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Percutaneous removal of unraveled HELEX® septal occluder 4 months post deployment
Patcharapong Suntharos1, Rukmini Komarlu1, Lourdes R Prieto1
1Department of Pediatric Cardiology, Cleveland Clinic Children's Hospital, Cleveland, Ohio.
Insights
A GORE® HELEX® Septal Occluder (HSO) unraveled after patent foramen ovale (PFO) closure, migrating through the tricuspid valve. Percutaneous removal was necessary despite initial stability, highlighting a rare complication.
Area of Science:
- Cardiology
- Medical Devices
- Interventional Cardiology
Background:
- The GORE® HELEX® Septal Occluder (HSO) is commonly used for percutaneous patent foramen ovale (PFO) closure.
- Successful deployment requires all three eyelets to be captured by the locking loop, which can be challenging in long-tunnel PFOs.
Observation:
- An unlocked HSO, though initially well-positioned after PFO closure, unraveled.
- The right atrial disc migrated through the tricuspid valve, while the left atrial disc remained apposed to the septum.
Findings:
- The patient underwent PFO closure before liver transplantation to prevent embolic events.
- Instrumentation for central line placement may have contributed to the HSO unraveling.
- The dislodged HSO was percutaneously removed 15 weeks post-implantation.
Implications:
- This case highlights a rare but serious complication of HSO deployment, emphasizing the need for careful monitoring.
- Potential mechanical disruption from other procedures in the right atrium could compromise device stability.
- Percutaneous retrieval is feasible even for partially endothelialized devices.
Abstract:
The GORE® HELEX® Septal Occluder (HSO: W.L. Gore & Associates; Flagstaff, AZ) is preferentially used at our institution for percutaneous closure of the patent foramen ovale (PFO). Adequate deployment of the device requires capture of three sequential eyelets by the locking loop. At times, the right atrial eyelet is not caught, particularly when a long tunnel PFO causes too much separation between the discs. Although rarely, unlocked devices have been left in the atrial septum with no untoward events provided they appear stable in the catheterization laboratory and the shunt has been eliminated. We report a patient in whom an unlocked, but otherwise well positioned, HSO subsequently unraveled with the right atrial disc migrating through the tricuspid valve while the left atrial disc remained well apposed to the left side of the atrial septum. The PFO was closed prior to liver transplantation to prevent an embolic event during the transplant. The patient required placement of several internal jugular central lines prior to transplant, and this instrumentation in the right atrium may have caused unraveling of the device. The HSO was removed percutaneously 15 weeks after implantation despite a well-seated and likely partially endothelialized left atrial disc.
