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This resulted in all three eyelets being<br />

successfully captured by the locking<br />

loop. There was no residual shunt<br />

around the device and its proper<br />

position was documented.<br />

The patient received 400 units / kg of<br />

heparin for 24 hours and 200 units / kg<br />

for another day. Antibiotics were<br />

repeated twice during the first 24 hours.<br />

Transthoracic echocardiography showed<br />

a good result with no residual shunt.<br />

The patient was dismissed 48 hours<br />

after the procedure.<br />

Discussion:<br />

This was our first implantation of<br />

<strong>Version</strong> 2.0 of the GORE ® HELEX Septal<br />

Occluder. Several modifications of<br />

the prior version have been made by<br />

W. L. <strong>Gore</strong> & Associates to improve<br />

the handling of the delivery system.<br />

Specifically, the mandrel has been<br />

reinforced by a stainless steel wire to<br />

prevent potential kinking. This issue<br />

intermittently occurred with the previous<br />

version when the distal end of the<br />

mandrel was sharply bent or pushed<br />

forward during the delivery procedure.<br />

The result of a kinked mandrel included<br />

an inability to properly configure the<br />

left-sided disc, thus alleviation of this<br />

potential issue with the new version of<br />

the device is a beneficial improvement.<br />

Despite the mandrel stiffener, it is still<br />

recommended to not push the mandrel<br />

forward during the procedure, which<br />

is under normal circumstances an<br />

unnecessary maneuver.<br />

As a second modification, the gray<br />

control catheter of the improved device<br />

now has a hydrophilic lubricious coating<br />

intended to decrease the frictional<br />

forces within the delivery catheter.<br />

This markedly improves the kinesthetic<br />

feel with which the device may be<br />

deployed. In our case, the decreased<br />

Figure 5: In the first attempt, the device was noted to be unequally deployed<br />

across the septum. The device was completely reloaded into the delivery<br />

catheter and a second attempt was initiated.<br />

Figure 6: Under echocardiography guidance, the left side of the<br />

GORE ® HELEX Device showed a flat configuration and was noted to be<br />

well-apposed to the atrial septum.<br />

Figure 7: Following deployment of the right disc, echocardiography<br />

revealed that the device was in good position, capturing the septal tissue.<br />

No residual shunt was seen.

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