Roberto Moratto

Experience with the Stentor endograft at four Italian centers.

Purpose: To report the outcome of an Italian multicenter trial of endovascular abdominal aortic aneurysm (AAA) exclusion using the Stentor device. Methods: Between April 1995 and July 1996, 66 patients (63 men; average age 69 years, range 53 to 84) with infrarenal AAAs meeting the inclusion criteria were enrolled. The average diameter of the aneurysm was 4.6 cm (range 4.2 to 7). Three (4.5%) of the 66 AAAs were anastomotic aneurysms. Results: Sixteen (25%) tubular and 50 (76%) bifurcated endograft procedures were attempted; 4 (6.1%) were converted and 1 terminated owing to technical faults with the bifurcated grafts second limb. One tube graft was too short and failed to exclude an anastomotic aneurysm. Sixty (91%) endograft procedures were completed successfully. Six (9.1%) vascular complications occurred, three in one patient who subsequently died of pulmonary embolism 72 hours postoperatively (1.5% mortality). There were four (6.1%) proximal endoleaks; two sealed spontaneously in < 1 month, and a third was converted (7.6% conversion rate). The fourth is being observed. Clinical success (aneurysm exclusion with no death or endoleak) at 30 days was 86.3% (57/66). In the 23-month follow-up of 57 eligible patients, 2 patients died of unrelated causes and 1 graft limb thrombosed, requiring a crossover femoral bypass. One patient was converted to surgical repair at 5 months postoperatively when increasing aneurysm size signaled an undisclosed endoleak (1.8% late conversion rate). Five other secondary endoleaks were treated with endovascular techniques. Conclusions: The Stentor was technically feasible in 10% to 40% of AAA candidates in this study, although deployment of the second limb was problematic in the bifurcated device. Introduction of the second-generation Vanguard endograft brought this study to an end.

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.

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.

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.

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.