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.

1st Department of Medicine University Medical Center Mannheim Germany

Cardiac Electrophysiology Division Department of Medicine Englewood Hospital and Medical Center NJ

Center for Arrhythmia Care Heart and Vascular Institute University of Chicago Pritzker School of Medicine IL

CorVita Science Foundation Chicago IL

Department of Cardiology Amphia Hospital Breda the Netherlands

Department of Cardiology Amsterdam Cardiovascular Sciences Heart Failure and Arrhythmias Amsterdam University Medical Centers Location University of Amsterdam Heart Center the Netherlands

Department of Cardiology and Amsterdam Cardiovascular Sciences Amsterdam University Medical Centers Location VUMC the Netherlands

Department of Cardiology Cardiovascular Research Institute Maastricht Maastricht University Medical Center the Netherlands

Department of Cardiology Flevoziekenhuis Almere the Netherlands

Department of Cardiology Homolka Hospital Prague Czech Republic

Department of Cardiology Isala Heart Centre Zwolle the Netherlands

Department of Cardiology OLVG Amsterdam the Netherlands

Department of Cardiology Radboud University Medical Center Nijmegen the Netherlands

Department of Cardiology St Antonius Hospital Nieuwegein the Netherlands

Department of Cardiology Tergooi Medisch Centrum Blaricum the Netherlands

Department of Cardiology The Heart Centre Rigshospitalet University of Copenhagen Denmark

Department of Electrophysiology Catharina Hospital Eindhoven the Netherlands

Department of Electrophysiology Heart Center at University of Leipzig Germany

Department of Internal Medicine 1 Jena University Hospital Germany

Department of Medicine 1 Ludwig Maximillians University Hospital München Germany

Department of Medicine Cardiology Columbia University Irving Medical Center New York NY

Division of Cardiology Northwestern Memorial Hospital Northwestern University Chicago IL

Division of Cardiology Section of Electrophysiology Emory University Atlanta GA

European Reference Network for Rare Low Prevalence and Complex Diseases of the Heart

German Center for Cardiovascular Research Munich Heart Alliance Germany

German Center for Cardiovascular Research Partner Site Heidelberg Mannheim Germany

Heart Surgery Heart Center Dresden Carl Gustav Carus Medical Faculty Dresden University of Technology Germany

Icahn School of Medicine at Mount Sinai Mount Sinaï Hospital New York NY

Klinik für Innere Medizin 3 Schwerpunkt Kardiologie und Angiologie Universitätsklinikum Schleswig Holstein Campus Kiel Germany

Liverpool Heart and Chest Hospital United Kingdom

Medical Spectrum Twente Enschede the Netherlands

Medisch Centrum Leeuwarden the Netherlands

National Heart and Lung Institute Imperial College London United Kingdom

Office of the Director of Clinical Electrophysiology Research and Lead for Inherited Arrhythmia Specialist Services University College London and Barts Heart Centre United Kingdom

Oxford Biomedical Research Centre Oxford University Hospitals NHS Trust United Kingdom

St George's University Hospitals NHS Foundation Trust London United Kingdom

St George's University of London United Kingdom

The Valley Health System Ridgewood NJ

University and University Hospital Würzburg Germany

Werkgroep Cardiologische Centra Nederland Utrecht the Netherlands

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Bardy GH, Lee KL, Mark DB, Poole JE, Packer DL, Boineau R, Domanski M, Troutman C, Anderson J, Johnson G, et al. ; Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT) Investigators. Amiodarone or an implantable cardioverter-defibrillator for congestive heart failure. N Engl J Med. 2005;352:225–237. doi: 10.1056/NEJMoa043399 PubMed

Moss AJ, Hall WJ, Cannom DS, Daubert JP, Higgins SL, Klein H, Levine JH, Saksena S, Waldo AL, Wilber D, et al. . Improved survival with an implanted defibrillator in patients with coronary disease at high risk for ventricular arrhythmia. Multicenter automatic defibrillator implantation trial investigators. N Engl J Med. 1996;335:1933–1940. doi: 10.1056/NEJM199612263352601 PubMed

