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Advantages of sphincterotomy and nasobiliary tube drainage in the treatment of cystic duct stump leak complicating laparoscopic cholecystectomy.

We have used sphincterotomy and nasobiliary tube drainage in preference to other forms of endoscopic therapy to manage three cases of cystic duct stump leak complicating laparoscopic cholecystectomy. The ability to monitor daily nasobiliary tube output and to perform repeat cholangiograms without subjecting the patients to multiple endoscopies permitted precise determination of cystic duct stump leak closure and timely discharge. We observed that an approximate doubling of the 24-h nasobiliary tube output coincided with closure of the cystic duct stump leak at cholangiography. Bile ascites was present in two of the cases and was conveniently removed by CT-guided placement of peritoneal drains. All cystic duct stump leaks sealed after 5 days of nasobiliary tube drainage. The advantages of sphincterotomy and nasobiliary tube drainage include precise determination of cystic duct leak closure, final device removal without follow-up endoscopy, and ongoing decompression of the biliary tree after removal of the nasobiliary tube.

Adolescent↗

[Clinical use of the artificial heart, indications and results].

Clinical experience with the artificial heart now comprises 520 cases. 390 patients had to be supported mechanically when they could not be weaned off cardiopulmonary bypass. 177 (45%) subsequently had their assist devices removed and 100 (25.4%) were discharged. Good functional results were achieved, since 30 of 36 long-term survivors are in NYHA class I or II. 140 underwent two-stage cardiac transplantation. Of 63 patients implanted with a ventricular assist device (VAD) 71% were transplanted and 51% survived. A total artificial heart (TAH) was used in 77 cases, 81% were transplanted and 47% survived. Five patients received TAH implantations as a permanent replacement of the failing heart. Though the clinical courses were complicated by strokes and infections and the patients were tethered to bulky drive units, it was proven that the TAH may sustain human life for up to 622 days, much longer than so far achieved in animal experiments. Improvements of the atrial connectors and valve holding components and of the biocompatibility of the blood contacting surfaces should overcome the complication of thromboembolism. Fully implantable devices which are currently being developed will avoid the problem of drive-line infections and provide fuller mobility to the patient.

Assisted Circulation↗

Clinical strategies in intravascular gas exchange.

Specific therapies in the management of acute pulmonary failure remain elusive, with attention being focused instead on novel supportive measures. The benefits of extracorporeal gas exchange support remain uncertain, and the perceived simplicity of intravascular gas exchange has, therefore, attracted much interest. Initial clinical experience with the intravascular oxygenator (IVOX) device confirms its safety and simplicity, but estimated mean gas-transfer values represent only 25% of basal gas-exchange requirements. The inherent limitations of IVOX as an oxygenator are discussed, providing a rationale for considering IVOX as primarily a CO2 removal device. Reappraisal of the clinical place of intravascular gas exchange and the identification of specific applications most likely to yield benefit to patients are suggested. Design modifications enhancing efficacy are anticipated, further strengthening the potential of intravascular gas-exchange devices in selected patients with pulmonary failure.

Carbon Dioxide↗

Hybrid advanced Ilizarov techniques: analgesia use and patient satisfaction.

Patients involved in the initial Western application of the Ilizarov technique experienced frequent pain and could not tolerate the device. With "hybrid advanced" Ilizarov techniques, half-pins and other components are added to minimize these adverse reactions. In this study of advanced techniques, we determined patient satisfaction (with end results), device tolerance, pain levels, and need for analgesia. These techniques used at least 1 half-pin on each ring--except for the distal tibial ring, which had 3 transfixing wires--perpendicular to either another half-pin or a transfixing wire. Eighty-one consecutive patients treated with advanced techniques were prospectively studied until the treatment was completed and the device removed. All patients received intravenous analgesia while hospitalized. Narcotic and non-narcotic analgesia was available to all patients, and analgesia use was measured. In addition, patient satisfaction and pain level were recorded. All patients were satisfied with end results and tolerated the device prescribed by their physician. Mean postoperative hospitalization was 5.1 days. Upon discharge from the hospital, 3 patients (3.7%) with moderate pain used postoperative narcotics for a mean of 6 days (range, 1-11 d), and 41 patients (50.6%) with mild pain used over-the-counter non-narcotic analgesia or prescription antiinflammatory medication for a mean of 4.4 days (range, 1-35 d). The other 37 patients (45.7%) were comfortable and did not require analgesia. In general, patients undergoing hybrid-advanced Ilizarov techniques infrequently needed postoperative analgesia.

