Surgery News - June 2008 - (Page 3)

JUNE 2008 • SURGERY NEWS NEWS Aprotinin Found Unsafe for High-Risk Cardiac Surgery B Y M A RY A N N M O O N Else vier Global Medical Ne ws large randomized trial was terminated early when an interim analysis showed “a strong trend” toward death in high-risk cardiac surgical patients who received aprotinin, compared with two lysine analogues. On the basis of the trial’s results, Bayer HealthCare Pharmaceuticals recalled its remaining U.S. supplies of the drug (see sidebar). “Despite the possibility of a modest reduction in the risk of massive bleeding, the strong and consistent negative mortality trend associated with aprotinin as compared with lysine analogues precludes its use in patients undergoing high-risk cardiac surgery,” said Dr. Dean A. Fergusson of the Ottawa Health Research Institute and his associates (N. Engl. J. Med. 2008;358:2319-31). The Blood Conservation Using Antifibrinolytics in a Randomized Trial (BART) research group compared the serine protease inhibitor aprotinin with two lysine analogues, tranexamic acid and aminocaproic acid, to determine which agent better reduced the risk of massive postoperative bleeding among high-risk cardiac surgery patients. The BART study enrolled 2,468 patients undergoing high-risk elective or urgent surgery requiring cardiopulmonary bypass at 19 Canadian medical centers in 2002-2007. These subjects were randomly assigned in roughly equal numbers to receive one of the three hemostatic drugs. Of the 2,331 patients in the intention-totreat analysis, 781 received aprotinin, 770 received tranex- amic acid, and 780 received aminocaproic acid. The trial was terminated early after an interim analysis of data on more than 2,000 participants showed “a strong trend toward higher mortality in the aprotinin group than in the other two groups.” Aprotinin did curb massive bleeding. Nine percent of the aprotinin group had this complication, compared with 12% in each of the other two groups. However, 30-day mortality from any cause in 2,328 patients analyzed was 6% with aprotinin, compared with 3.9% with each of the two lysine analogues. “When we compared the combined mortality rates in the lysine-analogue groups with the rate in the aprotinin group, we noted a significant absolute increase of 2.1%, or a relative increase of 54%, in the number of deaths in the aprotinin group,” the researchers said. Further data analysis showed that the drug doubled the risk of death from cardiac causes specifically, including cardiogenic shock, right ventricular failure, heart failure, or MI. In an accompanying editorial, Dr. Wayne A. Ray and Dr. C. Michael Stein of Vanderbilt University, Nashville, Tenn., wrote BART provided “modest” evidence that aprotinin was more effective at maintaining hemostasis, although the difference between it and the lysine analogues was only of borderline statistical significance. Aprotinin patients had slightly less need for blood products postoperatively than the other two groups (N. Engl. J. Med. 2008;358:2398-400). None of the drug manufacturers contributed medications or financial support to the study. Three study authors reported receiving consulting or lecture fees from Bayer. Dr. Ray has received grant support from Pfizer Inc. BART Study Prompts Aprotinin Recall HealthCare Pharmaceuticals Food and Drug Administration May that it Bayerrecall all remaining supplies in notified the would of aprotinin (Trasylol) in the United States, according to an FDA statement. Results from a randomized study of more than 2,000 patients found that the risk of death associated with the antifibrolytic drug outweighed the benefits of controlling bleeding in high-risk cardiac surgery patients (see story). Trasylol, which was approved to help control bleeding and reduce the need for blood transfusions during cardiac surgery, will remain available to investigators on a limited basis for use in patients who meet strict criteria, the FDA said in a statement. Investigators who want access to the drug must submit a protocol for FDA review. Bayer agreed to an FDA request to suspend marketing of the drug in November 2007 based on preliminary findings from the Blood Conservation Using Antifibrinolytics in a Randomized Trial (BART) study. To see the FDA statement, visit www.fda.gov/ bbs/topics/NEWS/2008/NEW01834.html. —Heidi Splete Dr. Hiram C. Polk Jr. observed that the fascination with tight blood glucose control in surgical patients is only 7 or 8 years old. Infections • from page 1 The pendulum has recently begun to swing infections, and septic shock—occurred with- away from tight control, but this careful in 30 days in 117 of the 995 study partici- study will push it back, he predicted. Dr. Polk said in his own ongoing prospecpants, or 11.7%. The incidence was 15.3% among the 13% of subjects who had dia- tive study of surgical practices at small betes and 8.8% in nondiabetic patients. Pa- community hospitals, he has been struck by tients who developed postoperative infec- the contrast between the careful attention tions had a mean postoperative blood given to avoiding hypothermia versus the glucose level of 142 mg/dL and