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ACP HospitalistWeekly 7-29-09

Highlights

• Flu vaccine trials, approvals underway

Neurology

• NIHSS score a poor predictor of proximal occlusion in acute cerebral ischemia
• Higher NIHSS score may predict clinical outcomes after tPA use for ischemic stroke

Cardiology

• Time to defibrillation varies widely among hospitals, but reasons remain unknown

FDA update

• Propofol injectable, pneumococcal vaccine recalled
• FDA analysis finds electronic cigarettes contain carcinogens, toxins
• Safety review of omalizumab targets cardiovascular, cerebrovascular effects

Cartoon caption contest

• Vote for your favorite entry

Physician editor: A. Scott Keller, FACP

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Highlights

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Flu vaccine trials, approvals underway

The federal government last week announced the start of trials for a vaccine against the pandemic swine-origin H1N1 virus and approved a new vaccine for seasonal influenza.

The trials will include about 2,400 healthy adult volunteers at eight sites in the U.S., the July 23 New York Times reported. Patients will be given one or two shots, each containing 15 or 30 micrograms of vaccine. The recipients will be monitored for side effects and tested for the development of antibodies to the pandemic virus.

Officials told the New York Times that trials would take about two months, after which a more widespread vaccination program could begin. Even if approval moves quickly, it will not be possible to create enough vaccine for everyone in the U.S. by fall, however. For the tests, which are being overseen by the National Institute of Allergy and Infectious Diseases, vaccines are being produced by Sanofi-Pasteur and CSL Biotherapies. Novartis is also testing a vaccine for the FDA, the newspaper reported.

All three companies, along with three others, are also at work on the 2009-2010 seasonal influenza vaccine approved by the FDA last week. The seasonal vaccine comprises three virus strains that U.S. and international officials believe are likely to cause the most illness during the upcoming flu season: an A/Brisbane/59/2007 (H1N1)-like virus, an A/Brisbane/10/2007 (H3N2)-like virus and a B/Brisbane/60/2008-like virus.

Although the seasonal vaccine will not protect against the pandemic flu strain, vaccination will still be important this year for those Americans for whom it is recommended, including health care personnel, the FDA said.

ACP Hospitalist compiled a list of resources to help physicians and their patients stay up-to-date about the outbreak of swine-origin (H1N1) influenza A.

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Neurology

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NIHSS score a poor predictor of proximal occlusion in acute cerebral ischemia

Although a high score on the National Institutes of Health Stroke Scale (NIHSS) correlates with having a proximal arterial occlusion (PO) in patients with acute cerebral ischemia, no score threshold can be safely applied to determine whether such patients should have angiographic imaging, a new study found.

In a prospective cohort study, researchers dichotomized 699 acute cerebral ischemia patients by presence of PO, including a subgroup of 177 subjects with middle cerebral artery M1 occlusion. Admission non-enhanced CT scans were obtained, followed by CT angiograms. NIHSS scores were obtained at admission, 24 hours after admission, at discharge, and at six-month follow-up. The study was published in the July 16 online Stroke.

Patients with a PO had a higher median NIHSS score than the overall median (9 vs. 5, P<0.0001). Patients with middle cerebral M1 occlusion had a median NIHSS score of 14. An NIHSS score of >10 had an 81% positive predictive value for PO, but only 48% sensitivity with a majority of PO patients who presented with lower NIHSS scores. On average, the NIHSS scores of patients found to have PO were just 2.8 points higher than the average for all presenting patients. To detect 90% of patients with PO, all patients with an NIHSS score >2 would need to undergo angiographic imaging, the researchers found.

One limitation to the study is that patients who were unable to get intravenous contrast were excluded. Such patients are likely to have had greater comorbidities, and may have influenced the predictive relationship between the NIHSS score and presence of PO in some way, the authors noted. On the whole, however, the results indicate that while there is a need to evaluate acute stroke patients efficiently, physicians wouldn’t catch the majority of POs if they tried to increase efficiency by excluding patients with low NIHSS scores from angiographic and perfusion imaging, the authors said.

