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Reliability of radiographic assessment of distraction osteogenesis site.

The presence of three of four continuous cortices on anteroposterior and lateral radiographs has been stated to be an indication of bony healing of distraction osteogenesis. In this study the authors assessed the level of agreement of radiographic assessment of bony union. Forty-two lower extremity radiographs of consolidating distraction gaps were reviewed by nine examiners on two occasions for number of cortices and whether fixator removal was indicated. For number of cortices, the kappa coefficients for interobserver and intraobserver variability were 0.127 and 0.290. For fixator removal, the interobserver and intraobserver coefficients were 0.352 and 0.461. Variation in assessment of number of cortices was slightly better than chance, indicating an inadequate measure of healing. The clinicians used radiographic criteria other than three of four cortices for fixator removal. The decision to remove an external fixation device based on radiographic assessment alone resulted in intraobserver and interobserver variability moderately above chance.

Device Removal↗

Comparison of two doses of oestradiol benzoate administered at a resynchronised oestrus on reproductive performance of dairy cows.

OBJECTIVE: To compare the effects of two doses of oestradiol benzoate (ODB) administered as part of a treatment designed to resynchronise returns to oestrus on the reproductive performance of cows in a controlled breeding program. DESIGN: Cohort study. PROCEDURE: Lactating dairy cows on two farms were treated to synchronise three successive oestrous cycles. An intravaginal progesterone releasing insert (IVP4) was used to synchronise the first oestrous cycle. The cows were then treated 15 days after the first treatment by reinsertion of an IVP4 that had been used to synchronise the first oestrus and administration of 1.0 mg of oestradiol benzoate (ODB) i.m. at device insertion. The IVP4 device was removed 8 days later and either 0.5 (n = 421) or 1.0 mg of ODB (n = 446) was administered 24 h later. Injections of (ODB) with or without the use of an IVP4 were used to synchronise the third oestrous cycle. Different synchronisation treatments were used to synchronise first and third oestrous cycles but differences were included in statistical models to account for variation in the data. This enabled examination of effects due to differences in the dose of ODB used to synchronise the second synchronised oestrus. RESULTS: The dose of ODB (0.5 or 1.0 mg) administered just before the second synchronised oestrus did not significantly (P > 0.10) affect the cumulative pregnancy rates over three successive rounds of artificial insemination, the mating start date to the conception intervals, the conception rates to the first or second insemination, the proportion of cows submitted for insemination at the second synchronised oestrus or the proportion of cows that were not pregnant yet failed to show signs of oestrous (phantom cows) identified within each herd. CONCLUSION: There was no difference in reproductive performance between cows receiving either 0.5 mg or 1.0 mg ODB after removal of used IVP4 devices that had been inserted to resynchronise them for a second insemination.

Administration, Intravaginal↗

[The migrating intrauterine device. Case report and review of the literature].

We report a case of migration of an intrauterine contraceptive device (IUCD) detected during pregnancy one year after insertion. The advanced gestation of the pregnancy and the absence of symptoms lead to expectant management. There were no complications during the pregnancy or delivery. A CT Scan in the post-partum period suggested that the IUCD was located in the region of the small bowel. Laparoscopy confirmed that the IUCD was superficially embedded in the intestinal wall but with no mucosal lesion. The device was removed with the aid of a mini-laparotomy. The migration of an IUCD into the abdominal cavity is rare. A literature review spanning the past 18 years revealed 165 reported cases. The IUCD was located in the following sites: omentum 45, rectosigmoid 44, peritoneum 41, bladder 23, appendix eight, small bowel two, adnexa one, iliac vein one. The majority of the authors recommend removal of copper containing devices, because of the potential for inflammatory reactions that can cause bowel obstruction and perforation. Initial laparoscopy has mostly superceded laparotomy but conversion may be necessary if difficulties arise.

Adult↗

Sexual transmission of hepatitis C virus from a patient with chronic disease to his sex partner after removal of an intrauterine device.

