Transcatheter Closure of Patent Ductus Arteriosus under Echocardiography Guidance: A Randomized Controlled Noninferiority Trial

Abstract

Background. Percutaneous occlusion under fluoroscopy guidance has become the preferred method for the treatment of patent ductus arteriosus (PDA). To avoid radiation exposure and contrast agent use, PDA occlusion under transthoracic echocardiography (TTE) guidance was conducted. Objectives. We assessed the hypothesis that the success rate of percutaneous PDA occlusion under TTE was noninferior to that under fluoroscopy guidance. Methods. In this single-center trial, 100 patients were randomly assigned in a 1 : 1 ratio to the TTE group (n = 50) or to the fluoroscopy group (n = 50). The primary endpoint was the success rate of occlusion, with the noninferiority margin set at 8% for the between-group difference in intention-to-treat analysis. Secondary endpoints were hospitalization duration, cost, procedure time, and rate of adverse events including occluder migration, hemolysis, peripheral vascular complications, and residual shunt at 1-month and 12-month follow-up. Results. Patient, defect, and device characteristics were similarly distributed between groups. The success rate of occlusion was 98% for the TTE group and 100% for the fluoroscopy group (absolute difference: −2%; 95% confidence interval: −5.9% to 1.9%). Cost and procedure duration were significantly lower in the TTE group, without adverse events in either group at a median of 12.0 months (range, 10.0–15.5 months) of follow-up. Conclusion. Percutaneous PDA occlusion can be performed via TTE guidance safely and effectively, and the success rate of the TTE-guided procedure was noninferior to that under fluoroscopy guidance, with reduced cost and procedure time. The trial is registered with http://www.chictr.org.cn (ChiCTR-ICR-15006334).

Evaluation of Cardiac Function Characteristics after Patent Ductus Arteriosus Closure in Children and Adults by Echocardiographic Data

“…In general, normal fetuses are functionally closed within 10-15 hours of birth by contraction of the smooth muscle in the medial layer of the ductus arteriosus wall and permanently closed within 2-3 weeks of birth by formation of wrinkles in the endothelium of the ductus arteriosus and fibrosis of the subintimal connective tissue [15][16][17][18]. If PDA occurs, it will influence the body's hemodynamics, mainly because part of the aortic blood shunts through the PDA to the pulmonary artery, and then the shunt to the pulmonary artery blood flow and the right heart system blood flow, together entering the left atrium and left ventricle again through the pulmonary circulation, increasing the left ventricular volume load [19][20][21].…”

Uso de la ecocardiografía en el cierre percutáneo de ductus arterioso persistente en el Instituto Nacional de Salud del Niño, San Borja,Lima – Perú

“…In our study, we found that the use of TTE reduced the procedure time, eliminated the need for femoral arterial access, and avoided the use of contrast agents. It also minimized radiation exposure, benefiting both patients and operators without compromising the effectiveness of defect closure, as supported by scientific literature (11)(12)(13) . TTE has also been successfully used for interventricular and atrial septal defects with the same objective of reducing radiation doses and decreasing the need for angiographies (16,17) .…”

Transesophageal echocardiography-guided percutaneous patent ductus arteriosus closure without fluoroscopy

“…This method successfully occludes PDA through femoral vein without using contrast agents and X-ray. In addition, there are no severe complications indicating the safety and effectiveness of this technique [ 14 ]. However, this technique also has some limitations.…”

“…To the best of our knowledge, this is the largest cohort which explores the safety and effectiveness of transcatheter femoral vein occlusion of PDA under TEE guidance in children. In our center, the longest surgical time at the initial stage was 2 h, and the shortest time was 20 min with an average duration of 40.2 min, which indicates that this method represents a better alternative than other methods considering the learning curve [ 14 ]. However, it is also noteworthy that cases with surgical time longer than 2 h possibly need to be changed to open surgery to avoid the increased risks due to the prolonged operation.…”