A Matched Case-Control Study on Open and Endovascular Treatment of Popliteal Artery Aneurysms.

OBJECTIVE: To compare early and late results of open and endovascular management of popliteal artery aneurysm in a retrospective single-center matched case-control study Methods: From 1981 to 2015, 309 consecutive interventions for popliteal artery aneurysm were performed in our institution, in 59 cases with endovascular repair and in 250 cases with open repair. Endovascular repair was preferred in older asymptomatic patients, while open repair was offered more frequently to patients with a thrombosed popliteal artery aneurysm and a poor run-off status. A one-to-one coarsened exact matching on the basis of the baseline demographic, clinical, and anatomical covariates significantly different between the two treatment options was performed and two equivalent groups of 56 endovascular repairs and open repairs were generated. The two groups were compared in terms of perioperative results with χ2 test and of follow-up outcomes with the Kaplan-Meier curves and log-rank test. RESULTS: There were no differences between the two groups in terms of perioperative outcomes. Median duration of follow-up was 38 months. Five-year survival rates were 94% in endovascular repair group and 89.5% in open repair group (p = 0.4, log-rank 0.6). Primary patency rates at 1, 3, and 5 years were 81%, 78%, and 72% in endovascular repair group and 82.5%, 80%, and 64% in open repair group (p = 0.8, log-rank 0.01). Freedom from reintervention at 5 years was 65.5% in endovascular repair group and 76% in open repair group (p = 0.2, log-rank 1.2). Secondary patency at 1, 3, and 5 years was 94%, 86%, and 74% in endovascular repair group, and 94%, 89%, and 71% in open repair group, respectively (p = 0.9, log-rank 0.01). The rates of limb preservation at 5 years were 94% in endovascular repair group and 86.4% in open repair group (p = 0.3, log-rank 0.8). CONCLUSION: Open repair and endovascular repair of popliteal artery aneurysms provided in this retrospective single-center experience similar perioperative and follow-up results in equivalent groups of patients.

Italian Percutaneous EVAR (IPER) Registry: outcomes of 2381 percutaneous femoral access sites' closure for aortic stent-graft.

AIM: The aim of this paper was to report outcomes of endovascular aneurysm repair with percutaneous femoral access (pEVAR) using Prostar XL and Proglide closure systems (Abbot Vascular, Santa Clara, CA, USA), from the multicenter Italian Percutaneous EVAR (IPER) registry. METHODS: Consecutive patients affected by aortic pathology treated by EVAR with percutaneous access (pEVAR) between January 2010 and December 2014 at seven Italian centers were enrolled in this multicenter registry. All the operators had an experience of at least 50 percutaneous femoral access procedures. Data were prospectively collected into a dedicated online database including patient's demographics, anatomical features, intra- and postoperative outcomes. A retrospective analysis was carried out to report intraoperative and 30-day technical success and access-related complication rate. Uni- and multivariate analyses were performed to identify factors potentially associated with an increased risk of percutaneous pEVAR failure. RESULTS: A total of 2381 accesses were collected in 1322 patients, 1249 (94.4%) male with a mean age of 73.5±8.3 years (range 45-97). The overall technical success rate was 96.8% (2305/2381). Major intraoperative access-related complications requiring conversion to surgical cut-down were observed in 3.2% of the cases (76/2381). One-month pEVAR failure-rate was 0.25% (6/2381). Presence of femoral artery calcifications resulted to be a significant predictor of technical failure (OR: 1.69; 95% CI: 1.03-2.77; P=0.036) at multivariate analysis. No significant association was observed with sex (P=0.28), obesity (P=0.64), CFA diameter (P=0.32), level of CFA bifurcation (P=0.94) and sheath size >18 F (P=0.24). The use of Proglide was associated with a lower failure rate compared to Prostar XL (2.5% vs. 3.3%) despite not statistically significant (P=0.33). CONCLUSION: The results of the IPER registry confirm the high technical success rate of percutaneous EVAR when performed by experienced operators, even in presence of demanding anatomies. Femoral calcification represents the only predictor of percutaneous access failure.

BRAVISSIMO: 12-month results from a large scale prospective trial.

