Midterm results of endovascular treatment of superficial femoral artery disease with biodegradable stents: single-center experience.

PURPOSE: To assess the midterm efficacy of a biodegradable poly-l-lactic acid (PLLA) stent in the treatment of superficial femoral artery (SFA) occlusive disease. MATERIALS AND METHODS: Between June 2009 and April 2011, 35 de novo SFA lesions were treated with 43 biodegradable stents. This nonrandomized, retrospective, single-center study included patients with moderate or severe claudication, lower-limb rest pain, or ischemic ulceration restricted to the toes; symptoms were classified as Rutherford category 2 (48.6%), 3 (37.1%), 4 (8.6%), or 5 (5.7%). The population included 28 men and had a mean age of 71 years (range, 51-81 y). Follow-up included clinical examination and color-flow duplex imaging. Mean follow-up was 38.3 months (range, 30-58 mo). RESULTS: Technical success was reported in all patients (100%). There were no intraoperative or immediate (< 30 d) complications.. During follow-up, one in-stent occlusion and seven in-stent restenoses occurred, all of which were successfully treated with percutaneous transluminal angioplasty. Primary and secondary patency rates were 77.1% and 97.1% at 24 and 36 months, respectively. No stent recoil or stent fracture was encountered. Late follow-up (> 12 mo) by ultrasound confirmed total reabsorption of the stent structures. Clinical improvement (ie, an upward shift of at least two Rutherford categories) was achieved in all 35 patients. CONCLUSIONS: Midterm results for biodegradable PLLA stents for atherosclerotic SFA lesions were associated with high technical success and secondary patency rates, without stent recoil and vessel remodeling.

Durability and efficacy of tibial arterial stent placement for critical limb ischemia.

PURPOSE: To analyze the efficacy and durability of long-term tibioperoneal arterial stent placement for selected cases of symptomatic chronic limb ischemia (CLI). MATERIALS AND METHODS: From January 2005 to June 2012, 168 limbs (155 patients) were treated with percutaneous transluminal angioplasty (PTA)/stent placement for de novo tibial stenosis or occlusion in at least one tibial artery. Most patients (92.9%) were classified with severe disease (Rutherford category 5/6). Concomitant interventions were performed in 58%. Bare metal (84%) and drug-eluting (16%) stents were used. Indications for stent placement were residual stenosis after PTA (> 30%), elastic recoiling, and dissection. Primary endpoints were freedom from symptomatic intrastent restenosis, target lesion revascularization (TLR), major amputation, and overall survival (OS). RESULTS: Technical success rate was 99%. Within 30 days, five deaths (3.2%) occurred, and a 1.8% (95% confidence interval [CI], 0.1%-27.2%) major adverse cardiac event rate, 3.6% (95% CI, 0.1%-22.1%) major adverse limb event rate, and 1.8% (95% CI, 0%-27.5%) amputation rate were recorded. Mean follow-up was 33 months (range, 1-96 mo). Symptomatic intrastent restenosis occurred in 20 limbs (12%) at a mean of 10.3 months ± 11.27; this was identified as a prognostic factor for limb loss (P = .045). TLR was necessary in 10.8% of limbs, for a limb salvage rate of 89.2%. OS was influenced by age (> 75 y; P < .001), diabetes (P = .048), and renal insufficiency and/or dialysis (P < .001). Estimated survival rate was 63% at 36 months (hazard ratio, 1.63; 95% CI, 54%-70%). CONCLUSIONS: Stent placement offers promising short- to long-term restenosis and patency rates, even in cases of multilevel symptomatic disease. Rigorous follow-up is vital.

Bifurcated coronary stents for infrapopliteal angioplasty in critical limb ischemia.

