The SICD-PSL project: observatory of Subcutaneous Implantable Cardioverter-Defibrillators at Pitié-Salpêtrière (SICD-PSL)
Context
- Implanted for 30 years, implantable cardioverter-defibrillators (ICDs) are based on the principle of a subcutaneous device connected to an endocavitary defibrillation lead and, where applicable, 1 or 2 pacemaker leads for the atrium and the coronary sinus. More than 15,000 French patients benefited from them in 2018. Worldwide, nearly 4 million patients have implantable electronic cardiac devices (IECDs), including 400,000 in France.
- Although it reduces mortality in patients with heart disease, this technology has certain drawbacks: lead-related complications, while infrequent, are far from negligible in number and in terms of morbidity and mortality.
- To address this, there is now a subcutaneous defibrillation lead, which offers the same safety and effectiveness as conventional defibrillators without lead-related drawbacks, but follow-up for this procedure remains limited to the DISQ-F registry, set up in 2015 and closed in 2020. Note that the use of the subcutaneous implantable defibrillator (S-ICD) continues to increase worldwide and at our Pitié-Salpêtrière Hospital site.
- For all these reasons, creating a local database for our center, incorporating DISQ-F data and providing continuous follow-up, seems essential.
Project objectives
- Demonstrate the effectiveness of the subcutaneous implantable cardioverter-defibrillator (S-ICD),
- Identify factors explaining benefits and risks in patients implanted with an S-ICD.
Patient benefits
- Improved management of patients with cardiac rhythm disorders,
- Improved understanding of the effectiveness and per-procedural incidents of the S-ICD procedure.
Study duration
- Total study duration : 15 years (10-year inclusion period + between 5 and 15 years of follow-up, depending on the date patients are included in the study)
Overall budget
€202,894
Project leads
Dr Nicolas BADENCO (Institute of Cardiology – Arrhythmology Unit, IHU ICAN (Cardiometabolism and Nutrition), INSERM 1166, AP-HP Sorbonne University – Pitié-Salpêtrière Hospital)
Prof. Estelle Gandjbakhch (Institute of Cardiology – Arrhythmology Unit, IHU ICAN, Pitié-Salpêtrière Hospital)
Dr Stéphane SCHUMACHER (Cardiology and Vascular Medicine, Versailles Hospital Center)
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Francine Trocmé
Direction communication et mécénat
06 81 64 97 88 – f.trocme@ihuican.org
