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Blood saving program: a multicenter Italian experience.

To assess the causes of failure in a blood saving program and the consequent need for homologous transfusions during major orthopedic surgery, data were collected from six orthopedic centers where an autotransfusion program was carried out from 1992-1994. The 1,576 (1,016 female and 560 male) patients studied (average age 63.6 +/- 10 years) were treated either for total hip prosthesis (1,144 pts) total knee prosthesis (212 pts), plate and screw removal plus hip prosthesis (8 pts), hip revision (cup 48 pts, stem 10 pts, cup plus stem 146 pts) and total knee revision (8 pts). Ninety percent of patients did not undergo homologous transfusions, which was significantly connected to: male sex (8% versus 11.7% p = 0.02), younger age (63.2 vs 66.9 years, p = 0.0001), higher weight (male 76 vs 70.7 Kg. p = 0.003, female 65.6 vs 61.9 Kg. p = 0.0003); higher baseline Hb (13.9 vs 12.8 g/dl, p = 0.0041), shorter operation time (110 vs 128 minutes, p = 0.0001); use of indobufen for antithromboembolic prophylaxis (indobufen 4.6% vs heparin calcium 15.2% vs low molecular weight heparin 9% p = 0.0001). On the contrary, the factors favoring homologous transfusions were: peripheral anesthesia (spinal and epidural 15.3% vs general 9.3% vs integrated 9.8% p = 0.016), total hip or knee revision, fixation device removal before hip prosthesis, systemic hypertension and coronary heart disease.

Aged↗

Long term effect on IOP of a stainless steel glaucoma drainage implant (Ex-PRESS) in combined surgery with phacoemulsification.

AIM: To evaluate the efficacy and safety of a stainless steel miniature glaucoma drainage device (Ex-PRESS R50) for the surgical treatment of primary open angle glaucoma (POAG) and cataract when combined with phacoemulsification. METHODS: Clinical, prospective, multicentre, single treatment arm, non-randomised, non-masked study. The Ex-PRESS device was implanted at the limbus under a conjunctival flap. Phacoemulsification cataract extraction and in the bag IOL implantation were performed through clear cornea temporally. PRIMARY OUTCOME: IOP change; secondary outcomes: side effects and VA changes. RESULTS: 26 eyes of 25 patients were implanted with the device. The mean (SD) follow up was 23.9 (10.4) months and the mean age was 75.1 (7.1) years. 17/26 eyes have more than 3 years of follow up. One case was discontinued because of device removal, one because of death, and three were lost to follow up. EFFICACY: preoperative IOP was 21 (4) mm Hg; at 1, 2, and 3 years IOP was 15.3 (3.1) mm Hg (35% reduction), 16.6 (2.7) mm Hg (29% reduction), and 16 (2.6) mm Hg (22% reduction) respectively. Kaplan-Meyer determined overall success rate (IOP < or = 21 mm Hg at the last visit with or without medications) as 76.9%. The number of antiglaucoma medications was reduced by 95% at year 1. Only six patients (23%) were taking IOP lowering treatment at their last visit, five with one medication and one with two medications. Side effects: early postoperative complications were clinically mild and included six cases of hypotony (IOP <5 mm Hg), three cases of hyphaema (<2 mm) with no clinically significant further effects. Long term complications were two cases (7.7%) of device rotation (one treated by reposition) and three cases (11.5%) of conjunctival erosion at 2 and 3 years. CONCLUSIONS: The Ex-PRESS implant, combined with phacoemulsification cataract extraction, is clinically safe and effective, maintaining in the long term a large reduction in IOP and in the number of antiglaucoma medications.

Aged↗

Flow rate dependent ex vivo deheparinization with immobilized cationic ligand.

