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are as high as 95% at 6 months [19]. Thrombus formation on the device is exceedingly rare, as is clinically relevant
new-onset atrial fibrillation.
CardioSEAL Device
The CardioSEAL device is a self-expanding, double square disc device, made out of a nickel-cobalt-based alloy
covered by Dacron. Each disc consists of 4 arms. Safety and efficacy of this device have been reported in observa-
tional studies [63,79,80]. The device is no longer manufactured.
STARFlex Device
The STARFlex device, a self-expanding, double square disc device, is similar to the CardioSEAL device. It is also
made out of a nickel-cobalt-based alloy and covered by Dacron. The device was associated with an increased risk of
atrial fibrillation and device thrombus formation [84] and is no longer on the market.
Figulla II PFO Occluder
The design of this occluder is similar to that of the Amplatzer PFO Occluder, with slight changes such as a lower-
profile left atrial disc and the absence of a hub on the left atrial side [81,82]. The safety and efficacy of this device have
been shown in smaller registries and case series [81,82]. Because of patent infringement concerns, it was not intro-
duced in the United States.
Gore HELEX Septal Occluder
The HELEX device consists of a single nitinol wire frame covered with expanded polyte trafluoroethylene (ePTFE)
with a left atrial, central, and right atrial eyelet and a locking loop holding the device together [22,85]. The Gore
HELEX septal occluder was effective but technically challenging to deploy and is no longer commercially available.
It was replaced by the next-generation occluder based on a similar principle, the Gore Cardioform Septal Occluder.
Gore Cardioform Septal Occluder
The Cardioform device is a double disc device made out of a nitinol frame, covered by expanded polytetrafluoro-
ethylene (ePTFE). Although reported success rates are high, a lower complete closure rate has been reported with this
device [74]. On the other hand, this device is preferred by other operators who argue that it is better tolerated by pa-
tients (fewer patients complaining of chest discomfort than with the Amplatzer series of occluders). The group at
UCLA (University of California, Los Angeles) has reported that the Cardioform device has the highest complete
closure rate of any device based on transcranial Doppler bubble study assessment for residual shunting [86].There
has not been a report of atrial erosion with the HELEX or Cardioform devices [87e89], but there are 2 cases of hemo-
pericardium out of 40,000 sold devices due to a fractured nitinol wire (publication in process). Of all Amplatzer PFO
device implants, there were 2 erosions reported on a comprehensive review of the device company’s registry pub-
lished in 2008 [90].
Nondouble Disc Devices
FlatStent Occluder
The FlatStent Occluder consists of a polyurethane foam and a nitinol-based wire framework [83]. The design of
the FlatStent Occluder is based on the assumption that systems minimizing the amount of material exposed to the
(A) (B) (C) (D) (E)
FIGURE 14.4 Fluoroscopy-guided implantation (left anterior oblique projection) of a 25 mm Amplatzer PFO Occluder in a 40-year-old
patient with prior stroke and a PFO with right-to-left shunting. (A) Advancement of the sheath over the wire placed in the left atrium. (B)
Opening of the left-sided portion of the occluder within the left atrium. (C) Opening of the right-sided portion of the occluder within the right
atrium under continued tension. (D) Assessment of the device position. (E) Release of the device with final assessment of device position.
VII. SAFETY, TECHNICAL ASPECTS TO PFO CLOSURE, AND FUTURE OUTLOOK
DEVICES 179
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circulating blood might reduce device-related complications such as thrombus formation, erosion, or atrial arrhyth-
mias. However, experience with this device is limited [91,92], and it remains to be determined whether the concept
translates into similar outcomes as with the double disc devices.
NobleStitch EL Occluder
This system for PFO closure uses, similar to some femoral vascular closure devices, a stitch technology to suture the
septum primum and secundum, producing an “S-shape” closure of the PFO [93]. It emerged out of similar devices
tested over the past decade with unsatisfactory results. First experience with this device was recently reported in the
NobleStitch EL Italian registry of 192 patients [93,94]. Procedural success was achieved in 96% of patients, but at a
mean follow-up of 200 days, an exceedingly high rate of residual shunt was found (significant right-to-left shunting
in 11%) [93].