BACKGROUND: Approximately 40% of patients infected with hepatitis C virus (HCV) have no history of blood transfusion or other high-risk practice. Other causes should be considered. GOAL: The goal was to describe sexual transmission of HCV from a chronic carrier to his female partner during unprotected vaginal intercourse after removal of an intrauterine device. STUDY DESIGN: A heterosexual woman who was a regular blood donor acquired acute HCV infection from her sex partner, who was chronically infected. The study included an interview and phylogenetic analysis of sequences of virus obtained from the couple. RESULTS: Risk factors other than vaginal sexual relations with her partner were ruled out. Phylogenetic analysis showed that sequences from the couple clustered together in all trees generated, in comparison with local and GenBank controls. CONCLUSION: The temporal relationship between removal of the intrauterine device and the acute hepatitis suggests that vaginal mucosal damage might have favored transmission of HCV. Barrier precautions should be suggested whenever damage of the vaginal tract has occurred.

Adult↗

Long-term, totally implantable central venous access ports connected to a Groshong catheter for chemotherapy of solid tumours: experience from 178 cases using a single type of device.

The aim of this study was to examine the early and late complications rate of central venous access ports connected to the Groshong catheter for long-term chemotherapy delivering. All patients suffering from a neoplastic disease, who required long-term chemotherapy and underwent insertion of implantable ports during a 21-month period (1 October 1994-30 June 1996) were prospectively studied. A single type of port was used, constructed of titanium and silicone rubber (Dome Port, Bard Inc., Salt Lake City, U.S.A), connected to an 8 F silastic Groshong catheter tubing (Bard Inc.). A team of different operators (two general surgeons, one interventional radiologist and four anaesthesiologists) was involved in inserting the port. All devices were placed in the operating room under fluoroscopic control. A central venous access form was filled in by the operator after the procedure and all ports were followed prospectively for device-related and overall complications. Data from the follow-up of these patients were entered in the form and collected in a database. Follow-up continued until the device was removed, the patient died or the study was closed. 178 devices, comprising a total of 32,089 days in situ, were placed in 175 patients. Three patients received a second device after removal of the first. Adequate follow-up was obtained in all cases (median 180 days, range 4-559). 138 devices (77.5%) were still in situ when the study was closed. Early complications included six pneumothoraxes, three arterial punctures and two revisions for port and/or catheter malfunction (overall early complications in 8 patients). Late complications included 3 cases (1.68% of devices) of catheter rupture and embolisation (0.093 episodes/1000 days of use), 2 cases (1.12% of devices) of venous thrombosis (0.062 episodes/1000 days of use), 1 case (0.56% of devices) of pocket infection (0.031 episodes/1000 days of use), and 4 cases (2.24% of devices) of port-related bacteraemias (0.124 episodes/1000 days of use). Infections were caused by coagulase-negative Staphylococcus aureus (4 cases) and Bacillus subtilis (1 case); they required port removal in 3 out of 5 cases. This study represents the largest published series of patients with totally implantable access ports connected to Groshong catheters; this device is a good option for long-term access to central veins and delivery of chemotherapeutic regimens, including continuous intravenous infusions. The low incidence of major complications related to implantation and management of these devices support increased use in oncology patients.

Adolescent↗

Enhanced precision of estrus and luteinizing hormone after progesterone and prostaglandin in heifers.

Objectives were to determine if low progesterone and increased basal luteinizing hormone for 3 d after injecting prostaglandin F2 alpha would affect precision of preovulatory surges of luteinizing hormone and onset of estrus in Holstein heifers. In experiments 1 and 2, heifers received progesterone devices for 10 d and prostaglandin F2 alpha on the 7th d after inserting progesterone device. For controls, progesterone devices were removed when prostaglandin F2 alpha was injected, and control devices were installed for 3 d. In experiment 1, jugular blood was sampled every 2 or 4 h from injection of prostaglandin F2 alpha until 108 h after removing progesterone to determine basal and peak secretion of luteinizing hormone. In treatment heifers, basal luteinizing hormone tended to increase, and intervals to peak secretion of luteinizing hormone were shorter and more precise than for controls. In experiment 2, heifers were observed for estrus for 30 min every 4 h for 96 h after removing progesterone devices. Intervals to onset of estrus for experimental heifers were shorter and more precise than for controls. After exogenous prostaglandin F2 alpha, 1 to 2 ng of progesterone per milliliter of serum for 2 to 3 d allows increased basal luteinizing hormone and is associated with increased precision of preovulatory secretion of luteinizing hormone and onset of estrus. This may be an acceptable method to control ovulation precisely for fixed time insemination of cattle.

