Transcatheter Closure of Patent Ductus Arteriosus under Echocardiography Guidance: A Randomized Controlled Noninferiority Trial
Joint Authors
Zhang, Fengwen
Ouyang, Wenbin
Zhao, Guangzhi
Lu, Wenxin
Zou, Mengxuan
Pan, Xiangbin
Wang, Cheng
Source
Journal of Interventional Cardiology
Issue
Vol. 2020, Issue 2020 (31 Dec. 2020), pp.1-6, 6 p.
Publisher
Hindawi Publishing Corporation
Publication Date
2020-10-05
Country of Publication
Egypt
No. of Pages
6
Main Subjects
Abstract EN
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).
American Psychological Association (APA)
Wang, Cheng& Zhang, Fengwen& Ouyang, Wenbin& Zhao, Guangzhi& Lu, Wenxin& Zou, Mengxuan…[et al.]. 2020. Transcatheter Closure of Patent Ductus Arteriosus under Echocardiography Guidance: A Randomized Controlled Noninferiority Trial. Journal of Interventional Cardiology،Vol. 2020, no. 2020, pp.1-6.
https://search.emarefa.net/detail/BIM-1187780
Modern Language Association (MLA)
Wang, Cheng…[et al.]. Transcatheter Closure of Patent Ductus Arteriosus under Echocardiography Guidance: A Randomized Controlled Noninferiority Trial. Journal of Interventional Cardiology No. 2020 (2020), pp.1-6.
https://search.emarefa.net/detail/BIM-1187780
American Medical Association (AMA)
Wang, Cheng& Zhang, Fengwen& Ouyang, Wenbin& Zhao, Guangzhi& Lu, Wenxin& Zou, Mengxuan…[et al.]. Transcatheter Closure of Patent Ductus Arteriosus under Echocardiography Guidance: A Randomized Controlled Noninferiority Trial. Journal of Interventional Cardiology. 2020. Vol. 2020, no. 2020, pp.1-6.
https://search.emarefa.net/detail/BIM-1187780
Data Type
Journal Articles
Language
English
Notes
Includes bibliographical references
Record ID
BIM-1187780