Randomized Controlled Trial

. 2024 Nov;17(11):e010822.

doi: 10.1161/CIRCOUTCOMES.124.010822. Epub 2024 Nov 19.

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

Reinoud E Knops^#¹, Jolien A de Veld^#¹, Abdul Ghani², Lucas V A Boersma^{1

3}, Juergen Kuschyk^{4

5}, Mikhael F El Chami⁶, Hendrik Bonnemeier⁷, Elijah R Behr^{8

9}, Tom F Brouwer¹, Stefan Kääb^{10

11

12}, Suneet Mittal¹³, Shari Pepplinkhuizen¹, Anne-Floor B E Quast¹, Lonneke Smeding¹, Willeke van der Stuijt¹, Anouk de Weger¹, Nick R Bijsterveld¹⁴, Sergio Richter^{15

16}, Marc A Brouwer¹⁷, Joris R de Groot¹, Kirsten M Kooiman¹, Pier D Lambiase¹⁸, Petr Neuzil¹⁹, Kevin Vernooy²⁰, Marco Alings^{21

22}, Timothy R Betts²³, Frank A L E Bracke²⁴, Martin C Burke²⁵, Jonas S S G de Jong²⁶, David J Wright²⁷, Ward P J Jansen²⁸, Zachary I Whinnett²⁹, Peter Nordbeck³⁰, Michael Knaut³¹, Berit T Philbert³², Jurren M van Opstal³³, Alexandru B Chicos³⁴, Cornelis P Allaart³⁵, Alida E Borger van der Burg³⁶, Jose M Dizon³⁷, Marc A Miller³⁸, Dmitry Nemirovksy³⁹, Ralf Surber⁴⁰, Gaurav A Upadhyay⁴¹, Jan G P Tijssen¹, Arthur A M Wilde^{1

12}, Louise R A Olde Nordkamp¹; PRAETORIAN Investigators

Collaborators, Affiliations

Collaborators

PRAETORIAN Investigators:
Jude F. Clancy, Raul Weiss, Jim W. Cheung, Dominic A.M.J. Theuns, Tjeerd Germans

