Limits...
Current perspectives in percutaneous atrial septal defect closure devices.

Bissessor N - Med Devices (Auckl) (2015)

Bottom Line: Complications reported in the literature include thrombus formation, air embolization, device embolization, erosions, residual shunts, and nickel hypersensitivity.Modern devices have intermediate to long term data with outcomes that have been favorable.In this review, commonly used devices and deployment procedures are discussed together with a look at devices that show promise for the future.

View Article: PubMed Central - PubMed

Affiliation: Department of Cardiology, The Epworth Hospital, Melbourne, VIC, Australia ; Division of Interventional Cardiology, The Alfred Hospital, Melbourne, VIC, Australia ; Department of Clinical Science, Charles Sturt University Albury Campus, NSW, Australia ; Heart Foundation, Griffith University, QLD, Australia.

ABSTRACT
In the last decade, percutaneous atrial septal defect (ASD) closure has become the treatment of choice in most clinical presentations of ASD. Percutaneous ASD closure has established procedural safety through operator experience and improved device structure and deliverability. There have also been advances in diagnostic capabilities. Devices have evolved from large bulky meshes to repositionable, minimal residual mesh content that easily endothelializes and conforms well to surrounding structures. Biodegradable technology has been introduced and will be closely watched as a future option. The evolution of ASD closure device usage in the last four decades incorporates development that minimizes a wide range of serious side effects that have been reported over the years. Complications reported in the literature include thrombus formation, air embolization, device embolization, erosions, residual shunts, and nickel hypersensitivity. Modern devices have intermediate to long term data with outcomes that have been favorable. Devices are available in multiple sizes with improved delivery mechanisms to recapture, reposition, and safely close simple and complex ASDs amenable to percutaneous closure. In this review, commonly used devices and deployment procedures are discussed together with a look at devices that show promise for the future.

No MeSH data available.


Related in: MedlinePlus

Amplatzer septal occluder – St Jude Medical, Inc., Saint Paul, MN, USA (most widely used).
© Copyright Policy
Related In: Results  -  Collection

License
getmorefigures.php?uid=PMC4508077&req=5

f1-mder-8-297: Amplatzer septal occluder – St Jude Medical, Inc., Saint Paul, MN, USA (most widely used).

Mentions: The ASO device is FDA approved since 2001 for closure of ASD and has the widest usage (Figure 1).1,9 The ASO is easily visualized on TEE and fluoroscopy. Based on ease of delivery, support and proctoring, ASO has the most outcome data for all ASD closure devices over the last 20 years. Its straightforward deployment and proven efficacy in both simple and complex lesions has made it most popular for ASD closure. ASO may also be used for off label patent foramen ovale closure. The device enjoys a high success rate due to ease of deployment and is repositionable before final deployment. The deployed device conforms to the shape of surrounding structures. The device structure is a self-expanding double disk with larger left atrial disk and a starting size 4 mm connector waist. The structure is a nitinol metal wire mesh framework and is recapturable. There are 26 disk sizes measured at the waist from 4 mm to 38 mm. The ASO right disk/left disk size combinations include 18/18 mm, 25/18 mm, 30/30 mm, 35/25 mm combinations. The delivery sheath sizes range from 6F to 12F. In cases with large ASDs where positioning the ASO device may be difficult, a Hausdorf sheath may facilitate deployment. The most serious risk would be device erosion, which is associated with oversizing the device or rim deficiency. It is unclear what the actual device erosion rate is; there are 240 cases reported with an estimated worldwide implant rate of 240,000 devices (0.1%) but is also estimated at 0.2%–0.5%.9,10 The mechanism is thought to be due to friction between the left atrial disk wire mesh and the aortic or atrial wall. TTE may detect the aorto–atrial fistula or pericardial effusion but the event is so rare that it is not clear if routine TTE surveillance is worthwhile. Surgical removal of the device and patch closure of the defect is reported. The FDA has required the manufacturer to undertake a prospective study to better understand the ASO performance and the potential to develop erosions.2


Current perspectives in percutaneous atrial septal defect closure devices.