Zeppenfeld K, Tfelt-Hansen J, de Riva M, Winkel BG, Behr ER, Blom NA, Charron P, Corrado D, Dagres N, de Chillou C, et al. . 2022 ESC guidelines for the management of patients with ventricular arrhythmias and the prevention of sudden cardiac death. Eur Heart J. 2022;43:3997–4126. doi: 10.1093/eurheartj/ehac262 PubMed

Bardy GH, Smith WM, Hood MA, Crozier IG, Melton IC, Jordaens L, Theuns D, Park RE, Wright DJ, Connelly DT, et al. . An entirely subcutaneous implantable cardioverter-defibrillator. N Engl J Med. 2010;363:36–44. doi: 10.1056/NEJMoa0909545 PubMed

Chambers ES, Vukmanovic-Stejic M. Skin barrier immunity and ageing. Immunology. 2020;160:116–125. doi: 10.1111/imm.13152 PubMed PMC

van der Stuijt W, Quast ABE, Baalman SWE, Olde Nordkamp LRA, Wilde AAM, Knops RE. Improving the care for female subcutaneous ICD patients: a qualitative study of gender-specific issues. Int J Cardiol. 2020;317:91–95. doi: 10.1016/j.ijcard.2020.05.091 PubMed

Knops RE, Pepplinkhuizen S, Delnoy P, Boersma LVA, Kuschyk J, El-Chami MF, Bonnemeier H, Behr ER, Brouwer TF, Kaab S, et al. . Device-related complications in subcutaneous versus transvenous ICD: a secondary analysis of the PRAETORIAN trial. Eur Heart J. 2022;43:4872–4883. doi: 10.1093/eurheartj/ehac496 PubMed PMC

Knops RE, van der Stuijt W, Delnoy P, Boersma LVA, Kuschyk J, El-Chami MF, Bonnemeier H, Behr ER, Brouwer TF, Kääb S, et al. . Efficacy and safety of appropriate shocks and antitachycardia pacing in transvenous and subcutaneous implantable defibrillators: analysis of all appropriate therapy in the PRAETORIAN trial. Circulation. 2022;145:321–329. doi: 10.1161/circulationaha.121.057816 PubMed

Januszkiewicz L, Barra S, Providencia R, Conte G, de Asmundis C, Chun JKR, Farkowski MM, Guerra JM, Marijon E, Boveda S. Long-term quality of life and acceptance of implantable cardioverter-defibrillator therapy: results of the European Heart Rhythm Association survey. Europace. 2022;24:860–867. doi: 10.1093/europace/euac011 PubMed

Knops RE, Olde Nordkamp LRA, Delnoy PHM, Boersma LVA, Kuschyk J, El-Chami MF, Bonnemeier H, Behr ER, Brouwer TF, Kääb S, et al. . Subcutaneous or transvenous defibrillator therapy. N Engl J Med. 2020;383:526–536. doi: 10.1056/NEJMoa1915932 PubMed

Pedersen SS, Carter N, Barr C, Scholten M, Lambiase PD, Boersma L, Johansen JB, Theuns D. Quality of life, depression, and anxiety in patients with a subcutaneous versus transvenous defibrillator system. Pacing Clin Electrophysiol. 2019;42:1541–1551. doi: 10.1111/pace.13828 PubMed

Thienel M, Haum M, Sadoni S, Novotny J, Estner HL, Fichtner S, Lackermair K. Impairment of quality of life in patients with implanted subcutaneous cardioverter defibrillator (S-ICD) compared to implanted transvenous cardioverter defibrillator therapy. Patient Prefer Adherence. 2022;16:3027–3033. doi: 10.2147/PPA.S378741 PubMed PMC

Pedersen SS, Mastenbroek MH, Carter N, Barr C, Neuzil P, Scholten M, Lambiase PD, Boersma L, Johansen JB, Theuns DA. A comparison of the quality of life of patients with an entirely subcutaneous implantable defibrillator system versus a transvenous system (from the EFFORTLESS S-ICD quality of life substudy). Am J Cardiol. 2016;118:520–526. doi: 10.1016/j.amjcard.2016.05.047 PubMed

Hlatky MA, Boineau RE, Higginbotham MB, Lee KL, Mark DB, Califf RM, Cobb FR, Pryor DB. A brief self-administered questionnaire to determine functional capacity (the Duke Activity Status Index). Am J Cardiol. 1989;64:651–654. doi: 10.1016/0002-9149(89)90496-7 PubMed

Ware JEJ, Snow KK, Kosinski M, Gandek B. SF-36 Health Survey: Manual & Interpretation Guide. Nimrod Press; 1993.

