Device Closure of Perimembranous Ventricular Septal Defect: Choosing Between Amplatzer Occluders

Abstract

Background: Off-label device closure of perimembranous ventricular septal defect (pmVSD) is well reported in the literature with encouraging results. However, technical challenges may be encountered. Objectives: To evaluate and compare feasibility, technical aspects, procedural outcomes, and mid-term follow-up of pmVSD closure using Amplatzer™ occluders. Patients and Methods: From July 2015 to July 2018, patients in whom pmVSD closure was attempted using an Amplatzer occluder were retrospectively identified from our institution's database. Device selection was made according to the defect anatomy that was obtained via ventriculography and trans-esophageal echocardiography. Follow-up evaluations were done at discharge, then at 1, 3, 6, and 12 months and yearly thereafter with transthoracic echocardiography and electrocardiogram. Results: In total, 8 Amplatzer Duct Occluder (ADO), 27 ADO II, and 17 Amplatzer Muscular VSD Occluder (AMO) were used in 51 patients with a mean age of 7.4 ± 6.9 years and a mean weight of 25.4 ± 19.8 kg. Implantation was successful in 50/51 patients (98.0%). There was no procedure related mortality. One ADO accidentally embolized to the aorta after release and was surgically recaptured from the iliac artery. All ADO II were delivered retrogradely with the least amount of time ( p = 0.002) and the lowest radiation exposure ( p < 0.001). Minor valvular disturbances occurred in 8/49 patients (16.3%), including five tricuspid regurgitation (three with ADOII and two with AMO) and three trivial aortic regurgitations (two with ADO and one with ADOII). On a median follow-up of 194 days (range, 60–895 days), no surgical device removal was necessary. At 6 months of follow-up, trivial residual shunt was present in 5/49 patients (10.2%), among which none occurred with ADO. One complete atrioventricular block was detected 18 months after ADO implantation and required permanent pacing. Conclusions: Transcatheter closure of PmVSD using Amplatzer occluders is feasible, safe and efficacious in properly selected patients. The major key factor behind high procedural success rate is proper device selection. ADOII is remarkably superior in terms of device softness, flexibility and faster implantation process. Yet, its use is limited to small defects with particular anatomy.

Percutaneous closure of restrictive‐type perimembranous ventricular septal defect using the new KONAR multifunctional occluder: Midterm outcomes of the first middle‐eastern experience

“…We aimed with our device selection protocol that was mainly based on covering the LV entry, to achieve complete closure. 4,5,15 Despite that, our results showed that residual shunting was 60.0% (12/20) Finally, complete heart block remains the most worrisome complication that can occur immediately or anytime during follow-up. 4,16 No case of rhythm disturbance was documented in our series and we credibly do not expect its occurrence.…”

“…The slim delivery cable played an important role in controlling that risk before device release as a hand-dye injection through the delivery sheath was necessary to delineate the LRD-to-AoV position. 5 In our series, AVR was documented, before discharge, in one 3-year-old girl in whom a 9/7 device was chosen to occlude an (11 mm LV entry;…”

“…1 Despite that, a large number of clinical reports documenting successful off-label defect closure with different devices were published in many centers worldwide. [2][3][4][5] Since the first Rashkind double umbrella device, 6 occluders are continuously being upgraded to improve the efficiency and outcomes of this interventional approach while reducing the rate of complications. 7 In May 2018, a new promising device, the KONAR-MF™ ventricular septal defect (VSD) occluder (Lifetech, Shenzhen, China), received the CEmark approval for VSD transcatheter closure 5 years after first in man implantation.…”

Recent achievements in transcatheter closure of ventricular septal defects: a systematic review of literature and a meta-analysis

“…Finally, 44 studies were taken into analysis with a total number of 4050 patients (Supplementary material, Table S2) Table S2). Moreover, type of devices used in studies through analyzed years is presented in Table S2) [14,41]. 40/44 (90.91%) studies reported a success rate of > 90%.…”

“…It was classified as transient and the patient was discharged in a good condition. After 18 months, the presence of CAVB was again revealed during a routine follow-up and the patient required permanent pacemaker implantation [14].…”