Patient Selection and Procedural Considerations for Coronary Orbital Atherectomy System

Abstract

CoronaryFrom the early days of percutaneous coronary intervention (PCI) it became apparent that the presence of severe coronary calcification was a predictor of worse clinical outcomes. In the era of plain old balloon angioplasty, severe coronary calcification was associated with an increased risk of coronary dissection and procedural failure, while in the bare-metal stent era, it was associated with a higher incidence of in-stent restenosis and target lesions revascularisations (TLRs).1,2 The advent of drug-eluting stents (DES) changed the landscape of coronary intervention through the reduced risk of restenosis and TLR, thereby allowing the interventional treatment of complex lesions and high-risk patients.However, a recent patient-level pooled analysis from seven contemporary stent trials revealed that patients with severely calcified lesions still have worse clinical outcomes compared with those without severe coronary calcification.3 Patients with severe lesion calcification were less likely to have undergone complete revascularisation, resulting in a higher residual Syntax score, which is a powerful determinant of prognosis. The latest ACCF/AHA/SCAI and ESC/EACTS PCI guidelines and European expert consensus on rotational atherectomy state that rotational atherectomy has a limited role in facilitating the dilation or stenting of lesions that cannot be crossed or expanded with PCI. 7-12Rotational atherectomy should not be performed routinely for de novo lesions or in-stent restenosis. The purpose of this review is to provide insights for procedural considerations and patient selection from the currently available publications assessing the OAS. Diamondback 360 ® Coronary Orbital Atherectomy SystemThe Diamondback 360 ® Coronary OAS is the device to facilitate stent delivery in patients who are acceptable candidates for PCI due to de novo, severely calcified coronary artery lesions (see Figure 1).The Diamondback 360 ® Coronary OAS is the device to facilitate stent delivery in patients who are acceptable candidates for PCI due to AbstractDespite advances in technology, percutaneous coronary intervention (PCI) of severely calcified coronary lesions remains challenging.Rotational atherectomy is one of the current therapeutic options to manage calcified lesions, but has a limited role in facilitating the dilation or stenting of lesions that cannot be crossed or expanded with other PCI techniques due to unfavourable clinical outcome in long-term follow-up. However the results of orbital atherectomy presented in the ORBIT I and ORBIT II trials were encouraging. In addition to these encouraging data, necessity for sufficient lesion preparation before implantation of bioresorbable scaffolds lead to resurgence in the use of atherectomy. This article summarises currently available publications on orbital atherectomy (Cardiovascular Systems Inc.) and compares them with rotational atherectomy. KeywordsOrbital atherectomy system, percutaneous coronary intervention, severely calcified lesion

Orbital atherectomy for the treatment of severely calcified coronary lesions: evidence, technique, and best practices

“…A comparison of these atherectomy devices with regard to mechanism of action, clinical indication, and technical features is shown in Table 2. In-depth review articles comparing these devices and corresponding clinical data were recently published [1,6,[35][36][37]. We present here a detailed review of orbital atherectomy trials/ studies, technique, and best practices.…”

“…Continual flow allows plaque debris to be continuously washed away in the blood stream and may decrease ischemia and distal embolization. In carbon block testing, the average particle size created by OAS is 2.04 μm; 98.3% of particles are smaller than the diameter of a red blood cell; and 99.2% of particles are smaller than the diameter of a capillary [37]. The combination of these features unique to OAS may lead to improved perfusion of the distal circulation, particularly during lesion treatment when the risk of embolization is highest.…”

“…Slow and steady advancement at 1 mm/s traverse rate results in significantly larger luminal gain as compared to 10 mm/s traverse rate (Figure 4) in the same number of passes. Advancing the travel knob slowly can increase the radius of orbit and allow time to potentially create fractures within the calcium [37]. Rapid advancement (>10 mm/s) may increase the risk for dissections and perforations with reduced treatment effect.…”

Use of rotablation to rescue a “fractured” micro catheter tip: A case report

“…In patient-level pooled analysis from seven contemporary trials, coronary calcification was associated with 33% increase in mortality rate irrespective of the Syntax score[4]. While this could be attributed to the residual and untreated coronary artery disease, coronary calcification is also considered as marker of more advanced and atherosclerotic disease making those patients at higher risk prior to any coronary intervention[5,6]. Regardless of the mechanism, heavily calcified segments may render coronary stenoses undilatable with conventional balloon angioplasty thus compromising optimal stent deployment.…”

Use of the orbital atherectomy system backed up with the guide-extension catheter for a severely tortuous calcified coronary lesion

“…Diamondback 360 ® Coronary Orbital Atherectomy System (OAS) (Cardiovascular Systems Inc.) has only one crown of a small size (1.25 mm), so it is easy to deliver and has a dual mechanism of action, which is different from that of rotational atherectomy (RA) (Rotalink Plus TM , Boston Scientific, Natic, MA, USA). 2 We present a case wherein a severe calcified coronary lesion with proximal vessel tortuosity was successfully treated using OAS with the backup of a guide-extension (GE) catheter.…”