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What Possible Complications Can Occur?
No procedure is risk-free and you have to compare the potential benefits with the potential risks. Complications
with the use of the Amplatzer and Gore Cardioform devices are rare, and the following events have been described:
1) Atrial fibrillation: In the trials, up to 5% of people who had a device implanted developed atrial fibrillation. This
was usually transient (a single episode) but could last on and off for several (2e6) weeks. Since blood clots can
form during atrial fibrillation and cause a stroke, there may be a need for blood thinners and antiarrhythmic
medication for 1e3 months.
2) Chest pain: About 1 in 500 people develop severe chest pain, which we believe is due to excessive scar tissue
formation over the device. If this does not go away within the first 1e3 months, either spontaneously or with
antiinflammatory medical therapy, then the only way to treat this is to remove the device. Since there is so
much scar tissue, the device cannot be removed with a catheter and you would have to undergo open-heart
surgery.
3) Blood clot: This could form on the device. Since these devices are made of foreign substances, the body may
respond by forming blood clots on it. We used TEE at 1e6 months post implant in thousands of patients to
determine if there were any blood clots on the device, but have not observed any blood clots on our patients who
have received Amplatzer or Gore devices. This somewhat unpleasant method to check the device is no longer
routine. Within 3e6 months, the body covers these devices with fibrous scar tissue. We believe that this prevents
future clots from forming. To help prevent these blood clots from forming, we place patients on weak blood
thinners for a short period of time. We are currently using acetylsalicylic acid for 1 year and clopidogrel for
1 month after implant, medications that inhibit platelets in the blood from initiating blood clots. Other centers
may use shorter periods for these drugs.
4) Infection: Since these devices are foreign substances, they could catch bacteria that pass through the bloodstream.
Bacteria may get into a person’s bloodstream during surgery, but also during dental cleaning. To prevent infection
of the freshly implanted device, patients should avoid dental work for 3 months and take antibiotics
prophylactically, that means 1 h before any dental procedures and when other invasive procedures are
performed. This is the same recommendation as for patients who have a prosthetic heart valve, but in most
centers, this recommendation is limited to the first 3e12 months after PFO closure.
5) Erosion: Worldwide, there have been 1,000,000 Amplatzer devices implanted to close ASDs (large holes in the
heart) or PFOs. There are 200 reports (<1 in 5000) where the device has caused an erosion in the wall of the heart.
This rare event, however, has generally required open-heart surgery to correct the condition and resulted in death
in a few patients. Most of these episodes occurred with the larger ASD devices.
Of the 40,000 Gore Cardioform devices delivered to date, there are 2 reports of perforation of the heart wall due
to a fracture of one of the scaffold wires. This can cause blood to form in the sac around the
heart (hemopericardium) and may require emergency evacuation as well as surgical removal of the device.
6) Major complication: It is extremely rare to have a severe complication such as a stroke, heart damage, or death
from a PFO closure procedure. These serious problems have not occurred in our practice.
What Side Effects Can Occur With the PFO Closure Device?
In addition to the possible complications associated with this device, there are 2 side effects that some people have
described.
1) Since this is a foreign substance in the heart, it is possible that the device can irritate the heart chambers in which it
is placed. This often causes palpitations or irregular heartbeats and potentially could cause persisten t
arrhythmias, that is, sustained irregular heartbeats. Depending on how bothersome and chronic these
palpitations are, the patient may be given medications to treat the arrhythmia or need a blood thinner.
2) Some patients report an increased incidence of headaches in the 1e2 months following placement of the device.
Most of these patients have had a history of migraine in the past, so it is difficult to know whether this effect is
caused by the device. On the other hand, a number of reports suggest that chronic migraine headaches may be
diminished in the long run following closure of the PFO.
3) More than 10% of people are allergic to nickel, which is contained in almost all septal closure devices. The
shedding of nickel from these devices is, however, minimal and temporary. Although device explantation for that
reason has been described, the respective risk is so small that prior testing is not warranted.
VII. SAFETY, TECHNICAL ASPECTS TO PFO CLOSURE, AND FUTURE OUTLOOK
RANDOMIZED CONTROLLED CLINICAL TRIALS OF PFO CLOSURE FOR STROKE 231
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What Instructions Must I Follow After I Have a PFO Closure Device Placed?
Some operators deem no restrictions necessary. To prevent dislodgment of the device, we recommend that no
strenuous physical activity be performed for 1 month following the device implantation. If you have a desk job,
you could return to work 2 days after the procedure. Do not lift anything heavier than 10 pounds for 2 weeks.
You will need to take acetylsalicylic acid (at least 81 mg) for 3e12 months and clopidogrel 75 mg for 1 month. You
should return within 1e3 months for a follow-up transthoracic (in some centers transesophageal) echocardiogram or
transcranial Doppler ultrasound examination.
You will need to take antibiotics, usually amoxicillin, before any dental work, at least in the first months. This will
prevent any infection getting started on the device. If you are allergic to penicillin, an alternative antibiotic can be
used.
Could My PFO Have Contributed to My Transient Ischemic Attack?
It is definitely possible. The question is, did you have a TIA, which is assumed to be due to a small blood clot (an
embolus) that came from the legs, up the vein s to the right side of the heart, and then crossed through the PFO over
to the left atrium, and went up to your brain, or did you actually have a complex migraine? A complex migraine also
causes transient neurologic deficits (numbness, tingling, and weakness), which can last 20 min to a few hours.
Neither a TIA nor a complex migraine causes a defect to be seen on a brain MRI. Migraine is more common in people
with a PFO (about 50% of people with PFO have migraines) and is thought to be due to a chemical or venous (low
oxygenated) blood that goes across the PFO and travels to the brain where the chemical triggers a migraine in sus-
ceptible people. Things that we would evaluate in your history include a history of migraines, previous headaches,
and visual disturbances like shimmering waves or bright zigzag lines.