OBJECTIVE: The goal of this article is to report the preliminary results of infrapopliteal percutaneous transluminal angioplasty stenting with the Nile Croco coronary bifurcated stent (Minvasys, Gennevilliers, France) for selected patients with critical limb ischemia (CLI). METHODS: From October 2006 to December 2010, 31 patients with CLI with below-the-knee TransAtlantic Inter-Society Consensus C and D lesions at the popliteal (n = 17, 54.8%) and distal tibioperoneal trunk (n = 14, 45.2%) bifurcations, with suboptimal primary percutaneous transluminal angioplasty results (residual stenosis >30%, elastic recoiling, or dissection), with at least two-vessel runoff to the foot (present or after percutaneous transluminal angioplasty), free of aortoiliac arterial disease, and at high surgical risk (more than three risk factors) were treated with the Nile Croco coronary bifurcated stent. Study end points included technical success, immediate and midterm primary and secondary patency rates, clinical improvement, and limb salvage. RESULTS: Technical success was achieved in all patients (100%) without any intraoperative complications. Early complications included an acute stent occlusion and an acute compartment syndrome for a collateral arterial branch perforation. Median follow-up was 12.1 months (range, 1-32). Primary and secondary patency rates were 96.7% and 86.2% (95% confidence interval [CI], 67.2%-94.6%) at 30 days and and 100% and 96.6% (95% CI, 78.0%-99.5%) at 1 year, respectively. Clinical improvement (an upward shift of at least two Rutherford categories) was achieved in 28 patients (90.3%). A major amputation was required in one patient (3.2%). The overall limb salvage rate at 1 year was 96.7% (95% CI, 78.6%-99.5%). CONCLUSIONS: Preliminary data suggest that the Nile Croco bifurcated stent for below-the-knee angioplasty in selected patients with CLI is associated with high rates of technical success, early and midterm patency, and clinical improvement. Limb salvage rates are acceptable for this technically highly challenging anatomy, yet further studies with larger patient populations are necessary to validate these results.

Use of combined thoracic and abdominal endografts for proximal severe neck angulation in abdominal aortic aneurysms.

PURPOSE: To evaluate endovascular aneurysm repair (EVAR) of abdominal aortic aneurysms (AAA) with severe neck angulation (SNA) utilizing a thoracic endograft placed proximal to a bifurcated endograft. METHODS: A retrospective review was conducted of 28 consecutive EVAR patients (25 men; mean age 71 years, range 62-86) with proximal SNA ≥60° treated electively between December 2006 and May 2011. The average AAA neck diameter was 23 mm (range 22-28), with a mean length of 25 mm (range 10-51) and a mean maximum sac diameter of 63 mm (range 55-98). The mean neck angulation was 73° (range 60-92). All patients received an endograft designed for the thoracic aorta (Relay) placed as a proximal extension above a bifurcated abdominal aortic endograft (IntuiTrak Powerlink). RESULTS: Technical success was achieved in 100% of cases. An intraoperative type I proximal endoleak was successfully treated with stent deployment, and 2 type II endoleaks spontaneously resolved within 30 days. In all 28 patients, endograft integrity and correct positioning were confirmed at the latest imaging follow-up (mean 23.7 months, range 6-43). Fifteen (56%) aneurysm sacs were stable and 13 (46%) were reduced in size. Two patients died of unrelated causes during follow-up. CONCLUSION: The unique morphology of SNA requires the development of a precise proximal fixation technology for successful endovascular repair. This hybrid solution exploits the technological advances of the thoracic aortic endograft and the stability of an anatomically fixed bifurcated endograft. This device combination may be an alternative solution for patients with SNA who are unsuitable for traditional surgery.

Urgent carotid artery stenting with technical modifications for patients with transient ischemic attacks and minor stroke.

PURPOSE: To evaluate the safety and efficacy of urgent carotid artery stenting (CAS) with technical modifications in patients with recent (<24 hours) initial or recurrent (≥2 episodes in 24 hours) transient ischemic attacks (TIA) or with minor stroke. METHODS: A single-center, prospective, observational study was begun in March 2005 to assess an urgent CAS protocol for the treatment of selected high-risk patients with carotid artery disease who presented within 24 hours of an initial or recurrent TIA or minor stroke. Up to June 2011, 78 patients (59 men; mean age 76 years) with TIA (n=57) or minor stroke (n=21) underwent urgent CAS (within 48 hours) for severe internal carotid artery stenosis. Outcome measures were major adverse cardiac and cerebrovascular events (MACCE), modifications in the National Institutes of Health Stroke Scale (NIHSS) values for minor stroke patients, and postoperative stroke and death rates. RESULTS: Technical and procedural success rates were 100% and 97.4%, respectively; 1 intraoperative minor stroke occurred due to stent thrombosis. At 30 days, 2 patients had recurrent minor stroke; one subsequently died after a hemorrhagic brain infarction. The MACCE rate was 3.8%. There were no cases of myocardial infarction or access-related complications. Of the 20 surviving minor stroke patients, 14 showed improvement in neurological deficit on the NIHSS scale at 30 days, while 5 remained stable and one was neurologically impaired. CONCLUSION: Urgent CAS in selected patients with symptomatic carotid stenosis was satisfactory in preventing the recurrence of TIA and stroke in this study. Urgent CAS with careful patient selection, contemporary tools (medical and technical), and expert technique may represent a possible solution for some patients with recent or recurrent TIA or minor stroke.

