FemoSeal® Device Use for Femoral Artery Closure by Different Techniques.

BACKGROUND: Common femoral artery is still the most frequently used site for vascular access, mostly for peripheral arterial interventions, and its puncture remains a significant source of patient's morbidity. Manual compression (MC) has been the gold standard for hemostasis after femoral catheterization until recently, but only in the last few years, vascular closure devices (VCDs) are replacing MC due to their rapid development. Nowadays, vascular surgeons (VSs) are also becoming familiar with VCDs. The purpose of this study was to investigate FemoSeal® arterial closure system use in terms of safety and efficacy in patients undergoing transfemoral peripheral procedure and evaluate the complication risk factors. METHODS: A retrospective analysis to compare 2 different specialists and technique with systematic implantation of FemoSeal® VCD was performed in a cohort of vascular patients treated by endovascular procedure with femoral artery access site over a 2-year period and sheaths ranged from 6F to 8F. All the patients were on antiplatelet therapy and received heparin during the procedure. The FemoSeal® was deployed in common femoral arteries. All patients were examined for access site complication by VS in both groups 20-24 hrs after VCD deployment and 1 and 6 weeks after the procedure with clinical visit and ultrasound duplex scan. Complications, as minor and major hematomas, pseudoaneurysm formation, vessel occlusion or dissection, and infection were recorded. RESULTS: During the study period, 130 FemoSeal® were deployed in 114 patients, 102 FemoSeal® in VS group, and 28 in interventionalist group. Mean age was 57 ± 24 years. There was no significant difference between the 2 groups in terms of comorbidities. Patient follow-up ranged from 1 to 15 months. All but 3 of the FemoSeal® devices were successfully deployed (all 3 cases in group 2). Mobilization time was 6 ± 4 hrs following interventions, and the discharge time ranged from 6 hrs to 7 days after procedure. Early discharge (within 6 hrs) was obtained in 23% of group 1 and in 0 cases of group 2 (P = 0.008). Delayed discharge was obtained in 74% of group 1 (67 pts) and in 70% of group 2 (18 pts) on postoperative day 1 (P = 0.47). Technical success was achieved in 99% of group 1 and in 93% of group 2 (P = 0.87). There were no perioperative deaths. There were no significant differences in terms of minor bleeding complications (P = 0.21) or infections or transfusion needing (P 0.06) in both groups. FemoSeal®-related complications occurred in 6 patients (1 in group 1 and 5 in group 2; P = 0.0017). All complications occurred following therapeutic intervention with 6F sheath introducer. Complication rate resulted significatively higher in group 2 in terms of pseudoaneurysm development (P < 0.0001) and transfusion needing (P = 0.03) in a subgroup analysis on peripheral arterial disease (Rutherford 3-5). Only chronic limb ischemia was found to be independent predictor of complications due to VCD use. CONCLUSIONS: Our data suggest that when simple guidelines are observed, the device is safe, effective, and easy to deploy and allows for early ambulation and discharge. However, appropriate randomized clinical trials could clarify the correct guideline to minimize the complication rates.

First clinical experience with the Innova versus the Protege EverFlex self-expanding bare metal stents in superficial femoral artery occlusions.