Radiofrequency Fusion
Some studies investigated the use of radiofrequency for percutaneous PFO closure without leaving behind an
implanted device. However, closure rates of about 50% (as reported in small registries) were substantially lower
than those achieved with established devices, and further device development was suspended [95e97].
SAFETY
Percutaneous PFO closure is a safe, effective, and durable procedure. Primary technical success approaches 100%,
and rates of effective closure at 6 months were 94e96% with the Amplatzer PFO Occluder, and 86% with the STAR-
Flex device [17e 19]. Residual shunts, which are associated with increased rates of recurrent events, can be treated
successfully with a second device [98,99,106].
Randomized trials showed excellent safety results for percutaneous PFO device closure [17]. Albeit rare, device-
or procedure-related complications may occur (Table 14.2) [8,9,17e19,22]. We estimate that over a million patients
were treated with PFO closure over the past few decades; of these, only a limited number of serious or lethal com-
plications have been reported [100]. Atrial fibrillation, mostly occurring only intra- or early post-procedural, has
been reported in about 5% of patients after percutaneous PFO closure [17,84,101], with lower rates observed with
the Amplatzer PFO occluder [74,102]. Device thrombus formation may rarely occur [17,101,102], and few cases of
atrial erosion have been reported [103].
Despite the general safety of the devices and the procedure, there are reports of the necessity of surgical removal
for a variety of reasons. In a global survey of 13,736 percutaneous PFO device implantations performed over 9 years
at 18 institutions, 38 devices (0.28% [95% confidence interval: 0.20%e0.37%]) required surgical removal. There were
a wide range of causes cited for these removals. The most common cause for explantation was chest pain in 14 pa-
tients, often believed to be secondary to nickel allergy to the PFO occluding device. Other causes for explantation
included persistence of a residual shunt in 12 cases, which would have been corrected percutaneously in many in-
stitutions; these further included the presence of thrombus on 4 devices, pericardial effusion in 2, perforation of the
atrium or aortic root in 2, recurrent stroke in 1, endocarditis in 1, and undocumented reasons in 2 patients.
The vast majority of PFO closure procedures are performed safely with minimal complications. However, there is a
small (0.28%) incidence of severe long-term problems associated with PFO closure that might require surgical removal
of the device. In addition, the frequency of surgical explantation was found to be device-dependent; some of the de-
vices seem to be safer than others [104]. In the experience of the authors of about 8000 PFO closures predominantly
with Amplatzer devices, there was only 1 surgical explantation for pericardial effusion.
INFORMED CONSENT
In interventional cardiology, benefits and risks of procedures need to be well balanced in each individual patient,
taking into account anatomical and technical considerations, along with the patient’s age and comorbid burden.
Shared decision making actively involves the patient and includes an open and individualized discussion about
the current evidence, pros and cons of PFO closure in the particular context, as well as personal values and prefer-
ences of the individual patient [74,105]. In some centers, a 1 in 500 risk of requiring open heart surgery is discussed
with the patient as part of the informed consent process. The probability of a causal role of the PFO in the specific
situation and the likelihood of recurrence of the index event need to be discussed, as well as the rates of procedural
complications observed with device closure and alternative medical management. In patients with paradoxical
VII. SAFETY, TECHNICAL ASPECTS TO PFO CLOSURE, AND FUTURE OUTLOOK
14. PERCUTANEOUS PFO CLOSURE180
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embolism, the risks and benefits of a one-time procedure (also referred to as a “mechanical vaccination”) must be
weighed against the risk of lifelong oral anticoagulation.
CONCLUSION
Percutaneous PFO closure can be performed safely as an outpatient procedure. Despite the growing number of
device closure procedures performed during the last decade, this procedure is still underutilized in clinical practice.
Indications can be expanded and may include primary preventive closure of selected high-risk patients (Chapter 18).