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Higher NIHSS score may predict clinical outcomes after tPA use for ischemic stroke

A higher National Institutes of Health Stroke Scale (NIHSS) score, extensive early CT changes and baseline antiplatelet use are associated with a higher risk of intracerebral hemorrhage after thrombolytic therapy, but only the NIHSS score is associated with clinical outcome, a new study found.

Researchers studied 965 acute ischemic stroke patients who were treated with intravenous tissue plasminogen activator (tPA) within three hours of symptom onset. The mean time from symptom onset to tPA treatment was 145 ± 33 minutes, and the mean and median NIHSS at enrollment was 14. Post-tPA symptomatic intracerebral hemorrhage was defined as a worsening on the NIHSS score of >4 points within 36 hours with evidence of hemorrhage on follow-up neuroimaging. Early CT changes were graded using the Alberta Stroke Program Early CT Score (ASPECTS). A good clinical outcome was defined as a modified Rankin scale of 0-2 at 90 days. The study was published in the July 16 online Stroke.

Symptomatic intracerebral hemorrhage struck 5.6% of patients, with incidence increased in those with those with baseline antiplatelet use (single antiplatelet: OR, 2.04, 95% CI, 1.07 to 3.87, P=0.03; double antiplatelet: OR, 9.29, 95% CI, 3.28 to 26.32, P<0.001), higher NIHSS score (OR, 1.09 per point, CI, 95% CI, 1.03 to 1.15 per point, P=0.002), and CT changes (ASPECTS 8 to 9: OR, 2.26, 95% CI, 0.63 to 8.10, P=0.21; ASPECTS <7: OR, 5.63, 95% CI, 1.66 to 19.10, P=0.006). A higher NIHSS score was associated with decreased odds of good clinical outcome (OR, 0.82 per point, 95% CI, 0.79 to 0.85 per point, P<0.001), but there was no relationship between clinical outcome and CT changes or baseline antiplatelet use.

The study is limited in that enrolled subjects may not be representative of stroke patients in clinical practice, since exclusion criteria were prior disabling stroke, severe renal disease or multiple comorbidities that limit life expectancy. The finding of an especially increased risk of symptomatic intracerebral hemorrhage with double antiplatelet therapy is novel and requires future confirmation, the authors noted. Since there was no association between prior use of antiplatelet therapy and clinical outcome, the results don’t support using this factor to withhold tPA treatment, they concluded.

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Cardiology

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Time to defibrillation varies widely among hospitals, but reasons remain unknown

Time to defibrillation after in-hospital cardiac arrest varies widely among hospitals, but not because of traditional factors, a recent study reports.

Researchers used the National Registry of Cardiopulmonary Resuscitation to examine how much rates of delayed defibrillation (>2 minutes) varied at U.S. hospitals and what factors were associated with such delays. Data from 7,479 adult patients who had cardiac arrest at 200 hospitals were analyzed. The study results appear in the July 27 Archives of Internal Medicine.

Adjusted rates of delayed defibrillation among hospitals ranged from 2.4% to 50.9%. After adjustment for patient factors, hospital-level factors explained most of the difference: "We found a 46% greater odds of patients with identical covariates getting delayed defibrillation at one randomly selected hospital compared with another," the authors wrote. However, most traditional hospital factors, such as academic status, did not affect time to defibrillation, with the exception of bed volume (odds ratios, 0.62 [95% CI, 0.48 to 0.80] for 200 to 499 beds vs. <200 beds and 0.74 [95% CI, 0.53 to 1.04] for >500 beds vs. <200 beds) and location of cardiac arrest (odds ratios, 1.92 [95% CI, 1.65 to 2.22] for telemetry unit vs. ICU and 1.90 [95% CI, 1.61 to 2.24] for unmonitored unit vs. ICU). Hospitals with better time to defibrillation also had better adjusted rates of survival to hospital discharge.

The authors acknowledged their study's limitations, including its observational design and its lack of information on some important hospital characteristics, such as nurse-to-patient ratio. However, they concluded that rates of defibrillation after in-hospital cardiac arrest vary widely among U.S. hospitals, but few facility characteristics were found to explain this variation. Future research, they wrote, should examine the processes used at top-performing hospitals so that they can be implemented at other institutions. The authors of an accompanying editorial also called for more research, writing, "Once effective strategies have been developed and tested, individual hospitals can implement and adapt those strategies that are feasible within their local environment."

