Does Drug-Eluting Bead TACE Enhance the Local Effect of IRE? Imaging and Histopathological Evaluation in a Porcine Model.

OBJECTIVES: We conducted an in vivo trial on swine to compare the ablation volumes of irreversible electroporation (IRE) followed by drug-eluting beads transarterial chemoembolization (DEB-TACE) versus IRE only. MATERIALS AND METHODS: Nine swine underwent CT-guided IRE in one liver lobe and IRE immediately followed by DEB-TACE in a different liver lobe. For DEB-TACE, 100-300 µm beads (DC-Beads®) were loaded with 50 mg doxorubicin. For IRE, the NanoKnife® was used employing two electrodes according to the vendor's protocol. Imaging follow-up was performed including CT-based lesion volume assessment using contrast-enhanced CT (venous phase) on days 1, 3, and 7 after the procedure. Three animals were killed for histopathological analysis after each follow-up. RESULTS: Ablation volumes in CT in the IRE + DEB-TACE group were 15.4 ± 10.5 ml on day 1, 8.7 ± 5.6 ml on day 3, and 1.6 ± 0.7 ml on day 7. In the IRE group, the corresponding values were 5.2 ± 5.2 ml on day 1, 1.0 ± 1.2 ml on day 3, and 0.1 ± 0.1 ml on day 7. On day 1 and day 3, ablation volumes of IRE + TACE group were significantly larger than in the IRE group (p < 0.05). 96% of beads were depicted in or around ablative lesions. 69% of these beads were found in the surrounding hemorrhagic infiltration and 31% within the ablative lesion itself. CONCLUSIONS: Combination of IRE immediately followed by DEB-TACE resulted in larger ablation volumes compared to IRE alone, suggesting that local efficacy of IRE can be enhanced by post-IRE DEB-TACE.

The quantity of bone cement influences the anchorage of augmented pedicle screws in the osteoporotic spine: A biomechanical human cadaveric study.

BACKGROUND: The aim of this comparative biomechanical human cadaveric study was to investigate the anchorage of augmented screws with two different volumes of bone cement. For this purpose the effect of cranio-caudal loadings on pedicle screws was evaluated and axial pullout tests were performed. METHODS: A total of 50 pedicle screws (25 augmented/25 non-augmented) were instrumented into osteoporotic vertebra of fresh human cadavers. The augmented screws were grounded by two different volumes of bone cement (1.5cm3 vs 4cm3). Biomechanical performance was assessed by performing a cyclic loading protocol (frequency: 3Hz, load range: 20-200N, number of cycles: 100,000), followed by axial pullout (13 augmented/11 non-augmented) or by either directly measuring axial pullout strength (12 augmented/12 non-augmented). FINDINGS: The median T-score of the specimens was -4.25 (range: -6.38 to -2.4). Pullout tests with and without cyclic preloading showed significantly increased pullout strength in augmented screws (Fmax: augmented: 1159N (SD 395N); non-augmented: 532N (SD 297N); p<0.05). No significant difference in the pullout strength was found concerning the quantity of cement (Fmax (direct pullout): 4.0cm3: 1463N (SD 307N); 1.5cm3: 1214N (SD 236N); p>0.05). The pullout strength significantly decreased in high-volume augmented screws after cyclic loading (Fmax (4.0cm3): direct pullout 1463N (SD 307N); cyclic preload: 902N (SD 435N); p<0.05). INTERPRETATION: Biomechanical advantages of augmented pedicle screws can also be found after cyclic preload. However, our results indicate that the anchoring stability of high-volume augmented pedicle screws after cyclic loading is disadvantageous compared to moderate augmented screws; thus high-volume augmentation should be avoided.

Electromagnetically Navigated In Situ Fenestration of Aortic Stent Grafts: Pilot Animal Study of a Novel Fenestrated EVAR Approach.

PURPOSE: Assess electromagnetically guided in situ fenestration of juxtarenal aortic stent grafts in an in vivo model. METHODS: Using a newly developed electromagnetic guidance system together with a modified, electromagnetically guidable catheter with steerable tip, an electromagnetically trackable guidewire and a custom in situ fenestrateable stent graft, a series of seven animal experiments was performed. In a swine model, stent grafts were placed juxtarenally, covering the renal arteries. Subsequently, the perfusion of the renal arteries was restored using electromagnetically guided in situ fenestration of the graft at the renal ostia followed by covered stent placement. Intervention times and technical success were assessed. RESULTS: The individual components were successfully combined for the animal experiments. Thirteen of fourteen fenestration experiments in seven animals were successful in restoring perfusion through in situ fenestration. Fenestration (catheter introduction-guidewire placement in renal artery across graft) could be achieved in on average 10.5 ± 9.2 min, and subsequent covered stent placement (guidewire placement-covered stent placement) took on average 32.7 ± 17.5 min. No significant differences between left and right side reperfusion times could be detected. Reperfusion in <30 min was achieved in 3/14 attempts. CONCLUSION: Electromagnetically navigated in situ aortic fenestration for juxtarenal aortic stent grafts was feasible in a healthy animal model. Identified remaining challenges were: shortening the procedure to avoid long warm ischemia times, using an aortic aneurysm animal model, and improving the stability of the stent graft material.

