Aaron Fargion

Early and long-term comparison of endovascular treatment of iliac artery occlusions and stenosis

OBJECTIVES This study evaluated early and long-term results of endovascular treatment of iliac artery occlusions and compared these outcomes with those in patients treated for stenotic lesions. METHODS During a 10-year period ending in January 2010, 223 endovascular procedures to treat aortoiliac occlusive disease (PAD) were performed. All patients were prospectively enrolled in a dedicated database. The intervention was performed for iliac occlusion in 109 patients (group 1) and for iliac stenosis in 114 (group 2). Early results were analyzed and compared by χ² and Fisher exact tests. Follow-up consisted of clinical examination and duplex scanning at discharge, ≤ 3 months, at 6 and 12 months, and yearly thereafter. Follow-up results were analyzed with Kaplan-Meier curves and compared with the log-rank test. RESULTS The two groups had similar risk factors for atherosclerosis and comorbidities. Critical limb ischemia was more common in group 1 (20.5%) than in group 2 (8.5%; P = .01). Intraoperative technical details were similar, except for a higher percentage of brachial and contralateral femoral access and more frequent use of nitinol stents in group 1. Two immediate technical failures occurred, one in both groups, requiring immediate conversion to surgical bypass. Four intraoperative iliac ruptures occurred, two in each group; all were successfully treated with covered stents. An additional 10 immediate complications occurred (8 in group 1; 2 in group 2), one of which required conversion to open surgical bypass. The cumulative rate of perioperative complications was 9% in group 1 and 3.5% in group 2 (P = .08). Primary patency at 30 days was 97.3% and 98.7%, respectively. Mean duration of follow-up was 28.4 months; 203 patients (91%) had a regular postoperative follow-up visit. At 60 months, primary patency in group 1 vs group 2 was 82.4% vs 77.7% (P = .9), assisted primary patency was 90.6% vs 85.5% (P = .4), and estimated secondary patency was 93.1% vs 92.8% (P = .3). The cumulative rate of reintervention during follow-up (excluding reinterventions performed in the perioperative period) was 2.5% in group 1 and 12.5% in group 2 at 60 months (P = .09). Univariate analysis in group 1 failed to find any of the examined risk factors significantly affected long-term primary patency rates. CONCLUSIONS In our experience, endovascular treatment of iliac occlusions provides excellent early and long-term results, similar to those obtained in the treatment of stenotic lesions.

Comparison of Early and Midterm Results of Open and Endovascular Treatment of Popliteal Artery Aneurysms

BACKGROUND Aim of this study was to retrospectively compare perioperative (<30 days) and 2-year results of open and endovascular management of popliteal artery aneurysms (PAAs) in a single-center experience. METHODS From January 2005 to December 2010, 64 PAAs in 59 consecutive patients were operated on at our institution; in 43 cases, open repair was performed (group 1), whereas the remaining 21 cases had an endovascular procedure (group 2). Data from all the interventions were prospectively collected in a dedicated database, which included main preoperative, intraoperative, and postoperative parameters. Early results in terms of mortality, graft thrombosis, and amputation rates were analyzed and compared by χ(2) text or Fisher exact text. The surveillance program consisted of clinical and ultrasonographic examinations at 1, 6, and 12 months and yearly thereafter. Follow-up results (survival, primary and secondary patency, limb salvage) were analyzed by Kaplan-Meier curves, and differences in the two groups were assessed by log-rank test. RESULTS There were no differences between the two groups in terms of sex, age, risk factors for atherosclerosis, and comorbidities; PAAs were symptomatic in 48% of cases in group 1 and in 29% in group 2 (P = 0.1). Fifteen patients with mild-to-moderate acute ischemia due to PAA thrombosis underwent preoperative intra-arterial thrombolysis, 13 in group 1 and 2 in group 2. In open surgery group, nine cases were treated with aneurysmectomy and prosthetic graft interposition, and in seven cases, the aneurysm was opened and a prosthetic graft was placed inside the aneurysm. In 27 cases, ligation of the aneurysm with bypass grafting (21 prosthetic grafts and 6 autologous veins) was carried out. In group 2, 20 patients had endoprosthesis placement, whereas in the remaining patient, a multilayer nitinol stent was used. There was one perioperative death in a patient of group 2 who underwent concomitant endovascular aneurysm repair and PAA endografting. Cumulative 30-day death and amputation rate was 4.5% in group 1 and 4.7% in group 2 (P = 0.9). Follow-up was available in 61 interventions (96%) with a mean follow-up period of 22.5 months (range: 1-60). Estimated primary patency rates at 24 months were 78.1% in group 1 and 59.4% in group 2 (P = 0.1). Freedom from reintervention rates at 24 months were 79% in group 1 and 61.5% in group 2 (P = 0.2); estimated 24-month secondary patency rates were 81.6% in group 1 and 78.4% in group 2 (P = 0.9), and freedom from amputation rates were 92.7% and 95%, respectively (P = 0.7). CONCLUSIONS Endovascular treatment of PAAs provided, in our initial experience, satisfactory perioperative and 1-year results, not significantly different from those obtained with prosthetic open repair in patients with similar clinical and anatomical status. There is, however, a trend toward poorer primary patency rates among patients endovascularly treated, who also seem to require more frequently a reintervention.

