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Severely calcified lesions present many challenges to PCI. Orbital Atherectomy System (OAS) is a device which allows for vessel preparation and treatment of severely calcified coronary lesions. This study evaluated clinical safety and results of the initial commercial experience of OAS in a real world setting.
A retrospective analysis was completed on all coronary OAS cases at our institutions that occurred between April 2014 thru August 31, 2015 (n=112). In-hospital and 30 day outcomes were assessed for procedure success, complications and device related events. Statistical analysis was performed using SPSS (IBM V.22).
Baseline and procedural characteristics are described in the table below. Perforation occurred in 0.9% (n=1), dissection occurred in 1.8% (n=2), and no-reflow phenomenon occurred in 0.9% of cases (n=1). There were no cases of bleeding complications, emergent bypass, 30-day MI, 30-day TVR, or stent thrombosis. 1 (0.9%) patient had a stroke within 30 days of PCI. Restenosis occurred in 3.6% of patients (n=4). 30 day mortality occurred in 1.8% of patients (n=2) due to non-cardiac causes from post-operative complications from non-cardiac surgery.
In this first report of the commercial experience with coronary OAS, procedure success, adverse events, and clinical outcomes were favorable. This data demonstrates the safety and effectiveness of OAS in treating severely calcified coronary artery disease.
|AgeGenderBody Weight||7462.5% Male79.4Kg|
|Current SmokerRenal Insufficiency (Cr>1.5)Dialysis Dependent||7.1%25.9%7.1%|
|Prior MIPrior PCIPrior CABG||20.5%37.5%18.8%|
|Presenting with MIPresenting with stable anginaPresenting with unstable angina||14.3%17.9%64.3%|
|Avg # of vessels treatedAvg # of stentsDirect stenting||1.41.925.9%|
|Intravascular imaging used||9.8%|
|Radial access siteTemporary pacemaker placedMechanical support used||17.9%8.9%16.1%|
|Contrast volume usedRadiation exposureMaximum inflation pressure||137 mL24.6 mins.19.7 ATM|