If you have had previous transient numbness on the same side and place, it would be unusual for a blood clot to
go to the same spot on 2 different occasions. If that is the case, a complex migraine with transient neurologic deficit
would be the more likely diagnosis. However, a complex migraine may wel l be triggered by a PFO and PFO closure
might cure it.
Why Was My PFO Not Previously Detected? Is Echocardiography the Only Way to Diagnose This?
The best noninvasive way to detect a PFO is by using some sort of contrast agent during an echocardiography
(either transth oracic or transesophageal or by transcranial Doppler). Each method has its pros and cons, but each
requires an intravenous injection of contrast solution creating microbubbles that are detected by the ultrasound.
A PFO does not make any murmur that can be picked up during a physical exam, like with a stethoscope. That
is why it is never diagnosed by a routine physical exam or an electrocardiogram (ECG). The ultimate way to confirm
the presence of a PFO is with a heart catheterization where a guidewire is passed across the atrial septum. That
proves that there is still a connection between the upper 2 heart chambers, which should have closed after birth.
I Had a Transient Ischemic Attack; Are There Any Other Tests You Would Recommend for Me?
Another cause of emboli to the brain is an arrhythmia called atrial fibrillation. Even if a simple ECG does not show
any abnormality, it would be good to be thorough and get an extended ECG monitor for days or even weeks.
How Soon Should I Have This Procedure?
If you had a TIA, there is less emergency than if you had an MRI-documented stroke. In every case, it is advisable
to get it closed as soon as your specialist has concluded that your stroke could have been caused by your PFO.
What Is the Recovery Like?
The catheter-based procedure is very simple. We do it on an outpatient basis. The groin may be bruised for a few
days and there are rare cases of bleeding in the groin after the procedure. Most people can go back to work in a few
days. The devices are well tolerated but may cause mild transient chest discomfort, like something pulling inside, for
the first month. Acetaminophen can be given if needed. People eventually can get back to their regular exercise and
have participated in marathon or Ironman races after closure.
VII. SAFETY, TECHNICAL ASPECTS TO PFO CLOSURE, AND FUTURE OUTLOOK
19. FREQUENTLY ASKED QUESTIONS: PFO CLOSURE WITH THE AMPLATZER OR GORE CARDIOFORM DEVICES232
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Is There Any Exclusion Criteria to Device Closure?
We have not come across a PFO that could not be closed. Even the presence of an inferior vena cava filter is not a
problem. If the vein from the groin to the heart is blocked, we have placed the PFO closure device from the neck vein.
Will I Be Able to Feel the Device?
Most people tolerate the device once it becomes covered with scar tissue and do not feel it. Sometimes people tell
us that they can feel a tugging sensation, which is not painful, especially when they turn on their left side in bed.
Can I Travel With the Implanted Device? Will the Device Trigger Airport Security Systems?
Yes, you may travel with an implanted device. In case you have a patient identification card, just take it along
while traveling. The device will not trigger airport security systems. There is much less metal in the device than
in frames for glasses or wedding bands. Furthermore, metal parts in both the Amplatzer and Gore Cardioform de-
vices are made of an alloy of nickel and titanium, which are only weakly magnetic and cannot trigger magnetic
detection devices.
Can I Have a Magnetic Resonance Imaging Study After Having the Device Implanted?
Yes, the PFO closure devices are made from nonferromagnetic metal and are therefore compatible with magnetic
resonance imaging (MRI). The device, however, cannot be checked by MRI.
Can I Have My PFO Closed if I Am Pregnant?
Pregnancy per se is not a contraindication to placing a PFO closure device, especially if the stroke occurred during
pregnancy. However, since the PFO closure device is placed using X-ray guidance during a catheter-based proced-
ure, the risk of X-ray exposure must be weighed against the potential benefits of the procedure. Hence, you should
discuss this issue with your treating physician. For the rare cases that cannot wait, there is an option to perform PFO
closure without using X-rays at all.
In Your Expert Opinion, Is There Anything Else I Should Know or Consider Prior to Having My PFO
Closed?
On the TEE, you may have a large PFO or an atrial septum that is flimsy (atrial septal aneurysm). These factors
increase your risk of having a stroke through the PFO. So that pushes us toward strongly recommending to have
your PFO closed. Additionally, the separation of the septum (wall) dividing the right and left atrium may be incom-
plete. This is called an ASD and that alone justifies that the defect should be closed (and there is FDA approval for
that). For unusual cases, it is advisable to go to a large hospital, where they have done a lot of PFO/ASD closures
(like more than 300).
http://www.youtube.com/watch?v¼ikOkF42XfLQ: Ask the Specialist: Hole in the Heart.
http://pfofoundation.org: PFO Foundation.
VII. SAFETY, TECHNICAL ASPECTS TO PFO CLOSURE, AND FUTURE OUTLOOK
RANDOMIZED CONTROLLED CLINICAL TRIALS OF PFO CLOSURE FOR STROKE 233
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Index
‘Note: Page numbers followed by “f” indicate figures and “t” indicate tables.’
