Entrapped Crown of Orbital Atherectomy Device by Intimal Tissue Entanglement During Peripheral Intervention.
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ABSTRACT:
SUBMITTER: Hendrani AD
PROVIDER: S-EPMC8311039 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:BackgroundPercutaneous coronary intervention of severely calcified lesions carries a high risk of adverse events despite the use of contemporary devices. The Classic Crown Orbital Atherectomy System (OAS) was safe and effective for severely calcified lesion preparation in the ORBIT II study (Evaluate the Safety and Efficacy of OAS in Treating Severely Calcified Coronary Lesions) but was not optimized for tight lesions. COAST (Coronary Orbital Atherectomy System Study) evaluated the safety and efficacy of calcified lesion preparation before stent implantation with the Diamondback 360 Micro Crown Coronary OAS, designed for use in tighter lesions.MethodsCOAST was a prospective, multicenter, single-arm study that enrolled 100 patients with severely calcified de novo coronary lesions at 17 sites in the United States and Japan. The primary effectiveness end point was procedural success, defined as stent delivery with residual stenosis <50% without in-hospital major adverse cardiac events (MACE), and the primary safety end point was freedom from MACE (composite of cardiac death, myocardial infarction, or target vessel revascularization) at 30 days.ResultsThe OAS Micro Crown was inserted in all patients. A stent was delivered with a residual stenosis <50% in all except one patient (99.0%). Procedural success was achieved in 85 (85.0%) subjects versus 391 (88.9%) in ORBIT II (P=0.30), and freedom from MACE at 30 days was achieved in 85.0% versus 89.6% in ORBIT II (P=0.21). Freedom from MACE was 77.8% at 1 year.ConclusionsPrestent preparation of severely calcified lesions using the novel Micro Crown OAS resulted in similar rates of procedural success and freedom from MACE compared with the Classic Crown OAS. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT02132611.
| S-EPMC7434218 | biostudies-literature
Project description:We report a rare case of crown fracture and detachment from a coronary orbital atherectomy system. During orbital atherectomy in an angulated and calcified coronary vessel, the crown was completely detached and left distal to the stenosis. It was successfully retrieved using a gooseneck snare and a guide-extension catheter. (Level of Difficulty: Advanced.).
| S-EPMC8305085 | biostudies-literature
Project description:IntroductionOur objective was to describe the contemporary outcomes of orbital atherectomy (OA) vs. rotational atherectomy (RA) use for inpatient percutaneous coronary intervention (PCI) in the United States. Data on the use of OA vs. RA in contemporary inpatient PCI are limited.MethodsWe queried the Nationwide Readmission Database (NRD) from January to November for the years 2016-2017 to identify hospitalizations of patients who underwent PCI with atherectomy. We conducted a multivariate regression analysis to identify variables associated with in-hospital mortality.ResultsWe included 77,040 records of patients who underwent inpatient PCI with atherectomy. Of those, 71,610 (93%) had RA, and 5430 (7%) had OA. There was no significant change in the trend of using OA or RA over 2016 and 2017. OA was less utilized in patients presenting with ST-segment elevation myocardial infarction (STEMI) (4.3% vs. 46.8%, p < 0.001). In our cohort, OA was associated with lower in-hospital mortality (3.1% vs. 5%, p < 0.001) and 30-day urgent readmission (< 0.01% vs. 0.2%, p = 0.009), but a higher risk of coronary perforation (1.7% vs. 0.6%, p < 0.001) and cardiac tamponade (1% vs. 0.3%, p < 0.001) and a higher cost of index hospitalization ($28,199 vs. $23,188, p < 0.001) compared with RA.ConclusionRA remains the predominant atherectomy modality for inpatient PCI in the United States (93%). There was no change in the trend of use for either modality over the years 2016 and 2017. OA was noted to have a lower incidence of in-hospital death, but a higher risk of coronary perforation and a higher cost of index hospitalization for the overall unmatched cohorts.
| S-EPMC8126522 | biostudies-literature
Project description:Despite significant improvements in stent design, severe coronary calcification continues to impede adequate stent expansion and is associated with worse clinical outcomes. Angiography is limited in its ability to detect and comprehensively characterise calcified plaque. Intravascular imaging provides information on lesion morphology guiding appropriate treatment strategies. Orbital atherectomy allows for lesion preparation of severely calcified plaque prior to stent implantation. Utilising a unique mechanism of action incorporating centrifugal forces, a standard 1.25 mm eccentrically mounted and diamond-coated burr orbits bi-directionally to ablate calcified plaque. Lesion preparation with orbital atherectomy allows for modification of calcified plaque to facilitate stent expansion.