Final operative and midterm results of the European experience in the RELAY Endovascular Registry for Thoracic Disease (RESTORE) study.

PURPOSE: Thoracic endovascular aortic repair is increasingly becoming the standard treatment of many thoracic aortic pathologies. New reliable and accurate stent grafts are emerging to widen the endovascular treatment options. We report the results of RELAY (Bolton Medical, Barcelona, Spain) in the large RELAY Endovascular Registry for Thoracic Disease (RESTORE) European registry. METHODS: RESTORE is a multicenter, prospective European registry involving 22 centers in seven European countries. The RELAY device is composed of a stent graft (self-expanding nitinol stents and a polyester vascular graft) and a delivery device specifically designed for the thoracic aorta. Included were acute and elective patients presenting with a variety of pathologies (aneurysms, dissections, ulcerations, intramural hematomas, pseudoaneurysms) and lesions in different aortic and anatomic locations (ascending, arch, descending and thoracoabdominal). RESULTS: The registry enrolled 304 patients from April 2005 to January 2009. All-cause mortality at 30 days was 7.2%. Freedom from all cause mortality and freedom from device- and procedure-related mortality at 2 years were 78.5% and 95.9%, respectively. An average of 1.26 graft components were used per patient, with a technical success of 97.7% irrespective of the etiology. Early endoleak rate was 4.6%. Perioperatively, stroke and paraplegia were registered in 1.6% and 2.0%, respectively. CONCLUSIONS: The results of RESTORE support the safety of thoracic endovascular aortic repair with the RELAY stent graft, even in acute and complicated situations. The device was highly efficient in angulated aortic anatomies, with acceptable mortality and a low rate of neurologic complications.

Endovascular treatment of patients with types A and B thoracic aortic dissection using Relay thoracic stent-grafts: results from the RESTORE Patient Registry.

PURPOSE: To evaluate the safety and performance of Relay stent-grafts in patients with acute or chronic aortic dissections. METHODS: Patients with types A or B aortic dissections suitable for treatment with Relay stent-grafts and followed for 2 years after thoracic endovascular aortic repair (TEVAR) were identified from a company-sponsored registry database established in January 2006. Ninety-one consecutive patients (69 men; mean age 65 years) underwent TEVAR with Relay stent-grafts for dissection. Most patients (76, 84%) had type B dissections; 61 of all patients were classified as chronic and 30 as acute. RESULTS: The technical success rate was 95% (97% in acute, 95% in chronic, and 93% in type B dissections). The type I endoleak rate was 7% (7% in acute and 8% in chronic dissections); all occurred in patients with type B dissections. Paraplegia, paraparesis, and stroke occurred in 4, 1, and 2 patients, respectively; 2 cases of paraplegia occurred in patients with acute type B dissections. Thirty-day mortality was 8% (13% in acute and 5% in chronic dissections); all deaths occurred in patients with type B dissections. The 2-year survival rate was 82% in the overall population and 84% in patients with type B dissections. CONCLUSION: The combination of Relay's features, such as stent conformability, radial force, atraumatic design, and controlled deployment and fixation, may contribute to the safety of the Relay stent-grafts for the treatment of thoracic aortic dissections, including acute and chronic type B dissections.

Carotid artery stent fracture identification and clinical relevance.