The BRAVISSIMO study is a prospective, non-randomized, multi-center, multi-national, monitored trial, conducted at 12 hospitals in Belgium and 11 hospitals in Italy. This manuscript reports the findings up to the 12-month follow-up time point for both the TASC A&B cohort and the TASC C&D cohort. The primary endpoint of the study is primary patency at 12 months, defined as a target lesion without a hemodynamically significant stenosis on Duplex ultrasound (>50%, systolic velocity ratio no greater than 2.0) and without target lesion revascularization (TLR) within 12 months. Between July 2009 and September 2010, 190 patients with TASC A or TASC B aortoiliac lesions and 135 patients with TASC C or TASC D aortoiliac lesions were included. The demographic data were comparable for the TASC A/B cohort and the TASC C/D cohort. The number of claudicants was significantly higher in the TASC A/B cohort, The TASC C/D cohort contains more CLI patients. The primary patency rate for the total patient population was 93.1%. The primary patency rates at 12 months for the TASC A, B, C and D lesions were 94.0%, 96.5%, 91.3% and 90.2% respectively. No statistical significant difference was shown when comparing these groups. Our findings confirm that endovascular therapy, and more specifically primary stenting, is the preferred treatment for patients with TASC A, B, C and D aortoiliac lesions. We notice similar endovascular results compared to surgery, however without the invasive character of surgery.

Endovascular treatment of aorto-iliac aneurysms: four-year results of iliac branch endograft.

INTRODUCTION: The aim of this report was to analyse early and mid-term outcomes of endovascular treatment (endovascular aneurysm repair, EVAR) for aorto-iliac aneurysms with the use of an iliac branch device (IBD). REPORT: A total of 85 EVAR procedures with IBD were electively carried out in 81 patients between September 2007 and August 2012. Technical success was obtained in 98.7% of the cases. The mean follow-up duration was 20.4 months (SD ± 15.4). There was one IBD occlusion (1.2%). Estimated 48 months' survival, freedom from re-intervention and branch occlusion were 76.7%, 88.3% and 98%, respectively. CONCLUSIONS: EVAR for aorto-iliac aneurysms using IBD is an effective procedure with low complication and re-intervention rates at mid-term follow-up.

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.

A 20-year experience with surgical management of true and false internal carotid artery aneurysms.

AIM OF THE STUDY: The aim of this study was to retrospectively analyse early and late results of surgical management of internal carotid artery (ICA) true and false aneurysms in a single-centre experience. MATERIALS AND METHODS: From January 1988 to December 2011, 50 consecutive interventions for ICA aneurismal disease were performed; interventions were performed for true ICA aneurysm in 19 cases (group 1) and for ICA post-carotid endarterectomy (CEA) pseudo-aneurysm in the remaining 31 (group 2). Early results (<30 days) were evaluated in terms of mortality, stroke and cranial nerves' injury and compared between the two groups with χ(2) test. Follow-up results (stroke free-survival, freedom from ICA thrombosis and reintervention) were analysed with Kaplan-Meier curves and compared with log-rank test. RESULTS: All the patients in group 1 had open repair of their ICA aneurysm; in group 2 open repair was performed in 30 cases, while three patients with post-CEA aneurysm without signs of infection had a covered stent placed. There were no perioperative deaths. Two major strokes occurred in group 1 and one major stroke occurred in group 2 (p = 0.1). The rates of postoperative cranial nerve injuries were 10.5% in group 1 and 13% in group 2 (p = 0.8). Median duration of follow-up was 60 months (range 1-276). Estimated 10-year stroke-free survival rates were 64% in group 1 and 37% in group 2 (p = 0.4, log rank 0.5); thrombosis-free survival at 10 years was 66% in group 1 and 34% in group 2 (p = 0.2, log rank 1.2), while the corresponding figures in terms of reintervention-free survival were 68% and 33%, respectively (p = 0.2, log rank 1.8). CONCLUSIONS: Surgical treatment of ICA aneurismal disease provided in our experience satisfactory early and long-term results, without significant differences between true and false aneurysms. In carefully selected patients with non-infected false aneurysm, the endovascular option seems to be feasible.

AnacondaTM: the Italian Registry. Study protocol and preliminary perioperative results.