Bissessor N - Med Devices (Auckl) (2015)

Amplatzer septal occluder – St Jude Medical, Inc., Saint Paul, MN, USA (most widely used).
© Copyright Policy
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4508077&req=5

f1-mder-8-297: Amplatzer septal occluder – St Jude Medical, Inc., Saint Paul, MN, USA (most widely used).
Mentions: The ASO device is FDA approved since 2001 for closure of ASD and has the widest usage (Figure 1).1,9 The ASO is easily visualized on TEE and fluoroscopy. Based on ease of delivery, support and proctoring, ASO has the most outcome data for all ASD closure devices over the last 20 years. Its straightforward deployment and proven efficacy in both simple and complex lesions has made it most popular for ASD closure. ASO may also be used for off label patent foramen ovale closure. The device enjoys a high success rate due to ease of deployment and is repositionable before final deployment. The deployed device conforms to the shape of surrounding structures. The device structure is a self-expanding double disk with larger left atrial disk and a starting size 4 mm connector waist. The structure is a nitinol metal wire mesh framework and is recapturable. There are 26 disk sizes measured at the waist from 4 mm to 38 mm. The ASO right disk/left disk size combinations include 18/18 mm, 25/18 mm, 30/30 mm, 35/25 mm combinations. The delivery sheath sizes range from 6F to 12F. In cases with large ASDs where positioning the ASO device may be difficult, a Hausdorf sheath may facilitate deployment. The most serious risk would be device erosion, which is associated with oversizing the device or rim deficiency. It is unclear what the actual device erosion rate is; there are 240 cases reported with an estimated worldwide implant rate of 240,000 devices (0.1%) but is also estimated at 0.2%–0.5%.9,10 The mechanism is thought to be due to friction between the left atrial disk wire mesh and the aortic or atrial wall. TTE may detect the aorto–atrial fistula or pericardial effusion but the event is so rare that it is not clear if routine TTE surveillance is worthwhile. Surgical removal of the device and patch closure of the defect is reported. The FDA has required the manufacturer to undertake a prospective study to better understand the ASO performance and the potential to develop erosions.2

Bottom Line: Complications reported in the literature include thrombus formation, air embolization, device embolization, erosions, residual shunts, and nickel hypersensitivity.Modern devices have intermediate to long term data with outcomes that have been favorable.In this review, commonly used devices and deployment procedures are discussed together with a look at devices that show promise for the future.

View Article: PubMed Central - PubMed

Affiliation: Department of Cardiology, The Epworth Hospital, Melbourne, VIC, Australia ; Division of Interventional Cardiology, The Alfred Hospital, Melbourne, VIC, Australia ; Department of Clinical Science, Charles Sturt University Albury Campus, NSW, Australia ; Heart Foundation, Griffith University, QLD, Australia.

ABSTRACT
In the last decade, percutaneous atrial septal defect (ASD) closure has become the treatment of choice in most clinical presentations of ASD. Percutaneous ASD closure has established procedural safety through operator experience and improved device structure and deliverability. There have also been advances in diagnostic capabilities. Devices have evolved from large bulky meshes to repositionable, minimal residual mesh content that easily endothelializes and conforms well to surrounding structures. Biodegradable technology has been introduced and will be closely watched as a future option. The evolution of ASD closure device usage in the last four decades incorporates development that minimizes a wide range of serious side effects that have been reported over the years. Complications reported in the literature include thrombus formation, air embolization, device embolization, erosions, residual shunts, and nickel hypersensitivity. Modern devices have intermediate to long term data with outcomes that have been favorable. Devices are available in multiple sizes with improved delivery mechanisms to recapture, reposition, and safely close simple and complex ASDs amenable to percutaneous closure. In this review, commonly used devices and deployment procedures are discussed together with a look at devices that show promise for the future.

No MeSH data available.


Related in: MedlinePlus