Outcomes from a tertiary care center using a catheter thrombectomy system for managing acute iliofemoral deep vein thrombosis.

OBJECTIVE: The aim of the present study was to report a large, single-center experience using the ClotTriever thrombectomy system (Inari Medical, Irvine, CA) for the management of acute iliofemoral (IF) deep vein thrombosis (DVT). One limitation of all endovascular devices for the treatment of acute IF-DVT has been the inability to completely remove all acute thrombus and the need for adjunctive thrombolysis with its attendant risk of bleeding complications. METHODS: A single-center retrospective review of consecutive patients with acute IF-DVT treated with the ClotTriever thrombectomy system (Inari Medical) is reported. Procedural efficacy was evaluated by an independent core imaging laboratory (Syntactx, New York, NY). Both procedural and in-hospital safety were assessed during the index hospitalization. The treated vein patency was assessed using duplex ultrasound at 30 days after the procedure. RESULTS: A total of 96 patients were included in the present retrospective review, 40 of whom (40%) had contraindications to thrombolytic therapy. In terms of efficacy, 93 patients (97%) had ≥75% thrombus removal. During the index hospitalization, two patients (2%) had experienced a symptomatic pulmonary embolus. However, no mortality, major bleeding, or device-related complications had occurred in the study population. Of the 96 patients, 64 had undergone duplex ultrasound at 30 days after the procedure. Of the 64 patients, 62 had normal flow (97%), 53 (83%) had normal compressibility, and 11 (17%) had partial compressibility. CONCLUSIONS: The ClotTriever thrombectomy catheter was both safe and effective in our cohort of patients with acute IF-DVT outside a randomized clinical trial.

Treatment of acute limb ischemia with a percutaneous mechanical thrombectomy-based endovascular approach: 5-year limb salvage and survival results from a single center series.

OBJECTIVES: The study evaluated long-term limb salvage and survival of an endovascular approach that incorporates mechanical thrombectomy (PMT) in the management of arterial thrombosis. BACKGROUND: Acute limb ischemia is associated with a high risk of amputation and death. Previous reports from the United States (U.S.) of surgical and nonsurgical treatments are limited to primarily 30 days to 1 year. METHODS: Single-center, retrospective review of 57 consecutive patients (30 male, 27 female; mean age 63.8 +/- 13.8 years) treated for limb threatening ischemia due to thrombotic arterial occlusions. Data includes baseline assessments, procedural outcomes, in-hospital complications, 30-day, and long-term follow-up. RESULTS: Ninety-three percent of patients (n = 53) presented with onset of symptoms (<14 days). Angiography following PMT showed thrombus removal complete/substantial 36 (63.6%), partial 16 (28.0%), and minimal 5 (8.8%), respectively. Catheter-directed thrombolysis was used after PMT in 18 patients (31.6%). In-hospital success with limb salvage was attained in 96.5% (n = 55) with mortality of 3.5% (n = 2). Thirty-day limb salvage and mortality were 94.7% (n = 54) and 5.3% (n = 3), respectively. At mean 5-year follow-up (mean = 62 months), three patients have been lost to follow-up. The results of 54/57 (94.7%) are available. Amputation free survival was 94.7% (n = 36/38) with long-term mortality rate of 29.6% (n = 16/54). CONCLUSIONS: Acute limb ischemia treated with PMT alone or in combination with thrombolysis, followed by definitive therapy, results in favorable long-term limb salvage. Allowing for appreciable long-term mortality in vascular patients, survivors demonstrate amputation-free success from the initial endovascular procedure with low reintervention rate.

The use of femoropopliteal stent-grafts for critical limb ischemia.

Peripheral vascular disease of the femoropopliteal segment is one of the most common anatomic locations leading to patient symptoms. Traditional open surgical bypass has started to be supplanted by a surge in lower risk endovascular procedures. Though midterm results of endovascular therapy have been acceptable, longer term results, especially in long diffuse disease, appear to be less durable than their surgical alternatives. Recently the Viabahn, a percutaneously placed PTFE stent-graft, has been approved for use in the femoropopliteal artery. Though the majority of the data for this stent-graft has been derived from patients with complex (>10 cm length) lesions, most of the patients have been claudicants. The population with critical limb ischemia is at particularly high risk for cardiovascular mortality and may benefit from this less invasive approach. However, stent-graft utilization is more complex and many variables must be evaluated before and during the procedure to allow for optimal procedural outcomes.

Usefulness of optical coherent reflectometry with guided radiofrequency energy to treat chronic total occlusions in peripheral arteries (the GRIP trial).

Optical coherent reflectometry, a forward-looking, fiberoptic-guided device was used in 72 patients to direct radiofrequency energy across the central intraluminal portion of 75 chronic total occlusions in peripheral arteries (iliac, femoral, and popliteal) that failed attempts with conventional guidewires. The system was successful in crossing 76% of the chronic total occlusions with no clinical perforations or distal embolizations, and complications consisted of a single dissection greater than or equal to grade C.

Use of glycoprotein IIb/IIIa platelet inhibitors in peripheral vascular interventions.

