ACP HospitalistWeekly
In the News for the Week of 4-20-11
Highlights
Updated guidelines on preventing bloodstream infections released
Updated guidelines for preventing intravascular catheter-related infections were jointly released last week by more than a dozen governmental agencies and professional organizations. More...
Off-label recombinant factor VIIa common but potentially harmful in U.S. hospitals
Off-label use of recombinant factor VIIa is widespread in U.S. hospitals but could increase risk of adverse events, according to two new studies published yesterday in Annals of Internal Medicine. More...
Perioperative care
Bulk of patients with MI after noncardiac surgery don't have ischemic symptoms
More than 65% of patients who have a myocardial infarction (MI) within 30 days of noncardiac surgery don't experience ischemic symptoms, a new study found. More...
Cardiology
D-dimer testing may help rule out acute aortic dissection
Plasma d-dimer testing may be helpful in determining which patients do not have acute aortic dissection, according to a new meta-analysis. More...
FDA news
C. diff and dengue tests cleared by FDA
New tests that can assist with diagnosis of Clostridium difficile and dengue fever were recently cleared for marketing, the FDA announced. More...
Cartoon caption contest
Put words in our mouth
ACP HospitalistWeekly wants readers to create captions for this cartoon and help choose the winner. Pen the winning caption and win a $50 gift certificate good toward any ACP product, program or service. More...
Physician editor: A. Scott Keller, FACP
Highlights
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Updated guidelines on preventing bloodstream infections released
Updated guidelines for preventing intravascular catheter-related infections were jointly released last week by more than a dozen governmental agencies and professional organizations.
The guidelines, which replace a 2002 edition, were released by the Centers for Disease Control and Prevention and the Healthcare Infection Control Practices Advisory Committee (HICPAC), and developed by a working group led by clinical scientists from the National Institutes of Health Clinical Center Critical Care Medicine Department, along with 14 other professional organizations. Major areas of emphasis include educating and training health care personnel, using maximal sterile barrier precautions during catheter insertion, cleaning skin with chlorhexidine, and avoiding routine replacement of central venous catheters. Specific recommendations include:
- Only trained personnel who demonstrate competence should undertake insertion and maintenance of intravascular catheters, and they should be periodically assessed for knowledge of and adherence to guidelines.
- In adults, use an upper extremity site for insertion of a peripheral or midline catheter. Replace a catheter inserted in a lower extremity site to an upper extremity site as soon as possible.
- Use a midline catheter or peripherally inserted central catheter (PICC), instead of a short peripheral catheter, when the duration of IV therapy will likely exceed six days.
- Weigh the risks and benefits of placing a central venous device at a recommended site to reduce infectious complications against the risk for mechanical complications such as pneumothorax, thrombosis and hemothorax. Promptly remove any intravascular catheter that is no longer essential.
- Avoid using the femoral vein for central venous access in adult patients. Use a subclavian site, rather than a jugular or femoral site, in adult patients to minimize infection risk for nontunneled central venous catheter placement.
- Avoid the subclavian site in hemodialysis patients and patients with advanced kidney disease, to avoid subclavian vein stenosis.
- Use ultrasound guidance (if this technology is available) to place central venous catheters to reduce the number of cannulation attempts and mechanical complications. Ultrasound guidance should only be used by those fully trained in its technique.
- Use maximal sterile barrier precautions, including the use of a cap, mask, sterile gown, sterile gloves, and a sterile full body drape, for the insertion of central venous catheters, PICCs, or guidewire exchange.
- Prepare skin with an antiseptic (70% alcohol, tincture of iodine, or alcoholic chlorhexidine gluconate solution) before peripheral venous catheter insertion. Prepare skin with a >0.5% chlorhexidine preparation with alcohol before central venous catheter and peripheral arterial catheter insertion and during dressing changes. If there is a contraindication to chlorhexidine, tincture of iodine, an iodophor, or 70% alcohol can be used as alternatives.
The guidelines working group was led by the Society of Critical Care Medicine in collaboration with the Infectious Diseases Society of America, Society for Healthcare Epidemiology of America, Surgical Infection Society, American College of Chest Physicians, American Thoracic Society, American Society of Critical Care Anesthesiologists, Association for Professionals in Infection Control and Epidemiology, Infusion Nurses Society, Oncology Nursing Society, American Society for Parenteral and Enteral Nutrition, Society of Interventional Radiology, American Academy of Pediatrics, Pediatric Infectious Diseases Society, and the HICPAC.
