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. 2024 Apr 8:13:e47525.
doi: 10.2196/47525.

National Tunisian Study of Cardiac Implantable Electronic Devices: Design and Protocol for a Nationwide Multicenter Prospective Observational Study

Sonia Chabrak  1 , Abdeddayem Haggui  2 , Emna Allouche  3 , Sana Ouali  4 , Afef Ben Halima  5 , Slim Kacem  6 , Salma Krichen  7 , Sonia Marrakchi  8 , Wafa Fehri  9 , Mohamed Sami Mourali #  4 , Zeineb Jabbari  4 , Manel Ben Halima  10 , Elyes Neffati  11 , Aymen Heraiech  11 , Mehdi Slim  11 , Salem Kachboura  10 , Habib Gamra  12 , Majed Hassine  12 , Sondes Kraiem  13 , Sofien Kammoun  13 , Leila Bezdah  3 , Gouider Jridi  14 , Hatem Bouraoui  14 , Samir Kammoun  15 , Rania Hammami  15   16 , Rafik Chettaoui  1 , Youssef Ben Ameur  17 , Fares Azaiez  17 , Rami Tlili  17 , Kais Battikh  18 , Hedi Ben Slima  19 , Rim Chrigui  1 , Samia Fazaa  1 , Islem Sanaa  20 , Yassine Ellouz  1 , Mohamed Mosrati  21 , Sami Milouchi  16   22 , Soumaya Jarmouni  1 , Wacef Ayadi  7 , Malek Akrout  7 , Rabie Razgallah  23 , Wissal Neffati  23 , Meriem Drissa  16   17 , Selma Charfeddine  15   16 , Salem Abdessalem  16 , Leila Abid  15 , Lilia Zakhama  24
Affiliations

National Tunisian Study of Cardiac Implantable Electronic Devices: Design and Protocol for a Nationwide Multicenter Prospective Observational Study

Sonia Chabrak et al. JMIR Res Protoc. .

Abstract

Background: In Tunisia, the number of cardiac implantable electronic devices (CIEDs) is increasing, owing to the increase in patient life expectancy and expanding indications. Despite their life-saving potential and a significant reduction in population morbidity and mortality, their increased numbers have been associated with the development of multiple early and late complications related to vascular access, pockets, leads, or patient characteristics.

Objective: The study aims to identify the rate, type, and predictors of complications occurring within the first year after CIED implantation. It also aims to describe the demographic and epidemiological characteristics of a nationwide sample of patients with CIED in Tunisia. Additionally, the study will evaluate the extent to which Tunisian electrophysiologists follow international guidelines for cardiac pacing and sudden cardiac death prevention.

Methods: The Tunisian National Study of Cardiac Implantable Electronic Devices (NATURE-CIED) is a national, multicenter, prospectively monitored study that includes consecutive patients who underwent primary CIED implantation, generator replacement, and upgrade procedure. Patients were enrolled between January 18, 2021, and February 18, 2022, at all Tunisian public and private CIED implantation centers that agreed to participate in the study. All enrolled patients entered a 1-year follow-up period, with 4 consecutive visits at 1, 3, 6, and 12 months after CIED implantation. The collected data are recorded electronically on the clinical suite platform (DACIMA Clinical Suite).

Results: The study started on January 18, 2021, and concluded on February 18, 2023. In total, 27 cardiologists actively participated in data collection. Over this period, 1500 patients were enrolled in the study consecutively. The mean age of the patients was 70.1 (SD 15.2) years, with a sex ratio of 1:15. Nine hundred (60%) patients were from the public sector, while 600 (40%) patients were from the private sector. A total of 1298 (86.3%) patients received a conventional pacemaker and 75 (5%) patients received a biventricular pacemaker (CRT-P). Implantable cardioverter defibrillators were implanted in 127 (8.5%) patients. Of these patients, 45 (3%) underwent CRT-D implantation.

Conclusions: This study will establish the most extensive contemporary longitudinal cohort of patients undergoing CIED implantation in Tunisia, presenting a significant opportunity for real-world clinical epidemiology. It will address a crucial gap in the management of patients during the perioperative phase and follow-up, enabling the identification of individuals at particularly high risk of complications for optimal care.

Trial registration: ClinicalTrials.gov NCT05361759; https://classic.clinicaltrials.gov/ct2/show/NCT05361759.

International registered report identifier (irrid): RR1-10.2196/47525.

Keywords: Tunisia; cardiac resynchronization therapy; complication; design; implantable cardioverter defibrillator; pacemaker; study.

PubMed Disclaimer

Conflict of interest statement

Conflicts of Interest: None declared.

Figures

Figure 1
Figure 1
The Timeline of the Nature CIED study.
See this image and copyright information in PMC

References

    1. Priori SG, Blomström-Lundqvist C, Mazzanti A, Blom N, Borggrefe M, Camm J, Elliott PM, Fitzsimons D, Hatala R, Hindricks G, Kirchhof P, Kjeldsen K, Kuck KH, Hernandez-Madrid A, Nikolaou N, Norekvål TM, Spaulding C, Van Veldhuisen DJ, 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 Nov 01;36(41):2793–2867. doi: 10.1093/eurheartj/ehv316.2293363 - DOI - PubMed
    1. Glikson M, Nielsen JC, Kronborg MB, Michowitz Y, Auricchio A, Barbash IM, Barrabés JA, Boriani G, Braunschweig F, Brignole M, Burri H, Coats AJS, Deharo JC, Delgado V, Diller GP, Israel CW, Keren A, Knops RE, Kotecha D, Leclercq C, Merkely B, Starck C, Thylén I, Tolosana JM, ESC Scientific Document Group 2021 ESC Guidelines on cardiac pacing and cardiac resynchronization therapy. Eur Heart J. 2021 Sep 14;42(35):3427–3520. doi: 10.1093/eurheartj/ehab364.6358547 - DOI - PubMed
    1. Zecchin M, Torre M, Carrani E, Sampaolo L, Ciminello E, Ortis B, Ricci R, Proclemer A, Sinagra G, Boriani G. Seventeen-year trend (2001-2017) in pacemaker and implantable cardioverter-defibrillator utilization based on hospital discharge database data: an analysis by age groups. Eur J Intern Med. 2021 Feb;84:38–45. doi: 10.1016/j.ejim.2020.09.003. https://linkinghub.elsevier.com/retrieve/pii/S0953-6205(20)30348-4 S0953-6205(20)30348-4 - DOI - PubMed
    1. Raatikainen MJP, Arnar DO, Merkely B, Nielsen JC, Hindricks G, Heidbuchel H, Camm J. A decade of information on the use of cardiac implantable electronic devices and interventional electrophysiological procedures in the European Society of Cardiology Countries: 2017 report from the European Heart Rhythm Association. Europace. 2017 Aug 01;19(suppl_2):ii1–ii90. doi: 10.1093/europace/eux258.4100657 - DOI - PubMed
    1. Diemberger I, Lorenzetti S, Vitolo M, Boriani G. Infective endocarditis in patients with cardiac implantable electronic devices: impact of comorbidities on outcome. Eur J Intern Med. 2019 Aug;66:e9–e10. doi: 10.1016/j.ejim.2019.06.015.S0953-6205(19)30215-8 - DOI - PubMed

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