With the expanding use of endovascular techniques for the treatment of peripheral vascular disease, consideration of glycoprotein IIb/IIIa receptor inhibitors to enhance the safety and efficacy of these procedures has increased. The scientific literature shows the benefits with the use of these agents in coronary vasculature interventions. However, data evaluating treatment with glycoprotein IIb/IIIa receptor inhibitors during peripheral vascular procedures is limited, with the vast majority of the trials investigating abciximab. With the varied vascular beds and end organs that may be affected by peripheral vascular intervention, the safety and efficacy may need to be studies for each area. The current literature ranging from carotid stenting to thrombolysis and mechanical thrombectomy for acute limb ischemia is reviewed, and recommendations are discussed on the use of these agents. The forthcoming results of controlled clinical trials should further clarify the clinical applications of these agents in peripheral vascular intervention.

The role of radiation therapy in the treatment of femoropopliteal occlusive disease.

With the success of brachytherapy in the coronary vessels as a guide, it has also shown promising initial results as an adjunct for the treatment and prevention of restenosis of femoropopliteal occlusive disease. With the rapid evolution of endovascular therapy, defining the role of brachytherapy will become even more important. The purpose of this review is to provide an overview of the role of brachytherapy in the treatment of restenosis following femoropopliteal endovascular intervention.

Mechanical thrombectomy in peripheral arterial interventions.

Acute arterial closure either from thrombosis or embolization often is a serious and potentially life-threatening clinical problem. Traditional surgical treatment options, such as bypass or balloon embolectomy, are efficacious but their overall clinical success is limited by the significant morbidity and mortality associated with the procedures. The use of less invasive stand-alone thrombolysis is limited by bleeding risk and the inherent delay in restoration of blood flow. Mechanical devices have been developed to help speed percutaneous treatment of arterial occlusion due to clot. Mechanical thrombectomy is best illustrated by rheolytic thrombectomy, which has matured as a therapy for acute limb ischemia. When experienced operators utilize this therapy with other complimentary endovascular devices, they often can allow for successful, less invasive therapy for this patient population at low risk of amputation and death.

Clinical evaluation of the Zilver vascular stent for symptomatic iliac artery disease.

PURPOSE: To evaluate the safety and effectiveness of the Zilver vascular stent in the treatment of de novo or restenotic lesions in the external and common iliac arteries. MATERIALS AND METHODS: Regardless of the results of an initial percutaneous transluminal angioplasty (PTA), 151 consecutive patients were implanted with Zilver vascular stents (Cook, Bloomington, Ind) in up to two stenotic (< or =10 cm) or occluded (< or =5 cm) atherosclerotic lesions of the external or common iliac arteries. The primary endpoint was the rate of major adverse events within 9 months after the procedure. Major adverse events were defined as death, myocardial infarction, target lesion revascularization, and limb loss. Secondary endpoints included acute procedural success, 30-day clinical success, 9-month patency rate, 9-month functional status (on the basis of the validated Walking Impairment Questionnaire), and ankle-brachial index (ABI). RESULTS: of 1-, 6-, and 9-month follow-up are reported. Results The 9-month device and/or procedural-related major adverse event rate (adjudicated by an independent clinical events committee) was 2.7%. The all-cause major adverse event rate was 7.5%. Both rates were substantially below the prespecified objective performance criterion of 16%. The acute procedure success rate and 30-day clinical success rate were 98.0% and 94.0%, respectively. The 9-month patency rate, measured with duplex ultrasonography, was 92.9%. Significant improvement in the ABI and walking distance and walking speed scores, relative to preprocedural values, was seen at 1 month and was maintained through 9-month follow-up. CONCLUSIONS: The Zilver vascular stent is safe and effective as an adjunct to PTA in the treatment of symptomatic disease of the iliac arteries.

Functional and clinical outcomes of nitinol stenting with and without abciximab for complex superficial femoral artery disease: a randomized trial.

OBJECTIVE: To evaluate the effect of glycoprotein IIb/IIIa inhibition during nitinol stenting, of superficial femoral occlusive disease. BACKGROUND: Stent implantation in the superficial femoral artery has been associated with suboptimal results while Glycoprotein IIb/IIIa inhibitors have shown improved procedural results during coronary intervention. We evaluated abciximab infusion during (Smart Stent) implantation in superficial femoral obstructions. METHODS: We conducted a randomized placebo controlled trial. The two primary end points include: (1) 9-month restenosis defined as a decrease in ankle brachial index and in-stent duplex ultrasound restenosis: (2) adverse events defined as death (30 days) or repeat revascularization within 9 months. RESULTS: Twenty-seven patients were randomized to abciximab and 24 patients to control (placebo). The primary end point of cumulative restenosis occurred in 15.4% of patients administered abciximab and in 12% administered placebo (P = 0.873). The primary restenosis endpoint in diabetics and total occlusions were similar at 14.3% and 15.4% respectively. The composite end point of 30-day mortality and 9-month revascularization occurred in 5.8% abciximab and 0% (P = 0.274) placebo with no 30-day deaths. Graded treadmill time and Rutherford class were all significantly improved in both groups, but the abciximab group did not appear to demonstrate any identifiable effect. CONCLUSION: (Smart Stent) nitinol stenting of the superficial femoral artery was associated with favorable functional outcomes at 9 months. Adjunctive abciximab did not appear to demonstrate any identifiable effect.

