Preclinical evaluation of a new self‐expanding device for closure of muscular ventricular septal defects in a pig model

Abstract

Our preclinical study shows successful closure of iatrogenic created mVSDs without residual shunting. The device is characterized by a more controlled deployment, an independent deployment of disk and waist, and a good alignment of the left ventricular disk to the muscular septum.

Development and preclinical evaluation of a biodegradable ventricular septal defect occluder

“…Transcatheter closure of ventricular septal defect (VSD) was first described by Lock et al in 1988. Since then, several devices have been developed . The introduction of the Amplatzer septal occluder (ASO) has enlarged the application of percutaneous techniques to VSD.…”

Developing High Medical Technology, a Challenge for Developing Countries: The Percutaneous Closure of Atrial Septal Defects Using Nit-Occlud ASD-R: Early and Mid-term Results

“…In our series, the mean fluoroscopy time was 16 minutes, which is slightly shorter than the average of 18.3 minutes reported in the reviewed literature. 11 -32 The longest fluoroscopy times were documented in cases where it was necessary to replace the first device with one of larger size or where technical problems occurred. The median procedure time was 77 minutes, which is comparable to the times reported by other groups.…”

“…The median procedure time was 77 minutes, which is comparable to the times reported by other groups. 11 -32 The fluoroscopy and procedure times are longer if the first chosen device is too small for the defect, which increases the risk of an embolization, or if it is too large, stretching the defect and risking arrhythmias. If the device is too large, the proximal disk cannot adequately configure, which results in the device showing a bulky configuration into the right auricle because the stent cannot expand.…”

“…Histopathological findings 74 days after implantation show complete endothelialization and no inflammatory reaction to foreign material. 32 Real-time MR guidance for placement of magnetic resonance(MR)-compatible ASD occlusion devices in vitro and in an animal model of patent foramen ovale were described by Buecker et al 33,34…”

Chronic hypobaric hypoxia, patent arterial duct and a new interventional technique to close it

“…[21][22][23][24][25] This system has been already tested in animals with good results. 26 We also made an initial clinical experience with the device showing the feasibility of 28 recently published, in Mexico, a very interesting article about hypertensive ducts. We can corroborate this observation: patients with hypertensive ducts at high altitude tend to show an improvement of the elevated pulmonary pressure after closing the defects and maintain it low with the time.…”