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FDA notice relating to New England Compounding Center product recall
AST
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In a statement distributed Oct. 15 and revised Oct. 16, the U.S. Food and Drug Administration advised providers not to use any products distributed by the New England Compounding Center. The statement reports that on Oct. 6, NECC announced the recall of all its products, which include solutions used in organ recovery and transplantation as well as injections, some of which have been used to treat patients later considered for organ donation.
The OPTN/UNOS Disease Transmission Advisory Committee recommends that OPO staff should consider the possibility of recent potential exposure to NECC products in potential organ donors. The risk to recipients of organs from donors who have received affected products is unknown. The transplant team will need to consider the balance of risk and benefit for each potential recipient when making the decision to accept or decline an organ from these donors.
Related article:
FDA statement on fungal meningitis outbreak: Additional patient notification advised (U.S. Food and Drug Administration)
FDA warns about fungal meningitis in transplant patient who received NECC cardioplegia solution (Forbes)
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• We are an FDA licensed manufacturer.
• We label peptides, monoclonal antibodies, reagents, chemical and proteins for cancer treatments.
• Our above products can be labeled with radioisotopes such as I-125, I-131, P32, Tc99m, Y90 and AC-225. • We have a multicurie isotope license and an animal facility.
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AST launches new Institutional Support Program
AST
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Are you interested in receiving recognition and increased exposure for your transplant center? Do you support the future of transplantation and value the educational, networking, and research opportunities that the American Society of Transplantation (AST) provides to its members? If the answer to these questions is yes, please consider having your center participate in AST's Institutional Support Program.
With a charitable contribution of $3,000, your center will receive valuable benefits, including recognition through the year, and access to the AST membership. For more information or to make a contribution, click here. All donations are tax-deductible.
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Identify Antibodies That May Compromise Graft Survival
- Detect Presence of Complement Fixing Antibodies
- Investigate risk of developing Antibody Mediated Rejection (AMR)
Request a Complimentary Sample Kit! FREE SAMPLE
For Research Use Only. Not for use in diagnostic procedures.
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AST call for board nominations
AST
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Dr. Robert Gaston, AST Past President and Chair of the AST Awards and Nomination Committee, is pleased to invite nominations of qualified and dedicated individuals to serve on the AST Board of Directors. Open positions for the 2013-2014 Board include a one-year President-Elect term, and three Councilor-at-Large positions (each for three-year terms). The term of service will begin at the annual members business meeting scheduled for May 20, 2013 at the American Transplant Congress. For a nomination to be seriously considered by the committee, the nominee should have had significant involvement in, and service to the AST. The nominee should have demonstrated ability to think strategically, commit to working effectively within a collective decision-making body and have knowledge of or experience with governance. Please visit the AST website to submit a nomination. Completed nominations must be submitted by 5 P.M. Eastern time on Friday, Nov. 30. Late nominations will not be accepted. The final slate of candidates will be distributed to the membership for a vote prior to the 2013 ATC.
Thoracic and Critical Care Travel Awards for 2013 ATC
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We are pleased to announce that the Thoracic and Critical Care Community of Practice will offer two travel awards for the best abstract within the areas of cardio-thoracic transplantation and critical care medicine. Members with an interest in these areas are encouraged to submit abstracts to the 2013 ATC submission site. The abstract submission deadline is Nov. 30. To submit your abstract, please visit the 2013 ATC meeting website. The qualifications for the award can be viewed here.
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Submit your abstracts to AST's Cutting Edge of Transplantation by Oct. 31
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B Cells from Bedside to Bench to Bedside: A Comprehensive Look at B Cells and Antibodies in Transplantation With so many recent advances on the biology of B cells and with antibody-mediated rejection having become one of the major hurdles to long-term transplant survival, it is time for clinicians and basic scientists to join forces to solve the clinical problem using the most up-to-date knowledge and technologies.
View the full program and faculty list. Registration opens soon with 50 percent off deals if you register by Nov. 30!
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Genetic testing can be a cost-effective way to increase the number of living related donor transplants. Mutational analysis may help direct long-term treatment plans, including pre-operative screening of potential kidney transplant recipients and living related donors.
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✓ Hypothermic preservation of a single kidney using physiologic pulsatile preservation and membrane oxygenation: a proven technology from Waters Medical Systems (more than 40 years clinical experience)
✓ Simplifies the perfusion process (provides more options to view, chart, and trend data, offers web-based remote monitoring, and a transportable design)
✓ Meets or exceeds current FDA standards and AOPO and UNOS Preservation Guidelines.
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When it comes to saving lives, MNX understands organ transplant logistics. Every shipment is urgent, and every step critical. That’s why MNX offers specialty services that are tailored for organ transportation. From expedited ground service to charter flights, MNX has the proven experience and operational resources you can count on.