BACKGROUND: To evaluate outcomes of superficial femoral artery (SFA) stenting with Boston Scientific Innova stent system (Boston Scientific Corporation Place, Natick, Massachusetts, United States) compared with ev3 Protege stent system (Endovascular, Inc., Plymouth, Minnesota, United States) in terms of safety and effectiveness and to identify factors predictive of restenosis. METHODS: From March 2012 to January 2013, 71 patients with SFA TASC (Trans Atlantic Inter-Societal Consensus)-II B and C occlusive lesions were treated by percutaneous transluminal angioplasty with stenting (30 patients in the Innova group and 41 cases in the Protege group) and were evaluated by retrospective observational data analysis. Chi-square tests for categorical data and time to event provided two-sided p values with a level of significance at 0.05 and 95% confidence intervals (CIs). Survival curves for primary patency were plotted using the Kaplan-Meier method. Univariate analysis for diabetes, hypercholesterolemia, smoking, hypertension, and critical limb ischemia was performed according to the Cox proportional hazards model. RESULT: The mean follow-up was 14 months (range 1-18 months). The occlusive lesions treated were ≤15 cm in length. The 12-month primary patency rate was significantly higher in the Protege group (81.5%; 31/38) than the Innova group (43.3%; 13/30; hazard ratio [HR] 3.0; 95% CI: 1.38-6.8; p = 0.005. The secondary patency was similar to the primary comparison data and showed a significant advantage for the Protege stent (HR 2.9; 95% CI: 1.21-6.99; p = 0.01). Univariate analysis demonstrated that diabetes and smoking were significantly related to patency failure in both groups. CONCLUSIONS: SFA stenting is generally a safe procedure, but the effectiveness and patency rates are significantly lower for Innova than Protege. Furthermore, preoperative diabetes and smoking continue to be associated with low primary patency rate. These preliminary data suggest that Innova stent is not the treatment of choice for SFA lesions.

Outcome after preoperative or intraoperative use of intra-arterial urokinase thrombolysis for acute popliteal artery thrombosis and leg ischemia.

OBJECTIVES: To evaluate the outcome of acute popliteal artery aneurysm (PAA) thrombosis and leg ischemia after preoperative or intraoperative use of intra-arterial urokinase thrombolysis. MATERIALS AND METHODS: From 2000 to 2009, 86 patients with acute leg ischemia (Rutherford grade IB to IIA) from PAA thrombosis were treated by immediate surgery including intraoperative thrombolysis (group A: 47 cases) or preoperative thrombolysis (group B: 39 cases) followed by acute (<24 hours) or elective surgery. Chi-square tests for categorical data and time to event provided two-sided p values with a level of significance at 0.05 and all confidence intervals (CIs) at the 95% level. RESULTS: The mean follow-up was 45 months. The 2-year primary patency was 61.7% (29/47) for group A and 43.6% (17/39) for group B (hazard ratio [HR] 1.85; 95% CI: 0.96 to 3.54; p = 0.06). The 2-year secondary patency was 70.2% (33/47) for group A and 53% (21/39) for group B (HR 1.86; 95% CI: 0.91 to 3.81; p = 0.08). One-month amputation rate was 18% in group A and 29% in group B (p < 0.001), and 12-month amputation rate was 19% (9/47) in group A and 44% (17/39) in B (p = 0.05). In group A, 28% of patients required fasciotomy and in group B, 59% (p < 0.05). Effective thrombolysis allowed 82% limb salvage patency in group B. No systemic or locoregional complications during thrombolysis were recorded, but four cases of worsening ischemia were recorded. CONCLUSION: Our results suggest that the immediate surgery with intraoperative thrombolysis improved the outcome of patients with acute leg ischemia due to PAA thrombosis in terms of limb salvage.

Clinical experience with Zarzio® in Europe: what have we learned?

Biosimilars are similar, but non-identical, versions of existing biological drugs for which patents have expired. Despite the rigorous approval process for biosimilars, concerns have been expressed about the efficacy and safety of these products in clinical practice. Biosimilars of filgrastim, based on the originator product Neupogen®, have been available since 2008 and are now in widespread clinical use in Europe and elsewhere. Three biosimilar G-CSFs have been approved based on a combination of physicochemical and biological protein characterisation, pharmacokinetic and pharmacodynamic assessment in healthy volunteers and efficacy and safety data in patients with cancer. To assess whether biosimilars are effective in the real-world clinical practice setting, a pooled analysis of five post-approval studies of biosimilar G-CSF (Zarzio®) that included 1,302 adult patients who received at least one cycle of chemotherapy with G-CSF support for the prevention of neutropenia was conducted. A total of 36 % of patients had a febrile neutropenia risk of >20 %, while 39.6 % had a risk of 10-20 % based on chemotherapy regimen. The occurrence of severe or febrile neutropenia was within the range of that observed in previous studies of originator G-CSF. In addition, the safety profile of Zarzio® was consistent with that reported for originator G-CSF and the known safety profile of G-CSF. Initial concerns about the use of biosimilars, at least with regard to biosimilar G-CSFs, appear to be unfounded. Adoption of cost-effective biosimilars should help reduce healthcare costs and improve patient access to biological treatments.