Adolescent↗

Rate of thrombus accumulation on intravenacaval IVOX devices explanted from human clinical trial patients with acute respiratory failure.

The weight gain of IVOX devices removed from the first 49 human clinical trials patients after from 1 to 29 days of implantation into the venae caval blood stream has been assessed. Each patient had received sufficient systemic heparin to maintain activated clotting times between 150 and 200 s while the IVOX device was indwelling. The nature of the material accumulating on the IVOX device was documented histologically as being thrombus in various stages of development. The weight gain findings indicate that an average of 2.0 g of thrombus accumulates per 24 h on IVOX devices indwelling in the venous blood stream of moderately anticoagulated human acute respiratory failure patients. The rate of weight gain per 24 h of the IVOX device was more rapid during the first 96 h after its implantation than during its second, third, or fourth week of implantation. The accumulated thrombus on the IVOX hollow fibers was associated with a small but measurable decrease (approximately 1%/day) in gas transfer efficiency of the implanted device. The data support the conclusion that IVOX can function effectively and safely without major thrombus formation for up to 29 days in moderately anticoagulated human acute respiratory failure patients.

Acute Disease↗

Conservative management of infections in cochlear implant recipients.

OBJECTIVE: The goal of this study was to evaluate a conservative management strategy of postoperative infection after cochlear implantation. METHODS: A retrospective review of the medical records of 108 cochlear implant patients operated on at the University of California, San Francisco between 1991 and 2000 and 133 cochlear implant patients from the University of Iowa between 1997 and 2000 showed 4 patients with evidence of postoperative infections. The clinical presentation, intervention, laboratory results, and outcome are analyzed in each case. RESULTS: Minimal surgical intervention with limited incision and drainage with prolonged postoperative antibiotics was effective in treating postoperative cochlear implant infections without the need for device removal. Implant function remained unaffected after surgery. CONCLUSION: Postoperative cochlear implant infections can be effectively controlled with limited surgical and prolonged medical management. Chronic implant infections may be explained by a primary immunodeficiency. With appropriate treatment leading to infection control, a conservative management strategy is advocated before consideration of device explantation.

Adolescent↗

Analysis of factors related to successful transcatheter closure of secundum atrial septal defects using the HELEX septal occluder.

BACKGROUND: The HELEX septal occluder is a new transcatheter atrial septal defect occlusion device. This study analyzes the data collected from the first US clinical trials with this device to determine the most significant factors in successful use of the device. METHODS: Tables of subsets of data were constructed in categories of possibly significant patient and device variables compared with important outcomes. Chi2 analysis was used to determine which variables had significant impact on outcomes. RESULTS: The device was successfully implanted in 87% of patients (298/342). A major adverse event occurred in 5.8% (mostly device removal for various reasons). A significant residual leak persisted at 1 year in 2.6%. A fracture of the wire frame occurred in 8%--all were asymptomatic and only 1 required treatment. Overall composite success (no significant leak and no major adverse event) was seen in 91.5%. Patient age, body surface area, and device size had no significant influence on outcomes, except that wire frame fractures were more likely with the 35-mm device. Defect stretch diameter had the largest influence on outcomes, and implantation was possible in only 67% if the stretched diameter of the defect was >20 mm. Device-defect ratio also had a significant effect on delivery success and composite success. CONCLUSIONS: The HELEX septal occluder is best suited for small to moderate atrial septal defects with a stretch diameter <20 mm. Although composite success was achieved in 80% of patients when a device-defect ratio <1.6 was necessitated or elected, use of a device that provided a ratio >2 resulted in 95% composite success, and is recommended when possible.

Cardiac Catheterization↗

Clinical evaluation of the new Pall leucocyte-depleting blood cardioplegia filter (BC1).

It is now widely acknowledged that autologous leucocytes are inappropriately activated during cardiopulmonary bypass (CPB). Removal of these activated leucocytes has been proposed as a clinical intervention. Several papers have recently reported benefits of systemic leucocyte depletion during CPB. There is also evidence that leucocyte-depleted blood cardioplegia is advantageous in the globally ischaemic human heart transplant setting. Recently, a new leucocyte-depleting filter for blood cardioplegia has been developed (Pall, BC1). In this paper, we report on the safety and efficiency of this device in the clinical situation. Fourteen patients undergoing routine cardiac surgery were recruited into this study. The BC1 blood cardioplegia filter was found to be an efficient leucocyte-depleting device, removing in excess of 70% (p = 0.001) of white blood cells, on average, from up to 5.3 litres of blood cardioplegia. The filter removed a small proportion of platelets (typically 11.3%), however, this was not statistically significant and no bleeding problems were encountered. Red cell removal was negligible and was not statistically significant, and no evidence of haemolysis was noted. The filter offered a very low resistance to flow with a mean pressure drop (deltaP) of 10.8 mmHg at a mean flow rate of 315 ml/min. We conclude that the Pall BC1 filter is a safe and efficient device for use with blood cardioplegia.

