TY - JOUR
T1 - Complications and failure modes of coronary embolic protection devices
T2 - Insights from the MAUDE database
AU - Megaly, Michael
AU - Morcos, Ramez
AU - Khalil, Charl
AU - Garcia, Santiago
AU - Basir, Mir
AU - Maini, Brijeshwar
AU - Khalili, Houman
AU - Burke, M. Nicholas
AU - Alaswad, Khaldoon
AU - Brilakis, Emmanouil S.
N1 - Funding Information:
Khaldoon Alaswad: consulting/speaker honoraria from Boston Scientific, Cardiovascular Systems Inc, Abbott Vascular, Teleflex. Mir Basir: Consulting/Speaker Abbott Vascular, Abiomed, Cardiovascular Systems, Chiesi, Zoll. Emmanouil Brilakis: consulting/speaker honoraria from Abbott Vascular, American Heart Association (associate editor Circulation), Amgen, Biotronik, Boston Scientific, Cardiovascular Innovations Foundation (Board of Directors), ControlRad, CSI, Ebix, Elsevier, GE Healthcare, InfraRedx, Medtronic, Siemens, and Teleflex; research support from Regeneron and Siemens; owner, Hippocrates LLC; shareholder: MHI Ventures. All other authors have nothing to disclose.
Publisher Copyright:
© 2021 Wiley Periodicals LLC.
PY - 2022/2/1
Y1 - 2022/2/1
N2 - Background: There is limited data on complications associated with the use of coronary embolic protection devices (EPDs). Methods: We queried the Manufacturer and User Facility Device Experience database between November 2010 and November 2020 for reports on coronary EPDs: Spider FX (Medtronic, Minneapolis, MN) and Filterwire EZ (Boston Scientific, Natick, MA). Results: We retrieved 119 reports on coronary EPD failure (Spider FX n = 33 and Filterwire EZ n = 86), most of which (78.2%) occurred during saphenous vein graft interventions. The most common failure mode was inability to retrieve the EPD (49.6%), with the filter trapped against stent struts in 76.2% of the cases. Other device complications included filter fracture (28.6%), failure to cross (7.6%), failure to deploy (7.6%), and failure to recapture the filter (3.4%). Filter fracture (54.5 vs. 29.1%) and failure to recapture (9.1 vs. 2.1%) were more commonly reported, while failure to deploy the filter (0 vs. 10.5%) was less commonly reported with the Spider-FX. Conclusions: The most common modes of failure of coronary EPDs are the failure of retrieval (49.6%), followed by the filter fracture (28.6%). When using EPDs, careful attention to the technique is essential to avoid failures and subsequent complications.
AB - Background: There is limited data on complications associated with the use of coronary embolic protection devices (EPDs). Methods: We queried the Manufacturer and User Facility Device Experience database between November 2010 and November 2020 for reports on coronary EPDs: Spider FX (Medtronic, Minneapolis, MN) and Filterwire EZ (Boston Scientific, Natick, MA). Results: We retrieved 119 reports on coronary EPD failure (Spider FX n = 33 and Filterwire EZ n = 86), most of which (78.2%) occurred during saphenous vein graft interventions. The most common failure mode was inability to retrieve the EPD (49.6%), with the filter trapped against stent struts in 76.2% of the cases. Other device complications included filter fracture (28.6%), failure to cross (7.6%), failure to deploy (7.6%), and failure to recapture the filter (3.4%). Filter fracture (54.5 vs. 29.1%) and failure to recapture (9.1 vs. 2.1%) were more commonly reported, while failure to deploy the filter (0 vs. 10.5%) was less commonly reported with the Spider-FX. Conclusions: The most common modes of failure of coronary EPDs are the failure of retrieval (49.6%), followed by the filter fracture (28.6%). When using EPDs, careful attention to the technique is essential to avoid failures and subsequent complications.
KW - Filterwire EZ
KW - Spider FX
KW - embolic protection devices
KW - filters
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U2 - 10.1002/ccd.29717
DO - 10.1002/ccd.29717
M3 - Article
C2 - 33876860
AN - SCOPUS:85104738095
SN - 1522-1946
VL - 99
SP - 405
EP - 410
JO - Catheterization and Cardiovascular Interventions
JF - Catheterization and Cardiovascular Interventions
IS - 2
ER -