Effectiveness and Safety of Percutaneous Thrombectomy Devices: Comparison of Rotarex and Angiojet in a Physiological Circulation Model.

OBJECTIVE: To compare the percutaneous Rotarex and Angiojet thrombectomy devices with regard to effectiveness and in vitro safety. METHODS: The Rotarex and Angiojet devices were evaluated in an established in vitro pulsatile flow model with a human femoropopliteal vessel phantom. First pass recanalisation and thrombus weight were assessed after thrombectomy, as well as micro- and macro-emboli. Further, histological evaluation of the vascular phantom was performed to analyse vascular injuries. RESULTS: Thrombus weight did not differ significantly prior to the thrombectomy between the groups, but the Rotarex showed slight advantages in thrombus removal vs. the Angiojet regarding first pass recanalisation. Micro- and macro-emboli occurred in most of the endovascular manoeuvres performed; however, significantly more macro-emboli (2.37 ± 1.51 vs. 0.87 ± 0.83; p = .048) were observed using the Rotarex than the Angiojet. Macroscopic dissections were detected in the Rotarex group (n = 3) but not in the Angiojet group. Microscopic vascular injuries were detected significantly more often in the Rotarex group (Rotarex: 531.61 µm ± 102.81 µm; Angiojet: 705.42 µm ± 61.68 µm [p = .001]). CONCLUSION: Both devices showed a comparable performance, with a slight advantage for the Rotarex regarding first pass recanalisation. Significantly more thrombo-emboli, and vascular injuries were observed in the Rotarex group with the latter being obviously the more tissue preserving procedure but potentially with a lower rate of recanalisation. Based on the present results, clinical randomised trials, including long term follow up, are needed to optimise and improve the use of catheter based procedures, taking into account the thrombus entity, localisation, and clinical history.

Aortic stiffening and its impact on left atrial volumes and function in patients after successful coarctation repair: a multiparametric cardiovascular magnetic resonance study.

BACKGROUND: The increased cardiovascular morbidity of adults with late repair of aortic coarctation (CoA) has been well documented. In contrast, successful CoA repair in early childhood has a generally good prognosis, though adverse vascular and ventricular characteristics may be abnormal, which could increase long-term risk. This study sought to perform a comprehensive analysis of aortic elasticity and left ventricular (LV) function in patients with aortic coarctation (CoA) using cardiovascular magnetic resonance (CMR). In a subgroup of patients, we assessed structure and function of the common carotid arteries to probe for signs of systemic vascular remodeling. METHODS: Fifty-one patients (median age 17.3 years), 13.9 ± 7.5 years after CoA repair, and 54 controls (median age 19.8 years) underwent CMR. We determined distensibility and pulse wave velocity (PWV) at different aortic locations. In a subgroup, common carotid artery distensibility, PWV, wall thickness and wall area were measured. LV ejection fraction (EF), volumes, and mass were measured from short axis views. Left atrial (LA) volumes and functional parameters (LAEFPassive, LAEFContractile, LAEFReservoir) were assessed from axial cine images. RESULTS: In patients distensibility of the whole thoracic aorta was reduced (p < 0.05) while PWV was only significantly higher in the aortic arch (p < 0.01). Distensibility of the descending aorta at the level of the pulmonary arteries and PWV in the descending aorta, both correlated negatively with age at CoA repair. LA volume before atrial contraction and minimal LA volume were higher in patients (p < 0.05). LAEFPassive and LAEFReservoir were reduced (p < 0.05), and LAEFReservoir correlated negatively with aortic arch PWV (p < 0.05). LVEF, volumes and mass were not different from controls. Carotid wall thickness and PWV were higher in patients compared to controls (p < 0.05). CONCLUSIONS: Patients after CoA repair have impaired bioelastic properties of the thoracic aorta with impact on LV diastolic function. Reduced descending aortic elasticity is associated with older age at time of CoA repair. The remodeling of the common carotid artery in our sub-study suggests systemic vessel wall changes.

[Cystectomy of a young patient with squamous cell metaplasia of the bladder and manifestation of condyloma]. / Zystektomie einer jungen Patientin mit verhornter plattenepithlialen Metaplasie der Harnblase und ausgeprägtem Kondylombefall.

