Abstract
BackgroundOrbital atherectomy (OA) is a known alternative to other atherectomy devices. However, some complex patient demographics (eg, left ventricular ejection fraction <25%) were excluded from the first‐in‐human trial (ORBIT I) and the pivotal FDA device approval trial (ORBIT II) which evaluated the safety and efficacy of OA in severely calcified de novo coronary lesions. This single‐operator cohort study aimed to examine the impact of OA on a real‐world complex Veterans Affairs patient subset.MethodsRetrospective analysis was completed on 40 consecutive patients with severely calcified coronary lesions who underwent OA prior to drug‐eluting stent placement at the Atlanta Veterans Affairs Medical Center from January 2015 to June 2017.ResultsOrbital atherectomy plus drug‐eluting stent placement was successful in all 40 cases. Chocolate focal force balloon angioplasty was the most commonly used post‐atherectomy balloon (N = 34, 85%). Few complications were observed, including one case (2.5%) of perforation and one case (2.5%) of no‐reflow. Neither acute stent thrombosis nor emergent coronary artery bypass grafting was observed. The intravascular ultrasound (IVUS)‐determined median [IQR] pre‐procedure minimum lumen area and post‐procedure minimum stent area (MSA) were 2.8 [2.2, 3.0] mm2 and 8.7 [7.7, 10.0] mm2, respectively (P < 0.0001, Mann‐Whitney test). Major adverse cardiovascular events, including all‐cause mortality, at 30 days and at a median [IQR] follow‐up of 197.5 [35.5, 461.3] days, was 5% and 10%, respectively. During that period, one target vessel revascularization (2.5%) was observed.ConclusionsThis study indicates that OA is a useful tool in performing high‐risk percutaneous coronary intervention effectively in VA patients with severely calcified coronary lesions. OA plaque modification in combination with a high utilization rate of IVUS and Chocolate focal force angioplasty facilitates stent delivery and optimal stent expansion, resulting in a large MSA.
Highlights
A steadfast antagonist to the interventional cardiologist, dense coronary calcifications of atheromatous plaque provide a major hindrance to successful revascularization
We present here the acute procedural, 30‐day, and 6.5‐month median follow‐up outcomes
This single‐center retrospective analysis of a Veterans Affairs cohort with severe coronary artery calcification revealed high efficacy and safety rates despite the complex disease state noted in these patients
Summary
A steadfast antagonist to the interventional cardiologist, dense coronary calcifications of atheromatous plaque provide a major hindrance to successful revascularization. Examples include increased risk of in‐stent restenosis or stent thrombosis with asymmetric stent expansion,[2,3,4,5] while aggressive balloon dilation in noncompliant anatomy can result in coronary dissection.[6] pretreatment interventions focus on decreasing the degree of calcifications to facilitate adequate angioplasty. The Diamondback 360 coronary orbital atherectomy (OA) system [CSI], St Paul, MN) is a proven asset as an alternative to rotational atherectomy (RA) for the treatment of these heavily calcified coronary lesions.[7,8,9,10,11] The purpose of this study was to retrospectively analyze the safety and effectiveness of OA for the treatment of high‐risk VA patients with severely calcified coronary lesions. We present here the acute procedural, 30‐day, and 6.5‐month median follow‐up outcomes
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