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Early post-transplant hospital readmission factors identified
Renal & Urology News
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Older kidney transplant recipients and those of African-American race are at significantly higher risk of early hospital readmission (EHR) after transplantation, a study found. In addition, EHR, defined as at least one hospital readmission to an acute care hospital within 30 days after discharge from initial kidney transplant, was significantly more likely among recipients of expanded criteria donor (ECD) kidneys, obese patients, those with diabetes or other comorbidities and those who had a longer initial hospital length of stay.
Related articles:
One-third of kidney transplant patient readmitted (Becker's ASC)
Improve outpatient management to cut readmissions (FierceHealthcare)
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Is it safe to withdraw steroids within 7 days of renal transplantation?
Clinical Transplantation (subscription required)
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Literature searches for all randomized controlled trials comparing VESW with steroid maintenance regimens were performed using MEDLINE, EMBASE and the Cochrane Library. Quality assessment was performed in each trial. Meta-analyses were performed to demonstrate the pooled effects of relative risk (RR) and weighted mean difference with 95 percent confidence intervals (CI).
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Cognitive performance as a predictor of hepatic encephalopathy in pretransplant patients with cirrhosis receiving psychoactive medications
Liver Transplantation (subscription required)
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Psychiatric disorders and medications may affect the cognitive performance of patients with cirrhosis and complicate the diagnosis and prediction of hepatic encephalopathy (HE). Researchers recently studied the association of psychoactive medications with cognitive performance and their effects on the ability of tests to predict HE development in patients with cirrhosis referred for transplant evaluation. Results indicate cognitive tests remain valid predictors of HE in the face of psychiatric diseases and medications.
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Decision-making in the face of end-stage organ failure: High-risk transplantation and end-of-life care
Current Opinion in Organ Transplantation (subscription required)
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Pediatric solid organ transplantation numbers have been increasing over the years. Research and the medical literature tends to focus on advancing the field and innovation — which often leads to higher risk and more complex procedures. How do we decide when it is too much — too much risk; too much uncertainty? Who makes that decision? Literature is scarce and usually focuses on end-of-life decision-making. This article does not purport to have the answers, but will highlight the depth and breadth of points that must be taken into consideration.
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Factors affecting long-term renal graft survival
Renal & Urology News
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Renal transplant patients who are female, younger, or receive a kidney from a living-related donor are significantly more likely to have a functioning renal allograft at 20 years, a study found. Absence of acute rejection also is associated with such long-term allograft survival.
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Solid-organ transplantation in older adults: Current status and future research
American Journal of Transplantation (subscription required)
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An increasing number of patients older than 65 years are referred for and have access to organ transplantation, and an increasing number of older adults are donating organs. Although short-term outcomes are similar in older versus younger transplant recipients, older donor or recipient age is associated with inferior long-term outcomes. This paper summarizes a recent trans-disciplinary workshop held by ASP, in collaboration with NHLBI, NIA, NIAID, NIDDK and AGS, to address issues related to kidney, liver, lung, or heart transplantation in older adults and to propose a research agenda in these areas.
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Comparison of communication and personal characteristics of living kidney donors and a matched quota sample
Clinical Transplantation (subscription required)
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Deceased organ donation does not meet the need for kidney transplants. Thus, it is important to examine topics relevant to kidney donors such as communication leading to the donation decision and donor characteristics. This study reports personal characteristics and communication leading to the decision to donate among living kidney donors and a demographically matched quota sample. Donors had higher scores for compassion, while non-donors reported more volunteerism.
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Preoperative prediction of the microvascular invasion of hepatocellular carcinoma with diffusion-weighted imaging
Liver Transplantation (subscription required)
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A recent study investigated whether diffusion-weighted imaging (DWI) could be useful in predicting the microvascular invasion (MVI) of hepatocellular carcinoma (HCC). Results indicate lower ADC values (1.11 × 10−3 mm2/second or less) can be a useful predictor of MVI during the preoperative evaluation of HCC.
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Prevention and treatment of coronary artery vasculopathy
Current Opinion in Organ Transplantation (subscription required)
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Cardiac allograft vasculopathy (CAV) is still one of the major causes of death following heart transplantation. The implementation of measures and lifestyles that help prevent CAV should be a priority of post heart transplantation management. Research should urgently evaluate mTOR inhibitors for the treatment of established CAV.
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Use of 13-valent pneumococcal conjugate vaccine and 23-valent pneumococcal polysaccharide vaccine for adults with immunocompromising conditions
Centers for Disease Control and Prevention
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On June 20, the Advisory Committee on Immunization Practices (ACIP) recommended routine use of 13-valent pneumococcal conjugate vaccine (PCV13; Prevnar 13, Wyeth Pharmaceuticals, Inc., a subsidiary of Pfizer, Inc.) for adults aged ≥19 years with immunocompromising conditions, functional or anatomic asplenia, cerebrospinal fluid (CSF) leaks, or cochlear implants (Table). This report outlines the new ACIP recommendations for PCV13 use; explains the recommendations for the use of PCV13 and PPSV23 among adults with immunocompromising conditions, functional or anatomic asplenia, CSF leaks, or cochlear implants; and summarizes the evidence considered by ACIP to make its recommendations.
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