Long-term follow-up study of endarterectomy versus angioplasty in patients with symptomatic severe carotid stenosis trial.

BACKGROUND AND PURPOSE: We aimed at comparing the long-term benefit-risk balance of carotid stenting versus endarterectomy for symptomatic carotid stenosis. METHODS: Long-term follow-up study of patients included in Endarterectomy Versus Angioplasty in Patients With Symptomatic Severe Carotid Stenosis (EVA-3S), a randomized, controlled trial of carotid stenting versus endarterectomy in 527 patients with recently symptomatic severe carotid stenosis, conducted in 30 centers in France. The main end point was a composite of any ipsilateral stroke after randomization or any procedural stroke or death. RESULTS: During a median follow-up of 7.1 years (interquartile range, 5.1-8.8 years; maximum 12.4 years), the primary end point occurred in 30 patients in the stenting group compared with 18 patients in the endarterectomy group. Cumulative probabilities of this outcome were 11.0% (95% confidence interval, 7.9-15.2) versus 6.3% (4.0-9.8) in the endarterectomy group at the 5-year follow-up (hazard ratio, 1.85; 1.00-3.40; P=0.04) and 11.5% (8.2-15.9) versus 7.6% (4.9-11.8; hazard ratio, 1.70; 0.95-3.06; P=0.07) at the 10-year follow-up. No difference was observed between treatment groups in the rates of ipsilateral stroke beyond the procedural period, severe carotid restenosis (≥70%) or occlusion, death, myocardial infarction, and revascularization procedures. CONCLUSIONS: The long-term benefit-risk balance of carotid stenting versus endarterectomy for symptomatic carotid stenosis favored endarterectomy, a difference driven by a lower risk of procedural stroke after endarterectomy. Both techniques were associated with low and similar long-term risks of recurrent ipsilateral stroke beyond the procedural period. CLINICAL TRIAL REGISTRATION URL: http://www.clinicaltrials.gov. Unique identifier: NCT00190398.

Outcome of carotid angioplasty with a novel open-cell carotid stent system.

BACKGROUND: The choice of carotid stent systems depends primarily on the anatomy of the carotid artery, the lesion morphology, and the patient's risk factors. Design improvements in devices, in terms of crossing profile and the ability to precisely position the stent, may greatly contribute to the procedural success without compromising acute clinical outcomes. METHODS AND RESULTS: The primary objective of this clinical registry was to evaluate the early safety and efficacy of a novel open-cell carotid stent system in an "all comer" population suitable for carotid artery stenting. The primary end point was the composite of ipsilateral stroke and "all-cause mortality" within 30 days after the procedure. Secondary end points entailed the rates of myocardial infarction and other clinical complications within the first 30 days following the procedure and up to the 6-month follow-up. Unsuccessful placement and/or withdrawal of the delivery system, as well as device-related complications involving the carotid artery and the rate of nonlesion-related embolisms, were evaluated relative to other currently available carotid stents. The 30-day composite death/stroke rate was 2.8% (3 of 106) while the overall stent system performance was similar to commonly used carotid stent systems. CONCLUSIONS: The utilized open-cell carotid stent system had favorable lesion crossing and positioning characteristics without compromising the 30-day composite death/stroke rate.

Amplatzer vascular plug for occlusion or flow reduction of hemodialysis arteriovenous access.

OBJECTIVE: Use of the Amplatzer vascular plug (AVP; St. Jude Medical Inc, St. Paul, Minn) for percutaneous occlusion of a hemodialysis arteriovenous access (AVA) is an emerging practice, and only a few reports by radiologists have been published. We report here a multidisciplinary experience of this technique not only for AVA occlusion but also for flow reduction in selected patients. METHODS: This preliminary study includes a series of 20 plugs of different generations (I, II, and IV) used in 19 hemodialysis patients (two children, 17 adults). Of these, 15 AVAs were autologous fistulas located at the elbow, 4 were autologous forearm fistulas, and 1 was a brachial-basilic polytetrafluoroethylene graft. AVP deployment was through a 4F to 8F sheath, with oversizing from 30% to 50% to reduce the risk of migration. AVA occlusion (n = 14), by placing the AVP in the vein at its origin, was performed for central vein occlusion after unsuccessful percutaneous recanalization (n = 4), high flow (n = 2), hand ischemia (n = 3), successful kidney transplant (n = 1), and brachial-basilic or brachial-brachial fistula second-stage superficialization technical failure (n = 4). Vein/polytetrafluoroethylene grafts were not removed. AVA flow reduction (n = 6), by placing the AVP in the radial artery, was performed for well-tolerated high flow (n = 3) or high flow associated with distal ischemia (n = 3). All patients underwent a postoperative evaluation at 6-month intervals that included a clinical examination and duplex scan. RESULTS: AVA occlusion or flow reduction was successfully achieved in all patients. Ischemia persisted in one patient and a revascularization with a distal bypass was necessary. Mean follow-up was 1.2 ± 0.8 years (range, 2 months-2.9 years). No plug migration, access revascularization, or other complication was observed. CONCLUSIONS: The results of this short preliminary study suggest that plug insertion for occlusion or for flow reduction in a hemodialysis AVA constitutes a reasonable alternative to coil insertion or to open surgery in selected patients.