A
Acute coronary revascularization, 106
Acute coronary syndrome patients, 100
Acute limb ischemia, 109
AF-RoPE. See Anatomicalefunctional
RoPE (AF-RoPE)
Agitated saline bubble study, 17
AHA/ASA. See American Heart
Association/American Stroke
Association (AHA/ASA)
AHI. See Apnea-hypopnea index (AHI)
Air aspiration, 39
Air embolism, 39
American Heart Association/American
Stroke Association (AHA/ASA), 59,
151
Amino acid tryptophan, 159e161
Amplatz, Kurt, 173e174, 174f
Amplatzer
Amplatzer-type occluders, 32, 37
devices, 133, 218
PFO closure with, 233
Amplatzer PFO Occluder (Amplatzer
PFOO), 59, 61e63, 75, 85f, 176e179,
179f, 185, 203e205, 218e219
Amplatzer PFO Occluder 25, 215
plus medical therapy, 133
Amplatzer septal occluder, 173e174
Amplatzer Vascular Plug, 215
Anatomicalefunctional RoPE (AF-RoPE),
52e53, 53t
Aneurysmal mobile septum primum, 187f
Angiographic/angiography, 29, 34e37
assessment of PFO and characteristics,
24
contrast, 200
Antecubital access, 17
Antiplatelet
agents, 95e96
medication, 106
therapy, 58, 74e75, 106e107, 174e175
Antithrombotic therapy effect in migraine,
124
Aortic valve, 97
Apnea-hypopnea index (AHI), 145
Apneic episode, 144
Arterial gas embolism, 159
Arterial thromboembolism, 109
Arteriovenous malformations (AVMs),
148e149, 200
As-treated analysis, 71
ASA. See Atrial septal aneurysm (ASA)
ASCOD phenotyping. See Atherosclerosis,
small-vessel disease, cardiac
pathology, other causes, dissection
phenotyping (ASCOD
phenotyping)
ASDs. See Atrial septal defects (ASDs)
Aspirin, 74e75
Atherosclerosis, 96, 101
Atherosclerosis, small-vessel disease,
cardiac pathology, other causes,
dissection phenotyping (ASCOD
phenotyping), 72
Atherosclerotic vessels, 163
Atmospheric pressure, 155
Atrial fibrillation, 96, 180, 232
Atrial septal aneurysm (ASA), 6e8, 46e47,
207f
Atrial septal defects (ASDs), 17, 228e229
combination with other, 9e10
Atrial septum, 3e4, 186
Aura, 129
MWA, 103e105, 117e118
MWoA, 117e118
AVMs. See Arteriovenous malformations
(AVMs)
B
Bard Clamshell double umbrella device,
59
Bivalirudin, 106
Bloodebrain barrier, 156
Brain, 97
magnetic resonance images, 157, 158f
Bronchial metastasis, 162
Bronchial tumor, 162
Bubble study
contrast agent during, 16
injection site for, 17
provocation maneuvers during, 17
C
Calcitonin geneerelated peptide (CGRP),
119
CANOA. See Effect of Clopidogrel and
Aspirin vs. Aspirin Alone on
Migraine Headaches after
Transcatheter Atrial Septal Defect
Closure (CANOA)
Carcinoid, 164
syndrome, 161e162
tumors, 159e161
Carcinoid heart disease
PFO
in carcinoid syndrome and, 162
closure in patients with, 162e163
and coronary vasospasm, 163e164
and cyanosis in patients with
carcinoid syndrome, 162
Cardiac computed tomography for
diagnosis of PFO, 25
Cardiac interventions, 97
Cardiac magnetic resonance imaging, 99
Cardioembolism, 46
Cardioform Closure Device, 230
Cardioform device, 179, 185
Cardioform Septal Occluder, 218e219
CardioSEAL device, 179
CardioSeal Septal Occlusion System, 75
CardioSEAL-STARFlex Occluder, 61e63
Catheter, 187
catheter-based
closure of PFO, 79
PFO closure, 203
procedure, 232
therapy, 176
probing and angiography, 16
Catheterization, 122
Cerebellar stroke, 195
Cerebral process, 130e131
CGRP. See Calcitonin geneerelated
peptide (CGRP)
Chiari network, 7e9
Chronic migraine, 129
Chronic obstructive pulmonary disease
(COPD), 146
Chronic pulmonary disorders, 146
percutaneous PFO closure for, 147
Clopidogrel, 124
CLOSE trial. See Patent Foramen Ovale
Closure or Anticoagulants vs.
