From 2017.06 to 2019.11, we included 38 patients who were recommended for PFO closure by the department of neurology at our hospital. 26 females and 12 males suffered from migraine with aura or cryptogenic stroke in the presence of a PFO. Age ranged from 9 to 57 years with a mean age of 36.2 ± 14.4 years. The patients who were recommended for PFO closure were enrolled by the criteria:
For migraine with aura, the patients were diagnosed by neurologists according to the criteria of the International Headache Society (2nd edition)[10]. For cryptogenic stroke or transient ischemic attack (TIA), the patients were diagnosed by neurologists with clinical and/or radiologically evidence.
For confirmation of a PFO, the patients were first screened by transcranial ultrasound for a right-to-left shunt. Next, patients were sent to transthoracic echocardiography (TTE) for advanced PFO evaluation: 1. confirmation of PFO; 2. ≥medium right-to-left shunt was detected (Right-to-left shunting, RLS, was detected with or without the Valsalva maneuver and > 10 microbubbles were detected in left atrium[11]).
Exclusive criteria: patients with psychiatric, neurodegenerative, inflammatory, infective diseases, pregnancy or contraindication to antiplatelet therapy were excluded. More patients baseline characters are described in Table 1.
Table 1
Variable | Value |
Total number | 38 |
Female/male | 26/12 |
Age(years) | 36.2 ± 13.4(9–57) |
Weight(kg) | 56.1 ± 12.7(29–75) |
Height(cm) | 161.4 ± 10.6 (138–178) |
Arrhythmia (IRBBB) | 4(10.5%) |
Migraine with aura | 28(73.7%) |
Additional migraine without aura | 16(57.1%) |
Other headache history | 4(14.3%) |
Mood disorder | 4(14.3%) |
Unresponsive to two medication | 26(92.9%) |
Cryptogenetic stroke | 10(26.3%) |
TIA | 4(40%) |
Multiple strokes | 2(20%) |
Migraine | 2(20%) |
Echocardiographic variable | |
With ASA | 4(10.5%) |
Hypermobile septum | 6(15.8%) |
Large PFO | 2(5.3%) |
RLS > 2 grade after Valsalva | 26(68.4%) |
Values are mean ± standard deviation. |
IRBBB: Incomplete Right Bundle Branch Block; TIA: transient ischemic attack; ASA: atrial septal aneurysm; PFO: Patent foramen ovale. |
All procedures were under institutional guidelines and were approved by the institutional review committee. Study approval was obtained from the Committee on Clinical Applications at the Second Xiangya Hospital and informed consent was obtained from the patients or patients’ parents (< 18 years old).
Procedure
The procedure was performed in a regular operating room by TEE navigation without fluoroscopy. All patients with supine position were TEE re-evaluated before the procedure. The main purpose was to reassure the PFO and provide device selection basis. When the re-evaluation confirmed the procedure, patients were given general anesthesia and routine sterilization. After puncture of the femoral vein, we inserted a 5 French sheath and advanced a 0.035-inch J-tipped stiff wire (Terumo Medical Corporation, Somerset, NJ, USA) into the superior vena cava with TEE monitoring. Heparin was given at a dose of 100 IU/kg and antibiotic prophylaxis was administered. With the J-tip wire in the superior vena cava, we retract the vascular sheath and enlarged the skin access according to the delivery sheath size. Then, we advanced the delivery sheath (Shanghai Shape Memory Alloy Co. Ltd., Shanghai, China) along the wire to the orifice of the inferior vena cava. With the tip of the delivery sheath in the orifice of the inferior vena cava, we retracted the tip of the inner sheath from the delivery sheath. Thereby, the right atrium was protected from the sharp tip of the inner sheath and the delivery sheath was delivered to the superior vena cava. Next, the tip of the delivery sheath was retracted and advanced into the right atrium. Then the wire and inner sheath were removed. Identifying a hollow sheath in the TEE, we slightly torqued the delivery sheath for the best angle, i.e. the angle where the tip of delivery sheath pointed directly towards the PFO. Usually, the sheath would approach the PFO or directly pass the PFO. Then we advanced the delivery sheath into the middle of the left atrium. If the tip of the delivery sheath and PFO could not be identified in the same plane in TEE because of the PFO maybe not in the best position of the atrial septum, then we used a so-called "catheter in sheath" technique to get through PFO. Then the AMPLATZER® PFO Occluder device (AGA Medical Corp, Plymouth, MN, USA) would be advanced into the left atrium and deployed in the PFO (Fig. 1).
Device selection criteria 1. Size of occluder was determined by the weak part of PFO zone because the device should cover the whole weak part; 2. If PFO combined with atrial septal aneurysm, the size of occluder was determined by the diameter of aneurysm.
“Catheter in sheath” technique Firstly, the delivery sheath should be the best angle approached to the atrial septum. A 5 Fr MPA 2 diagnostic catheter (Cordis, Johnson & Johnson, Warren, NJ, USA) and a straight stiff wire in it were put in the delivery sheath. Then the tip of the catheter could be torqued out of the delivery sheath and got the best approach to PFO with TEE probe rotating to detect PFO. If the tip of the catheter got closed to but not through the PFO, then the straight stiff wire could be advanced in the PFO. (Fig.
2)
Follow-up
Aspirin (3 mg/kg/day for children and 1 pill/day for an adult) was routinely administered for six months after the procedure. A contrast TEE at 3 months after discharge was scheduled to assess any residual shunting in basal condition and after Valsalva maneuver. A second TEE was recommended at 6 months in case of the residual shunt as well as device erosion, migration or thrombosis. Neurologists evaluated patients with any recurrent neurologic symptoms and computed tomography (CT) or magnetic resonance (MR) was recommended for any suspicious new ischemic event. For migraine patients, the neurologist reviewed the headache diary and assessed disability due to migraine, quality of life, and depression by Migraine Disability Assessment Questionnaire (MIDAS)[12], Quality of Life Questionnaire SF12v2[13], and the Beck Depression Inventory (BDI)[14] at respectively before operation and at 1st month, 3rd month, 6th month after operation. Ordinary follow-up was given at 1st month, 3rd month, 6th month, 1st year and 2nd year after operation for each patient.
Statistical Analysis
SPSS 25.0 (IBM, Armonk, NY, USA) was used for the analyses. Continuous variables are expressed as mean ± standard deviation. Differences between the 2 groups were analyzed using the independent-samples t-test for continuous variables and χ2 test for categorical variables. Paired-samples t-test was used to compare differences of variables pre- and post-procedurally. A P value < 0.05 was statistically significant.