Postpartum hemorrhage treated with gelfoam slurry embolization using the superselective technique: immediate results and 1-month MRI follow-up.

PURPOSE: To evaluate the efficacy and safety of superselective embolization of the uterine arteries in a postpartum hemorrhage. MATERIALS AND METHODS: Between November 2004 and January 2011, a total of 44 consecutive women (median ± standard deviation age 34 ± 3 years, range 23-41 years) were referred to our institution for postpartum intractable hemorrhage management. All patients were embolized with a microcatheter that was placed deep into the uterine arteries upstream of the cervical arteries. The embolic agent was a mixture of contrast medium and 5 × 5 × 5 cm pieces of gelfoam (Gelita-Spon) modified into a gelatin emulsion as follows: rapid mixing through a three-way stopcock with two 2.5-ml syringes. A 1-ml syringe was used for injection. One month after embolization, all patients underwent magnetic resonance imaging and clinical examination. RESULTS: Technical and clinical success was obtained in all cases. Thirty-five patients experienced bleeding related to poor retraction of the uterus, 7 patients because of a tear of the cervix and 2 because of a vaginal hematoma. Pre- and postembolization red blood cell transfusions were (mean ± standard deviation [SD]) 6 ± 1.2 (range 3-8) U and 2 ± 0.7 (range 2-4) U, respectively. One-month magnetic resonance imaging follow-up revealed no sign of ischemic myometrium or necrosis, and no instances of uterine rupture and no pelvic vein thrombosis. Incidental findings included two small intramyometrial hematic collections. All uterine arteries were patent via magnetic resonance angiography. Seventeen patients had concomitant fibroids, all of which appeared hypovascular. CONCLUSION: This technique permits good, safe clinical results with no marked damage to the uterine arteries or the uterus itself.

Anatomical and technical factors associated with stroke or death during carotid angioplasty and stenting: results from the endarterectomy versus angioplasty in patients with symptomatic severe carotid stenosis (EVA-3S) trial and systematic review.

BACKGROUND AND PURPOSE: The purposes of this study were to assess the relationships between anatomic and technical factors and the 30-day risk of stroke or death after carotid angioplasty and stenting in the Endarterectomy versus Stenting in Patients with Symptomatic Severe Carotid Stenosis (EVA-3S) trial and to perform a systematic review of the literature. METHODS: We included patients from EVA-3S in whom carotid stenting was attempted irrespective of allocated treatment. Two radiologists blinded to clinical data independently assessed the aortic arch and carotid arteries on procedural angiograms. In addition, we performed a systematic review of studies that reported 30-day risk of stroke or death in relation with arterial anatomy and technique. Outcomes were stroke or death and stroke occurring within 30 days of the carotid angioplasty and stenting procedure. RESULTS: Two hundred sixty-two patients from EVA-3S fulfilled the inclusion criteria (including 1 initially allocated to surgery and 13 in whom stent insertion failed).Within 30 days after the procedure, 25 (9.5%) patients had a stroke or had died. The risk of stroke or death was higher in patients with internal carotid artery-common carotid artery angulation ≥60° (relative risk, 4.96; 2.29 to 10.74) and lower in those treated with cerebral protection devices (relative risk [RR], 0.38; 0.17 to 0.85). In the systematic review (56 studies; 34 398 patients), the risk of stroke or death was higher in patients with left-sided carotid angioplasty and stenting (RR, 1.29; 1.05 to 1.58), increased internal carotid artery-common carotid artery angulation (RR, 3.41; 1.52 to 7.63), and when the target internal carotid artery stenosis was >10 mm (RR, 2.36; 1.28 to 3.38). There was no significant increase in risk of stroke or death in patients with Type III aortic arch, aortic arch calcification, or with ostial involvement, calcification, ulceration or degree of stenosis of the target internal carotid artery stenosis. The use of a cerebral protection device was associated with a lower risk of stroke or death (RR, 0.55; 0.41 to 0.73). Risk was not related with stent or cerebral protection device type. CONCLUSIONS: Our results strongly suggest that some technical and anatomic factors, especially extreme angulation of the carotid artery, have an impact on the risks of carotid angioplasty and stenting.