Carotid artery free-floating thrombus caused by paradoxical embolization from greater saphenous vein ascending thrombophlebitis.

Stroke of unknown origin in young patients is seen to be closely correlated with patent foramen ovale (PFO) than stroke in patients with established stroke mechanisms. We report a case of a young woman without cardiovascular risk factors who was admitted to our emergency department with listlessness and altered mental status. The clinical examination revealed right lower limb swelling. Magnetic resonance imaging and contrast-enhanced computed tomographic scans revealed a free floating thrombus of the left internal carotid artery (ICA) with a large bilateral frontal ischemic lesion. The diagnosis of a medium-sized PFO with moderate right-to-left contrast shunting was made after transesophageal echocardiography. No other cardiac sources for embolization were detected, while an ascending thrombophlebitis of the right greater saphenous vein was detected by venous Doppler ultrasonography. These findings support the diagnosis of ICA free-floating thrombus caused by paradoxical embolization (via the PFO) of clot from the greater saphenous vein. The patient underwent emergency saphenofemoral disconnection with femoral vein thrombectomy and subsequently carotid artery thrombectomy under general anesthesia. No carotid atheromatous wall lesions were detected at surgical exploration; no immunologic pathology, hypercoagulable status, or malignancy were recorded. No hemorrhagic cerebral complications were observed in the postoperative period, and the patient had an improvement of her neurologic status (a reduction of the National Institutes of Health Stroke Scale score from 7 to 3). Her recovery was uneventful. The patient was transferred for rehabilitation on postoperative day 5 with oral anticoagulation. Six-month ultrasound follow-up revealed deep and superficial venous system and carotid artery patency. The patient was asymptomatic and anticoagulation was discontinued. Paradoxical cerebral embolization through a PFO is a rare phenomenon that, in our patient, appeared to have resulted in stroke caused by a free-floating thrombus in the ICA. Accurate evaluation of carotid and lower limb veins by duplex scan is mandatory in cases of stroke of unknown origin, and urgent surgical repair can be useful in order to improve the clinical outcome.

Randomized controlled trial of remote endarterectomy versus endovascular intervention for TransAtlantic Inter-Society Consensus II D femoropopliteal lesions.