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Off-label recombinant factor VIIa common but potentially harmful in U.S. hospitals
Off-label use of recombinant factor VIIa (rFVIIa) is widespread in U.S. hospitals but could increase risk of adverse events, according to two new studies published yesterday in Annals of Internal Medicine.
The procoagulant rFVIIa was approved by the FDA in 1999 for treatment of surgical or spontaneous bleeding in patients with hemophilia A or B who have inhibitors to factor VIII or IX. However, it is often used off-label to treat or prevent bleeding in patients with other conditions, and several trials have indicated a potential for thrombotic complications. In one study, researchers reviewed records for 12,644 patients who received rFVIIa during a hospital stay between 2000 and 2008. In that time period, off-label use increased by 140-fold, whereas use for thrombophilia increased less than four-fold, the authors found. Ninety-six percent of in-hospital rFVIIa use from 2000 to 2008 and 97% in 2008 was for off-label indications, such as body and brain trauma, cardiovascular surgery and intracranial hemorrhage. The authors noted that they could not verify the accuracy or completeness of the discharge diagnoses or medication records, but concluded that off-label use of rFVIIa is much more common than use for approved indications.
A second study, a meta-analysis involving several of the same authors, evaluated published research to determine the benefits and harms of in-hospital, off-label use of rFVIIa for intracranial hemorrhage, cardiac surgery, trauma, liver transplantation and prostatectomy. In 64 articles published from inception through 2010, off-label use of rFVIIa appeared to have no mortality benefit. Patients who received rFVIIa for intracranial hemorrhage had an increased risk for arterial thromboembolism with medium and high doses, and adults who received it for cardiac surgery had an increased risk for thromboembolism. The authors noted that evidence was limited overall and that they could not exclude publication bias, but concluded that off-label use of rFVIIa for these common five indications did not help and could in some conditions cause harm.
The authors of an accompanying editorial suggested that physicians may have begun prescribing rFVIIa for indications besides hemophilia to try to protect patients from excessive bleeding. However, they emphasized that such use does not appear to benefit patients, increases risk for thrombotic events, and costs approximately $10,000 per dose. "Allowing physician autonomy to choose medications is appealing, but not when it results in unhelpful, dangerous, and costly decisions," they wrote.
Perioperative care
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Bulk of patients with MI after noncardiac surgery don't have ischemic symptoms
More than 65% of patients who have a myocardial infarction (MI) within 30 days of noncardiac surgery don't experience ischemic symptoms, a new study found.
For a cohort study, researchers recruited 8,351 patients from 190 centers in 23 countries who were having noncardiac surgery, were at least 45 years old, had or were at risk of atherosclerotic disease, and were expected to stay in the hospital at least 24 hours. They evaluated MIs within 30 days of randomization by measuring four cardiac biomarker or enzyme assays within three days of noncardiac surgery, and by serial electrocardiograms at 6 to 12 hours and on the first, second, and 30th days after surgery. MI was defined by either autopsy findings, or an elevated level of a cardiac biomarker or enzyme and at least one of the following: ischemic symptoms, development of pathologic Q waves, ischemic changes on electrocardiography, coronary artery intervention, or cardiac imaging evidence of MI. Results were published in the April 19 Annals of Internal Medicine.
Five percent (n=415) of patients had a perioperative MI, 74.1% of which occurred within 48 hours of surgery and 65.3% with no ischemic symptoms of MI. The 30-day mortality rate was 11.6% among patients who had a perioperative MI and 2.2% among those who didn't (P<0.001). Among patients with a perioperative MI, mortality rates were elevated and similar between those with and without ischemic symptoms (9.7% vs 12.5%, goodness-of-fit test P=0.84). A total of 697 patients (8.3%) had elevated levels of an isolated cardiac biomarker or enzyme (but did not fulfill the study criteria for MI); such patients had a greater risk for nonfatal cardiac arrest and nonacute coronary revascularization than patients with no perioperative MI and no elevated cardiac biomarker or enzyme levels. Among those 697 patients with elevated biomarker or enzyme levels, 360 had elevated troponin levels and 337 had elevated creatine kinase-MB levels. A substantial proportion of patients with a perioperative MI didn't receive cardiovascular medications known to be effective in managing patients with nonoperative MI.
