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Real-world evidence for the use of subcutaneous implantable cardioverter–defibrillators in China: A single-center experience

Praktische Belege für den Einsatz subkutaner implantierbarer Kardioverter-Defibrillatoren in China: Erfahrungen aus einem Einzelzentrum

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Abstract

Background

Subcutaneous implantable cardioverter–defibrillators (S-ICDs) have been shown to be non-inferior to transvenous ICDs in the prevention of sudden cardiac death (SCD), but there is still a lack of evidence from clinical trials in China. We investigated whether S‑ICD implantation in the Chinese population is safe and feasible and should be promoted in the future.

Methods

Consecutive patients undergoing S‑ICD implantation at our center were enrolled in this retrospective study. Data were collected within the median follow-up period of 554 days. Data concerning patient selection, implantation procedures, complications, and episodes of shock were analyzed.

Results

In total, 70.2% of all 47 patients (median age = 39 years) were included for secondary prevention of SCD with different etiologies. Vector screening showed that 98% of patients were with > 1 appropriate vector in all postures. An intraoperative defibrillation test was not performed on six patients because of the high risk of disease deterioration, while all episodes of ventricular fibrillation induced post implantation were terminated by one shock. As expected, no severe complications (e.g., infection and device-related complications) were observed, except for one case of delayed healing of the incision. Overall, 15 patients (31.9%) experienced appropriate shocks (AS) with all episodes terminated by one shock. Two patients (4.3%) experienced inappropriate shocks (IAS) due to noise oversensing, resulting in a high Kaplan–Meier IAS-free rate of 95.7%.

Conclusion

Based on appropriate patient selection and standardized implantation procedures, this real-world study confirmed the safety and efficacy of S‑ICD in Chinese patients, indicating that it may help to promote the prevention of SCD in China.

Zusammenfassung

Hintergrund

Subkutane implantierbare Kardioverter-Defibrillatoren (S-ICD) haben sich gegenüber transvenösen ICD bei der Prävention des plötzlichen Herztods (SCD) als nichtunterlegen erwiesen, aber es fehlt bislang noch Evidenz aus klinischen Studien in China. Die Autoren untersuchten, ob die S‑ICD-Implantation in der chinesischen Bevölkerung sicher und praktikabel ist und ob sie in Zukunft gefördert werden sollte.

Methoden

Konsekutiv sich zur S‑ICD-Implantation vorstellende Patienten im Zentrum der Autoren wurden in die vorliegende retrospektive Studie einbezogen. Für eine mittlere Nachbeobachtungsdauer von 554 Tagen wurden dabei Daten erhoben. Ausgewertet wurden die Daten zur Patientenselektion, zu den Implantationsverfahren, zu Komplikationen und Schockereignissen.

Ergebnisse

Zur Sekundärprävention des SCD unterschiedlicher Ätiologie wurden 70,2 % aller 47 Patienten (mittleres Alter: 39 Jahre) in die Studie eingeschlossen. Das Vektorscreening zeigte, dass 98 % der Patienten > 1 entsprechenden Vektor in allen Positionen aufwiesen. Ein intraoperativer Defibrillationstest wurde bei 6 Patienten wegen des hohen Risikos einer Krankheitsverschlechterung nicht durchgeführt, während alle Phasen von Kammerflimmern, die nach Implantation auftraten, durch einen Schock beendet wurden. Wie erwartet, wurden keine schweren Komplikationen (z. B. Infektionen und gerätbezogene Komplikationen) beobachtet, außer in einem Fall eine verzögerte Abheilung der Inzisionsstelle. Bei 15 Patienten (31,9 %) wurden adäquate Schocks (AS) ausgelöst, wobei alle Phasen durch einen Schock beendet wurden. In 2 Fällen (4,3 %) kam es zu inadäquaten Schocks (IAS) aufgrund von Oversensing, was zu einer hohen IAS-freien Rate nach Kaplan-Meier von 95,7 % führte.

Schlussfolgerung

Auf der Grundlage einer entsprechenden Patientenselektion und standardisierter Implantationsverfahren bestätigte die vorliegende Real-World-Studie die Sicherheit und Wirksamkeit von S‑ICD bei chinesischen Patienten als Hinweis darauf, dass diese Methode möglicherweise zur Förderung der Prävention des SCD in China beitragen kann.

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Funding

Sources: This study was supported by the National Key Clinical Specialty Discipline Construction Program of China (No. YW2021-002), the Shanghai Clinical Research Center for Interventional Medicine (No. 19MC1910300), and the Science and Technology Commission of Shanghai Municipality (No. 19441906500).

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Authors and Affiliations

  1. Department of Cardiology, Shanghai Institute of Cardiovascular Diseases, Zhongshan Hospital, Fudan University, Xietu Road, 1069, Shanghai, China

    Lei Zhang MD, Xiao Li MD, Yixiu Liang MD, Jingfeng Wang MD, Minghui Li MD, Lei Pan MD, Xueying Chen MD, Shengmei Qin MD, Jin Bai MD, Wei Wang MD,  Yangang Su MD &  Junbo Ge

  2. National Clinical Research Center for Interventional Medicine, Shanghai Clinical Research Center for Interventional Medicine, Shanghai, China

    Lei Zhang MD, Xiao Li MD, Yixiu Liang MD, Jingfeng Wang MD, Minghui Li MD, Lei Pan MD, Xueying Chen MD, Shengmei Qin MD, Jin Bai MD, Wei Wang MD,  Yangang Su MD &  Junbo Ge

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  1. Lei Zhang MD
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Correspondence to Yangang Su MD or Junbo Ge.

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Conflict of interest

L. Zhang, X. Li, Y. Liang, J. Wang, M. Li, L. Pan, X. Chen, S. Qin, J. Bai, W. Wang, Y. Su and J. Ge declare that they have no competing interests.

This article does not contain any studies with human participants or animals performed by any of the authors.

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The authors Lei Zhang, Xiao Li, and Yixiu Liang contributed equally to the manuscript.

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Zhang, L., Li, X., Liang, Y. et al. Real-world evidence for the use of subcutaneous implantable cardioverter–defibrillators in China: A single-center experience. Herz 48, 462–469 (2023). https://doi.org/10.1007/s00059-023-05192-4

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  • DOI: https://doi.org/10.1007/s00059-023-05192-4

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