Observational Study
Copyright ©The Author(s) 2019. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Clin Cases. Mar 6, 2019; 7(5): 562-571
Published online Mar 6, 2019. doi: 10.12998/wjcc.v7.i5.562
Safety of an improved patent ductus arteriosus occluder for transcatheter closure of perimembranous ventricular septal defects with abnormally attached tricuspid chordae tendineae
Lu He, Ya-Juan Du, Ge-Sheng Cheng, Yu-Shun Zhang
Lu He, Ya-Juan Du, Ge-Sheng Cheng, Yu-Shun Zhang, Department of Structural Heart Disease, Xi’an Jiaotong University Medical College First Affiliated Hospital, Xi’an 710061, Shaanxi Province, China
Author contributions: He L and Zhang YS contributed to study concept and design; Du YJ and Cheng GS contributed to data analysis and interpretation and critical revision of the article; He L contributed to drafting of the article; all the authors read and approved the final manuscript.
Institutional review board statement: The study was approved by the ethics committee of Xi’an Jiaotong University Medical College First Affiliated Hospital (Xi’an, China).
Informed consent statement: All patients gave informed consent.
Conflict-of-interest statement: None.
STROBE statement: The authors have read the STROBE Statement-checklist of items, and the manuscript was prepared and revised according to the STROBE Statement-checklist of items.
Open-Access: This article is an open-access article which was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
Corresponding author: Yu-Shun Zhang, MD, PhD, Professor, Department of Structural Heart Disease, Xi’an Jiaotong University Medical College First Affiliated Hospital, 277 Yanta West Road, Xi'an 710061, Shaanxi Province, China. zys2889@sina.com
Telephone: +86-29-85324078 Fax: +86-29-85324078
Received: December 22, 2018
Peer-review started: December 23, 2018
First decision: December 29, 2018
Revised: January 13, 2019
Accepted: January 29, 2019
Article in press: January 30, 2019
Published online: March 6, 2019
Processing time: 74 Days and 19.6 Hours
ARTICLE HIGHLIGHTS
Research background

Whether certain defects such as perimembranous ventricular septal defects (PmVSD) with abnormally attached tricuspid chordae tendineae are fit for interventional treatment is still disputable. We explored the feasibility and safety of transcatheter closure of PmVSD with abnormally attached tricuspid chordae tendineae using an improved patent ductus arteriosus (PDA) occluder through an observational, single-center study.

Research motivation

The off-label use of various devices has been reported for the transcatheter closure of PmVSD because of serious complications, such as heart block and tricuspid regurgitation, associated with conventional ventricular septal defect devices. However, whether PmVSD with abnormally attached tricuspid chordae tendineae are suitable for interventional treatment has rarely been reported. Therefore, this study hopes to provide guidance for the choice of occluder which can be used in such defects. That might allow a wider range of interventional therapy of PmVSD.

Research objectives

The research objective of this study was to explore the feasibility and safety of transcatheter closure of PmVSD with abnormally attached tricuspid chordae tendineae using an improved PDA occluder.

Research methods

We retrospectively analyzed 20 patients diagnosed with PmVSD with abnormally attached tricuspid chordae tendineae who underwent interventional treatment using an improved PDA occluder at our center from January 2012 to January 2016. Baseline characteristics and procedural and follow-up data were analyzed. This study is a single-center, non-randomized, observational study.

Research results

Our research found that the improved PDA occluder might provide an valid and secure option in selected patients diagnosed with PmVSD with abnormally attached tricuspid chordae tendineae. Given its nature, the present study shares all of the limitations of observational studies. In our study, the mean follow-up time was only 2.4 years. Although the major complications of PmVSD closure usually appears within this time frame, the results may have been affected. The small sample size is another limitation of this study.

Research conclusions

In this single-center, non-randomized, observational study cohort, despite its small sample size, our study suggests that using of the improved PDA occluder for the transcatheter closure of PmVSD with abnormally attached tricuspid chordae tendineae is a safe and promising treatment option. The availability of the improved PDA occluder might allow a wider range of interventional therapy of PmVSD.

Research perspectives

We used the improved PDA occluder for transcatheter closure of PmVSD with abnormally attached tricuspid chordae tendineae as a breakthrough point, and concluded that using of the improved PDA occluder for the transcatheter closure of PmVSD with abnormally attached tricuspid chordae tendineae is a safe and promising treatment option. However, the number of patients is too small, and the single-center observational study still has its own shortcomings. So we still believe that the highest level of evidence in clinical studies is a multi-center, prospective, randomized controlled study.