Percutaneous closure of patent foramen ovale in patients with paradoxical embolism: long-term risk of recurrent thromboembolic events.
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BACKGROUND: Patients with a patent foramen ovale (PFO) and paradoxical embolism are at risk for recurrent thromboembolic events. This study investigated the long-term risk of recurrent thromboembolic events in patients with PFO and paradoxical embolism after percutaneous PFO closure. METHODS AND RESULTS: Since 1994, a total of 80 patients with PFO and at least 1 paradoxical embolic event (transient ischemic attack [TIA], cerebrovascular accident [CVA], peripheral embolism) have undergone percutaneous PFO closure with 5 different devices. There were 30 women and 50 men, with a mean age of 52+/-12 years. Sixty patients had only a PFO, whereas 20 patients had both a PFO and an atrial septal aneurysm. The implantation procedure was successful in 78 patients (98%). During 5 years of follow-up (mean, 1.6+/-1.4 years; range, 0.1 to 5.0 years), the actuarial annual risk to suffer a recurrent thromboembolic event was 2.5% for TIA, 0% for CVA, 0.9% for peripheral emboli, and 3.4% for the combined end point of TIA, CVA, or peripheral embolism. A postprocedural shunt was a predictor of recurrent paradoxical embolism (RR, 4.2; 95% CI, 1.1 to 17.8; P=0.03). The risk for recurrent thromboembolic events in patients with both atrial septal aneurysm and PFO was not significantly increased compared with patients with only PFO (RR, 1.0; 95% CI, 0.2 to 4.7; P=0.95). CONCLUSIONS: Percutaneous PFO closure appears to be a promising technique in the prevention of recurrent systemic thromboembolism in patients with a PFO after a first event. Prospective studies comparing percutaneous PFO closure with antithrombotic medications or surgery must define its therapeutic value. (+info)
Reinterventions after repair of common arterial trunk in neonates and young infants.
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OBJECTIVES: To determine rates of reintervention after repair of common arterial trunk in the neonatal and early infant periods. BACKGROUND: With improving success in the early treatment of common arterial trunk, the need for reinterventional procedures in older children, adolescents and adults will become an increasingly widespread concern in the treatment of these patients. METHODS: We reviewed our experience with 159 infants younger than four months of age who underwent complete primary repair of common arterial trunk at our institution from 1975 to 1998, with a focus on postoperative reinterventions. RESULTS: Of 128 early survivors, 40 underwent early reinterventions for persistent mediastinal bleeding or other reasons. During a median follow-up of 98 months (range, 2 to 235 months), 121 reinterventions were performed in 81 patients. Actuarial freedom from reintervention was 50% at four years, and freedom from a second reintervention was 75% at 11 years. A total of 92 conduit reinterventions were performed in 75 patients, with a single reintervention in 61 patients, 2 reinterventions in 11 patients and 3 reinterventions in 3 patients. Freedom from a first conduit reintervention was 45% at five years. The only independent variable predictive of a longer time to first conduit replacement was use of an allograft conduit at the original repair (p = 0.05), despite the significantly younger age of patients receiving an allograft conduit (p < 0.001). Reintervention on the truncal valve was performed on 22 occasions in 19 patients, including 21 valve replacements in 18 patients and repair in 1, with a freedom from truncal valve reintervention of 83% at 10 years. Surgical (n = 29) or balloon (n = 12) reintervention for pulmonary artery stenosis was performed 41 times in 32 patients. Closure of a residual ventricular septal defect was required in 13 patients, all of whom underwent closure originally with a continuous suture technique. Eight of 16 late deaths were related to reintervention. CONCLUSIONS: The burden of reintervention after repair of common arterial trunk in early infancy is high. Although conduit reintervention is inevitable, efforts should be made at the time of the initial repair to minimize factors leading to reintervention, including prevention of branch pulmonary artery stenosis and residual interventricular communications. (+info)
Effect of reresection in extremity soft tissue sarcoma.
