Roberto Silingardi

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.

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.

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 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.

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.

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 (≤15 mm) aortic neck (32.5%), iliac ectasia (≥18 mm) in at least 1 iliac artery (32%), angulated (30°–60°) aortic neck (16%), large (≥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 (≥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.

The Italian Trial of Endovascular AAA Exclusion Using the Parodi Endograft

PURPOSE To report the outcome of the prospective 11-center Italian Parodi Trial using straight and tapered endografts for the endovascular exclusion of abdominal aortic aneurysms (AAA). METHODS From April 1994 to July 1995, 27 patients were evaluated and selected for endovascular AAA exclusion. The Parodi devices were delivered through femoral arteriotomies using 18 to 22F introducers and deployed by balloon expansion of the terminal stents. RESULTS Of 27 cases attempted, 24 endografts (15 tube, 9 aortomonoiliac) were implanted (1 deployment and 2 access failures [11.1%] were converted). Three endoleaks (12.5%) were treated intraoperatively with covered stents, two successfully, and the third sealed within 30 days. Three (12.5%) of the 24 treated patients died in-hospital of device-(n = 2) and procedure-related (n = 1) causes; the remaining 21 patients were discharged within 8 days. Of the 8 aortomonoiliac grafts in follow-up, only 1 (12.5%) failed in the mean 23-month (range 18 to 30) follow-up: however, 4 (31%) of 13 tube graft patients were converted to surgery within 18 months. Of the 16 (66.7%) surviving endografts at 2 years, 6 (38%) showed no change in the AAA diameter, while 10 (62%) had shrunk. CONCLUSIONS The tube graft was applicable in only about 5% of cases, and accurate endograft sizing and distal fixation were problematic. The aortomonoiliac design was not appealing to surgeons but fared better in the long term. Given the advent of newer endograft models, the Italian Parodi Trial has been terminated.

Midterm Outcomes of the Nellix Endovascular Aneurysm Sealing System A Dual-Center Experience

Purpose: To report midterm outcomes of the Nellix Endovascular Aneurysm Sealing (EVAS) System in the treatment of abdominal aortic aneurysm (AAA). Methods: Between September 2013 and July 2014, 64 AAA patients (mean age 76.6±6.8 years; 61 men) were treated with the EVAS system at 2 centers (only procedures performed at least 12 months prior to the analysis were included). Most patients were treated for a stable AAA, while 1 patient was treated for a ruptured aneurysm. Mean aneurysm diameter was 57.3±9.3 mm. The proximal neck measured a mean 21.5±3.3 mm in diameter and 27.0±12.1 mm long; the neck angle was 16.9°±19.3°. Eleven (17.2%) patients were treated outside the instructions for use (IFU). Results: Technical success was achieved in 63 (98.4%) of 64 patients; 1 type Ia endoleak was treated intraoperatively. One (1.6%) aneurysm-related death occurred at 4 months due to a secondary aortoenteric fistula. Overall, endoleaks occurred in 3 (4.7%) patients (2 type Ia, 1 type II). The estimated rates for 18-month overall survival, freedom from aneurysm-related death, and freedom from secondary interventions were 92.7%, 98.4%, and 95.0%, respectively. Patients treated outside the IFU had a significantly higher incidence of device-related complications (p=0.03). Conclusion: The use of the Nellix device in everyday clinical practice is safe and offers promising midterm results. The risk of secondary aortoenteric fistula requires further analysis. Longer follow-up is needed to assess the actual efficacy of the device, although the risk of migration with late endoleak seems low.

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° 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.

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.