Interdisciplinary managed case of a 29-Year-old patient with massive condylomas of the vulva and papillary squamous cell metaplasia of the bladder, leads after years of chronic cystitis and obstruction with meatus plastic and laser treatment to cystectomy with conduit and partial vulvectomy. After long lasting HPV infection with condyloma we also found a squamous cell carcinoma (pT1 G1) of the vulva.

Endovascular Aneurysm Sac Embolization for Treatment of Ruptured Aneurysms in the Aortoiliac Segment Using N-Butyl-Cyanoacrylate.

Background Aneurysmal rupture in the aortoiliac segment is a severe, life-threatening condition. Nowadays, in addition to surgical treatment, the implantation of a covered stent graft constitutes a feasible, minimally invasive treatment option. A novel approach is the add-on of transarterial aneurysm sac embolization with N-butyl-cyanoacrylate (NBCA). Here, we report our experience of performing this add-on embolization procedure after endovascular aneurysm repair for complex ruptured aneurysms of the aortoiliac segment. Material and Methods We describe six patients (mean age of 75.2 years; all male) with ruptured aneurysms in the visceral aortic and aortoiliac segment in whom a high-volume transarterial aneurysm sac embolization was performed as an add-on therapy to the implantation of an aortic prosthesis. The aim of this add-on intervention was to achieve the definite embolization of the aneurysmal rupture site and to ensure the best possible aneurysmal sealing. We report the feasibility, technical success, and considerations of using NBCA as well as clinical and follow-up imaging results, given their availability. Results Technical success was achieved in all cases. Clinical success was achieved in four cases. No periprocedural complications or reinterventions were reported. The mean full procedure time was 107.8 min. The mean radiation dose was 12,966.1 cGy/cm2. A mean amount of 10.7 mL of NBCA mixed with lipiodol in a 1:3 to 1:5 ratio was used for all patients. Available follow-up imaging up to 36 months after the procedure showed no aneurysm progression or endoleaks. In two patients, the NBCA cast had almost fully dissolved over the course of follow-up. Conclusions Our study underscores the notion that aneurysm sac embolization using high volumes of NBCA with ethiodized oil as an embolic agent is a feasible and add-on treatment option for optimizing the exclusion of the aneurysm from patients with ruptured aneurysms in the aortoiliac segment.

Percutaneous creation of direct intrahepatic portosystemic shunts - an alternative for failed TIPS creation.

INTRODUCTION: Direct intrahepatic portosystemic shunt creation is a feasible and safe alternative for transjugular intrahepatic portosystemic shunt creation. It needs equipment like endovascular ultrasound with restricted availability. We performed the procedure percutaneously with a common interventional armamentarium to make it more feasible. METHODS: Retrospective analysis of 8 percutaneous DIPS insertions between 2016 and 2020. RESULTS: The procedure was successful in 8/8 patients. There was no short-term death reported within 30 days. The longest reported patency is 5 years. CONCLUSION: Percutaneous DIPS creation is a feasible alternative for failed TIPS. Percutaneously the procedure can be completed faster than conventional DIPS using only minimal puncture equipment. LEVEL OF EVIDENCE: Level 4, Case Series.

Experimental Evaluation of the Effectiveness of Aspiration-Based Techniques to Treat Different Types of Acute Thromboembolic Occlusions in the Femoropopliteal Vascular System Using an In Vitro Flow Model.