Mark DB, Anstrom KJ, Sun JL, Clapp-Channing NE, Tsiatis AA, Davidson-Ray L, Lee KL, Bardy GH; Sudden Cardiac Death in Heart Failure Trial Investigators. Quality of life with defibrillator therapy or amiodarone in heart failure. N Engl J Med. 2008;359:999–1008. doi: 10.1056/NEJMoa0706719 PubMed PMC

Sears SF, Rosman L, Sasaki S, Kondo Y, Sterns LD, Schloss EJ, Kurita T, Meijer A, Raijmakers J, Gerritse B, et al. . Defibrillator shocks and their effect on objective and subjective patient outcomes: results of the PainFree SST clinical trial. Heart Rhythm. 2018;15:734–740. doi: 10.1016/j.hrthm.2017.12.026 PubMed

Köbe J, Hucklenbroich K, Geisendörfer N, Bettin M, Frommeyer G, Reinke F, Dechering D, Burgmer M, Eckardt L. Posttraumatic stress and quality of life with the totally subcutaneous compared to conventional cardioverter-defibrillator systems. Clin Res Cardiol. 2017;106:317–321. doi: 10.1007/s00392-016-1055-0 PubMed

Liberato ACS, Raitt MH, Zarraga IGE, MacMurdy KS, Dougherty CM. Health-related quality of life in the spironolactone to reduce ICD therapy (SPIRIT) trial. Clin Nurs Res. 2022;31:588–597. doi: 10.1177/10547738211036817 PubMed

Vollmann D, Lüthje L, Vonhof S, Unterberg C. Inappropriate therapy and fatal proarrhythmia by an implantable cardioverter-defibrillator. Heart Rhythm. 2005;2:307–309. doi: 10.1016/j.hrthm.2004.11.019 PubMed

Daubert JP, Zareba W, Cannom DS, McNitt S, Rosero SZ, Wang P, Schuger C, Steinberg JS, Higgins SL, Wilber DJ, et al. ; MADIT II Investigators. Inappropriate implantable cardioverter-defibrillator shocks in MADIT II: frequency, mechanisms, predictors, and survival impact. J Am Coll Cardiol. 2008;51:1357–1365. doi: 10.1016/j.jacc.2007.09.073 PubMed

Gold MR, Weiss R, Theuns DA, Smith W, Leon A, Knight BP, Carter N, Husby M, Burke MC. Use of a discrimination algorithm to reduce inappropriate shocks with a subcutaneous implantable cardioverter-defibrillator. Heart Rhythm. 2014;11:1352–1358. doi: 10.1016/j.hrthm.2014.04.012 PubMed

Theuns D, Brouwer TF, Jones PW, Allavatam V, Donnelley S, Auricchio A, Knops RE, Burke MC. Prospective blinded evaluation of a novel sensing methodology designed to reduce inappropriate shocks by the subcutaneous implantable cardioverter-defibrillator. Heart Rhythm. 2018;15:1515–1522. doi: 10.1016/j.hrthm.2018.05.011 PubMed

Yatomi A, Takami M, Fukuzawa K, Kiuchi K, Sakai J, Nakamura T, Sonoda Y, Takahara H, Nakasone K, Yamamoto K, et al. . Factors related to the skin thickness of cardiovascular implantable electronic device pockets. J Cardiovasc Electrophysiol. 2022;33:1847–1856. doi: 10.1111/jce.15613 PubMed

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ClinicalTrials.gov
NCT01296022