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Thirteen cases of misplaced intrauterine contraceptive devices removed from the abdominal cavity over a two year period at the Chelsea Hospital for Women, are reviewed. Five of the six plastic devices were removable laparoscopically but all the copper containing devices required a laparotomy for removal because of an omental or peritoneal reaction.
The timing of ovulation relative to the onset of oestrus and the preovulatory surge in luteinizing hormone (LH) was studied in red deer following treatments to synchronize oestrus and induce either a monovulatory or superovulatory response. Mature hinds (n = 36) were allocated randomly to two mating groups (n = 16 + 20), with respective treatments staggered by 4 weeks during the 1990 rut (March-April). Each hind was treated with an intravaginal controlled internal drug releasing (CIDR)-type S device for 14 days. Treatments to induce a monovulatory response included CIDR device alone (treatment A; n = 4 + 8) and additional injection of 200 iu pregnant mares' serum gonadotrophin (PMSG) at device removal (treatment B; n = 4 + 4). Treatments to induce a superovulatory response included injections of 200 iu PMSG and 0.5 units ovine follicle-stimulating hormone (FSH) at about time of removal of CIDR devices (treatment C; n = 4 + 4) and further treatment with gonadotrophin-releasing hormone (GnRH) analogue 18 h after removal of CIDR devices (treatment D; n = 4 + 4). The hinds were run with crayon-harnessed stags from insertion of CIDR devices (12 March or 9 April) and blood samples were taken every second day to determine plasma progesterone. Further blood samples were collected for determination of plasma LH and progesterone via indwelling jugular cannulae every 2 h for 72 h from removal of CIDR devices. Hinds were allocated randomly to an initial ovarian examination by laparoscopy at either 16 or 20 h (A and B), or 12 or 16 h (C and D) after the onset of oestrus, with laparoscopy repeated at intervals of 8 h until either ovulation was recorded (A and B), or for four successive occasions (C and D). All hinds received cloprostenol injections 15 days after device removal. A total of 28 hinds (78%) exhibited oestrus and a preovulatory LH surge, with mean (+/- SEM) times to onset of oestrus of 44.6 +/- 1.0 h (A; n = 7), 37.4 +/- 2.0 h (B; n = 7), 16.3 +/- 1.7 h (C; n = 6) or 14.0 +/- 1.7 h (D; n = 8). Failure to exhibit oestrus or LH surge was most prevalent among hinds in treatment A early in the rut.(ABSTRACT TRUNCATED AT 400 WORDS)
We carried out 310 blood-cultures on samples from patients receiving antibiotics for either known or suspected infective endocarditis or suspected septicaemia. The culture bottles were inoculated either directly or after the antibiotics had been removed from the blood sample by the Antimicrobial Removal Device System. Out of 63 bacterial isolates from 21 patients (15 infective endocarditis and 6 septicaemias), 45 were made by both methods, 16 only after treatment with the Antimicrobial Removal Device System and two only after conventional culture. Of the 45 paired isolates, eight were cultured more rapidly after Antimicrobial Removal Device System treatment compared with none by conventional culture. The Antimicrobial Removal Device System thus significantly increased the number of positive cultures and the speed of their isolation. In practice, Antimicrobial Removal Device System treatment proved useful in five of the 21 cases, but delayed culture in one. Its greatest value was in showing persistent bacteraemia in patients being treated for prosthetic valve endocarditis.
INTRODUCTION: Sacral neuromodulation is currently used in the pediatric patient population for refractory lower urinary tract dysfunction (LUTD). Evidence, however, is currently limited for institutional experiences of long-term outcomes for sacral neuromodulation in the pediatric patient population. OBJECTIVE: The objective of this study is to perform a retrospective review of a large multi-institutional cohort of pediatric patients that underwent sacral neuromodulation (SNM) for refractory LUTD, focused on rates of symptom improvement, quality of life, and bowel-bladder dysfunction measures following device implantation. Secondary objectives included assessing device complication rates and device removals due to failure or successful resolution of symptoms. METHODS: We performed a retrospective cohort study of pediatric patients at three children's hospitals that underwent SNM device implantation for refractory LUTD. Patients 4-18 years of age who were diagnosed with refractory LUTD and managed at a participating institution with follow-up were included. Outcomes were evaluated at baseline and post-operatively after two-stage device implantation at initial follow-up and annually until device removal or final follow-up. RESULTS: From 2010 to 2022, a total of 205 children underwent SNM procedures at three pediatric hospital centers. 204 patients completed the two-stage procedure for permanent device implantation with a median follow-up of 3.4 years (1.3, 4.9). One hundred seventy-eight patients reported partial (25%) or complete (54%) device response/symptom improvement by final follow-up. Comparison of patient-reported validated questionnaires completed at baseline and by final follow-up visit revealed significant improvement in median Pediatric Quality of Life Inventory (PedsQL) (p = 0.004) and Vancouver Nonneurogenic Lower Urinary Tract Dysfunction/Dysfunctional Elimination Syndrome bowel-bladder dysfunction (BBD) scores (p < 0.001). Of those with any device complication (n = 43;21%), 19 patients required device revision, and 20 required complete device removal. Separately, twenty-eight patients (13%) underwent device removal due to resolution of symptoms or treatment success at a median period of 5 years (4,7). CONCLUSION: SNM use demonstrated a majority of patients reporting at least partial subjective symptom improvement following device implantation across multiple institutions by final follow-up. SNM is a viable treatment option for refractory LUTD in the pediatric patient if willing to undergo an invasive procedure and in which thorough counseling of risks and benefits has occurred.
