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Catheterization and Cardiovascular... Oct 2022To evaluate the feasibility and safety of coronary orbital atherectomy (OA) for the treatment of calcified ostial lesions.
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.
Topics: Aged; Atherectomy; Atherectomy, Coronary; Coronary Angiography; Coronary Artery Disease; Humans; Percutaneous Coronary Intervention; Retrospective Studies; Severity of Illness Index; Stroke; Thrombosis; Treatment Outcome; Vascular Calcification
PubMed: 35989487
DOI: 10.1002/ccd.30369 -
Annals of Vascular Surgery Jan 2021Public focus on health care spending has increased attention on variation in practice patterns and overutilization of high-cost services. Mainstream news reports have...
BACKGROUND
Public focus on health care spending has increased attention on variation in practice patterns and overutilization of high-cost services. Mainstream news reports have revealed that a small number of providers account for a disproportionate amount of total Medicare payments. Here, we explore variation in Medicare payments among vascular surgeons and compare practice patterns of the most highly reimbursed surgeons to the rest of the workforce.
METHODS
2016 Medicare Provider Utilization Data were queried to identify procedure, charge, and payment data to vascular surgeons, identified by National Provider Identification taxonomy. Commonly performed services (>10/year) were stratified into categories (endovascular, open surgery, varicose vein, evaluation and management, etc.). Practice patterns of vascular surgeons comprising the top 1% Medicare payments (n = 31) were compared with the remainder of the workforce (n = 3,104).
RESULTS
In 2016, Medicare payments to vascular surgeons totaled $589 M. 31 vascular surgeons-1% of the workforce-received $91 million (15% of total payments). Practice patterns of the 1% differed significantly from the remainder of vascular surgeons (P < 0.05), with endovascular procedures accounting for 85% of their reimbursement. Specifically, the 1% received 49% of total Medicare payments for atherectomy ($121 M), 98% of which were performed in the office setting.
CONCLUSIONS
One percentage of vascular surgeons receive an inordinate amount of total Medicare payments to the specialty. This discrepancy is due to variations in volume, utilization, and site of service. Disproportionate use of outpatient atherectomy in a small number of providers, for example, raises concerns regarding appropriateness and overutilization. Given current scrutiny over health care spending, these findings should prompt serious discussion regarding the utility of personal and societal self-regulation.
Topics: Atherectomy; Databases, Factual; Fee-for-Service Plans; Humans; Medical Overuse; Medicare; Practice Patterns, Physicians'; Surgeons; Time Factors; United States; Vascular Surgical Procedures
PubMed: 32736025
DOI: 10.1016/j.avsg.2020.07.010 -
The Journal of Cardiovascular Surgery Apr 2019The orbital atherectomy system is a novel form of atherectomy that uses orbital sanding and pulsatile forces, an effective method of treatment for peripheral... (Review)
Review
The orbital atherectomy system is a novel form of atherectomy that uses orbital sanding and pulsatile forces, an effective method of treatment for peripheral atherosclerotic lesions with varying levels of occlusion. Although the devices only has a general indication from the FDA to treat atherosclerotic lesions, they are effective in treating all kinds of lesions, and can therefore mitigate effects of all severities of peripheral artery disease. This approach to endovascular therapy involves the use of differential sanding to preferentially ablate fibrous, fibrofatty and calcified lesions, while deflecting healthy intima away from the crown. The eccentrically mounted crown design allows the device to employ rhythmic pulsating forces that penetrate the medial layer, and cause cracking in the lesions in order to facilitate easier balloon inflation and intravascular drug elution. The combination of vessel modification and lumen enlargement through sanding can effectively restore blood flow to the extremities, and can eliminate risk of critical limb ischemia, as well as subsequent amputation. Extensive lab testing and clinical trials have confirmed the high success rates and low major adverse events associated with this form of treatment. The device is economically viable as well, since its cost is offset by the lower frequency of adjunctive therapy sessions when compared to other devices. Considering the results outlined in this manuscript, the Diamondback 360° is an effective form of atherectomy therapy for peripheral artery disease. In-depth understanding of the operation preparation, procedure, and best imaging techniques can help to optimize outcomes.
