Dataset Information

Orbital atherectomy of calcified coronary ostial lesions.

ABSTRACT:

Objectives

To evaluate the feasibility and safety of coronary orbital atherectomy (OA) for the treatment of calcified ostial lesions.

Background

Percutaneous coronary intervention (PCI) is increasingly being completed in complex patients and lesions. OA is effective for severely calcified coronary lesions; however, there is a dearth of evidence on the use of OA in ostial lesions, especially with long-term outcome data.

Methods

Data were obtained from a retrospective analysis of patients who underwent OA of heavily calcified ostial lesions followed by stent implantation from December 2010 to June 2019 at two high-volume PCI centers. Kaplan-Meier analysis was utilized to assess the primary endpoints of 30-day, 1-year, and 2-year freedom-from (FF) major adverse cardiac events (MACE: death, myocardial infarction, or target vessel revascularization), stroke, and stent thrombosis (ST).

Results

A total of 56 patients underwent OA to treat heavily calcified ostial coronary lesions. The mean age was 72 years with a high prevalence of diabetes (55%) and heart failure (36%), requiring hemodynamic support (14%). There was high FF angiographic complications (93%), and at 30-day, 1-year, and 2-year, a high FF-MACE (96%, 91%, and 88%), stroke (98%, 96%, and 96%), and ST (100%), respectively.

Conclusions

This study represents the largest real-world experience of coronary OA use in heavily calcified ostial lesions with long-term outcomes over 2 years. The main finding in this retrospective analysis is that, despite the complex patients and lesions included in this analysis, OA appears to be a feasible and safe treatment option for calcified coronary ostial lesions.

SUBMITTER: Chambers JW

PROVIDER: S-EPMC9804932 | biostudies-literature | 2022 Oct

REPOSITORIES: biostudies-literature

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Publications

Orbital atherectomy of calcified coronary ostial lesions.

Chambers Jeffrey W JW Martinsen Brad J BJ Sturm Robert C RC Mandair Divneet D Valle Javier A JA Waldo Stephen W SW Guzzetta Francesca F Armstrong Ehrin J EJ

Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions 20220821 4

<h4>Objectives</h4>To evaluate the feasibility and safety of coronary orbital atherectomy (OA) for the treatment of calcified ostial lesions.<h4>Background</h4>Percutaneous coronary intervention (PCI) is increasingly being completed in complex patients and lesions. OA is effective for severely calcified coronary lesions; however, there is a dearth of evidence on the use of OA in ostial lesions, especially with long-term outcome data.<h4>Methods</h4>Data were obtained from a retrospective analysi ...[more]

PMID: 35989487

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Project description: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.

Project description:Patients who undergo percutaneous coronary intervention (PCI) for severely calcified coronary lesions have long been known to have worse clinical and economic outcomes than patients with no or mildly calcified lesions. We sought to assess the likely cost-effectiveness of using the Diamondback 360(®) Orbital Atherectomy System (OAS) in the treatment of de novo, severely calcified lesions from a health-system perspective.In the absence of a head-to-head trial and long-term follow up, cost-effectiveness was based on a modeled synthesis of clinical and economic data. A cost-effectiveness model was used to project the likely economic impact. To estimate the net cost impact, the cost of using the OAS technology in elderly (? 65 years) Medicare patients with de novo severely calcified lesions was compared with cost offsets. Elderly OAS patients from the ORBIT II trial (Evaluate the Safety and Efficacy of OAS in Treating Severely Calcified Coronary Lesions) [ClinicalTrials.gov identifier: NCT01092426] were indirectly compared with similar patients using observational data. For the index procedure, the comparison was with Medicare data, and for both revascularization and cardiac death in the following year, the comparison was with a pooled analysis of the Harmonizing Outcomes with Revascularization and Stents in Acute Myocardial Infarction (HORIZONS-AMI)/Acute Catheterization and Urgent Intervention Triage Strategy (ACUITY) trials. After adjusting for differences in age, gender, and comorbidities, the ORBIT II mean index procedure costs were 17% (p < 0.001) lower, approximately US$2700. Estimated mean revascularization costs were lower by US$1240 in the base case. These cost offsets in the first year, on average, fully cover the cost of the device with an additional 1.2% cost savings. Even in the low-value scenario, the use of the OAS is cost-effective with a cost per life-year gained of US$11,895.Based on economic modeling, the recently approved coronary OAS device is projected to be highly cost-effective for patients who undergo PCI for severely calcified lesions.

Dataset Information

Orbital atherectomy of calcified coronary ostial lesions.

Objectives

Background

Methods

Results

Conclusions

Publications

Orbital atherectomy of calcified coronary ostial lesions.

Similar Datasets

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