Benefit of arterial duplex ultrasound stent imaging after. Drugeluting balloon for treatment of superficial femoral. Bridgewater, new jersey november 8, 2012 cordis corporation today announced that the u. Its chances of approval appear very bright, considering its positive clinical trial data to date. Early ultrasound surveillance key to predicting risk of reintervention in deep stenting patients. Comparison of secondgeneration stents for application in. Our surveillance programme has successfully identified and treated clinically silent in stent stenoses in 22% of patients with an sfa stent who may have progressed to symptomatic stenosis or occlusion. Duplex criteria for determination of instent stenosis after. Five essential components to treating peripheral artery. Any significant inflow disease must be treated before treating sfa and popliteal lesions. Drugeluting stents in the superficial femoral artery jacc. Covered stents in the sfa for claudication ucsf vascular surgery symposium 20 duration.
Treatment of superficial femoral artery disease remains challenging due to complex lesion. Cordis, c06150ml, cordis smart vascular stent system sfa. The utility of hemodynamic surveillance here is predicated on the ability to. Percutaneous angioplasty and stenting of the superficial.
To bail out means we still have to be prepared the choice of stent should be individualized. Control vascular stent systems for use in the superficial femoral artery sfa andor the proximal popliteal artery ppa. Jetstream atherectomy was performed using an expandable cutter catheter, two passes blades down and two passes blades up. Standards of practice for superficial femoral and popliteal. May 28, 2014 the sirolimuscoated cordis selfexpandable stent for the treatment of sfa disease sirocco trial was a doubleblind randomized controlled trial comparing the efficacy of the sirolimuseluting smart stent cordis corporation with its bms counterpart in the treatment of long sfa obstructions. The objective of this study was to assess 1year safety, efficacy, and invasiveness outcomes of endovascular stent grafting of symptomatic long lesions. Apr 30, 2012 paclitaxel eluting balloon application in sfa in stent restenosis plaisir the safety and scientific validity of this study is the responsibility of the study sponsor and investigators.
Standards of practice for superficial femoral and popliteal artery. An analysis of postthrombotic disease patients who received a nitinol stent has found that ultrasound surveillance should occur at frequent intervals up to two weeks postprocedure to predict risk of reintervention. Investigating the value of a surveillance scan of the. Duplex surveillance following peripheral endovascular. Houston methodist debakey heart and vascular center. My first intentional stent removal case arterial restoration posted on september 4, 2015 september 4, 2015 by docpark in 2007, at which i had performed about 20 standard endore remote endarterectomy, lemaitre vascular cases over about two years, this patient in his later 40s presented to me with ischemic rest pain of his right foot.
Oct 04, 2014 sfa stent removal taking off those full metal jackets posted on october 4, 2014 by docpark when conduit is limited, or ptfe or cadaver vein is being considered, in the setting of occluded sfa stents, i have found that it is possible and perhaps preferable to attempt removal of these stents using remote endarterectomy. A graftstent surveillance ultrasound is an ultrasound assessment of either stents or grafts that you have had placed in or around your arteries. The current trial enrollment has the majority of these lesions in the sfa, with only 4% of these in the popliteal artery. Comparison of secondgeneration stents for application in the. Listing a study does not mean it has been evaluated by the u. The zilver ptx stent also displayed a 0% fracture rate for 41 lesions at six months and 18 lesions at one year. Therefore, it is critical to perform an anklebrachial index at each visit. The unexpected finding of this study was that the restenosis rates in the uncoated nitinol stents were much lower than what had been expected, giving hope that sfa outcomes will improve as stent. Early ultrasound surveillance key to predicting re. The sirolimuscoated cordis selfexpandable stent for the treatment of sfa disease sirocco trial was a doubleblind randomized controlled trial comparing the efficacy of the sirolimuseluting smart stent cordis corporation with its bms counterpart in the treatment of long sfa obstructions. Bridgewater, nj march 12, 20 cordis corporation, a worldwide leader in the development of interventional vascular technology, today announced it has completed the acquisition of flexible stenting solutions, inc. Despite close surveillance and reintervention, anatomic patency at 1 year was poor. The sfa is subject to unique mechanical forces like compression and bending, which cause fatigue fractures in stents.
