Embolic Stroke Due to a Left Atrial Thrombus Two Years After Placement of an Atrial Septal Defect Closure Device

Raghu, Aarti; Kawalsky, Darryl; Feldman, Mark

doi:10.1016/j.amjcard.2006.05.067

Cited by 17 publications

(15 citation statements)

References 12 publications

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“…Only 1 such complication was found in 3 major studies (including 2 specifically aimed at detecting thrombosis rates), 9, 10, 11 and a report in 2006 claims to be first to report stroke from an Amplatzer device. 12 …”

Section: Results Of the Manufacturer And User Facility Device Experiementioning

confidence: 99%

Analysis of the US Food and Drug Administration Manufacturer and User Facility Device Experience database for adverse events involving Amplatzer septal occluder devices and comparison with the Society of Thoracic Surgery congenital cardiac surgery database

DiBardino

McElhinney

Kaza

et al. 2009

The Journal of Thoracic and Cardiovascular Surgery

171

136

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Objective Amplatzer (AGA Medical Corporation, Plymouth, Minn) septal and vascular occluder devices have significantly altered the care of patients with congenital heart disease. The relative frequency and consequence of complications resulting from the attempted placement of such devices, however, have not been well assessed. The purpose of this study is to use large databases to assess the frequency and severity of such complications and compare them with those of surgical atrial septal defect closure. Methods The US Food and Drug Administration Manufacturer and User Facility Device Experience database was quarried for all adverse events for Amplatzer septal occluder devices, which were categorized and analyzed with particular emphasis on management and outcome. The Society of Thoracic Surgery database was likewise quarried for the same data regarding atrial septal defect closures over a contemporaneous time period. By using a literature-derived denominator for total Amplatzer implant numbers, the results of the 2 therapies were compared. Results Since July 1, 2002, 223 adverse events in patients undergoing Amplatzer atrial septal defect closure were submitted to the Food and Drug Administration, resulting in 17 deaths (7.6%) and 152 surgical rescue operations (68.2%). Society of Thoracic Surgery data demonstrated 1537 primary operations with 2 deaths (0.13%) and 6 reoperations (0.39%). By extrapolating on published estimates of Amplatzer implantation to provide an implant denominator (n = 18,333), there was no difference between overall mortality for surgical (0.13%) and device closure (0.093%, P = .649). Rescue operation for device adverse events (0.83%) was 2.1 times more likely than reoperation for surgical closure (0.39%, P = .063). Mortality per adverse event was higher for device closure (7.6%) than for surgical closure (1.2%, P = .004), and the need for surgery per adverse event was higher for device closure (68.2%) than for surgical closure (3.6%, P < .001). The mortality for surgical management of a device adverse event (2.6%) was 20-fold higher than for primary elective atrial septal defect closure (0.13%, P < .0001). Conclusion Overall crude mortality for device and surgical closure atrial septal defect closure is equivalent, and the need for subsequent operation (surgical rescue) is more common in patients undergoing device closure than reoperation is in patients undergoing surgical closure. Complications from device closure tend to be serious and most often require urgent or emergency operative management, whereas the mortality for surgical management of a device complication appears higher than that of elective atrial septal defect closure. Further information is required in the form of postmarketing surveillance, such as a mandatory user registry with periodic end-user notification.

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Section: Results Of the Manufacturer And User Facility Device Experiementioning

confidence: 99%

Analysis of the US Food and Drug Administration Manufacturer and User Facility Device Experience database for adverse events involving Amplatzer septal occluder devices and comparison with the Society of Thoracic Surgery congenital cardiac surgery database

DiBardino

McElhinney

Kaza

et al. 2009

The Journal of Thoracic and Cardiovascular Surgery

171

136

View full text Add to dashboard Cite

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“…Thrombosis and embolism used to be the major problems in previous intracardiac shunt closure devices such as Cardioseal, Starflex, or Rashkind 6–9 . These complications have become relatively rare in patients using Amplatzer nitinol occluders, but not completely without such problems 10–13 . In the literature, most recorded thrombus formation occurred on interatrial devices and not those on VSD since its slower blood circulation in atrial chambers.…”

Section: Discussionmentioning

confidence: 99%

“…Thrombosis and embolism used to be one of the hazardous problems in previous intracardiac shunt closure devices such as Cardioseal, Starflex, or Rashkind 6–9 . However, such complications are relatively rare with the Amplatzer device, 7, 8 but still have been reported in some documents, especially in those of atrial septal defect cases 10–13 . The Amplatzer occluder has a fixed stainless steel pin bottom protruding out of the surface at the center of the discs on both sides.…”

Section: Introductionmentioning

confidence: 99%

A New Pan‐Nitinol Occluder for Transcatheter Closure of Ventricular Septal Defects in a Canine Model

Zhong-ru¹,

Qin²,

Hu³

et al. 2009

J Interven Cardiology

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“…The other recurrent event occurred in a patient with evidence of residual shunting after device closure and was likely due to embolism through the residual defect. Thrombus formation on the closure device may also occur and has been noted up to 5 years after a device implantation [23,24]. Thrombi appear to occur more often in patients after closure with a CardioSeal or a StarFLEX compared to the Amplatzer device [25,26].…”

Section: Closure Of the Asd2mentioning

confidence: 97%

“…A cardioembolic source has been shown to be the most frequent identifiable cause of a CIE in this young population, accounting for 13.3% to 24.0% of all strokes [5,6]. Paradoxical embolism, with migration of a thrombus from the venous to the arterial circulation, is a common source of emboli in patients with coexisting atrial communications.…”

Section: Introductionmentioning

confidence: 97%

Recurrence of cerebrovascular events in young adults with a secundum atrial septal defect

Lok

Winkens

Dimopoulos

et al. 2010

International Journal of Cardiology

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Embolic Stroke Due to a Left Atrial Thrombus Two Years After Placement of an Atrial Septal Defect Closure Device

Cited by 17 publications

References 12 publications

Analysis of the US Food and Drug Administration Manufacturer and User Facility Device Experience database for adverse events involving Amplatzer septal occluder devices and comparison with the Society of Thoracic Surgery congenital cardiac surgery database

Analysis of the US Food and Drug Administration Manufacturer and User Facility Device Experience database for adverse events involving Amplatzer septal occluder devices and comparison with the Society of Thoracic Surgery congenital cardiac surgery database

A New Pan‐Nitinol Occluder for Transcatheter Closure of Ventricular Septal Defects in a Canine Model

Recurrence of cerebrovascular events in young adults with a secundum atrial septal defect

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