Use of orbital atherectomy treatment in a high-volume clinical practice modifies non-compliant plaque to deliver durable long-term results.
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BACKGROUND: Resistant fibrotic calcified plaque is a major limitation in treating peripheral arterial disease (PAD). Percutaneous transluminal angioplasty (PTA) balloon pressures of 8-16 atm are typically required in these lesions. Ultrasound has detected significant dissection or plaque fracture immediately after balloon dilation in 76% of patients. Endovascular techniques are available that remove calcified plaque and alter lesion compliance, which minimizes dissection and stenting. A single-center experience evaluating the long-term durability of calcified plaque removal utilizing orbital atherectomy is presented. METHODS: Patients with PAD underwent primary intervention with orbital atherectomy followed by low-pressure balloon angioplasty. Lesion compliance markers, including balloon inflation pressures and times, dissection rates, and bail-out stent rates, were recorded. Twelve-month re-intervention rates were also tracked. RESULTS: Forty-six patients (57 lesions) were treated. Average age was 71 years and 74% of the patients were male. Rutherford classification was 3 to 5 for all patients. Lesion locations were in the common femoral artery (9%), superficial femoral artery (56%), popliteal artery (19%), and tibial/peritoneal arteries (16%). Average pretreatment stenosis was 90%. Adjunctive PTA was utilized in 82.5% of the lesions. Mean maximum inflation pressure was 5 atm for a mean of 2.3 minutes. Mean residual stenosis was 11%. One dissection occurred and no bailout stenting was required. Five patients (10.9%) returned for target lesion re-treatment. CONCLUSION: Orbital atherectomy modifies calcified lesion compliance in resistant peripheral arterial plaques as demonstrated by low balloon inflation pressures of short duration. Bail-out stenting was eliminated. Results were durable and the re-intervention rate was low. (+info)
Capture and removal of atheromatous plaque, from the lesion site, post directional atherectomy of long, in-stent restenotic superficial femoral artery lesions.
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The clinical impact of embolic debris released during lower-limb interventions is a source of discussion and controversy. Yet, the sheer magnitude of their number, overall area, and morphology suggest significance, especially in complex and high-risk patients. Technologies designed for lowering embolic burden are required to improve peripheral vascular intervention (PVI) outcomes and to reduce complication rates in a timely and cost-effective manner. This work details capture and removal of atheromatous plaque during post-atherectomy dilatation of long, in-stent, restenotic superficial femoral artery (SFA) lesions in two complex comorbid patients. In both cases, embolic removal was obtained by deployment of an embolic protection device (EPD) prior to the main intervention and by postdilating the lesion using the Proteus aspiration balloon. Captured and removed particles were analyzed and compared for content, count, and dimensions from both the EPD and the Proteus device. Both cases were successfully resolved, as determined by angiography with no sequelae. In both procedures, Proteus surpassed the EPD in the magnitude of removed embolic shower. In case 1, the Proteus balloon captured 228 particles, with a mean major axial dimension of 0.4 +/- 0.43 mm (range, 0.12-3.29 mm), while the distally positioned EPD captured 16 particles with a mean major axial dimension of 0.88 +/- 1.25 mm. Similarly, 719 particles of a mean 0.24 +/- 0.43 mm major axial dimension (range, 0.03-4.83 mm) were recovered in case 2. The capture efficiency presented by the Proteus device over the EPD suggests its potential to serve as a viable tool in complex PVIs, particularly in the dilatation of irregular atherectomized lesions. (+info)
A critical view of the peripheral atherectomy data in the treatment of infrainguinal arterial disease.
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BACKGROUND: Revascularization of the peripheral arteries remains technically challenging. By decreasing the volume of the atherosclerotic plaque, debulking procedures may confer superior primary patency after revascularization. AIMS: To assess the impact of atherectomy on primary patency rates at 12 months compared to balloon angioplasty and/or stent placement alone in patients with infrainguinal arterial disease. METHODS: A database search for "directional," "orbital," "rotational," and "laser atherectomy" in peripheral arterial disease (PAD) was performed. Studies were screened according to the STROBE (Strengthening the Reporting of Observational studies in Epidemiology) critical appraisal tool and summarized by population, methodology, and outcomes (primary patency and major adverse events). RESULTS: Only two randomized studies were found. Most of the data were obtained from single-arm studies and registries. The primary patency with directional atherectomy approaches 60% at 12 months as a stand-alone technique, whereas orbital atherectomy in conjunction with balloon angioplasty and stenting achieved primary patency rates of 90%. Laser atherectomy is universally employed with balloon angioplasty and stenting for in-stent restenosis lesions with a primary patency rate of 64%. Although there are data for the safe use of rotational atherectomy, robust data to support its effectiveness are lacking. The combination of drug-coated balloons and atherectomy for the treatment of heavily calcified lesions in patients with critical limb ischemia is under evaluation. CONCLUSION: Despite the successful procedural outcomes reported in clinical registries, the available data do not support the use of atherectomy alone in PAD. Larger randomized controlled studies are warranted to define its role in contemporary endovascular practice. (+info)
Expression of tumour necrosis factor alpha and accumulation of fibronectin in coronary artery restenotic lesions retrieved by atherectomy.