Animals↗

Preparation of a superantigen-adsorbing device and its superantigen removal efficacies in vitro and in vivo.

OBJECTIVE: A new superantigen-adsorbing device (SAAD) was developed, and its characteristics and efficacy in septic animals were evaluated. METHODS: The SAAD was prepared by stepwise chemical modification of a polystyrene-based composite fiber reinforced with polypropylene. Adsorption affinities for several factors and the biological effect of superantigen (SAg) removal were measured in vitro. Also, superantigen-infused rabbits were treated with SAAD, and the efficacy was evaluated in vivo. RESULTS: When the SAAD was evaluated for its ability to adsorb SAg in human plasma (1 ng/mL each), the adsorption rates were 74%, 76% and 85% for staphylococcal enterotoxins A, B and C, respectively, and 80% and 72% for toxic shock syndrome toxin-1 (TSST-1) and streptococcal pyrogenic exotoxin A, respectively. In addition, the SAAD showed some affinity towards other molecules, such as streptococcal pyrogenic exotoxin B, beta2-microglobulin, and vancomycin. Residual activities in whole blood samples containing TSST-1 (1 ng/mL) after incubation with the SAAD were 125 pg/mL for tumor necrosis factor alpha (TNF-alpha) production, and 359 pg/mL for interleukin-8 (IL-8) production (the initial activities: 194 pg/mL for TNF-alpha production, and 1029 pg/mL for IL-8 production). When TSST-1/lipopolysaccharide (LPS)-infused rabbits were subjected to extracorporeal blood purification with a SAAD column, 50% of the animals survived for a 14-day period after the infusion. In contrast, all control animals died within 3 days after the infusion. CONCLUSION: These results indicate that the SAg-adsorbing device may be useful in treating SAg-related diseases.

Adsorption↗

Bridging-to-recovery.

BACKGROUND: Patients with end-stage heart failure placed on a cardiac assist device show at least some degree of improvement of cardiac function. In a subgroup of selected patients, some hearts recovered considerable function. In these patients the device was removed and cardiac transplantation was no longer necessary. We report our long-term experience with these weaned patients. METHODS: As of today, 512 cardiac assist devices of various types (Berlin Heart, Berlin, Germany; Novacor, World Heart, Ottawa, Ontario, Canada; TCI, ThermoCardio Systems, Inc, Woburn, MA; DeBakey, Micromed Technology Inc, Houston, TX) were implanted in patients with end-stage heart failure in our institution. Of these, 95 patients belonged to a subgroup of patients with nonischemic, idiopathic, dilated cardiomyopathy who were implanted with a left ventricular support system (Novacor 84, TCI 10, Berlin Heart 1) between 1994 and 2000. All were routinely examined by echocardiography for improvement of cardiac function. The left ventricular diameter in diastole (LVIDd) and left ventricular ejection fraction (LVEF) served as the main parameters to assess changes in cardiac performance. Under the conditions of a running device, an LVIDd below 60 mm and an LVEF above 40% were the criteria to do further echocardiographic studies when the pump was turned off for up to 20 minutes. RESULTS: Twenty-eight patients (26 men, 2 women; ages 18 to 64 yrs; history of heart failure, 1 to 17 yrs) fulfilled the criteria of improved cardiac performance and were weaned from the device. Since then, 16 patients have continued "normal" heart function with follow-up times ranging from 1 month to 5.5 years (group B). Three patients died of noncardiac causes (group C). Eight patients were transplanted from 1 to 17 months later and one died on the waiting list (group A). Statistically significant differences between groups A and B were calculated for the duration of heart failure (9 versus 2 years, p = 0.0002). Differences in LVIDd before removal of the device (57 versus 51 mm, p = 0.0420), LVEF after 2 months of unloading (30 versus 49%, p = 0.0300), and LVEF preexplantation (43 versus 52%, p = 0.0001) were significant. Overall, 17% of the cohort of 95 patients were weaned successfully. CONCLUSIONS: Weaning from cardiac assist devices is feasible for selected patients; it saves donor hearts and is preferred to cardiac transplantation. However, as of today no reliable parameter predicts outcome after weaning and none determines the possibility of device removal before implantation in advance.

Adolescent↗

Microcatheter retrieval device for intravascular foreign body removal.