The fact that initially underpowered randomized controlled trials, investigating benefits of percutaneous PFO
closure over medical management in stroke patients, did not meet their primary endpoints might have further
contributed to a rather restrained use of this technique. Given the devastating sequelae that paradoxical embo-
lism-mediated clinical events may cause, a more proactive attitude toward PFO closure must be advocated.
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TABLE 14.2 Adverse Events of Percutaneous PFO Closure as Reported in Randomized Trials.
Complications CLOSURE I [17] PC [18] RESPECT [19] CLOSE [9] REDUCE [22] DEFENSE-PFO [8]
Device
STARFlex
Occluder
Amplatzer PFO
Occluder
Amplatzer
PFO Occluder
Different
Devices
(51% Amplatzer
PFO Occluder)
Helex or
Cardioform
Septal Occluder
Amplatzer PFO
Occluder
Major vascular
procedural
complications
3.2% e 0.6% ee e
Procedural
complications
e 1.5% e 5.9% ee
PFO-related hospital
admissions
e 6.4% versus 6.2% ee e e
Atrial fibrillation or
flutter
5.7% versus
0.7%
2.9% versus 1.0% 3.0% versus
1.5%
4.6% versus
0 9%a
a,b
6.6% versus 0.4%
a
e
Major bleeding 2.6% versus
1.1%
0.5% versus 1.4% e 0.8%versus
2.1%
b
1.8%versus 2.7% 0.0% versus 4.9%
Device/cardiac
thrombus formation
1.1% e 0.4% e 0.5% e
Device dislocation ee ee0.7% e
Cardiac tamponade ee 0.4% versus
0.0%
ee e
Nervous system
disorder
1.5%versus
3.5%
eeeee
Deaths
(all nondevice
related)
0.5% versus
0.7%
1.0%versus 0.0% 0.6% versus
1.2%
0.0% versus
0.0%
b
0.5% versus 0.0% 0.0% versus 0.0%
Serious adverse
events
16.9% versus
16.6%
21.1% versus 17.6% 23.0% versus
21.6%
35.7% versus
33.2%
b
23.1%versus 27.8% e
Comparisons for PFO closure versus medical treatment group.
a
atrial fibrillation or flutter,
b
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[106] Susuri N, Obeid S, Ulmi M, Siontis GCM, A Wahl, Windecker S, Nietlispach F, Meier B, Praz F. Second transcatheter closure for residual
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VII. SAFETY, TECHNICAL ASPECTS TO PFO CLOSURE, AND FUTURE OUTLOOK
14. PERCUTANEOUS PFO CLOSURE184
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CHAPTER
15
How I Do It: ICE-Guided Technique for
Percutaneous PFO Closure
Islam Abudayyeh
1
, Jonathan S. Gordin
2
, Jonathan M. Tobis
2
1
Loma Linda University Health, Loma Linda, CA, United States;
2
University of California, Los Angeles, Los Angeles,
CA, United States
OUTLINE
Introduction 185
Anatomic Considerations 187
Inserting the Intracardiac Echocardiography
Catheter 189
Manipulating the Intracardiac Echocardiography
Catheter 189
Closing the PFO 190
Post Deployment and Intracardiac Echocardiography
Catheter Withdrawal
193
Challenges
193
Unusual Cases: Tips and Tricks
193
References
200
INTRODUCTION
In order to close a patent foramen ovale (PFO) safely and effectively, it is important to understand the septal anat-
omy as it relates to surrounding structures (Chapter 1). Ultrasound imaging plays a central role in defining the PFO
or atrial septal defect anatomy. It may also help in crossing the septum, deploying the septal occluder, and assessing
the device position [1]. Some operators prefer to use the Amplatzer PFO Occluder (Abbott, St. Paul, MN, USA) or
devices derived from it, and deploy these devices with or without a prescreening transesophageal echocardiogram
using only fluoroscopic guidance at the time of implantation (Chapter 16). Other operators prefer the Cardioform
Occluder (W.L. Gore and Associates, Flagstaff, Arizona) due to its conformation to the contours of the atrial septal
anatomy and pliability, which makes it well tolerated by most patients [2]. There are reports of nickel allergy with the
Amplatzer PFO Occluder, but we are not aware of any reports of nickel allergy with the Cardioform device or with
other occluders; the Cardioform device is covered instead with Gore-Tex (e-PTFE). Many operators believe it is pref-
erable to have ultrasound imaging guidance during the deployment of the Cardioform device, or PFO devices in
general. This chapter will describe the technique of using intracardiac echocardiography (ICE) for PFO closure
and provide examples of difficult cases where special techniques are required [1].