Antiplatelet Therapy to Prevent
Stroke Recurrence trial (CLOSE trial)
CLOSURE I trial. See Evaluation of Starflex
Septal Closure System in Patients
With Stroke or Transient Ischemic
Attack Due to Possible Passage of
Clot of Unknown Origin Through
PFO (CLOSURE I trial)
Coherex Medical Inc, 179e180
Collateral blood flow, 97
Common migraine. See Migraine without
aura (MWoA)
Computed tomography (CT), 7, 16,
172e173
235
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Continuous positive airway pressure
(CPAP), 145
Contrast
agent during bubble study, 16
bubbles, 30
contrast-enhanced transthoracic
echocardiography, 100
medium, 203, 209
angiogram, 211e213
transcranial Doppler sonography, 120
COPD. See Chronic obstructive pulmonary
disease (COPD)
Coronary angiography, 99
Coronary artery
disease, 96
spasm, 164
stenosis, 99
Coronary embolism, 96, 97t,
103e105
Coronary ostia, 97
Coronary spasm
coronary vasospasm, 163
PFO
and coronary vasospasm in carcinoid
syndrome, 163e164
and coronary vasospasm status post
sclerotherapy, 164
and coronary vasospasm without
history of carcinoid or
sclerotherapy, 164
and vasoactive substances, 163
Coronary vasospasm, 163
in carcinoid syndrome, 163e164
without history of carcinoid or
sclerotherapy, 164
status post sclerotherapy, 164
Cortical spreading depolarization,
119e120, 122
CPAP. See Continuous positive airway
pressure (CPAP)
Cryptogenic stroke, 45e46, 53e54, 57, 70,
95, 106, 109, 117, 122, 172e173,
228e229
initial clinical, echocardiographic, and
radiological variables, 47t
patient characteristics with and without
PFO, 48t
PFO prevalence in, 50t
PFO-attributable fraction in, 52t
PFO-attributable fracture in, 51t
stroke/TIA recurrence rate, 51t
CT. See Computed tomography (CT)
Cyanosis in patients with carcinoid
syndrome, 162
D
Decompression illness (DCI), 121, 155e156
and PFO, 155e159
pathophysiology, 156, 156f
risk of DCI in presence, 157
and white matter lesions in divers
without DCI, 157
Decompression Sickness in Divers With or
Without Patent Foramen Ovale
(DIVER-PFO), 151
Deep venous thrombosis (DVT), 74e75,
99, 101e103, 110e111, 217e218
DEFENSE-PFO trial. See Device Closure
vs. Medical Therapy for
Cryptogenic Stroke Patients With
High-Risk Patent Foramen Ovale
trial (DEFENSE-PFO trial)
Delivery sheath, 209e210
Deoxygenated blood, 5
Device Closure vs. Medical Therapy for
Cryptogenic Stroke Patients With
High-Risk Patent Foramen Ovale
trial (DEFENSE-PFO trial), 101,
174e175, 218, 222, 230e233
Device embolization, 39
Device selection, 32e33
Dissolved inert gases, 156
DIVER-PFO. See Decompression Sickness
in Divers With or Without Patent
Foramen Ovale (DIVER-PFO)
Double disc devices
Amplatzer PFOO, 176e179
CardioSEAL device, 179
Figulla II PFO occluder, 179
gore Cardioform Septal Occluder,
179
gore HELEX septal occluder, 179
STARFlex device, 179
DVT. See Deep venous thrombosis (DVT)
Dyspnea, 147e148
E
Ear oximetry for diagnosis of PFO, 25
Early randomized trials of PFO closure
CLOSURE I trial, 68e69
early clinical trials randomizing
cryptogenic stroke patients, 69t
FDA approval of percutaneous PFO
closure for stroke, 75
limitation of, 72
meta-analyses of PFO closure early
trials for stroke, 73e75
RESPECT trial, 70e72
Echocardiographic guidance, 203, 204t
Echocardiography (ECG), 157, 163,
172e173, 232
for PFO diagnosis, 232
Effect of Clopidogrel and Aspirin vs.
Aspirin Alone on Migraine
Headaches after Transcatheter
Atrial Septal Defect Closure
(CANOA), 124
Embolic MI
causes, 96e97
etiologic association of PFO and, 99
prevalence, 96
Embolic stroke of undetermined source
(ESUS). See Cryptogenic stroke
Embolization, 217
EMBRACE trial, 46
Embryology of PFO, 3e4
Embryonic period, 143
Endocardial cushions, 3e4
Endothelium, 156
Epidemiological studies, 129e130
ePTFE. See Expanded
polytetrafluoroethylene (ePTFE)
Etiologic association of PFO and embolic
MIs, 99
Eustachian valve, 5, 8e9, 30e32,
195e196
Evaluation of Starflex Septal Closure
System in Patients With Stroke or
Transient Ischemic Attack Due to
Possible Passage of Clot of
Unknown Origin Through PFO
(CLOSURE I trial), 45e46, 49, 68e69,
73, 84, 174e175, 217e219
Exercise desaturation, 149e150
Exercise-induced dyspnea, 149
Exercise-induced hypoxemia, 149
Expanded polytetrafluoroethylene
(ePTFE), 179
F
FDA. See Food and Drug Administration
(FDA)
Femoral access, 17
Femoropopliteal arteries, 110
Fetal circulation, 4e5
Figulla II PFO occluder, 179
Figure-of-eight stitch procedure, 203e204
FlatStent Occluder, 179e180
Fluoroscopy, 29
Foam sclerotherapy, 164
Follow-up imaging, 37
Food and Drug Administration (FDA), 79,
228
approval of percutaneous PFO closure
for stroke, 75
Foramen ovale, 3e5
Fortification figure, 118
Fossa ovalis, 4e5, 190
Frequency of paradoxical coronary
embolism, 97e99
Functional MRI, 119
G
Gas bubbles, 156
Gastrointestinal tumors, 161
Global Initiative for Chronic Obstructive
Lung Disease (GOLD), 146
Gore Cardioform Atrial Septal defect
devices, PFO closure with, 228
Gore Cardioform Septal Occluder, 61, 75,
85f, 179
Gore Helex Septal Occluder, 179
Gore Helex Septal Occluder/Gore