OBJECTIVE: This study evaluated outcomes of remote endarterectomy (RE) vs endovascular (ENDO) interventions on TransAtlantic Inter-Societal Consensus (TASC)-II D femoropopliteal lesions and identified factors predictive of restenosis. METHODS: From October 2004 to December 2008, 95 patients with TASC-II D lesions were randomized 1:1 to receive RE of the superficial femoral artery (SFA) with end point stenting (51 patients) or ENDO, consisting of subintimal angioplasty with stenting (44 patients). The groups were balanced for age, sex, atherosclerotic risk factors, and comorbidities. Categoric data were analyzed with χ2 tests, and time to event provided two-sided P values with a level of significance at .05 and 95% confidence intervals (CIs). Survival curves for primary patency were plotted using the Kaplan-Meier method. Univariate analysis for diabetes, hypertension, dyslipidemia, smoking, and critical ischemia was performed according to the Cox proportional hazards model. RESULTS: The mean follow-up was 52.5 months (range, 35-75 months). Five RE patients and four ENDO patients were lost to follow-up (censored). Primary patency was 76.5% (39 of 51) in RE and 56.8% (25 of 44) in ENDO (hazard ratio [HR], 2.6; 95% CI, 0.99-4.2; P=.05) at 24 months and was 62.7% (32 of 46) in RE and 47.7% (21 of 40) in ENDO (HR, 1.89; 95% CI, 0.94-3.78; P=.07) at 36 months. Assisted primary patency was 70.6% (36 of 51) in RE and 52.3% (23 of 44) in ENDO (HR, 2.45; 95% CI, 1.20-5.02; P=.01). Secondary patency overlapped the primary comparison data at 12 and 24 months; at 36 months, there was a slight but significative advantage for RE (HR, 2.26; 95% CI, 1.05-4.86; P=.03). Univariate analysis demonstrated that hypercholesterolemia and critical limb ischemia (CLI) were significantly related to patency failure, whereas diabetes was significant only in ENDO. These factors (hypercholesterolemia and CLI) were independent predictors of patency on Cox multivariate analysis. CONCLUSIONS: RE is a safe, effective, and durable procedure for TASC-II D lesions. Our data demonstrate a significantly higher primary, assisted primary, and secondary patency of RE vs ENDO procedures. Furthermore, overall secondary patency rates remain within the standard limits, although preoperative CLI and dyslipidemia continue to be associated with worse outcomes. Taken together, these data suggest that RE should be considered better than an endovascular procedure in SFA long-segment occlusion treatment.

Endovascular central venous stenosis treatment ended with superior vena cava perforation, pericardial tamponade, and exitus.

Venous hypertension and outflow stenosis of arteriovenous hemodialysis access managed using endovascular procedures usually present a high technical success rate, with few complications. We reported a rare and fatal complication of superior vena cava perforation with pericardial tamponade 3 months after subclavian vein stenting. Interventional recanalization with stenting for the management of superior vena cava syndrome or central vein stenosis is a safe procedure with a low complication rate. Stent misplacement, reocclusion, migration, or access-related complications appear to occur most frequently.

Hybrid procedure for celiac trunk aneurysm repair via left reno-splenic bypass and stent-graft deployment.

Celiac trunk aneurysm is one of the rarest forms of splanchnic artery aneurysm. Conventional open vascular surgery is associated with increased rates of morbidity and mortality and can require complex vascular reconstruction.We describe the case of a 42-year-old patient with celiac trunk aneurysm whom we treated by means of a hybrid surgical-endovascular procedure. We performed a left reno-splenic bypass, after which we used a direct splenic artery approach to deploy a self-expandable 6 × 50-mm stent-graft across the splenic and hepatic arteries. One year later, the stability of the repair was confirmed.

Multiple instances of peripheral artery emboli from occult primary small cell lung cancer.

Most peripheral artery emboli originate in the heart, and systemic neoplastic emboli are infrequently associated with bronchogenic carcinoma. To our knowledge, there have been no reports of pulmonary vein infiltration by small cell lung cancer.We describe a highly unusual case of multiple instances of peripheral embolism as the first overt sign of occult primary small cell lung cancer. Tumor emboli infiltrated the pulmonary veins of a 62-year-old man who presented first with a transient ischemic attack and then with other ischemic symptoms. The uncommonly wide distribution of tumor emboli over a short time resulted in death.Improvements in diagnostic imaging have led to the early identification of relatively isolated small cell lung cancers. This patient's case underscores the importance of transesophageal echocardiography in detecting cardiac emboli when the cause of cerebral ischemic attack is unknown or if there might be multiple instances of arterial embolism. Computed tomography also has a role in the investigation of possible sources of emboli and unrecognized, asymptomatic embolization.

Prevention of Peritoneal Metastases from Colon Cancer in High-Risk Patients: Preliminary Results of Surgery plus Prophylactic HIPEC.

