Long-term safety and performance of the orbital atherectomy system for treating calcified coronary artery lesions: 5-Year follow-up in the ORBIT I trial

Bhatt, Parloop; Parikh, Parth; Patel, Apurva; Chag, Milan; Chandarana, Anish; Parikh, Roosha; Parikh, Keyur

doi:10.1016/j.carrev.2015.03.007

Cited by 32 publications

(32 citation statements)

References 31 publications

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“…Similarly, abrupt closure occurred in Table 4. Univariate analysis of factors influencing the incidence of major adverse cardiac events (MACE) and major cardiac and cerebrovascular events (MACCE) after rotational atherectomy procedure CABG -coronary artery bypass grafting; CI -confidence interval; COPD -chronic obstructive pulmonary disease; DAPT -dual antiplatelet therapy; GFR -glomerular filtration rate; HR -hazard ratio; IVUs -intravascular ultrasound; LVEF -left ventricular ejection fraction; OACoral anticoagulation; PCI -percutaneous coronary intervention; RCA -right coronary artery; TIA -transient ischaemic attack 0.9% of individuals after the use of OA, and in 1.8%, after the procedure, compared with rates from 1% to 4% from other studies that reported abrupt closure during RA [11,12]. Perforations occurred in 0.9% of patients after the use of OA and in 1.8% after the procedure, compared with 0.4% to 2.5% in RA studies reporting on this complication [15].…”

Section: Discussionmentioning

confidence: 94%

“…Treatment of challenging calcified lesions often leads to increased MACE rates. The ORBIT II trial reported the successful stent delivery in 97.7% of the included patients and residual stenosis < 50% in 98.6% with a low angiographic complication rate [11,12]. The incidence of slow-flow and no-reflow was notably very low, occurring in < 1% of patients.…”

Section: Discussionmentioning

confidence: 99%

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Long-term effects of rotational atherectomy in patients with heavy calcified coronary artery lesions: a single-centre experience

Bartuś¹,

Januszek

Legutko³

et al. 2017

Kardiol Pol

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A b s t r a c tBackground: Rotational atherectomy (RA) plays a significant role in contemporary percutaneous coronary interventions (PCI), especially in the era of population aging and expansion of PCI indications. Aim:The aim of the current study was to evaluate the rate of periprocedural complications, the long-term effectiveness of RA, and potential factors influencing the incidence of major adverse cardiac events (MACE) and major cardiac as well as cerebrovascular events (MACCE) after RA. Methods:The study included 60 consecutive patients who underwent effective RA between January 2002 and May 2016. Patients were followed-up for 2,616 days for MACE and MACCE. Results:The mean age of the enrolled patients was 72.1 years, and 78.3% were males. The mean follow-up period lasted 835.3 ± 611.8 days. Periprocedural complications occurred in 12 (20.0%) patients. In the follow-up of up to 2,616 days, 64% of patients were free of MACCE and 68% were free of MACE. Univariate Cox analysis revealed that MACCE occurred more often in patients from the high-risk group based on the EuroSCORE II and those with longer lengths of the implanted stent(s) after the RA procedure. In multivariate Cox regression analysis, both high-risk category and mean stent(s) length were identified as independent predictors of MACCE. EuroSCORE II was confirmed to be the only independent predictor of MACE after RA. Conclusions:Rotational atherectomy is a safe and sufficient technique for the endovascular treatment of heavily calcified coronary artery lesions. Individuals at a higher risk as assessed by the EuroSCORE II before RA and those with longer stent(s) implanted after RA are predisposed to MACCE in the follow-up.

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Section: Discussionmentioning

confidence: 94%

Section: Discussionmentioning

confidence: 99%

Long-term effects of rotational atherectomy in patients with heavy calcified coronary artery lesions: a single-centre experience

Bartuś¹,

Januszek

Legutko³

et al. 2017

Kardiol Pol

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“…Of the 33 subjects, the observed MACE rate at 2 years was 15 % (5/33), 3 years was 18 % (6/33) and 5 years 21 % (7/33). 23,24 The ORBIT II trial was a prospective, single-arm multicentre, non-blinded clinical trial that enrolled 443 consecutive patients with severely calcified vessel revascularisation (0.7 %) were reported. The incidence of slow flow or no reflow in the rotational atherectomy has been reported to be 6 % to 15 %, 25,26 whereas in the ORBIT II trial the rate of persistent slow flow/no reflow for orbital atherectomy were notably very low, occurring in 0.9 % of patients.…”

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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“…Recent studies have suggested that early phase neointimal hypertrophy is in part due to calcification. These lesions are more robust and may contribute to stent under expansion if treated with balloon angioplasty alone [1, 2]. The management of ISR is complex, with a few treatment modalities recognized other than the balloon angioplasty and further stent placement.…”

Section: Introductionmentioning

confidence: 99%

“…Unfortunately, implementation of these techniques can be ineffective in the presence of heavily calcified lesions. Calcified lesions are challenging as they can be associated with increased rates of stent restenosis due to being under expansion and poor apposition, which predispose to luminal loss and worse clinical outcome [1, 3]. OAS was recently introduced to the US market for the management of heavily calcified coronary lesions.…”

Section: Introductionmentioning

confidence: 99%

Novel Use of an Orbital Atherectomy Device for In-Stent Restenosis: Lessons Learned

Shaikh

Kelly

Gedela

et al. 2016

Case Reports in Cardiology

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We present a case of a 67-year-old man with stage III chronic kidney disease, uncontrolled diabetes mellitus, coronary artery disease, and high surgical risk who presented with two episodes of acute coronary syndrome attributed to in-stent restenosis (ISR) associated with heavily calcified lesions. In this case, we were able to improve luminal patency with orbital atherectomy system (OAS); however, withdrawal of the device resulted in a device/stent interaction, causing failure of the device. Given limitations in current evidence and therapies, managing ISR can be a technical and cognitive challenge. Balloon expansion of the affected region often provides unsatisfactory results, possibly related to significant calcium burden. OAS could be an efficacious way of reestablishing luminal patency in ISR lesions, as these lesions are often heavily calcified.

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Long-term safety and performance of the orbital atherectomy system for treating calcified coronary artery lesions: 5-Year follow-up in the ORBIT I trial

Abstract: The ORBIT I trial suggests that OAS treatment continues to offer a safe and effective method to change compliance of calcified coronary lesions to facilitate optimal stent placement in these difficult-to-treat patients.

Cited by 32 publications

References 31 publications

Long-term effects of rotational atherectomy in patients with heavy calcified coronary artery lesions: a single-centre experience

Long-term effects of rotational atherectomy in patients with heavy calcified coronary artery lesions: a single-centre experience

Patient Selection and Procedural Considerations for Coronary Orbital Atherectomy System

Novel Use of an Orbital Atherectomy Device for In-Stent Restenosis: Lessons Learned

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