The standard technique of catheter closure of patent ductus arteriosus (PDA) may be associated with arterial complications particularly in small pediatric patients. The aim of this study was to evaluate whether catheter closure of PDA in small children using an exclusive venous approach is a safe and effective alternative to closure with the standard technique. One hundred-twelve patients, aged 2 to 24 months, were randomly assigned in a 1:1 ratio to catheter closure of PDA using the standard technique (group 1) and an exclusive venous approach (group 2), respectively. In group 2, the procedure was guided using hand injections of contrast media through the delivery sheath and 2-dimensional and color Doppler echocardiography. Group 1: the PDA diameter ranged from 2 to 5.5 mm and the device diameter ranged from 4 to 8 mm. The PDA occluders were permanently implanted in all patients. Five losses of the arterial pulses that were restored with intravenous infusion of heparin and recombinant tissue plasminogen activator (rtPA), and 4 groin hematomas were the main complications of the procedure. Group 2: the mean PDA diameter ranged from 2.5 to 6 mm and the device diameter ranged from 3 to 8 mm. The PDA occluders were permanently implanted in all but 2 patients. There were no complications. Complete echocardiographic closure of PDA at 1-month follow-up was observed in all 110 patients. Exclusive transvenous PDA occlusion is an effective and safe technique that prevents the arterial complications of the standard approach in small children.
Transcatheter closure is the treatment of choice for most patients with a patent ductus arteriosus (PDA). However, the standard technique of this procedure requires arterial access and may be associated with arterial complications particularly in small pediatric patients. The aim of this study was to report experience with PDA catheter closure in small children using an exclusive venous approach.
Methods
From February 2010 to March 2015, 112 patients aged 2 to 24 months, with a PDA underwent PDA catheter closure in 4 European centers using the Amplatzer duct occluders (ADOs) I, II, and additional size (AS) (St. Jude Medical Inc., Saint Paul, Minnesota). The patients were screened by conventional transthoracic 2-dimensional (2D) and color Doppler echocardiography. The study inclusion criteria were: (1) full-term infants with a body weight >2 kg, (2) left to right shunt across the PDA, and (3) normal pulmonary arterial pressure. Patients were randomly assigned in 1:1 ratio to catheter closure with the standard technique (group 1 = 56 patients, age 3 to 24 months, median 8 months, body weight 4.2 to 9.8 kg, median 4.3 kg) and to closure using an exclusive venous approach (group 2 = 56 patients, age 1 to 21 months, median 7 months, body weight 2.6 to 9.5 kg, median 3.8 kg). Ninety-four patients had echocardiographic evidence of significant shunt through the PDA with left atrial enlargement and ventricular volume overload. Patients with additional cardiac anomalies that would require cardiac surgery, aortopulmonary window type PDAs, and PDAs larger than 6 mm were excluded from the study. All devices were implanted in the context of a protocol approved by the ethical committees of the participating hospitals. Informed parental consent was obtained in each patient.
In group 1, retrograde aortography with a 4Fr pigtail catheter was used for the assessment of PDA anatomy and size and for the guidance of the procedure. In group 2, the anatomy and the size of PDA were defined with anterograde aortography using a pigtail or a Berman catheter that was advanced through the ductus into the descending aorta. The procedure was guided using hand injections of contrast media through the delivery sheath (DS) and 2D and continuous-wave and color Doppler echocardiography from suprasternal and parasternal long- and short-axis view, respectively ( Figure 1 ). The occluders (ADO I, pulmonary end; ADO II, ADO II AS, waist diameter) were selected to be 1 to 2 mm larger than the ductal at its pulmonary diameter. The ADO I was implanted in older patients (body weight >8 Kg) with large (>5 mm) PDAs, preferably type A, and when an ADO II or ADO II AS was not available. A 7Fr to 8Fr (ADOI) and a 5Fr to 6Fr (ADO II, AS) DS was required. Once optimal position was confirmed, the devices were released by counterclockwise rotation of the delivery cable. A repeat complete echocardiographic and Doppler study was performed to check for residual shunts and device-related left pulmonary artery or aortic obstruction. All patients were discharged 24 hours after the procedure on no medication. A chest x-ray and complete 2D and continuous-wave and color Doppler echocardiographic studies were performed on all patients at 24 hours and 1 month after the procedure. Results are expressed as mean value ± SD or median when appropriate.