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FDA update

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Propofol injectable, pneumococcal vaccine recalled

The following items were voluntarily recalled by their manufacturers:

• Propofol Injectable Emulsion 10 mg/mL 100 mL vials, lot numbers 31305429B and 31305430B, due to the presence of elevated endotoxin levels in some vials with these lot numbers. At least 41 propofol-treated patients have reported post-operative fever, chills and other flu-like symptoms, reactions that appear to have been self-limiting with spontaneous resolution, an FDA notice said. Serious adverse effects, such as disseminated intravascular coagulopathy, acute respiratory distress syndrome, shock and death, are possible with exposure to products with high endotoxin levels. For use as an anesthetic, propofol should be used only by professionals trained in administering general anesthesia. For sedation of intubated, mechanically ventilated patients in the ICU, propofol should be administered only by persons skilled in the management of critically ill patients, the notice said.
• Lot number D50002 of Prevnar Pneumococcal 7-valent Conjugate Vaccine (Diphtheria CRM197Protein), single-dose pre-filled syringes. A portion of a bulk lot of the syringes, which wasn’t meant for commercial use, was inadvertently packaged and distributed with commercial product under Lot D50002. Manufacturer Wyeth has performed a medical assessment and concluded that the affected syringes present no health or safety risk to patients and that there is no need to revaccinate, an FDA notice said.

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FDA analysis finds electronic cigarettes contain carcinogens, toxins

A lab analysis of electronic cigarette samples found they contain carcinogens and toxic chemicals like diethylene glycol, an ingredient used in antifreeze, the FDA said last week.

Electronic cigarettes, or “e-cigarettes,” are battery-operated devices that usually contain nicotine, flavor and other chemicals, which are turned into a vapor that is inhaled. They haven’t been submitted to the FDA for evaluation or approval, and don’t carry health warnings like other nicotine replacement products do.

The agency analyzed the ingredients in a small sample of cartridges from two leading electronic cigarette brands. In one sample, the analyses detected diethylene glycol, a chemical used in antifreeze that is toxic to humans, and in several other samples, the FDA analyses detected carcinogens, including nitrosamines. Aside from this limited testing, the FDA said it has no way of knowing the levels of nicotine, or the amounts or kinds of other chemicals that various brands of electronic cigarettes deliver.

The FDA has been examining and detaining shipments of e-cigarettes at the border and the products it has examined so far meet the definition of a combination drug-device product under the Federal Food, Drug, and Cosmetic Act. The agency has been challenged regarding its jurisdiction over certain e-cigarettes in a case currently pending in federal district court. The FDA is planning additional activities to address its concerns about these products, it said in the release.

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Safety review of omalizumab targets cardiovascular, cerebrovascular effects

The FDA is evaluating the interim findings of an ongoing study of omalizumab (Xolair) that suggests an increase in several adverse cardiovascular and cerebrovascular conditions in patients treated with the drug, the agency said.

The conditions include ischemic heart disease, arrhythmias, cardiomyopathy and cardiac failure, pulmonary hypertension, cerebrovascular disorders, and embolic, thrombotic and thrombophlebitic events. The study is called “Evaluating the Clinical Effectiveness and Long-Term Safety in Patients with Moderate to Severe Asthma,” or EXCELS.

Omalizumab is approved for people aged 12 years and older with moderate to severe persistent asthma who test positive for reactivity to a perennial airborne allergen, and whose symptoms are inadequately controlled with inhaled corticosteroids. The FDA isn’t advising patients to stop taking the drug, nor is it recommending changes to prescribing information at this time, but urges providers to be aware of the potential risks.

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Cartoon caption contest

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Vote for your favorite entry

ACP HospitalistWeekly's cartoon caption contest continues. ACP staff has selected three finalists for the latest contest and is now asking readers to vote for their favorite caption to determine the winner.

"I'm afraid we may have to do a C-section."
"So, I guess you won't be breastfeeding?"
"And you thought 'OctoMom' got a lot of headlines ... "

Go online to view the cartoon and pick the winner, who receives a $50 gift certificate good toward any ACP program, product or service. Voting continues through Aug. 3, with the winner announced in the Aug. 5 issue.

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