Cardioform Septal Occluder and
Antiplatelet Medical Management
for Reduction of Recurrent Stroke
or Imaging-Confirmed Transient
Ischemic Attack in Patients with
PFO trial (Gore REDUCE Trial), 83
GPIIb/IIIa antagonists, 106
H
HDE. See Humanitarian device exemption
(HDE)
Headache syndromes, 117e118
INDEX236
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Helex Septal Occluder, 61e63, 218e219
Helium, 156
Heparin, 106
Hereditary hemorrhagic telangiectasia,
148e149
High-altitude pulmonary edema, 149
High-Risk Patent Foramen Ovale trial
(DEFENSE-PFO trial), 83e84
High-risk PFO, 222e224
Histamine, 130e131
5-HT. See 5-Hydroxytryptamine (5-HT)
Humanitarian device exemption (HDE),
75, 79
5-Hydroxyindolacetic acid, 161
5-Hydroxytryptamine (5-HT), 161f
Hypopneic episode, 144
Hypoxemia, 130, 144, 188, 222, 224
hypoxemia-driven pulmonary
vasoconstriction, 149
PFO and hypoxemic conditions,
144e151
pathophysiological interplay between
PFO and, 144
Hypoxia-driven pulmonary
vasoconstriction, 146
I
ICD. See Implanted pacemaker or
defibrillator (ICD)
ICE. See Intracardiac echocardiography
(ICE)
ICE-guided technique for percutaneous
PFO closure
Acuson ICE imaging catheter, 186f
anatomic considerations, 187e188, 187f
cases, 193e200
challenges, 193
inserting ICE catheter, 189
manipulating ICE catheter, 189e190
PFO, 190e192
post deployment and ICE catheter
withdrawal, 193
IHS. See International Headache Society
(IHS)
Imaging, 29
follow-up, 37
postprocedural assessment of device
position, 37
preprocedural, 30e33
procedural guidance, 34e37
special situations, 38e40
stages, 30e40
Implanted pacemaker or defibrillator
(ICD), 193
Index cryptogenic stroke, 176
Index stroke, 218e219
Inferior vena cava (IVC), 186
Informed consent, 180e181
Injection site for bubble study, 17
Intention-to-treat analysis, 70e71, 75
Interatrial septal defect, 218e219
Interatrial septal shunt, 219
Intermittent obstructive ventilation, 145
International Headache Society (IHS),
117e118
Interventional cardiology, 180e181
Intracardiac echocardiography (ICE), 16,
29, 38, 185, 192f, 196f, 203. See also
Transthoracic echocardiography
(TTE)
advantages and limitations, 20t
catheter, 185e186
inserting, 189
manipulating, 189e190
for diagnosis of PFO, 24
fluoroscopy, 199f
post deployment and ICE catheter
withdrawal, 193
Intravenous heparin, 206e207
Ischemic brain lesions, 157
Ischemic stroke, 46, 67, 158
IVC. See Inferior vena cava (IVC)
K
KaplaneMeier survival analysis, 49
L
LAA. See Left atrial appendage (LAA)
Large-artery atherosclerosis, 46
LASH. See Lipomatous atrial septal
hypertrophy (LASH)
Left atrial ablation, PFO closure after, 40
Left atrial appendage (LAA), 185e186
PFO closure after LAA occlusion, 40
Left ventricular assist device (LVAD),
150e151
implant, 150e151
Ligamentum arteriosum, 5e6
Limbus, 7
Lipomatous atrial septal hypertrophy
(LASH), 7
Lipomatous hypertrophy, 7
Liver biopsy, 163
LVAD. See Left ventricular assist device
(LVAD)
M
Magnetic resonance imaging (MRI), 16,
119, 172e173, 195, 221
for diagnosis of PFO, 26
Magnetoencephalography, 119
Malignant middle cerebral artery
infarction, 122
May-Thurner syndrome, 221e222
MCA. See Middle cerebral artery (MCA)
Mechanical vaccination, 180e181
Medical therapy, 95, 174
Medication, 129
Meier, Bernhard, 174f
Meta-analysis
of observational studies of PFO closure
for stroke, 61e64
of PFO closure trials for stroke
prevention, 84e86
MI. See Myocardial infarction (MI)
Middle cerebral artery (MCA), 158
Migraine, 118, 122e124, 129
antithrombotic therapy effect in, 124
aura in patients with RLS,
119e120
in individuals with PFO, 120e121
prevalence of migraine in individuals
with PFO, 120e121
shunt size in individuals with PFO
and migraine, 121
PFO closure effect on migraine severity,
121e122
stroke, 122, 123f
trials, 134
Migraine headache, 222
effect of antithrombotic therapy, 124
link between migraine, PFO, and stroke,
122e124
meta-analyses of trials of PFO closure
for, 134
MIST trial, 131e132
pathophysiology of migraine and
migraine aura in patients with RLS,
119e120
PFO closure for, 230
effect of PFO closure on migraine
severity, 121e122
PREMIUM trial, 133e134
PRIMA trial, 132e133
primary headaches, 117e118
secondary headaches, 118
Migraine Intervention with STARFlex
Technology trial (MIST trial),
131e132, 175e176
from observational studies, 132
Migraine with aura (MWA), 103e105,
117e118
Migraine without aura (MWoA),
117e118
Migraineurs, 129
MIST trial. See Migraine Intervention with
STARFlex Technology trial (MIST
trial)
MRI. See Magnetic resonance imaging
(MRI)
Multipurpose (MP), 193
Multivariate regression model, 48e49, 49t
MWA. See Migraine with aura (MWA)
MWoA. See Migraine without aura
(MWoA)
Myocardial infarction (MI), 67, 95, 98f,
104f, 158
differential diagnosis, 103e105
embolic MI
causes, 96e97
prevalence, 96
etiologic association of PFO and embolic
MIs, 99
frequency of paradoxical coronary
embolism, 97e99
incidence in patients with PFO, 101
patients with MI attributable to
paradoxical coronary embolism,
105e106
prevalence of PFO in acute coronary
syndrome patients, 100