Gender-related outcomes in the endovascular treatment of infrainguinal arterial obstructive disease

OBJECTIVE The purpose of this study was to retrospectively analyze early and midterm results of endovascular infrainguinal peripheral revascularizations in female patients in our single-center experience, paying particular attention to clinical, anatomic, and technical factors affecting perioperative and follow-up outcomes. MATERIALS AND METHODS From January 2000 to December 2010, 258 endovascular interventions for femoropopliteal disease were performed. Interventions were retrospectively divided into two groups: interventions performed in women (80 interventions, group 1) and interventions performed in men (178 interventions, group 2). The two groups of patients were compared in terms of demographic data, common risk factors for atherosclerosis, and comorbidities. Early (intraoperative and <30-day) results were analyzed in terms of technical success, conversion to open surgery, primary patency, secondary patency, and, for patients with critical limb ischemia, limb salvage. The follow-up program consisted of clinical and duplex scanning examinations with ankle-brachial index (ABI) measurement within the third postoperative month, at 6 and 12 months, and yearly thereafter. Follow-up results were analyzed in terms of survival, primary and secondary patency, assisted primary patency, and, for patients with critical ischemia, limb salvage. RESULTS There were no differences between the two groups in terms of risk factors for atherosclerosis, comorbidities, clinical, and anatomic status. Technical success was 96.9% and technical failure rates were 1.2% in group 1 and 3.9% in group 2 (P = .2). Three in-hospital deaths were recorded, all in group 2, whereas in-hospital thromboses occurred in five patients, two in group 1 and three in group 2; with conversion to surgical bypass in all these cases, and in three of the cases, major amputation was necessary (two in group 1 and one in group 2). Cumulative 30-day mortality was 1.1%, with no difference between women (no deaths) and men (three deaths, 1.6%; P = .4). Overall amputation rate at 30 days was 1.2%, again with no differences between the two groups (2.5% and 0.6%, respectively; P = .4); also, the rate of perioperative thrombosis (overall 2.7%) was similar between the two groups (2.5% and 3.3%, respectively; P = .9). Mean duration of follow-up was 17 months (range, 1-85 months). Estimated 36-month survival rates were 95% in group 1 and 84.5% in group 2 (P = .4; log-rank, 0.7). Cumulative primary patency rates at 36 months were 38% in group 1 and 42% in group 2 (P = .4; log-rank, 0.5). Assisted primary patency at 36 months was 45.1% in group 1 and 60.5% in group 2, whereas secondary patency rates were 63.5% and 76%, respectively (P = .8; log-rank, 0.03). CONCLUSION Endovascular treatment of femoropopliteal occlusive disease provides similar results between men and women at an intermediate follow-up. There is, however, a trend toward poorer results in women requiring further analysis at a longer follow-up period.