Aged↗

Exogenous interferon delays luteal regression in red deer hinds (Cervus elaphus) by suppressing steroid-induced endometrial oxytocin sensitivity.

Three groups of intact hinds (n = 10-18) and one group of ovariectomized hinds were treated with progesterone by mean, of Controlled Internal Drug Releasing (CIDR) devices for 13 days (device removal = Day 0). Group 1 served as controls; group 2 received injections of 4 mg recombinant bovine interferon-alpha,1 twice daily from Days 13 to 21; group 3 was run with a stag from Days 0 to 3, and all hinds were subsequently diagnosed pregnant; group 4 (ovariectomized) was treated with CIDR devices and estradiol to mimic steroid secretion during the estrous cycle. Progesterone profiles were determined from thrice-weekly plasma samples from Days -13 to 28. Rectal temperature was measured in a subset of groups 1 and 2 from Days 9 to 21. Oxytocin-induced prostaglandin F2 alpha release was measured in a subset of groups 1, 2, and 4 on Days 2, 4, 10, 16, and 18. Data are presented as means +/- SEM. Exogenous interferon delayed luteolysis (> or = 28 vs. 21.2 +/- 0.55 days, P < 0.0005) and induced transient pyrexia after the first injection (39.89 +/- 0.11 vs. 38.88 +/- 0.19 degrees C, p < 0.0005). Incidence of oxytocin-induced PGF2 alpha release in control hinds was greater on Days 2 and 18 than on Days 4 and 10 (8/8 and 7/8 vs. 3/8 and 0/8, respectively; p < 0.05) and was greater in control than in interferon-treated hinds on Days 16 and 18 (5/8 and 7/8 vs. 1/8 and 1/8, respectively; p < 0.05). Profiles of plasma progesterone concentration and oxytocin sensitivity in steroid-treated ovariectomized hinds did not differ from those in control hinds. These results suggest that steroid-controlled uterine oxytocin sensitivity is important in luteolysis and is suppressed by the administration of interferon, the putative embryonic pregnancy recognition signal in red deer.

Administration, Intravaginal↗

Copper loss from the copper T model TCu22OC.

The effect of mineral deposits on the copper dissolution rate of the Copper T Model TCu22OC was examined. 118 Copper T22OC devices removed from subjects for various medical and personal reasons after 12 to 72 months in utero were examined and graded based on the proportion of the total copper area covered with mineral deposits. The deposits increased in average size during the first three years of IUD use and then remained relatively constant. Seventeen percent of the devices were in situ for four or more years. Copper analysis was performed on 30 Copper T 22OC devices from selected periods of use : 12-14, 22-26, 36-39 and 48-72 months of use. The mean daily copper loss was 29.4 micrograms and the range, 7.3 to 62.1 micrograms. An inverse correlation between the amount of mineral deposit on the copper surface and the rate of copper loss was observed.

Copper↗

Evidence for the use of the antibiotic lock technique.

Long-term central venous catheters are essential for the treatment of patients requiring long-term intravenous medications, blood product support, and total parenteral nutrition. Thrombosis and infection, complications commonly associated with the use of these devices, represent an important cause of morbidity and mortality. To reduce the incidence of device removal because of persistent central venous catheter-related infection, the novel use of a highly concentrated antibiotic "lock" solution instilled into the catheter lumen for a defined time has been explored. This technique has been successful in numerous small uncontrolled studies, suggesting that an antibiotic lock may be effective in salvaging infected central venous access devices. Currently, the Centers for Disease Control and Prevention Guidelines on the management of central venous access device infections support the use of this technique only for patients requiring long-term access who repeatedly experience catheter-related bloodstream infections despite stringent catheter care. Additional studies are warranted to support these preliminary data.

Anti-Bacterial Agents↗

Effectiveness of antibiotic removal by the antibiotic-binding blood culture systems.

