The Official Journal of EuroPCR and the European Association of Percutaneous Coronary Interventions (EAPCI)

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

DOI: 10.4244/EIJ-D-19-00295

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
Disclaimer:

As a public service to our readership, this article - peer reviewed by the Editors of EuroIntervention - has been published immediately upon acceptance as it was received. The content of this article is the sole responsibility of the authors, and not that of the journal or its publishers.

To read the full content of this article, please log in to download the PDF.

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.

Sign in to read and download the full article

Forgot your password?
No account yet? Sign up for free!
Create my pcr account

Join us for free and access thousands of articles from EuroIntervention, as well as presentations, videos, cases from PCRonline.com

Read next article

Intracoronary polarimetry of a honeycomb-like structure