Chabrak Sonia, Haggui Abdeddayem, Allouche Emna, Ouali Sana, Ben Halima Afef, Kacem Slim, Krichen Salma, Marrakchi Sonia, Fehri Wafa, Mourali Mohamed Sami, Jabbari Zeineb, Ben Halima Manel, Neffati Elyes, Heraiech Aymen, Slim Mehdi, Kachboura Salem, Gamra Habib, Hassine Majed, Kraiem Sondes, Kammoun Sofien, Bezdah Leila, Jridi Gouider, Bouraoui Hatem, Kammoun Samir, Hammami Rania, Chettaoui Rafik, Ben Ameur Youssef, Azaiez Fares, Tlili Rami, Battikh Kais, Ben Slima Hedi, Chrigui Rim, Fazaa Samia, Sanaa Islem, Ellouz Yassine, Mosrati Mohamed, Milouchi Sami, Jarmouni Soumaya, Ayadi Wacef, Akrout Malek, Razgallah Rabie, Neffati Wissal, Drissa Meriem, Charfeddine Selma, Abdessalem Salem, Abid Leila, Zakhama Lilia
Pasteur Clinic, General and Cardiovascular Clinic of Tunis, Tunis, Tunisia.
Military Hospital, Faculty of Medicine of Tunis, University of Tunis, Tunis, Tunisia.
JMIR Res Protoc. 2024 Apr 8;13:e47525. doi: 10.2196/47525.
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.
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.
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).
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.
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.
ClinicalTrials.gov NCT05361759; https://classic.clinicaltrials.gov/ct2/show/NCT05361759.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR1-10.2196/47525.
在突尼斯，由于患者预期寿命的增加和适应证的扩大，心脏植入式电子设备（CIED）的数量正在增加。尽管它们具有挽救生命的潜力，并且显著降低了人群的发病率和死亡率，但数量的增加与多种早期和晚期并发症的发生有关，这些并发症与血管通路、囊袋、导线或患者特征有关。
本研究旨在确定CIED植入后第一年内发生并发症的发生率、类型和预测因素。它还旨在描述突尼斯全国范围内CIED患者样本的人口统计学和流行病学特征。此外，该研究将评估突尼斯电生理学家遵循心脏起搏和心脏性猝死预防国际指南的程度。
突尼斯心脏植入式电子设备国家研究（NATURE-CIED）是一项全国性、多中心、前瞻性监测研究，纳入接受初次CIED植入、发生器更换和升级手术的连续患者。患者于2021年1月18日至2022年2月18日在所有同意参与该研究的突尼斯公立和私立CIED植入中心入组。所有入组患者进入为期1年 的随访期，在CIED植入后1、3、6和12个月进行4次连续随访。收集的数据通过电子方式记录在临床套件平台（DACIMA Clinical Suite）上。
该研究于2021年1月18日开始，2023年2月18日结束。共有27名心脏病专家积极参与数据收集。在此期间，共有1500名患者连续入组该研究。患者的平均年龄为70.1（标准差15.2）岁，性别比为1:15。900名（60%）患者来自公共部门，而600名（40%）患者来自私营部门。共有1298名（86.3%）患者接受了传统起搏器植入，75名（5%）患者接受了双心室起搏器（CRT-P）植入。127名（8.5%）患者植入了植入式心律转复除颤器。其中，45名（3%）患者接受了CRT-D植入。
本研究将建立突尼斯接受CIED植入的最广泛的当代纵向队列，为真实世界临床流行病学提供了重要机会。它将弥补围手术期和随访期间患者管理方面的关键差距，有助于识别并发症风险特别高的个体，以便进行最佳护理。
ClinicalTrials.gov NCT05361759；https://classic.clinicaltrials.gov/ct2/show/NCT05361759。
国际注册报告识别码（IRRID）：RR1-10.2196/47525。