PURPOSE: In this in vitro study, the effectiveness and safety of four aspiration-based techniques for thrombectomy are evaluated for three types of thrombi in a flow model simulating the femoropopliteal segment. MATERIAL AND METHODS: Red, white, and mixed thrombi were produced in a standardized manner and used to simulate occlusion of a superficial femoral artery using a pulsatile flow model. Four techniques were compared: aspiration alone, aspiration + stent retriever, exposing thrombus to laser by an excimer laser system and a laser catheter + aspiration, and aspiration + mechanical fragmentation by a separator. Rate of first-pass recanalization, embolic events, and number of embolized fragments > 1 mm were compared. RESULTS: Aspiration alone, stent retriever, laser, and separator differed in rates of first-pass recanalization (53.3%; 86.6%; 20%; and 100%) and embolic events (40%; 93.3%; 73.3%; and 60%). Number of embolized fragments was lowest with aspiration and higher with separator, laser, and stent retriever. Rates of first-pass-recanalization (75%; 75%; and 45%) and embolic events (65%; 60%; and 75%) differed for red, white, and mixed thrombi. The mixed thrombus caused the highest number of embolized fragments, which was particularly high using the stent retriever. CONCLUSION: Additional use of mechanical techniques significantly enhances the effectiveness of thrombectomy but simultaneously provokes more embolism. Laser seems to negatively alter the structure of a thrombus and thus diminishes the effectiveness, while provoking embolism. All techniques had lowest effectiveness, but highest embolism with the mixed thrombus. This was particularly striking when a stent retriever was used with the mixed thrombus.

Clinical Evaluation of Non-Contrast-Enhanced Radial Quiescent-Interval Slice-Selective (QISS) Magnetic Resonance Angiography in Comparison to Contrast-Enhanced Computed Tomography Angiography for the Evaluation of Endoleaks after Abdominal Endovascular Aneurysm Repair.

PURPOSE: Contrast-enhanced (CE) angiographic techniques, such as computed tomographic angiography (CE-CTA), are most commonly used for follow-up imaging after endovascular aneurysm repair. In this study, CE-CTA and non-CE QISS-MRA were compared for the first time for assessing endoleaks and aneurysms at follow-up after abdominal EVAR. METHODS: Our study included 20 patients (17 male, median age 79.8 years) who underwent radial QISS-MRA and CE-CTA after EVAR at their first follow-up examination. Two interventional radiologists evaluated datasets from both techniques in each patient concerning presence of endoleaks, types of endoleaks, aneurysm diameter, and image quality. Interobserver and intermodal agreement were assessed with Cohen's Kappa. RESULTS: Image quality was rated as excellent or good for both modalities by both observers. Ferromagnetic embolization materials cause hyperdense artifacts in CE-CTA causing aneurysm sac diameter measurements to be inaccurate by up to 1 cm. Type 2 endoleaks with low-flow characteristics in CE-CTA were overlooked compared to radial QISS-MRA. Compared to CE-CTA, all endoleaks after abdominal EVAR were detected and classified correctly on QISS-MRA. The interobserver agreement between CE-CTA and QISS-MRA was almost perfect, except for type 2 endoleaks, where agreement was substantial. Intermodal aneurysm diameter correlate "very strongly" for both observers. CONCLUSIONS: Radial QISS-MRA is a contrast agent free technique for diagnosing and monitoring all types of endoleaks and aneurysms in patients after abdominal EVAR. It provides information about specific clinical questions concerning aneurysm diameter and presence and types of endoleaks without radiation exposure and the side effects associated with iodine-based contrast agents.

Reliability and accuracy of segmental bioelectrical impedance analysis for assessing muscle and fat mass in older Europeans: a comparison with dual-energy X-ray absorptiometry.

Segmental determination of muscle and fat mass (MM, FM) attains growing importance for judging effects of training and malnutrition in older people. This study evaluated the reliability and accuracy of segmental bioelectrical impedance analysis (sBIA) for use in older people. In 72 (40 men, 32 women) healthy elderly (mean age 69.0 ± 4.8 years), the MM and FM of right and left arm (RA, LA), right and left leg (RL, LL), and trunk were determined by sBIA (BC-418-MA, Tanita) and dual-energy X-ray absorptiometry (DXA) as a reference method. The sBIA provided in both sexes reliable values for limb and truncal MM and FM, except for MM of RL in women. The accuracy of sBIA displayed sex-specific bias. For MM, accurate values were noted for men's trunk and women's limbs (except LA). By contrast, MM was significantly underestimated in men's limbs by 6-18% and overestimated in women's LA (13%) and trunk (14%). Estimates of FM were accurate for men's arms as well as women's legs and trunk. However, FM was significantly overestimated in men's legs (34-37%) and trunk (60%), but underestimated in women's arms (27-35%). The proportional deviations of sBIA estimates from DXA values for limbs and trunk were significantly related to the respective MM or FM. The sBIA tends to underestimate MM in men and to overestimate in women. The reverse occurs for FM. The actual equations of the Tanita device may not completely represent the European older population and should be partly revised.