The Heparin Removal Device is a deheparinization system that provides a good alternative when adverse reaction to protamine is suspected or when a heparin coated device is employed for cardiopulmonary bypass. In a bovine model, after systemic heparinization with 300 IU/kg body wt, the authors investigated the rate of deheparinization using this plasmapheresis system that allows exposition of heparinized plasma to an immobilized cationic ligand. Blood was shunted through a heparin coated veno-venous circuit to the plasma separator at a flow rate of 500 ml/min (n = 3, body wt 68 +/- 4 kg) or 1,000 ml/min (n = 3, body wt 57 +/- 4 kg). All plasma separators remained patent without any failure of the devices. Blood samples were drawn at regular intervals for coagulation parameters. The evolution of the activated coagulation time (ACT) was measured during the first 60 min of the deheparinization procedure, and results were compared with spontaneous evolution in a control group (n = 3, body wt 73 +/- 5 kg) without reversal of heparinization. After heparin administration, mean ACT was longer than 1,000 sec in the three groups. Fifteen minutes later it was still > 1,000 sec in the control group, whereas it was 427 +/- 8 sec in the slow flow group (500 ml/min) and 340 +/- 26 sec in the high flow group (1,000 ml/min). At 30 min it was 1,000, 367 +/- 26, and 200 +/- 24 sec, respectively, in the three groups. A regression curve was calculated for each group, and areas under the curves were compared. Ex vivo deheparinization was efficient in normalization of ACT, but removal of heparin appeared to be flow rate dependent. Increased blood flow from 500 to 1,000 ml/min across the deheparinization system resulted in significant acceleration of ACT normalization (p < 0.05).

Animals↗

Technique for removal of left ventricular assist devices.

As the use of long-term implantable left ventricular assist devices increases, more surgeons will be required to remove the devices for transplantation or in the event of infection. We outline several maneuvers that facilitate device removal and several pitfalls that complicate the procedure. Important considerations include preventive measures at the time of device implantation and prevention of air embolism.

Embolism, Air↗

The monoblock appliance.

While the use of this appliance would appear to require relatively litlle operative time, it must be clearly understood that the function of this appliance is not as predictable as that of other types of removable devices. Under such circumstances, it is of great importance to ensure that a correct diagnosis and evaluation of the original condition has been made relative to the listed criteria; all factors must be considered and no diagnosis should be made purely and simply on the basis of an obvious increase in overjet and a class II malocclusion. In addition, the personality and nature of the patient is of paramount importance, since it is his cooperation and interest that in the end will lead to successful therapy.

Acrylic Resins↗

Acute and temporary ventricular support with BioMedicus centrifugal pump.

BACKGROUND: Short-term ventricular and pulmonary support can be provided by the Medtronic BioMedicus (Eden Prairie, MN) centrifugal pump, which is available in most cardiovascular surgery centers. This versatile pump can provide support during cardiopulmonary resuscitation, cardiopulmonary bypass, extracorporeal membrane oxygenation, and ventricular assistance. A common use of the pump is to provide ventricular assistance for patients after cardiotomy or cardiogenic shock. METHODS: From January 1986 to September 1995, 141 patients at The Methodist Hospital in Houston, Texas were placed on the BioMedicus centrifugal pump after postcardiotomy cardiac failure. Patient treatment and postimplant complications are discussed. RESULTS: Fifty-four percent of the patients were weaned; however, only 22% survived to discharge. There was a very high mortality rate in the early stage after support was discontinued, after weaning, and after device removal. CONCLUSIONS: A high incidence of complications and death is likely related to the period of attempted weaning from cardiopulmonary bypass before the initiation of ventricular support. When weaning a patient from the pump during cardiopulmonary bypass or during ventricular assistance, it is important to optimize preload, after-load, ventricular function, and cardiac rhythm. In patients who have had postcardiotomy support, avoiding fluid overload, low colloid oncotic pressure, hypoperfusion, and use of excessive inotropic and vasoactive medications improve results.

Adolescent↗

Blood purification for hypercytokinemia.

Blood purification has been steadily improved in the field of critical care, supported by advances in related biomedical technologies as well as efforts to develop better operating procedures. As it has become clear that hypercytokinemia plays a key role in the pathophysiology of critical pathological conditions, use of various blood purification techniques to control hypercytokinemia has been investigated. Answers to questions concerning the optimal cytokine-removing device (dialyzer/hemofilter/adsorber) as well as operating procedures and conditions of such devices in particular clinical conditions have been obtained in the course of such investigations. The recent success in real-time monitoring of cytokine levels in clinical practice to assess the extent of cytokine network activation may improve the precision and efficacy of blood purification in the treatment of hypercytokinemia. In addition, the recently documented effects of genetic factors on hypercytokinemia suggest that the introduction of tailor-made medicine considering the differences in genetic background among individual patients may improve the efficacy of blood purification as a countermeasure to hypercytokinemia.