This article reviews the latest developments in the literature concerning two types of catheter widely used in oncology: Hickman central venous catheters (CVCs) and totally implanted venous ports. It now seems possible to diagnose catheter-related bloodstream infections (CRBI) without removing the device; recent studies showed that paired quantitative blood cultures are the most reliable and convenient method for diagnosis of CRBI. Can CRBI be cured and treated without device removal? A decision-tree/flow-chart resulting from analysis of international data by French International Experts is presented. Futures trends are reviewed: new techniques for prevention, including catheters impregnated with antimicrobials and, antiseptic hubs; flushing and antibiotic lock techniques that can be used both for prevention and treatment.
From January 2000 to December 2001, six patients with craniosynostosis were treated. Involved sutures were coronal sutures in three patients, coronal and metopic sutures in one patient, multiple sutures (brachycephaly and oxycephaly) in one patient, and multiple sutures with a cloverleaf skull deformity in one patient. The age distribution of the patients was 4 months to 3 years. Four were male, and two were female. A frontal craniotomy was performed in four patients with brachycephaly. In one patient with brachycephaly, the osteotomies were made across the nasofrontal junction, across the roof of the orbit, and along the lateral orbital wall. In one patient with a cloverleaf skull deformity, a frontal bone osteotomy was first performed 1 cm above the roof of the orbit. A supraorbital frontal bar was then made across the nasofrontal junction, across the roof of the orbit, and down to the lateral orbital wall. The frontal bone flap was repositioned to the supraorbital bar using absorbable miniplates and screws. Distraction was started 3 to 7 days after the operation at a distraction rate of 1 mm/d. The real duration of the first operation was 90 to 120 minutes, and the second operation to remove the device took 40 to 50 minutes to perform. The distracted length was 15 to 25 mm. The consolidation period was 3 to 5 weeks. The follow-up period was 6 months to 1 year. Postoperative three-dimensional computed tomography demonstrated reossification at the bone flap and advancement of the fronto-orbital area. After surgery, the cranial volume increased 22.7% on average compared with before surgery. The mean ratio of the anteroposterior length to the transverse length of the cranial vault was changed from 0.96 before surgery to 1.04 after surgery. In conclusion, the advantages of distraction osteogenesis of the cranial vault are that it offers a less invasive technique, a shorter operation time, easy care, and postoperative safety as a result of minimal dissection of the dura. Disadvantages are the limited possibility of initial reshaping and the necessity of one more operation for device removal.
PURPOSE: Tunneled catheters play an important role in the delivery of hemodialysis, for both temporary and long-term vascular access. Proper catheter tip positioning is critical for optimal blood flow and performance. The modular Cannon Catheter II Chronic Hemodialysis Catheter is placed tip first, then tunneled back to the exit site, in a simple technique (retrograde tunneling) that provides precise tip placement within the right atrium. This retrospective study evaluated 6-month efficacy and safety of the Cannon catheter in 38 patients. METHODS: Monthly mean flow, pressure, Kt/V, and URR were determined. Safety parameters included early and late device-related complications, device removals, and device survival. RESULTS: 87% of subjects had history of vascular access failure. Cannon catheters were inserted via an internal jugular vein with retrograde tunneling in all patients without insertional complication. Mean flow ranged from 369.0 to 404.8 ml/min, with a trend for increasing flow over time. High flow allowed delivery of correspondingly high clearance. Mean URR remained > or = 71%; mean weekly Kt/V ranged between 1.55 and 1.60, above current K/DOQI adequacy guidelines. There were no device-related hospitalizations or deaths. Catheter-related bacteremia occurred in 3 patients over the 6 months (0.62 bacteremias/1,000 patient-days), resolving through out-patient treatment. The Cannon catheter provided extended high flow vascular access (> or = 6 months or until hemodialysis catheter-based access was no longer needed) in 95% of patients. CONCLUSION: Retrograde tunneling of the Cannon Catheter II Chronic Hemodialysis Catheter allowed optimal tip placement and high flow rates, as well as safe, reliable, extended use.