Early and long-term results of carotid endarterectomy in diabetic patients

PURPOSE To evaluate results of carotid endarterectomy (CEA) in diabetic patients in a large single-center experience. METHODS Over a 13-year period ending in December 2008, 4305 consecutive CEAs in 3573 patients were performed. All patients were prospectively enrolled in a dedicated database. Interventions were performed in diabetic patients in 883 cases (20.5%; group 1) and in nondiabetics in the remaining 3422 (79.5%; group 2). Early results in terms of 30-day stroke and death rates were analyzed and compared. Follow-up results were analyzed with Kaplan-Meier curves and compared with log-rank test. RESULTS Diabetic patients were more likely to be females and to have coronary artery disease, peripheral arterial disease, hyperlipemia, and arterial hypertension than nondiabetics. There were no differences between the two groups in terms of preoperative clinical status or degree of carotid stenosis. Interventions were performed under general anesthesia with somatosensory-evoked potentials (SEPs) monitoring in 67% of the patients in both groups, while the remaining interventions were performed under clinical monitoring. Shunt insertion (14% and 11%, respectively) and patch closure rates (79% and 76%, respectively) were similar between the two groups. There were no differences between the two groups in terms of neurological outcomes, while the mortality rate was higher in group 1 than in group 2 (P = .002; odds ratio [OR], 3.5; 95% confidence interval [CI], 1.5-8.3); combined 30-day stroke and death rate was significantly higher in group 1 (2%) than in group 2 (0.9%; P = .006; 95% CI, 1.2-3.9; OR, 2.2). At univariate analysis, perioperative risk of stroke and death in diabetic patients was significantly higher in patients undergoing intervention with SEP cerebral monitoring (95% CI, 0.9-39.9; OR, 5.9; P = .01), and this was also confirmed by multivariate analysis (95% CI, 1.1-23.1; OR, 8.3; P = .04). The same analysis in nondiabetics demonstrated that again the need for general anesthesia significantly increased perioperative risk, but this was not significant at multivariate analysis. Follow-up was available in 96% of patients, with a mean duration of 40 months (range, 1-166 months). There were no differences between the two groups in terms of estimated 7-year survival (87.3% and 88.8%, respectively; 95% CI, 0.57-1.08; OR, 0.8) and stroke-free survival (86.8% and 88.1%, respectively; 95% CI, 0.59-1.07; OR, 0.8). Diabetic patients had decreased severe (>70%) restenosis-free survival rates at 7 years than nondiabetics (77.4% and 82.2%, respectively; 95% CI, 0.6-1; OR, 0.8; P = .05). Univariate analysis demonstrated again that the use of instrumental cerebral monitoring significantly decreased stroke-free survival in diabetics (P = .01; log rank, 10.1), and this was also confirmed by multivariate analysis (95% CI, 1.7-17.7; OR, 5.4; P = .005). CONCLUSIONS In our experience, the presence of diabetes mellitus increases three-fold the risk of perioperative death after CEA, while there are no differences with nondiabetics in terms of perioperative stroke. However, the rate of stroke and death at 30 days still remains below the recommended standards. During follow-up, this difference becomes negligible, and results are fairly similar to those obtained in nondiabetics. Particular attention should be paid to patients undergoing intervention under general anesthesia, who seem to represent a subgroup of diabetics at higher perioperative risk, suggesting neurologic monitoring should be used when possible.

Comparison of Open and Endovascular Treatments of Post-carotid Endarterectomy Restenosis

AIM OF THE STUDY To compare early and long term results of open and endovascular treatment of post-carotid endarterectomy (CEA) restenosis in a single centre experience. METHODS From January 2005 to December 2011, ninety-nine consecutive interventions for primary severe post-CEA restenosis were performed: in 41 cases (41%, Group 1) open repair was carried out, whereas the remaining 58 patients (59%, group 2) underwent an endovascular treatment. Data concerning these interventions were prospectively collected in a dedicated database containing main pre, intra and postoperative variables. Early results in terms of 30-day stroke and death rates were analysed and compared with χ(2) test. Follow-up results were analysed with Kaplan Meier curves and compared with log-rank test. RESULTS Mean time from primary CEA was 75 months in group 1 and 42 months in group 2 (p = 0.002; 95% CI 12-52). There were no differences between the two groups in terms of demographic data, comorbidities, risk factors for atherosclerosis, preoperative clinical status or degree of stenosis on the operated side. In group 1 interventions consisted of redo-CEA in 37 patients and of carotid bypass in the remaining 4; all the patients in group 2 underwent stent placement with cerebral protection device. No perioperative deaths and ipsilateral neurological events occurred in both groups. One patient in group 1 suffered from a non-fatal acute myocardial infarction. Other six patients (14.5%) experienced transient cranial nerve injuries, with complete regression at 1-month follow-up; two patients had postoperative dysphagia due to neck haematoma, which was medically managed. Neither access-related nor systemic complications were recorded in group 2. Follow-up was available in 98% of the patients with a median duration of 24 months (range 3-72). There were no differences in terms of 4-year estimated survival and stroke-free survival, whereas patients in group 1 were more likely to develop severe (>80%) secondary restenosis (28.3% and 6.5%, respectively, p = 0.01, log rank 6.3) and to undergo secondary reintervention (22% and 11%, respectively p = 0.01, log rank 6). CONCLUSIONS despite the selection limits and bias of this study, in our experience open and endovascular surgery provided similar perioperative results in the management of post-CEA restenosis. Long term outcomes are similar, too, despite a slight increase in secondary restenosis and recurrent reinterventions among open surgery patients, warranting further studies and analysis.

