Percutaneous transluminal atherectomy: Preliminary results

Percutaneous transluminal atherectomy with the Simpson atherectomy catheter was performed in 10 patients with 14 severe atheromatous stenoses of the femoropopliteal arteries. Removal of plaque material with restoration of vessel patency was successful in all patients without complication. Further clinical follow-up will have to determine whether the recurrence rate of stenoses will be lower with this method than with conventional balloon angioplasty.     

Directional atherectomy in the treatment of stenotic dialysis access fistulas

Directional atherectomy has proved useful in the treatment of peripheral vascular occlusive disease, and the authors have begun using this modality in the treatment of patients with failing hemodialysis access fistulas. The authors describe their initial experience with 13 patients in whom directional atherectomy was used to treat stenotic hemodialysis fistulas. Directional atherectomy was the sole treatment modality for eight patients. Three patients underwent atherectomy after unsuccessful percutaneous transluminal angioplasty (PTA). In two patients, unsuccessful atherectomy necessitated subsequent PTA. Directional atherectomy was successful in 10 of 13 patients. In seven of these 10 patients who are still alive, the dialysis fistulas remain patent. Directional atherectomy is a safe and useful technique in the percutaneous treatment of hemodialysis fistula stenosis. Early data indicate patency rates that may be higher than those reported with PTA.     

Blue toe syndrome: treatment with percutaneous atherectomy

"Blue toe syndrome" refers to digital ischemia of the foot in the presence of palpable or Doppler audible pedal pulses. This clinical syndrome is caused by microembolization to small vessels from a proximal source. The use of percutaneous transluminal atherectomy is described in the treatment of embologenic superficial femoral artery lesions in seven patients. All seven had prompt healing of the ischemic toes, and none required surgical revascularization or amputation. One patient developed a recurrent stenosis at the atherectomy site and had a second episode of digital ischemia, which was treated by means of atherectomy with a larger device. Histologic study of atherectomy specimens suggests that emboli arise from adherent fibrinoplatelet aggregates or thrombus and less often from cholesterol-rich atheromatous plaque. Although either percutaneous transluminal angioplasty or atherectomy can be used to treat the underlying stenosis, percutaneous atherectomy offers the advantage of nonsurgical removal of embologenic material and provides material for histologic study. Percutaneous atherectomy is an effective method of treating embologenic superficial femoral stenoses in patients with ipsilateral blue toe syndrome.     

Aortoiliac angioplasty: is there a need for other types of percutaneous intervention?

In a retrospective study, the authors compared results in 81 patients who underwent 117 percutaneous transluminal angioplasty (PTA) procedures in the iliac arteries and 21 patients who underwent iliac artery atherectomy. Both groups were similar with respect to symptoms and risk factors. The overall technical success rates were 97.4% for PTA and 100% for atherectomy. The initial clinical success was 92.8% for PTA and 100% for atherectomy. Complications requiring surgery occurred in four of 117 (3.4%) PTA and one of 21 (4.8%) atherectomy procedures. The 2-year patency rate for PTA was similar to that achieved with atherectomy in a smaller patient population. These results indicate that atherectomy does not offer any definite advantage over conventional PTA for the routine management of iliac lesions and make it difficult to justify the additional expense and complexity of this technique.     

Peripheral atherectomy: experimental results with a new device

The size of present rotational atherectomy devices is limited in part by a tendency to produce vessel torsion. The authors designed and investigated a large-bore rotational atherectomy device for peripheral atherectomy in a single pass without significant torsion. A plaque was retrieved from 36 of 40 cadaveric iliac arteries. The mean plaque size was 8.4 x 3.9 mm, and the average number retrieved per artery was two. Thirty of 34 severely calcified arteries were treated successfully. Effluent study revealed no distal embolization; however, six perforations and four dissections occurred. Preliminary results suggest that a cutting surface with a relatively large diameter can be designed to be effective without producing vessel torsion. Changes in future designs will include added flexibility and expandable cutting surfaces to enhance safety and minimize entry diameter.     

