Liver transplantation for HCC in cirrhosis: Are Milan criteria outdated?

In Germany, organ allocation is based on the MELD-system and lab-MELD is usually low in patients with hepatocellular carcinoma (HCC) in cirrhosis. Higher medical urgency can be achieved by standard exception for HCC (SE-HCC), if Milan criteria (MC) are met. Noteworthy, UNOS T2 reflects MC, but excludes singular lesions < 2 cm. Thus, SE-HCC is awarded to patients with one lesion between 2 and 5 cm or 2 to 3 lesions between 1 and 3 cm. These criteria are static and do not reflect biological properties of HCC.We present a retrospective cohort of 111 patients, who underwent liver transplantation at UKSH, Campus Kiel between 2007 and 2017. No difference was found in overall survival for patient cohorts using Milan, UCSF, up-to-seven, and French-AFP criteria. However, there was a significantly reduced survival, if microvascular invasion was detected in the explanted organ and in patients with HCC-recurrence. The exclusive use of static selection criteria including MC appear to limit the access to liver transplantation.

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.

[Hepatocellular carcinoma]. / Hepatozelluläres Karzinom.

The therapeutic spectrum of hepatocellular carcinoma (HCC) in cirrhosis has expanded over the last decade and consists of surgical, interventional and systemic approaches. The tumor stage and liver function are important for the therapeutic strategy. Curation can be achieved by liver resection or transplantation. Access to transplantation is limited by organ shortage and waiting time. Locoregional therapies can be used as a bridge to transplant or for down-sizing in a neoadjuvant setting as well as palliative therapy. Advanced stages might benefit from systemic or immunotherapy. Modern multimodal therapy planning, timing and reevaluation are part of the tasks of tumor boards specialised in the liver, including the option of liver transplantation. Therapies can be used alone or in combination and according to the experience of the center. A curative strategy should always be pursued at initial presentation.

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.

Sexual Dysfunction Before and after Treatment of Infrarenal Aortic Aneurysm Patients.

OBJECTIVE: Sexual dysfunction is supposed to be one major complication after treatment of infrarenal aortic aneurysms. It is still controversial how many patients suffer from a sexual dysfunction already before their operation and if there are any procedure-specific differences in postoperative sexual function depending on the operative procedure performed, for example, open (OAR) or endovascular aortic repair (EVAR). METHODS: To answer these questions we conducted this prospective unicentric study using the International Index of Erectile Function (IIEF) and analyzed the sexual function of 56 male patients with an infrarenal aortic aneurysm before as well as 3, 6, and 12 months after their operation. 23 patients (median age 66.5 years) were treated by OAR and 33 patients (median age 75.8 years) by EVAR. RESULTS: We observed that the majority of the 56 patients analyzed (91.3% of the 23 OAR patients and 96.8% of the 33 EVAR patients) suffered from a sexual dysfunction already before their operation. A 56.5% of the OAR patients and 67.7% of the EVAR patients even disclaimed a severe sexual dysfunction prior to surgery. Age and operation method showed no significant influence on the IIEF score (P= 0.647 and P= 0.621, respectively). The change of the IIEF score over the 4 time points also did not significantly differ for age and operation method (P= 0.713 and P= 0.624, respectively). The IIEF scores were significantly different between time points T1 and T4 (P= 0.042), whereas between the other time points no significant differences were found. CONCLUSIONS: Sexual dysfunction is very common in infrarenal aortic aneurysm patients even before their operation. OAR and EVAR do not cause a procedure-specific deterioration of the sexual function.

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.

Accuracy of augmented reality surgical navigation for minimally invasive pedicle screw insertion in the thoracic and lumbar spine with a new tracking device.