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OBJECTIVE: To determine whether reresection affects survival in patients with inadequately resected, primary extremity soft tissue sarcoma. This study correlates reresection with local recurrence-free survival, metastasis-free survival, and disease-free survival. SUMMARY BACKGROUND DATA: Soft tissue sarcomas are rare neoplasms, with an incidence of approximately 6,000 per year in the United States. Because these tumors are rare and benign soft tissue tumors are common, many are initially thought to be benign and are excised without wide margins. METHODS: Patients who underwent treatment for primary tumors from July 1982 to June 1999 at a single institution were the subject of study. Two groups of patients were analyzed: those who underwent one definitive resection (one operation) and those whose tumors were previously resected and who were then referred for subsequent reresection (two operations). Patients were given adjuvant radiation or chemotherapy according to the standard of care. RESULTS: Of 1,092 patients with primary extremity soft tissue sarcoma underwent resection, 685 underwent definitive radical resection and 407 underwent reresection after undergoing excisional resection elsewhere. Median follow-up was 4.8 years. The 5-year disease-free survival rate of the definitive resection (one operation) group was 70%; that of the reresection (two operations) group was 88%. On multivariate analysis, reresection was adjusted and controlled for age, grade, depth, size, histology, and margins. Reresection remained a significant predictor of improved disease-free survival, even after these adjustments. To determine whether this difference was stage- or referral-biased, the patient population was divided by AJCC stage. In all stages there was a trend toward improved outcome; this was most marked for those with stage III disease (>5 cm, high-grade, and deep). CONCLUSIONS: Patients with extremity soft tissue sarcoma who undergo reresection with two "primary" operations have an improved survival compared with those who undergo one operation. The most plausible explanation, referral and selection bias, is questionable given the significance of reresection as a variable after adjusting for stage and other risk factors. This suggests that where indicated and possible, reresection should be liberally applied in patients with primary extremity soft tissue sarcoma. (+info)
Feasibility of hospital-based blood banking: a Tanzanian case study.
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The demand for blood transfusion is high in sub-Saharan Africa because of the high prevalence of anaemia and pregnancy related complications, but the practice is estimated to account for 10% of HIV infections in some regions. The main response to this problem by the international donor community is to establish vertically implemented blood transfusion services producing suitable (safe) blood at a cost of US$25-40 per unit. However, the economic sustainability of such interventions is questionable and it is argued here that hospital-based blood transfusion services operating at a basic adequate level are sufficient for low-income African countries. The results of a project aimed at improving such services in Tanzania are presented. The main findings are: (1) the cost per suitable blood unit produced was US$12.4; (2) at an HIV test sensitivity of 93.5% during the study period, discounted financial benefits of the interventions exceeded costs by a factor of between 17.2 and 37.1; (3) the cost per undiscounted year of life saved by use of these interventions was US$2.7-2.8; and (4) safe blood transfusion practices can be assured at an annual cost of US$0.07 per capita. Recommendations are made to ensure safe blood transfusion practices at hospital-based blood banks in Tanzania. (+info)
Unrelated donor bone marrow transplantation as treatment for chronic myeloid leukemia: the Spanish experience. The Chronic Myeloid Leukemia Subcommittee of the GETH. Grupo Espanol de Trasplante Hemopoyetico.
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BACKGROUND AND OBJECTIVE: To analyze the results of unrelated bone marrow transplantation (UDBMT) as treatment for chronic myeloid leukemia (CML) in Spain. DESIGN AND METHODS: Eighty-seven consecutive UDBMT performed in 9 centers between October 1989 and February 1998 were evaluated. This represents more than 95% of UDBMT for CML performed in adult transplant centers in Spain during this period. The patients' median age was 31.5 years (range, 12-49). The median interval from CML diagnosis to UDBMT was 30 months (range, 3-160). Seventy-nine percent of transplants were performed during the first chronic phase (1CP). RESULTS: Actuarial probability of survival and disease-free survival at 4 years for the whole series was 24% (95% confidence interval [CI]: 14%-34%) and 20% (CI: 10%-30%), respectively. The cumulative incidence of relapse and transplant-related mortality (TRM) was 7% (CI: 4%-10%) and 71% (CI: 60%-82%), respectively. The main causes of death were graft failure (n=7), infection (n=23), and graft-versus-host disease (GvHD) (n=25). The actuarial probability of acute GvHD grade II-IV and grade III-IV was 56% (CI:46%-66%) and 36% (CI: 26%-36%), respectively. The cumulative incidence of extensive chronic GvHD was 18% (CI: 9%-27%). Univariate analyses showed that the pre-transplant factor with the highest influence on survival was disease status at transplant (30% in 1CP vs. 0% in advanced phases; p=0.0001). Other pre-transplant factors influencing survival among patients in 1CP were: patient's age (older than 30 years 11% vs. 48%), interval diagnosis-transplantation (longer than 2 years 17% vs. 55%), donor type (HLA, B, DRB1 identical 32% vs. 25%), CMV serologic status (donor and recipient negative 63% vs. 24%), year of transplantation (before 1995 19% vs. 40%), and conditioning regimen (cyclophosphamide plus total body radiation 40% vs. 16%). The main risk factors had a cumulative effect on survival. Thus, probability of survival ranged from 66% (CI: 39%-93%) in patients in 1CP, under 40 years of age, transplanted from an HLA, A, B, DRB1 identical donor during the first two years after diagnosis, to 0% in those with three or more risk factors. INTERPRETATION AND CONCLUSIONS: This experience shows that UDBMT used to have a high TRM that has progressively decreased along the years. At the present time, the results are encouraging, particularly when UDBMT is performed under favorable conditions. (+info)
Developing a clinically useful actuarial tool for assessing violence risk.