Indication of Liver Transplantation for Hepatocellular Carcinoma Should Be Reconsidered in Case of Microvascular Invasion and Multilocular Tumor Occurrence.

Liver transplantation (LT) is routinely performed for hepatocellular carcinoma (HCC) in cirrhosis without major vascular invasion. Although the adverse influence of microvascular invasion is recognized, its occurrence does not contraindicate LT. We retrospectively analyzed in our LT cohort the significance of microvascular invasion on survival and demonstrate bridging procedures. At our hospital, 346 patients were diagnosed with HCC, 171 patients were evaluated for LT, and 153 were listed at Eurotransplant during a period of 11 years. Among these, 112 patients received LT and were included in this study. Overall survival after 1, 3 and 5 years was 86.3%, 73.9%, and 67.9%, respectively. Microvascular invasion led to significantly reduced overall (p = 0.030) and disease-free survival (p = 0.002). Five-year disease-free survival with microvascular invasion was 10.5%. Multilocular tumor occurrence with simultaneous microvascular invasion revealed the worst prognosis. In our LT cohort, predominant bridging treatment was transarterial chemoembolization (TACE) and the number of TACE significantly correlated with poorer overall survival after LT (p = 0.028), which was confirmed in multiple Cox regression analysis for overall and disease-free survival (p = 0.015 and p = 0.011). Microvascular tumor invasion is significantly associated with reduced prognosis after LT, which is aggravated by simultaneous occurrence of multiple lesions. Therefore, indication strategies for LT should be reconsidered.

Prospective, randomized single-center trial to compare cryoplasty versus conventional angioplasty in the popliteal artery: midterm results of the COLD study.

PURPOSE: To evaluate safety and efficacy of cryoplasty versus conventional angioplasty for focal popliteal arterial occlusive disease. MATERIALS AND METHODS: Patients with focal atherosclerotic stenoses and occlusions of the popliteal artery were randomized to cryoplasty or conventional angioplasty as the initial treatment strategy. The primary objective was target lesion patency. The secondary endpoint was treatment success without the need for stents. Duplex ultrasonography was performed at 3, 6, 9, and 15 months. RESULTS: Eighty-six patients (mean age, 72 years; age range, 50-94 years) were enrolled in this study. Forty patients were randomized to cryoplasty and 46 to conventional angioplasty. Demographics, risk factors, clinical stage of disease, and lesion details were comparable. On intention-to-treat basis, initial success was 35% for cryoplasty versus 54% for conventional angioplasty (P = .02). The rate of grade C dissection was 35% after cryoplasty and 26% after conventional angioplasty (P = .4). Optional long-term percutaneous transluminal angioplasty (PTA) was performed in 58% of cryoplasty patients. The rate of stent placement for dissection and/or residual stenosis was 30% after cryoplasty (including long-term dilation) and 39% after conventional angioplasty (P = .34). The mean (+/-standard deviation) target lesion patency at 9 months was 79.3% +/- 7.5 for cryoplasty and 66.7% +/-8.1 for conventional angioplasty; however, the results are not significant (P = .14). CONCLUSIONS: Cryoplasty of the popliteal artery alone showed a lower anatomic success when compared with conventional angioplasty. Combined with optional long-term PTA, however, stent placement was not needed more often. There was a trend toward higher patency after cryoplasty, but differences were not statistically significant and results of long-term follow-up have to be awaited.

Inferior Vena Cava Constriction After Liver Transplantation Is a Severe Complication Requiring Individually Adapted Treatment: Report of a Single-Center Experience.

