1.1 Study design and patient selection
A total of 112 patients(32 males and 80 females)with PDA who received interventional treatment in Suining Central Hospital from January 2017 to May 2022 were included. According to different interventional treatment methods, the patients were divided into two groups: Group 1 included 60 patients(15 males , 45 females,age 18.92±18.21years,BMI 18.53±4.05kg/m2) who underwent single venous approach under echocardiographic without angiography. Group 2 included 62 patients(17males , 35 females,age 17.79±16.41years,BMI 17.92±3.13kg/m2) who underwent conventional arteriovenous approach.There were no significant differences in age, gender and BMI between the two groups (P > 0.05) (Table 1). All patients were diagnosed with PDA by clinical physical examination, electrocardiogram, chest X-ray and transthoracic echocardiography (TTE).
Inclusion criteria :(1) Weight above 4kg; (2) audible cardiac murmur , volume overload, and symptomatic patients attributed to PDA; (3) funnel shaped patent ductus arteriosus; (4) resistance significant pulmonary hypertension.exclusion criteria:(1)combined with other congenital cardiovascular malformation requiring surgical repair;(2)large PDA;(3)right-to-left shunt across the PDA.
1.2 Ethics
The study was approved by the ethics committee of Suining Central Hospital and written informed consent was obtained from the patients’ parents.All subjects gave written informed consent in accordance with the Declaration of Helsinki.
1.3 Procedure
(1) Single venous approach under echocardiographic without angiography
The surgery was completed in the interventional catheterization room. The shape and position of PDA were evaluated under echocardiographic before the procedure . The narrowest width of the arterial duct in multiple views such as the standard parasternal short axis view, the supra-sternal long axis view and the high parasternal short axis view was measured.At the same time, the blood flow velocity of the proximal descending aorta and the origin of the left pulmonary artery were recorded as preoperative reference values. Local lidocaine was used for patients over 12 years old, and general anesthesia was used for children under 12 years old or unable to cooperate with preoperative fasting for 6 hours. The 6 French short sheaths was inserted into in the right femoral vessels before 50U/kg heparin was administered to the patients after cannulated.A 5 French MPA catheter was implanted through right femoral vein→ right atrium → right ventricle → pulmonary artery → ductus arteriosus → descending aorta with the assistance of the under guidewire guidance.Then, the 0.035 inch260cm guidewire exchanged MPA to establish the track.Then the MPA catheter was replaced with the guidewire (0.035 cmX260 cm) that the head end of the guidewire was left in the descending aorta without angiography.The occlude was selected as approximately 3-6mm larger than the narrowest width of the arterial duct measured under TTE. Before releasing the device, the appropriate and stable position was accepted when the retention skirt was seen opposing the ampulla in the descending aorta, and embed into the ductal ampulla under fluoroscopy guidance.The rest of the device was then displayed in the pulmonary artery end.Before the device was unscrewed,the shape and position of the occluder was again evaluated by TTE through multiple views. If the results of the occluder was not satisfactory, replaced the appropriate occluder and repeated above process until a satisfactory results was achieved.
(2) conventional arteriovenous approach
According to the conventional closure procedure , the anesthesia methods were the same as single venous group. The right femoral artery and the right femoral artery were punctured respectively. The 6 French MPA catheter implanted through right femoral vein was routinely used for right heart catheterization . In origin of the descending aorta ,the aortography view in the left lateral view 90° was performed using a 5 French pigtail cathete to record the position, shape and diameter of the ductus arteriosus.The track establishment procedure was the same as the heparin dose used in the single venous group.The track establishment procedure and heparin dosage in the conventional arteriovenous group were the same as those in the single venous group.The device was deployed from the descending aorta end.Before releasing the device,aortography was repeated to ensure accurate position and shape of the occluder.If there were abnormal adjustment in time to achieve satisfactory results.
1.3 Device Detail
The most frequently used device in our institution was the mushroom occluder, produced by Lifetech duct occluder ( Shenzhen, China) , and Shape Memory Alloy (Shanghai, China).
1.4 Follow-Up
Twenty-four hours after the procedure, the success rate of operation, complete closure rate ,operation time, X-ray fluoroscopic time, radiation dose, intraoperative contrast volume, preoperative and postoperative creatinine, preoperative and postoperative uric acid nitrogen, bed rest time, total hospital stay and incidence of vascular complications were compared between the two groups.All patients were underwent TTE, X-ray, and electrocardiography to evaluate prognosis at different time points (3 days, 1 month, 3 months, 6 months) after the operation.
1.5 Statistical Analysis
SPSS 26.0 software (IBM Corp, Armonk, NY, USA) was used for data analysis. If the measurement data were normal distribution, they were represented by X ±s. The comparison between the two groups was performed by two independent sample t test. Enumeration data were expressed as frequency (percentage), and chi-square test was used for comparison between groups. P<0.05 was considered statistically significant.