Off-label use of implantable devices and stents in congenital heart disease patient’s interventional procedures. a single center experience
Amira Nour, Maiy El sayed, Azza Elfiky, Hebattallah Attia, Alaa Roshdy, Yasmeen Abdelrazik, Amr Mansour · 2025
Read Off-label use of implantable devices and stents in congenital heart disease patient’s interventional procedures. a single center experience by Amira Nour, Maiy El sayed, Azza Elfiky, Hebattallah Attia, Alaa Roshdy, Yasmeen Abdelrazik, Amr Mansour (2025) in the Tower of Babel, a free online library of public-domain works preserved in clean, searchable text. No sign-up. The full text is served as a plain-text file at a predictable URL, where text is present: https://antarctic-labs.com/tower-of-babel/pmc-12836851.txt.
Description
Amira Nour and co-authors report how often their center used devices off-label in catheter procedures for congenital heart disease. Catheter care has transformed the field: defects once fixed only by open surgery are now treated through a vessel, with high success. But many devices and stents used were never designed or approved for these hearts. Odd anatomy and wide-ranging disease make the mismatch common.
The team reviewed four years of cases in their congenital and structural heart unit. They logged each patient's diagnosis, the procedure, the device used, and what followed, counting major and minor complications. In all, 410 patients had a procedure with an off-label device or stent. If off-label use is in fact routine, regulators and makers need these numbers. Families deserve to hear how often the catheter tool was borrowed from another job.
Catalog record
| CREATOR | Amira Nour, Maiy El sayed, Azza Elfiky, Hebattallah Attia, Alaa Roshdy, Yasmeen Abdelrazik, Amr Mansour |
|---|---|
| YEAR | 2025 |
| COLLECTION | PAPERS |
| FORMAT | TXT |
| FILE SIZE | 37 KB |
| VERSION | 1.0 |
| LICENSE | CC BY 4.0 |
| RIGHTS | CC BY |
| SOURCE | Europe PMC |