The initial imaging modality of choice to study the septum is trans thoracic echocardiography (TTE). However,
TTE is not very sensitive for identifying PFOs and does not show the fossa ovalis or the interface between the septum
primum and septum secundum due to its relationship with the axis of the chest where the TTE probe is applied
185
PFO Closure for Stroke, Myocardial Infarction, Peripheral Embolism, Migraine, and Hypoxemia
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(Chapter 2) [3]. In comparison, transesophageal echocardiography (TEE) is more accurate as the probe is placed in
the esophagus, directly behind the left atrium in close proximity to the septum; TEE operates at a higher frequency of
5e10 MHz, which provides a more detailed image at the cost of depth penetration [4]. With improvement in TEE
probes and processing technology, it is now routine to define the septal defect in 3 dimensions and identify adjacent
anatomical variations, such as multifenestrations or a septal aneurysm, which may not have been seen on TTE.
Furthermore, TEE prior to PFO closure is used to assess for a left atrial appendage (LAA) thrombus, valvular pathol-
ogies, intracardiac masses, anomalo us pulmonary veins, and other defects such as adjacent or distant atrial septal
defects. This, in combination with other diagnostic studies, is important before committing to percutaneous PFO
closure as a therapeutic procedure [5]. Fluoroscopy by itself is helpful but not deemed sufficient for a safe and reli-
able PFO closure by most operators [6]. However, in order to use TEE during the implantation procedure, the patient
is usually intubated or at least deeply sedated, which in contrast to intubation carries a risk of bronchial aspiration,
and the TEE imaging procedure is invasive in itself. An alternative is to use ICE during the procedure. The advan-
tages of ICE are that the entire closure can be done with the patient fully conscious and the operator is able to adjust
the probe without the need for an imaging specialist being present and subjected to substantial radiation [7]. The ICE
catheter operates at a higher frequency of 8e12 MHz, which limits depth penetration but provides detailed imaging
of cardiac structures with improved spatial resolution.
ICE catheters were first used in the 1980s. They are simple to manipulate but require additional training for image
interpretation and optimal visualization of the cardiac anatomy. Addition of phased array transducers on the tip pro-
vides Doppler and color-flow imaging. The addition of matrix transducers, without significantly increasing the cath-
eter size, allows for acquisition of volumetric 3D imaging, although with a limited window width and penetration
compared to TEE. An adult-size TEE probe measures just over 5 mm for the shaft and about 10 mm for the imaging
tip [8]. The ICE catheter measures 2.7 or 3 mm, which fit into an 8 or 9 French sheath respectively. The 2 most com-
mon probes are the Siemens Acuson (Siemens Healthcare, Erlangen Germany) and Abbott (St. Jude Medical, St.
Paul, MN, USA) probes. The tip houses a 64-element transducer, scanning vertically along the probe to provide a
90 degrees sector image (Fig. 15.1) [9].