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BACKGROUND: The formation of coronary artery neointima experimentally induced in piglets after cardiac transplantation is related to an immune-inflammatory reaction associated with increased expression of T cells and inflammatory mediators (tumour necrosis factor alpha and interleukin 1 beta) and upregulation of fibronectin. In vivo blockade of tumour necrosis factor alpha in rabbits after cardiac transplantation results in reduced neointimal formation. The objective of this study was to investigate the hypothesis that coronary restenosis after atherectomy or percutaneous balloon angioplasty is associated with a similar inflammatory cascade initiated by mechanical injury. METHODS: Specimens taken at coronary atherectomy were analysed from 16 patients. Nine had had the procedure performed twice, firstly, to remove a primary lesion, and secondly, to remove a restenotic lesion. Seven had percutaneous balloon angioplasty after removal of restenotic tissue. Coronary atherectomy specimens were analysed by immunohistochemistry for the presence of T cells, macrophages, major histocompatibility complex II, interleukin 1 beta, tumour necrosis factor alpha, fibronectin, and the receptor for hyaluronan mediated motility. RESULTS: The groups were clinically and angiographically similar with equivalent lumens before and after atherectomy. Restenotic lesions had increased expression of tumour necrosis factor alpha and fibronectin compared with the primary lesions (P < 0.05 for both). There was also a trend towards a greater number of T cells and increased expression of interleukin 1 beta. CONCLUSIONS: Restenosis is associated with increased expression of tumour necrosis factor alpha and fibronectin, suggesting that an immune-inflammatory reaction probably contributes to neointimal formation and may represent a form of wound healing and repair secondary to mechanical injury. (+info)
Directional atherectomy versus balloon angioplasty for coronary ostial and nonostial left anterior descending coronary artery lesions: results from a randomized multicenter trial. The CAVEAT-I investigators. Coronary Angioplasty Versus Excisional Atherectomy Trial.
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OBJECTIVES: We hypothesized that atherectomy would be superior to balloon angioplasty for ostial and nonostial left anterior descending coronary artery lesions. BACKGROUND: Balloon angioplasty of ostial coronary artery lesions has been associated with a lower procedural success rate and a higher rate of complications and of restenosis than angioplasty of nonostial stenoses. Directional coronary atherectomy has been proposed as an alternative therapy for ostial lesions. METHODS: In the Coronary Angioplasty Versus Excisional Atherectomy Trial (CAVEAT-I), 1,012 patients were randomized to undergo either procedure; 563 patients had proximal left anterior descending coronary artery lesions, of which 74 were ostial. We compared balloon angioplasty with directional atherectomy for early and 6-month results for ostial as well as nonostial proximal left anterior descending coronary artery lesions. RESULTS: Directional atherectomy led to an initially higher gain in minimal lumen diameter for ostial lesions (1.13 vs. 0.56 mm, respectively, p < 0.001) but a higher rate of adjudicated non-Q wave myocardial infarction (24% vs. 13%, respectively, p < 0.001) than balloon angioplasty and no improvement in restenosis rates (48% vs. 46%, respectively). In the nonostial proximal left anterior descending coronary artery lesions, angiographic restenosis was reduced (51% vs. 66%, p = 0.012), but this was also associated with a higher rate of periprocedural myocardial infarction (8% vs. 2%, p = 0.008 by site and 24% vs. 8%, p < 0.001 by adjudication) and no difference in the need for subsequent coronary artery bypass surgery (7.3% vs. 8.4%, respectively) or repeat percutaneous coronary intervention (24% vs. 26%, respectively). CONCLUSIONS: For ostial left anterior descending coronary artery stenoses, both procedures yielded similar rates of initial success and restenosis, but atherectomy was associated with more non-Q wave myocardial infarction. In this trial the predominant angiographic benefit (increased early gain and less angiographic restenosis) of atherectomy for the left anterior descending coronary artery was in proximal nonostial lesions. However, the tradeoffs for this angiographic advantage were more in-hospital myocardial infarctions and no decrease in clinical restenosis. (+info)
Apoptosis in human atherosclerosis and restenosis.
