Transvenous atrial septal defect occlusion in piglets with a "buttoned" double-disk device.

Abstract

The feasibility and safety of transvenous closure of atrial septal defects by a new device was tested in 20 piglets, in which atrial septal defects were created by foramen ovale dilatation with angioplasty balloons. The device was small enough to be introduced in a 7F or 8F sheath, and it measured 20-25 mm. It has no hooks and consists of a foam occluder from the left atrium and a counter-occluder from the right atrium, buttoned independently. The animals were observed by angiography and color flow mapping, and they were electively killed at various intervals up to 2 months after occlusion. The device was not thrombogenic and had endothelialized by 2-3 weeks. All atrial defects were found to be completely occluded. Complications occurred only with the first three prototype devices, including counter-occluder detachment, right atrial perforation, and need for double occlusion and pulmonary artery embolization. No such complications occurred in the last 17 experiments because of modifications of the device and operator experience. These observations showed the feasibility of occlusion of moderate-size atrial septal defects in piglets by a new device introduced through a small sheath. The method appears promising for potential human application. (Circulation 1990;81:312-318 tages over existing devices by relatively easy insertion and fewer associated complications. Methods ProtocolAtrial septal defects were created by foramen ovale dilatation with angioplasty balloon catheters in 20 piglets weighing 7-29 kg. The animals were heavily sedated by an initial dose of 10-20 mg/kg i.v. ketamine (100 mg/ml, Vetalar, Fort Dodge Laboratories, Fort Dodge, Iowa). The experiments were performed under sterile conditions. A femoral vein cutdown was performed under local anesthesia with 2% xylocaine, and the animals were heparinized (100 units/kg). A multipurpose marker catheter (Cordis, Hialeah, Florida) was introduced into the right atrium under fluoroscopy and was used to probe the foramen ovale. The marker catheter was used both for wire exchanges and dimension measurements after angiography. An angioplasty catheter (Olbert) with a balloon diameter of 10-12 mm was introduced over a 0.035 -in. exchange wire into the left atrium, through the foramen ovale. Three dilatations were performed with dilute contrast material for inflation periods up to 30 seconds. The angioplasty catheter was subsequently replaced by a marker angiographic catheter,

Contemporary Management of Patent Foramen Ovale

“…28 Bridges et al 29 first proposed that PFO closure would reduce the incidence of recurrent strokes and demonstrated a statistically significant effect of PFO closure on a small group of high-risk patients. Since then, numerous studies have shown that transcatheter PFO closure with current techniques is safe and seems to protect against recurrent strokes in this patient population.…”

Amplatzer Device closure of Atrial Septal Defects and Patent Ductus Arteriosus: Initial Experience

“…However, the procedure has not yet achieved widespread clinical use and is still investigational. Previous devices include the clamshell septal occluders [3,4], Sideris prosthesis (buttoned device) [5][6][7], the atrial septal defect occlusion system (ASDOS) [8,9], the Das Angel Wing [10,11] and the Pavenik monodisc [12]. All these were bulky devices, requiring larger sheaths for introduction which make their application difficult in small children.…”

“…As an alternative to surgery, a variety of devices for transcatheter closure of ASDs have been developed over the past 25 years, but none has gained wide acceptance. Large delivery sheaths, cumbersome implantation techniques, inability to recapture, structural failure, dislodgement and embolization of the device are some of the limitations of previously prescribed techniques [2][3][4][5][6][7][8][9][10][11][12]. This study describes our experience with transcatheter closure of ASDs and PDAs using a new self expanding, self-centering and repositionable device, the Amplatzer.…”

Historical Aspects of Transcatheter Occlusion of Atrial Septal Defects

“…The buttoned device was successfully implanted in 17 (85%) of 20 attempts. The failures were in the first three animals; presumably related inexperience of the operator and design imperfections (Sideris et al, 1990a). Full occlusion of the ASD and endothelialization of the device was demonstrated in all the 17 successful implantations.…”