risk of MI in patients with venous
thromboembolism, 101e103
secondary prevention after paradoxical
embolic MI, 106e107
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N
New York Heart Association (NYHA), 147
Nickel-cobaltebased alloy, 179
Nitinol wire mesh, 176e179
Nitric oxide, 130e131
Nitrogen, 156
narcosis, 157
NNT. See Number needed to treat (NNT)
NobleStitch EL occluder, 180
Noncerebral embolism, 109
Nondouble disc devices
FlatStent Occluder, 179e180
NobleStitch EL occluder, 180
radiofrequency fusion, 180
Number needed to treat (NNT), 222
NYHA. See New York Heart Association
(NYHA)
O
Observational multicenter study, 60
Observational studies of PFO closure for
stroke, 57, 59e61
device-related complications stratified
by treatment arm, 63t
medical therapy, 58e59
meta-analysis, 61e64
pathophysiology, 57e64
recurrent neurological events and major
complications, 63t
Obstructive sleep apnea (OSA), 144e146
Occlutech, Helsingborg, Sweden, 179
Octreotide therapy, 163
Odds ratio (OR), 48e49
ODI. See Oxygen desaturation index (ODI)
Oral anticoagulation, 58, 106e107
OSA. See Obstructive sleep apnea (OSA)
Ostium secundum, 4
Oxygen desaturation index (ODI), 145
Oxygenated blood, 5
P
P-value, 222
Pacman sign, 39
Paradoxical coronary embolism, 96e99,
100t
patients with MI attributable to,
105e106
Paradoxical embolism, 45e46, 57, 79, 96,
109, 172, 218e219, 224. See also Risk
of Paradoxical Embolism (RoPE)
clinical presentation, 110
diagnosis, 110e111
epidemiology, 109e110
management, 111e112
MI in presence of PFO, 106e107
paradoxical embolismemediated MI, 95
Paradoxical embolization, 172, 217
Paradoxical fat embolism, 105
Paradoxical peripheral embolism,
109e110, 111f
Partial pressure of gas (Pgas), 156
Patent foramen ovale (PFO), 4, 16, 29,
45e46, 57, 79, 95, 102t, 103f, 109, 117,
119e120, 122e124, 130, 130t, 135f,
135te136t, 143, 144f, 156e157, 160t,
171, 173f, 185, 188f, 190e192, 198f,
221e223, 228. See also Percutaneous
PFO closure
advantages and limitations, 20t
anatomy, 4
variations and clinical importance,
6e7
angiographic assessment and
characteristics, 24
ASA, 8
carcinoid heart disease and, 159e163
cardiac computed tomography for
diagnosis, 25
characteristics, 7t
closure, 95e96, 107, 159, 203, 217
alternative treatments, 229
cause stroke, 229
cryptogenic stroke, 228e229
device in pregnancy, 233
effect on migraine severity, 121e122
interventional treatment, 219
after left atrial appendage occlusion,
40
for migraine headaches, 230
in patients with carcinoid heart
disease, 162e163
without prior (transesophageal)
echocardiography, 38
pulmonary embolism, 217e218
randomized trials, 218
combination with other atrial septal
defects, 9e10
coronary spasm and PFO, 163e164
DCI and, 155e157
definite documentation, 19f
device closure, 112
device residing partially in tunnel of, 39
ear oximetry for diagnosis, 25
embryology, 3e4
etiologic association and embolic MIs,
99
Eustachian valve and Chiari network,
8e9
exclusion criteria to device closure, 233
feel sensation of device, 233
with fixed opening, 4
full spectrum of, 222e224
clinical case, 221e222
indication, 223f
and hypoxemic conditions, 144e151
and COPD, 146
and exercise desaturation, 149e150
and high-altitude pulmonary edema,
149
and LVAD implant, 150e151
and OSA, 144e146
pathophysiological interplay between
hypoxemia and, 144
and POD syndrome, 147e148
and pulmonary AVM, 148e149
and pulmonary hypertension,
146e147
ICE for diagnosis, 24
imaging for PFO closure, 30t
in-hospital complications, 38e39
incidence of MI in patients with, 101
left atrial ablation or left atrial
appendage closure after, 40
lipomatous hypertrophy and clinical
implications, 7
magnetic resonance imaging for
diagnosis, 26
meta-analyses of trials of PFO closure
for migraine headache, 134
MRI after having device implantation,
233
occluder embolization, 39e40
percutaneous closure of interatrial
shunts, 228e229
persistence and consequences, 6
PFO-attributable fraction, 49
PFO-related pathologies, 172e173
postnatal circulation, 5e6
prenatal circulation, 4e5
prevalence
in acute coronary syndrome patients,
100
in individuals with migraine,
120e121
propensity, 46e47
randomized controlled clinical trials of
PFO closure for stroke, 230e
233
complications, 231
contribution to transient ischemic
attack, 232
duration for TIA procedure, 232
echocardiography for diagnosis, 232
explanation of procedure to close
PFO, 230
instructions, 232
recovery like procedure, 232
side effects, 231
tests recommendation for transient
ischemic attack, 232
secondary prevention after paradoxical
embolic MI in presence,
106e107
society guidelines on PFO closure, 151
systemic embolism and stroke with, 57
TCD for diagnosis of, 22e24
TEE for diagnosis of, 20e22
travel with implanted device, 233
TTE for diagnosis of, 17e19
ultrasound detection, 16
Patent Foramen Ovale Closure on
Obstructive Sleep Apnea Syndrome
(PCOSA), 145e146, 151
Patent Foramen Ovale Closure or
Anticoagulants vs. Antiplatelet
Therapy to Prevent Stroke
Recurrence trial (CLOSE trial),
80e84, 88, 101, 112, 222, 230e233
Patent foramen ovale occluder (PFOO),
