Michal Crha

Novel biodegradable polydioxanone stents in a rabbit airway model

OBJECTIVE This study was undertaken to evaluate safety and biocompatibility of a novel biodegradable polydioxanone stent in a rabbit tracheal model. Metallic and silicone stents represent standard therapeutic approaches for hollow organ stenosis, although complications have been reported repeatedly. Biodegradable stents could reduce the risks associated with this procedure while still achieving the purpose of maintaining lumen patency. METHODS A commercially available polydioxanone suture strand with a long safety record was used to manufacture the self-expanding stents. The polydioxanone stents were then implanted bronchoscopically and under fluoroscopic guidance into the tracheas of white rabbits (N = 25). Periodic clinical examination was performed. Histopathologic examination concluded the study for the 5 experimental groups at 3, 4, 5, 10, and 15 weeks after implantation. RESULTS There were no unexpected deaths and no stent displacements during the study. The animals remained in good condition, without stent debris expectoration. Macroscopic examination revealed that the tracheal lumen stayed open. Histologic examination showed that tracheal damage score was highest 5 weeks after stenting, including in-stent necrosis of the epithelium. Stent degradation was complete with no remnants after 10 weeks, leaving the trachea completely healed at 15 weeks after implantation. CONCLUSIONS This animal airway model has demonstrated acceptable safety and biocompatibility of this novel biodegradable polydioxanone stent. We suggest that polydioxanone stenting be used for further clinical studies for cases in which complete stent degradation after temporary airway treatment is desirable.

Self-expandable biodegradable biliary stents in porcine model

BACKGROUND Treatment or prevention of a benign biliary tree stricture is an unresolved problem. A novel self-expandable biodegradable polydioxanon biliary stent in a porcine model was studied. MATERIALS AND METHODS This new stent was used in 23 pigs. Feasibility and safety of surgical stenting, time of biodegradation, and histologic reaction in 2, 8, 13, and 20 wk of a follow-up were studied. All stents were inserted into a common bile duct through a duodenal papilla following small dilatation. After surgical evaluation of abdominal cavities, the pigs were sacrificed to remove common bile ducts with the stents. All bile ducts were assessed by macroscopic and histopathologic examination. RESULTS Self-expansion was correct in all cases. Neither bile duct obstruction nor postsurgical complications were observed. Macroscopic evaluation indicated lightening of the stent color in 2 wk, a partial disintegration in 8 wk, and a complete absorption in 13 and 20 wk. Histologic evaluation in general substantiated a mild-to-moderate inflammatory reaction in the lamina propria during the whole follow up and had no clinical consequences. No cholangitis, necrosis, abscess, or excessive fibroplasia was found in a hepatoduodenal ligament. CONCLUSIONS Our results suggest that polydioxanon biodegradable self-expanding stents seem to be useful for biliary system implantation, offer a good biocompatibility, and completely degrade within 13 wk.

Semi-spherical Radiofrequency Bipolar Device - A New Technique for Liver Resection: Experimental In Vivo Study on the Porcine Model.

The incidence of colorectal carcinoma is still growing in the Czech Republic and also all around the world. With success of oncological treatment is also growing a number of potential patients with liver metastases, who can profit from surgical therapy. The aim of this study was to confirm on porcine models that this method by using new surgical device is effective and safe for patients who have to undergo liver resection. The primary hypothesis of the study was to evaluate whether this new device is able to consistently produce homogeneous and predictable areas of coagulation necrosis without the Pringle maneuver of vascular inflow occlusion. The secondary hypothesis of the study was to compare the standard linear radiofrequency device and a new semi-spherical bipolar device for liver ablation and resection in a hepatic porcine model. Twelve pigs were randomly divided into two groups. Each pig underwent liver resection from both liver lobes in the marginal, thinner part of liver parenchyma. The pigs in first group were operated with standard using device and in the second group we used new developed semi-spherical device. We followed blood count in 0th, 14th and 30th day from operation. 14th day from resection pigs underwent diagnostic laparoscopy to evaluate of their state, and 30th day after operation were all pigs euthanized and subjected to histopathological examination. Histopathological evaluation of thermal changes at the resection margin showed strong thermal alteration in both groups. Statistical analysis of collected dates did not prove any significant (p < 0.05) differences between standard using device and our new surgical tool. We proved safety of new designed semi-spherical surgical. This device can offer the possibility of shortening the ablation time and operating time, which is benefit for patients undergoing the liver resection.

A Novel Defibrillation Tool: Percutaneously Delivered, Partially Insulated Epicardial Defibrillation

INTRODUCTION Epicardial defibrillation systems currently require surgical access. We aimed to develop a percutaneous defibrillation system with partially-insulated epicardial coils to focus electrical energy on the myocardium and prevent or minimize extra-cardiac stimulation. METHODS We tested 2 prototypes created for percutaneous introduction into the pericardial space via a steerable sheath. This included a partially-insulated defibrillation coil and a defibrillation mesh with a urethane balloon acting as an insulator to the face of the mesh not in contact with the epicardium. The average energy associated with a chance of successful defibrillation 75% of the time (ED75) was calculated for each experiment. RESULTS Of 16 animal experiments, 3 pig experiments had malfunctioning mesh prototypes such that results were unreliable; these were excluded. Therefore, 13 animal experiments were analyzed - 6 canines (29.8±4.0kg); 7 pigs (41.1±4.4kg). The overall ED75 was 12.8±6.7J (10.9±9.1J for canines; 14.4±3.9J in pigs [P=0.37]). The lowest ED75 obtained in canines was 2.5J while in pigs it was 9.5J. The lowest energy resulting in successful defibrillation was 2J in canines and 5J in pigs. There was no evidence of coronary vessel injury or trauma to extra-pericardial structures. CONCLUSION Percutaneous, epicardial defibrillation using a partially insulated coil is feasible and appears to be associated with low defibrillation thresholds. Focusing insulation may limit extra-cardiac stimulation and potentially lower energy requirements for efficient defibrillation.

Technical development of a new semispherical radiofrequency bipolar device (RONJA): ex vivo and in vivo studies

The aim of this study is to inform about the development of a new semispherical surgical instrument for the bipolar multielectrode radiofrequency liver ablation. Present tools are universal; however they have several disadvantages such as ablation of healthy tissue, numerous needle punctures, and, therefore, longer operating procedure. Our newly designed and tested semispherical surgical tool can solve some of these disadvantages. By conducting an in vivo study on a set of 12 pigs, randomly divided into two groups, we have compared efficiency of the newly developed instrument with the commonly used device. Statistical analysis showed that there were no significant differences between the groups. On average, the tested instrument RONJA had shorter ablation time in both liver lobes and reduced the total operating time. The depth of the thermal alteration was on average 4 mm larger using the newly tested instrument. The new radiofrequency method described in this study could be used in open liver surgery for the treatment of small liver malignancies (up to 2 cm) in a single application with the aim of saving healthy liver parenchyma. Further experimental studies are needed to confirm these results before clinical application of the method in the treatment of human liver malignancies.