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Guidewire fracture during orbital atherectomy for peripheral artery disease: Insights from the Manufacturer and User Facility Device Experience database
Author(s) -
Isom Nicholas,
Masoomi Reza,
Thors Axel,
Bunte Matthew,
Prasad Anand,
Hance Kirk,
Gupta Kamal
Publication year - 2019
Publication title -
catheterization and cardiovascular interventions
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.988
H-Index - 116
eISSN - 1522-726X
pISSN - 1522-1946
DOI - 10.1002/ccd.27933
Subject(s) - medicine , atherectomy , arterial disease , percutaneous , surgery , radiology , peripheral , revascularization , complication , stent , vascular disease , cardiology , myocardial infarction , restenosis
Background/Objectives Orbital atherectomy (OA) is routinely being used for plaque modification to facilitate percutaneous revascularization in patients with peripheral arterial disease (PAD) and arterial calcification. Guidewire fracture (GWF) during OA, though anecdotally described, has not been studied in a systematic manner. We conducted a review of the Manufacturer and User Facility Device Experience (MAUDE) database to study the reports of wire fracture and its management and consequences. Methods We queried the MAUDE database for all events involving the current generation of the OA device: “Diamondback 360 Peripheral Orbital Atherectomy System”, and “Stealth 360° Orbital PAD System”. Results We identified 62 reports of GWF during OA for PAD. The superficial femoral artery was the most commonly involved atherectomy site. The wire fractured at the soft tip in a majority of cases (68%). Embolized wire fragments were left in the patient in 36 cases (58%), retrieved percutaneously in 10 cases (16%), and trapped by a stent against the arterial wall in eight cases (13%). Lastly, eight patients (13%) underwent surgery for removal of the wire fragment. Conclusions This is the first published report to study the complication of GWF during peripheral OA. GWF is an uncommon but has significant procedural and clinical consequences. It results in a high rate of ancillary rescue procedures (including surgery) and is associated with a higher risk of arterial thrombosis and complications from wire retrieval attempts. The risk of wire fracture may be avoided with carefully adherence to the IFU.