The effectiveness of antibiotic removal by the BACTEC aerobic resin-containing blood culture medium (16B) and the Antimicrobial Removal Device (ARD) was compared for 12 antibiotics: ampicillin, cephalothin, cefoperazone, cefotaxime, moxalactam, nafcillin, gentamicin, tobramycin, azlocillin, mezlocillin, piperacillin, and ticarcillin. The ability to recover eight commonly encountered species of bacteria from antibiotic-containing serum by these two systems showed that recovery of antibiotic-exposed bacteria was dependent not only upon the amount and rate of the antibiotic removal but also upon the kinetics of bacterial killing by the antibiotic(s). The 16B medium had difficulty recovering organisms exposed to ticarcillin and moxalactam, whereas the ARD had difficulties with moxalactam and sometimes with cefotaxime and cefoperazone. Although neither system was able to recover all species of microorganisms tested, these in vitro results suggest that to use optimally these new culture systems, knowledge of the suspected pathogen(s), the amount and kind of antibiotic(s) administered, and the rate of bacterial killing by the antibiotic(s) is required.

Adsorption↗

Comparative clinical experience with 3 IUDs, TCu 380 Ag, TCu 220C and Mahua ring, in Tianjin, People's Republic of China.

A comparative study of three IUD models assigned at random was carried out at 5 hospitals in Tianjin. The experience of 2762 acceptors was analyzed by life table techniques. At the end of one year the net cumulative first segment pregnancy rates of the TCu 380Ag and the TCu 220C were 0.1 and 0.3 per 100, respectively, significantly below the 3.0 per 100 pregnancy rate of the Mahua double ring. The expulsion rate of the TCu 220C at the end of the first year, 1.6 per 100, was significantly lower than the expulsion rates of the other two devices. Removals for bleeding and pain cumulated to 3.3 per 100 at one year for users of the TCu 220C, significantly less than 6.8 per 100 for acceptors of the TCu 380Ag. Over all categories of termination, women who used the TCu 220C had the lowest one year termination rate, 5.5 per 100, while those who were assigned the Mahua device had the highest one year termination rate, 13.9 per 100.

Adult↗

Improved gas exchange performance of the intravascular oxygenator by active blood mixing.

The intravascular oxygenator and carbon dioxide removal device (IVOX; CardioPulmonics, Salt Lake City, UT) has been shown to perform 30% of the gas exchange in animals and patients with acute respiratory failure. Among the factors that limit gas exchange is the mass transfer resistance in the blood phase. To determine if a reduction in mass transfer resistance by mixing venous blood can enhance the O2 transfer and CO2 removal by IVOX, a right atrium-pulmonary artery venovenous bypass circuit was used in sheep to model the adult vena cava. A size 9 IVOX (894 fibers with 0.41 m2 surface area, n = 5) was incorporated in the bypass circuit and the blood flow controlled by a roller pump ranging from 1 to 4 l/min. An intra-aortic balloon was placed near the shaft of the IVOX and pulsated at the rate adjusted to best improve CO2 removal (100-120 bpm). O2 transfer and CO2 removal were measured with balloon pulsation on and off at different flow rates. Results showed that blood mixing by pulsation of the balloon caused a 25-49% increase in O2 transfer by IVOX, and this increase remained relatively constant throughout the full flow range. CO2 removal was also increased by up to 35%, but at flows between 3.5 and 4 l/min, the effect of mixing was diminished. It is concluded that reduction in the mass transfer resistance by blood mixing improves gas exchange. Because O2 is more diffusion limited, it is more dependent upon mixing of blood for gas exchange than CO2. More design improvements to incorporate active mixing may further enhance the gas exchange performance of IVOX.

Animals↗

Ex vivo model of an immobilized-enzyme reactor.

Immobilized-enzyme reactors are beginning to be studied for a variety of therapeutic applications. To facilitate the design of these devices for different clinical situations and a diverse patient population, mathematical models may be valuable. An immobilized-heparinase (EC 4.2.2.7) reactor was selected as a model system. The device removes heparin from blood that has been anticoagulated to prevent thrombus formation. Heparinase was immobilized to cross-linked agarose particles. A mathematical model was developed to describe the clearance of heparin by the reactor ex vivo and compared to experimental clearances measured in sheep. The model accounted for enzymatic degradation as well as the binding of heparin and its breakdown products to antithrombin. The device was modeled as a steady-state continuously stirred tank reactor. Molar conservation equations within the agarose particles accounted for simultaneous diffusion and chemical reaction. The model had no adjustable parameters and was able to predict the clearance of heparin within 5-25% for three different animals and 12 different perfusions.