Topics: Atherectomy; Femoral Artery; Humans; Peripheral Arterial Disease; Popliteal Artery; Risk Factors; Treatment Outcome; Vascular Calcification; Vascular Patency
PubMed: 30698373
DOI: 10.23736/S0021-9509.19.10879-8 -
Cardiovascular Revascularization... Feb 2019
Topics: Atherectomy, Coronary; Coronary Angiography; Drug-Eluting Stents; Everolimus; Humans; Percutaneous Coronary Intervention; Plaque, Atherosclerotic; Polymers; Tokyo
PubMed: 30799046
DOI: 10.1016/j.carrev.2019.01.015 -
The Journal of Invasive Cardiology Mar 2023Severe coronary artery calcification (CAC) remains challenging during percutaneous coronary intervention (PCI) and often requires 1 or more advanced calcium modification...
BACKGROUND
Severe coronary artery calcification (CAC) remains challenging during percutaneous coronary intervention (PCI) and often requires 1 or more advanced calcium modification tools.
OBJECTIVES
We describe the combination use of rotational (RA) or orbital atherectomy (OA), with intravascular lithotripsy (IVL), termed rotatripsy and orbital-tripsy, respectively, for modifying CAC prior to stent implantation during PCI.
METHODS
We performed a retrospective analysis of patients treated with rotatripsy or orbital-tripsy at our center between July 2019 and March 2022. The primary efficacy endpoint was procedural success (successful stent implantation, <30% residual stenosis visually, Thrombolysis in Myocardial Infarction 3 flow; absence of types C to F dissection/perforation or loss of side branch ≥2.0mm visually) without in-hospital major adverse cardiovascular event (MACE, defined as cardiovascular death, myocardial infarction [MI], target-vessel revascularization).
RESULTS
A total of 25 patients (14 rotatripsy and 11 orbital-tripsy) were included in our study. The mean age was 72.2 ± 7.6 years and 76% were men. PCI was guided by intravascular imaging in 24 patients (96%). All cases were treated with either RA or OA before utilization of IVL. Procedural success was achieved in 22 cases (88%) with 1 sidebranch loss without periprocedural MI (4%) and 2 in-patient deaths (8%) unrelated to the procedure (1 intracerebral hemorrhage and 1 cardiac arrest).
CONCLUSION
We describe efficacious use of both rotatripsy and orbital-tripsy to modify severe CAC during PCI in a real-world setting. Intravascular imaging can guide appropriate use of these devices to complement each other to modify severe CAC to achieve optimal outcomes.
Topics: Male; Humans; Middle Aged; Aged; Female; Percutaneous Coronary Intervention; Atherectomy, Coronary; Calcium; Retrospective Studies; Coronary Vessels; Treatment Outcome; Coronary Artery Disease; Myocardial Infarction; Atherectomy; Lithotripsy; Vascular Calcification; Coronary Angiography
PubMed: 36645333
DOI: 10.25270/jic/22.00272 -
Catheterization and Cardiovascular... Nov 2022
Topics: Humans; Treatment Outcome; Atherectomy; Angioplasty, Balloon; Peripheral Arterial Disease; Vascular Patency
PubMed: 36378720
DOI: 10.1002/ccd.30430 -
Journal of Vascular Surgery Jan 2021The effectiveness of rotational atherectomy in the treatment of complex superficial femoral artery (SFA) lesions remains poorly defined. Outcomes of SFA lesions treated...
BACKGROUND
The effectiveness of rotational atherectomy in the treatment of complex superficial femoral artery (SFA) lesions remains poorly defined. Outcomes of SFA lesions treated with rotational atherectomy were analyzed.
METHODS
This retrospective review assessed all patients who underwent rotational atherectomy of the SFA at a single institution between 2015 and 2018. The data of all patients were deidentified, and the study was approved by the Institutional Review Board. Informed consent was not obtained for this retrospective analysis. Main outcomes were Kaplan-Meier primary patency rate, freedom from major amputation, and 2-year survival rate. The effect of drug-coated balloon angioplasty (DCBA) on patency and time to death was investigated with univariate regression. The safety profile for atherectomy and DCBA was assessed by the 30-day incidence of major amputation and all-cause mortality.
