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The Journal of Cardiovascular Surgery Feb 2022
Topics: Atherectomy; Femoral Artery; Humans; Peripheral Arterial Disease; Popliteal Artery; Treatment Outcome; Vascular Calcification
PubMed: 35179335
DOI: 10.23736/S0021-9509.21.12202-5 -
Journal of Vascular Surgery Mar 2022Atherectomy has become commonplace as an adjunct to interventional treatments for peripheral arterial disease, but the procedures have been complicated by risks...
OBJECTIVE
Atherectomy has become commonplace as an adjunct to interventional treatments for peripheral arterial disease, but the procedures have been complicated by risks including distal embolization and arterial perforation. This study aimed to examine the safety and effectiveness of a novel atherectomy system to treat femoropopliteal and below-knee peripheral arterial disease.
METHODS
The Revolution Peripheral Atherectomy System (Rex Medical LP, Conshohocken, Pa) was studied in 121 patients with 148 femoropopliteal and below-knee lesions, enrolled at 17 United States institutions. Technical success was defined when the post-atherectomy angiographic stenosis was ≤50%, as assessed by an independent core laboratory. Major adverse events were adjudicated by an independent Clinical Events Committee.
RESULTS
Among 148 site-identified target lesions in 121 patients, 21.4% were in the superficial femoral artery, 13.7% involved the popliteal artery, and 67.9% were in tibial arteries; 3.1% involved more than one segment. Technical success was 90.2%, with stenoses decreasing from 73% ± 19% at baseline to 42% ± 14% after atherectomy. Adjunctive treatment after atherectomy included angioplasty with uncoated balloons in 91%, drug-coated balloons in 11%, bare stent deployment in 8%, and drug-eluting stent placement in 3%. Procedural success (<30% residual stenosis) was achieved in 93.7% of target lesions. Complications during the procedure included one target vessel perforation and two distal embolizations; each of which were adjudicated by the Clinical Events Committee as unrelated to the device and were not visualized angiographically by the core laboratory. Freedom from major adverse events was 97.3% through 30 days. The Kaplan-Meier estimates of primary, assisted primary, and secondary patency were 81.6%, 87.7%, and 91.6% at 6 months, respectively.
CONCLUSIONS
The use of the Revolution Peripheral Atherectomy System was associated with few procedural complications and a high rate of success at the index procedure and through 6 months.
Topics: Aged; Aged, 80 and over; Angiography; Atherectomy; Equipment Design; Female; Femoral Artery; Humans; Male; Middle Aged; Peripheral Arterial Disease; Popliteal Artery; Prospective Studies; Tibial Arteries; Time Factors; Treatment Outcome; United States; Vascular Patency
PubMed: 34624496
DOI: 10.1016/j.jvs.2021.08.107 -
JACC. Cardiovascular Interventions Sep 2021
Topics: Angioplasty, Balloon, Coronary; Atherectomy, Coronary; Coronary Angiography; Humans; Treatment Outcome
PubMed: 34503749
DOI: 10.1016/j.jcin.2021.07.017 -
Journal of the American Heart... Sep 2019Background Limited data exist to describe factors that influence the use of different endovascular treatments for peripheral arterial disease. Therefore, we studied sex... (Comparative Study)
Comparative Study Observational Study
Background Limited data exist to describe factors that influence the use of different endovascular treatments for peripheral arterial disease. Therefore, we studied sex differences in the utilization of endovascular treatment modalities and their impact on arterial patency. Methods and Results We analyzed procedures from 2010 to 2016 in the Vascular Quality Initiative for arteries treated with percutaneous transluminal angioplasty (PTA) alone, stenting (with/without PTA), and atherectomy (with/without PTA). We explored sex differences in treatment modality by arterial segment (iliac, femoropopliteal, and tibial) with multivariable logistic regression. We used Kaplan-Meier survival analysis and multivariable Cox regression to study sex differences in arterial reintervention and occlusion. In this cohort, patients (n=58 247, mean age 68 years, 41% women,) had 106 073 arteries treated (median=2 arteries, interquartile range=1-3). Half (50%) of these arteries were treated with stents, 39% with PTA alone, and 11% with atherectomy. After risk adjustment, women were less likely to undergo stenting or atherectomy (versus PTA alone) in the femoropopliteal (stent risk ratio=0.78 [0.74-0.82]; atherectomy risk ratio=0.69 [0.58-0.82]) and tibial arteries (stent risk ratio=0.70 [0.55-0.89]; atherectomy risk ratio=0.87 [0.70-1.07]). In the iliac arteries there was no sex difference in stenting, and atherectomy was rarely used (0.2%). Women underwent reintervention in the femoropopliteal arteries (hazard ratio=1.28 [1.17-1.40]) or developed an occlusion in the iliac (hazard ratio=1.42 [1.12-1.81]) and femoropopliteal arteries (hazard ratio=1.19 [1.06-1.34]) more frequently than men. Conclusions Women were less likely to undergo stenting or atherectomy and had higher rates of occlusion and reintervention, especially in the femoropopliteal arteries. Evidence-based guidelines are needed to guide optimal use of endovascular treatments for men and women.