Percutaneous retrograde tibial access in limb salvage.

PURPOSE: To describe a novel technique for percutaneous retrograde access of the tibial vessels after antegrade access failure in patients with chronic limb-threatening ischemia. METHODS: Six patients who had failed antegrade access to infrapopliteal occlusions had attempted retrograde tibial puncture and wire passage into the proximally patent vessel. Endovascular intervention was carried out utilizing standard techniques. The patients were followed for functional class and wound healing. RESULTS: All six patients were successfully recanalized. Five patients experienced rapid and dramatic healing of wounds that had previously been refractory to conservative therapy. The other patient did not experience healing and ultimately died of progressive intractable congestive heart failure in the setting of a severe ischemic cardiomyopathy. CONCLUSIONS: Retrograde tibial access can be a valuable technique in the armamentarium of a peripheral interventionist treating patients with chronic critical limb ischemia.

Infrapopliteal Endovascular Techniques: Indications, Techniques, and Results.

The emerging field of endovascular therapy is opening up new therapeutic avenues for the treatment of peripheral vascular disease. The infrapopliteal arterial bed is a complex vascular bed. Treatment is usually restricted to patients with limb-threatening ischemia. Although education and medical therapy play a cornerstone role in long-term success, endovascular therapy offers a potentially easy low-risk treatment for early healing of damaged tissue. Surgical therapy remains the gold standard of treatment, but there remains significant associated morbidity and mortality. A clear understanding of the vascular anatomy, disease process, extent of tissue damage and comorbidities is necessary in forming the treatment plan for any particular patient. Close follow-up and possible retreatment is a key responsibility for the endovascular physician.

Clinical results for the training-phase roll-in patients in the Intracoil femoralpopliteal stent trial.

The purpose of this study was to report the results of the roll-in patients for the multicenter IntraCoil trial in the femoropopliteal arteries at 9-month follow-up. Ninety-three roll-in patients (mean age, 67.8 +/- 10.5 years; 62.4% male gender) constituted the learning phase for the 22 clinical sites. Obstructive femoropopliteal artery disease up to 15 cm was treated with stenting. Clinical patency was measured over a 9-month period by clinical and hemodynamic data as well as the Rutherford scale. Diabetes mellitus was present in 35.5%. Twenty-nine percent of lesions treated were occlusions. The mean reference diameter for treated lesions was 4.27 +/- 1.11 mm, while the mean lesion length was 3.83 +/- 3.69 cm. Acute angiographic success by operator evaluation was obtained in 98.9% of patients. Major complications occurred in 3.2%. No patient experienced abrupt or subacute closure. There were two reports of failure to deliver assigned stent. In both incidences, the stent was removed without surgical intervention. There were also three reports of stent misplacement (moving during delivery), one report of stent migration, one report of delivery system failure. At 30-day and 9-month follow-up of successfully treated patients, 100%/77.9% remained free of major adverse clinical events (MACE) and 100%/81.8% target lesion revascularization (TLR), respectively. At 9-month follow-up, ankle-brachial index increased from 0.66 +/- 0.22 to 0.83 +/- 0.20 while mean maximum walking time increased form 4.47 +/- 3.02 to 5.91 +/- 3.97 min. The use of the IntraCoil stent appears to have a short learning curve. Excellent clinical and hemodynamic patency is seen at 9 months. The randomized comparison trial comparing the IntraCoil to angioplasty is pending.

Rheolytic thrombectomy in the management of limb ischemia: 30-day results from a multicenter registry.

PURPOSE: To evaluate the use of rheolytic thrombectomy (RT) with the AngioJet catheter for treatment of lower extremity ischemia due to arterial/graft thrombotic occlusion. METHODS: A retrospective multicenter review was performed of 99 consecutive patients (52 men; mean age 67 +/- 13 years, range 30-90) who underwent RT for thrombotic occlusions in native arteries (n=80) or bypass grafts (n=19). Pre- and postprocedural limb ischemia and in-hospital events were evaluated. Amputation and mortality rates at 30 days were determined. RESULTS: The majority of patients (78.8%) presented within 14 days of symptom onset. RT resulted in substantial to complete thrombus removal in 70 (70.7%) patients and partial in 22 (22.2%); there was no angiographic change in 7 (7.1%). Adjunctive post RT thrombolysis was used in 37 patients. Underlying stenoses found in 81 limbs were treated with one or more of the following procedures: balloon angioplasty (n=62), stenting (n=35), or nonemergent surgical revision (n=5). In-hospital complications included 2 major amputations, 5 cases of minor tissue loss, 7 rethromboses, and 3 cases of transient renal insufficiency. Four (4.0% patients died in-hospital; the 95 surviving patients all had viable limbs at discharge. Mortality and amputation rates at 30 days were 7.1% and 4.0%, respectively. CONCLUSIONS: Percutaneous treatment of thrombotic occlusions with RT, followed by definitive treatment of the underlying stenosis, is a promising therapeutic option for patients with limb-threatening ischemia.