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left atrial plate was released after withdrawal of the delivery system to close the atrial septum and the outer sheath was retracted to release the occlusion device waist and right atrial plate, so that the atrial septum was between the left and right umbrella folder.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).