were sig- spotty performance in perioperative blood nificantly older as well as more likely to glucose monitoring. “Hypothermia is being avoidhave received more than two ed in 98% of cases. On the othunits of RBCs intraoperatively. er hand, nearly one-third of all A multivariate regression diabetics are not monitored for analysis showed only three sigintraoperative glucose during nificant predictors of postoperlong surgical procedures. And ative infections: emergent 29% of people with very high surgery and a higher American glucose in the holding area don’t Society of Anesthesiologists get their blood glucose moniclassification—which are factors tored at all,” said Dr. Polk, an beyond control—and postoperACS Fellow and senior professor ative hyperglycemia, which is Prompt treatment of surgery at the University of readily manageable. A postopof postop Louisville (Ky.). erative blood glucose level 40 hyperglycemia Strict perioperative blood glumg/dL higher than normal was could favorably cose control is routine only in independently associated with a impact quality of cardiac surgery, because of the 30% increased risk of postop insurgical care. abundant evidence that it influfection. And a postop blood gluDR. ROGERS ences outcomes, Dr. E. Patchen cose greater than 180 mg/dL was associated with an adjusted two-fold in- Dellinger pointed out, adding that it’s irrational not to apply the same practice in othcrease in infection risk. Preoperative blood glucose level, race, er fields of surgery. “Clearly the biology is the same,” argued age, and diabetes status were not related to the risk of postoperative infection, he said. Dr. Dellinger, an ACS Fellow who is profesThere was a strong relationship between sor and vice chairman of surgery and chief postoperative hyperglycemia and the risk of of the general surgery division at Universisurgical site infections, which account for ty of Washington Medical Center, Seattle. “There are still nonbelievers who are unabout one-quarter of all postoperative infections occurring annually in U.S. patients. convinced of this important relationship,” Prevention and prompt treatment of postop commented Dr. Dana K. Andersen, an ACS hyperglycemia could therefore have a major Fellow who is professor and vice chair of favorable impact on the quality of surgical surgery at Johns Hopkins University, Baltimore. services, he noted. Glucose Control pathic Association in which Medicare would replace the current SGR with a system of six separate physician service Fee Fix • from page 1 categories: primary and preventive care, would reflect increasing practice costs. other evaluation and management serCurrently, Medicare physician pay- vices, major procedures, anesthesia serments are calculated using the Sustain- vices, imaging and diagnostic services, able Growth Rate (SGR), which sets a and minor procedures and all other spending target based on the gross do- physician services. Spending targets would be based on mestic product. Whenever the spending target is exceeded, Medicare pay- the current SGR factors, such as trends ments must be cut. Physician groups in physician spending and beneficiary have objected to the use of this formula enrollment, but would not include the gross domestic product. for years, saying that it fails The GDP would be reto track rising practice costs. placed with a statutorily set And surgeons in particular percentage point growth alare opposed because lowance for each service surgery has a relatively low category. rate of growth but is cut at Establishing separate the same rate as are other physician service categories rapidly growing physician would allow policy makers services. to adjust targets and pay“There’s no question that ments to each service area, the SGR is broken and we’re Payment cuts rather than making acrossin dire straits,” said Dr. make it hard for the-board cuts. “We feel Mabry, a general surgeon in surgeons to keep that this will allow ConPine Bluff, Ark. budgets on track, The constant Medicare and force some to gress and the administration to better control the payment cuts not only make retire early. management of those indiit hard for surgeons to keep DR. MABRY vidual services,” he said. budgets on track, but also But representatives from other physiforce some to retire early, creating an access problem for the entire commu- cian groups voiced concerns about the nity, he said. Between 1997 and 2004, ACS alternative. The proposal would seven counties in Arkansas lost all of create “mini SGRs” and would require their general surgeons, which led to sig- careful study to ensure that it didn’t just nificantly reduced services at five hos- compound the current problem, Dr. pitals and the closing of two in those ar- Cecil B. Wilson, immediate past chair eas, Dr. Mabry noted. This experience of the board o http://www.fda.gov/bbs/topics/NEWS/2008/NEW01834.html http://www.fda.gov/bbs/topics/NEWS/2008/NEW01834.html

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Surgery News - June 2008 Contents Work Hours New Digs Banking Blood Improved Imaging

Surgery News - June 2008

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