Transcatheter device closure of perimembranous ventricular septal defects: mid-term outcomes

Jian Yang, Lifang Yang, Yi Wan, Jian Zuo, Jun Zhang, Wensheng Chen, Jun Li, Lijun Sun, Shiqiang Yu, Jincheng Liu, Tao Chen, Weixun Duan, Lize Xiong, Dinghua Yi, Jian Yang, Lifang Yang, Yi Wan, Jian Zuo, Jun Zhang, Wensheng Chen, Jun Li, Lijun Sun, Shiqiang Yu, Jincheng Liu, Tao Chen, Weixun Duan, Lize Xiong, Dinghua Yi

Abstract

Aims: The aim of this study was to evaluate the safety and efficacy of transcatheter closure for perimembranous ventricular septal defect (pmVSD) and its long-term results. The most common congenital heart condition is pmVSD. Transcatheter closure of pmVSD is a recently described technique with limited results for mid- to long-term follow-up.

Methods and results: Between June 2002 and June 2008, 848 patients with pmVSD were enrolled in our study and treated percutaneously with pmVSD occluders. All patients were followed up until December 2008, an average of 37 months. According to colour Doppler transthoracic echocardiography before the intervention and ventriculography, the average end-diastolic pmVSD size was 5.1 and 5.4 mm, respectively. Placement of the device was successful in 832 patients (98.1%) and the median device size was 8.6 mm. During follow-up, 103 adverse events (12.4%) were reported. Most adverse events were categorized as minor and there were nine major adverse events (8.7%), including two complete atrioventricular block requiring pacemaker implantation. Kaplan-Meier estimates showed >85% freedom from major or minor adverse events during a maximal follow-up of 79 months.

Conclusions: In experienced hands, transcatheter pmVSD closure can be performed safely and successfully with low morbidity and mortality. Long-term prognostic results are favourable, and the transcatheter approach provides a less-invasive alternative that may become the first choice in selected pmVSD patients. This trial is registered with ClinicalTrials.gov, number NCT00890799.

Figures

Figure 1
Figure 1
(A) Lateral view of the Shanghai symmetrical perimembranous ventricular septal defect occluder; (B) front view of the Shanghai symmetrical perimembranous ventricular septal defect occluder.
Figure 2
Figure 2
Classification of perimembranous ventricular septal defect and ventriculography before the release of the occluders. (A) In the tubular type, the shunt jet is long, and the diameter in the left and right sides of the septum is the same. (B) In the window-like type, the shunt jet is scattered immediately after crossing the septum. (C) In the aneurysmal type, the shunt jet has an aneurysmal shape. (D) In the conical type, the shunt jet is wide on the left side of the septum and narrow on the right side. (E) Ventriculography before the release of occluders in tubular perimembranous ventricular septal defect, same patient as in (A). (F) Ventriculography before the release of occluders in window-like perimembranous ventricular septal defect, same patient as in (B). (G) Ventriculography before the release of occluders in aneurysmal perimembranous ventricular septal defect, same patient as in (C). (H) Ventriculography before the release of occluders in conical perimembranous ventricular septal defect, same patient as in (D).
Figure 3
Figure 3
Removal of the perimembranous ventricular septal defect occluder in a 13-year-old boy 746 days post-intervention due to moderate tricuspid insufficiency. (A) The tricuspid valve was encroached upon by the occluder, leading to moderate tricuspid insufficiency; (B) The Shanghai perimembranous ventricular septal defect occluder was explanted, and the perimembranous ventricular septal defect was repaired.
Figure 4
Figure 4
Kaplan–Meier estimates of outcomes (freedom from major adverse events and mixed major and minor adverse events). Dotted lines are the 95% confidence interval levels.

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