Effectiveness and Safety of Atherectomy versus Plain Balloon Angioplasty for Limb Salvage in Tibioperoneal Arterial Disease

PurposeTo 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 MethodsPatients 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.ResultsThe 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.ConclusionsIn 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.     

Percutaneous transluminal rotational atherectomy in the treatment of peripheral vascular disease using a transluminal endatherectomy catheter (TEC): Initial results and angiographic follow-up

Purpose To evaluate the clinical results of percutaneous transluminal rotational atherectomy in the treatment of peripheral vascular disease. Methods Rotational atherectomy was performed in 39 patients aged 39–87 years (mean 66.6 years). A total of 71 lesions (43 stenoses and 28 occlusions) were treated in 40 limbs. Additional balloon angioplasty was required in 54% of lesions. Fifteen patients (37.5%) presented in Fontaine stage II, 10 patients (25%) in Fontaine stage III and 15 patients (37.5%) in Fontaine stage IV. Rotational atherectomy at 750 rpm was carried out over a 0.014-inch guidewire with continuous aspiration into a vacuum, bottle. Follow-up angiography and color flow Doppler examinations were performed in 22 patients (23 limbs) after a mean period of 6 months (range 2–14 months) Results There was one primary technical failure. In 36 of 40 lesions there was a good angiographic result with residual stenoses in less than 30%. In 70 lesions treated by rotational atherectomy, however, 54% showed residual stenoses of 30%–50% and these cases required additional balloon angioplasty. The mean ankle-brachial index improved significantly (p<0.001), from 0.49 before the procedure to 1.01 after the procedure. A single distal embolus, related to primary recanalization, occurred and there were two large inguinal hematomas. Cumulative clinical patency after 6 months was 83.8% and cumulative angiographic patency after 6 months was 79.1%. Conclusion Percutaneous rotational atherectomy is a promising approach for the treatment of chronic peripheral vascular disease. Further prospective, randomized studies are necessary to compare percutaneous transluminal angioplasty with this new technical approach.     

Peripheral artery atherectomy: description of technique and report of initial results

Percutaneous transluminal atherectomy has been developed for treatment of peripheral artery stenoses. The atherectomy catheter is inserted through a sheath, and the resection window of the catheter is positioned adjacent to the vascular stenosis. The balloon is inflated, and the motor-driven cutting blade advanced. The balloon is then deflated, the catheter withdrawn, and the atheromatous material, which resembles the resected material of an endarterectomy, removed from the catheter. This process is repeated until the resection provides an adequate lumen. To date, 12 arterial lesions (three common iliac, two external iliac, four superficial femoral, and three popliteal artery) in ten patients have been resected with excellent angiographic results. The conditions of seven patients who underwent atherectomy for relief from claudication were improved by the criteria of ankle/arm ratios and/or claudication distance. Three patients successfully underwent atherectomy for limb salvage. More data on long-term patency and restenosis rates are needed before the ultimate role of atherectomy in the management of peripheral artery disease can be determined.     

Directional atherectomy in iliac stent failure: Clinical technique and histopathologic correlation

Purpose: To assess the feasibility and efficacy of directional atherectomy in the treatment of iliac stent stenosis or occlusion and to evaluate the histologic composition of excised atherectomy specimens. Methods: Directional atherectomy of six occluded and 10 severely stenosed iliac stents was undertaken in 12 patients at a mean interval of 28 months (range 3–69 months) after stent insertion for occlusive aortoiliac disease. In cases of stent occlusion, atherectomy was preceded by low-dose thrombolysis. In all patients stent clearance with return of femoral pulses was achieved within 24 hr and there were no significant complications. All excised specimens were sent for histologic examination. Results: Eleven patients (92%) remain symptom free with unlimited walking distance at a mean follow-up interval of 11.5 months (range 3–31 months) after treatment. Histologic examination revealed typical myointimal hyperplasia at three excision sites, intimal fibrosis at three sites, atheroma at four sites and organized thrombus at six sites. Conclusion: Atherectomy offers an effective treatment in iliac stent occlusion and restenosis with no significant adverse effects. Debulking of these lesions seems to offer a more logical approach than simple balloon angioplasty. Clinical and duplex follow-up confirms satisfactory outcome within the first year but longer-term results are not yet known. The histologic data obtained demonstrate that stent restenosis and occlusion are likely to be multifactorial, and challenge the assumption that myointimal hyperplasia is the sole cause of iliac stent occlusion.     