Blood Component Removal↗

Evaluation of a new method for silver point removal.

A new device for removing silver points was evaluated. The instrument consists of a trepan bur to expose the end of the silver point and a hollow tube which fits over the exposed tip and is bonded to it with cyanoacrylate adhesive. Twenty groups with 10 extractors and silver points in each group were tested for adhesive strength with respect to overlap between extractor and silver point, snugness of fit, and setting time of the adhesive. The adhesive strengths were evaluated using the Instron Universal Testing Machine. Adhesive strengths of 2 to 5 kg were readily achieved, and such adhesion should be adequate under typical clinical conditions for silver point removal. The amount of overlap (in the range of 1 to 3 mm) and snugness of fit were significant in relation to adhesive strengths. A setting time of 5 min was adequate for maximum bonding, except when there was loose fit between the extractor and the silver point. Clinically, the device appears to be an effective method for silver point removal.

Adhesiveness↗

Comparison of extraction devices for the removal of supraglottic foreign bodies.

OBJECTIVE: By using a porcine model, the efficacy of various extraction devices for airway foreign body removal was examined. METHODS: The upper airways of euthanized swine were occluded with a rubber ball, glass marble, or grape. A Magill forceps, a spongestick forceps, and a nasal trumpet attached to suction were used by test subjects for foreign body removal. Extraction success and time were recorded for each removal attempt. Satisfaction scores were recorded for each foreign body and device combination. RESULTS: Seven paramedics, seven residents, and seven attending physicians participated. A total of 189 attempts were analyzed. Success rates for foreign body extraction with Magill and spongestick forceps were similar, with both devices superior to nasal trumpet (98% and 97% vs. 83%, respectively, p < 0.001). For successful ball removal attempts, the mean extraction time with spongestick forceps was less than those for both Magill forceps and nasal trumpet: 12.4 (95% confidence interval [CI], 10-14.7) versus 23.4 (95% CI, 16.3-30.3) and 21.2 (95% CI, 14.2-28.3) seconds, respectively. For marble removal, the mean extraction time with spongestick forceps also was less than Magill forceps and nasal trumpet: 10.8 (95% CI, 8.7-12.8) versus 18.4 (95% CI, 12.8 to 23.8) and 16.7 (95% CI, 12.6-20.8) seconds, respectively. For grape removal, the mean extraction times with both spongestick and Magill forceps were less than that of nasal trumpet: 11.8 (95% CI, 7.1 to 16.4) and 8.1 (95% CI, 6.8-9.4) versus 15.6 (95% CI 10-21.2) seconds, respectively. Subjects preferred the spongestick forceps for removal of the glass and rubber ball to the Magill forceps and nasal trumpet. CONCLUSION: In this porcine model, the SF appeared to be the most efficient and preferred device for extracting the type of airway foreign body that is associated with fatal asphyxiation.

Airway Obstruction↗

Can patients treat themselves with a small novel light based hair removal system?

BACKGROUND AND OBJECTIVES: This study was designed to evaluate the safety and effectiveness of a small, low energy light based system for hair removal, when used by non-healthcare professionals ("patients") for self treatment in home-like environment following instructions and guidance provided by a physician. STUDY DESIGN/MATERIALS AND METHODS: A total of 73 patients between the ages of 19 and 54 years with skin types I through IV were enrolled in the study out of which 67 completed the study. Two treatment sites were chosen from among the arms, axilla, legs, bikini, back, belly, chest or face. The hair on the sites was trimmed and photographed. Each patient performed two self-treatments, using the hair removal device on their designated body sites, under the Investigator's direction. The first self-treatment was performed at the Investigator's office by the patient while the second self-treatment was performed 4 weeks later at a hotel room, simulating the home environment. Follow-up visits to evaluate the safety and efficacy of the treatments were performed 2 and 12 weeks following the last self-treatment. RESULTS: The mean hair reduction was 33.6%, 4 weeks after the first self-treatment, 44.3%, 2 weeks following the last self-treatment, and 32.3%, 12 weeks following the last treatment. All the noted side effects were mild and transient. Transient erythema was noted in 47.5% of the patients. Other transient side effects reported include edema (5%), hyperpigmentation (4.75%), crusting (2.35%), hypopigmentation (1.55%), and blistering (1.4%). All noted side effects were resolved by the 12-week follow-up visit. CONCLUSIONS: With adequate training and instruction, patients may administer self-treatments for hair removal with this small light based unit in a safe and effective manner.