BACKGROUND: This study was conducted to identify the prevalence, risk factors, and clinical relevance of carotid artery stent fracture. METHODS: Commercially available carotid stents were implanted in this prospective, observational study that began in January 2004. Indications included asymptomatic patients (stenosis >80%), symptomatic patients (stenosis >60%), and ulcerated lesions (>50%). Stent integrity was assessed with plain radiography at 12 months. Data were analyzed in April 2009 on a series of 341 consecutive patients treated with carotid artery stenting with at least 12 months follow-up. RESULTS: Stent fracture prevalence was 3.4% at 12 months (95% confidence interval, 1.7%-6.1%). The median clinical follow-up was 30 months (range, 12-64 months) for 323 eligible patients. Treatment included 23.6% of symptomatic patients. According to univariate analysis, calcification type III increased the odds of stent fracture by more than 4.5 times (odds ratio [OR], 4.74; P = .006) and angulation >45 degrees increased the odds of stent fracture by 6.5 times (OR, 6.51; P = .008). Carotid stent cell type, stent length, and stent over-sizing were not correlated with stent fracture incidence. Stent fracture was not associated with stroke (0%), transient ischemic attack (0%), or death (0%). Restenosis was significantly associated with stent fracture (P < .001). Multivariate analysis evidenced that type III calcification (OR, 3.90; P = .029) and angulation >45 degrees (OR, 4.69; P = .026) were important risk factors for carotid stent fracture. CONCLUSIONS: Carotid stent fracture is a rare complication after CAS and is associated with vessel angulation, calcification, and restenosis. In this series, fracture identification was independent of stroke, transient ischemic attack, and mortality.

Endovascular preservation of full pelvic circulation with external iliac-to-internal iliac artery "cross-stenting" in patients with aorto-iliac aneurysms.

Common iliac artery (CIA) aneurysms that extend into the iliac bifurcation and internal iliac artery (IIA) usually require exclusion of the IIA, exposing pelvic ischemic complication risks. This case report presents an endovascular technique of "cross-stenting" in a short proximal landing zone with complete exclusion of the CIA aneurysm using a covered stent graft with a longer uncovered stent extending into one branch of the IIAs, maintaining full pelvic circulation. External iliac artery to IIA cross-stenting with an additional uncovered stent warrants further investigation, because it seems to extend graft stent placement indications, increase stability, and help avoid IIA exclusion.

Inflammatory abdominal aortic aneurysm endovascular repair into the long-term follow-up.

BACKGROUND: To investigate long-term outcomes for inflammatory abdominal aortic aneurysms (IAAA) after endovascular treatment (EVAR). METHODS: Between May 1997 and January 2009, 9 male patients (Mean 67 years, range 54-75 years) with IAAA were treated with EVAR using commercially available endografts. Results were assessed using contrast-enhanced computed tomography (CT) at 3 months, 12 months, and biannually thereafter. Echo-color duplex scanning was also recommended at 3, 6, and 12 months after discharge, and annually thereafter. Primary endpoints were aneurysm-related mortality, aneurysm sac evolution, perianeurysmal fibrosis (PAF) thickness, and hydronephrosis progression. RESULTS: No aneurysm-related deaths were observed during the long-term follow-up of eight patients (one patient death unknown). Maximum aneurysm sac diameter progressively reduced in eight patients (89%) and remained unchanged in one (11%). The absolute mean reduction of the aneurysm size was 26.2%. PAF regressed in two patients (22%), reduced in five (56%), and remained unchanged in two (22%). The absolute median reduction of the PAF thickness was 55.1%. No endoleak was observed during the follow-up period. Hydronephrosis persisted in all three patients who were preoperatively diagnosed with this pathology. Survival rates were 89%, 66.7%, and 66.7% at 12, 36, and 60 months, respectively. CONCLUSIONS: This series suggests that EVAR for IAAA into the long-term is associated with a positive trend for both PAF and aneurysm diameter reduction. EVAR does not seem to offer any benefits for hydronephrosis, but seems to effectively exclude the aneurysm sac in anatomically suitable patients.

Collected world and single center experience with endovascular treatment of ruptured abdominal aortic aneurysms.