Affiliations

¹ Department of Cardiology, Amsterdam Cardiovascular Sciences Heart Failure and Arrhythmias, Amsterdam University Medical Centers Location University of Amsterdam, Heart Center, the Netherlands (R.E.K., J.A.d.V., L.V.A.B., T.F.B., S.P., A.-F.B.E.Q., L.S., W.v.d.S., A.d.W., J.R.d.G., K.M.K., J.G.P.T., A.A.M.W., L.R.A.O.N.).
² Department of Cardiology, Isala Heart Centre, Zwolle, the Netherlands (A.G.).
³ Department of Cardiology, St. Antonius Hospital, Nieuwegein, the Netherlands (L.V.A.B.).
⁴ First Department of Medicine, University Medical Center Mannheim, Germany (J.K.).
⁵ German Center for Cardiovascular Research, Partner Site Heidelberg, Mannheim, Germany (J.K.).
⁶ Division of Cardiology, Section of Electrophysiology, Emory University, Atlanta, GA (M.F.E.C.).
⁷ Klinik für Innere Medizin III, Schwerpunkt Kardiologie und Angiologie, Universitätsklinikum Schleswig-Holstein, Campus Kiel, Germany (H.B.).
⁸ St George's University of London, United Kingdom (E.R.B.).
⁹ St George's University Hospitals NHS Foundation Trust, London, United Kingdom (E.R.B.).
¹⁰ Department of Medicine I, Ludwig-Maximillians University Hospital, München, Germany (S.K.).
¹¹ German Center for Cardiovascular Research, Munich Heart Alliance, Germany (S.K.).
¹² European Reference Network for Rare, Low Prevalence and Complex Diseases of the Heart (S.K., A.A.M.W.).
¹³ The Valley Health System, Ridgewood, NJ (S.M.).
¹⁴ Department of Cardiology, Flevoziekenhuis, Almere, the Netherlands (N.R.B.).
¹⁵ Department of Electrophysiology, Heart Center at University of Leipzig, Germany (S.R.).
¹⁶ Heart Surgery, Heart Center Dresden, Carl Gustav Carus Medical Faculty, Dresden University of Technology, Germany (S.R.).
¹⁷ Department of Cardiology, Radboud University Medical Center, Nijmegen, the Netherlands (M.A.B.).
¹⁸ Office of the Director of Clinical Electrophysiology Research and Lead for Inherited Arrhythmia Specialist Services, University College London and Barts Heart Centre, United Kingdom (P.D.L.).
¹⁹ Department of Cardiology, Homolka Hospital, Prague, Czech Republic (P. Neuzil).
²⁰ Department of Cardiology, Cardiovascular Research Institute Maastricht, Maastricht University Medical Center, the Netherlands (K.V.).
²¹ Department of Cardiology, Amphia Hospital, Breda, the Netherlands (M.A.).
²² Werkgroep Cardiologische Centra Nederland, Utrecht, the Netherlands (M.A.).
²³ Oxford Biomedical Research Centre, Oxford University Hospitals NHS Trust, United Kingdom (T.R.B.).
²⁴ Department of Electrophysiology, Catharina Hospital Eindhoven, the Netherlands (F.A.L.E.B.).
²⁵ CorVita Science Foundation, Chicago, IL (M.C.B.).
²⁶ Department of Cardiology, OLVG, Amsterdam, the Netherlands (J.S.S.G.d.J.).
²⁷ Liverpool Heart and Chest Hospital, United Kingdom (D.J.W.).
²⁸ Department of Cardiology, Tergooi Medisch Centrum, Blaricum, the Netherlands (W.P.J.J.).
²⁹ National Heart and Lung Institute, Imperial College London, United Kingdom (Z.I.W.).
³⁰ University and University Hospital Würzburg, Germany (P. Nordbeck).
³¹ Heart Surgery, Heart Center Dresden, Carl Gustav Carus Medical Faculty, Dresden University of Technology, Germany (M.K.).
³² Department of Cardiology, The Heart Centre, Rigshospitalet, University of Copenhagen, Denmark (B.T.P.).
³³ Medical Spectrum Twente, Enschede, the Netherlands (J.M.v.O.).
³⁴ Division of Cardiology, Northwestern Memorial Hospital, Northwestern University, Chicago, IL (A.B.C.).
³⁵ Department of Cardiology, and Amsterdam Cardiovascular Sciences, Amsterdam University Medical Centers, Location VUMC, the Netherlands (C.P.A.).
³⁶ Medisch Centrum Leeuwarden, the Netherlands (A.E.B.v.d.B.).
³⁷ Department of Medicine-Cardiology, Columbia University Irving Medical Center, New York, NY (J.M.D.).
³⁸ Icahn School of Medicine at Mount Sinai, Mount Sinaï Hospital, New York, NY (M.A.M.).
³⁹ Cardiac Electrophysiology Division, Department of Medicine, Englewood Hospital and Medical Center, NJ (D.N.).
⁴⁰ Department of Internal Medicine I, Jena University Hospital, Germany (R.S.).
⁴¹ Center for Arrhythmia Care, Heart and Vascular Institute, University of Chicago Pritzker School of Medicine, IL (G.A.U.).

^# Contributed equally.

PMID: 39561235
PMCID: PMC11575910
DOI: 10.1161/CIRCOUTCOMES.124.010822

Randomized Controlled Trial

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

Reinoud E Knops et al. Circ Cardiovasc Qual Outcomes. 2024 Nov.

. 2024 Nov;17(11):e010822.

doi: 10.1161/CIRCOUTCOMES.124.010822. Epub 2024 Nov 19.