Percutaneous intravascular US as adjunct to catheter-based interventions: preliminary experience in patients with peripheral vascular disease

Catheter-based ultrasound (US) transducers may be introduced into the vascular system to record high-resolution images of the vessel wall and lumen. The potential advantages and existing liabilities of percutaneous intravascular US as an adjunct to transluminal vascular recanalization were investigated. A 6.6-F braided, polyethylene catheter enclosing a rotary drive shaft with a single-element, 20-MHz transducer at the distal tip was used in 17 patients undergoing percutaneous transluminal (balloon) angioplasty (PTA) alone (10 patients), PTA with implantation of an endovascular stent (two patients), atherectomy alone (two patients), or laser angioplasty with PTA and/or atherectomy (three patients). The arteries treated and examined included the common iliac in five patients, the external iliac in two, the superficial femoral in nine, and a vein graft-arterial anastomosis in one. In 14 cases PTA was employed as sole or adjunctive therapy; plaque cracks were clearly delineated with intravascular US in all 14 (100%) and dissections were observed in 11 (78%). Plaque-arterial wall disruption was less prominent in the arteries treated with mechanical atherectomy. The results of laser angioplasty reflected the adjunctive modality employed. After stent implantation, serial intravascular US documented effacement of PTA-induced plaque cracks and/or dissections. Intravascular US also aided in the quantitative assessment of luminal cross-sectional areas after the procedures (19.0-51.8 mm2). The observations recorded in this preliminary group of 17 patients illustrate the potential utility of intravascular US as an adjunct to conventional angiography in patients undergoing percutaneous revascularization.     

1990 ARRS Executive Council Award. Intravascular sonography in the detection of arteriosclerosis and evaluation of vascular interventional procedures.

The purpose of this study was to evaluate the use of intravascular sonography for the detection of arteriosclerosis and to determine the effects of vascular interventional procedures on the arterial wall. A catheter-based 20-MHz transducer was used. Forty patients were studied. Twelve had clinical evidence of peripheral vascular disease, 13 were healthy renal donors, and 15 underwent vascular interventional procedures. The aorta and the ipsilateral iliac artery were examined in real time under fluoroscopic guidance and the results were compared with angiography. Sonography in eight of the 13 renal donors showed arterial wall abnormalities in the absence of angiographic evidence of disease. Sonography of the 15 patients after angioplasty or atherectomy demonstrated plaque fractures, intramural dissections, or atherectomy grooves. Our experience suggests that intravascular sonography is of value in reducing the use of angiography to monitor progress or complications of vascular interventional procedures.     

Directional atherectomy treatment for hemodialysis access: early results.

The Simpson atherectomy device was used to treat 12 intragraft stenoses, six complete subclavian vein occlusions, and 14 venous outflow stenoses in 24 patients undergoing hemodialysis. Patients were followed up clinically and by means of venography at approximately 1, 3, 6, 9, and 12 months after treatment. Twenty-eight atherectomy specimens were examined histologically. Twenty-six (81%) of 32 lesions were treated with initial technical success. Including technical failures, seven (58%) of 12 intragraft stenoses are angiographically patent at a mean of 5.0 months and five (50%) of 10 are clinically patent at 6 months. Three (50%) of six subclavian veins are angiographically patent at a mean of 5.6 months, and four (67%) of six are clinically patent at 6 months. Three (21%) of 14 venous outflow stenoses are angiographically patent at a mean of 5.0 months and five (38%) of 13 are clinically patent at 6 months. Histologic examination showed neointimal fibromuscular hyperplasia in 26 of 28 lesions. When 30% or less angiographic residual stenosis is used as the criterion for initial technical success, directional atherectomy appears to be effective therapy for intragraft stenoses and, with balloon angioplasty, for some catheter insertion-related subclavian occlusions. Directional atherectomy appears to have a recurrence rate for venous outflow stenoses similar to that for balloon angioplasty when the same criterion is used.     

