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Clinical experience with the Hemopump.

Complications associated with surgical procedures generally required for implantation of left ventricular assist devices (LVADs) may limit them from providing adequate circulatory support for patients suffering from profound left ventricular failure (LVF). Such problems are minimized with the use of the Hemopump, a recently developed intraarterial LVAD. This 7 mm transvalvular axial flow blood pump is percutaneously powered by an external console with a flexible drive cable. Since April 1988, we have used the device effectively in 12 patients. Indications for device application included postcardiotomy shock in eight patients, acute allograft rejection in two, severe allograft failure in one, and acute myocardial infarction in one. The Hemopump was inserted from the femoral approach in eight patients, the ascending aorta in three, and the abdominal aorta in one. During the first 12 hr of support, cardiac index (CI) ranged from 1.14-2.98 L/min/m2, and pump flow was 3.0 to 3.6 L/min. As the patients' hearts recovered, the pump speed was gradually reduced. Circulatory support ranged from 26 to 139 hr; 10 of 12 patients were successfully weaned. The mean CI before device removal was 2.74 +/- 0.4 L/min/m2, and the pump flow was 2.14 +/- 0.69 L/min. No device-related infections or thromboembolic episodes occurred. Plasma-free hemoglobin remained within acceptable levels during pumping. Six patients survived more than 30 days after pump removal. Thus, the Hemopump can provide safe, stable, temporary circulatory support and can be expeditiously applied with minimal complications.

Adult↗

Two-compartment technique to remove ophthalmic viscosurgical devices.

To avoid postoperative intraocular pressure peaks, complete removal of all ophthalmic viscosurgical devices (OVDs) used during cataract surgery is important. Depending on the kind of OVD used, different removal techniques have been applied. We describe a technique that was used in more than 250 eyes for safe removal of OVDs, especially viscoadaptive OVDs such as sodium hyaluronate 2.3% (Healon5). It takes advantage of the viscoadaptive properties of Healon5 and was named the 2-compartment technique.

Cataract Extraction↗

The artificial urinary sphincter (AS 800): experience in 166 consecutive patients.

The artificial urinary sphincter model AS 800 was implanted in 166 patients with incontinence of various etiologies. Followup ranged from 6 to 94 months, with a mean of 41.6 months. Patient age ranged from 5 to 84 years, with a mean age of 59.4 years. There were 10 female patients (6%) and 156 male patients (94%). The cuff was implanted around the bladder neck in 27 patients (16%) and around the bulbous urethra in 139 (84%). A total of 40 reoperations (27 revisions and 13 device removals) was performed in 32 of 166 patients (19.3%). There were 13 mechanical device failures (7.8%), 11 cuff erosions (6.6%) and 2 periprosthetic infections (1.2%). Total or near total continence was achieved in 125 patients (75.3%), while 25 (15.1%) had improved urinary control.

Adolescent↗

Symptom responses, long-term outcomes and adverse events beyond 3 years of high-frequency gastric electrical stimulation for gastroparesis.

The aims were to determine symptom responses and long-term outcomes in gastroparetic patients receiving gastric electrical stimulation (GES) therapy beyond 3 years by presenting per protocol analysis and intention-to-treat (ITT) analysis. Data collected at baseline, 1 year and beyond 3 years in 55 patients included total symptom scores (TSS), nutritional status, weight, hospitalizations, the use of prokinetic and/or antiemetic medications, HbA1c in diabetics and adverse events. Of the 55 patients, 10 died of non-pacemaker-related complications, six had the devices removed and two could not be reached. The remaining 37 patients had the device activated for a mean of 45 months. Both per protocol and ITT analysis demonstrated that TSS, hospitalization days and the use of medications were all significantly reduced at 1 year and were sustained beyond 3 years. Average TSS decreased by 62.5% for the 37 patients completing 3 years of GES. At implantation, 15/37 patients required nutritional support and only five continued beyond 3 years. Mean HbA1c level in diabetics was significantly reduced from 9.5 to 7.9% at 3 years. We conclude that a significant improvement in symptoms and all measures of clinical outcome can be maintained for greater than 3 years with GES in patients with refractory gastroparesis.

Adult↗

Continuous sonographic monitoring of IUD extraction during pregnancy: preliminary report.

