3 ▏Results
3.1. Operation situation. All the 128 patients with TEE-guided percutaneous PFO closure were successful, and one of them showed poor stability of the closure umbrella, and the replacement of a larger closure umbrella was successful. The average operation time (from puncture to removal of sheath tube) of the patients was 20~32 (25.6±4.2)min, the average hospitalization time was 2~3(2.8±0.4) d, and the hospitalization cost was 2.8-3.2 (3.0±0.5) ten thousand RMB. After the operation, cTCD examination showed that there were 122 patients without large number of RLS shunts, and the effective rate was 95.31%. In the residual RLS shunt, there were 6 cases, but the position of the sealer was fixed and there was no shift. 30 patients with migraine underwent percutaneous PFO occlusion, 24 patients relief after operation, with a relief rate of 80%. All the patients recovered and were discharged from the hospital without peripheral vascular injury or pericardial effusion and other complications after surgery. The clinical effect of percutaneous PFO under the guidance of TEE were shown in (Table 1).
3.2. Follow-up. Postoperative follow-up was conducted from 1 to 36(28.8±3.6) months, and no follow-up was lost. CTCD was added to determine whether there was residual shunt of RLS at 1 and 3 months of follow-up. TTE, chest X-ray, and electrocardiogram were reexamined at other times, and brain MRI was performed if necessary. 98 cases of CS with PFO underwent percutaneous blockade were followed up without cerebral embolism recurrence. 30 cases of PFO occluder treated patients had significantly relieved migraine in 26 cases, with a remission rate of 86.7% after 3 months. There was no significant remission in 4 migraine patients, but the PFO occluder was stable, and cTCD examination showed no medium-large amount of RLS. After 3 months, due to the intima coverage on the surface of the sealing device, only 4 case was followed up to observe a small-medium amount of RLS shunt in the residual, and the position of the sealing device was fixed without displacement or thrombosis. No patients suffered from stroke recurrence, migraine recurrence, pericardial effusion, occluder displacement, new atrial fibrillation, residual shunt, thrombosis and new valve regurgitation complications occurred.
4 Discussion
4.1. PFO closure prevent recurrent stroke. The effect of PFO closure on stroke recurrence was greatest in patients with an ASA or large shunt (RR 0.27, 95% CI: 0.11–0.70, P=0.01) [3]. Several case-control studies have shown that PFO prevalence was three times higher in patients with cryptogenic stroke than in controls without stroke or stroke patients with a known cause, and this difference was amplified to five times higher in younger adults (under 55 years of age) with cryptogenic stroke. The association between PFO and cryptogenic stroke is stronger if there is an ASA [2, 7]. Younger patients with high RoPE scores will benefit the most from PFO closure[8]. In this study review cTCD 6 cases exist medium to large of RLS, 122 cases had no shunt or a small amount of RLS, and the effective success rate of plugging was 95.31% after surgery. With the endothelialization of the occluder, residual shunt will subsequently improved, postoperative 3 months review cTCD when only 2 patient still exist small-medium of RLS, postoperative march plugging effectively the success rate of 98.4%, significantly higher than the literature reported[3,9], it has to do with this research strictly grasp the indications made plugging, the guidance of TEE is more clear, at the same time for long tunnel or merge septal dilatoma patients chosen ASD closure, the blocking effect is more accurate.
4.2. TEE- guided percutaneous PFO closure. The most significant feature of this technique is to use echocardiography as the only guidance tool for percutaneous interventional therapy, and to abandon the previous X-ray guidance method to avoid the exposure of the surgeon and patients, to radiation and the injury of X-rays and contrast agents[5, 6]. TEE is considered as the gold standard for PFO detection, and the sensitivity and specificity are 100%. Echocardiography can visually display the impact of the occluder on the mitral valve, coronary sinus, and pulmonary vein, and real-time monitoring of the occluder release process, which allows for occlude replacement if it is found to be incorrectly positioned [2,5,6].This study analyzed 128 patients in our hospital who were successful in the percutaneous PFO closure surgery under the guidance of TEE, and one patient showed poor stability of the occluder. The main reason was that PFO was long tunnel type and the primary compartment was weak, which was then recovered and replaced with a larger PFO occluder. Postoperative follow-up of 1-36(28.8±3.6)months, 128 cases were made of postoperative follow-up, not yet pericardial effusion, occluder shift and erosion, atrioventricular block, new atrial fibrillation, residual shunt, thrombosis and new complications such as valvular regurgitation. The results show that TEE-guided percutaneous PFO blocking operation is safe and effective, this technique avoids the radiation and use of contrast agents in selected patients, and the near and medium efficacy of CS recurrence prevention is satisfactory.
4.3. Migraine and PFO. Multiple studies have reported a significant association between migraine headaches and the presence of PFO, particularly migraine with aura. A 2016 meta-analysis pooled 21 case-control studies (n=5,572) to show that there is higher prevalence of migraine (OR 2.46, 95% CI: 1.55–3.91, P=0.0001) and migraine with aura (OR 3.36, 95% CI: 2.04–5.55, P<0.001) in PFO patients compared to non-PFO patients [10]. Studies have also demonstrated a right-to-left shunt in 41–48% of patients with migraine with aura [11]. In this study, 30 migraine patients with PFO and medium-large RLS shunt were blocked by PFO, and 24 migraine patients were relieved after surgery, with a remission rate of 80%. Three months after the surgery, 30 patients with PFO blocking therapy were reexamined, and 26 of them experienced significant relief of migraine, with a remission rate of 86.7%, which was consistent with literature reports[10,11]. 4 migraine patients showed no significant remission, but the PFO occluder was stable, and cTCD examination showed no medium - large amount of RLS, indicating that there were many reasons for migraine, and medium - large amount of RLS in PFO combination may only be one of the main reasons.
4.4. Advantages and indications of percutaneous PFO closure. The cumulative Kaplan-Meier 5-year estimate of the probability of stroke was 4.9% in the antiplatelet group [12]. The results from the Gore-REDUCE trial therefore supported the findings of other trials that transcatheter PFO closure was superior to medical therapy alone in patients with cryptogenic stroke, with an NNT =28 to prevent one stroke in 24 months. Importantly, this trial carefully selected patients who were more likely to have stroke attributable to PFO, hence increasing the likelihood that PFO closure would be effective[3,9,13,14]. In brief, these studies indicate that in patients aged <60 years, PFO closure probably confers a reduction in ischemic stroke recurrence compared with antiplatelet therapy alone, while it also incurs a risk of persistent atrial fibrillation and device-related adverse events [14, 15]. Patients with presumably pathogenic PFOs who are likely to benefit most from closure over medical therapy should be identified, and specific features that suggest the greatest benefit are the presence of an ASA or a large right-to-left shunt. The results of PFO were consistent with those of this group. Postoperative follow-up of 1-36(28.8±3.6)months showed no new atrial fibrillation, which was considered to be related to strict case selection, small sample size, short follow-up time, and appropriate selection of TEE-guided sealer size.