2 ▏Methods
2.1. Patients. Patients were diagnosed with CS or migraine with
PFO in our hospital from January 2018 to June 2021. There were 128
patients who received TEE-guided percutaneous PFO closure in our
department, including 98 patients with CS, 30 patients with migraine,
combined PFO and large right-to-left shunt (RLS). There were 52 male
patients and 76 female patients. The patients’ mean age was from 26 to
55 (42.60±8.50) years. Valsalva action PFO (5.8±1.2)mm. All patients
with brain MRI examination, transthoracic echocardiography (TTE),
contrast-enhanced transcranial doppler (cTCD), and transesophageal
echocardiography (TEE). This study was approved by
institutional review boards of our hospital, all patients signed
the statement of informed consent.
2.2. Ultrasonic evaluation. Preoperative routine TEE examination
in all patients. The morphology, size, tunnel length, and structural
characteristics of PFO were observed in multiple sections, including
whether there was atrial septal dilatoma, resting RLS, or large amount
of RLS, combined with inferior vena cava valve >10 mm or
Chiari’s network and other PFO anatomical risk factors, except other
cardiac factors causing cerebral apoplexy. RLS was graded by
contrast-transthoracic echocardiography (cTTE) in terms of the number of
microbubbles present in the left ventricular cavity on a single frame of
still images. CTCD adopts the two-sided criterion of microbubble number
grading, which can be used to know whether there is RLS or not and its
shunt size in detail.
2.3. Procedure. Tracheal intubation under general anesthesia, PFO
was reevaluated from different perspectives by TEE, right femoral vein
was punctured. After intravenous heparin injection (100 units/kg), the
5F single-curved catheter was sent to the middle of the left atrium
through PFO under the guidance of TEE, and a 260 mm long and hard
guidewire was sent to the left upper pulmonary vein or left atrial
appendage along the catheter. Withdraw the 5F single-bend catheter and
send the long sheath tube along the guide wire to the middle of the left
atrium. The guide was inserted into the delivery sheath, and the
occlusion device was fed along the delivery sheath into the left atrium.
The left atrial plate was released after withdrawal of the delivery
system to close the atrial septum and the outer sheath was retracted to
release the occlusion device waist and right atrial plate, so that the
atrial septum was between the left and right umbrella folder. Multiple
TEE view and push- pull tests were used to assess the location of the
occluding device, the presence of residual shunt, the condition of the
valve, the relationship of the occluding device to the coronary sinus,
superior vena cava, inferior vena cava, and pulmonary vein, and the
presence or absence of pericardial effusion. After TEE confirmed that
the position and shape of the sealing device were good, the sealing
device was released and the pressure was applied to stop bleeding after
surgery. Domestic PFO occlusion device (produced by Beijing Starway
Medical Technology Inc) or imported Amplatzer PFO occlusion device was
selected, and domestic ASD occlusion device (produced by Shanghai Shape
Memory Alloy Material Co. Ltd) was selected for some patients with
atrial septal dilatoma (Figure1).
Figure1. The procedure of percutaneous closure of PFO under the guidance
of TEE.
A. The morphology, size, tunnel length, and structural characteristics
of PFO were evaluated in multiple sections. B. The catheter and sheath
were withdrawn while maintaining the guide wire in the left atrium. C. A
9Fr to 10Fr delivery sheath was then selected according to the diameter
of the occlude and was inserted into the left atrium along the guide
wire. D. PFO occluder was then inserted for percutaneous closure of PFO
under TEE guidance.
2.4. Follow-up. TTE and electrocardiography were performed in
both groups at 1 month, 3 months, 6 months, and 1 year after discharge
and annually thereafter. Patients were followed up by TTE to assess
cardiac function, occlusion device morphology, residual shunt status,
and other indicators. Additionally, the patients’ chest X-rays and
electrocardiograms were double-checked in cases involving complications.
cTCD examination was also performed at 1 and 3 months after PFO plugging
to detect whether there was residual medium or large amount of RLS shunt
and evaluate the blocking effect. At the same time, the success rate,
effective occlusion rate, complications (pericardial effusion, occluder
displacement, peripheral hematoma, etc.), recurrence of ischemic stroke,
relief of migraine, and other adverse events, including bleeding and new
arrhythmia, were observed with follow-up
2.5. Statistical Analysis. Descriptive statistics were used for
patients’ characteristics. Continuous variables with normal distribution
are presented as mean±standard deviation. All statistical analyses were
performed using the SPSS software (version 24.0 for Windows).