Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Multicenter Study
. 2023 Mar 30;25(3):1144-1151.
doi: 10.1093/europace/euac275.

Major gaps in the information provided to patients before implantation of cardioverter defibrillators: a prospective patient European evaluation

Łukasz Januszkiewicz  1 , Sérgio Barra  2 , Eloi Marijon  3   4   5 , Rui Providencia  6   7 , Carlo de Asmundis  8 , Julian K R Chun  9 , Michał M Farkowski  10 , Giulio Conte  11   12 , Serge Boveda  13   5   8
Affiliations
Multicenter Study

Major gaps in the information provided to patients before implantation of cardioverter defibrillators: a prospective patient European evaluation

Łukasz Januszkiewicz et al. Europace. .

Retraction in

Abstract

Aims: Information provided to patients prior to implantable cardioverter-defibrillator (ICD) insertion and their participation in the decision-making process are crucial for understanding ICD function and accepting this lifelong therapy. The aim of this study is to evaluate the extent to which different aspects related to ICD and quality of life were transmitted to patients prior to ICD implantation.

Methods and results: Prospective, multicenter European study with an online questionnaire initiated by the European Heart Rhythm Association. The questionnaire was filled-in directly and personally by the ICD patients who were invited to participate. A total of 1809 patients (majority in their 40s-70s, with 624 women, 34.5%) from 10 European countries participated in the study. The median time from first ICD implantation was 5 years (interquartile range 2-10). Overall, 1155 patients (71.5%) felt optimally informed at the time of device implantation, however many respondents received no information about ICD-related complications (n = 801, 49.6%), driving restrictions (n = 718, 44.5%), and possibility of end-of-life ICD deactivation (n = 408, 25.4%). Of note, women were less frequently involved in the decision-making process than men (47.3% vs. 55.9%, P = 0.003) and reported to be less often optimally informed before ICD implantation than men (61.2% vs. 76.8%, P < 0.001). More women mentioned the desire to have learned more about ICD therapy and the benefit/risk balance (45.4% vs. 33.7% of men; P < 0.001).

Conclusions: This patient-based evaluation provides alarming findings on the lack of information provided to patients prior ICD implantation, particularly for women.

Keywords: Complication; Patient-centred care; Patients’ values; Shared decision-making; Sudden death.

PubMed Disclaimer

Conflict of interest statement

Conflict of interest: Ł.J. has received speaker/consultant fees from Biotronik, Medtronic. E.M. has served as a consultant for Medtronic, Boston Scientific, Abbott, and Zoll. Research grants from Medtronic, Abbott, Boston Scientific, Biotronik, and Microport. M.M.F. has received speaker/proctoring fees from Abbott Medical Poland and Medtronic Poland. G.C. has received research grants from the Swiss National Foundation and research grants and speaker fees from Boston Scientific. S.B. has served as consultant for Medtronic, Boston Scientific, Microport, and Zoll. All the other authors have no conflict of interest to declare.

Figures

Graphical Abstract
Graphical Abstract
Figure 1
Figure 1
Summary of major gaps in information provided to ICD recipients. ICD, implantable cardioverter-defibrillator.
Figure 2
Figure 2
Bar graph showing what information patients received before ICD implantation. ICD, implantable cardioverter-defibrillator.
Figure 3
Figure 3
(A) Graph showing treatment discussion before the ICD implantation. (B) Graph showing participation in the decision about the ICD implantation. ICD, implantable cardioverter-defibrillator.
Figure 4
Figure 4
Bar graph showing patients’ need for specific information about living with an ICD. ICD, implantable cardioverter-defibrillator.
See this image and copyright information in PMC

Comment on

References

    1. Priori SG, Blomström-Lundqvist C, Mazzanti A, Blom N, Borggrefe M, Camm Jet al. ESC Scientific Document Group. 2015 ESC guidelines for the management of patients with ventricular arrhythmias and the prevention of sudden cardiac death: the task force for the management of patients with ventricular arrhythmias and the prevention of sudden cardiac death of the European Society of Cardiology (ESC) endorsed by: Association for European Paediatric and Congenital Cardiology (AEPC). Eur Heart J 2015;36:2793–867. - PubMed
    1. MedTech Europe . Statistics for Cardiac Rhythm Management products. Available at:https://www.medtecheurope.org/wp-content/uploads/2016/03/crm-charts-2020...(20 April 2022 date last accessed).
    1. Barisone M, Hayter M, Ghirotto L, Catania G, Zanini M, Dal Molin Aet al. The experience of patients with an implantable cardioverter-defibrillator: a systematic review and meta-synthesis of qualitative studies. Eur J Cardiovasc Nurs 2022;21:677–86. - PubMed
    1. Konstantino Y, Shafat T, Novack V, Novack L, Amit G. Incidence of implantable cardioverter defibrillator therapy and mortality in primary and secondary prevention of sudden cardiac death. Isr Med Assoc J 2015;17:760–3. - PubMed
    1. Tomzik J, Koltermann KC, Zabel M, Wilich SN, Reinhold T. Quality of life in patients with an implantable cardioverter defibrillator: a systematic review. Front Cardiovasc Med 2015;2:34. - PMC - PubMed