Adult↗

Outcomes of congenital heart surgery patients after extracorporeal life support at Texas Children's Hospital.

The objective of this study was to investigate the outcomes of children with heart failure of various etiologies requiring temporary use of currently available technology in the U.S.A. after extracorporeal life support (ECLS) [left ventricular assist device (LVAD) or extracorporeal membrane oxygenation (ECMO)] at Texas Children's Hospital. Between July of 1995 and October of 2002, 2847 patients underwent congenital heart surgical repairs with the aid of cardiopulmonary bypass at Texas Children's Hospital. During this period, 17 patients required chronic mechanical circulatory assistance with Biomedicus centrifugal pump (n=8) or Thoratec LVAD (n=4), and ECMO (n=5). Six out of 17 patients required ECLS for postcardiotomy heart failure. Seven of the 17 patients had congenital heart disease, six had cardiomyopathy, three had late acute rejection following heart transplantation, and one had myocardial infarction. Twelve patients survived and five patients expired. Six of 12 survivors recovered sufficient cardiac function to allow device removal; and the remaining six patients underwent heart transplantation. Three out of five deaths were ECMO patients. The need for ECLS following repair of congenital heart disease is extremely rare in our institution. The requirement for the use of ECMO confers a significantly higher mortality presumably because of associated combined cardiopulmonary failure. Congenital heart disease appears to be associated with significantly higher mortality.

Adolescent↗

IVOX with gradual permissive hypercapnia: a new management technique for respiratory failure.

IVOX (intravenous oxygenator and CO2 removal device) augments venous gas exchange in patients with severe respiratory failure. Controlled hypoventilation with permissive hypercapnia reduces airway pressures during mechanical ventilation and augments CO2 exchange through the IVOX. To quantify the additive effects of gradual permissive hypercapnia and IVOX on gas exchange and reduction of airway pressures, 13 adult sheep underwent tracheostomy and severe smoke inhalation injury. Seven were mechanically ventilated alone (control), and six had mechanical ventilation, systemic anticoagulation, and implantation of IVOX (size 7 with 0.21-m2 surface area) (IVOX group). Both groups were anesthetized and paralyzed for 24 hr. In the IVOX group, minute ventilation was decreased in a stepwise fashion to produce a gradual increase in PaCO2, from 30 to 95 mm Hg, over 12 hr, and then sustained for an additional 12 hr. Sodium bicarbonate was given intravenously as necessary to keep arterial pH above 7.25. There were no significant differences in mean arterial pressure, cardiac output, or pulmonary artery pressure between the two groups. In the IVOX/permissive hypercapnia group, IVOX CO2 removal increased as a linear function of PaCO2 (y = 0.87x + 8.99, R2 = 0.80). IVOX CO2 removal was only 40 ml/min at normocapnia (40 mm Hg) but increased to 91 ml/min when PaCO2 was 95 mm Hg. Both peak inspiratory pressure and minute ventilation of the IVOX/permissive hypercapnia group were significantly lower than the control group, 30 +/- 4 mm Hg vs 51 +/- 3 mm Hg and 3.9 +/- 0.3 liters vs 8.4 +/- 0.5 liters (P < 0.05) respectively.(ABSTRACT TRUNCATED AT 250 WORDS)

Acute Disease↗

Ventricular assist device support in patients with mechanical heart valves.