BACKGROUND Reports on vena cava occlusion after liver transplantation (LT) are rare, but this finding represents a severe complication in the early postoperative period. In the context of the complex presentation of a patient after LT, symptoms are often misinterpreted and can be subtle. MATERIAL AND METHODS In our cohort of 138 LTs performed between 2014 and 2017 at our University's Transplantation Department, 117 transplantations were valid for further analysis after exclusion of pediatric transplantations and transplants with primary non-function grafts. In 101 cases (73%), patients received a deceased-donor full-size organ. Living-donor LT was performed in 8 patients (6.4%) and 8 patients (6.4%) received a split graft. We report on 6 patients who had inferior vena cava (IVC) occlusion and summarize the treatment choices. RESULTS In our series, patients with positive findings (age 38-70 years) received an orthotopic full-size deceased-donor graft with end-to-end IVC anastomosis. In the subsequent period, imaging revealing IVC occlusion was done on a follow-up basis (n=2), due to dyspnea (n=1), and for progressive ascites (n=2). In 3 cases, a thrombus was found. We give detailed information on our treatment options from interventional treatment to transcardial thrombus removal and anastomosis augmentation. CONCLUSIONS IVC constriction and subsequent thrombosis are severe complications after LT that require individually adapted treatment in specialized centers. Since patients often present with subclinical symptoms, vascular diagnosis should be performed early to detect caval anastomosis pathologies. Despite regular ultrasonography, we favor CT and cavography for subsequent quantification. We also review the literature on IVC occlusion after LT.

Total percutaneous endovascular aneurysm repair with the dual 6-F Perclose-AT preclosing technique: a case-control study.

PURPOSE: To determine the safety and efficacy of total percutaneous access closure for endovascular aortic aneurysm repair with a suture-mediated preclosing technique. MATERIALS AND METHODS: One hundred thirty-two femoral access sites in 70 patients who underwent endovascular aortic aneurysm repair were closed percutaneously with off-label use of two F-6 Perclose AT devices preapplied at a 90 degrees angle. Femoral access sizes ranged from 12 to 24 F. Technical success, complications, and procedure and access closure times were evaluated. Follow-up with computed tomography and/or magnetic resonance imaging was scheduled at 1-4 days and 3, 6, and 12 months and used to obtain groin hematoma and scar severity scores (grades 1-3). Data were compared with those from a cohort of 67 patients who underwent endovascular aortic aneurysm repair with surgical femoral cutdown. RESULTS: Technical success was achieved with the preclosing technique in 127 of the 132 arteries (96.2%). Two to four closure devices were used per groin. Five technical failures were managed intraoperatively with surgical suture. There was no access-related mortality and no late groin complications. The mean procedure duration was 91 minutes +/- 32, and the mean access closure time was 12 minutes +/- 9. For surgical management, the mean procedure time was 153 minutes +/- 112 (P < .05), and the mean closure time was 12 minutes +/- 13 (not statistically significant). Hematoma severity score at 1-4 days was 1.8 for total percutaneous endovascular aneurysm repair and 2.1 for surgical closure. Scar severity scores at 3, 6, and 12 months were 1.1, 1.0, and 1.0 for total percutaneous endovascular aneurysm repair and 2.4, 2.4, and 2.3 for surgical management, respectively. CONCLUSIONS: Total percutaneous endovascular aneurysm repair with a dual 6-F-Perclose preclosing technique is safe and effective. Compared with femoral cutdown, there are fewer late groin complications and scar tissue formation is less severe.

Feasibility of a circulation model for the assessment of endovascular recanalization procedures and periprocedural thromboembolism in-vitro.

Aim of this study was to establish a simple and highly reproducible physiological circulation model to investigate endovascular device performance. The developed circulation model included a pneumatically driven pulsatile pump to generate a flow rate of 2.7 L/min at 70 beats per minute. Sections from the superficial femoral arteries were used in order to simulate device/tissue interaction and a filter was integrated to analyze periinterventional thromboembolism of white, red and mixed thrombi. The working fluid (3 L) was a crystalloid solution constantly tempered at 36.5 °C. To evaluate the model, aspiration thrombectomy, stent-implantation and thrombectomy with the Fogarty catheter were performed. Usability of the model was measured by the System Usability Scale (SUS) - Score. Histological specimens were prepared and analyzed postinterventional to quantify tissue/device interaction. Moreover, micro- and macroembolism were evaluated for each thrombus entity and each device. Results were tested for normality using the D'Agostino-Pearson test. Statistical comparisons of two groups were performed using the Student's t-test. All devices were able to remove the occlusions after a maximum of 2 attempts. First-pass-recanalization was not fully achieved for aspiration thrombectomy of mixed thrombi (90.6%), aspiration thrombectomy of red thrombi (84.4%) and stent-implantation in occlusions of red thrombi (92.2%). Most micro- and macroembolism were observed using the Fogarty catheter and after stent-implantation in occlusions of white thrombi. Histological examinations revealed a significant reduction of the vascular layers suggesting vascular damage after use of the Fogarty catheter (327.3 ± 3.5 µm vs. 440.6 ± 3.9 µm; p = 0.026). Analysis of SUS rendered a mean SUS-Score of 80.4 which corresponds to an excellent user acceptability of the model. In conclusion, we describe a stable, easy to handle and reproducible physiological circulation model for the simulation of endovascular thrombectomy including device performance and thromboembolism.