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BACKGROUND: A new actuarial method for violence risk assessment--the Iterative Classification Tree (ICT)--has become available. It has a high degree of accuracy but can be time and resource intensive to administer. AIMS: To increase the clinical utility of the ICT method by restricting the risk factors used to generate the actuarial tool to those commonly available in hospital records or capable of being routinely assessed in clinical practice. METHOD: A total of 939 male and female civil psychiatric patients between 18 and 40 years old were assessed on 106 risk factors in the hospital and monitored for violence to others during the first 20 weeks after discharge. RESULTS: The ICT classified 72.6% of the sample as either low risk (less than half of the sample's base rate of violence) or high risk (more than twice the sample's base rate of violence). CONCLUSIONS: A clinically useful actuarial method exists to assist in violence risk assessment. (+info)
Risk assessment in patients with Ph+ chronic myelogenous leukemia at first relapse after allogeneic stem cell transplant: an EBMT retrospective analysis. The Chronic Leukemia Working Party of the European Group for Blood and Marrow Transplantation.
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Patients with Ph+ chronic myelogenous leukemia who relapse after a first allogeneic stem cell transplant still have a possibility of long-term survival. To assess the value of the individual therapeutic options, the factors predicting outcome should be identified. We investigated data from 500 patients who relapsed before July 1996; follow-up was updated during 1998. The actuarial survival from relapse was 34.2% (95% confidence interval [CI]: 29. 9%-38.5%) at 5 years and 23.4% (95% CI: 18.9%-27.9%) at 10 years. Survival after relapse was significantly related to 5 factors: time from diagnosis to transplant (< 2 years vs >/= 2 years), disease phase at transplant (first chronic phase vs other), disease stage at relapse (cytogenetic or chronic phase vs advanced phase), time from transplant to relapse (< 1 year vs >/= 1 year), and donor type (HLA-identical sibling vs volunteer unrelated donor). The effects of individual adverse risk factors were cumulative: The probability of survival at 10 years decreased stepwise from 42% (0 factors), 32% (1 factor), 14% (2 factors), 3% (3 factors), to 0% (4 or 5 factors). Novel strategies for high-risk patients are warranted. We conclude that these 5 factors should be taken into account when comparing results of salvage therapies in patients with Ph+ chronic myeloid leukemia relapsing after allogeneic stem cell transplant. (+info)
Tacrolimus (FK506) and methotrexate as prophylaxis for acute graft-versus-host disease in pediatric allogeneic stem cell transplantation.
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Currently, limited data exist on the role of tacrolimus (FK506) in pediatric allogeneic marrow transplantation. Forty-one patients who received tacrolimus as prophylaxis were reviewed, with a median age of 9 years (range 0.2-16 years). Twenty-one patients underwent related donor transplants and 20 underwent unrelated donor transplants. All patients received tacrolimus beginning the day prior to transplant at a dose of 0.03 mg/kg/day by continuous i.v. infusion. When clinically possible, patients were switched to oral therapy in two divided doses, at four times the intravenous dose. Tacrolimus levels were monitored twice a week, and dosages adjusted to maintain serum levels 5-15 ng/ml. Common adverse effects included hypomagnesemia (98%), hypertension (49%), nephrotoxicity (34%), and tremors (32%). Less common side-effects (<10% cases) included seizures and hyperglycemia. The median time to ANC recovery (ANC >500 x 106/l) was 15 days. For the related donor group, the incidence of grade II-IV acute GVHD was 33%, and grade III-IV GVHD 19%. For the unrelated donor group, the incidence of grade II-IV acute GVHD was 55%, and grade III-IV GVHD 30%. Overall, tacrolimus therapy was well tolerated as prophylaxis for acute GVHD in pediatric patients undergoing allogeneic transplantation. (+info)