176e179
Patent foramen ovale-atrial septal
aneurysm trial (PFO-ASA trial),
67e68
Patent foramen ovalemediated
decompression illness,
interventions for, 159
Patient-specific PFO propensity, 47e48
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Patient-specific stroke recurrence risk,
47e48
PAVM. See Pulmonary arteriovenous
malformations (PAVM)
PCOSA. See Patent Foramen Ovale Closure
on Obstructive Sleep Apnea
Syndrome (PCOSA)
Per-protocol analysis, 71
Percutaneous closure (PC)
devices, 59
of interatrial shunts, 228e229
trial, 69e70
Percutaneous Closure of Patent Foramen
Ovale in Migraine with Aura trial
(PRIMA trial), 132, 175e176
trial, 132e133
Percutaneous Left Atrial Appendage
Closure vs. Warfarin for Atrial
Fibrillation trial (PROTECT-AF
trial), 218
Percutaneous PFO closure, 171. See also
Patent foramen ovale (PFO)
accumulating evidence for clinical
applications, 174e176
for chronic pulmonary disorders, 147
development of percutaneous
techniques for PFO closure,
173e174
devices, 176e180, 177te178t
double disc devices, 176e179
nondouble disc devices, 179e180
fluoroscopy-guided technique, 204t
ICE-guided technique
Acuson ICE imaging catheter, 186f
anatomic considerations, 187e188,
187f
cases, 193e200
challenges, 193
inserting ICE catheter, 189
manipulating ICE catheter, 189e190
PFO, 190e192
post deployment and ICE catheter
withdrawal, 193
informed consent, 180e181
radiation exposure of TEE and
interventional cardiologist, 204t
angiography, 208fe209f, 212f
ASA and device selection, 207f
delivery sheath, 209e210
device deployment, 210e213
device selection criteria, 206f
final angiogram after release of
device, 214f
frugal PFO closure, 205t
passing PFO, 206e209
preliminary exams and device
selection, 204e206
second occluder for residual shunt,
215, 215f
Thebesian ledge mistaken as atrial
septum, 214f
TTE with bubble test diagnostic for
PFO, 208f
safety, 180
Percutaneous PFO device closure, 107
Peripheral emboli, 109
Peripheral ischemia, 67
Peripheral vasoconstriction, 157
Peripheral venous throsmbosis, 57
Periprocedural paroxysmal atrial
fibrillation, 133
PET. See Positron emission tomography
(PET)
PFO. See Patent foramen ovale (PFO)
PFO closure and antiplatelet therapy vs.
antiplatelet therapy only trial
(REDUCE trial), 101, 230e233
PFO in Cryptogenic Stroke Study (PICSS),
58, 67e68
PFO-ASA trial. See Patent foramen ovale-
atrial septal aneurysm trial
(PFO-ASA trial)
PFOO. See Patent foramen ovale occluder
(PFOO)
Pgas. See Partial pressure of gas (Pgas)
PICSS. See PFO in Cryptogenic Stroke
Study (PICSS)
Placebo effect, 130e131
Placental circulation, 5
Platelets, 124
Platypnea-orthodeoxia syndrome (POD
syndrome), 6, 147e148, 148f
Polyester, 176e179
Positive test, 21
Positron emission tomography (PET),
119
Post hoc analyses, 133
Postprocedural assessment of device
position, 37
Pregnancy, PFO closure device in, 233
expert opinion, 233
PREMIUM trial. See Prospective,
Randomized Investigation to
Evaluate Incidence of Headache
Reduction in Subjects with Migraine
and PFO Using Amplatzer PFO
Occluder to Medical Management
trial (PREMIUM trial)
Preprocedural imaging, 30e33
assessing and characterizing PFO, 32
device selection, 32e33
screening, 30e32, 31t
PRIMA trial. See Percutaneous Closure of
Patent Foramen Ovale in Migraine
with Aura trial (PRIMA trial)
Primary atrial septum, 3e4
Primary efficacy endpoint, 54
Primary headaches, 117e118
Primary safety outcome, 54
Primordial single atrium, 3e4
Procedural guidance, 34e37
angiography, 34e37
Prophylaxis, 124
Prospective, Randomized Investigation to
Evaluate Incidence of Headache
Reduction in Subjects with
Migraine and PFO Using
Amplatzer PFO Occluder to
Medical Management trial
(PREMIUM trial), 133e134
Provocation maneuvers during bubble
study, 17
Pulmonary
AVM, 148e149, 149f
circulation, 156
disorders, 144
embolism, 95, 99, 110e111, 217e218
filtration capacity, 156
hypertension, 146e147
monoamine oxidases, 163
vascular constriction, 5
vascular resistance, 143
vasculature, 173
Pulmonary arteriovenous malformations
(PAVM), 119e120
R
Radiofrequency fusion, 180
Randomized controlled trials. See
Randomized trials
Randomized Evaluation of Recurrent
Stroke Comparing PFO Closure to
Established Current Standard of
Care Treatment trial (RESPECT
trial), 70e72, 74e75, 174e175, 218,
222, 230e233
early follow-up of, 70e72, 71t
long-term follow-up, 72
Randomized trials, 112, 117, 180, 181t
evolution of guidelines, 86
evidence-based algorithm, 88f
guideline recommendations in North
America and Europe, 87t
on PFO closure for stroke, 79e80,
81te82t, 230e233
CLOSE trial, 80e83
DEFENSE-PFO trial, 83e84
Gore REDUCE trial, 83
lessons learned from PFO closure
trials for stroke prevention, 86
meta-analyses of PFO closure trials
for stroke prevention, 84e86
patient selection for PFO closure for
stroke, 86e88
thrombus in transit, 80f
unanswered questions, 88e89
rCBF. See Regional cerebral blood flow
(rCBF)
Recovery like procedure, 232
Recurrent neurological events, 58, 58f,
60e61, 62f, 63t
REDUCE trial. See PFO closure and
antiplatelet therapy vs. antiplatelet