RESULTS
Fifty-three patients (mean age, 70.2 ± 9.8 years; 73% male; 65% critical limb-threatening ischemia; 47 [90%] current or former smokers; seven [13%] with prior failed ipsilateral endovascular intervention) underwent rotational atherectomy (Jetstream; Boston Scientific, Marlborough, Mass) with mean follow-up of 543 days. Forty-six (87%) patients underwent DCBA (Lutonix; BD Bard, Covington, Ga) after atherectomy. Mean lesion length was 13.2 ± 9.0 cm. Thirty-one (58%) lesions were TransAtlantic Inter-Society Consensus C or D class. At 1-month follow-up, 39 of 45 (87%) patients experienced improvement in symptoms and Rutherford class. An improvement in ankle-brachial index was also noted in 13% of patients without improvement of symptoms, with no patients progressing to surgical bypass or major amputation. Mean ankle-brachial index increased from 0.54 ± 0.035 to 0.90 ± 0.031 at 1 month after intervention (P < .001) and remained constant out to 18 months. Mean toe pressure increased from 36 ± 3.8 mm Hg to 67 ± 4.5 mm Hg at 1 month after intervention (P < .001) and remained constant out to 18 months. Kaplan-Meier primary patency rate was 75% (95% confidence interval, 61%-85%) at 12 months and 65% (51%-77%) at 24 months. There was a trend toward improved primary patency after adjunctive DCBA compared with plain balloon angioplasty at 1 year (75% vs 43%; P = .1082). There was no significant difference in mortality between adjunctive DCBA and plain balloon angioplasty at 2 years (11% vs 0%). The 2-year incidence of major amputation in critical limb-threatening ischemia patients was 3.9% (1.2%-6.5%). One patient died and none underwent amputation within 30 days.
CONCLUSIONS
Rotational atherectomy with adjunctive DCBA of long SFA lesions has excellent long-term patency. Two-year major amputation and mortality rates are low, and the technique has an exceptional safety profile.
Topics: Aged; Aged, 80 and over; Atherectomy; Female; Femoral Artery; Humans; Male; Middle Aged; Peripheral Arterial Disease; Retrospective Studies; Treatment Outcome
PubMed: 32325226
DOI: 10.1016/j.jvs.2020.03.040 -
Annals of Vascular Surgery Feb 2022Atherectomy is currently being used extensively for occlusive peripheral artery disease (PAD) interventions without proven benefits. This analysis examines the effects... (Comparative Study)
Comparative Study Observational Study
BACKGROUND
Atherectomy is currently being used extensively for occlusive peripheral artery disease (PAD) interventions without proven benefits. This analysis examines the effects of atherectomy and other endovascular interventions on patient survival.
OBJECTIVES
The aim of this study is to compare overall survival for patients undergoing PAD endovascular interventions, such as plain old balloon angioplasty (POBA), stent deployment and atherectomy.
METHODS
Propensity score matched cohorts were constructed to conduct pairwise comparisons of overall survival in patients who underwent stenosis and occlusive PAD interventions between May 2011 and February 2020 using Vascular Quality Initiative (VQI) regional registry data. Inverse probability treatment weighting method was used to compare secondary outcomes of in-hospital mortality, length of stay, complications and major amputations. Comparative analysis was performed for POBA vs stenting, POBA vs atherectomy, and stenting vs atherectomy.
RESULTS
A total number of 15281 eligible cases were identified. After propensity score matching, 6094, 4032, and 3312 cases were used to compare POBA versus stent deployment, POBA versus atherectomy and stent versus atherectomy, respectively. Stent deployment had significantly better overall survival compared with POBA and atherectomy (P < 0.001). Multivariable Cox proportional hazard models suggested stenting was associated with a reduction in mortality hazard by 30% compared with POBA (HR: 0.7; 95% CI: 0.6-0.82; P < 0.001) and a 40% mortality reduction compared with atherectomy (HR: 0.6; 95% CI: 0.48-0.75; P < 0.001). No significant difference was found between POBA and atherectomy. There was no statistical difference in other secondary outcomes which were comparable among all cohorts.
CONCLUSIONS
Stent deployment was significantly superior to POBA and atherectomy in terms of overall survival with comparable complication and amputation rates. The natural history of PAD patients presenting with claudication is associated with an extremely low annual mortality risk. Therefore, further examinations of outcomes, especially in regards to mortality rates, both POBA and atherectomy on the management of PAD patients especially those presenting with claudication is warranted.
Topics: Aged; Amputation, Surgical; Angioplasty, Balloon; Atherectomy; Female; Hospital Mortality; Humans; Length of Stay; Limb Salvage; Male; Middle Aged; Peripheral Arterial Disease; Propensity Score; Registries; Retrospective Studies; Risk Assessment; Risk Factors; Stents; Time Factors; Treatment Outcome
PubMed: 34644639
DOI: 10.1016/j.avsg.2021.08.004 -
Catheterization and Cardiovascular... Oct 2022The aim of this study was to compare the ability of two different atherectomy modalities, the directional atherectomy system (DAS) and the orbital atherectomy system... (Randomized Controlled Trial)
Randomized Controlled Trial
OBJECTIVES
The aim of this study was to compare the ability of two different atherectomy modalities, the directional atherectomy system (DAS) and the orbital atherectomy system (OAS), to modify plaque and augment luminal gain as evaluated by angiography and intravascular ultrasound (IVUS) in patients with symptomatic femoro-popliteal peripheral arterial disease (PAD).