A nitinol stent fracture was identified in 72 of 110 patients 65. Vascular stent systems receive fda approval for use in sfa first stent in the u. The treatment decision for instent restenosis isr involving the superficial femoral artery sfa is complex. The primary mode of stent failure has been instent stenosis, which occurs in up to 40% of treated lesions. Instent stenosis is a frequent complication of superficial femoral artery sfa endovascular intervention and can lead to stent occlusion or symptom recurrence. Instent stenosis after sfa angioplasty and stenting can be predicted by both psv and vr data as measured by du imaging. Utility of covered stents in treating instent restenosis feat.
A graft stent surveillance ultrasound is an ultrasound assessment of either stents or grafts that you have had placed in or around your arteries. Zeller the author started by presenting recent data regarding subintimal angioplasty of transatlantic intersociety consensus ii class cd lesions tasc ii cd lesions, stressing a primary 12month patency of 52% to 73% sidhu r et al. Stenting of the sfa is associated with an acceptable success rate even after five years and in patients with long sfa lesions, noted giovanni torsello, m. As the population with sfa stenting continues to increase, occurrence of isr has become.
Sfa stenting and the promise of des in the peripheral. It is important to routinely monitor the stents and grafts in your arteries as they can renarrow. At 6 months, angiography revealed an in stent mean lumen diameter of 4. Jetstream atherectomy system superficial femoral artery. The eluvia drugeluting stent system showed superior results in the first headtohead des sfa trial. A protocol for scheduled arterial duplex surveillance specifically in the cli population may help maximize outcomes. The innova stent provides strength necessary to stay open within the challenging and dynamic sfa. Outcomes of the japanese multicenter viabahn trial of. Duplex criteria for determination of instent stenosis. Proper and timely detection of seal failure after evar. Surveillance with cta is commonly recommended at 1 month and at 1 year after the index procedure, followed by annual color doppler ultrasound surveillance if significant aneurysm growth and endoleaks are absent.
Buthimpact of a colorflow duplex surveillance program on infrainguinal vein. Important clinical issues include the problem intimal hyperplasia inside a minimally expandable metal stent, the natural history persistent claudication with low risk of limb loss, and. Many operators advocate surveillance at 3 or 6month intervals for up to the first year after stent implantation. More recent sfa stent reports using selfexpanding nitinol designs have shown improved 1 to 2year primary and secondary patency rates, but secondary reintervention rates for occlusion or instent restenosis isr remain high 20%30% at 1 year. The primary mode of stent failure has been in stent stenosis, which occurs in up to 40% of treated lesions. If long stenting is inevitable, frequent monitor is helpful to detect adverse stent complication. High incidence of restenosisreocclusion of stents in the. As of october 2015, cordis is a part of cardinal health, bringing together two important players in the healthcare industry and creating an unmatched combined offering in the cardiovascular space that will ensure greater access to quality products and services worldwide. There are minimal data comparing bypass vs primary sfa stent. Stent fractures after superficial femoral artery stenting ncbi. Sfa stent removal taking off those full metal jackets posted on october 4, 2014 by docpark when conduit is limited, or ptfe or cadaver vein is being considered, in the setting of occluded sfa stents, i have found that it is possible and perhaps preferable to attempt removal of these stents using remote endarterectomy. University of california television uctv 1,439 views. The worst performing stent was luminexx during all test cycles.
Fiftyeight limbs in 55 patients who underwent stenting of the sfa. Endovascular treatment of a superficial femoral artery aneurysm. Food and drug administration fda has approved the s. Symptomatic superficial femoral artery pseudoaneurysm due. Primary patency rates for 517 patients were, respectively, 86 percent, 75 percent and 61 percent at one, three and five years.
The stent design for the sfa ppa indication incorporates varying segment lengths of 2. Drugeluting stents in the superficial femoral artery. Contemporary followup imaging after endovascular repair of lower. Duplex surveillance following peripheral endovascular procedures is. Role of sfa stent in dcb era stenting or not the patient and the lesion characters bail out short spot stenting. The treatment of superficial femoral artery instent. Marc bonaca from brigham and womens hospital, boston, ma duration. It is cut from a nickel titanium alloy nitinol tube and consists of a series of segments each connected to the next in a unique pattern to allow for flexibility and vessel conformability. Sfa stent removal taking off those full metal jackets a. We describe a rare case of an 8cm sfa pseudoaneurysm due to stent fracture 3 years from the index procedure performed for occlusive disease successfully. To reduce or prevent restenosis, the zilver ptx stent is coated with paclitaxel, a drug approved for clinical use as an anticancer agent. Percutaneous angioplasty and stenting of the superficial femoral and.
