Safety and feasibility of orbital atherectomy for the treatment of calcified coronary lesions

Parikh, Keyur; Chandra, Praveen; Choksi, Nishit; Khanna, Puneet; Chambers, Jeffrey W.

doi:10.1002/ccd.24700

Cited by 125 publications

(79 citation statements)

References 16 publications

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“…The Diamondback 360 Coronary OAS uses a differential sanding mechanism of action to remove plaque while potentially minimizing damage to the medial layer of the vessel. A drive shaft with an eccentrically mounted diamond-coated crown provides proximal and distal sanding to remove or reduce occlusive material and restore luminal patency (FIGURE 1C) [51]. The crown's orbital diameter expands radially via centrifugal force.…”

Section: Diamondback 360 Coronary Oasmentioning

confidence: 99%

“…The first in man assessment of coronary orbital atherectomy to treat de novo calcified coronary lesions occurred during the ORBIT I clinical trial [51]. Fifty patients with de novo calcified coronary lesions were enrolled in this nonrandomized, multicenter trial in India.…”

Section: Clinical Studies Utilizing Orbital Atherectomy: Orbit I and Ormentioning

confidence: 99%

“…Six dissections (Types A-C) without clinical sequelae and one perforation were reported; however, there was no incidence of slow flow or distal embolization. In contrast to previous PCI trials, ORBIT I reported low rates of MACE (6% at 30 days and 8% at 6 months) [51]. Long-term follow-up was collected on a single-center subset of ORBIT I subjects enrolled at CIMS Hospital Pvt.…”

Section: Clinical Studies Utilizing Orbital Atherectomy: Orbit I and Ormentioning

confidence: 99%

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Evaluation of the Diamondback 360 Coronary Orbital Atherectomy System for treatingde novo, severely calcified lesions

Chambers

Diage

2014

Expert Review of Medical Devices

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Section: Diamondback 360 Coronary Oasmentioning

confidence: 99%

Section: Clinical Studies Utilizing Orbital Atherectomy: Orbit I and Ormentioning

confidence: 99%

Section: Clinical Studies Utilizing Orbital Atherectomy: Orbit I and Ormentioning

confidence: 99%

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Evaluation of the Diamondback 360 Coronary Orbital Atherectomy System for treatingde novo, severely calcified lesions

Chambers

Diage

2014

Expert Review of Medical Devices

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“…RA showed favourable results in treating HCCL in recent registries; however, there are no randomised trials concerning the use of RA in patients with severe TLC and AMI [20][21][22]. OA, a newcomer to coronary interventions, was first introduced in coronary arteries in 2013 in the ORBIT I trial [23]. Recent studies showed promising results of OA in hospital as well as in long-term follow-up [24,25].…”

Section: Discussionmentioning

confidence: 99%

Patients with acute myocardial infarction and severe target lesion calcifications undergoing percutaneous coronary intervention have poor long-term prognosis

Zimoch

Kübler²,

Kosowski³

et al. 2017

Kardiol Pol

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A b s t r a c t Background:To assess the influence of severe target lesion calcification (TLC) on the outcomes of patients undergoing percutaneous coronary interventions (PCI) due to acute myocardial infarction (AMI).Aim: Contemporary data concerning coronary artery calcifications (CAC) are based on pooled analyses from randomised trials with short follow-up. We still lack the knowledge on how CAC in target lesions affect long-term prognosis of patients with AMI in everyday practice. Methods:We evaluated clinical and laboratory data of 206 consecutive patients who underwent coronary angiography and PCI due to AMI. Primary endpoints were all-cause death and recurrent hospitalisations due to acute coronary syndrome (ACS). Results:Severe TLC lesions were present in 17% of patients. These patients were older (71 vs. 65 years, p = 0.02) and more often diagnosed with non-ST segment elevation myocardial infarction (77% vs. 58%, p = 0.03). Patients with severe TLC had lower rates of PCI success (80% vs. 97%, p < 0.0001) and less often achieved full revascularisation during index procedure (14% vs. 41%, p = 0.003). During 30 months follow-up patients with severe TLC more often suffered from another ACS (37% vs. 13%, p = 0.0005) and had higher all-cause mortality (31% vs. 16%, p = 0.04). Multivariate Cox regression model showed severe TLC to be an independent predictor of another ACS (HR 2.8; 95% CI 1.4-5.6; p = 0.004). Conclusions:Severe TLC are not uncommon in patients with ACS. The presence of severe TLC is a prognostic factor of another ACS in AMI patients undergoing PCI.

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“…22 Fifty patients with de novo calcified coronary lesions were enrolled in this non-randomised, multi-centre trial in India.…”

Section: Clinical Evaluation For Coronary Orbital Atherectomy Systemmentioning

confidence: 99%

Patient Selection and Procedural Considerations for Coronary Orbital Atherectomy System

Sotomi

Shlofmitz

Colombo

et al. 2016

Interventional Cardiology Review

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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

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Safety and feasibility of orbital atherectomy for the treatment of calcified coronary lesions

Cited by 125 publications

References 16 publications

Evaluation of the Diamondback 360 Coronary Orbital Atherectomy System for treatingde novo, severely calcified lesions

Evaluation of the Diamondback 360 Coronary Orbital Atherectomy System for treatingde novo, severely calcified lesions

Patients with acute myocardial infarction and severe target lesion calcifications undergoing percutaneous coronary intervention have poor long-term prognosis

Patient Selection and Procedural Considerations for Coronary Orbital Atherectomy System

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