BACKGROUND: Due to potential thromboembolic complications, mechanical valves within the native heart are often considered contraindications to ventricular assist device (VAD) support. METHODS: A retrospective review of VAD cases between June 1982 and March 1998 showed 8 patients with mechanical valves who were supported with Thoratec (Pleasanton, CA) VADs. RESULTS: There were 6 males and 2 females ranging in age from 20 to 69 years (mean 49.8+/-5.6). Four patients were supported when they could not be weaned from cardiopulmonary bypass after reparative procedures and were thought to have reversible injuries. Four patients were supported as a bridge-to-cardiac transplantation. Two patients had mechanical mitral valves, 2 had aortic valve replacements, 1 had an aortic homograft and mechanical mitral valve, 2 had mechanical aortic and mitral prosthesis, and 1 patient had aortic, mitral, and tricuspid valves. The types of valvular prostheses were St. Jude (5 patients) and Bjork-Shiley (3 patients). Duration of support ranged from 3.0 to 150 days (mean 34 days). Four patients were supported with biventricular assist devices and 4 had left VADs. Dextran and intravenous heparin anticoagulation were used in the shorter duration patients, with warfarin being used in the bridge patients. One patient received warfarin and aspirin. At the time of autopsy or device removal, only 1 of the 12 mechanical intracardiac valves showed any evidence of thrombosis, including the aortic valves in 2 patients supported for 2 and 5 months. There were no clinical thromboembolic events. Four patients (50%) were discharged (1 weaned, 3 transplanted). CONCLUSIONS: The 50% (4 of 8) survival rate compares favorably with the 44% (41 of 92) overall survival rate for our Thoratec patients (bridge plus recovery) who did not have mechanical prosthetic valves. These data suggest that patients with mechanical intracardiac valves can be supported for short durations with some additional risk, which is yet to be determined.

Adult↗

Multicenter clinical evaluation of the HeartMate vented electric left ventricular assist system in patients awaiting heart transplantation.

BACKGROUND: Despite advances in heart transplantation and mechanical circulatory support, mortality among transplant candidates remains high. Better ways are needed to ensure the survival of transplant candidates both inside and outside the hospital. METHODS: In a prospective, multicenter clinical trial conducted at 24 centers in the United States, 280 transplant candidates (232 men, 48 women; median age, 55 years; range, 11-72 years) unresponsive to inotropic drugs, intra-aortic balloon counterpulsation, or both, were treated with the HeartMate Vented Electric Left Ventricular Assist System (VE LVAS). A cohort of 48 patients (40 men, 8 women; median age, 50 years; range, 21-67 years) not supported with an LVAS served as a historical control group. Outcomes were measured in terms of laboratory data (hemodynamic, hematologic, and biochemical), adverse events, New York Heart Association functional class, and survival. RESULTS: The VE LVAS-treated and non-VE LVAS-treated (control) groups were similar in terms of age, sex, and distribution of patients by diagnosis (ischemic cardiomyopathy, idiopathic cardiomyopathy, and subacute myocardial infarction). VE LVAS support lasted an average of 112 days (range, < 1-691 days), with 54 patients supported for > 180 days. Mean VE LVAS flow (expressed as pump index) throughout support was 2.8 L x min(-1) x m(-2). Median total bilirubin values decreased from 1.2 mg/dL at baseline to 0.7 mg/dL (P =.0001); median creatinine values decreased from 1.5 mg/dL at baseline to 1.1 mg/dL (P =.0001). VE LVAS-related adverse events included bleeding in 31 patients (11%), infection in 113 (40%), neurologic dysfunction in 14 (5%), and thromboembolic events in 17 (6%). A total of 160 (58%) patients were enrolled in a hospital release program. Twenty-nine percent of the VE LVAS-treated patients (82/280) died before receiving a transplant, compared with 67% of controls (32/48) (P <.001). Conversely, 71% of the VE LVAS-treated patients (198/280) survived: 67% (188/280) ultimately received a heart transplant, and 4% (10/280) had the device removed electively. One-year post-transplant survival of VE LVAS-treated patients was significantly better than that of controls (84% [158/188] vs 63% [10/16]; log rank analysis P =.0197). CONCLUSION: The HeartMate VE LVAS provides adequate hemodynamic support, has an acceptably low incidence of adverse effects, and improves survival in heart transplant candidates both inside and outside the hospital. The studies of the HeartMate LVAS (both pneumatic and electric) for Food and Drug Administration approval are the only studies with a valid control group to show a survival benefit for cardiac transplantation.

Cohort Studies↗

Transpedicular fixation of thoracolumbar vertebral fractures.