Retrograde Rotablator in Limb Salvage: A New Technique Using an Open Approach

Conventional vascular surgery and balloon angioplasty have poor results in severe and diffuse atherosclerotic disease of the infrapopliteal arteries. High-speed rotational atherectomy (Auth Rotablator) has not succeeded either, because of poor long-term patency and the non-reflow phenomenon. We report a case of limb salvage with long occlusion of the three infrapopliteal vessels. The anterior tibial artery was treated with retrograde Auth Rotablator atherectomy by an open approach through the pedal artery, resulting in full patency of the anterior tibial artery and healing of the skin lesions. The microparticulate debris from the ablation was drained out through the pedal arteriotomy, avoiding the complications associated with conventional antegrade high-speed rotational atherectomy.     

Changes in the National Endovascular Management of Femoropopliteal Arterial Disease: An Analysis of the 2011–2019 Medicare Data

PurposeTo describe national trends in the utilization of endovascular approaches (including balloon angioplasty, atherectomy, and stent placement) for the management of femoropopliteal peripheral arterial disease (PAD).Materials and MethodsThe Medicare Physician/Supplier Procedure Summary dataset containing 100% of Part B claims was interrogated for years 2011–2019. The Current Procedural Terminology codes specific for femoropopliteal angioplasty, stent placement, and atherectomy were used to create summary statistics for utilization by year, place of service (hospital inpatient, hospital outpatient, and office-based laboratory), and provider specialty (cardiology, radiology, and surgery).ResultsThe use of atherectomy increased from 34,732 (33%) procedures in 2011 to 75,435 (53%) procedures in 2019, and atherectomy became the dominant treatment strategy for femoropopliteal PAD. The relative utilization of stent placement (36,793 [35%] to 28,899 [20%]) and angioplasty only (34,398 [32%] to 38,228 [27%]) decreased concomitantly from 2011 to 2019. By 2019, the use of atherectomy was twofold higher in office-based laboratories than in the outpatient hospital setting (44,767 and 20,901, respectively). Treatment strategy varied by provider specialty in 2011 when cardiologists used atherectomy most frequently (17,925 [43%]), whereas radiologists used angioplasty alone (5,928 [6%]) and surgeons stented (18,009 [37%]) most frequently. By 2019, all specialties utilized atherectomy most frequently (29,564 [59%] for cardiology, 10,912 [58%] radiology, and 33,649 [47%] surgery).ConclusionsThe national approach to endovascular management of femoropopliteal PAD has changed since 2011 toward an implant-free strategy, including a multifold increase in the use of atherectomy. Discordant rates of atherectomy use between the ambulatory hospital and office-based settings highlight the need for comparative effectiveness studies to guide management.     

Peripheral Simpson atherectomy. Indications and results of a new transluminal procedure for vascular recanalization

A report is given on the experience acquired to date with a new catheter method (Simpson atherectomy, S-AE) for reducing arteriosclerotic stenoses in the pelvic and leg arteries of 47 patients. If the correct instrument size is selected, one can regularly perform complete atherectomies in femoropopliteal vessels. The result of recanalization is not affected by the form of the stenosis, but eccentric, calcified or ulcerated lesions are ideal indications. Percutaneous transluminal angioplasty and atherectomy can be used as complementary methods to optimize percutaneous peripheral vascular recanalization. The histological findings, methodological limitations, and clinical results are discussed.     