Non-contrast-enhanced magnetic resonance imaging for visualization and quantification of endovascular aortic prosthesis, their endoleaks and aneurysm sacs at 1.5 T.

PURPOSE: After an endovascular aortic aneurysm repair (EVAR), a follow-up at 1, 6 and every 12 months is recommended for remainder of the patient's life. The diagnostic standard methods for diagnosing endoleaks and visualization of aneurysms in EVAR-patients are: invasive digital subtraction angiography (DSA), contrast enhanced (CE) computed tomographic angiography (CE-CTA), and magnetic resonance angiography (CE-MRA). These techniques, however, require the use of iodine- or gadolinium-based contrast agents with rare, but possibly life threatening side effects such as renal impairment, thyrotoxicosis and allergic reactions, nephrogenic systemic fibrosis, and cerebral gadolinium deposition. The aim of this prospective study was to compare a non-contrast-enhanced MRI protocol (consist of four MRI methods) with DSA and CE-CTA for visualization and quantification of endovascular aortic prosthesis, their endoleaks and aneurysms. MATERIAL AND METHODS: Eight patients (mean age 76.8 ±â€¯4.9 years, 63% male), whose thoracic, abdominal, or iliac aneurysms were treated with different endovascular prosthesis and suffered from type I-V endoleaks, were examined on a 1.5 Tesla MR system. Quiescent-interval slice selective MR angiography (QISS-MRA), 4-dimensional (4D)-flow MRI, T1- and T2-mapping, as well as DSA and CE-CTA were used for the visualization and quantification of endoprosthesis, endoleaks, and aneurysms in these patients. RESULTS: QISS-MRA provided good visualization of endoleaks and comparable quantification of aneurysm size with respect to CE-CTA and DSA. The 4D-flow MRI provided additional information about the wall shear stress, which could not be determined using DSA. In contrast to CE-CTA, T1- and T2-mapping provided detailed information about heterogeneous areas within an aneurysm sac. CONCLUSIONS: Compared to DSA and CE-CTA, the proposed MRI methods provide improved anatomical and functional information for various types of endoprostheses and endoleaks. In addition, hemodynamic parameters of the aorta and information on the content of aneurysm sac are provided as well. Within the frame of personalized medicine, the personalized diagnosis enabled by this non-CE MRI protocol is the foundation for a personalized and successful treatment.

Comparison of Efficacy, Embolism Rate and Safety of Thrombectomy with Stent Retrievers in an Anterior Circulation Stroke Model.