Feasibility of electromagnetically guided transjugular intrahepatic portosystemic shunt procedure.

OBJECTIVES: To develop an electromagnetic navigation technology for transjugular intrahepatic portosystemic shunt (TIPS) creation and translate it from phantom to an in-vivo large animal setting. MATERIAL AND METHODS: A custom-designed device for TIPS creation consisting of a stylet within a 5 French catheter as well as a software prototype were developed that allow real-time tip tracking of both stylet and catheter using an electromagnetic tracking system. Feasibility of navigated TIPSS creation was tested in a phantom by two interventional radiologists (A/B) followed by in-vivo testing evaluation in eight domestic pigs. Procedure duration and number of attempts needed for puncture of the portal vein were recorded. RESULTS: In the phantom setting, intervention time to gain access to the portal vein (PV) was 144 ± 67 s (A) and 122 ± 51 s (B), respectively. In the in-vivo trials, TIPS could be successfully completed in five out of eight animals. Mean time for the complete TIPS was 245 ± 205 minutes with a notable learning curve towards the last animal. CONCLUSIONS: TIPS creation with the use of electromagnetic tracking technology proved to be feasible in-vitro as well as in-vivo. The system may be useful to facilitate challenging TIPSS procedures.

Endovascular placement of an extraluminal arterial bypass graft - in vitro feasibility study.

PURPOSE: A novel approach for arterial bypass grafting using exclusively endovascular techniques was established in-vitro in a phantom model. MATERIAL AND METHODS: The experimental setting consisted of a gel-wax phantom with two embedded parallel fluid-filled silicon tubes simulating the superficial femoral vessels. Through an 8-French sheath, a re-entry catheter (OUTBACK®, Cordis) was placed in the simulated artery and used to puncture the vascular wall. Then a 0.014-inch guide wire was advanced into the extravascular space. With the curved needle of the re-entry catheter, the guide wire was steered on a course parallel to the vessel wall in the extravascular space for 5-10 cm. At the desired reentry site, the re-entry catheter was used to puncture the vascular wall again in order to regain access to the endovascular space. Once the tip of the guide wire had safely been placed in the vascular lumen, a self-expandable stent graft (VIABAHN® GORE®) was deployed to complete the extraluminal bypass. RESULTS: Endovascular placement of an extraluminal bypass was successfully achieved in 20 attempts. The mean duration of the procedure amounted to 14:58 (minutes: seconds) (SD ± 3:56). CONCLUSIONS: This in-vitro study suggests that endovascular placement of an extraluminal arterial bypass graft is technically feasible.

Electromagnetic Real Time Navigation in the Region of the Posterior Pelvic Ring: An Experimental In-Vitro Feasibility Study and Comparison of Image Guided Techniques.

BACKGROUND: Electromagnetic tracking is a relatively new technique that allows real time navigation in the absence of radiation. The aim of this study was to prove the feasibility of this technique for the treatment of posterior pelvic ring fractures and to compare the results with established image guided procedures. METHODS: Tests were performed in pelvic specimens (Sawbones®) with standardized sacral fractures (Type Denis I or II). A gel matrix simulated the operative approach and a cover was used to disable visual control. The electromagnetic setup was performed by using a custom made carbon reference plate and a prototype stainless steel K-wire with an integrated sensor coil. Four different test series were performed: Group OCT: Optical navigation using preoperative CT-scans; group O3D: Optical navigation using intraoperative 3-D-fluoroscopy; group Fluoro: Conventional 2-D-fluoroscopy; group EMT: Electromagnetic navigation combined with a preoperative Dyna-CT. Accuracy of screw placement was analyzed by standardized postoperative CT-scan for each specimen. Operation time and intraoperative radiation exposure for the surgeon was documented. All data was analyzed using SPSS (Version 20, 76 Chicago, IL, USA). Statistical significance was defined as p< 0.05. RESULTS: 160 iliosacral screws were placed (40 per group). EMT resulted in a significantly higher incidence of optimal screw placement (EMT: 36/40) compared to the groups Fluoro (30/40; p< 0.05) and OCT (31/40; p< 0.05). Results between EMT and O3D were comparable (O3D: 37/40; n.s.). Also, the operation time was comparable between groups EMT and O3D (EMT 7.62 min vs. O3D 7.98 min; n.s.), while the surgical time was significantly shorter compared to the Fluoro group (10.69 min; p< 0.001) and the OCT group (13.3 min; p< 0.001). CONCLUSION: Electromagnetic guided iliosacral screw placement is a feasible procedure. In our experimental setup, this method was associated with improved accuracy of screw placement and shorter operation time when compared with the conventional fluoroscopy guided technique and compared to the optical navigation using preoperative CT-scans. Further studies are necessary to rule out drawbacks of this technique regarding ferromagnetic objects.

