Dr. Brock Cookman describes this real-world case to demonstrate the importance of imaging to determine strategy and treatment in complex scenarios and how the unique dual-action mechanism of action (MOA) of the Diamondback 360® Coronary Orbital Atherectomy System sands superficial and fractures deep calcium.
A 77-year-old male patient presented with chest pain and associated radiation to the left arm with exertion concerning for unstable angina. He had a stress test concerning for inferior ischemia and underwent cardiac catheterization. He underwent PCI of the RCA as the culprit vessel for his unstable angina; however, he was found to have significant calcified stenosis of the LAD/Diagonal.
Physiologic assessment in the form of RFR was hemodynamically significant in the LAD distribution at 0.87. RFR of the diagonal was not hemodynamically significant. He was scheduled for staged intervention of the LAD with intravascular imaging and potential atherectomy. Intravascular imaging of the LAD showed a heavily calcified stenosis; the arc of calcium was greater than 180º, thickness greater than 0.5 mm and a length of calcium greater than 5 mm.
Based on the OCT-based calcium scoring system, this patient would score 4 out of 4 points. Without appropriate calcium modification, there is significant concern for stent under expansion and ultimately poor long-term outcomes.
Orbital atherectomy was performed of the LAD with appropriate lesion modification. There was evidence of calcium modification/fracturing on the post-atherectomy images. Post-OCT guided PCI showed greater than 90% stent expansion without evidence of proximal or distal edge dissection.
Due to plaque shifting into the diagonal, PCI was performed with a stent into the diagonal as well with final kissing balloon inflations.
Indications Statement: The Diamondback 360® Coronary Orbital Atherectomy System (OAS) is a percutaneous orbital atherectomy system indicated to facilitate stent delivery in patients with coronary artery disease (CAD) who are acceptable candidates for PTCA or stenting due to de novo, severely calcified coronary artery lesions.
Contraindications: The OAS is contraindicated when the ViperWire Advance® Coronary Guide Wire cannot pass across the coronary lesion or the target lesion is within a bypass graft or stent. The OAS is contraindicated when the patient is not an appropriate candidate for bypass surgery, angioplasty, or atherectomy therapy, or has angiographic evidence of thrombus, or has only one open vessel, or has angiographic evidence of significant dissection at the treatment site and for women who are pregnant or children.
Warnings/Precautions: Performing treatment in excessively tortuous vessels or bifurcations may result in vessel damage; The OAS was only evaluated in severely calcified lesions, A temporary pacing lead may be necessary when treating lesions in the right coronary and circumflex arteries; On-site surgical back-up should be included as a clinical consideration; Use in patients with an ejection fraction (EF) of less than 25% has not been evaluated.
See the instructions for use before performing Diamondback 360 Coronary Orbital Atherectomy System procedures for detailed information regarding the procedure, indications, contraindications, warnings, precautions, and potential adverse events.
Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.
Case study and images courtesy of Dr. Cookman.
Results may vary.
Suggestions on case studies offered by the physician are based on their experience using the Diamondback® Orbital Atherectomy System and are their opinion. Medical decisions for your patients are to be based upon their condition and your medical judgment. CSI does not recommend or endorse any particular course of treatment or medical choice. Before using any medical device, including those demonstrated or referenced in this case study, review all relevant Instructions for Use, with particular attention to the indications, contraindications, warnings and precautions, and steps for use of the device.
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