Animals↗

Percutaneous transhepatic mechanical thrombectomy for acute mesenteric venous thrombosis.

PURPOSE: To present the management of symptomatic acute mesenteric venous thrombosis using a percutaneous thrombectomy device followed by resection of necrotic intestine. CASE REPORT: A 60-year-old woman developed acute abdomen and melena. Diffuse and extensive mesenteric and portal vein thromboses were diagnosed by computed tomography. Percutaneous transhepatic mechanical thrombectomy with an Oasis thrombectomy device removed approximately 80% of the thrombus in the portal and superior mesenteric veins. The patient underwent laparotomy immediately after thrombectomy, in which 100 cm of necrotic intestine was resected. Catheter-directed urokinase thrombolysis was performed for 3 days to address residual thrombi. The result was excellent, and the patient recovered without short bowel syndrome. CONCLUSIONS: The hydrodynamic thrombectomy system is a quick, reliable, efficient device that may offer an alternative to thrombolysis and surgical thrombectomy. Combining mechanical thrombectomy devices and surgery can be used to treat symptomatic acute mesenteric venous thrombosis.

Abdominal Pain↗

A new method of monitoring recovery and weaning the Thoratec left ventricular assist device.

BACKGROUND: Recent scientific and clinical data suggest that chronic mechanical ventricular unloading may lead to myocardial recovery. Evaluating and monitoring patients for myocardial recovery and the optimal methods of weaning the left ventricular assist device are not well defined. METHODS: Six patients with advanced heart failure and severe mitral regurgitation have undergone successful bridge to recovery using a Thoratec left ventricular assist device. Data that details their monitoring for myocardial recovery and weaning from the left ventricular assist device were prospectively collected. RESULTS: Clinical data collected during the recovery phase included chest roentgenogram, echocardiography, plasma norepinephrine, tumor necrosis factor-alpha, bioimpedance, and cardiopulmonary exercise testing (peak oxygen consumption). Normalization of these variables with a 10% increase in the peak oxygen consumption was obtained before weaning. The Thoratec device rate and percent systole were manipulated to allow gradual reloading of the ventricle. The weaning process occurred for more than 5 to 10 days to allow time for observation of the ventricle and its response to the increasing workload. CONCLUSIONS: Select patients with advanced congestive heart failure and severe mitral insufficiency can benefit from mechanical device support. We describe our technique of monitoring for myocardial recovery using clinical variables. Our technique of weaning allows for gradual reloading of the ventricle and a longer period of observation before device removal. Additional research is needed to determine which variables will accurately predict long-term myocardial recovery and the optimal weaning method.

Adult↗

Recovery of fertility and outcome of planned pregnancies after the removal of Norplant subdermal implants or Copper-T IUDs.

The recovery of fertility after discontinuation of NORPLANT implant use was assessed in ninety women who stated a desire for a new child at the time of removal. Three subjects were lost to follow-up after removal. The cumulative probability of conception in the remaining 87 women was 25, 49, 73 and 86 percent at one, three, six and twelve months after removal, respectively. Nine observations were censored either because of the use of a contraceptive method soon after removal of the implants (n = 7) or separation (n = 2). All other cases were pregnant at the end of two years with exception of three subjects where a male factor for infertility was present. There was no significant correlation between the length of NORPLANT use and the length of the interval from removal to conception. A significantly higher frequency of intervals longer than 6 months was observed among women older than 30 years as compared to younger women. Pathology during pregnancy was cholestasia (n = 5), hypertension (n = 1) and gestational diabetes (n = 1). The outcome was term delivery in 59 cases, premature delivery in 4 cases, and spontaneous abortion in 7 cases. One woman is still pregnant and the outcome is unknown in 4 cases. One premature infant died. A contemporary control group of Copper T users enrolled under the same criteria as NORPLANT implant users provided 44 women who had the device removed to become pregnant. The cumulative probability of pregnancy was 27, 69, 84 and 89 at one, three, six and twelve months and all were pregnant by the end of the second year. Six censored observations occurred because of the use of another contraceptive method after removal (n = 3) or loss to follow-up (n = 3). The outcome of pregnancy was term delivery in 23 cases and abortion in 7 cases. Recovery of fertility occurred at a normal rate after NORPLANT implant removal and the incidence of problems detected in the ensuing pregnancy were within the expected range for Chilean women.

Age Factors↗