Lucas V. A. ^{[1
,3
]}

Kuschyk, Juergen ^{[4
,5
]}

El Chami, Mikhael F. ^{[6
]}

Bonnemeier, Hendrik ^{[7
]}

Behr, Elijah R. ^{[8
,9
]}

Brouwer, Tom F. ^{[1
]}

Kaeaeb, Stefan ^{[10
,11
,12
]}

Mittal, Suneet ^{[13
]}

Pepplinkhuizen, Shari ^{[1
]}

Quast, Anne-Floor B. E. ^{[1
]}

Smeding, Lonneke ^{[1
]}

van der Stuijt, Willeke ^{[1
]}

de Weger, Anouk ^{[1
]}

Bijsterveld, Nick R. ^{[14
]}

Richter, Sergio ^{[15
,16
]}

Brouwer, Marc A. ^{[17
]}

de Groot, Joris R. ^{[1
]}

Kooiman, Kirsten M. ^{[1
]}

Lambiase, Pier D. ^{[18
]}

Neuzil, Petr ^{[19
]}

Vernooy, Kevin ^{[20
]}

Alings, Marco ^{[21
,22
]}

Betts, Timothy R. ^{[23
]}

Bracke, Frank A. L. E. ^{[24
]}

Burke, Martin C. ^{[25
]}

de Jong, Jonas S. S. G. ^{[26
]}

Wright, David J. ^{[27
]}

Jansen, Ward P. J. ^{[28
]}

Whinnett, Zachary I. ^{[29
]}

Nordbeck, Peter ^{[30
]}

Knaut, Michael ^{[31
]}

Philbert, Berit T. ^{[32
]}

van Opstal, Jurren M. ^{[33
]}

Chicos, Alexandru B. ^{[34
]}

Allaart, Cornelis P. ^{[35
]}

Borger van der Burg, Alida E. ^{[36
]}

Dizon, Jose M. ^{[37
]}

Miller, Marc A. ^{[38
]}

Nemirovksy, Dmitry ^{[39
]}

Surber, Ralf ^{[40
]}

Upadhyay, Gaurav A. ^{[41
]}

Tijssen, Jan G. P. ^{[1
]}

Wilde, Arthur A. M. ^{[1
,12
]}

Olde Nordkamp, Louise R. A. ^{[1
]}

机构：

[1] Univ Amsterdam, Heart Ctr, Dept Cardiol, Amsterdam Univ Med Ctr Locat, Amsterdam, Netherlands

[2] Isala Heart Ctr, Dept Cardiol, Zwolle, Netherlands

[3] St Antonius Hosp, Dept Cardiol, Nieuwegein, Netherlands

[4] Univ Med Ctr Mannheim, Dept Med 1, Mannheim, Germany

[5] German Ctr Cardiovasc Res Partner Site Heidelberg, Mannheim, Germany

[6] Emory Univ, Div Cardiol, Sect Electrophysiol, 550 Peachtree St NE, Atlanta, GA 30308 USA

[7] Univ Klinikum Schleswig Holstein, Innere Med 3, Schwerpunkt Kardiol & Angiol, Campus Kiel,Schittenhelmstr 12, D-24105 Kiel, Germany

[8] St Georges Univ London, St Georges Vasc Inst, London, England

[9] St Georges Univ Hosp NHS Fdn Trust, Neonatol, London, England

[10] Ludwig Maximillians Univ, Dept Dermatol & Allergol, Munich, Germany

[11] Munich Heart Alliance, German Ctr Cardiovasc Res, Munich, Germany

[12] European Reference Network Rare & Low Prevalence, Rome, Italy

[13] Valley Hlth Syst, Ridgewood, NJ USA

[14] Flevoziekenhuis, Dept Gynaecol, Almere, Netherlands

[15] Univ Leipzig, Dept Electrophysiol, Heart Ctr, Strumpellstr 39, D-04289 Leipzig, Germany

[16] Tech Univ Dresden, Carl Gustav Carus Fac Med, Heart Ctr Dresden, Dept Cardiac Surg, Dresden, Germany

[17] Radboud Univ Nijmegen, Dept Gynaecol, Med Ctr, Nijmegen, Netherlands

[18] UCL, Barts Heart Ctr, Lead Inherited Arrhythmia Specialist Serv, London, England

[19] Homolka Hosp, Dept Cardiol, Prague, Czech Republic

[20] Maastricht Univ, Med Ctr, Dept Cardiol, Cardiovasc Res Inst, Maastricht, Netherlands

[21] Amphia Hosp, Dept Cardiol, Breda, Netherlands

[22] Univ Utrecht, Literatura Hispan, Utrecht, South Africa

[23] Oxford Univ Hosp NHS Trust, Oxford Biomed Res Ctr, NIHR, Oxford, England

[24] Catharina Hosp, Dept Electrophysiol, Eindhoven, Netherlands

[25] CorVita Sci Fdn, Chicago, IL USA

[26] OLVG, Dept Cardiol, Amsterdam, Netherlands

[27] Liverpool Heart & Chest Hosp, Cardiothorac Surg, Liverpool, England

[28] Tergooi Med Ctr, Dept Geriatr, Blaricum, Netherlands

[29] Imperial Coll London, Natl Heart & Lung Inst, London, England

[30] Univ Hosp Wurzburg, Wurzburg, Germany

[31] Tech Univ Dresden, Carl Gustav Carus Fac Med, Heart Ctr Dresden, Dept Cardiac Surg, Dresden, Germany

[32] Copenhagen Univ Hosp, Rigshospitalet, Heart Ctr, Dept Cardiol, Copenhagen, Denmark

[33] Med Spectrum Twente, Enschede, Netherlands

[34] Northwestern Univ, Northwestern Mem Hosp, Div Cardiol, Chicago, IL 60611 USA

[35] Amsterdam Univ Med Ctr, Amsterdam Cardiovasc Sci Res Inst, Dept Intens Care Med, Locat VUmc, Amsterdam, Netherlands

[36] Med Ctr Leeuwarden, Leeuwarden, Netherlands

[37] Columbia Univ, Irving Med Ctr, Dept Med, New York, NY USA

[38] Icahn Sch Med Mt Sinai, Mt Sinai Hosp, New York, NY 10029 USA

[39] Englewood Hosp & Med Ctr, Cardiac Electrophysiol Div, Dept Med, Englewood, NJ 07631 USA

[40] Univ Hosp Jena, Dept Internal Med 3, Jena, Germany

[41] Univ Chicago Med, Ctr Arrhythmia Care, Heart & Vasc Ctr, Pritzker Sch Med, Chicago, IL USA

来源：

CIRCULATION-CARDIOVASCULAR QUALITY AND OUTCOMES | 2024年 / 17卷 / 11期

关键词：

arrhythmias; cardiac; defibrillators; implantable; mental health; quality of life; THERAPY; SHOCKS; AMIODARONE;

D O I：

10.1161/CIRCOUTCOMES.124.010822

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

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.

引用

页数：10

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