BACKGROUND: Case and single center reports have documented the feasibility and suggested the effectiveness of endovascular aneurysm repair (EVAR) of ruptured abdominal aortic aneurysms (RAAAs), but the role and value of such treatment remain controversial. OBJECTIVE: To clarify these we examined a collected experience with use of EVAR for RAAA treatment from 49 centers. METHODS: Data were obtained by questionnaires from these centers, updated from 13 centers committed to EVAR treatment whenever possible and included treatment details from a single center and information on 1037 patients treated by EVAR and 763 patients treated by open repair (OR). RESULTS: Overall 30-day mortality after EVAR in 1037 patients was 21.2%. Centers performing EVAR for RAAAs whenever possible did so in 28% to 79% (mean 49.1%) of their patients, had a 30-day mortality of 19.7% (range: 0%-32%) for 680 EVAR patients and 36.3% (range: 8%-53%) for 763 OR patients (P < 0.0001). Supraceliac aortic balloon control was obtained in 19.1% +/- 12.0% (+/-SD) of 680 EVAR patients. Abdominal compartment syndrome was treated by some form of decompression in 12.2% +/- 8.3% (+/-SD) of these EVAR patients. CONCLUSION: These results indicate that EVAR has a lower procedural mortality at 30 days than OR in at least some patients and that EVAR is better than OR for treating RAAA patients provided they have favorable anatomy; adequate skills, facilities, and protocols are available; and optimal strategies, techniques, and adjuncts are employed.

Treatment of ruptured abdominal aortic aneurysm after endovascular abdominal aortic repair: A comparison with patients without prior treatment.

OBJECTIVE: A retrospective analysis of immediate outcomes following aneurysm rupture (rAAA) in two groups: patients previously treated at our center with primary endovascular repair (EVAR) and patients without previous EVAR for abdominal aortic aneurysms (AAA) in an 8-year period. METHODS: Fourteen patients with a confirmed rAAA identified throughout the follow-up period following primary EVAR repair at our center (from a population of 820 AAA treated at our center in election) were retrospectively compared with 155 patients without previous EVAR in the same time period, from the introduction of an intention-to-treat protocol with EVAR for rAAA in January 1999. Primary study outcomes included 30-day mortality and severe systemic complications following rAAA correction with both open and EVAR treatments. RESULTS: In the 14 patients secondary interventions were necessary throughout follow-up prior to rupture in 43% (6/14). The mean time to rupture was 50.23 months (9-113). The mean increase in maximum aneurysmal diameter at rupture was 18.39 mm. Type of endoleaks observed at rupture: 35.7% I proximal, 35.7% III contralateral stump disconnection, 14.3% I distal, 14.3% III midgraft tear: treatment at rupture included five EVAR corrections with aortouniiliac endografts, four EVAR corrections with extensions, and five surgical conversions. Thirty-day mortality between the two groups, 28.5% (patients with prior EVAR) 38.7% (patients without prior EVAR), and severe systemic complications, 50% vs 37.6%, were not found to be statistically significant. Hemodynamic instability, 36% (patients with prior EVAR) 63% (patients without prior EVAR), was found to be an independent predictor of 30-day mortality (P < .0001), whereas severe systemic complications, 50% vs 33.5%, did not influence the same outcome (P = .852). CONCLUSIONS: In terms of mortality, it would be logical to expect a protection from the endograft in patients with previous EVAR. A trend seems to confirm this assumption, but no statistical significance was found, which may be due to the small population size.

Endovascular treatment of abdominal aortic aneurysms with the Powerlink Endograft System: influence of placement on the bifurcation and use of a proximal extension on early and late outcomes.

