Orbital-Tripsy: Novel Combination of Orbital-Atherectomy and Intravascular-Lithotripsy, in Calcified Coronaries After Failed Intravascular-Lithotripsy.
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ABSTRACT:
SUBMITTER: Chiang CSM
PROVIDER: S-EPMC8305089 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:BackgroundThe unprotected calcified Left Main disease represents a high-risk subset for percutaneous coronary intervention (PCI), and it is associated with a higher number of periprocedural complications and an increased rate of in-stent thrombosis and restenosis. Adequate lesion preparation plays a crucial role in achieving a favorable PCI outcome. Rotational Atherectomy (RA) is a well-established plaque-modifying method; nevertheless, the data regarding the effectiveness of RA in LM diseases is scarce. Recently, the novel ShockWave-Intravascular-Lithotripsy(S-IVL) device has been introduced to the PCI armamentarium in order to modify the calcified plaque.MethodsWe performed a retrospective evaluation of 44 consecutive subjects who underwent the LM-PCI, and who were supported by either the RA or S-IVL.ResultsThe Rota group consisted of 29 patients with a mean syntax score of 28.0 ± 7.5. The S-IVL group was composed of 15 subjects with a syntax score of 23.3 ± 13.0 There were no statistical differences regarding MACE between the RA and Shockwave arms of the in-hospital group (10.3% vs. 6.7%), or in the six month (17.2% vs. 13.3%) follow-up group.ConclusionsRA and S-IVL could be safe and effective therapeutic strategies for calcified LM disease. Further studies with a higher number of participants and longer follow-up times are warranted to establish the potential benefits of RA and S-IVL for the management of LM stenosis.
| S-EPMC9330248 | biostudies-literature
Project description:ObjectivesTo evaluate the feasibility and safety of coronary orbital atherectomy (OA) for the treatment of calcified ostial lesions.BackgroundPercutaneous 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.MethodsData 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).ResultsA 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.ConclusionsThis 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.
| S-EPMC9804932 | biostudies-literature
Project description:Left main coronary artery disease subtends a large area of potentially jeopardized myocardium. Percutaneous coronary intervention for severe left main coronary artery disease is a reasonable treatment option for select patients. Severe coronary artery calcium of the left main artery increases the complexity of percutaneous coronary intervention and is associated with increased risk of periprocedural complications and worse long-term clinical outcomes. Intravascular lithotripsy (IVL) utilizes sonic pressure waves to modify severe coronary artery calcium and has emerged as a safe and effective alternative to coronary atherectomy. However, left main lesions were excluded from regulatory approval clinical trials of IVL. Herein, we review all available data regarding the use of IVL treatment for severe left main coronary artery disease.
| S-EPMC11308112 | biostudies-literature
Project description: Not available
| S-EPMC8084382 | biostudies-literature
Project description:Intravascular lithotripsy can be used as an effective therapy for lesion preparation in severely calcified lesions. The mechanism, as shown by optical coherence tomography, is calcium fractures. The aforementioned modification is performed with minimal risk of perforation, no-reflow and a low incidence of flow-limiting dissection and myocardial infarctions. Other techniques, such as cutting or scoring balloons and rotational atherectomy have also been shown to increase luminal diameter, but other complications, such as distal embolization, induced by these treatment modalities, are a source of concern. This review describes a single-center study of all-comer patients, including those with complex characteristics. This therapy is very effective, with a very low risk of complications. In this article, we characterize the mechanism of action of the intravascular lithotripsy catheter, its optical coherence tomography validation, clinical applications, and comparison with other calcium-modifying technologies, as well as future directions, which can be used to improve the technology.
| S-EPMC10167520 | biostudies-literature
Project description: Not available
| S-EPMC7489459 | biostudies-literature
Project description:BackgroundManagement of heavily calcified coronary arteries is still a major challenge in interventional cardiology. Inadequate stent expansion in calcific lesions is the single most important predictor of stent thrombosis and in-stent restenosis. Rotational atherectomy (RA) is an important tool to modify the calcium burden but is associated with limitations and requires specific skills. Intravascular lithotripsy (IVL) is a novel technique to treat calcified stenotic lesions and has been proposed as an alternative to RA with promising results.Case summaryWe report a case of a patient with severely calcified right coronary artery stenosis successfully treated with combination of RA and IVL.DiscussionIn this case, we demonstrate that the RA and IVL are complementary strategies, not sufficient on their own and not alternative to each other.
| S-EPMC7898579 | biostudies-literature
Project description:IntroductionThe combination of intravascular lithotripsy (IVL) and drug-coated balloon (DCB) angioplasty for calcified peripheral lesions is associated with promising short-term results. However, data regarding the 12 months performance of this treatment option is missing. This study reports on the outcomes of IVL and DCB angioplasty for calcified femoropopliteal disease.MethodsPatients treated with IVL and DCB for calcified femoropopliteal lesions between February 2017 and September 2020 were included into this study. The primary outcome measure of this analysis was primary patency. Secondary patency, freedom from target lesion revascularization (TLR) and overall mortality were additionally analyzed.ResultsFifty-five (n = 55) patients and 71 lesions were analyzed. Most patients presented with long-term limb-threatening ischemia (n = 31, 56%), 47% (n = 26) were diabetics, and 66% (n = 36) had long-term kidney disease. The median lesion length was 77 mm (interquartile range: 45-136), and 20% (n = 14) of the lesions were chronic total occlusions (CTOs). Eccentric calcification was found in 23% of the vessels (n = 16), and circumferential calcium (peripheral arterial calcium scoring system [PACSS] Class 3 and 4) was present in 78% (n = 55) of the treated lesions.The technical success after IVL amounted to 87% (n = 62) and the procedural success to 97% (n = 69). A flow-limiting dissection was observed in 2 cases (3%). Both the rates of target lesion perforation and distal embolization were 1% (n = 1). A bail-out scaffold was deployed in 5 lesions (7%). At 12 months the Kaplan-Meier estimate of primary patency was 81%, the freedom from TLR was 92% and the secondary patency 98%. The overall survival amounted to 89%, while the freedom from major amputation to 98%. The presence of eccentric disease, CTOs, or PACSS Class 4 did not increase the risk for loss of patency or TLR.ConclusionsIn this challenging cohort of patients, the use of IVL and DCB for calcified femoropopliteal lesions was associated with promising 12 months outcomes and an excellent safety profile.
| S-EPMC9896408 | biostudies-literature
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: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