BACKGROUND CONTEXT: Minimally invasive approaches are increasingly used in spine surgery. The purpose of navigation systems is to guide the surgeon and to reduce intraoperative x-ray exposure. PURPOSE: This study aimed to determine the feasibility and clinical accuracy of a navigation technology based on augmented reality surgical navigation (ARSN) for minimally invasive thoracic and lumbar pedicle screw instrumentation compared with standard fluoroscopy-guided minimally invasive technique. STUDY DESIGN/SETTING: Cadaveric laboratory study. METHODS: ARSN was installed in a hybrid operating room, consisting of a flat panel detector c-arm with two dimensional/three dimensional imaging capabilities and four integrated cameras in its frame. The surface-referenced navigation device does not require a bony reference but uses video cameras and optical markers applied to the patient's skin for tracking. In four cadavers, a total of 136 pedicle screws were inserted in thoracic and lumbar vertebrae. The accuracy was assessed by three independent raters in postoperative conventional computed tomography. RESULTS: The overall accuracy of ARSN was 94% compared with an accuracy of 88% for fluoroscopy. The difference was not statistically significant. In the thoracic region, accuracy with ARSN was 92% compared with 83% with fluoroscopy. With fluoroscopy, unsafe screws were observed in three normal cadavers and one with scoliosis. Using ARSN, unsafe screws were only observed in the scoliotic spine. No significant difference in the median of time for K-wire placement was recorded. As no intraoperative fluoroscopy was necessary in ARSN, the performing surgeon was not exposed to radiation. CONCLUSIONS: In this limited cadaveric study minimally invasive screw placement using ARSN was demonstrated to be feasible and as accurate as fluoroscopy. It did not require any additional navigation time or use of any intraoperative x-ray imaging, thereby potentially permitting surgery in a protective lead garment-free environment. A well-powered clinical study is needed to demonstrate a significant difference in the accuracy between the two methods. CLINICAL SIGNIFICANCE: ARSN offers real-time imaging of planned insertion paths, instrument tracking, and overlay of three dimensional bony anatomy and surface topography. The referencing procedure, by optical recognition of several skin markers is easy and does not require a solid bony reference as necessary for conventional navigation which saves time. Additionally, ARSN may foster the reduction of intraoperative x-ray exposure to spinal surgeons.

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.

In-vivo treatment accuracy analysis of active motion-compensated liver SBRT through registration of plan dose to post-therapeutic MRI-morphologic alterations.

BACKGROUND/PURPOSE: In-vivo-accuracy analysis (IVA) of dose-delivery with active motion-management (gating/tracking) was performed based on registration of post-radiotherapeutic MRI-morphologic-alterations (MMA) to the corresponding dose-distributions of gantry-based/robotic SBRT-plans. METHODS: Forty targets in two patient cohorts were evaluated: (1) gantry-based SBRT (deep-inspiratory breath-hold-gating; GS) and (2) robotic SBRT (online fiducial-tracking; RS). The planning-CT was deformably registered to the first post-treatment contrast-enhanced T1-weighted MRI. An isodose-structure cropped to the liver (ISL) and corresponding to the contoured MMA was created. Structure and statistical analysis regarding volumes, surface-distance, conformity metrics and center-of-mass-differences (CoMD) was performed. RESULTS: Liver volume-reduction was -43.1 ±â€¯148.2 cc post-RS and -55.8 ±â€¯174.3 cc post-GS. The mean surface-distance between MMA and ISL was 2.3 ±â€¯0.8 mm (RS) and 2.8 ±â€¯1.1 mm (GS). ISL and MMA volumes diverged by 5.1 ±â€¯23.3 cc (RS) and 16.5 ±â€¯34.1 cc (GS); the median conformity index of both structures was 0.83 (RS) and 0.80 (GS). The average relative directional errors were ≤0.7 mm (RS) and ≤0.3 mm (GS); the median absolute 3D-CoMD was 3.8 mm (RS) and 4.2 mm (GS) without statistically significant differences between the two techniques. Factors influencing the IVA included GTV and PTV (p = 0.041 and p = 0.020). Four local relapses occurred without correlation to IVA. CONCLUSIONS: For the first time a method for IVA was presented, which can serve as a benchmarking-tool for other treatment techniques. Both techniques have shown median deviations <5 mm of planned dose and MMA. However, IVA also revealed treatments with errors ≥5 mm, suggesting a necessity for patient-specific safety-margins. Nevertheless, the treatment accuracy of well-performed active motion-compensated liver SBRT seems not to be a driving factor for local treatment failure.

Prospective study of the E-liac Stent Graft System in patients with common iliac artery aneurysms: 30-Day results.

OBJECTIVES: To study the safety and feasibility of the E-liac Stent Graft System® in patients with aorto/iliac aneurysms. METHODS: A prospective multicentric European registry of patients receiving the E-liac Stent Graft System® was conducted. Endpoints of the study included the technical success as well as periprocedural events and 30-day endoleaks, reinterventions, internal and external iliac artery patency and mortality. RESULTS: Between July 2014 and June 2016, a total of 45 patients (93% men, mean age 72 years, range 53-90 years) were enrolled at 11 sites in four European countries. Five patients received an isolated iliac treatment. Thirty-seven patients were treated with a combination of an abdominal stent graft and a unilateral E-liac and three in combination with bilateral E-liac. All E-liac Stent Grafts (48) were implanted in the intended position and the internal iliac arteries were successfully bridged. Two patients did not receive clinical success, due to endoleak type Ia of the aortic stent graft. At 30-day follow-up, clinical success rate was 96%. Three successful endovascular reinterventions were performed within the 30-day follow-up: one due to a type Ia endoleak in the common iliac artery, one due to type Ia endoleak of the aortic stent graft, and one due to bilateral lower limb claudication provoked by stent graft limb stenosis. At 30-day, a 100% survival rate and complete absence of pelvic or buttock ischemia/claudication were reported. Primary patency at 30 days was 100% for the internal iliac artery and 98% for the external iliac artery with an assisted patency of 100% in the latter. CONCLUSIONS: The high clinical success rate, low rates of device-related reinterventions (2%), and excellent patency rate demonstrate the safety and feasibility of the E-liac Stent Graft System. Long-term results are awaited to state efficacy and durability. Clinical Trials.gov. Identifier no. NCT02209194.