OBJECTIVE: We evaluated the influence of placement of the bifurcated Powerlink endograft (Endologix Inc, Irvine, Calif) on the aortic bifurcation, with the addition of a proximal extension, in the endovascular treatment (EVAR) of selected patients with atherosclerotic abdominal aortic aneurysms (AAAs). METHODS: From September 1999 to June 2007, 205 patients were treated with the bifurcated Powerlink endograft for atherosclerotic AAA at two Italian centers with shared protocols. Patients were retrospectively divided in two groups according to treatment with the bifurcated graft only (n = 126), or its placement on the bifurcation with the addition of a proximal extension (n = 79) at the initial procedure. Study end points included postoperative complications, secondary procedures, immediate and late conversion, migration, endoleak, death, and aneurysmal sac behavior. RESULTS: Overall technical success was 98.5%. Additional procedures were performed in 18%, and postoperative complications occurred in 11.2% (systemic, 8.3%; local, 2.9%). Median follow-up was 42.4 months (range, 6-94 months). Secondary procedures were recorded in 11.2%, migration in 3.9%, type I proximal endoleak in 7.8%, and late conversions in 2.4%. Placement on the bifurcation and the addition of an extension were associated with a higher incidence of postoperative complications (7.1% vs 17.7%, P = .020). A reduced incidence of endoleak (19% vs 8.9%, P = .048), secondary procedures (14.3% vs 6.3%, P = .04), and migration (6.3% vs 0%, P = .024) were observed in the group with a proximal extension. Analysis of single variables reveals that migration was significantly influenced by placement of the graft on the bifurcation (47% vs 0%, P < .001). Both placement on the bifurcation and the addition of an extension positively influenced the type I proximal endoleak rate (3.8% vs 35.3% P < .001) and the need for a secondary intervention (6.3% vs 35.3% P < .001) Two aneurysm ruptures and five cases of late conversion occurred in the group treated with a bifurcated graft only (4%, P = .52, P = .159). Analysis of aneurysm sac behavior was not statistically significant: enlargement, 4.1% vs 1.3% (P = .158); reduction, 34.1% vs 40.5% (P = .542). CONCLUSION: The placement of the bifurcated Powerlink endograft on the aortic bifurcation with a proximal extension for complete sealing seems to improve late outcomes, particularly secondary procedures, migration, and endoleak development. Larger prospective studies with longer follow-up are necessary to confirm these promising results.

The INNOVATION Trial: four-year safety and effectiveness of the INCRAFT® AAA Stent-Graft System for endovascular repair.

BACKGROUND: This paper reports the 4-year safety and effectiveness of the INCRAFT® AAA Stent-Graft System (Cordis Corp., Milpitas, CA, USA), an ultra-low-profile device for the treatment of abdominal aortic aneurysms. METHODS: The INNOVATION Trial is the prospective, first-in-human, multicenter trial to evaluate the safety and effectiveness of the INCRAFT® System. Patients underwent annual clinical and computed tomography angiography examination as part of the study protocol. The INCRAFT® AAA Stent-Graft System is a customizable tri-modular design, with an ultra-low profile (14-Fr) delivery system. Patient were treated under approved protocol, the prescribed clinical and imaging follow-up at annually through 5 years. Results analyzed and adjudicated by a clinical events committee, independent core laboratory, and a data safety and monitoring board. This manuscript reports results through 4 years of follow-up. RESULTS: A total of 60 patients were enrolled in the trial, all of whom were successfully treated. Follow-up rates at 1 and 4 years were 93% (56/60) and 85% (51/60), respectively. All-cause mortality at 4 years was 17.6% and no death was AAA-, device-, or procedure-related. The secondary reintervention rate at 1 year was 4.6%, primarily the result of stent thrombosis. In total, 10 patients required 13 post-procedure interventions within 4-years of follow-up (2 to repair a type I endoleak, 4 to repair a type II endoleak, 1 for stent thrombosis, 1 for renal stenosis, 1 for aneurysm enlargement, 2 for limb migration and 2 for prosthesis stenosis or occlusion). There were 4 cases (10%) of aneurysm enlargement reported at the 4 year follow-up. At 4 years, 38 out of 39 patients were free from type I and III endoleaks. There were no proximal type I or type III endoleaks at 4-year follow-up. Core laboratory evaluation of the postoperative imaging studies indicated absence of endograft migration while a single fracture was demonstrated without any clinical sequelae. CONCLUSIONS: The INCRAFT® AAA Stent-Graft System provides a minimally invasive and durable solution for patients undergoing EVAR that has been associated with a low frequency of device-related events through 4 years of follow-up.

Comparing outcomes of carotid endarterectomy with international benchmarks: audit from an Italian vascular surgery department.