The significance of the location of intrauterine contraceptive device in relation to the gestational sac on pregnancy outcome was studied in 13 pregnant women after extraction of the device. Of the seven women (group 1) who had the intrauterine contraceptive device removed after initial localization by sonography, two (28.5%) miscarried. In both cases the device was located cephalad or lateral to the gestational sac. In six women (group 2) continuous sonographic scanning was undertaken to visualize the extraction procedure. Traction on an intrauterine device located laterally (two cases) or cephalad (one case) to the gestational sac was followed by distortion of the sac configuration. Gentle intermittent traction on the contraceptive device resulted in successful extraction procedure. These preliminary observations suggest that pregnancies with an intrauterine contraceptive device located laterally or cephalad to the gestational sac are at greater risk during extraction of the device. Sonographic monitoring of the extraction procedure during pregnancy may minimize the hazards of intrauterine contraceptive device failure.

Abortion, Spontaneous↗

Use of environmental scanning electron microscopy to evaluate dental stain removal.

The purpose of the study was to assess the usefulness of environmental scanning electron microscopy (ESEM) to evaluate stain removal from extracted teeth. The ESEM differs from conventional SEM in that no sample preparation is needed, eliminating artifactual changes. Furthermore, the same sample can be viewed on multiple occasions, allowing "before" and "after" pictures of the same tooth. As a model stain removal device, we tested the Sonicare sonic toothbrush, which has previously been shown to remove dental stain in vivo. Twelve freshly extracted teeth with extrinsic coffee, tea or tobacco stain were obtained for the study. Nine of these had heavy stain (stain covering more than one-third buccal or lingual surface) and were used without further modification. Three teeth were treated in vitro with chlorhexidine and a mixture of coffee and tea to enhance staining. All teeth were examined by ESEM at three times: prior to brushing, after 15-30 seconds of brushing, and after 60-80 seconds of brushing. Light microscopy and 35 mm photography was also done to correlate the ultrastructural changes with those visible at low magnification. Water, mouthwash and 30% slurry of toothpaste were used as fluid vehicles during brushing, but little difference in stain removal was noted among these three fluids. Approximately half the stain was removed within 15-30 seconds, and most visible stain was removed in 60-80 seconds of brushing. Pits and crevices of tooth enamel that were smaller than the bristle diameter, and thus would be inaccessible to abrasive cleaning by direct bristle contact, were generally found to be stain-free. These findings confirm previous reports of the stain removal effectiveness of the Sonicare, and demonstrate the usefulness of ESEM for stain removal studies.

Chlorhexidine↗

Alveolar distraction osteogenesis vs. vertical guided bone regeneration for the correction of vertically deficient edentulous ridges: a 1-3-year prospective study on humans.

The purpose of this prospective study was to compare vertical guided bone regeneration (GBR) and vertical distraction osteogenesis (DO) for their ability in correcting vertically deficient alveolar ridges and their ability in maintaining over time the vertical bone gain obtained before and after implant placement. Eleven patients (group 1) were treated by means of vertical GBR with autogenous bone and e-PTFE membranes, while 10 patients (group 2) were treated by means of DO. In group 1, six patients received implants at the time of GBR (subgroup 1A), while five patients had implants placed at the time of membrane removal (subgroup 1B). In group 2, implants were placed at the time of distraction device removal. A total of 25 implants were placed in group 1 and 34 implants were placed in group 2 patients. Three to 5 months after implant placement, patients were rehabilitated with implant-borne dental prostheses. The following parameters were evaluated: (a) bone resorption of the regenerated ridges before and after implant placement; (b) peri-implant clinical parameters 1, 2, and 3 years after prosthetic loading of implants; (c) survival and success rates of implants. Bone resorption values before and after implant placement were significantly higher in group 1. The results suggested that both techniques may improve the deficit of vertically resorbed edentulous ridges, although distraction osteogenesis seems to be more predictable as far as the long-term prognosis of vertical bone gain is concerned. Implant survival rates as well as peri-implant clinical parameters do not differ significantly between the two groups, whereas the success rate of implants placed in group 2 patients was higher than that obtained in group 1 patients.

Adolescent↗

Treatment of nasopharyngeal stenosis by prosthetic hollow stents: Clinical experience in eight patients.

