Percutaneous retrieval of the locked helex septal occluder

Abstract

The HELEX device is approved for percutaneous closure of an atrial septal defect (ASD). It is also often used off-label to close patent foramen ovale (PFO). The device is well tolerated because it is very flexible, but this characteristic increases the likelihood of embolization of locked implants. While the company provides a mechanism to retrieve devices that do not lock correctly, retrieval of locked and released devices is much more difficult. A case of percutaneous retrieval of an embolized, locked HELEX device is reported. This device was successfully retrieved from the aorta by snaring the left atrial eyelet and unlocking the device. A variety of potential techniques for retrieval of these devices was explored on the bench top. Strategies which can be used to successfully retrieve embolized HELEX devices are described.

Comparison of residual shunt rates in five devices used to treat patent foramen ovale

“…Another patient required placement of an Amplatzer device due to postprocedure embolization of the originally placed 25‐mm Helex device. This case and the description of the method of retrieval have been previously reported .…”

Comparison of residual shunt rate and complications across 6 different closure devices for patent foramen ovale

“…All device groups except for the Amplatzer Cribriform group had patients who complained of episodic palpitations. Unique adverse events include prompt surgical extraction of the PFO closure device due to a wire frame fracture causing cardiac tamponade ( n = 1, Cardioform group) (submitted for publication), device embolization requiring endovascular removal and percutaneous placement of a new device ( n = 1, Helex group), and thrombus formation on the device ( n = 3, CardioSEAL group) …”

Asymptomatic embolized HELEX® PFO closure device: Catheter based retrieval and value of routine echocardiography the following day

“…In ours and the previously reported cases [12,13], a GooseNeck snare was used to successfully retrieve the HELEX® device. The HELEX® device consists of a single nitinol wire with a mounted ePTFE occlusion membrane.…”

“…Both cases happened within 24 h of implantation. Poommipanit et al [12] described successful percutaneous retrieval of the HELEX® device that embolized to the aorta without significant complications. Yared et al [13] reported retrieval of a HELEX® device that was caught within the tricuspid valve apparatus.…”

“…There are several locations where a snare can attach to the HELEX® device including the right and left eyelets and the right and left atrial discs. In a bench top study, Poommipanit et al [12] describe ex-vivo snaring of the HELEX® device from its various parts using a GooseNeck snare. Snaring of the left atrial eyelet leads to release of the locking loop and straightening of the nitinol wire, allowing easy retrieval into a recovery sheath.…”