The most frequent surgical treatment of thoracolumbar fractures is still the Harrington rod system despite some adverse effects, the most serious being the locking of five to seven segments. The new pedicular fixation modifications suggested by Magerl and Dick lock only two segments and give far better stability of the fractures. Used internally, the system is convenient for the patient, permitting early mobilization, often without any external support. The instrument, called the "posterior segmental fixator" (PSF), is used both as a reduction device and as a fixation device. The injured vertebra is grafted through the pedicle, giving security against late collapse after device removal. Twenty patients treated with this method had an average follow-up period of ten months. The primary reduction attains 88% of the calculated height of the injured vertebra, with only a few percent loss during follow-up time. Clearance of fragments in the spinal canal, diagnosed with computed tomography scan in eight patients, was successfully accomplished in all but one, with only distraction or reduction of the fragment through a limited laminotomy. The instrumentation in these cases was lateral to the dura. Nine patients with neurologic deficits improved and could walk without support or with crutches within a few months. One patient with complete paraplegia remained unchanged.

Adolescent↗

Safety and acceptability of post-abortal IUD insertion and the importance of counseling.

This nonrandomized observational clinical study evaluated the safety and acceptability of intrauterine device insertion either immediately or 2 weeks after abortion, according to the patient's preference. Participants were 300 women with first-trimester abortions who agreed to immediate or delayed insertion. End points were bleeding patterns, pregnancy, expulsion, perforation, infection and device removal at 2, 6 and 10 weeks after insertion, and acceptance rates before and after counseling procedures were improved. The overall initial acceptance rate was 35.8%, and the actual acceptance rate was 31.7%. After counseling procedures were improved, the initial and actual acceptance rates increased substantially (17.7% vs. 44.3% and 10.2% vs. 42.0%, respectively). Bleeding, expulsion rates and pain did not differ significantly between the immediate and delayed insertion groups after IUD insertion. No pregnancies, perforations or cases of pelvic inflammatory disease were recorded in either group. Immediate post-abortal insertion offers the advantage of being a painless procedure. The quality of counseling is critical to improving acceptance of post-abortion contraception.

Abortion, Induced↗

Short- and long-term mechanical ventricular assistance towards myocardial recovery.

Long-term LVADs are primarily used as a bridge to transplantation because cardiac transplantation currently offers a better long-term outlook for most patients. Some patients will not get the opportunity for transplantation due to organ shortages and long waiting lists, however, and alternate care strategies must be considered. LVAD weaning and explantation may be an appropriate course of action for patients who have IDC and in whom transplantation is not the optimal therapy. The data demonstrate that LVAD weaning may be performed successfully in selected patients with IDC, and that transplantation may be delayed or avoided altogether; however, VAD weaning is not without its risks. Many of the patients have demonstrated recurrence of heart failure at various times after undergoing device removal. Through proper monitoring, most of these patients can be identified early enough to be relisted for transplantation, although some will require reinsertion of an LVAD while waiting. The critical steps in establishing a successful VAD weaning program are proper patient selection, ventricular unloading in the early stages, the institution of heart failure medications, frequent monitoring for ventricular recovery, and a period of ventricular retraining before explantation. In addition, the surgeons must be able to perform the explantation procedure with a low operative mortality. As experience with LVAD weaning and explantation grows, we may be able to better predict which patients may be successfully treated without resorting to transplantation. Explantation may eliminate, or safely delay, the need for cardiac transplantation. Although it is unlikely that these patients will be studied in a randomized fashion, the collection of accurate and complete data may allow us to establish a database that can answer many of today's questions.

Female↗

Return of fertility after discontinuation of depot medroxyprogesterone acetate and intra-uterine devices in Northern Thailand.

796 Thai women who stopped using the long-acting injectable contraceptive 'Depo-Provera' (medroxyprogesterone acetate) and 125 women who had an intra-uterine device removed to have a planned pregnancy were followed-up to ascertain the delay between conception and the end of contraception, and to determine the proportion of women who did not conceive in the 2 years after discontinuation. The median delay before conception was 5.5 months plus the estimated duration of the effect of the last injection of depo-provera and 4.5 months after discontinuing the IUD. Since depo-provera acts for approximately 15 weeks, women can except a median delay to conception of around 9 months after their last injection. The proportions of women who did not conceive within 1 year and within 2 years of stopping contraception by the two methods were similar. There was no evidence to suggest that prolonged use of depo-provera increases the delay before conception, and the return of fertility among never pregnant ex-users resembled that of ever pregnant ex-users.

Delayed-Action Preparations↗