OBJECTIVE: A series of nasopharyngeal appliance designs is presented that represents our evolving experience over a 20-year period in the adjunctive use of prosthetic stents in the surgical correction of nasopharyngeal stenosis. DESIGN: Retrospective assessment of effectiveness of two nasopharyngeal stenosis hollow stent designs in a consecutive series of patients for relief of nasal obstructive symptoms. SETTING: Tertiary academic medical center, Craniofacial Program at Children's Hospital. PATIENTS: Four patients with nasopharyngeal stenosis were treated with a preoperatively fabricated stent made from a clasped palatal appliance onto which hollow acrylic conduits were extended through surgically re-created pharyngeal ports. A subsequent set of four patients with nasopharyngeal stenosis were treated with intraoperatively-fashioned silastic grommets, as opposed to palatal appliances. INTERVENTIONS: Postoperative intraoral stenting of nasopharyngeal ports. MAIN OUTCOME MEASURES: Maintenance of pharyngeal port opening after 1 year, improvement in nasal airway obstructive symptoms. RESULTS: The palatal appliance stents were less well tolerated and had a lower maintenance of port patency after device removal (4 of 8, 50%). The silastic grommets provided better retention into the ports and increased patient tolerance, as well as better 1-year port maintenance (6 of 8, 75%). CONCLUSIONS: The grommet stent appliance offers numerous advantages over a conventional dental-clasped appliance for prosthetic nasopharyngeal stenting, including obviation of extensive preoperative preparation, ease of insertion and removal, and exchange of air during the stenting period. Improved nasopharyngeal patency with this device may be due to greater patient tolerance and subsequent longer use.

Adolescent↗

Hysteroscopic removal of intrauterine devices with missing filaments.

Ninety-one patients using intrauterine devices (IUD with nonvisible filaments on examination underwent hysterscopy for location and retrieval of the devices. These were among 320 patients who underwent hysterscopy for a variety of indications. All but 6 patients for whom additional surgery was planned were given local anesthesia. In 78 patients, the device was found within the uterine cavity and removed under hysterscopic control. In the remaining 13, no intrauterine device was observed. Six of these 13 patients had a translocated device which was removed either by laparoscopy or laparotomy. Hysteroscopy is proposed as a useful and effective method of diagnosis and management in ambulatory patients when the filaments of the IUD are absent.

Endoscopes↗

Clinical evaluation of an external urine collection device for nonambulatory incontinent women.

Chronic urinary incontinence is a frequent complication of a variety of neurological diseases and is a major clinical problem among the aged. Urinary incontinence may be the pivotal factor that determines whether a patient requires long-term institutional care. For management of urinary incontinence in aged, nonambulatory women use of absorbent products may not prevent decubitus ulcers, while chronic use of indwelling urethral catheters results in bacteriuria and its complications. An effective external urine collection device for women, analogous in function to the condom catheter for men, may improve care by reducing complications, averting admissions to chronic care facilities and lowering medical costs. During 125 patient-days we evaluated 63 applications of an external urine collection device on 7 incontinent women in a nursing home. Each device was allowed to remain in situ for a maximum of 48 hours. Only 14 per cent of the devices required premature replacement due to unacceptable urine leakage. The median device wear time was 48 hours. The only adverse reactions observed were minimal erythema at 2 of 63 device removals and transient periurethral edema in 1 patient, which disappeared with continued use of the device. Thus, this device, exploiting an adhesive developed for ostomy appliances, was effective in maintaining patient dryness and was not associated with severe local reactions. These results appear to warrant clinical trials for extended periods in incontinent women.

Aged↗

Effects of controlled dynamic disc distraction on degenerated intervertebral discs: an in vivo study on the rabbit lumbar spine model.