A miniature accelerometer-based guidance device for percutaneous computed tomography-guided punctures.

PURPOSE: Percutaneous punctures are often performed under computed tomography (CT) guidance using a freehand method. Especially in challenging cases, initial accuracy of the needle placement is highly dependent on the radiologist's experience. Thus, a miniature lightweight guidance device was developed which is capable of assisting a radiologist during the needle placement process. METHODS: The device utilizes an accelerometer to measure the needle's tilt by calculating a set of orientation angles. This set can be matched with the coordinate system of the CT imaging software during a simple alignment process. After that, the needle's orientation can be expressed in terms of projected angles in the axial and sagittal planes. The accuracy of the device was evaluated in a phantom study, and initial clinical trials were carried out performing facet joint punctures in a swine cadaver. RESULTS: The sensor was embedded in a cube with dimensions of [Formula: see text] and a total weight of about 11 g which can be attached to the puncture needle at its rear end or handgrip. A graphical user interface (GUÌ) has been created offering visual real-time orientation guidance. Results of the phantom experiments showed differences between planned target and performed puncture angles of [Formula: see text] for in-plane and [Formula: see text] for out-of-plane punctures. CONCLUSION: The results of the phantom and ex vivo study suggest that the device is useful to assist a radiologist in CT-guided percutaneous punctures and helps navigating the needle with high precision.

Surgical treatment of neonatal mastitis by periareolar drainage.

PURPOSE: Neonatal mastitis is a rare but challenging problem that commonly appears within the first 8 weeks after birth. Abscess formation in an infant's breast can lead to acute complications and longterm dysfunction. To our knowledge, no publication focuses on surgical techniques and postoperative care to avoid breast scarring in neonates. We herein present our surgical approach by periareolar drainage to avoid this long term complications. METHODS: After reviewing the medical database of our hospital from 2002 to 2012, 11 cases (6 females and 5 males; 10 unilateral and 1 bilateral) of neonatal mastitis were found. Four cases required surgery, performed by periareolar drainage (n = 4, 4:11). Our data were compared with data obtained from a literature review using Medline and Cochrane databases. RESULTS: In all our patients that underwent surgery, clinical symptoms were reduced directly after surgery. Our results were comparable with those reported in the literature, which included 163 patients (105 [64.42%] required surgery) from seven publications. Regarding our surgical technique, we have not observed any long-term complications during follow up examinations (range 12-116 months postoperative; mean, 77.36 months), which have been reported in the literature. CONCLUSIONS: Even if the acute infection can be cured by parenteral antibiotics and surgical incision if necessary, the longterm problems of scarring after mastitis, especially from surgical incisions at the site of maximum swelling, can lead to severe functional and aesthetic problems. To avoid such scarring, we herein present our surgical approach to mastitis by periareolar drainage.

Technical concepts for vascular electromagnetic navigated interventions: aortic in situ fenestration and transjugular intrahepatic porto-systemic shunts.

This work presents concepts for complex endovascular procedures using electromagnetic navigation technology (EMT). Navigation software interfacing a standard commercially available navigation system was developed, featuring registration, electromagnetic field distortion correction, breathing motion detection and gating, and state-of-the-art 3D imaging post processing. Protocols for endovascularly placed, in-situ fenestrated abdominal aortic stent grafts and an EMT guided transjugular intrahepatic portosystemic shunt (TIPSS) creation have been designed. A dedicated set of interventional devices was developed for each of the procedures: For aortic in-situ fenestration a combination of high-porosity stentgrafts, steerable catheters and electromagnetically navigated guidewires was used, for TIPSS a dual-navigated (sheath and stylet) TIPSS-device was designed and manufactured. The developed devices underwent phantom testing, in preparation for animal experiments to prove the feasibility of the approach. Once established, these systems could aid in performing these challenging interventional radiology procedures, exploiting the unique characteristics of electromagnetic navigation and solving multiple of the problems associated with these interventions being performed under X-ray fluoroscopy, such as lacking real-time 3D information or extensive exposure to ionizing radiation.