Early and Intermediate Results of Elective Endovascular Treatment of True Visceral Artery Aneurysms

BACKGROUND To retrospectively analyze early and follow-up results of endovascular management of visceral artery aneurysms (VAAs) in a single-center experience. METHODS From 2007 to June 2013, 26 consecutive elective endovascular interventions for VAAs were performed in 26 patients; preoperative, intraoperative, and postoperative data were prospectively collected in a dedicated database. Early (<30 days) and follow-up results were evaluated. RESULTS The site of aneurysm was splenic artery in 17 patients, common hepatic artery in 3 patients, renal artery and pancreaticoduodenal artery in 2 cases each, and gastroduodenal artery and celiac trunk in one case each. All the lesions were asymptomatic, and the mean diameter was 22.8 mm. Interventions consisted in coiling in 19 cases; in 4 patients a covered stent was placed, whereas the remaining 3 patients had a multilayer stent. Technical success was 89%. There were no perioperative deaths; 1 patient with splenic artery aneurysm had coils migration with symptomatic splenic infarction and underwent successful redo coils packing. Median duration of follow-up was 18 months. During follow-up, 1 aneurysm-unrelated death occurred. One asymptomatic thrombosis of a treated vessel was recorded, with a 2-year estimated patency rate of 91%. Mean aneurysmal diameter at the latest follow-up was 20.2 mm (P = 0.001 in comparison with preoperative values; 95% confidence interval 1.9-5.2). Complete exclusion of the aneurysm occurred in all but 1 patient, who had a limited increasing in the diameter of its splenic aneurysmal sac after coiling. Another patient developed a more distal aneurysm of the splenic artery after 24 months. No reinterventions were required. Freedom from aneurysm-related complications at 2 years was 72.9% (Standard Error, 0.09). CONCLUSIONS In our experience, endovascular treatment of VAA, when feasible, provided excellent perioperative results with low rates of complications and reinterventions. Even if the risk of developing aneurysm-related complications during follow-up is substantial, most of them can be watched without the need for repeated interventions.

Endovascular Repair of a Ruptured Popliteal Artery Aneurysm Associated with Popliteal Arteriovenous Fistula

Popliteal artery aneurysms (PAAs) represent the most common peripheral arterial aneurysm and are a significant cause of patient morbidity and limb loss. Complications of PAA include distal embolisation, thrombosis and, rarely, rupture. Whereas open surgical repair remains the gold standard, endovascular exclusion has been demonstrated to be a valid alternative in selected patients. We present an unusual case of ruptured PAA associated with popliteal vein arteriovenous fistula that was successfully treated with an endovascular approach. In our opinion, higher-risk patients as well as patients presenting with rupture may constitute a subgroup warranting an endovascular approach whenever possible.

Early and midterm results of kissing stent technique in the management of aortoiliac obstructive disease.