STUDY DESIGN: An in vivo study on the rabbit lumbar spine model. OBJECTIVES: Effects of temporary dynamic distraction on intervertebral discs were studied on the lumbar spine rabbit model to characterize the changes associated with disc distraction and to evaluate feasibility of temporary disc distraction to previously compressed discs in order to stimulate disc regeneration. SUMMARY OF BACKGROUND DATA: Studies have shown that accelerated degeneration of the intervertebral disc results from altered mechanical loading conditions. The development of methods for the prevention of disc degeneration and the restoration of disc tissue that has already degenerated are needed. METHODS: New Zealand white rabbits (n = 32) were used for this study. The rabbits were randomly assigned to one of five groups. In 12 animals, the discs were first loaded for 28 days using a custom-made external loading device to stimulate disc degeneration. After 28 days loading time, the discs in six animals were distracted for 7 days and in six animals for 28 days using the same external device, however, modified as dynamic distraction device. In six animals, the discs were distracted for 28 days without previous loading; and in six animals, the discs were loaded for 28 days and afterwards the loading device removed for 28 days for recovery without distraction. Six animals were sham operated. The external device was situated; however, the discs remained undistracted and they also served as controls. After 28 to 56 days loading and distraction time, the animals were killed and the lumbar spine was harvested for examination. Disc height, disc morphology, cell viability, relative neutral zone, and tangent modulus were measured. RESULTS: After 28 days of loading, the discs demonstrated a significant decrease in disc space. Histologically, disorganization of the architecture of the anulus occurred. The number of dead cells increased significantly in the anulus and cartilage endplate. These changes were reversible after 28 days of distraction. The disc thickness increased significantly as compared with the specimens from the 28 days loading group without distraction. Histologically, the discs showed signs of tissue regeneration after 28 days of distraction. The number of dead cells decreased significantly in comparison with the loaded discs without distraction. The flexibility of compressed discs was higher than of compressed/distracted discs. CONCLUSIONS: The results of this study suggest that disc regeneration can be induced by axial dynamic distraction in the rabbit intervertebral disc. The decompressed rabbit intervertebral discs showed signs of tissue recovery on a biologic, cellular, and a biomechanical level after 28 days of distraction.

Animals↗

In vitro testing of a current cell salvaging device for the removal of malignant cells from contaminated blood.

The efficiency of a current cell washing device for removing tumor cells from bovine blood was examined under laboratory conditions. In the in-vitro laboratory, anticoagulated bovine blood was seeded with known numbers of immunocytochemical stained human malignant epithelial cells (KB) grown in culture. The blood was subjected to cell washing. Blood samples were taken before and after cell washing for identification of the tumor cells. The samples were then analyzed under florescence microscopy and pre- and post-cell washing tumor cell counts in 20 microscopic fields were recorded. It was determined that the mean tumor cell removal efficiency was 86% +/- 13% using the cell salvaging technique. Two-way ANOVA revealed a significant difference between the pre- and post-cell washing samples (p < 0.001) with no difference between trials (p = NS). The results are discussed in terms of the potential safety of cell salvaged blood for the surgical care patient.

Analysis of Variance↗

Ocular devices for the controlled systemic delivery of insulin: in vitro and in vivo dissolution.

Both in vitro flow-through and in vivo device removal methods were utilized to determine the dissolution rate of insulin from a Gelfoam(R) based eye device. The dissolution profiles generated by these two methods are comparable. The in vivo data suggests that there is a direct relationship between blood glucose lowering and the rate of release of insulin from the device. The in vitro dissolution results indicate that the release of insulin from the device is flow-rate dependent. The prolonged activity of the insulin is due to the gradual release of insulin from the device which results from the lachrymal system's slow and constant tear production.

Animals↗

Absence of bacteremia after insertion or removal of intrauterine devices.

A prospective study of the risk of bacteremia in 84 women having insertion and in 16 women having removal of intrauterine devices was performed. Bacteremia was not found in any of these 100 women at 1 to 3, 15, or 30 minutes after the procedure or in any of 57 women studied again 1.5 hours later. Because of the remote risk of bacteremia, the presence of congenital or valvular heart disease need not be an absolute contraindication to the use of an intrauterine device for contraception in an otherwise healthy young woman. Prophylactic antimicrobial therapy during insertion or removal of an intrauterine device appears to be unnecessary in the absence of evident pelvic infections. The risk of bacteremia during removal of an intrauterine device from an infected uterus cannot be determined from this study.

Female↗

Resynchrony of postpartum dairy cows previously treated for anestrus.