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BACKGROUND: Apoptosis has been recognized in normal, including rapidly proliferating, cell populations and is inferred to be potentially responsible for the maintenance of stable cell numbers in tissues with various degrees of proliferative activity. Previous studies performed in rats indicated that despite the persistence of a relatively high level of injury-induced proliferative activity, total arterial smooth muscle content at 12 weeks remained unchanged from that measured at 2 weeks, suggesting that accrual of vascular smooth muscle cells is mitigated by cell death. The extent to which apoptosis may be observed in human atherosclerosis and/or restenosis, however, has not been previously established. METHODS AND RESULTS: We performed immunohistochemical studies on 56 specimens retrieved from patients undergoing directional atherectomy for primary atherosclerotic lesions or recurrent arterial narrowing after percutaneous revascularization (restenosis). Immunohistochemical staining disclosed evidence of apoptosis in 35 (63%) of the 56 specimens studied. When present, immunohistochemical evidence of apoptosis was typically limited to < 2% of cells in the specimen. The finding of apoptosis, however, was not distributed equally among four groups of specimens studied. Specimens retrieved from patients with restenosis were more frequently observed to contain foci of apoptosis than specimens retrieved from patients with primary atherosclerotic lesions. Among 14 peripheral arterial specimens from patients with restenosis, 13 (93%) contained foci of apoptosis; in contrast, apoptosis was observed in only 6 (43%) of 14 peripheral specimens from patients with primary lesions (P = .0046). Among coronary arterial specimens, apoptosis was observed in 12 (86%) of 14 specimens from patients with restenosis versus 6 (29%) of 14 specimens from patients with primary obstructions (P < .0075). CONCLUSIONS: Apoptosis is a feature of human vascular pathology, including restenotic lesions and, to a lesser extent, primary atherosclerotic lesions. The findings of the present study suggest that apoptosis may modulate the cellularity of lesions that produce human vascular obstruction, particularly those with evidence of more extensive proliferative activity. (+info)
Directional atherectomy versus balloon angioplasty in segmental femoropopliteal artery disease: two-year follow-up with color-flow duplex scanning.
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PURPOSE: Directional atherectomy is an endovascular interventional technique for excision and removal of obstructive arterial lesions. To evaluate whether atherectomy would provide better results than conventional balloon angioplasty (BA) in symptomatic femoropopliteal disease, a prospective randomized study comparing the early and late outcomes of these techniques was conducted. The rate of restenosis or occlusion was assessed by use of color-flow duplex scanning during the follow-up period. METHODS: Seventy-three patients were randomized between atherectomy (38 patients) and BA (35 patients). All patients had segmental lesions of the femoropopliteal arteries amenable to either technique. The median follow-up duration was 13 months (range 1 to 39). Follow-up comprised regular clinical and hemodynamic assessment and color-flow duplex examinations. Restenosis was defined on the basis of a peak systolic velocity ratio of 2.5 or greater, and occlusion of the treated segment was diagnosed if flow signals were absent, that is, loss of patency. RESULTS: Residual stenoses (> or = 30% diameter reduction) resulted in five patients (13%) undergoing atherectomy and three patients (9%) undergoing BA. At 1 month clinical and hemodynamic improvement by Society for Vascular Surgery/International Society for Cardiovascular Surgery criteria for lower limb ischemia was observed in 34 patients (89%) treated with atherectomy and in 34 (97%) treated with BA. By life-table analysis the cumulative rate of clinical and hemodynamic success at 2 years was 52% in patients treated with atherectomy and 87% in patients treated with BA (p = 0.06). The patency rate at 2 years of treated segments was 34% in the atherectomy group and 56% in patients treated with BA (p = 0.07). In patients with lesions greater than 2 cm, the 1-year patency rate of AT was significantly lower than BA (p = 0.03). CONCLUSIONS: Atherectomy does not result in an improved clinical and hemodynamic outcome. Furthermore atherectomy of segmental atherosclerotic femoropopliteal disease does not result in a better patency rate than BA, and, in lesions with greater length than 2 cm, the atherectomy results are significantly worse. (+info)