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Orbital Atherectomy Plaque Modification Assessment of the Femoropopliteal Artery Via Intravascular Ultrasound (TRUTH Study).

ABSTRACT: The Tissue Removal Assessment with Ultrasound of the SFA and Popliteal (TRUTH) study assessed the performance of the orbital atherectomy system (OAS) to treat femoropopliteal arteries, including determining its effect on plaque removal.Patients with symptomatic femoropopliteal peripheral arterial disease were treated with the OAS followed by adjunctive balloon angioplasty (BA). Intravascular ultrasound (IVUS) images were collected pre- and post-OAS and post-OAS BA. Patients were followed through 12 months post-procedure.Twenty-nine lesions were treated with OAS-BA in 25 patients. The mean maximum balloon inflation pressure was 5.2 ± 1.2 atm. Virtual histology IVUS (VH-IVUS) analysis revealed at the maximum calcium ablation site that calcium reduction was responsible for 86% of the lumen area increase. The minimum lumen area increased from 4.0 mm(2) to 9.1 mm(2) (<.0001), and the percentage of area stenosis decreased from 76.9% to 43.0% (<.0001) after OAS-BA. At 12 months, the target lesion revascularization rate was 8.2%, and ankle-brachial index and Rutherford classification improved significantly from baseline through follow-up.The VH-IVUS analysis reveals that OAS modifies the calcified component of the plaque burden. It is hypothesized that calcium modification by OAS changes the lesion compliance, allowing for low pressure adjunctive BA. The clinical outcomes were favorable through 12-month follow-up.

SUBMITTER: Babaev A

PROVIDER: S-EPMC4647186 | biostudies-literature | 2015 Oct

REPOSITORIES: biostudies-literature

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Orbital Atherectomy Plaque Modification Assessment of the Femoropopliteal Artery Via Intravascular Ultrasound (TRUTH Study).

Babaev Anvar A Zavlunova Susanna S Attubato Michael J MJ Martinsen Brad J BJ Mintz Gary S GS Maehara Akiko A

Vascular and endovascular surgery 20151020 7

<h4>Objective</h4>The Tissue Removal Assessment with Ultrasound of the SFA and Popliteal (TRUTH) study assessed the performance of the orbital atherectomy system (OAS) to treat femoropopliteal arteries, including determining its effect on plaque removal.<h4>Methods</h4>Patients with symptomatic femoropopliteal peripheral arterial disease were treated with the OAS followed by adjunctive balloon angioplasty (BA). Intravascular ultrasound (IVUS) images were collected pre- and post-OAS and post-OAS ...[more]

PMID: 26490645

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Project description:Background:Orbital 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. Methods:Retrospective 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. Results:Orbital 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. Conclusions:This 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:BackgroundCardiac valvular calcification is associated with the overall coronary plaque burden and considered an independent cardiovascular risk and prognostic factor. The purpose of this study was to evaluate the relationship between the presence of valvular calcification and plaque morphology and/or vulnerability.MethodsTransthoracic echocardiography was used to assess valvular calcification in 280 patients with coronary artery disease who underwent radiofrequency intravascular ultrasound (Virtual Histology IVUS, VH-IVUS). A propensity score-matched cohort of 192 patients (n = 96 in each group) was analyzed. Thin-capped fibroatheroma (TCFA) was defined as a necrotic core (NC) >10% of the plaque area with a plaque burden >40% and NC in contact with the lumen for ≥3 image slices. A remodeling index (lesion/reference vessel area) >1.05 was considered to be positive.ResultsPatients were divided into two groups: any calcification in at least one valve (152 patients) vs. no detectable valvular calcification (128 patients). Groups were similar in terms of age, risk factors, clinical diagnosis, and angiographic analysis after propensity score-matched analysis. Gray-scale IVUS analysis showed that the vessel size, plaque burden, minimal lumen area, and remodeling index were similar. By VH-IVUS, % NC and % dense calcium (DC) were greater in patients with valvular calcification (p = 0.024, and p = 0.016, respectively). However, only % DC was higher at the maximal NC site by propensity score-matched analysis (p = 0.029). The frequency of VH-TCFA occurrence was higher depending on the complexity (p = 0.0064) and severity (p = 0.013) of valvular calcification.ConclusionsThere is a significant relationship between valvular calcifications and VH-IVUS assessment of TCFAs. Valvular calcification indicates a greater atherosclerosis disease complexity (increased calcification of the coronary plaque) and vulnerable coronary plaques (higher incidence of VH-TCFA).

Dataset Information

Orbital Atherectomy Plaque Modification Assessment of the Femoropopliteal Artery Via Intravascular Ultrasound (TRUTH Study).

Publications

Orbital Atherectomy Plaque Modification Assessment of the Femoropopliteal Artery Via Intravascular Ultrasound (TRUTH Study).

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