Adverse Events Related to Orbital Atherectomy: Lessons Learned from an Analytic Review of the MAUDE Database

DOI: 10.4244/EIJ-D-19-00295

Nauman Khalid1; Hasan Javed2; Toby Rogers3; Hayder Hashim4; Evan Shlofmitz5; Jason P. Wermers6; Yuefeng Chen7; Anees Musallam8; Jaffar M. Khan9; Rebecca Torguson10; Nelson L. Bernardo11; Ron Waksman12;

1. Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC
2. Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC
3. Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC. Cardiovascular Branch, Division of Intramural Research, National Heart, Lung, and Blood Institute National Institutes of Health, Bethesda, MD
4. Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC
5. Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC
6. Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC
7. Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC
8. Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC
9. Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC
10. Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC
11. Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC
12. Section of Interventional Cardiology, MedStar Washington Hospital Centre, Washington, DC, United States

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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, optimizing procedural outcomes. The Diamondback 360® Coronary Orbital Atherectomy System (Cardiovascular Systems, Inc., St. Paul, Minnesota, 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 utilizes centrifugal force to orbit at either 80,000 or 120,000 rpm. OA has a unique bidirectional mechanism and allows continuous antegrade flow during atherectomy. Robust data on the most commonly reported complications and failure modes associated with OA are limited. We analysed the post-marketing surveillance data from the US Food and Drug Administration Manufacturer and User Facility Device Experience (MAUDE) database to report these endpoints.

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calcified stenosisdrug-eluting stentartherectomy

Coronary interventionsOther coronary interventions

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