Surgery News - May 2008 - (Page 3)

M AY 2 0 0 8 • SURGERY NEWS NEWS Heparin Contaminant Linked With Adverse Reactions The contaminant now has been identified in heparin products in the U.S. and 10 other countries. B Y E L I Z A B E T H M E C H C AT I E Else vier Global Medical Ne ws link between oversulfated chondroitin sulfate and the serious adverse events associated with heparin has been established, the Food and Drug Administration announced on April 21 in a briefing that provided an update on the agency’s ongoing investigation. Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, said that there is a “solid, mechanistic link” between oversulfated chondroitin sulfate (OSCS)—identified by the agency in March as the heparinlike contaminant—and the types of adverse reactions associated with heparin products that have been reported to the FDA. A spike in reports of allergic reactions or cases of hypotension in people who received heparin, including fatal cases, was first noted in November 2007 and continued through February 2008, prompting Baxter Healthcare Corp. to recall single-dose and multidose heparin vials, and HEP-LOCK heparin flush products in February. Dr. Woodcock explained that animal data and in vitro testing indicate that the contaminant can trigger events that would lead to these types of reactions, based on changes in “blood mediators.” The findings will be published soon in a peer-reviewed journal, she said. When the FDA announced in March that the heparinlike contaminant identified in heparin products was OSCS, the agency did not know whether it was related to the adverse events. From Jan. 1, 2007, though April 13, 2008, 81 deaths associated with one or more allergic or hypotensive symptoms had been reported to the FDA, according to an update of these reports provided on April 21. The 81 cases were among the total of 131 deaths associated with heparin reported last year; most were reported from November 2007 through February 2008. The adverse events are dose related and have been reported only in association with a large intravenous bolus of heparin. OSCS is a chemically modified form of a naturally occurring product that mimics the activity of heparin. During the briefing, Dr. Woodcock announced that OSCS has been identified in heparin products in the United States and in Germany, Australia, Canada, Denmark, France, Italy, the Netherlands, New Zealand, Japan, and China. The only countries where adverse reactions have been reported are the United States and Germany; not all have been associated with Baxter products. At the present time, Dr. Woodcock said the heparin supply in the United States “is tested and free of this contaminant.” The United States Pharmacopeia (USP) and the European Pharmacopeia will be instituting requirements for testing heparin products for this contaminant, she added. High levels of dermatan sulfate, a known byproduct of the process of obtaining heparin active pharmaceutical ingredient (API) from pigs, also have been identified in some heparin products, according to Dr. Woodcock. There is no evidence that dermatan sulfate is harmful, but it is considered an impurity and should be kept to a low level, she said, noting that there will be USP requirements to test heparin products for this as well. The FDA also announced that contaminated lots of heparin have been traced back to 12 companies in China that have supplied crude heparin or heparin API, but the FDA has not yet determined where in the supply chain—or even why—the contaminant was introduced. The briefing was held days after the FDA met with regulators in several countries and Chinese officials, the USP and European Pharmacopeia, and academic heparin experts. For information and to report adverse events and deaths related to contaminated heparin, visit www.fda.gov/ cder/drug/infopage/heparin/default.htm. Older Blood Poses Higher Mortality Risks in Cardiac Surgery Patients BY SUSAN BIRK MedPAC Supports Bundling Payment WA S H I N G T O N — The Medicare Payment Advisory Commission’s recent decision to recommend bundling payment for hospitalization would essentially give hospitals and physicians an incentive to control costs and avoid readmissions. At its April meeting, the commission (MedPAC) unanimously voted to include a bundling recommendation in the report that will be conveyed to Congress in June. As a first step, physicians and hospitals should be required to report to the Centers for Medicare and Medicaid Services (CMS) on resource use and readmissions during an “episode of care,” a period that is proposed to include the first 30 days following hospitalization. The data would be confidential initially, but by the third year, the information should be made public, MedPAC commissioners recommended. Once the resource and readmission data are in hand, CMS should start adjusting payment to hospitals, according to the recommendation. There would be the possibility for gainsharing among hospitals and physicians. The commissioners also voted to direct CMS to study the feasibility of “virtual” bundling. With virtual bundling, the payment would