The study compared the outcome in patients with advanced colonic cancer at high risk of peritoneal metastases (mucinous or signet-ring cell) without peritoneal or systemic spread, treated with standard colectomy or a more aggressive combined surgical approach. The study included patients with colonic cancer with clinical T3/T4, any N, M0, and mucinous or signet ring cell histology. The 25 patients in the experimental group underwent hemicolectomy, omentectomy, bilateral adnexectomy, hepatic round ligament resection, and appendectomy, followed by HIPEC. The control group comprised 50 patients treated with standard surgical resection during the same period in the same hospital by different surgical teams. Outcome data, morbidity, peritoneal recurrence rate, and overall, and disease-free survival, were compared. Peritoneal recurrence developed in 4% of patients in the experimental group and 22% of controls without increasing morbidity (P < 0.05). Actuarial overall survival curves disclosed no significant differences, whereas actuarial disease-free survival curves showed a significant difference between groups (36.8 versus 21.9 months, P < 0.01). A more aggressive preventive surgical approach combined with HIPEC reduces the incidence of peritoneal recurrence in patients with advanced mucinous colonic cancer and also significantly increases disease-free survival compared with a homogeneous control group treated with a standard surgical approach without increasing morbidity.

Management of symptomatic venous aneurysm.

Venous aneurysms (VAs) have been described in quite of all the major veins. They represent uncommon events but often life-threatening because of pulmonary or paradoxical embolism. We describe our twelve patients' series with acute pulmonary emboli due to venous aneurysm thrombosis. Our experience underlines the importance of a multilevel case-by-case approach and the immediate venous lower limbs duplex scan evaluation in pulmonary embolism events. Our data confirm that anticoagulant alone is not effective in preventing pulmonary embolism. We believe that all the VAs of the deep venous system of the extremities should be treated with surgery as well as symptomatic superficial venous aneurysm. A simple excision can significantly improve symptoms and prevent pulmonary embolism.

Heparin-induced thrombocytopenia type II because of heparin-coated polytetrafluoroethylene graft used to bypass.

Heparin-induced thrombocytopenia type II is an immune-mediated syndrome that may arise in a time-dependent manner after heparin therapy. Thrombocytopenia and thrombosis in patients exposed to heparin are suggestive of this syndrome.

Preoperative evaluation of retroperitoneal venous system anomalies during abdominal aortic aneurysm rupture.

The association of a retroaortic left renal vein and an abdominal aortic aneurysm (AAA) fistula is an infrequent event. We present two cases of AAA rupture into the retroaortic left renal vein. Preoperative computed tomography (CT) assessment showed retroperitoneal bleeding due to a large AAA rupture with an associated unusual retroaortic left renal vein. Patients underwent successful arteriovenous fistula sutures with abdominal aortoiliac replacement. The patients had uneventful recoveries, and they were discharged on the seventh to ninth postoperative day (POD) without renal complications. The clinical onset was characterized by the unique syndrome: continuous abdominal bruit, abdominal and left flank pain with an associated pulsatile mass (Mansour Triad). Moreover patients presented with haematuria, proteinuria and a large non-functional left kidney on the imaging scan. The CT-scan may suggest the presence of the venous anomaly. Unusual anatomical presentation recommends a careful surgical approach during AAA operations.

Primary tibial vein aneurysm with recurrent pulmonary emboli.

We report the case of a 42-year-old man with pleuritic chest pain, shortness of breath, and associated tachycardia. Three months before, he had been treated for similar features with the diagnosis of pulmonary emboli. Computed tomography scan showed multiple bilateral pulmonary emboli. He had no clinical evidence of deep venous thrombosis, but an accurate venous duplex examination revealed a thrombosis of the posterior tibial vein aneurysm. Thrombolysis, a temporary inferior cava filter (ICV filter), and tangential aneurysmectomy and lateral venorrhaphy were performed. Accurate duplex scan evaluation of lower limb venous system is mandatory in all cases of pulmonary embolism; anticoagulation may be ineffective in preventing pulmonary embolism, and the surgical repair is treatment of choice of this pathology because it is safe and effective.