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Six conceptuses were collected from red deer hinds on day 22 after synchronization of oestrus with intravaginal progesterone-releasing devices (removal of device = day 0). Within 24 h of culture in vitro, the supernatant from five of six conceptuses showed detectable antiviral activity. Interferon alpha (IFN-alpha) receptors were identified by immunohistochemistry on the luminal surface of the endometrium, in the neurohypophysis and paraventricular hypothalamus, but not in the ovaries of the hinds from which the conceptuses were collected. Another 16 intact hinds were synchronized as above. Injection of 4 mg IFN i.m. twice a day on days 13-15 had no effect on cloprostenol-induced oxytocin secretion on day 15 and did not prevent cloprostenol-induced luteal regression. Sixteen ovariectomized hinds received a protocol of steroid treatment to mimic ovarian hormone secretion during the normal oestrous cycle. On day 16, hinds showed undulant oxytocin secretion that showed a degree of temporal association with uterine PGF2 alpha release. Treatment with 4 mg IFN-alpha I 1 twice a day on days 13-16 had no effect on this spontaneous oxytocin secretion, but reduced the magnitude of cloprostenol-induced oxytocin secretion on day 17 (P < 0.05). These results indicate that red deer conceptuses secrete an anti-luteolytic IFN to which the endometrium expresses a receptor during early pregnancy. The presence of IFN receptors in the hypothalamus and posterior pituitary and the IFN-induced suppression of extra-ovarian oxytocin secretion provides tentative evidence of an involvement of the central nervous system in maternal recognition of pregnancy in deer.
Unlike previous medical device laws, the Safe Medical Devices Act of 1990 (SMDA), which became effective November 28, 1991 applies to "device-user facilities" such as hospitals and long-term care facilities. Final regulations are scheduled for release later this spring. The SMDA's primary goals are to: Ensure all devices currently in or entering the marketplace are safe and effective Enable the U.S. Food and Drug Administration (FDA) to learn quickly about serious problems with medical devices Remove defective devices (old and new) from the market To achieve these goals, Congress has given the FDA new review and enforcement powers, including the authority to impose fines on those in violation of the law. Incidents in which a medical device caused or contributed to the death, serious illness, or serious injury of a patient are referred to as medical device-reportable (MDR) events. A user must report MDR deaths to the FDA and to the manufacturer (if known). Serious illnesses and serious injuries caused by or attributed to the use of a device must be reported to the device manufacturer or, if the manufacturer is unknown, to the FDA. Facilities must report MDR events to the FDA semiannually and maintain incident files for two years after reporting the MDR event. The FDA may assess civil penalties against parties that do not comply with the SMDA's reporting provisions. Healthcare facilities must develop and implement employee training and education programs to help physicians, nurses, and other allied health employees identify and report MDR events.
The purpose of the study was to determine the effectiveness of a concept of combined interdisciplinary rehabilitation for children with mandibulofacial dysostosis, developed at the Center for Facial Malformations. It consists of binaural implantation of bone-anchored hearing aids and gradual distraction of the mandible. After audiological testing and mandibular distraction on a phantom head designed with data from a spiral CT, the surgery was done in three steps: implanting the fixtures for BAHA and the bone-lengthening device, removing the device after six weeks and completing the BAHA implantation two months later. The distraction procedure and orthodontic treatment were performed on an outpatient basis. The results (six patients, ages 6-19 years) were excellent: after implantation of the BAHA system speech perception increased from approximately 85% with the conventional BCHA to 95-100% with the BAHA. Quality of life was reported to be much better because of the general cosmetic improvement as well as the good acoustic orientation and sound quality with the new hearing devices. We conclude that the interdisciplinary approach provides favorable conditions for rehabilitation in cases of complex malformations of the head and neck.
