Adverse events with orbital atherectomy: an analytic review of the MAUDE database

Introduction

Coronary artery calcification (CAC) poses a challenge for successful percutaneous coronary intervention. CAC is associated with worse periprocedural and long-term clinical outcomes because of difficult device delivery and inadequate stent expansion. Atherectomy can effectively ablate and modify calcified plaques, optimising procedural outcomes. The Diamondback 360® Coronary Orbital Atherectomy System (Cardiovascular Systems, Inc., St. Paul, MN, USA) is indicated for lesion preparation of de novo severely calcified coronary lesions before stent implantation. Orbital atherectomy (OA) employs an eccentrically mounted 1.25 mm diamond-coated crown that utilises centrifugal force to orbit at either 80,000 or 120,000 rpm. OA has a unique bidirectional mechanism ...