Authors

Collaborators

PRAETORIAN Investigators:
Jude F. Clancy, Raul Weiss, Jim W. Cheung, Dominic A.M.J. Theuns, Tjeerd Germans

Affiliations

¹ Department of Cardiology, Amsterdam Cardiovascular Sciences Heart Failure and Arrhythmias, Amsterdam University Medical Centers Location University of Amsterdam, Heart Center, the Netherlands (R.E.K., J.A.d.V., L.V.A.B., T.F.B., S.P., A.-F.B.E.Q., L.S., W.v.d.S., A.d.W., J.R.d.G., K.M.K., J.G.P.T., A.A.M.W., L.R.A.O.N.).
² Department of Cardiology, Isala Heart Centre, Zwolle, the Netherlands (A.G.).
³ Department of Cardiology, St. Antonius Hospital, Nieuwegein, the Netherlands (L.V.A.B.).
⁴ First Department of Medicine, University Medical Center Mannheim, Germany (J.K.).
⁵ German Center for Cardiovascular Research, Partner Site Heidelberg, Mannheim, Germany (J.K.).
⁶ Division of Cardiology, Section of Electrophysiology, Emory University, Atlanta, GA (M.F.E.C.).
⁷ Klinik für Innere Medizin III, Schwerpunkt Kardiologie und Angiologie, Universitätsklinikum Schleswig-Holstein, Campus Kiel, Germany (H.B.).
⁸ St George's University of London, United Kingdom (E.R.B.).
⁹ St George's University Hospitals NHS Foundation Trust, London, United Kingdom (E.R.B.).
¹⁰ Department of Medicine I, Ludwig-Maximillians University Hospital, München, Germany (S.K.).
¹¹ German Center for Cardiovascular Research, Munich Heart Alliance, Germany (S.K.).
¹² European Reference Network for Rare, Low Prevalence and Complex Diseases of the Heart (S.K., A.A.M.W.).
¹³ The Valley Health System, Ridgewood, NJ (S.M.).
¹⁴ Department of Cardiology, Flevoziekenhuis, Almere, the Netherlands (N.R.B.).
¹⁵ Department of Electrophysiology, Heart Center at University of Leipzig, Germany (S.R.).
¹⁶ Heart Surgery, Heart Center Dresden, Carl Gustav Carus Medical Faculty, Dresden University of Technology, Germany (S.R.).
¹⁷ Department of Cardiology, Radboud University Medical Center, Nijmegen, the Netherlands (M.A.B.).
¹⁸ Office of the Director of Clinical Electrophysiology Research and Lead for Inherited Arrhythmia Specialist Services, University College London and Barts Heart Centre, United Kingdom (P.D.L.).
¹⁹ Department of Cardiology, Homolka Hospital, Prague, Czech Republic (P. Neuzil).
²⁰ Department of Cardiology, Cardiovascular Research Institute Maastricht, Maastricht University Medical Center, the Netherlands (K.V.).
²¹ Department of Cardiology, Amphia Hospital, Breda, the Netherlands (M.A.).
²² Werkgroep Cardiologische Centra Nederland, Utrecht, the Netherlands (M.A.).
²³ Oxford Biomedical Research Centre, Oxford University Hospitals NHS Trust, United Kingdom (T.R.B.).
²⁴ Department of Electrophysiology, Catharina Hospital Eindhoven, the Netherlands (F.A.L.E.B.).
²⁵ CorVita Science Foundation, Chicago, IL (M.C.B.).
²⁶ Department of Cardiology, OLVG, Amsterdam, the Netherlands (J.S.S.G.d.J.).
²⁷ Liverpool Heart and Chest Hospital, United Kingdom (D.J.W.).
²⁸ Department of Cardiology, Tergooi Medisch Centrum, Blaricum, the Netherlands (W.P.J.J.).
²⁹ National Heart and Lung Institute, Imperial College London, United Kingdom (Z.I.W.).
³⁰ University and University Hospital Würzburg, Germany (P. Nordbeck).
³¹ Heart Surgery, Heart Center Dresden, Carl Gustav Carus Medical Faculty, Dresden University of Technology, Germany (M.K.).
³² Department of Cardiology, The Heart Centre, Rigshospitalet, University of Copenhagen, Denmark (B.T.P.).
³³ Medical Spectrum Twente, Enschede, the Netherlands (J.M.v.O.).
³⁴ Division of Cardiology, Northwestern Memorial Hospital, Northwestern University, Chicago, IL (A.B.C.).
³⁵ Department of Cardiology, and Amsterdam Cardiovascular Sciences, Amsterdam University Medical Centers, Location VUMC, the Netherlands (C.P.A.).
³⁶ Medisch Centrum Leeuwarden, the Netherlands (A.E.B.v.d.B.).
³⁷ Department of Medicine-Cardiology, Columbia University Irving Medical Center, New York, NY (J.M.D.).
³⁸ Icahn School of Medicine at Mount Sinai, Mount Sinaï Hospital, New York, NY (M.A.M.).
³⁹ Cardiac Electrophysiology Division, Department of Medicine, Englewood Hospital and Medical Center, NJ (D.N.).
⁴⁰ Department of Internal Medicine I, Jena University Hospital, Germany (R.S.).
⁴¹ Center for Arrhythmia Care, Heart and Vascular Institute, University of Chicago Pritzker School of Medicine, IL (G.A.U.).