OBJECT: The aim of this study was to define better the incidence of surgical complications and untoward side effects of chronic vagus nerve stimulation (VNS) in a population of children with medically refractory epilepsy. METHODS: The authors retrospectively reviewed the cases of 74 consecutive patients (41 male and 33 female) 18 years of age or younger (mean age 8.8 years, range 11 months-18 years) who had undergone implantation of a vagal stimulator between 1998 and 2001 with a minimum follow up of 1 year (mean 2.2 years). Of the 74 patients treated, seven (9.4%) had a complication ultimately resulting in removal of the stimulator. The rate of deep infections necessitating device removal was 3.5% (three of 74 patients who had undergone 85 implantation and/or revision procedures). An additional three superficial infections occurred in patients in whom the stimulators were not removed: one was treated with superficial operative debridement and antibiotic agents and the other two with oral antibiotics only. Another four stimulators (5.4%) were removed because of the absence of clinical benefit and device intolerance. Two devices were revised because of lead fracture (2.7%). Among the cohort, 11 battery changes have been performed thus far, although none less than 33 months after initial implantation. Several patients experienced stimulation-induced symptoms (hoarseness, cough, drooling, outbursts of laughter, shoulder abduction, dysphagia, or urinary retention) that did not require device removal. Ipsilateral vocal cord paralysis was identified in one patient. One patient died of aspiration pneumonia more than 30 days after device implantation. CONCLUSIONS: Vagus nerve stimulation remains a viable option for improving seizure control in difficult to treat pediatric patients with epilepsy. Surgical complications such as hardware failure (2.7%) or deep infection (3.5%) occurred, resulting in device removal or revision. Occasional stimulation-induced symptoms such as hoarseness, dysphagia, or torticollis may be expected (5.4%).
This report describes an original, removable, peripheral device: a microinjector that injects a single dose of fluid chemical into a particular site in the brain of freely moving rats. The microinjector was constructed especially for simultaneous use with a microdrive for microelectrode recording of single neuron activity but can be utilized alone. The microinjector is simple, lightweight, small, and easy to operate and maintain.
OBJECTIVE: To compare the use of gonadotrophin releasing hormone (GnRH) and oestradiol benzoate (ODB) administered following a synchronised pro-oestrus on reproductive performance of lactating dairy cows and the submission rates of non-pregnant cows following resynchronisation. DESIGN: Cohort study. PROCEDURE: Lactating Holstein cows enrolled in a controlled breeding program were first treated with an intravaginal progesterone releasing insert (IVP4) for 8 days, 2.0 mg of ODB intramuscular (i.m.) at device insertion (Day 0), an analogue of PGF2alpha at device removal and either 1.0 mg of ODB i.m., 24 h after device removal (ODB group, n = 242), or 0.25 mg of a GnRH agonist (GnRH group, n = 152) injected i.m. approximately 34 h after device removal. Every cow was artificially inseminated between 49 and 56 h after removal of its insert (Day 10). Cows detected in oestrus 1 day after artificial insemination (AI) that were not detected in oestrus on the previous day were re-inseminated on that day. All cows treated on Day 0 were resynchronised for reinsemination by insertion of a used IVP4 device on Day 23. Oestradiol benzoate at a dose of 1.0 mg was administered i.m. at the time of device insertion. Inserts were removed 8 days later (Day 31) and 1.0 mg of ODB was injected i.m. 24 h later. Those cows detected in oestrus between Days 31 and 35 were artificially inseminated. On Day 46 these cows were resynchronised for a third round of AI by insertion of an IVP4 device, used previously to synchronise cows for the first and second rounds of AI, and administration of 1.0 mg of ODB i.m.. Eight days later inserts were removed. Cows detected in oestrus between Days 54 and 58 were artificially inseminated. Bulls were run with the herd between rounds of AI and removed after 21 weeks of mating. RESULTS: Treatment with ODB or GnRH at the first synchronised pro-oestrus did not significantly alter the reproductive performance over three rounds of AI or over a 21-week breeding period. Treatment also did not alter submission rates at the second round of AI or the proportion of non-pregnant and non-return cows ('phantom' cows) detected and did not result in significant differences in concentrations of progesterone in plasma 10 and 18 days after removal of inserts at the first round of AI. Treatment with GnRH reduced the proportion of cows detected in oestrus at the first round of AI (36.2 vs 97.5%; P < 0.001). CONCLUSION: Administration of GnRH compared to ODB at a synchronised pro-oestrus results in similar reproductive performance. Treatment with GnRH reduced the proportion of cows detected in oestrus following treatment. This may offer advantages to the way AI is managed by enabling insemination at a fixed-time and removing the need for the detection of oestrus.
We describe the closure of a subclavian artery puncture site with a percutaneous suture device after removal of a pacemaker lead 1 week after its inadvertent positioning in the left ventricle via the subclavian artery. The lead was retracted from the left ventricle into the aorta and linked to a guiding catheter introduced via femoral artery access. The lead and the guiding catheter were removed from the artery to the subclavian area. This manoeuvre allowed the placement of a percutaneous arterial suture device (Perclose) to close the puncture site.