PURPOSE: Various stent retrievers differing in stent design and mechanical properties are currently available for the treatment of ischemic stroke. We conducted this in vitro study to compare the efficacy, embolism rate, and safety of commercially available stent retrievers and prototypes. MATERIALS AND METHODS: Whole blood thrombi were produced in a Chandler loop. The thrombi were inserted into the curved M1 segment of a silicone model of the anterior cerebral circulation. Thrombectomy maneuvers were performed with six commercially available stent retrievers and 2 prototypes with different strut thickness. Wall-stent apposition, first pass recanalization rate, retraction force, and embolism rate were compared. RESULTS: Devices with complete wall-stent apposition had the highest first pass recanalization rate and lowest embolism rate, but showed the highest retraction force. The prototype with thinner struts had a comparable recanalization and embolism rate, while a lower retraction force had to be applied compared to the prototype with thicker struts. CONCLUSION: Complete wall-stent apposition facilitates a higher recanalization rate and lower embolism rate but also correlates to a higher necessary retraction force and thus possibly higher risk of endothelium damage. Stent modifications leading to a reduced retraction force do not compromise efficacy and embolism rate. KEY POINTS: · Complete wall-stent apposition facilitates an effective thrombectomy. · Complete wall-stent apposition leads to higher retraction force and possibly greater endothelium damage. · Modifications of strut thickness do not compromise recanalization and embolism rate. · Thinner struts correlate with a lower retraction force. CITATION FORMAT: · Larsen N, Oberbeck K, Lima de Miranda R et al. Comparison of Efficacy, Embolism Rate and Safety of Thrombectomy with Stent Retrievers in an Anterior Circulation Stroke Model. Fortschr Röntgenstr 2018; 190: 1053 - 1058.

CIRSE vascular closure device registry.

PURPOSE: Vascular closure devices are routinely used after many vascular interventional radiology procedures. However, there have been no major multicenter studies to assess the safety and effectiveness of the routine use of closure devices in interventional radiology. METHODS: The CIRSE registry of closure devices with an anchor and a plug started in January 2009 and ended in August 2009. A total of 1,107 patients were included in the registry. RESULTS: Deployment success was 97.2%. Deployment failure specified to access type was 8.8% [95% confidence interval (95% CI) 5.0-14.5] for antegrade access and 1.8% (95% CI 1.1-2.9) for retrograde access (P = 0.001). There was no difference in deployment failure related to local PVD at the access site. Calcification was a reason for deployment failure in only <0.5% of patients. Postdeployment bleeding occurred in 6.4%, and most these (51.5%) could be managed with light manual compression. During follow-up, other device-related complications were reported in 1.3%: seven false aneurysms, three hematoma >5.9 cm, and two vessel occlusions. CONCLUSION: The conclusion of this registry of closure devices with an anchor and a plug is that the use of this device in interventional radiology procedures is safe, with a low incidence of serious access site complications. There seems to be no difference in complications between antegrade and retrograde access and other parameters.

Percutaneous intraluminal recanalization of long, chronic superficial femoral and popliteal occlusions using the Frontrunner XP CTO device: a single-center experience.

The purpose of this study was to examine the safety and efficacy of the Frontrunner XP CTO (chronic total occlusion) Catheter (Cordis) for recanalization of long femoropopliteal artery occlusions. A Frontrunner catheter was used to treat 26 CTOs in SFA after guidewire failure (68.3 +/- 8.8 years). Sixty-seven percent of patients had severe claudication. Critical lower limb ischemia with rest pain or minor tissue loss was present in three and eight patients, respectively. All the lesions were considered complex (TASC B, C, and D); 68% of the lesions were heavily calcified. The mean lesion length was 17.6 cm (range, 10-42 cm). The initial attempt to cross the occlusion with the CTO guidewire V18 was unsuccessful in 26 of 76 limbs (34.26%). A secondary attempt using the Frontrunner catheter (crossover approach, 27%; antegrade, 73%) performed in all 26 failed cases was successful in 17 limbs (65.38%), increasing the technical success rate to 88.12%. The main reasons for failure with the Frontrunner were inability to cross the lesion due to heavy calcification (six of nine) and inability to re-enter the true lumen after subintimal passage of the occluded segment (three of nine). The mean fluoroscopy time was 22.9 min. Minor complications included one distal extension of the dissection with involvement of the first popliteal segment and one perforation in the occluded segment. No major complications were seen. In conclusion, recanalization with the Frontrunner CTO catheter is a simple and safe method with a high technical success rate in the endovascular treatment of long superficial femoral artery occlusions and should be an alternative method after guidewire failure.

Leash your guiding catheter: or how to obtain a stable catheter position for crossover iliac embolization procedures.

We present a safe and quick technique for crossover embolization procedures of the internal iliac artery with high-profile guiding catheter systems, after a pull-through maneuver with establishment of a crossover catheter-snare system. The attached snare is used to stabilize and direct the guiding catheter.