Initial experience with orbital atherectomy in a tertiary centre in the Netherlands

Area of Science:

• Cardiology
• Interventional Cardiology
• Medical Devices

Background:

• The Diamondback 360 orbital atherectomy (OA) system gained CE mark approval in Europe in January 2021.
• The first European procedure using OA was performed at the Thoraxcenter, Erasmus Medical Center, Rotterdam.

Purpose of the Study:

• To evaluate the procedural safety and efficacy of orbital atherectomy (OA) in its initial application.
• To assess the outcomes of OA in a tertiary care setting in the Netherlands.

Main Methods:

• A prospective single-centre registry included patients with de novo severely calcified coronary artery disease undergoing OA.
• Device success (<50% stenosis post-OA) and procedural success (<50% residual stenosis post-stenting) were primary endpoints.
• Calcium debulking effects were assessed via invasive imaging, with safety monitored for 30 days.

Main Results:

• Twenty-nine patients (39 coronary arteries) were treated between February and June 2021.
• Lesions were heavily calcified (mean length 32 mm, arc 320°).
• Superficial sanding (90%) and deeper medial calcium fracturing (63%) were observed, with 66% device success and 94% procedural success. No safety events occurred within 30 days.

Conclusions:

• Initial experience with OA for heavily calcified coronary lesions shows favorable plaque modification and debulking.
• The procedure demonstrated high procedural success and clinical safety in this cohort.
• Orbital atherectomy is a viable option for complex calcified coronary lesions.