As the atrial septum is oriented superiorly and medially to where the inferior vena cava (I VC) enters the right
atrium, it is fairly straightforward to place the ICE probe in the right atrium such that it faces the septum and
visualizes the anatomy around the fossa ovalis during procedures. Simple maneuvers can then be used to study
the adjace nt anatomy and device deployment. We recommend using a 9 French 24 cm long sheath, which extends
beyond the posterior bend of the iliac vein; this avoids any risk of inducing pain or perforation when passin g the
ICE probe from the femoral vein. In co mparison, TEE has both a wider field of view and a rotating omniplane to
show the anatomy and septal rims from any aspect (Fig. 15.2). ICE is not able to fully define the inferior borders in
relation to the defect, especially in cases where there is a deficient IVC rim. Use of an ICE catheter adds additional
direct costs to the procedure and requires operator familiarity with manipulating the probe to obtain the necessary
images. The cost of an ICE catheter can be mitigated by use of a resterilized probe and performing the procedure
under conscious sedation , obviating the need for an anesthesiologist or requiring a postoperative unit for patient
recovery [10]. A comparison study assessed the costs between TEE and ICE imaging techniques and showed them
to be simila r [11]. Additionally, the operat or using ICE has to be comforta ble controlling the probe and sedating the
patient while performing PFO closure. Obtaining that skill requires some training and an appreciation of the limits
of ICE imaging.
FIGURE 15.1 The Acuson intracardiac echocardiography imaging catheter requires an 8F sheath.
15. HOW I DO IT: ICE-GUIDED TECHNIQUE FOR PERCUTANEOUS PFO CLOSURE186
VII. SAFETY, TECHNICAL ASPECTS TO PFO CLOSURE, AND FUTURE OUTLOOK
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ANATOMIC CONSIDERATIONS
The Chiari network shunts blood from the IVC into the right atrium and toward the PFO. In utero, this serves to
direct the flow of blood a cross the interatrial septum to the left atrium during gestation, thus bypa ssing the fluid-
filled lungs (Chapter 1). A large Chiari network can become an obstacle to crossing into the right atrium f rom the
IVC, diverting the ICE catheter to variable unwanted directions. Since an ICE catheter cannot be guided over a wire,
it is prudent to stop when encountering any resistance and gently turn the catheter to navigate it into the right
atrium with minimal force [12]. A review of the ba sic anatomy ca n then be done us ing the views described below.
A septal aneurysm can occur in the septum primum and is defined as either a septal deflection into either atrium of
>10 mm beyond the plane of the atrial septum or a total septal deflection for both chambers of >15 mm (Fig. 15.3).
FIGURE 15.2 The tip of an intracardiac echocardiography imaging catheter. The transducer array is radioopaque and lines up along the end of
the catheter to generate an image with the field of view vertical in the same axis as the catheter.
FIGURE 15.3 Aneurysmal mobile septum primum and thicker more stable septum secundum seen with intracardiac echocardiography
imaging.
VII. SAFETY, TECHNICAL ASPECTS TO PFO CLOSURE, AND FUTURE OUTLOOK
ANATOMIC CONSIDERATIONS 187
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If the PFO flap is open, it may be visualized as left-to-right shunting of blood between the atria by co lor flow
Doppler [13]. This is expected as baseline left atrial pressure is physiologically slightly higher than right atrial pres-
sure [14]. During a Valsalva maneuver, straining, coughing, certain phases of breathing, or in those with pulmonary
hypertension, right-to-left shunting may be seen by color flow Doppler. Right-to-left shunting is also seen in the
presence of hypoxemia, due to shunting of deoxygenated blood to the left atrium across the PFO [15]. Pointing
the ICE imaging transducer to bring the anatomy of interest into view is done by deflecting the ICE catheter
anterior-posterior or right-left, advancing and retracting it, and with gentle catheter rotation as described below
(Fig. 15.4).
FIGURE 15.4 (Top) Image of the right atrium showing the location of a PFO within the fossa ovalis, and position of the intracardiac echo-
cardiography (ICE) imaging catheter and closure device in relation to the septum, superior vena cava (SVC), and inferior vena cava (IVC). The red
arrow indicates the flow of blood from the IVC toward the PFO. (Bottom) Depiction of the right atrium and location of the ICE catheter imaging
field of view as it is used to scan across the different anatomical planes of the right atrium.
VII. SAFETY, TECHNICAL ASPECTS TO PFO CLOSURE, AND FUTURE OUTLOOK
15. HOW I DO IT: ICE-GUIDED TECHNIQUE FOR PERCUTANEOUS PFO CLOSURE188
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