A new airway spiral stent designed to maintain airway architecture with an atraumatic removal after full epithelization-Research of feasibility and viability in canine patients with tracheomalacia.

OBJECTIVE: Surgical management of tracheomalacia is a challenge, with current treatments still presenting numerous complications. In the field of veterinary medicine, this same pathology is present in a significant number of dogs. For this reason, we present an experimental clinical trial performed on canines with tracheobronchomalacia, using a new atraumatic removable tracheal spiral stent (SS). Both implantation procedure and clinical improvement have been analyzed in this study. METHODS: In this study, four small dogs, a mean weight of 4.89 kg and body condition scores IV-V, were included. SS was implanted by two different surgical approaches. Image and clinical follow-up have been performed during 90 days. Symptoms were evaluated from 1 to 10 every week. RESULTS: This study achieved 100% technical and clinical success. Median tracheal diameters were as follows: cervical 10.85 (3.3), inlet 7.75 (2.1), and carina 7.75 (1.9) mm, and length was 77.5 (26) mm. A 12 × 10 × 100-mm SS was implanted in all cases. Goose honk cough punctuation improved from 8 to 1; also, there were important changes in exercise intolerance, a mean weight loss of 8.76%. The values of modified Karnofsky scale varied from 50 (20) before surgery to 90 (10) after 30 days of surgery. Neither granuloma tissue nor fractures of the prosthesis was observed. CONCLUSION: The results in dogs are promising, and a new therapeutic alternative seems to be available for veterinarian field. The similarity of this disease between dogs and newborns suggests that this SS design can also be useful for human trials.

Reactivity Study of a Biodegradable Polydioxanone Tracheal Stent in a Rabbit Model. / Stent traqueal biodegradable de polidioxanona. Estudio de la reactividad en conejo.

INTRODUCTION: The objective of this study was to evaluate tracheal reactivity induced by a biodegradable polydioxanone tracheal stent. MATERIALS AND METHODS: Twenty-two rabbits were divided into 3 groups assigned to different survival times (30, 60 and 90days post-implantation). A biodegradable stent was implanted in each animal, except for 1 of each group (negative control). Implantation was performed through a small tracheotomy under fluoroscopic control. CT and histopathological studies were scheduled at the end of survival times. RESULTS: No animal died during the procedure or follow-up. The stent had disappeared in 100% of the cases at 90days, in 50% at 60days, and in none at 30days. CT studies revealed a greater tracheal wall thickness at 30days than at 60 and 90days (1.60±0.41mm in the central part of the stent versus 1.11±0.18 and 0.94±0.11; P=.007, respectively). No granulomas were observed on histopathology. Some degree of histological changes were noted at 30days, which had reduced at 60 and 90days. Differences were also found in both CT and histology between animals in which the stent was present and animals in which it had degraded. CONCLUSIONS: Polydioxanone stents produce a mild reaction that reverts with tracheal degradation. The use of these biodegradable stents in benign tracheal disease is promising.

Ten-year retrospective study of treatment of malignant colonic obstructions with self-expandable stents.

PURPOSE: To describe the use of self-expandable metallic stents to manage malignant colorectal obstructions and to compare the radiation dose between fluoroscopic guidance of stent placement and combined endoscopic and fluoroscopic guidance. MATERIALS AND METHODS: From January 1998 to December 2007, 467 oncology patients undergoing colorectal stent placement in a single center were included in the study. Informed consent was obtained in all cases. All procedures were performed with fluoroscopic or combined fluoroscopic and endoscopic guidance. Inclusion criteria were total or partial colorectal obstruction of neoplastic origin. Exclusion criteria were life expectancy shorter than 1 month, suspicion of perforation, and/or severe colonic neoplastic bleeding. Procedure time and radiation dose were recorded, and technical and clinical success were evaluated. Follow-up was performed by clinical examination and simple abdominal radiographs at 1 day and at 1, 3, 6, and 12 months. RESULTS: Of 467 procedures, technical success was achieved in 432 (92.5%). Thirty-five treatments (7.5%) were technical failures, and the patients were advised to undergo surgery. Significant differences in radiation dose and clinical success were found between the fluoroscopy and combined-technique groups (P < .001). Total decompression was achieved in 372 cases, 29 patients showed remarkable improvement, 11 showed slight improvement, and 20 showed clinical failure. Complications were recorded in 89 patients (19%); the most significant were perforation (2.3%) and stent migration (6.9%). Mean interventional time and radiation dose were 67 minutes and 3,378 dGy·cm(2), respectively. CONCLUSIONS: Treatment of colonic obstruction with stents requires a long time in the interventional room and considerable radiation dose. Nevertheless, the clinical benefits and improvement in quality of life justify the radiation risk.