A microcatheter foreign body retrieval device is described and its first two clinical applications are presented. The device functions identically to larger loop snare retrievers. It permits access to small vessels and was successful in its first clinical applications.

Adult↗

Difficult tracheal intubation induced by maxillary distraction devices in craniosynostosis syndromes.

BACKGROUND: Difficult intubation occurred during anaesthesia for removal of maxillary distraction devices in five of seven children with syndromal craniosynostoses (four with Apert, two with Pfeiffer and one with Crouzon syndrome). METHODS: Intubation was assessed in terms of laryngeal view and an established intubation difficulty score and had been straightforward before device insertion. Difficulty was induced by trismus due to device insertion and by increased maxillary prominence. This was compounded by preexisting mandibular hypoplasia. Cephalometric analysis, with each child acting as their own control, demonstrated anterior displacement of the maxilla and increased maxillary vertical height, as well as increased protuberance of the maxillary incisors. RESULTS: All five difficult tracheal intubations were associated with preoperative Mallampati scores of 3 or 4 and the nine straightforward intubations with scores of 1 or 2. Maximal interincisor distance was less than the lower 95% confidence limit for age in all five children who were difficult to intubate at the time of device removal. No child had a failed intubation, but all had significantly increased intubation difficulty. CONCLUSIONS: In view of the risks of trauma, hypoxia and aspiration associated with difficult direct laryngoscopy, we recommend elective fibreoptic intubation at anaesthesia for removal of maxillary distraction osteogenesis devices in these children.

Adolescent↗

[Ability to conceive after intentional interruption of intrauterine contraception].

Out of 3415 first insertions, the intrauterine contraceptive device was removed in 152 women (4.45%) owing to planned pregnancy. Nineteen cases dropped out of evidence, so that 133 remained for further analysis. Out of these 133 women, 120 (90.23%) became pregnant, the reamining 13 (9.77%) did not. In the first three months following the removal of the intrauterine contraceptive device, 77 women 57.89% conceived, 3--6 months after the removal 22 (16.54%), 6--12 months 18 (13.53%), and after one year 3 women (2.26%) were recorded pregnant. The ability to conceive is analysed according to the age of the women surveyed, the length of the use of intrauterine contraceptive devices, and the number of previous births and abortions. It is concluded that the use of intrauterine contraception has no influence on the later ability and speed of conception and that, for this reason, this contraception method could be considered fully reversible.

Abortion, Induced↗

Bacterial adhesion on titanium nitride-coated and uncoated implants: an in vivo human study.

Titanium nitride (TiN) has been used in many fields as a surgical instrument coating that makes the surgical materials more resistant to wear and corrosion. The aim of the present study was an in vivo evaluation of the bacterial adhesion to TiN-coated (test) and uncoated (control) titanium implants. Six patients aged between 21 and 25 years and in excellent systemic health participated in the study. All of the participants gave their informed consent. The participants were selected on the basis of good periodontal health and no signs of mouth breathing. In each of the 6 participants, a removable acrylic device was adapted to the molar-premolar region of each quadrant of the jaws. One 4 x 13 mm titanium implant was glued to the buccal aspect of each device. The plasma spray covered 11.5 mm of the body of the implant, whereas the neck was machined titanium. Test implants were glued to the right devices and control implants were glued to the left devices. After 24 hours, the implants were removed from each device and processed for scanning electron microscopy for evaluation of the machined portion of the implant covered by bacteria. A total of 24 implants were used in this study, 12 test and 12 control. Surface characterization of the machined portion of the neck of the implant was performed on an additional 10 implants (5 test and 5 control). On test implants the implant surface covered by bacteria was significantly lower compared with that of control implants (P = .0001). The surface roughness was similar in both groups. TiN surfaces showed a significant reduction of the presence of bacteria, and this fact could probably be important in the decrease of the inflammation of the peri-implant soft tissues.

Adult↗

Outcome of Staphylococcus aureus bacteremia according to compliance with recommendations of infectious diseases specialists: experience with 244 patients.

