دورية أكاديمية
Transcatheter Closure of Patent Ductus Arteriosus under Echocardiography Guidance: A Randomized Controlled Noninferiority Trial
| العنوان: | Transcatheter Closure of Patent Ductus Arteriosus under Echocardiography Guidance: A Randomized Controlled Noninferiority Trial |
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| المؤلفون: | Cheng Wang, Fengwen Zhang, Wenbin Ouyang, Guangzhi Zhao, Wenxin Lu, Mengxuan Zou, Xiangbin Pan |
| المصدر: | Journal of Interventional Cardiology, Vol 2020 (2020) |
| بيانات النشر: | Wiley, 2020. |
| سنة النشر: | 2020 |
| المجموعة: | LCC:Diseases of the circulatory (Cardiovascular) system |
| مصطلحات موضوعية: | Diseases of the circulatory (Cardiovascular) system, RC666-701 |
| الوصف: | 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). |
| نوع الوثيقة: | article |
| وصف الملف: | electronic resource |
| اللغة: | English |
| تدمد: | 0896-4327 1540-8183 |
| Relation: | https://doaj.org/toc/0896-4327; https://doaj.org/toc/1540-8183 |
| DOI: | 10.1155/2020/4357017 |
| URL الوصول: | https://doaj.org/article/626227e6a3bd4c00a8c4b1804ddedb48 |
| رقم الأكسشن: | edsdoj.626227e6a3bd4c00a8c4b1804ddedb48 |
| قاعدة البيانات: | Directory of Open Access Journals |
Full Text Finder | تدمد: | 08964327 15408183 |
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| DOI: | 10.1155/2020/4357017 |