AIM: AnacondaTM is an infrarenal stent-graft for the endovascular treatment (EVAR) of abdominal aortic aneurysms (AAA). The AnacondaTM Italian Registry is an observational multicentre registry that started in Italy on March 2009. The aim of this study is to present the registry protocol and to evaluate the interim perioperative results. METHODS: Patient data collected covered both retrospective and new cases. The case record forms are divided into preoperative data (population characteristics and clinical data), preoperative morphological data, intraoperative data, perioperative data (30-days from AnacondaTM implant) and follow-up record forms. The inclusion criteria are: AAA with a maximum sac diameter ≥ 5 cm, AAA with rapid expansion, symptomatic AAA or with a contained rupture, aorto-iliac aneurysms, proximal neck length ≥ 15 mm and diameter of the proximal aortic neck between 16 and 31.5 mm. No exclusion criteria were considered regarding aorto-iliac tortuosity, wall calcification or thrombosis and no exclusion criteria were considered regarding the patients age, comorbidities or life expectancy. Seven postoperative follow-up controls (visit and imaging) were required: at 30-days from the AnacondaTM implant, 6 months, 1 year and then annually up to 5 years. The registry is still open to new case enrollment. RESULTS: The reported results reflect the registry cases as at March 15, 2011. At this date, 787 cases were present in the database: 722 (91.7%) were male and 65 (8.3%) female. The mean patient age was 76.6 years with a range between 50 and 94 years. The ASA class was ≥ 3 in 635 patients (80.6%). The mean aneurysmal sac diameter was 55.73 ± 9.5 mm. The mean proximal aortic neck length was 26.52 ± 12.31 mm. Of the 787 patients treated, 11 cases of immediate surgical conversion were reported (1.3%). The overall 30-day mortality rate was 1.2% (10 cases): but 30-day death occurred in 0.9% of successful endograft implants and in 27.2% of surgical conversions (p<0.001). In fourteen cases (1.7%) an iliac leg thrombosis occurred and a native iliac artery thrombosis occurred in only five cases (0.5%). The 30-day overall occurrence of endoleaks was observed in 95 cases (12%): 5 cases of type I proximal endoleak (0.6%), 89 cases of type II endoleak (11.3%) and 1 case of type III endoleak (0.1%). No cases of endograft dislocation were reported. CONCLUSION: This is an interim report on the study protocol and on the preliminary early results. Presently there are no definitive conclusions, however the perioperative results show that the AnacondaTM endograft seems to be safe and effective in the treatment of AAA, even in a high risk cohort of patients. Definitive and long-term results are needed.

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.

Hybrid treatment of aortic arch aneurysms.

AIM: Aim of this study was to retrospectively analyze the experience of a single center in the hybrid treatment of aortic arch aneurysms. METHODS: From January 2005 to August 2008 a hybrid treatment for complex aortic aneurysms (aortic arch, thoracoabdominal aorta or thoracic and abdominal segments at the same time) was performed in 34 patients. In 11 cases a hybrid exclusion of an aortic arch aneurysm was carried out. Perioperative results in terms of morbidity and mortality were assessed. Follow-up examination consisted of computed tomography scan and chest X-ray at discharge, 6 and 12 months, and yearly thereafter. Mid-term survival and graft-related complications were analyzed. RESULTS: All the patients were males with a mean age of 74 years, range 68-81. Intraoperative technical success was achieved in all the cases. At 30 days one patient died for an acute stroke. The overall 30-day mortality rate was 9.1%. One frenic nerve paralysis and one acute re-spiratory failure with pneumonia were observed with an overall 30-day major morbidity rate of 18.2%. During follow-up (mean duration 19.3 months, range 1-36) no death, reintervention, conversion, aneurysm-related complication or graft thrombosis were recorded. CONCLUSION: Hybrid approaches to the treatment of complex aortic lesions involving the arch can be successfully used. However, perioperative complications remain still not irrelevant and long-term efficacy has to be proved.

Routine completion angiography during carotid endarterectomy is not mandatory.

OBJECTIVE: Intraoperative quality control after carotid endarterectomy (CEA) has been advocated to improve the results of surgical treatment of extracranial carotid artery disease. The aim of this study was to evaluate the usefulness of completion angiography (CA) in prevention of stroke and restenosis after CEA in a single center experience. MATERIALS AND METHODS: Data concerning 914 consecutive CEAs performed in 3 years (2000-2002) were prospectively collected in a dedicated database. Patients were divided into two groups: in the first group (mandatory-CA group; 430 cases) CA was routinely carried out, except in presence of contraindications to iodinate contrast agents; in the second group (selective-CA group, 484 cases) CA was performed only in selected cases, at surgeon's discretion. RESULTS: There were no significant differences between the two groups in terms of neurological complications at awakening (0.5% in mandatory-CA group and 0.4% in selective-CA group; p=n.s.) and in 30-day stroke and death rate (1.9% and 1.4%, respectively; p=n.s.). A surgical revision on the basis of CA findings was performed in 5 cases in mandatory-CA group and in 2 cases in selective-CA group (1.2% and 0.4%, respectively; p=n.s.). In the second group, the conditions significantly associated with the need for CA examination were internal carotid near-occlusion, preoperative symptoms, shunt insertion, kind of surgical reconstruction, redo surgery. Estimated absence of ipsilateral stroke and absence of restenosis at 18 months was 98.9% and 89.7% in mandatory-CA group and 99.3% and 93.4% in selective-CA group (p=n.s.) respectively. CONCLUSIONS: Based on our experience, routine CA following CEA is not suggested. A policy of selected CA at the surgeon's discretion seems to make the intervention safe and durable as well.