BACKGROUND: The aim of this study was to compare the outcomes of carotid endarterectomy (CEA) in the current practice of our department of vascular surgery with international benchmarks. METHODS: In-patient data from 488 CEA performed in both symptomatic 145 (29.7%) and asymptomatic 343 (70.3%) patients with a > or = 60% stenosis at the level of the internal carotid artery. Comprehensive retrospective review of the records for all the CEAs performed during a 2-year period. The main outcome measures were death rate, and fatal and non-fatal stroke rates perioperatively, and at 30 and 180 days. RESULTS: The fatal and non-fatal stroke rates of symptomatic patients were: 0.7% perioperatively, 0.7% at 30 days, and 0.7% at 180 days. The fatal and non-fatal stroke rates of asymptomatic patients were: 0.6% perioperatively, 0.6% at 30 days, and 0.3% at 180 days. The death rates of symptomatic patients were 0% for all time periods. The death rates of asymptomatic patients were: 0% perioperatively, 0% at 30 days, and 0.3% at 180 days. CONCLUSIONS: The present comprehensive audit shows that our surgeons achieve CEA outcomes comparable with international benchmarks.

Mechanical thrombectomy in proximal subclavian artery in-stent occlusion.

PURPOSE: Mechanical thrombectomy is an established tool for endovascular therapy of acute/chronic in-stent occlusions of the lower extremities, especially for the superficial femoral artery. The authors report the use of the Rotarex catheter system for an in-stent proximal subclavian occlusion. CASE PRESENTATION: A 51-year-old female patient with previous multiple attempts at left subclavian revascularization; primary endovascular stenting at the origin of the subclavian artery occluded at 3 months, and a carotid-subclavian bypass was placed distally to the stent. After 6 months from the first treatment, the patient was readmitted with an acute left arm ischemia and full occlusion of the bypass was confirmed at computed tomography angiography. An anterograde thrombectomy for in-stent restenosis, together with PTA with a drug-eluting balloon was performed in the subclavian artery with confirmed patency at 6 months. CONCLUSION: Mechanical thrombectomy together with drug-eluting balloon PTA for in-stent occlusion or restenosis of the subclavian artery could be a promising procedure with a lower invasivity and risk with respect to surgical options.

Endovascular repair of traumatic thoracic aortic injury: final results from the relay endovascular registry for thoracic disease.

BACKGROUND: In blunt thoracic aortic injury, thoracic endovascular aortic repair (TEVAR) offers a less invasive alternative to open chest surgery. New reliable and accurate stent grafts have widened the endovascular treatment options. We report our experience with the Relay stent graft Bolton Medical, Sunrise, FL; Barcelona, Spain) for treatment of this injury. METHODS: Relay Endovascular Registry for Thoracic Disease (RESTORE) is a multicenter, prospective European registry, which enrolled patients treated with the Relay stent graft for thoracic aortic diseases from April 2005 to January 2009. Regular follow-up examinations were conducted for up to 24 months. This paper analyzes the cohort of patients treated for traumatic aortic injury. RESULTS: Forty adult trauma patients from 12 European centers underwent TEVAR. Mean age was 40 years and 34 patients were male. The proximal landing zone involved aortic arch zones 1 to 2 in 40% and zone 3 in 55% of procedures. Technical success was achieved in all cases. One (2.5%) patient suffered a rupture of the iliac artery. No patient developed procedure-related paraplegia or required conversion to open surgery. Follow-up imaging demonstrated complete exclusion of the traumatic tear and regression of the false aneurysms without endoleak or graft infolding. One late device-related complication was reported; penetration of the distal end of the stent graft treated by stent-graft extension. Thirty-day mortality was 2.5 % (n = 1), and late mortality 2.5% due to a secondary accident. Actuarial 2-year survival was 93.7%. CONCLUSIONS: Thoracic endovascular aortic repair with the Relay stent graft is a safe and effective treatment for patients with traumatic aortic injury.

Thoracic endograft for abdominal aortic aneurysms, an unusual application for severe neck angulation: case report and literature review.