Laparoscopic blood-saving liver resection using a new radiofrequency-assisted device: preliminary report of an in vivo study with pig liver.

BACKGROUND: The aim of any device designed for liver resection is to allow blood saving and quick resections. This may be optimized using a minimally invasive approach. A radiofrequency-assisted device is described that combines a cooled blunt-tip electrode with a sharp blade on one side in an in vivo preliminary study using hand-assisted laparoscopy to perform partial hepatectomies. METHODS: Eight partial hepatectomies were performed on pigs with hand-assisted laparoscopy using the radiofrequency-assisted device as the only method for transection and hemostasis. The main outcome measures were transection time, blood loss, transection area, transection speed, blood loss per transection area, and tissue coagulation depth. The risk for biliary leak also was assessed using the methylene blue test. RESULTS: The transection time was 13 +/- 7 min for a mean transected area of 34 +/- 11 cm(2). The mean total blood loss was 26 +/- 34 ml. The mean transection speed was 3 +/- 1 cm(2)/min, and the blood loss per transection area was 1 +/- 1 ml/cm(2). Abdominal examination showed no complications in nearby organs. One biliary leak was identified in one case using the methylene blue test. The transection surface was 34 +/- 11 cm(2), and the mean tissue coagulation depth was 9 +/- 2 mm. The inviability of the coagulated surface was assessed by adenine dinucleotide (NADH) staining. CONCLUSIONS: The radiofrequency-assisted device has shown with a laparoscopic approach that it can perform liver resections faster and with less blood loss using a single device in a minimally invasive manner without vascular control than other commercial devices. The results show no significant differences with the same device used in an open procedure.

Small ablation zones created previous to saline infusion result in enlargement of the coagulated area during perfusion RF ablation: an ex vivo experimental study.

One of the strategies for enlarging coagulation zone dimensions during RF ablation of liver tumours is to infuse saline solutions into the tissue during ablation. The aim of this study was to evaluate experimentally whether the creation of a small coagulation adjacent to a bipolar RF applicator and prior to perfused RF ablation would allow enlargement of the coagulation zone. Thirty bipolar RF ablations (group A, n = 15; group B, n = 15) were performed in excised bovine livers. Additionally, in group B a monopolar RF application (60 W, 20 s) was performed before bipolar ablation using three small additional electrodes. Electrical parameters and dimensions of the ablation zone were compared between groups. Despite the fact that all three ablation zone diameters were greater in group B, only one of the minor diameters was significantly longer (5.52 +/- 0.66 cm versus 4.87 +/- 0.47 cm). Likewise, volume was significantly bigger in group B (100.26 +/- 24.10 cm(3) versus 79.56 +/- 15.59 cm(3)). There were no differences in the impedance evolution, allowing a relatively high constant power in both groups (around 90 W). The efficacy of delivering energy (expressed as the delivered energy per coagulation volume) was significantly better in group B, showing a lower value (578 J cm(-3) versus 752 J cm(-3)). These results suggest that the creation of small ablation zones prior to saline infusion improves the performance of this perfusion system, and hence the total volume.

RF tumor ablation with internally cooled electrodes and saline infusion: what is the optimal location of the saline infusion?

BACKGROUND: Radiofrequency ablation (RFA) of tumors by means of internally cooled electrodes (ICE) combined with interstitial infusion of saline may improve clinical results. To date, infusion has been conducted through outlets placed on the surface of the cooled electrode. However, the effect of infusion at a distance from the electrode surface is unknown. Our aim was to assess the effect of perfusion distance (PD) on the coagulation geometry and deposited power during RFA using ICE. METHODS: Experiments were performed on excised bovine livers. Perfusion distance (PD) was defined as the shortest distance between the infusion outlet and the surface of the ICE. We considered three values of PD: 0, 2 and 4 mm. Two sets of experiments were considered: 1) 15 ablations of 10 minutes (n > or = 4 for each PD), in order to evaluate the effect of PD on volume and diameters of coagulation; and 2) 20 additional ablations of 20 minutes. The effect of PD on deposited power and relative frequency of uncontrolled impedance rises (roll-off) was evaluated using the results from the two sets of experiments (n > or = 7 for each PD). Comparisons between PD were performed by analysis of variance or Kruskal-Wallis test. Additionally, non-linear regression models were performed to elucidate the best PD in terms of coagulation volume and diameter, and the occurrence of uncontrolled impedance rises. RESULTS: The best-fit least square functions were always obtained with quadratic curves where volume and diameters of coagulation were maximum for a PD of 2 mm. A thirty per cent increase in volume coagulation was observed for this PD value compared to other values (P < 0.05). Likewise, the short coagulation diameter was nearly twenty five per cent larger for a 2 mm PD than for 0 mm. Regarding deposited power, the best-fit least square function was obtained by a quadratic curve with a 2 mm PD peak. This matched well with the higher relative frequency of uncontrolled impedance rises for PD of 0 and 4 mm. CONCLUSION: Saline perfusion at around 2 mm from the electrode surface while using an ICE in RFA improves deposition of energy and enlarges coagulation volume.

