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.