be adjusted based on aggregate use of services over an entire episode of care. Finally, MedPAC voted to recommend that CMS create a voluntary pilot to test actual bundled payment in selected disease conditions. The pilot could throw some light on how the hospital or accountable care organization receiving the payment decided to share funds, as well as how Medicare might share in any savings, according to MedPAC staff. The pilot represents the ultimate goal of Medicare to make bundled payments, said MedPAC chairman Glenn Hackbarth, who is a health care consultant in Bend, Ore. The data collection and adjusting payment based on readmission are interim steps aimed at getting providers to collaborate to improve care and cut costs, said Mr. Hackbarth. Commissioner Ronald Castellanos, a urologist who is in private practice in Fort Myers, Fla., said he thought it would take 5 or 10 years to make the collaboration work. However, he agreed that successful collaboration was the ultimate end point. —Alicia Ault Else vier Global Medical Ne ws of red blood stored for inTransfusions15ofdays or morecells crease the risk serious complications and both short- and longterm mortality following cardiac surgery, according to a retrospective study of more than 6,000 patients. “The relative risk of postoperative death is increased by 30% in patients given blood that has been stored for more than 2 weeks,” wrote Dr. Colleen Gorman Koch and her colleagues at the Cleveland Clinic Foundation. Earlier studies comparing older and newer blood have yielded conflicting results. These studies examined small or heterogeneous samples, did not control for confounding factors, and used end points that did not reflect specific organ function, such as length of hospital stay. The present study analyzed data on 3,130 cardiac surgery patients transfused with 10,782 units of blood stored for more than 14 days and 2,872 patients transfused with 8,802 units of blood stored for 14 or fewer days during cardiac surgery at the Cleveland Clinic between 1998 and 2006. It excluded patients whose transfusions consisted of both newer and older blood and those with trauma and heterogeneous chronic diseases. Patients underwent coronary artery bypass graft surgery, cardiac valve surgery, or a combina- tion of the two. The older and newer blood groups shared similarities on most baseline and operative variables. The primary end point was a composite of in-hospital adverse events defined by the Society of Thoracic Surgeons. Follow-up survival status was ob- TRANSFUSIONS WITH OLDER BLOOD LED TO HIGHER RATES OF PROLONGED VENTILATION, RENAL FAILURE, SEPTICEMIA, AND MOF. tained from the Social Security Death Index (N. Engl. J. Med. 2008;358:1229-39). The study found a significant association between blood storage time and the serious adverse events composite end point, which occurred in 22.4% of the patients who received newer blood and 25.9% of those who received older blood. The link remained after adjustments were made for coexisting conditions and other risk factors. Patients who were transfused with older blood, compared with those who received newer blood, had significantly higher rates of in-hospital mortality (2.8% vs. 1.7%), prolonged ventilation (9.7% vs. 5.6%), renal failure (2.7% vs. 1.6%), septicemia or sepsis (4.0% vs. 2.8%), and multisystem organ failure (0.7% vs. 0.2%). Risk of death was significantly lower among patients who received newer units of blood; 1year death rates were 7.4% and 11.0% for the newer and older blood groups, respectively. The mortality increase among older blood patients was most pronounced within 6 months of surgery. “The adverse effects of transfusing older blood persisted even after adjustment for perioperative factors known to be associated with an adverse outcome in this population,” the researchers wrote (data were not presented). These findings warrant further study before any broad-based changes in blood banking practices are made, they said. The study’s results, while important, are not enough to warrant a change in blood supply practices, said Dr. John W. Adamson in an accompanying editorial. Because the study population had a median age of 70 years, “by definition, the patients had a substantial number of coexisting illnesses.” Also, the result could reflect a problem unique to cardiopulmonary bypass, because all patients underwent that procedure. Blood management and blood conservation programs, to reduce the amount of blood transfused in procedures, would be the most effective course of action, said Dr. Adamson of the Veterans Affairs San Diego Health System, University of California, San Diego. http://www.fda.gov/cder/drug/infopage/heparin/default.htm http://www.fda.gov/cder/drug/infopage/heparin/default.htm

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Surgery News - May 2008 Contents New Lung Approach Speeds Extubation Innovative GI Procedures May Improve Diabetes Quality Programs Differ on Risk Data Crystal Ball Medical Modeling Ventricular Valve Taking Stock

Surgery News - May 2008

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