BACKGROUND
Atherectomy is frequently utilized in the treatment of complex PAD. To date, there are no head-to-head comparisons of existing devices and their selection is based mostly on operator preference rather than on supportive data.
METHODS
This was a single-center, prospective, randomized trial designed to assess the impact of DAS in comparison to OAS on atherosclerotic plaque. Pre- and postatherectomy lesion characterization was performed by angiography and IVUS. Drug-coated balloon (DCB) angioplasty was performed after atherectomy with similar analysis repeated.
RESULTS
Sixty patients were randomized to undergo either DAS or OAS. Pretreatment angiographic and IVUS characteristics were similar in the DAS and OAS groups. DAS led to a greater reduction in plaque volume throughout the entire lesion (5.9% vs. 1.1%, p = 0.003). This corresponded to a greater increase in total vessel and lumen volume by IVUS (161.5 mm vs. 50.2 mm , p = 0.001; 178.6 mm vs. 47.0 mm , p = 0.004, respectively), as well as a reduction in angiographic stenosis (40% vs. 70%, p < 0.001). After DCB, 10 patients required stenting for suboptimal results in the OAS group compared with two in the DAS group (p = 0.021).
CONCLUSIONS
Compared to OAS, DAS demonstrated a greater plaque volume reduction and luminal gain with significantly fewer stents needed post-DCB.
Topics: Humans; Angiography; Angioplasty, Balloon; Atherectomy; Coated Materials, Biocompatible; Femoral Artery; Peripheral Arterial Disease; Plaque, Atherosclerotic; Popliteal Artery; Prospective Studies; Treatment Outcome; Ultrasonography, Interventional; Vascular Patency
PubMed: 35842776
DOI: 10.1002/ccd.30339 -
Journal of Vascular and Interventional... Mar 2023To evaluate the effectiveness and safety of atherectomy versus plain balloon angioplasty (POBA) for treatment of critical limb ischemia (CLI) due to tibioperoneal...
PURPOSE
To evaluate the effectiveness and safety of atherectomy versus plain balloon angioplasty (POBA) for treatment of critical limb ischemia (CLI) due to tibioperoneal arterial disease (TPAD).
MATERIALS AND METHODS
Patients enrolled in the Vascular Quality Initiative registry who had CLI (Rutherford Class 4-6) and underwent atherectomy versus POBA alone for isolated TPAD were retrospectively identified. Of eligible patients, a cohort of 2,908 patients was propensity matched 1:1 by clinical and angiographic characteristics. The atherectomy group comprised 1,454 patients with 2,183 arteries treated, and the POBA group comprised 1,454 patients with 2,141 arteries treated. The primary study endpoint was major ipsilateral limb amputation. Secondary endpoints were minor ipsilateral amputations, any ipsilateral amputation, primary patency, target vessel reintervention (TVR), and wound healing at 12 months.
RESULTS
The median follow-up period was 507 days, the mean patient age was 69 years ± 11.7, and the mean occluded length was 6.9 cm ± 6.5. There was a trend toward higher technical success rates with atherectomy than with POBA (92.9% vs 91.0%, respectively; P = .06). The rates of major adverse events during the procedure were not significantly different. The 12-month major amputation rate was similar in the atherectomy and POBA groups (4.5% vs 4.6%, respectively; P = .92; odds ratio, 0.97; 95% CI, 0.68-1.37). There was no difference in 12-month TVR (17.9% vs 17.8%; P = .97) or primary patency (56.4% vs 54.5%; P = .64) between the atherectomy and POBA groups.
CONCLUSIONS
In a large national registry, treatment of CLI from TPAD using atherectomy versus POBA showed no significant differences in procedural adverse events, major amputations, TVR, or vessel patency at 12 months.
Topics: Humans; Aged; Retrospective Studies; Limb Salvage; Ischemia; Risk Factors; Peripheral Arterial Disease; Treatment Outcome; Angioplasty, Balloon; Atherectomy; Vascular Patency
PubMed: 36442743
DOI: 10.1016/j.jvir.2022.11.021