To determine whether recommendations of infectious diseases specialists affect outcome for patients, we evaluated 244 hospitalized patients with Staphylococcus aureus bacteremia. We offered our management recommendations to each patient's physicians and then assessed the clinical outcome for both patients for whom our consultative advice was followed and those for whom our advice was not heeded. All patients were followed up for 12 weeks after their first positive blood culture. Our management advice was followed for 112 patients (45.9%) and partially or completely ignored for 132 patients (54.1%). Patients for whom our recommendations were followed were more likely to be cured of their S. aureus infection and less likely to relapse (P < .01), despite having significantly more metastatic infections (P < .01) at the outset of therapy, than were those for whom our recommendations were not followed. Failure to follow recommendations to remove an infected intravascular device was the most important risk for treatment failure. After controlling for other factors, logistic regression analysis revealed that patients whose intravascular device was not removed were 6.5 times more likely to relapse or die of their infection than were those whose device was removed. Our findings suggest that patient-specific management advice by infectious diseases consultants can improve the clinical outcome for patients with S. aureus bacteremia.

Algorithms↗

Bacteriologic study of IUDs removed from Nigerian Igbo women.

Intrauterine contraceptive devices (IUDs) removed from 50 Igbo women were subjected to bacteriologic studies. High vaginal swabs from the women were cultured simultaneously. In 49 of the 50 IUDs, the culture was negative. The author concludes that the African IUD wearer, like her Caucasian peer, can safely combat any bacterial nidus introduced during device insertion.

Adult↗

Full thickness resection device (FTRD) for endoluminal removal of large bowel tumours: development of the instrument and related experimental studies.

We describe a novel device for full thickness resectioning of large bowel lesions. The device has been assessed in experimental studies. Tumours of the large bowel are a frequent disease with increasing incidence figures. If detected at an early stage, local treatment of colon tumours is possible through an endoluminal access. Currently, full thickness resection can only be performed in the rectum with the TEM technique, while snare resection through the flexible endoscope will only allow mucosa resection. We have developed a new device which allows full thickness bowel wall resections up to the splenic flexure. The device, called full thickness resection device (FTRD) has a flexible shaft and a multifunctional front-end. It can be inserted into the colon over a flexible endoscope. After the device is advanced to the tumour, the head can be opened and the tumour, including safety margins, is pulled into the resection chamber inside the device head by means of two tissue graspers. The bowel wall invagination can be visualised with the endoscope to ensure that the tumour is completely pulled into the resection head. The head is then closed and the resection mechanism is activated. A semicircular stapling suture is fired through the bowel wall and a rotary knife is used to cut the tissue. Specimens of > 3 cm can be harvested with FTRD. Prototypes of the device have been successfully tested in a series of animal experiments in parallel to the technical development of the instrument. These experiments could demonstrate that full thickness bowel wall resection is feasible using a flexible instrument and endoscopic visualisation.

Journal Article↗

Complications of indwelling venous access devices in cancer patients.

PURPOSE: We undertook this study to review our experience with indwelling vascular access devices in cancer patients to identify factors associated with complications. PATIENTS AND METHODS: A total of 322 indwelling devices were placed in 274 cancer patients by a single surgeon. Devices were placed via percutaneous insertion in 72% (231 of 322) and via venous cutdown in 28% (91 of 322). We placed external catheters in 209 of 322 patients (65%) and subcutaneous infusion ports in 113 of 322 (35%). RESULTS: Pneumothorax occurred in four of 231 (1.7%) of the percutaneously placed devices. Postoperative complications included sepsis and thrombosis, which necessitated premature removal of the devices. Device related sepsis occurred in 28 of 209 patients (13%) with catheters and six of 113 patients (5%) with subcutaneous ports. Thrombosis occurred in 21 of 209 patients (10%) with catheters and seven of 113 (6%) with subcutaneous ports. In 15 of 19 devices removed for thrombosis, the tip was above the T3 level. Seventeen devices were placed in the saphenous vein, with a complication rate similar to that observed in upper-body devices. CONCLUSION: We found a significantly (P < .05, chi 2 analysis) increased incidence of thrombotic complications in patients with triple-lumen catheters (10 of 48) compared with double-lumen catheters (11 of 160), as well as a significantly (P < .05) decreased mean time until catheter failure (40 v 146 days). We also observed a significant increase in the rate of thrombosis in patients with a catheter tip above the T3 level. We therefore recommend the use of fluoroscopy at the time of placement to assure adequate catheter length and tip position and the use of triple-lumen catheters only when necessary for concurrent drug administration.

Catheterization, Central Venous↗