Idiomas disponibles
Idiomas disponibles
Procedure
CAUTION: Intracardiac echocardiography (ICE) or transesophageal echocardiography (TEE) is recommended
as an aid in evaluating the PFO and placing the Amplatzer™ Talisman™ PFO Occluder. If TEE is used, the
patient's esophageal anatomy must be adequate for placement and manipulation of the probe.
CAUTION: Be cautious when using fluoroscopic X-ray guidance, which may be used during placement of the
device.
CAUTION: Do not use a power injection system to put contrast solution through the sheath.
1. Puncture the femoral vein and perform a standard right-heart catheterization.
2. Perform an angiogram to demonstrate the PFO:
a. Catheterize the left atrium using a 45° LAO position and cranial angulation of 35°– 45°.
b. Inject contrast medium into the right upper lobe pulmonary vein.
NOTE: Occluder size and placement are based on the morphology and location of the PFO.
3. Use the J-tip guidewire to gain access through the PFO.
4. Use ICE or TEE to assess PFO morphology.
NOTE: PFO morphology is best assessed using a short axis view, where the PFO is visualized adjacent to the aortic
valve, and the septum primum is oriented in a near horizontal position (ICE septal short-axis view; TEE angles 30°,
45°, and 60°). Using this view, the excursion of the septum primum, length of the PFO tunnel, and the thickness of the
septum secundum are assessed. These features should also be assessed using a long axis bicaval view (ICE septal
bicaval view; TEE angles 90°, 105°, and 120° — see Figure 2 and Figure 3 in Appendix A: Supplemental Information).
Atrial Septal Aneurysm (ASA): An atrial septal aneurysm is a redundancy or saccular deformity of the septum
primum with increased mobility and bulging into the right atrium or the left atrium. ASA is defined as an excursion of
the septum primum of ≥10 mm from the plane of the atrial septum into the right atrium or left atrium or a combined total
excursion into the right atrium and left atrium of ≥15 mm. A prominent ASA is defined as having a combined excursion
of ≥20 mm.
PFO Tunnel Length: The PFO tunnel length is defined as the maximum overlap between the septum primum and
septum secundum. A long tunnel is defined as a tunnel length ≥10 mm.
Septum Secundum Thickness: The septum secundum thickness is defined as the maximum thickness of the
septum secundum within 10 mm from the PFO. A thickened septum secundum is defined as thickness ≥10 mm.
Lipomatous hypertrophy of the septum secundum is defined as having a thickness of ≥15 mm.
NOTE: If TEE imaging is used, Steps 4 – 6 can be performed prior to femoral access, if desired.
5. Use ICE or TEE to measure the distance from the PFO to the aortic root and the distance from the PFO to superior
vena cava orifice (see Figure 3B and Figure 3C in Appendix A: Supplemental Information).
ICE Imaging
PFO as assessed by ICE in short axis view with measurement of septum primum excursion (a), PFO tunnel length
2A
(b), and septum secundum thickness (c).
2B PFO as assessed by ICE in long axis bicaval/SVC view with measurement of septum primum length (a).
PFO as assessed by ICE in septal view with measurement of septum primum excursion into left atrium (a) and right
2C
atrium (b).
TEE Imaging
Measurement of septum primum excursion (a), PFO tunnel length (b), and septum secundum thickness (c) in the
3A
short axis 50-degree view (range 30 to 60 degrees to visualize the aortic root en face).
Distance from the PFO to aortic root (a) in the 30-degree view (range 0 to 45 degrees to visualize the aortic root en
3B
face)
Distance from the PFO to the orifice of the superior vena cava (SVC) (a) in the bicaval 90-degree view (range 80 to
3C
125 degrees to minimize foreshortening of the SVC).
NOTE: If imaging cannot clearly localize the PFO, place a wire through the PFO to help with identification.
6. Size the device based on the PFO morphology while taking into consideration the distances from the PFO to the aortic
root and SVC.
Most PFOs can be adequately covered with the 25 mm device. Consider the use of a larger device (30-35 mm) if the
PFO has an atrial septal aneurysm (ASA) with other features (for example, long tunnel or thickened septum
secundum) that may result in a substantial residual shunt or an unsecured position across the septum. Use of the 35
mm device should only be considered in cases where a secure device position cannot be achieved with the 30 mm
device.
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