Double‐Umbrella Device for Transvenous Closure of Patent Ductus Arteriosus and Atrial Septal Defect: First Experience

Abstract

A new device for transcatheter closure of heart defects was constructed and used to close a patent ductus arteriosus (PDA) in seven adult patients and an atrial septal defect (ASD) in six adult patients. The device consisted of two self-opening umbrellas and a piece of Ivalon. A Dacron patch was sewn on the "male" umbrella for the ASD closure. The device required a 9 Fr introducing venous sheath for PDA and a 14 Fr sheath for the ASD. The venoarterial (right femoral vein-PDA or ASD-left femoral artery) long wire track was arranged. The "male" umbrella and the Ivalon were inserted transvenously one after another, advanced over the long wire across the PDA or ASD and extruded into the aorta or left atrium, respectively. The "female" umbrella was advanced transvenously over the long wire into the pulmonary artery (for PDA) or into the right atrium (for ASD). The metal conus on the long wire was used to pull the "male" umbrella while a special stiff pusher was used to bring the "female" umbrella to the "male" umbrella along the long wire. By these means the umbrellas interlocked at the defect level and closed it. The long wire was then removed through the left femoral artery. Protrusion of the interlocked device through the PDA occurred in one patient and through the ASD in two patients. In all three patients the device was kept on the wire until surgery and an early postrelease device embolization was avoided. In all other patients the defects were successfully closed. The follow-up of 3-27 months was uneventful in all patients. These results indicate that the described procedure is effective and safe, and warrants further clinical trial.

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.…”

Initial experience in Brazil with the Helex septal occluder for percutaneous occlusion of atrial septal defects

“…In the last 10-15 years, major advances in the percutaneous treatment of atrial septal defects with the use of several occluding devices has occurred with progressive improvement in the results [1][2][3][4][5][6][7][8][9][10][11][12][13][14] . Because this approach currently provides excellent occlusive results with minimum morbidity and mortality in short and medium follow-up with obvious advantages regarding the surgical approach [8][9][10][11][12][13][14][15][16][17] , it is considered the method of choice for the treatment of selected patients in several medical centers around the world.…”

“…Because this approach currently provides excellent occlusive results with minimum morbidity and mortality in short and medium follow-up with obvious advantages regarding the surgical approach [8][9][10][11][12][13][14][15][16][17] , it is considered the method of choice for the treatment of selected patients in several medical centers around the world. However, some devices have not been widely accepted by interventionists because they possess characteristics far from those considered ideal [1][2][3][4][5][6][7] . The most commonly used, including in our group, are the Amplatzer Septal Occluder (AGA Medical Corporation, Golden Valley, MN) [10][11][12][13][14][15][16] the CardioSEAL septal occluder and the STARFlex (Nitinol Medical Technologies, Boston, MA) 8,9 .…”

Fechamento Percutâneo da Comunicação Interatrial

“…Em 1991, Babic 16 descreveu sua prótese ASDOS, composta de 2 umbrellas contrapostas e auto-expansíveis, com armação de fio de nitinol e revestida de poliuretano, necessitando de um introdutor de liberação de 10Fr. A experiência inicial de 20 casos mostrou sucesso de implante em 80%, elevado índice de complicações e a oclusão completa se deram em apenas 60% dos casos.…”