Topics: Aged; Aged, 80 and over; Angioplasty; Atherectomy; Databases, Factual; Female; Healthcare Disparities; Humans; Lower Extremity; Male; Middle Aged; Peripheral Arterial Disease; Risk Assessment; Risk Factors; Sex Factors; Stents; Time Factors; Treatment Outcome
PubMed: 31475624
DOI: 10.1161/JAHA.119.013088 -
Vascular Dec 2017Objectives To evaluate the novel Phoenix Atherectomy System as percutaneous treatment of de novo and restenotic infrainguinal arterial lesions. Methods This prospective,... (Clinical Trial)
Clinical Trial
Objectives To evaluate the novel Phoenix Atherectomy System as percutaneous treatment of de novo and restenotic infrainguinal arterial lesions. Methods This prospective, multicenter, nonrandomized investigational device exemption trial was conducted across 16 US and German centers between August 2010 and April 2013. Intention-to-treat enrollment was 128 patients (mean age: 71.8 years, 59% male) with 149 lesions (mean length: 34 mm, mean diameter stenosis: 89.5%), and the primary analysis per-protocol population consisted of 105 patients with 123 lesions. The primary efficacy endpoint, technical success, was the achievement of acute debulking with a post-atherectomy residual diameter stenosis ≤50% (before adjunctive therapy). The primary safety endpoint was the major adverse event (MAE) rate through 30 days. Results For the primary analysis per-protocol population, the rate of lesion technical success was 95.1% (117/123), with the lower limit of the 95% CI 90.6%, meeting the prospectively established target performance goal of ≥86%. After post-atherectomy adjunctive therapy, residual stenosis was ≤30% for 99.2% (122/123) of lesions (mean final diameter stenosis 10.5%). Improvement of ≥1 Rutherford class occurred for 74.5% of patients through 30 days and for 80% through six months. MAEs were experienced by 5.7% (6/105) of patients through 30 days (with the upper limit of the 95% CI 11.0%, meeting the target performance goal of <20%), and 16.8% through six months. Six-month freedom from TLR and TVR was 88.0% and 86.1%, respectively. Conclusions Based on the high rate of technical success and the low rates of MAEs through six months, the Phoenix Atherectomy System is safe and effective for the debulking of lower-extremity arterial lesions. ClinicalTrials.gov identifier NCT01541774.
Topics: Aged; Aged, 80 and over; Atherectomy; Constriction, Pathologic; Equipment Design; Female; Germany; Humans; Lower Extremity; Male; Middle Aged; Peripheral Arterial Disease; Prospective Studies; Recurrence; Time Factors; Treatment Outcome; United States; Vascular Patency
PubMed: 28950783
DOI: 10.1177/1708538117712383 -
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: No ID Found -
Kardiologia Polska 2021
Topics: Angioplasty, Balloon, Coronary; Atherectomy, Coronary; Coronary Artery Disease; Humans; Lithotripsy; Treatment Outcome
PubMed: 33890748
DOI: 10.33963/KP.15962 -
Kardiologia Polska 2023
Topics: Humans; Non-ST Elevated Myocardial Infarction; Atherectomy; Coronary Artery Disease; Lithotripsy
PubMed: 36446072
DOI: 10.33963/KP.a2022.0269 -
Circulation Journal : Official Journal... Mar 2023
Topics: Humans; Atherectomy, Coronary; Calcinosis; Coronary Artery Disease; Arteries; Vascular Calcification; Treatment Outcome; Coronary Angiography; Atherectomy
PubMed: 36725006
DOI: 10.1253/circj.CJ-22-0664 -
The American Journal of Cardiology Oct 1993An assessment of complications is essential to the evaluation of directional coronary atherectomy. Major complications--such as death, Q wave myocardial infarction, or... (Review)
Review
An assessment of complications is essential to the evaluation of directional coronary atherectomy. Major complications--such as death, Q wave myocardial infarction, or the need for emergency bypass surgery to correct acute vessel closure--result from a variety of familiar mechanisms, including dissection, thrombosis, or guiding catheter injury. In addition, unique complications of this device, such as catheter nose cone injury or vascular perforation, may also result in severe ischemia. With prompt recognition of the cause, most ischemic complications can be successfully treated in the catheterization laboratory. Less severe complications, such as femoral vascular injury, also require recognition and appropriate treatment in order to minimize sequelae. Although several large series have now documented that the overall incidence of atherectomy complications appears similar to that reported for conventional balloon angioplasty, no direct comparisons can be made until randomized trials (such as Coronary Angioplasty Versus Excisional Atherectomy Trial [CAVEAT]) are analyzed, to control for potential demographic or lesion-specific influences on complication rates.
Topics: Atherectomy, Coronary; Cardiac Catheterization; Coronary Artery Bypass; Coronary Artery Disease; Coronary Thrombosis; Coronary Vasospasm; Coronary Vessels; Emergencies; Humans; Myocardial Infarction; Postoperative Complications
PubMed: 8213570
DOI: 10.1016/0002-9149(93)91038-j