Overview
Dr. Ramesh Daggubati used orbital atherectomy in the treatment of a multi-vessel disease percutaneous coronary intervention (PCI).
Dr. Ramesh Daggubati used orbital atherectomy in the treatment of a multi-vessel disease percutaneous coronary intervention (PCI).
A 60-year-old African American male smoker was referred for a percutaneous coronary intervention (PCI) of severely calcified lesions in the mid left anterior descending (mLAD) and ramus intermedius coronary arteries. The patient was deemed to be high risk for bypass surgery due to COPD, low ejection fraction (30%) and current dialysis treatment, but was an appropriate candidate for atherectomy. Medical history included hypertension, multi-vessel coronary artery disease, and decompensated heart failure requiring multiple hospital admissions.
The patient presented with unstable angina at an outlying hospital where a cardiac catheterization revealed 80% stenosed mLAD and 70% stenosed ostial ramus intermedius lesions. Severe calcification was noted in both via angiography.
The patient’s Syntax score was 15.
Right common femoral arterial access was obtained, and a ventricular assist system was inserted and provided cardiac output support throughout the procedure. For the PCI, arterial access was achieved through the right radial artery and a 6 Fr Extra Back-Up (EBU) guide catheter was used to engage the left main artery.
The Diamondback 360® Coronary Orbital Atherectomy System (OAS) 1.25 mm Classic Crown was inserted and advanced to the LAD lesions. Two separate LAD lesions were treated, a proximal and distal segment. The proximal segment was treated with four OAS runs on low speed (80,000 rpm) while the distal segment was treated with three OAS runs on low speed, and the Diamondback® crown was then removed. Post orbital atherectomy, the lesions were further treated with a 2.5 mm x 12 mm balloon dilatation catheter, which presented with no waisting. Balloon angioplasty was followed by successful delivery and deployment of a 3.0 mm x 38 mm drug-eluting coronary stent at 12 atm to the mLAD. Additional balloon inflations at 14 atm, were performed, and the stent expanded with ease. A second drug eluting stent – 3.0 mm x 12 mm – was delivered proximal to the initial stent, with slight overlap, deployed at 14 atm to cover the entire lesion and treated area.
Treatment of the lesion in the ostial ramus intermedius coronary artery followed. A frontline guide wire was delivered into the distal vessel, and a 1.2 mm x 6 mm over-the-wire balloon was inserted. An exchange to the ViperWire Advance® followed. OAS treatment consisted of four runs on low speed. Post OAS, a frontline guide wire was re-inserted into the LAD for an angiographic marker to ensure optimal coverage of the ostium of the ramus intermedius. A 3.0 mm x 8 mm drug-eluting stent was inserted and deployed at 14 atm. No complications were noted during the procedure. Total procedure time was two hours, one minute including ventricular assist system implant and explant. Total contrast use was 140 ml and total fluoroscopy time was 37.3 minutes.
In summary, successful orbital atherectomy, PTCA and stenting of the mLAD and ramus intermedius was performed in this complex procedure.
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.
*Based on minimum reference vessel diameter as determined by orbit testing in a carbon block model system.
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.