Cows that are diagnosed as anestrus (defined as >3 weeks postpartum, not detected in estrus by 1 week before commencement of seasonal breeding and without a palpable corpus luteum) have a lower probability of being inseminated, a lower conception rate to insemination and hence a lower probability of pregnancy within the breeding period. A current progesterone (P) and estradiol benzoate (EB) treatment for anestrus results in an 85% insemination rate, but only 57% of cows not conceiving to that first insemination are subsequently detected in estrus 14-28 days later. Resynchrony after an initial anestrous treatment has been used to increase the probability that cows not conceiving to first insemination will subsequently be detected in estrus. Anestrous cows (n=971) were initially treated with an intravaginal P-releasing device for 6 days and given 1 mg EB 1 day after device removal (day of EB treatment=Day 0). Cows detected in estrus between Days 0 and 3 were assigned randomly to be treated with reinsertion of a used P-releasing device for 8 days (commencing on Day 15), with 0.5 mg EB at reinsertion and again 1 day after removal (EB-RS), treatment as for EB-RS group but with substitution of 250 microg GnRH for EB at device reinsertion (GnRH-RS), or left as untreated controls (no-RS). Resynchrony treatments increased the proportion of non-pregnant cows detected in estrus from Days 14 to 28 compared to no-RS (79.1, 69.8, and 55.1% for EB-RS, GnRH-RS, and no-RS, respectively; P<0.05). Fewer cows were pregnant by Days 28 and 56 following GnRH-RS than EB-RS and no-RS. The final pregnancy rate was higher following EB-RS treatment than no-RS or GnRH-RS treatment (95.0, 88.3, and 88.6%; P<0.05). In conclusion, EB-RS enhanced reproductive performance of anestrous cows compared to no-RS.

Anestrus↗

Removal of massive right atrial thrombus guided by transesophageal echocardiography.

Formation of massive right atrial thrombi around a peritoneovenous shunt is a known complication of these devices. Removal of an obstructive right atrial thrombus requires cardiopulmonary bypass and has been associated with a high morbidity and mortality. Transesophageal echocardiography was used in this case to diagnose and guide the surgical removal of a massive right atrial thrombus.

Adult↗

Comparison of the laryngeal mask (LMA) and laryngeal tube (LT) with the new perilaryngeal airway (CobraPLA) in short surgical procedures.

BACKGROUND AND OBJECTIVE: We compared the laryngeal mask airway (LMA) and the laryngeal tube (LT) with the newly introduced perilaryngeal airway (CobraPLA, PLA) with regard to haemodynamic responses induced by airway insertion, clinical performance and occurrence of postoperative sore throat after short surgical procedures. METHODS: After premedication, 90 ASA I-II patients awaiting short surgical procedures were randomized to receive, LMA, LT or PLA. Anaesthesia was induced with intravenous propofol (2.5 mg kg(-1)) and mivacurium (0.2 mg kg(-1)). Number of attempts, time of insertion of the device, any other unwanted effect, mean aterial pressure, heart rate, oxygen saturation and end-tidal carbon dioxide were recorded. At the end of surgery, the cuff of the device was immediately deflated and the airway device was removed. The device was examined and noted for the presence of visible blood. Patients were asked to rate their throat soreness, dysphonia and dysphagia 1 and 24 h postoperatively. RESULTS: There were no differences in haemodynamic variables. Insertion times for the devices were similar (LMA: 20 +/- 11 s, LT: 19 +/- 14 s and PLA: 21 +/- 12 s.) The success rates at first insertion were lower in the (LMA group (57%) when compared with the PLA (97%, P < 0.05). The number and type of airway interventions for achieving an effective airway were similar. When the airways were removed 50% of the PLA devices had positive blood traces, while only 17% of the LMA and LT devices had positive blood traces (P < 0.01). Fifty percent of the patients suffered from a sore throat in the PLA group, which was significantly higher than in the LMA and LT groups (P < 0.05). CONCLUSION: We conclude that haemodynamic, ventilation and oxygenation variables throughout the surgery were similar with, LMA, LT and PLA, but LT and PLA were easier to insert; LMA and LT caused less mucosal trauma.

Adult↗

Performance of the copper T 200 in parous adolescents: are copper IUDs suitable for these women?

The clinical performance of a cohort of 995 parous adolescents, first-time users of the T-Cu 200B was studied and compared with a cohort of paired controls 10 years older, of the same parity. Life-table analysis showed that pregnancy, expulsion rates, as well as removals for bleeding and/or pain were higher in adolescents but within ranges already reported in the literature on this device. Removals for infection were few and not significantly different. Although the clinical performance of the T-Cu 200B in adolescents is not as good as in older women, the performance is similar or better than that reported for other reversible methods in this age group. Our conclusion is that IUDs should not be contraindicated for parous adolescents as long as adequate counseling, screening of risk factors, skillful insertion and follow-up are provided.

Adolescent↗