B-13 | Impella Cardiac Perforation Events - A Report from FDA MAUDE Database

BackgroundImpella® device (Abiomed Inc., Danvers, MA, USA) is a non-pulsatile microaxial flow pump that continuously propels blood from the left ventricle (LV) to the ascending aorta to provide short-term mechanical circulatory support, for example in patients with cardiogenic shock. Although bleeding and vascular complications have been reported data on cardiac perforation are limited. We analyzed data from the Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database to investigate this complication.MethodsMAUDE database was searched for all entries from inception to December 2021 with the search term “impella perforation”. From the 273 Results filter was applied for the identifier code for Impella “OZD”. Entries were furthered searched manually to eliminate non-cardiac perforations, and incomplete entries. Frequency of events, cause and deaths were recorded.ResultsA total of 50 events of ventricular perforation related to Impella were reported between 2009 and 2021, 49 in LV and 1 in right ventricle. Most common cause of perforation was repositioning of device (n=12, 24%), followed by manipulation of heart during cardiac surgery (n=7, 14%) and guidewire-related (n=7, 14%). Friable necrotic tissue due to infarction was thought to be the underlying factor in 24% (n = 12) cases. Emergent surgical repair was done in 84% (n = 42) cases. Perforation led to death in 12 (24%) cases, while 16 patients (32%) survived; outcome was not reported for majority (n=21, 42%) of events. Thirty-one (62%) perforations were related to Impella CP while 11 (22%) were due to Impella 5.5. Highest number of events (n=16) were reported in year 2021.ConclusionsAlthough difficult to ascertain from this dataset Impella use increasing. Cardiac perforation is an extremely rare but serious complication of Impella related to device repositioning, manipulation of heart during surgery and guidewire. Necrotic tissue may be the underlying cause however careful handling of device as recommended by manufacturer is important to prevent complications.DisclosuresM. A. Sheikh Nothing to disclose. R. Patel Nothing to disclose. Y. Al-khadra Nothing to disclose. A. M. Hafiz Nothing to disclose. BackgroundImpella® device (Abiomed Inc., Danvers, MA, USA) is a non-pulsatile microaxial flow pump that continuously propels blood from the left ventricle (LV) to the ascending aorta to provide short-term mechanical circulatory support, for example in patients with cardiogenic shock. Although bleeding and vascular complications have been reported data on cardiac perforation are limited. We analyzed data from the Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database to investigate this complication. Impella® device (Abiomed Inc., Danvers, MA, USA) is a non-pulsatile microaxial flow pump that continuously propels blood from the left ventricle (LV) to the ascending aorta to provide short-term mechanical circulatory support, for example in patients with cardiogenic shock. Although bleeding and vascular complications have been reported data on cardiac perforation are limited. We analyzed data from the Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database to investigate this complication. MethodsMAUDE database was searched for all entries from inception to December 2021 with the search term “impella perforation”. From the 273 Results filter was applied for the identifier code for Impella “OZD”. Entries were furthered searched manually to eliminate non-cardiac perforations, and incomplete entries. Frequency of events, cause and deaths were recorded. MAUDE database was searched for all entries from inception to December 2021 with the search term “impella perforation”. From the 273 Results filter was applied for the identifier code for Impella “OZD”. Entries were furthered searched manually to eliminate non-cardiac perforations, and incomplete entries. Frequency of events, cause and deaths were recorded. ResultsA total of 50 events of ventricular perforation related to Impella were reported between 2009 and 2021, 49 in LV and 1 in right ventricle. Most common cause of perforation was repositioning of device (n=12, 24%), followed by manipulation of heart during cardiac surgery (n=7, 14%) and guidewire-related (n=7, 14%). Friable necrotic tissue due to infarction was thought to be the underlying factor in 24% (n = 12) cases. Emergent surgical repair was done in 84% (n = 42) cases. Perforation led to death in 12 (24%) cases, while 16 patients (32%) survived; outcome was not reported for majority (n=21, 42%) of events. Thirty-one (62%) perforations were related to Impella CP while 11 (22%) were due to Impella 5.5. Highest number of events (n=16) were reported in year 2021. A total of 50 events of ventricular perforation related to Impella were reported between 2009 and 2021, 49 in LV and 1 in right ventricle. Most common cause of perforation was repositioning of device (n=12, 24%), followed by manipulation of heart during cardiac surgery (n=7, 14%) and guidewire-related (n=7, 14%). Friable necrotic tissue due to infarction was thought to be the underlying factor in 24% (n = 12) cases. Emergent surgical repair was done in 84% (n = 42) cases. Perforation led to death in 12 (24%) cases, while 16 patients (32%) survived; outcome was not reported for majority (n=21, 42%) of events. Thirty-one (62%) perforations were related to Impella CP while 11 (22%) were due to Impella 5.5. Highest number of events (n=16) were reported in year 2021. ConclusionsAlthough difficult to ascertain from this dataset Impella use increasing. Cardiac perforation is an extremely rare but serious complication of Impella related to device repositioning, manipulation of heart during surgery and guidewire. Necrotic tissue may be the underlying cause however careful handling of device as recommended by manufacturer is important to prevent complications. Although difficult to ascertain from this dataset Impella use increasing. Cardiac perforation is an extremely rare but serious complication of Impella related to device repositioning, manipulation of heart during surgery and guidewire. Necrotic tissue may be the underlying cause however careful handling of device as recommended by manufacturer is important to prevent complications.