Appropriate monitoring for and treatment of edge restenosis, especially. Dake reported that the zilver drugeluting stent showed an equal major adverse event mae rate to conventional angioplasty for treating sfa lesions at its sixmonth followup point. The goal of treating peripheral artery disease pad in the superficial femoral artery sfa is limb salvage and improving quality of life. Name eluvia drugeluting vascular stent system boston scientific des sfa paclitaxeleluting selfexpanding stent system objective to determine whether the boston scientific nitinol drugeluting stent shows acceptable performance at 9 months when treating superficial femoral sfa andor proximal popliteal artery ppa lesions up to 110mm in. A global randomized controlled multicenter trial with 2. Hemodynamic assessment for lower extremity intervention why. Benefit of arterial duplex ultrasound stent imaging after superficial. The stent design for the sfappa indication incorporates varying segment lengths of 2. Paclitaxel eluting balloon application in sfa in stent. Ultrasound surveillance surveillance postintervention. Covered stents in the treatment of superficial femoral artery disease.
Differences in stent design might play a major role in the appearance of stent strut. Duplex criteria for determination of instent stenosis after angioplasty. Arterial duplex ultrasound stent imaging adsi can be used in the surveillance for recurrent stenosis. Threeyear data from resilient show that the lifestent stent has durable patency and better quality of life and function than balloon angioplasty in the superficial femoral artery. Imaging surveillance following endovascular aneurysm repair. Longterm results of open and endovascular revascularization. Sfa stent patency recent trials data available from 91 patients. Our results highlight the importance of ultrasound surveillance following stent placement. Sfa stenting was performed in 165 limbs of 117 patients from january 2009 to december 20.
From a right cfa approach, a left external iliac aneurysm and a left sfa aneurysm are treated with stent placements. Cook medical, bloomington, indiana for the treatment of obstructive atherosclerotic disease of the superficial femoral artery sfa. Paclitaxel eluting balloon application in sfa in stent restenosis plaisir the safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Primary patency at 12 months 360 30 days was achieved in 78. The cook zilver ptx selfexpanding stent may become the first drugeluting stent available in the united states if it is cleared by the fda later this year. Midterm outcome of femoral artery stenting and factors. December 7, 2012 more than half of patients treated for claudication or critical limb ischemia cli with stenting of the superficial femoral artery sfa had primary patency at five years.
To stent or not is a still challenging issue in current period but dont be afraid. The treatment decision for in stent restenosis isr involving the superficial femoral artery sfa is complex. The 7 sfa stents showed differences in the incidence of high strain zones, which indicates a potential for stent fracture, as demonstrated by the mechanical fatigue tests. Duplex ultrasound du criteria for sfa instent stenosis and correlation with. Stent fractures after superficial femoral artery stenting. At 6 months, angiography revealed an instent mean lumen diameter of 4.
Outward radial force allows the stent to fully open, while strong compression resistance enables the stent to maintain lumen diameter even during vessel movement and external pressure. Stent surveillance was performed using the ankle brachial index abi after stenting and at 3, 6, 12, 18 and 24 months, and computed tomography ct angiography or duplex scans were performed at 12 and 24 months after stenting. Our surveillance programme has successfully identified and treated clinically silent instent stenoses in 22% of patients with an sfa stent who may have progressed to symptomatic stenosis or occlusion. Jul 15, 2011 a drugeluting, selfexpanding stent that does not use a drugcarrier polymer is before the u. Critical evaluation of stents in the peripheral arterial. What role will dcb play in the clinical landscape 17. Although endovascular stenting in the superficial femoral artery sfa is well established for peripheral vascular disease, stent fracture is one of the complications that decrease the longterm patency of this treatment. Background the use of the selfexpanding nitinol stent has improved the patency rate of sfa after percutaneous transluminal angioplasty pta.
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