therapy only trial (REDUCE trial)
Reflex pulmonary vasoconstriction, 145
Refractory hypoxemia, 147
Regional cerebral blood flow (rCBF), 118
Residual shunt
detection, 37
reclosure in case of significant, 40
RESPECT trial. See Randomized
Evaluation of Recurrent Stroke
Comparing PFO Closure to
Established Current Standard of
Care Treatmenttrial (RESPECT trial)
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Right-to-left shunt (RLS), 6, 119e120,
130e131, 144, 157
diagnostic criteria for intracardiac, 17
international consensus for grading of
RLS severity, 18t
pathophysiology of migraine and
migraine aura in patients with,
119e120
Risk of Paradoxical Embolism score (RoPE
score), 46e53, 49f, 86, 111
calculator, 50t
validation, 51e52
RLS. See Right-to-left shunt (RLS)
RoPE score. See Risk of Paradoxical
Embolism score (RoPE score)
S
SCAD. See Spontaneous coronary artery
dissection (SCAD)
Scintillating scotoma, 118
Sclerotherapy, 164
Screening, 30e32, 31t
Scuba divers, 156
Second occluder for residual shunt at
follow-up, 215
Secondary headaches, 118
Secondary ischemic stroke prophylaxis,
145e146
Secundum, 190
Selective mortality, 223e224
Septal aneurysm, 185e187
Septal occluder, 185
Septum primum, 3e4, 185e187, 190
Septum secundum, 3e4, 143, 185e186
Serotonin, 130e131, 159e161, 173
Sham control arm, 134
Shunt size in individuals with PFO and
migraine, 121
Sizing balloons, 33
Small-artery occlusion, 46
Society guidelines on PFO closure, 151
South Pacific Underwater Medicine
Society (SPUMS), 158
SPARC. See Stroke Prevention and
Atherosclerosis Research Centre
(SPARC)
Spontaneous coronary artery dissection
(SCAD), 103e105
SPUMS. See South Pacific Underwater
Medicine Society (SPUMS)
ST-segment elevation MI (STEMI),
98e99
STARFlex device, 68e69, 84, 85f, 179
STARFlex Septal Closure System, 68e69,
218
STEMI. See ST-segment elevation MI
(STEMI)
Stroke, 6, 8, 118, 119t, 122e124, 224
cortical ischemic, 219
cryptogenic, 228e229
of determined etiology, 46
evidence by neuroimaging, 218
index, 218e219
in patients with migraine, 122e124
with PFO, 57, 229
PFO closure
patient selection, 86e88
randomized controlled clinical trials,
230e233
randomized trials, 222
prevention
lessons learned from PFO closure
trials, 86
meta-analyses of PFO closure trials,
84
e86
of undetermined etiology, 46
Stroke Prevention and Atherosclerosis
Research Centre (SPARC), 50e51
Subdural electrocorticography, 122
Subendocardial late gadolinium
enhancement, 99
Superior vena cava (SVC), 190
Sustained mass depolarization, 122
SVC. See Superior vena cava (SVC)
Systemic embolism with PFO, 57
Systemic fetal circulation, 143
T
TCD. See Transcranial Doppler (TCD)
TCT. See Transcatheter Cardiovascular
Therapeutics (TCT)
TEE. See Transesophageal
echocardiography (TEE)
Tension-type headache, 117e118
Thebesian valve, 36e37
Three-dimensional echocardiography (3D
echocardiography), 16
Thromboembolic ischemia, 118
Thromboembolism, 96
Thrombolytic medication, 105
Thrombus, 109, 172
aspiration, 105
TIA. See Transient ischemic attack (TIA)
TOAST. See Trial of Org 10172 in Acute
Stroke Treatment (TOAST)
Transcatheter Cardiovascular
Therapeutics (TCT), 132
Transcatheter closure arm, 63e64
Transcranial Doppler (TCD), 100, 110, 132,
145, 193e195, 194f, 232
bubble study, 16
advantages and limitations, 20t, 24
for diagnosis of PFO, 22e24
diagnostic accuracy, 19t, 23e24
grading with microembolic signals,
23f
protocol for, 23
Spencer Logarithmic Scale for, 23t
sonography, 158
ultrasonography, 157
Transesophageal contrast
echocardiography, 121
Transesophageal echocardiography (TEE),
4, 16, 29, 50e51, 60, 67e68, 98e 99,
132, 144f, 145, 158, 173, 185e186, 203
, 205f, 228, 232
advantages and limitations, 20t, 22
bicaval view by, 21f
for diagnosis of PFO, 20e22
diagnostic accuracy, 19t, 21e22
protocol for, 20e21
Transient focal neurologic deficits, 129
Transient ischemic attack (TIA), 59, 67e68,
109, 228
Transthoracic contrast echocardiography,
59e60
Transthoracic echocardiography (TTE), 16,
29, 60, 132, 145e146, 158, 185e186,
203e204, 208f, 232
advantages and limitations, 19, 20t
apical four-chamber view by, 18f
for diagnosis of PFO, 17e19
diagnostic accuracy, 18e19, 19t
protocol for, 18
Trial of Org 10172 in Acute Stroke
Treatment (TOAST), 46
Trigeminovascular system, 119
TTE. See Transthoracic echocardiography
(TTE)
U
Ultrasonography, 16
Ultrasound
detection of PFO, 16
imaging, 185
United Kingdom Sports Diving Medical
Committee (UKSDMC), 158
Unoxygenated fetal lungs, 143
V
Valsalva maneuver, 17, 30, 95, 103e105,
159, 200
Valvula venae cavae inferioris. See
Eustachian valve
Vasoactive substances, 163
Venous thromboembolism (VTE), 74e75
MI risk in patients with, 101e103
Venous thrombus, 109
Visual-spatial skills, 157
W
Warfarin-Aspirin Recurrent Stroke Study
(WARSS), 68
White matter lesions in divers without
DCI, 157
candidates for investigation, 158
imaging tests for detection of PFO, 158
interventions for patent foramen
ovalemediated decompression
illness, 159
Working memory, 157
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