Direct dose correlation of MRI morphologic alterations of healthy liver tissue after robotic liver SBRT.

PURPOSE: For assessing healthy liver reactions after robotic SBRT (stereotactic body radiotherapy), we investigated early morphologic alterations on MRI (magnetic resonance imaging) with respect to patient and treatment plan parameters. PATIENTS AND METHODS: MRI data at 6-17 weeks post-treatment from 22 patients with 42 liver metastases were analyzed retrospectively. Median prescription dose was 40 Gy delivered in 3-5 fractions. T2- and T1-weighted MRI were registered to the treatment plan. Absolute doses were converted to EQD2 (Equivalent dose in 2Gy fractions) with α/ß-ratios of 2 and 3 Gy for healthy, and 8 Gy for modelling pre-damaged liver tissue. RESULTS: Sharply defined, centroid-shaped morphologic alterations were observed outside the high-dose volume surrounding the GTV. On T2-w MRI, hyperintensity at EQD2 isodoses of 113.3 ± 66.1 Gy2, 97.5 ± 54.7 Gy3, and 66.5 ± 32.0 Gy8 significantly depended on PTV dimension (p = 0.02) and healthy liver EQD2 (p = 0.05). On T1-w non-contrast MRI, hypointensity at EQD2 isodoses of 113.3 ± 49.3 Gy2, 97.4 ± 41.0 Gy3, and 65.7 ± 24.2 Gy8 significantly depended on prior chemotherapy (p = 0.01) and total liver volume (p = 0.05). On T1-w gadolinium-contrast delayed MRI, hypointensity at EQD2 isodoses of 90.6 ± 42.5 Gy2, 79.3 ± 35.3 Gy3, and 56.6 ± 20.9 Gy8 significantly depended on total (p = 0.04) and healthy (p = 0.01) liver EQD2. CONCLUSIONS: Early post-treatment changes in healthy liver tissue after robotic SBRT could spatially be correlated to respective isodoses. Median nominal doses of 10.1-11.3 Gy per fraction (EQD2 79-97 Gy3) induce characteristic morphologic alterations surrounding the lesions, potentially allowing for dosimetric in-vivo accuracy assessments. Comparison to other techniques and investigations of the short- and long-term clinical impact require further research.

A multicenter 12-month experience with a new iliac side-branched device for revascularization of hypogastric arteries.

OBJECTIVE: The aim of this study was to investigate the 1-year safety and efficacy of a new iliac side-branched device (IBD) for revascularization of the hypogastric arteries. METHODS: Patients receiving the E-liac (Jotec GmbH, Hechingen, Germany) side-branched device at six German vascular centers either as a stand-alone procedure or in combination with abdominal aortic aneurysm exclusion were included in a prospectively created data bank. Collected data were analyzed for baseline characteristics, procedural events, and clinical follow-up; variables included endoleaks, reinterventions, and internal iliac artery (IIA) patency. RESULTS: Between January 2012 and January 2015, a total of 70 patients (69 men [98.6%]) with a median age of 74 years (range, 51-87 years) were consecutively treated; 66 patients had aneurysmatic disease of the iliac arteries, 2 patients had a para-anastomotic aneurysm after aortobi-iliac reconstruction, and another 2 patients had a type Ib endoleak after endovascular aneurysm repair. A total of 82 IIAs were revascularized, 12 bilaterally. Technical success was achieved in 100% (82/82) of the revascularized IIAs. All IBDs were patent at the end of the procedure. No instances of myocardial infarction, stroke, conversion to open repair, mesenteric or spinal cord infarction, or buttock necrosis were observed. There was one perioperative death (1.4%) in a 70-year-old patient with intraoperative gastrointestinal bleeding leading to multiple organ failure, which resulted in the patient's death on the fifth postoperative day. Within 30 days, one symptomatic occlusion of a treated common iliac artery (CIA) was observed. In two other patients, an asymptomatic kinking of the CIA segment of the IBD was revealed in the predischarge follow-up duplex ultrasound examination and corrected with relining. Median follow-up was 12 months (range, 6-16 months). One patient was lost during the follow-up period. Survival at 1 year was 98.5% with all IIAs remaining patent, whereas two CIA and two external iliac artery limb occlusions occurred. According to life-table analysis, the freedom from occlusion in a patient was 92% at 1 year, and freedom from type I endoleak was 87% at 1 year. CONCLUSIONS: This first ever 1-year study reports the results with the new E-liac device and shows that it can be safely applied for the treatment of aortoiliac aneurysmatic disease with low reintervention rates and high patency rates. Long-term data are needed to confirm the durability of the device.