BACKGROUND To retrospectively analyze the early and the midterm results of endovascular management of aortoiliac obstructive disease with the kissing stent technique. METHODS From January 2005 to September 2012, 229 consecutive endovascular interventions for aortoiliac obstructive disease were performed; data from all the interventions were prospectively collected in a dedicated database. In 41 patients, the kissing stent technique at the level of aortic bifurcation was performed (group 1), whereas in the remaining 188 it was not (group 2). Perioperative results were compared with chi-squared test. Follow-up results were analyzed with Kaplan-Meier curves and compared with log-rank test. RESULTS Trans-Atlantic Inter-Society Consensus II C and D lesions were present in 66% of patients in group 1 and in 28.5% in group 2 (P < 0.001), whereas iliac occlusion rather than stenosis was detected in 78% of patients in group 1 and in 50% in group 2 (P = 0.001). The mean number of placed stents was 2.5 in group 1 and 1.4 in group 2 (P < 0.001). Technical success was 100% in group 1 and 98% in group 2 (P = 0.3). The rate of perioperative complications was 7.3% in group 1 and 4.2% in group 2 (P = 0.4). At 30 days, neither deaths nor major cardiovascular complications occurred. There was no thrombosis or significant restenosis at the early postoperative follow-up visit. Mean duration of follow-up was 22 months. Primary patency rates at 4 years were 70.5% (standard error [SE], 0.09) in group 1 and 75.5% (SE, 0.06) in group 2 (P = 0.7). At the same interval, assisted primary and secondary patency and survival rates were also similar; reintervention rates were 15.5% in group 1 (SE, 0.1) and 19.5% in group 2 (SE, 0.06; P = 0.6). CONCLUSIONS The kissing stent technique provided satisfactory results in patients with obstructive aortoiliac diseases, without an increase in immediate and midterm complications, representing an effective solution in complex anatomies.

Secondary Procedures Following Iliac Branch Device Treatment of Aneurysms Involving the Iliac Bifurcation: The pELVIS Registry:

Purpose: To evaluate the incidence and reasons for secondary procedures in patients treated with iliac branch devices (IBDs) for isolated iliac aneurysm or aortoiliac aneurysms involving the iliac bifurcation. Methods: Between January 2005 and December 2015, 575 surgical-high-risk patients (mean age 72.0±8.4 years; 558 men) with isolated iliac aneurysms (n=79) or aortoiliac aneurysms involving the iliac bifurcation (n=496) were treated with placement of 650 ZBIS or Gore IBDs (75 bilateral) in 6 European centers. The primary outcome was procedure-related reinterventions for occlusion or high-grade (>70%) stenosis of the bridging device, occlusion of the ipsilateral common or external iliac artery (EIA), type I/III endoleak, rupture, or infection following IBD implantation. Clinical and radiological data were analyzed based on preset definitions of comorbidities, aneurysm morphology, intraoperative variables, and follow-up strategies. Results: Nine (1.6%) reinterventions were performed within 30 days for occlusion or endoleak. Among 10 (1.5%) occluded EIAs ipsilateral to a deployed IBD, 6 underwent a reintervention with additional stent placement after thrombolysis (n=4) or a femorofemoral or iliofemoral crossover bypass (n=2). Three of 14 patients with early type I endoleak had a reintervention for an insufficient proximal sealing zone (stent-grafts in 2 common iliac arteries and 1 bifurcated endograft). Mean clinical and radiological follow-up were 32.6±9.9 and 29.8±21.1 months, respectively. Forty-two (7.3%) patients underwent reinterventions in the follow-up period. The overall postoperative reintervention rate was 8.9%. Both external and common iliac segments occluded in 30 (4.6%) IBDs; 2 patients had a crossover bypass and 14 were treated with endovascular techniques. In the other 14 patients, no specific treatment was performed. Seven (1.2%) patients with isolated EIA occlusion were treated during follow-up. Nineteen of the overall 28 patients with type I endoleak underwent endovascular repair. The other 9 were under radiological surveillance due to less significant (<5 mm) sac increase. No reintervention was performed to recanalize 11 (1.6%) occluded internal iliac arteries. Conclusion: Midterm experience with placement of IBDs is associated with a low incidence of secondary procedures due to type I endoleaks and occlusions. The main reasons for reinterventions seem to be short proximal sealing zone and poor conformability of the ZBIS device in elongated EIAs.

Aortic type B dissection with acute expansion of iliac artery aneurysm in previous endovascular repair with iliac branched graft

We report the case of a patient previously treated with an iliac branch endograft for isolated iliac artery aneurysm who developed, more than 2 years later, a type B aortic dissection resulting in the acute expansion of the previously excluded iliac aneurysm. Successful endovascular salvage is described.