Fat-Suppressed Gadolinium-Enhanced Three-Dimensional Magnetic Resonance Angiography Adequately Depicts the Status of Iliac Arteries Following Atherectomy and Stent Placement

Fat-suppressed, three-dimensional magnetic resonance angiography (3D MRA) was performed on nine patients with 11 iliac artery stenoses following atherectomy or stent placement. The MRA accurately depicted continued patency, restenosis, or aneurysm formation when compared with immediate posttreatment conventional arteriography. Therefore MRA is accurate and can be used independently for clinical decision making.     

Mechanical Recanalization of Subacute Vessel Occlusion in Peripheral Arterial Disease with a Directional Atherectomy Catheter

Purpose

To retrospectively examine the technical feasibility and safety of directional atherectomy for treatment of subacute infrainguinal arterial vessel occlusions.

Methods

Five patients (one woman, four men, age range 51–81?years) with peripheral arterial disease who experienced sudden worsening of their peripheral arterial disease–related symptoms during the last 2–6?weeks underwent digital subtraction angiography, which revealed vessel occlusion in native popliteal artery (n?=?4) and in-stent occlusion of the superficial femoral artery (n?=?1). Subsequently, all patients were treated by atherectomy with the SilverHawk (ev3 Endovascular, USA) device.

Results

The mean diameter of treated vessels was 5.1?±?1.0?mm. The length of the occlusion ranged 2–14?cm. The primary technical success rate was 100%. One patient experienced a reocclusion during hospitalization due to heparin-induced thrombocytopenia. There were no further periprocedural complications, in particular no peripheral embolizations, until hospital discharge or during the follow-up period of 1?year.

Conclusion

The recanalization of infrainguinal arterial vessel occlusions by atherectomy with the SilverHawk device is technically feasible and safe. In our limited retrospective study, it was associated with a high technical success rate and a low procedure-related complication rate.     

Midterm results after atherectomy-assisted angioplasty of below-knee arteries with use of the Silverhawk device

PURPOSE: Prospective evaluation of the 3- and 6-month results after atherectomy of below-knee arterial lesions with a reference diameter of at least 2.0 mm with use of the Silverhawk device. MATERIALS AND METHODS: Fifty-two below-knee lesions in 33 patients (61% men; mean age, 70 years +/- 11) with chronic peripheral occlusive disease of the lower limbs were treated with directional atherectomy. Target lesions were the popliteal artery (segment 3), n = 4 (8%); tibioperoneal trunk, n = 22 (42%); peroneal artery, n = 18 (34%); anterior tibial artery, n = 5 (10%); posterior tibial artery, n = 3 (6%); and in-stent lesions, n = 8 (16%). All interventions were performed via a 6-F sheath. The average degree of diameter stenosis was 89% +/- 10% (range, 70%-100%; n = 12 [23%] occlusions) and the mean lesion length was 48 mm +/- 28. RESULTS: All but one lesion (2%) could be treated with the atherectomy catheter. After additional balloon angioplasty, all but one lesion was treated, with a residual stenosis no greater than 30% (98%), with 7.2 passes per lesion +/- 2.8 (range, 1-12) performed with the device. Fifteen lesions (29%) were treated after predilation and 37 (71%) were treated with primary atherectomy. In 15 lesions (29%), additional balloon angioplasty was performed, and two lesions required stent implantation as a result of dissection. The mean stenosis diameter after atherectomy was 12% +/- 18% (range, 0-100%). After additional therapy, the mean stenosis diameter was 6% +/- 9% (range, 0%-30%). A residual stenosis no greater than 30% was achieved in 50 lesions (96%). The mean ankle-brachial index significantly increased from 0.46 +/- 0.27 to 0.80 +/- 0.34 before discharge and remained improved during follow-up. One procedural complication (3%) was observed in which an intermittent occlusion of the target vessel occurred after an unsuccessful attempt to cross the lesion with the atherectomy device; this was then treated successfully with local lysis. One patient with one treated lesion died during follow-up. The rates of restenosis of at least 70% (diagnosed by duplex ultrasonography) were 14% (seven of 51 lesions) after 3 months and 22% (11 of 51) after 6 months. The 3-month and 6-month cumulative event-free survival were 91% +/- 4.1% and 76.9% +/- 5.8% and the 3-month and 6-month cumulative patency rates were 98% +/- 1.9% and 94.1% +/- 3.3%, respectively. CONCLUSION: Below-knee native vessel lesions with a diameter of at least 2.0 mm can be treated with the Silverhawk catheter with a high success rate and a low complication rate. Midterm technical and clinical results are encouraging. Additional balloon angioplasty might be necessary in selected cases.     