Spontaneous renal artery dissection: long-term outcomes after endovascular stent placement.

PURPOSE: To report long-term clinical and morphologic results after stent placement for spontaneous renal artery dissection (SRAD). MATERIALS AND METHODS: Between 1991 and 2006, 16 consecutive patients (13 men; mean age, 42 y +/- 12) presented with SRAD in 17 arteries. All patients had uncontrolled hypertension at the time of presentation. Nine patients had lower back pain, 10 had progressive renal insufficiency, and three had both. All patients underwent renal angiography and stent implantation. They were followed up clinically and with renal imaging. RESULTS: Baseline blood pressure and plasma creatinine levels were 176/107 mm Hg and 142 micromol/L, respectively. Successful renal artery recanalization and stent implantation were achieved in all patients. After a mean follow-up of 8.6 years +/- 3.4, mean blood pressure was 118/78 mm Hg, with Seven patients were taking no antihypertensive medication, with five and four patients taking single or double antihypertensive agents, respectively. The most recent follow-up showed that plasma creatinine levels were normal, and imaging of the renal arteries showed no sign of restenosis or occlusion in all patients. CONCLUSIONS: Stent implantation for symptomatic SRAD is an effective treatment in the long term and represents a safe alternative to surgery.

Low-flow maturation failure of distal accesses: Treatment by angioplasty of forearm arteries.

BACKGROUND: Forearm artery lesions are a frequent cause of distal fistula maturation failure. Surgical treatment is difficult because of highly calcified arteries. To redo the arteriovenous anastomosis higher up the forearm is technically difficult and often ineffective because arteries cannot be enlarged. It also causes a loss in puncture zone. Creation of brachial accesses leads to a high risk of distal ischemia. METHODS: From September 2000 to September 2006, we performed percutaneous transluminal angioplasty (PTA) of forearm arteries in 25 patients with failing distal access maturation. We reported immediate results of the dilatation and retrospectively analyzed the outcome of the accesses after the procedure. RESULTS: Forearm artery PTA was achieved in all 25 patients. Three main complications occurred: severe spasms precluding precise assessment of the artery patency after dilatation, rupture easily treated by prolonged low-pressure balloon inflation, and early rethrombosis leading to access loss. Follow-up was available in 23 patients. PTA failed to restore a sufficient access flow in two patients (the access loss and an insufficient increase in flow). In the remaining 21 (91%), accesses started to be used for hemodialysis without difficulties. Primary patency access rates after PTA were 83% (range, 60%-93%) at 1 year and 74% (range, 47%-89%) at 2 years. Secondary access patency rates were 86% (range, 64%-95%) at 1 and 3 years. CONCLUSION: When a distal access fails to mature because of forearm artery lesions, PTA should be done and will salvage the fistula without risk of distal ischemia and cardiac failure. Efficacy of PTA clearly influences surgical strategy and is a major argument in favor of attempting to create distal accesses in patients with mild distal artery lesions. Even in cases of failure, such as early occlusion of the fistula, this technique does not jeopardize further proximal access creation. Forearm access creation should be avoided only in cases of extremely severe distal artery lesions.

[Stenosis of the carotid bifurcation: stenting or surgery?]. / Sténose de la bifurcation carotidienne: stent ou chirurgie?

Systematic medical treatment and control of risk factors are essential in all cases. The rate of stroke or death for asymptomatic carotid artery stenosis (>60%) is 2% per year. Symptomatic carotid artery stenosis (>50%) must be treated without delay (10% risk of recurrence in the first two weeks). In 2008, carotid endarterectomy is still the gold standard for treatment of patients with severe carotid stenosis. Carotid stenting is an alternative for patients with inaccessible lesions or at high risk for surgery (French recommendations 2007).A multidisciplinary approach is recommended. Successful endovascular treatment requires careful patient selection and an operator and team with extensive experience.