| S-EPMC6918479 | biostudies-literature
Project description: Not available
| S-EPMC8311989 | biostudies-literature
Project description:Calcified coronary lesions are notorious for posing technical difficulty during angioplasty. Fortunately, more devices are available to tackle coronary calcifications. However, there remain difficult cases whereby a single modality is insufficient. Here we report the feasibility and success of a case, using Novo combination of Shockwave Lithotripsy after Orbital Atherectomy. (Level of Difficulty: Intermediate.).
| S-EPMC8305089 | biostudies-literature
Project description:Entanglement has a capacity to enhance imaging procedures, but this remains unexplored for attosecond imaging. Here, we elucidate that possibility, addressing orbital angular momentum (OAM) entanglement in ultrafast processes. In the correlated process non-sequential double ionization (NSDI) we demonstrate robust photoelectron entanglement. In contrast to commonly considered continuous variables, the discrete OAM allows for a simpler interpretation, computation, and measurement of entanglement. The logarithmic negativity reveals that the entanglement is robust to incoherence and an entanglement witness minimizes the number of measurements to detect the entanglement, both quantities are related to OAM coherence terms. We quantify the entanglement for a range of targets and field parameters to find the most entangled photoelectron pairs. This methodology provides a general way to use OAM to quantify and measure entanglement, well-suited to attosecond processes, and can be exploited to enhance imaging capabilities through correlated measurements, or for generation of OAM-entangled electrons.
| S-EPMC9365801 | biostudies-literature
Project description:Compared to rotational atherectomy (RA), orbital atherectomy (OA) has been shown to decrease procedure failure and reintervention rates in the treatment of severely calcified coronary artery lesions. Our objective was to explore the cost-effectiveness of OA compared to RA in the Japanese healthcare system. A decision-analytic model calculated reintervention rates and consequent total 1-year costs. Effectiveness inputs were therapy-specific target lesion revascularization (TLR) rates and all-cause mortality, pooled from clinical studies. Index and reintervention costs were determined based on claims data analysis of n = 33,628 subjects treated in 2014-2016. We computed incremental cost-effectiveness in Japanese Yen (JPY) per life year (LY) gained based on differences in 1-year cost and projected long-term survival, assuming OA device cost between JPY 350,000 and JPY 550,000. OA was found to be associated with improved clinical outcomes (12-month TLR rate 5.0 vs. 15.7%) and projected survival gain (8.34 vs. 8.16 LYs (+0.17), based on 1-year mortality of 5.5 vs. 6.8%). Total 1-year costs were lower for device cost of JPY 430,000 or less, and reached a maximum ICER of JPY 753,445 per LY at the highest assumed device cost, making OA dominant or cost-effective across the tested range, at ICERs substantially below the willingness-to-pay threshold. In conclusion, orbital atherectomy for the treatment of severely calcified coronary artery lesions, compared to rotational atherectomy, is a cost-effective treatment approach in the Japanese healthcare system due to improved clinical performance.
| S-EPMC6153894 | biostudies-literature
Project description:BackgroundIn January 2021, the Diamondback 360 orbital atherectomy (OA) system received CE mark approval and became available in Europe. The first procedure in Europe was performed at the Thoraxcenter, Erasmus Medical Center, Rotterdam, the Netherlands.AimsTo report the procedural safety and efficacy of the initial experience with OA in a tertiary care institution in the Netherlands.MethodsPatients with de novo severely calcified coronary artery disease who were treated with intended invasive imaging-guided OA were included in a prospective single-centre registry. Device success, defined as less than 50% stenosis after OA, and procedural success, defined as successful stent implantation with less than 50% residual stenosis, were evaluated. Calcium debulking effects were assessed by invasive imaging. Safety was assessed up to 30 days after the index procedure.ResultsBetween February 2021 and June 2021, 29 patients with a total of 39 coronary arteries underwent OA. Target lesions were heavily calcified with a mean length of 32 mm and a calcium arc of 320 degrees. Invasive imaging was applied in all but one patient and 36 vessels. Superficial sanding was observed in almost all vessels (90%) and fracturing of deeper medial calcium in more than half of the vessels (63%), with a device success of 66% and procedural success of 94%. The mean stent symmetry index was 0.84, indicating good circular stent expansion. No primary safety events occurred during 30 days of follow-up.ConclusionOur initial experience with OA for heavily calcified coronary lesions demonstrated favourable debulking effects and plaque modification, with high procedural success and clinical safety.
| S-EPMC10140256 | biostudies-literature
Project description: Not available
| S-EPMC7489459 | biostudies-literature