突尼斯全国心脏植入式电子设备多中心前瞻性研究（突尼斯NATURE-CIED研究）：一年期并发症及预测因素
National Tunisian Multicenter Prospective Study on Cardiac Implantable Electronic Devices (Tunisian NATURE-CIED study): One-year complications and predictive factors.
作者信息
Chabrak Sonia, Allouche Emna, Ouali Sana, Haggui Abdeddayem, 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, 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, Abid Leila, Zakhama Lilia, Abdessalem Salem
机构信息
Cardiology Department, Pasteur Clinic, Tunis, Tunisia.
Cardiology Department, Faculty of Medicine of Tunis, Charles Nicolle Hospital, University of Tunis, Tunis, Tunisia.
出版信息
Heart Rhythm O2. 2025 May 13;6(8):1077-1087. doi: 10.1016/j.hroo.2025.05.004. eCollection 2025 Aug.
BACKGROUND
The prevalence of cardiac implantable electronic devices (CIEDs) in Tunisia is rising because of increased life expectancy and broader indications. This has led to a higher incidence of complications related to vascular access, device pockets, leads, and patient characteristics.
OBJECTIVE
We aimed to evaluate the prevalence, types, and predictors of complications occurring within the first year after CIED implantation and to profile the demographic and epidemiologic characteristics of CIED recipients in Tunisia.
METHODS
The National Tunisian Multicenter Prospective Study on Cardiac Implantable Electronic Devices is a nationwide, prospective study. We enrolled consecutive patients, from January 2021 to February 2022, undergoing de novo implantation of pacemakers, implantable cardioverter defibrillators, cardiac resynchronization therapy devices, generator replacements, and upgrading procedures. Patients attended 4 follow-up visits within the first year.
RESULTS
We enrolled 1500 patients with a mean age of 70.1 ± 15.2 years. Most (86.5%) received conventional pacemakers. The overall complication rate was 8.6%, with 129 complications in 80 patients. No significant associations were found between age or gender and complication rates. However, overweight and obesity were independent predictors of overall complications. Procedures performed in private health care settings were associated with a 56.2% reduction in complication rates. Generator replacements were linked to a 64.2% decrease in complication rates. Conversely, urgent or out-of-hours procedures increased the risk of complications by 62.7%. Procedures performed by non-electrophysiologist implanters were associated with an 89.5% increase in overall complication rates.
CONCLUSION
Complications were more prevalent with cardiac resynchronization therapy devices. Identifying specific procedural predictors may pinpoint patients at higher risk, affecting personalized treatments and CIED implantation strategies.
背景
由于预期寿命延长和适应症范围扩大，突尼斯心脏植入式电子设备（CIED）的普及率正在上升。这导致了与血管通路、设备囊袋、导线和患者特征相关的并发症发生率更高。
目的
我们旨在评估CIED植入后第一年内发生并发症的患病率、类型和预测因素，并描述突尼斯CIED接受者的人口统计学和流行病学特征。
方法
突尼斯全国心脏植入式电子设备多中心前瞻性研究是一项全国性的前瞻性研究。我们纳入了2021年1月至2022年2月期间连续接受起搏器、植入式心脏复律除颤器、心脏再同步治疗设备、发生器更换和升级手术的患者。患者在第一年内进行了4次随访。
结果
我们纳入了1500例患者，平均年龄为70.1±15.2岁。大多数（86.5%）接受了传统起搏器。总体并发症发生率为8.6%，80例患者出现129例并发症。年龄或性别与并发症发生率之间未发现显著关联。然而，超重和肥胖是总体并发症的独立预测因素。在私立医疗机构进行的手术与并发症发生率降低56.2%相关。发生器更换与并发症发生率降低64.2%相关。相反，紧急或非工作时间手术使并发症风险增加62.7%。由非电生理学家植入者进行的手术与总体并发症发生率增加89.5%相关。
结论
心脏再同步治疗设备的并发症更为普遍。识别特定的手术预测因素可能会确定高风险患者，影响个性化治疗和CIED植入策略。
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