Improved perfusion system for bipolar radiofrequency ablation of liver: preliminary findings from a computer modeling study.

Current systems for radiofrequency ablation of liver tumors are unable to consistently treat tumors larger than 3 cm in diameter with a single electrode in a single application. One of the strategies for enlarging coagulation zone dimensions is to infuse saline solutions into the tissue through the active electrodes. Nevertheless, the uncontrolled and undirected diffusion of boiling saline into the tissue has been associated with irregular coagulation zones and severe complications, mainly due to reflux of saline along the electrode path. In order to improve the perfusion bipolar ablation method, we hypothesized that the creation of small monopolar coagulation zones adjacent to the bipolar electrodes and previous to the saline infusion would create preferential paths for the saline to concentrate on the targeted coagulation zone. Firstly, we conducted ex vivo experiments in order to characterize the monopolar coagulation zones. We observed that they are practically impermeable to the infused saline. On the basis of this finding, we built theoretical models and conducted computer simulations to assess the feasibility of our hypothesis. Temperature distributions during bipolar ablations with and without previous monopolar coagulation zones were obtained. The results showed that in the case of monopolar coagulation zones the temperature of the tissue took longer to reach 100 degrees C. Since this temperature value is related to rise of impedance, and the time necessary for this process is directly related to the volume of the coagulation zone, our results suggest that monopolar sealing would allow larger coagulation zones to be created. Future experimental studies should confirm this benefit.

Evolving technology in bipolar perfused radiofrequency ablation: assessment of efficacy, predictability and safety in a pig liver model.

Bipolar radiofrequency (RF) ablation, especially with perfusion of saline, has been shown to increase volume over monopolar conventional methods. The aims of this study are to study whether this method is linked to too flattened thermal lesions and premature rise of impedance and to elucidate some safety concerns. Eighteen RF ablations were performed using a 1.8-mm-diameter bipolar applicator in the liver of nine healthy pigs through laparotomy with or without temporary vascular occlusion [the Pringle maneuver (PGM)]: group A (n=9), without PGM; group B (n=9), with PGM. Hypertonic saline solutions (3% and 20 %) were injected through the applicator at a rate of 400 ml/h during the procedure. The pigs were followed up and they were euthanased on the 15th day. Impedance, current, power output, energy output, temperatures, diameters of thermal lesion, volume, sphericity ratio of thermal lesion were correlated among groups. Impedance at the end of the procedure (50.00 Omega+/-28.39 and 52.88 Omega+/-26.77, for groups A and B, respectively) was very similar to the starting impedance (50 Omega). In a median of 1 (range, 0-6) time per RF ablation procedure a reduction of 30 W from the selected power supply was observed during the RF ablation procedure linked to a slight increase of impedance. Volume and short diameter of thermal lesion were 21.28 cm3+/-11.78 and 2.85 cm+/-0.87 for group A, 87.51 cm3+/-25.20 and 4.31 cm+/-0.65 for group B. Continuous thermal between both electrodes were described with a global sphericity ratio of 1.91. One major complication (thermal injury to the stomach) was encountered in a case of cross-sectional necrosis of the targeted liver and attributed to heat diffusion after the procedure. This method has been shown to determine: (1) the relative control of impedance during the procedure; (2) ovoid and relatively large thermal lesions with less dependence upon closest vessels.

Use of an introducer sheath for colonic stent placement.

We describe a technical modification of Wallstent implantation for the treatment of malignant rectosigmoid and descending colonic obstructions. The modification is the routine placement of an introducer sheath via the rectum before stent implantation in order to straighten the rectosigmoid region. This device facilitates catheter and guide wire manipulations and obtaining specimen biopsies for histopathological studies. The introducer sheath has been used without complications in 21 consecutive patients.