Our goal was to achieve complete proximal sealing in severe aortic neck angulation (SNA) during endovascular aneurysm repair (EVAR) of a patient with an abdominal aortic aneurysm (AAA) unfit for surgery. An 82-year-old patient with an infrarenal AAA of 9.8 cm with an SNA of 90 degrees was admitted for acute coronary syndrome. Following coronary treatment, the patient was considered unfit for surgery and therefore was evaluated for EVAR. Aneurysm sac exclusion was obtained with the deployment of a Powerlink bifurcated graft (Endologix Inc, Irvine, CA) inside a Relay thoracic endograft (Bolton Medical, Florida) placed just below the most distal renal artery. At 6 months, computed tomographic angiography confirmed correct graft placement, complete aneurysm exclusion, and a reduction in the aneurysmal sac. In AAA patients with an SNA at high risk of EVAR failure, the adaptability of a thoracic endograft could be considered for proximal sealing.

Single-center experience with the Talent LPS endograft in patients with at least 5 years of follow-up.

PURPOSE: To evaluate long-term results in patients undergoing elective endovascular aneurysm repair (EVAR) using the Talent LPS endograft to treat abdominal aortic aneurysm (AAA). METHODS: Fifty patients (49 men; median age 72 years, range 54-89) were treated electively between 1997 and 2001 with the Talent LPS endograft chosen for various anatomical reasons, including short (< or =15 mm) aortic neck (32.5%), iliac ectasia (> or =18 mm) in at least 1 iliac artery (32%), angulated (30 degrees -60 degrees ) aortic neck (16%), large (> or =28 mm) aortic neck (6%), and tapered, reversed tapered, or bulging aortic neck (14%). A quarter of patients were preoperatively classified as unfit for AAA open repair, and 58% were high risk (ASA III or IV). The primary endpoints were immediate success, aneurysm-related and non-aneurysm-related mortality, secondary interventions, graft-related complications, graft migration (> or =5 mm), and structural failure. RESULTS: Implantation success was achieved in 96% (48/50). Four (8%) patients died within 30 days; in follow-up, the mortality rate was 51% over a mean 47.7+/-27.4 months (minimum of 5 years). Aneurysm-related mortality was 12% (6/50); 3 (6%) patients were converted. The overall reintervention rate was 16% (8/50). There were 9 (18%) endoleaks in 8 patients: 4 type I (2 proximal, 2 distal), 3 type II, and 2 type III. The migration rate was 4% (1 ruptured AAA, 1 endoleak). Individual cases of graft kinking and stent fracture occurred in this series. CONCLUSION: Despite the small population, trends in our results suggest that the Talent stent-graft performs well over the long term. Surveillance, especially with regard to migration and graft integrity, remains of great importance.

A single-center experience in open and endovascular treatment of hemodynamically unstable and stable patients with ruptured abdominal aortic aneurysms.

OBJECTIVE: To retrospectively compare a single center's immediate and mid-term outcomes of ruptured abdominal aortic aneurysm open and endovascular repair (EVAR) for two patient groups-hemodynamically stable and unstable patients-in the same time period. METHODS: Patients presenting at our center with confirmed rupture of an abdominal aortic aneurysm between December 1999 and April 2006 were considered according to an intention-to-treat model with EVAR. Patients with symptomatic or acute (but not ruptured) AAAs were not included in this study. Thirty-three patients underwent EVAR, and 91 underwent open repair. Seventy-two patients (EVAR, 45%; open, 63%) were classified as hemodynamically unstable at arrival, and 52 were classified as stable (EVAR, 55%; open, 37%). Ninety-seven percent of EVAR procedures commenced under local anesthesia, and 100% of open repairs occurred with general anesthesia. Overall successful graft deployment, 30-day mortality, overall reintervention rate, and complications were the study primary end points. RESULTS: Overall successful graft deployment for EVAR was 91%; for open repair, it was 96%. Overall 30-day mortality for EVAR was 30% (unstable, 53%; stable, 11%), and the rate was 46% for open repair (unstable, 61%; stable, 21%). The EVAR postoperative reintervention rate (within 30 days) was 15% (unstable, 20%; stable, 11%), and for open repair it was 10% (unstable, 9%; stable, 15%). We recorded a 27% severe complication rate for EVAR patients (unstable, 40%; stable, 17%), and for patients treated with open repair, it was 33% (unstable, 35%; stable, 29%). Our overall EVAR eligibility rate was 52%, and our overall EVAR treatment rate was 27%. CONCLUSIONS: Our study's overall results for EVAR remain encouraging when compared with those of conventional repair, but large randomized trials are required to confirm the efficacy of the procedure.