Endarterectomy versus stenting in patients with symptomatic severe carotid stenosis.

BACKGROUND: Carotid stenting is less invasive than endarterectomy, but it is unclear whether it is as safe in patients with symptomatic carotid-artery stenosis. METHODS: We conducted a multicenter, randomized, noninferiority trial to compare stenting with endarterectomy in patients with a symptomatic carotid stenosis of at least 60%. The primary end point was the incidence of any stroke or death within 30 days after treatment. RESULTS: The trial was stopped prematurely after the inclusion of 527 patients for reasons of both safety and futility. The 30-day incidence of any stroke or death was 3.9% after endarterectomy (95% confidence interval [CI], 2.0 to 7.2) and 9.6% after stenting (95% CI, 6.4 to 14.0); the relative risk of any stroke or death after stenting as compared with endarterectomy was 2.5 (95% CI, 1.2 to 5.1). The 30-day incidence of disabling stroke or death was 1.5% after endarterectomy (95% CI, 0.5 to 4.2) and 3.4% after stenting (95% CI, 1.7 to 6.7); the relative risk was 2.2 (95% CI, 0.7 to 7.2). At 6 months, the incidence of any stroke or death was 6.1% after endarterectomy and 11.7% after stenting (P=0.02). There were more major local complications after stenting and more systemic complications (mainly pulmonary) after endarterectomy, but the differences were not significant. Cranial-nerve injury was more common after endarterectomy than after stenting. CONCLUSIONS: In this study of patients with symptomatic carotid stenosis of 60% or more, the rates of death and stroke at 1 and 6 months were lower with endarterectomy than with stenting. (ClinicalTrials.gov number, NCT00190398 [ClinicalTrials.gov].).

[Treatment of carotid stenosis: angioplasty, a reasoned choice]. / Traitement d'une sténose carotide: angioplastie, un choix raisonné.

UNLABELLED: MASTERING THE SURGICAL ACT: Over the last decade, the technique of carotid angioplasty has progressed and it can now be considered as mastered thanks to the combination of platelet antiaggregants, miniaturisation of the material, stenting and the use of cerebral protection devices. POTENTIAL COMPLICATIONS: Notably the occurrence of cerebral embolism despite protection. Haemorrhagic complications are also possible. After a delay of 6 months, the re-stenosis rate is of around 10%. RESULTS OF RANDOMISED STUDIES: These globally demonstrate the equivalence between endoluminal treatment and surgery, notably in patients at high surgical risk. IN PRACTICE: Carotid angioplasty can be proposed in cases of severe non-atheromatous stenosis localised away from the bifurcation. It is contraindicated in the case of asymptomatic atheromatous stenosis without surgical comorbidity and when the particular anatomic conditions complicate catheterism of the carotid axis.

[Carotid artery angioplasty: where are we in 2004?]. / Angioplastie carotide: où en est-on en 2004?

Carotid artery stenting (CAS) is currently being investigated as an alternative treatment to carotid endarterectomy (CEA). Cerebral embolism is the most serious risk of CAS. Carotid artery stenting is still not reimbursed and unauthorised not authorised in routine in France (excepted in trials with ethical committee approval). CAS is now feasible, with a high technical success, which may improves with learning curve and with a better patient selection of the patients. A number of higher risk situations for CEA represents ideal indications for CAS, such as restenosis after CEA, stenosis due to prior neck radiation and radical neck surgery, and lesions in the distal internal carotid artery or involving high, retromandibular bifurcation.

Arterial percutaneous angioplasty in upper limbs with vascular access devices for haemodialysis.

BACKGROUND: The purpose of this study was to evaluate retrospectively the clinical context and effectiveness of arterial percutaneous transluminal angioplasty (PTA) of arterio-venous fistulae in chronic haemodialysis patients. METHODS: Between May 1992 and June 1997, arterial PTA was performed in 33 patients with a total of 35 angioaccess devices of the upper limbs (18 arterio-venous fistulae and 17 PTFE grafts). Clinical indications for arterial PTA were unexplained acute thrombosis in 12 patients (34.3%), insufficient blood flow in 13 patients (37.1%), and severe limb ischaemia in 10 patients (28.6%), two of whom had skin ulcerations and one had severe neurological damage. Follow-up periods varied between 1 and 55 months (mean 15.5 months). RESULTS: PTA was attempted in 22 radial, 10 brachial and seven ulnar arteries. Angioplasty was successful (i.e. residual stenosis of