The objectives in this study were to determine whether treatment with progesterone (P4) via an intravaginal device would induce estrus and development of corpora lutea (CL) with typical life spans and whether treatment with estradiol benzoate (EB) following device removal would enhance the responses. At treatment initiation (d 0), suckled beef cows (n = 362) that were anestrous received one of the following: 1) an intravaginal device containing P4 for 7 d plus an injection of 1 mg of EB 24 to 30 h after device removal (P4+EB), 2) an intravaginal device containing P4 for 7 d (P4), 3) a sham device for 7 d plus an injection of 1 mg of EB 24 to 30 h after device removal (EB), or 4) a sham device for 7 d (control). Progesterone treatment increased the proportion of cows that formed CL with a typical lifespan (P < .001) and exhibited behavioral estrus (P < .05). Treatment with EB in combination with P4 increased (P < .001) the proportion of cows that exhibited estrus. Treatment with P4 alone had no effect, but the combination of P4 and EB increased (P < .01) the proportion of cows that formed short-lived or typical lifespan CL by the end of the experiment compared with untreated cows. In summary, treatment with P4 increased the incidence of estrus and the proportion of cows that formed CL with a typical lifespan. Treatment with P4 resulted in resumption of luteal function in suckled beef cows that were anestrous, with most cows developing CL with a typical lifespan, whereas EB enhanced the expression of estrus.
The objective was to compare the probability of pregnancy after fixed-time insemination in cows diagnosed as non-pregnant and re-inseminated following the Ovsynch protocol, with or without exogenous progesterone. Cows (n=415) used in this study originated from 25 farms. Upon diagnosis of non-pregnancy between 30 and 60 days after AI, cows were randomly assigned to receive either a progesterone releasing intravaginal device (PRID; n=208) or a placebo intravaginal device (PID; n=207). All cows received GnRH at enrollment (Day 0), PGF(2alpha) concurrent with intravaginal device removal 7 days later, GnRH on Day 9 and fixed-time insemination 16h later (Day 10). Cows observed in estrus prior to Day 7, had the device removed and were inseminated. Ovaries were examined by transrectal palpation at the time of enrollment and the prominent structures were assessed and recorded. Body condition score, lameness status, interval from previous insemination, and times bred at enrollment were recorded. At intravaginal device removal, the occurrence and intensity of vaginitis was determined according to the amount of debris on the device. Overall, the intravaginal device retention rate was 91%. A total of 5.2% of PID-treated cows and 2.9% of PRID-treated cows were detected in estrus within the 7 days treatment period. Pregnancy status was diagnosed between 30 and 56 days after insemination and all cows were followed for a minimum of 150 days after enrollment. Approximately 28% of cows had evidence of mild vaginitis in response to the intravaginal device, whereas 6% of cows had copious debris associated with the intravaginal device at removal. The probability of pregnancy after fixed-time insemination was 43.8% versus 34.9% in PRID-treated versus PID-treated animals. Exogenous progesterone provided through an intravaginal device to non-pregnant cows that had not displayed estrus improved the probability of pregnancy after fixed-time AI.
Red deer hinds (n = 38) were treated in the breeding season with five different gonadotrophin regimens to investigate the temporal relationship between oestrus, ovulation and the LH surge. All hinds were treated with progesterone-impregnated controlled internal drug release (CIDR) devices to synchronize oestrus. The five treatments were as follows: treatment 1, controls; treatments 2, 3 and 4, 1200 iu pregnant mares' serum gonadotrophin (PMSG) was administered i.m. 72 h before CIDR device withdrawal (treatments 3 an 4 were also injected i.v. with 0.4 mg synthetic GnRH 12 or 18 h after CIDR device withdrawal, respectively); treatment 5, 200 iu PMSG was administered i.m. 72 h before CIDR device withdrawal and 0.5 iu FSH was administered in eight equal doses at intervals of 12 h starting from the time of PMSG injection. The hinds were run with crayon-harnessed stages to determine the time of oestrus onset. Blood samples were collected every 2 days for 26 days after CIDR device removal to determine concentrations of plasma progesterone and every 2 h for 72 h after CIDR device removal to determine plasma LH profiles. Laparoscopy for ovary examination was performed 6 or 12 h after oestrus onset and was repeated twice at intervals of 12 h. Final ovulation rate was determined on day 7 after CIDR device removal. All hinds received 500 micrograms cloprostenol i.m. on day 13. A total of 30 and 34 hinds exhibited oestrus and ovulation, respectively.(ABSTRACT TRUNCATED AT 250 WORDS)