Development of four different devices to turn over introducer sheaths.

INTRODUCTION: We developed four prototype sheath-turning auxiliary devices (STADs) and evaluated them in an in vitro study setup designed to enable the change of catheter direction in endovascular interventions. METHODS: Four different prototypes, A through D, of STADs were designed and created by modifying commercially available dilators and catheters. All STADs work with different anchor-like tips to ensure fixation inside the vessel at the puncture site. The STAD is loaded into the introducer sheath, retracted with the introducer sheath, and turned at the puncture site. The STADs were tested in an in vitro vascular study setup using bovine veins. Success rates and procedure times were calculated, and the handling, reliability, and overall performance were evaluated. The maximum soft tissue thickness (STTmax) applicable was tested using bovine vessels with 7-mm thickness surrounded by a soft tissue phantom consisting of chicken breast. A retrospective cross-sectional observation in 108 patients from our center was performed to provide mean STTmax at the common femoral artery in patients for comparison. RESULTS: The success rate ranged between 75% for prototype D and 90% for prototypes A and C. The procedure time averaged 60 seconds (range, 25-165 seconds). The mean handling was rated 2.4 (good) for prototype A, 2.0 (good) for prototype B, 2.6 (satisfactory) for prototype C, and 3.5 (poor) for prototype D. Mean reliability was rated 3.4 (satisfactory) for prototype A, 2.0 (good) for prototype B, 1.6 (good) for prototype C, and 2.4 (good) for prototype D. Mean overall performance was rated 2.0 (good) for prototype C, 2.6 (satisfactory) for prototype B, 3.3 (poor) for prototype D, and 3.4 (poor) for prototype A. In the cross-sectional patient observation, the mean STTmax was 3.3 cm (range, 0,5-13 cm) with a 95% confidence interval of the distribution including an STTmax of up to 8 cm. The STTmax was ≤ 5 cm in 100 of 108 patients (93%). The applicable STTmax for prototype A was 1 cm (8 of 10 successful cases), 3 cm for prototype B (9 of 10 successful cases), 5 cm for prototype C (8 of 10 successful cases), and 3 cm for prototype D (7 of 10 successful cases). CONCLUSIONS: All four STAD prototypes offered the ability of turning the sheaths at the puncture site in an in vitro vascular study setup. In the future, this concept may allow routine clinical performance of turning maneuvers at the groin vascular access site.

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.

Retrospective study of rapid-exchange monorail versus over-the-wire technique for femoropopliteal angioplasty.

PURPOSE: The purpose of this study was to compare procedural outcome of rapid-exchange (RX) monorail versus conventional over-the-wire (OTW) technique for femoropopliteal angioplasty. MATERIALS AND METHODS: Demographic data, procedure details, angioplasty success, and complications of 328 consecutive percutaneous transluminal angioplasties (PTAs) were collected from a prospective database and retrospectively analyzed. Procedure details included duration of fluoroscopy, area-dose product, amount of contrast agent, sheath sizes, access route, length of stenosis, presence of total occlusion, technical and anatomical success (residual stenosis < 30% in the absence of complications), need for bail-out stenting, and periprocedural complications. The RX technique alone was used in 102 of 328 cases (31%); the OTW technique, in 226 of 328 of cases (68%). RESULTS: Technical success was 98% for the RX versus 95.4% for the OTW technique (p = 0.2). A significantly greater number of stents had to be implanted due to angioplasty failure when the OTW technique was used (RX, 5.9%; OTW, 13.7%; p = 0.04). There were no significant differences in fluoroscopy time, dose-area product, or amount of contrast medium used. The RX system facilitated the use of smaller sheath sizes (5 Fr = 38% and 6 Fr = 59% for RX versus 5 Fr = 16.8% and > or = 6 Fr = 82.5% for OTW) but showed only a tendency toward lower overall complication rates (16.6% [17/102] in the RX group versus 19.9% [45/226] in the OTW group; p = 0.09). There was no effect on length of hospitalization. RX monorail systems were not associated with higher procedural costs when compared to conventional OTW technique. CONCLUSION: We conclude that RX monorail systems seem to enhance the technical success of femoropopliteal angioplasty. Although smaller sheath sizes can be used due to the lower profile of the RX systems, there is only a tendency toward lower complication rates.