^# Contributed equally.

PMID: 39561235
PMCID: PMC11575910
DOI: 10.1161/CIRCOUTCOMES.124.010822

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.

Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT01296022.

Keywords: arrhythmias, cardiac; defibrillators, implantable; mental health; quality of life.

PubMed Disclaimer

Conflict of interest statement

Dr Knops reports consultancy fees and research grants from Abbott, Boston Scientific, Medtronic, and Cairdac and has stock options from AtaCor Medical, Inc. Dr El Chami reports consultancy fees from Boston Scientific and Medtronic. Dr Mittal reports consultancy fees from Boston Scientific and Medtronic. K.M. Kooiman reports consultancy fees from Boston Scientific. Dr Lambiase reports educational and research grants from and is in the research board of Boston Scientific, and reports research grants from Abbott. Dr Vernooy reports consultancy fees from Medtronic and Abbott. M.C. Burke is a consultant and receives honoraria, as well as research grants from Boston Scientific and has equity in and is chief medical officer for AtaCor Medical, Inc. Dr Wright has consultancy arrangements with Boston Scientific and Medtronic and iRhythm and a research grant from Boston Scientific. Dr Nordbeck reports modest speaker honoraria from Biotronik, Boston Scientific, and Medtronic. Dr Miller reports consultancy fees from Boston Scientific. Dr Whinnett is an advisor for Boston Scientific and is on the advisory board for Medtronic and Abbot and reports speaker fees from Medtronic. The other authors report no conflicts.

Figures

**Figure 1.**
**Flowchart of questionnaire completion.** Questionnaires were considered completed if at least 1 36-Item Short Form Health Survey subscale was available. QoL indicates quality of life; S-ICD, subcutaneous implantable cardioverter-defibrillator; and TV-ICD, transvenous implantable cardioverter-defibrillator.

**Figure 2.**
**Outcomes between subcutaneous implantable cardioverter-defibrillator (S-ICD) and transvenous implantable cardioverter-defibrillator (TV-ICD) over time.** Questionnaire outcomes over time between the S-ICD and TV-ICD. A, Duke Activity Status Index (DASI). B, Mental health subscale of 36-Item Short Form Health Survey (SF-36). C, Bodily pain subscale of SF-36. The course of all remaining subscales can be found in Supplemental Material (Figure S1).

**Figure 3.**
**Subgroup analysis at 30 months. Subgroup analysis at 30-month follow-up. A**, Mental health. B, Bodily pain. C, Duke Activity Status Index (DASI). BMI indicates body mass index; SF-36, 36-Item Short Form Health Survey; S-ICD, subcutaneous implantable cardioverter-defibrillator; and TV-ICD, transvenous implantable cardioverter-defibrillator.

**Figure 4.**
**Quality of life after a shock. Median change score (dark line), presented with interquartile range. A**, Social functioning. B, Role limitations due to emotional problems. C, Mental health. Orange, subcutaneous implantable cardioverter-defibrillator (S-ICD); blue, transvenous implantable cardioverter-defibrillator (TV-ICD). For patients without a shock, their change score from baseline to 12 months was used. An analysis using the change score from baseline to 30 months showed comparable results. Numbers of patients without a shock differ as not all subscales were completed by all patients. One patient with a shock did not complete the SF-36. Three patients had both an appropriate and an inappropriate shock.

See this image and copyright information in PMC

References

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

Collaborators

Affiliations

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

Authors

Collaborators

Affiliations

Abstract

Conflict of interest statement

Figures

References

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Associated data

LinkOut - more resources

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