One study limitation was that cardiac markers were measured only until day 3 after surgery, so additional asymptomatic MIs may have been missed, the authors noted. Given that the highest risk for death after perioperative MI occurs in the first 48 hours, there is a "need to quickly diagnose and intensely monitor and implement treatments for perioperative MI, just as with nonoperative MI," they wrote. Until definitive trials are done, offering patients with coronary artery stenosis "long-term management with secondary prophylaxis cardiac interventions known to be beneficial (such as a statin or an angiotensin-converting enzyme inhibitor) seems reasonable," they advised. Also, since most patients who have a perioperative MI won't have ischemic symptoms, physicians should require perioperative troponin monitoring to avoid missing these MIs, they wrote.
Cardiology
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D-dimer testing may help rule out acute aortic dissection
Plasma d-dimer testing may be helpful in determining which patients do not have acute aortic dissection, according to a new meta-analysis.
Researchers performed a meta-analysis of seven studies involving 298 patients with acute aortic dissection and 436 without to determine whether testing plasma d-dimer (DD) could help clinicians rule out acute aortic dissection. Included studies reported acute aortic dissection confirmed by standard imaging within two weeks of symptom onset; measured plasma DD with standardized assays; included controls without acute aortic dissection; and provided absolute true-positives, false-positives, true-negatives, and false-negatives, or enough data to allow these numbers to be derived. Each study included 16 to 94 patients with acute aortic dissection, with a mean/median age of 53 to 70 years, most of whom were men. The study results were published in the April 15 American Journal of Cardiology.
The study authors used a threshold of 500 ng/mL as a positive DD finding. Data were pooled across studies, and sensitivity, specificity, positive and negative predictive values, and positive and negative likelihood ratios were estimated. Sensitivity and negative predictive value were both high (0.97 [95% CI, 0.94 to 0.99] and 0.96 [95% CI, 0.93 to 0.98], respectively), while specificity and positive predictive value were both low (0.56 [95% CI, 0.51 to 0.60] and 0.60 [95% CI, 0.55 to 0.66], respectively). Discriminative ability was excellent with negative likelihood ratio but not with positive likelihood ratio (0.06 [95% CI, 0.03 to 0.12] and 2.43 [95% CI, 1.89 to 3.12], respectively).
The meta-analysis could not examine DD's diagnostic performance in different settings, and the results may be more applicable to patients at low and moderate risk than to those at high risk, the authors noted. They also pointed out that since acute aortic dissection has a high mortality rate, it may be dangerous to forgo further imaging based on a negative DD value in situations where the value has not been adequately tested, such as certain age ranges. Finally, they acknowledged that all of the included studies were observational. However, they concluded, "Use of this screening tool may help physicians decide whether to order additional diagnostic procedures to confirm the diagnosis of [acute aortic dissection]." They called for additional prospective studies to quantify the utility of DD testing in a variety of clinical settings.
FDA news
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C. diff and dengue tests cleared by FDA
New tests that can assist with diagnosis of Clostridium difficile and dengue fever were recently cleared for marketing, the FDA announced.
The Cepheid Xpert C. difficile /Epi assay is designed to rapidly detect the toxin B gene associated with C. difficile infection. The test determines if C. difficile is in a patient's stool and whether it is the epidemic 027/NAP1/BI strain. The assay is automated and works on the Cepheid GeneXpert Dx System, which consists of an instrument that houses single-use disposable cartridges, a personal computer, and software that allows tests to be run and viewed quickly. The test is intended for use as an aid in diagnosis. The detection of the 027/NAP1/B1 strain is for epidemiological purposes only and should not be used to determine or monitor treatment, according to an FDA press release.
The DENV Detect IgM Capture ELISA test is the first test to help diagnose dengue fever or dengue hemorrhagic fever, reported an FDA press release. The test detects antibodies to dengue virus in blood samples from patients who have signs and symptoms of dengue and will be available for use in clinical laboratories. Diagnostic testing for dengue is complicated by the fact that an IgM antibody response to the dengue virus infection is not detectable until 3 to 5 days after the onset of fever, so a test result can be negative even though a person has dengue. Most reported dengue cases in the continental U.S. occur in people returning from Latin America, the Caribbean and Southeast Asia. Recently, dengue outbreaks have occurred in Hawaii, Texas, and Florida.
Cartoon caption contest
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Put words in our mouth
ACP HospitalistWeekly wants readers to create captions for this cartoon and help choose the winner. Pen the winning caption and win a $50 gift certificate good toward any ACP product, program or service.
E-mail all entries to acphospitalist@acponline.org. ACP staff will choose finalists and post them online for an online vote by readers. The winner will appear in an upcoming edition.
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