Clinical Impact and Predictors of the Slow-Flow Phenomenon after Endovascular Treatment of Infrapopliteal Lesions Using the Crosser Catheter in Patients with Critical Limb Ischemia

PurposeTo determine the clinical impact and predictors of slow flow after endovascular treatment (EVT) using the Crosser catheter for debulking infrapopliteal lesions associated with critical limb ischemia.Materials and MethodsThis retrospective study included 65 patients with critical limb ischemia (70 limbs, 90 infrapopliteal lesions), who underwent EVT using the Crosser catheter between November 2011 and February 2017. The Crosser catheter was used when the balloon catheter could not be passed through the lesion or could not be dilated sufficiently. Slow flow was evaluated after atherectomy using Crosser and was defined as delayed antegrade flow to the foot (total number of cine frames >35).ResultsFollowing atherectomy, slow flow developed in 37 infrapopliteal lesions (41.1%). Despite secondary treatment, slow flow persisted in 29 of 37 lesions (78%). After atherectomy using the Crosser catheter, the balloon could be passed through the lesion in all cases. The wound healing rate at 1 year after EVT (overall, 67.8%) was significantly poorer in the presence of slow flow (rate with vs. without slow flow, 45.3% vs. 84.4%, respectively; P = .006), especially among patients with stage ≥3 baseline wound, ischemia, and foot infection. The active length of the Crosser catheter was a predictor of slow flow (odds ratio, 1.05; 95% confidence interval, 1.03–1.08; P < .001), with an optimal cutoff of 100 mm.ConclusionsSlow flow is associated with a poorer wound healing rate at 1 year, especially for patients with severe baseline ischemia. To reduce the risk of slow flow, the active length of the Crosser catheter should be kept at <100 mm.     

Endovascular treatment of femoropopliteal stenoses/occlusions with a SilverHawk directional atherectomy device: immediate results and 12-month follow-up

Purpose

This paper reports our immediate and 12-month follow-up results in the treatment of arterial stenoses/occlusions of the femoropopliteal region with the use of the SilverHawk directional atherectomy device (EV3, USA).

Materials and methods

In an 18-month period, we treated 18 patients (13 men, five women, age range 39–81 years) with the SilverHawk directional atherectomy device. Inclusion criteria were symptomatic femoropopliteal stenosis/insufficiency, nonresponsiveness to medical therapy, and Rutherford categories 3–5. Exclusion criteria were based on the preliminary colour Doppler ultrasound (US) assessment and were plaque with a calcified component >50% and inadequate upstream and/or downstream vascular bed. Patients with severe vascular impairment, classified as TransAtlantic Inter-Society Consensus (TASC) D, were also excluded.

Results

The procedure was successfully completed in all cases, with evident recanalisation and sufficient wall remodelling. No major complication was observed. At assessment immediately after the procedure and over the following days, an improvement in clinical symptoms and in the Rutherford scale was observed. Follow-up at 2 and 12 months identified one case of distal reocclusion subsequently treated with amputation, and two cases of restenosis (primary patency 79%) successfully treated with a repeat procedure (secondary patency 96%).

Conclusions

The SilverHawk directional atherectomy device proved to be an effective and safe tool in all our patients treated for femoropopliteal stenosis/occlusion, with a significant improvement in both imaging findings and clinical signs and symptoms.