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ACP HospitalistWeekly 11-18-09

Highlights

• Antivirals, even after 48 hours, may help hospitalized H1N1 influenza patients
• Best way to get details on physician errors: Ask them

Critical care

• Prone positioning doesn’t improve mortality for ARDS patients

Heart failure

• Thirty-day heart failure readmissions unchanged between 2004 and 2006

Pulmonary embolism

• Handheld devices help diagnose PE in the ED

FDA update

• Class 1 recall issued for aortic catheter
• Liposyn II and III and Propofol Injectable Emulsion recalled
• Genzyme Corp medications may contain foreign particles
• Romidepsin approved for CTCL
• FDA investigates external biphasic defibrillators

From ACP Hospitalist

• Second annual 'Top Docs' issue now online

Cartoon caption contest

• Vote for your favorite entry

Physician editor: A. Scott Keller, FACP

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Highlights

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Antivirals, even after 48 hours, may help hospitalized H1N1 influenza patients

U.S. patients hospitalized with 2009 H1N1 influenza last spring appeared to benefit from antiviral therapy even when it was received after 48 hours, a new study suggests.

Researchers examined the medical charts of 272 U.S. patients who were hospitalized for at least 24 hours for influenza-like illness (temperature of 100°F or higher, and cough or sore throat), and who tested positive for the 2009 H1N1 virus using a real-time reverse-transcriptase polymerase chain reaction assay. Testing was performed by either the CDC or one of 24 state health departments; illness onset ranged from April 1, 2009 to June 5, 2009. These patients represent 25% of those hospitalized with the illness whose cases were reported to the CDC between May 1 and June 9, 2009. The study was published in the November 12 New England Journal of Medicine.

Forty-five percent of patients were children under 18 years old, while 5% were at least 65 years old. Seventy-three percent of patients had one or more underlying medical conditions, including asthma, diabetes and pregnancy, as well as heart, lung and neurologic diseases. Of 249 patients who had chest radiography, 40% had findings consistent with pneumonia. Twenty-five percent of the patients were admitted to an ICU, and 28% of those admitted to an ICU (19 patients) died. The median age of those who died was 26 years (range, 1.3 years to 57 years), and the median time from onset of illness to death was 15 days (range, 4 days to 52 days).

Data on the use of antiviral drugs were available for 268 patients. Of these, 75% began antiviral therapy at a median of three days after illness onset, though 39% received it within 48 hours of symptom onset. Of the 19 patients who died, 90% received antivirals and all received antibiotics; the median time from their illness onset to antiviral initiation was eight days. No patients who died received antivirals within 48 hours of symptom onset. Patients admitted to the ICU and those who died were more likely than patients not admitted to be older and to have shortness of breath, a neurologic disorder, pneumonia, acute respiratory distress syndrome or sepsis, and a longer time between illness onset and start of antiviral therapy.

Though quick initiation of antiviral therapy is clearly preferable, these study data suggest use of antivirals is beneficial for patients with suspected 2009 H1N1 infection even beyond 48 hours after symptom onset, and especially for patients with pneumonia, the authors said. Study limitations include the fact that it was voluntary and thus subject to reporting bias; that it included only patients with confirmed H1N1 (and not those who may have had it but were untested); and that tests weren’t obtained in a standardized manner.

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Best way to get details on physician errors: Ask them

Physician self-reporting may be a valuable, yet underused, source of information on the reasons underlying common diagnostic errors, a national survey suggests.

Researchers administered a six-question survey asking physicians at 22 U.S. institutions to report three cases of diagnostic errors and their perceived causes, seriousness and frequency. Of 583 cases reported, 28% were rated as major, 41% as moderate and 31% as minor or insignificant. Pulmonary embolism and drug reactions or overdose were the most commonly missed or delayed diagnoses (each with 4.5% of the total), followed by lung cancer (3.9%), colorectal cancer (3.3%), acute coronary syndrome (3.1%), breast cancer (3.1%) and stroke (2.6%). The study is in the Nov. 9 Archives of Internal Medicine.

Physicians surveyed readily reported on errors and shared their experiences, the authors noted, suggesting that tapping into physicians’ clinical experience might uncover many errors that are missed by existing error surveillance and reporting systems. The survey gave physicians a venue to share their experiences anonymously in a blame-free setting, they added.

Beyond raising awareness, asking physicians to report on errors has several advantages, the authors said. These include:

• Compelling physicians to reflect on past cases and learn from what went wrong;
• Revealing patterns in diagnostic errors, such as inadequate follow-up of abnormal imaging studies;
• Looking beyond individual diagnoses to generic factors that that cut across disease areas;
• Highlighting how cognitive and system errors overlap; and
• Bringing hidden errors to light in order to encourage institutions to make improvements aimed at minimizing errors.

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Critical care

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Prone positioning doesn’t improve mortality for ARDS patients

Prone positioning doesn’t provide a survival benefit over supine positioning in patients with moderate and severe acute respiratory distress syndrome (ARDS), a new study found.

Researchers randomly assigned 342 mechanically ventilated adults with ARDS to undergo supine or prone positioning during ventilation. Patients were drawn from 23 centers in Italy and two in Spain and were prospectively stratified into subgroups with moderate and severe hypoxemia. Those in the prone position remained so for at least 20 hours per day, either until the ARDS resolved or the study ended. In the supine group, prone positioning was used only as a rescue maneuver in cases of life-threatening hypoxemia. Mechanical ventilation was given according to a set protocol in both groups, while other interventions—such as nutrition and sedation—were not specified. The primary outcome was all-cause mortality 28 days after enrollment; mortality after six months and mortality from any cause at ICU discharge were secondary outcomes.

Mortality rates were similar among prone patients and supine patients at 28 days (31% vs. 32.8%; relative risk, 0.97; 95% CI, 0.84-1.13; P=0.72) and six months (47% vs. 52.3%; RR, 0.9; 95% CI, 0.73-1.11; P=0.33). The prone group had a significantly higher complication rate. Outcomes were similar between supine and prone patients with moderate hypoxemia at 28 days (25.5% vs. 22.5%; RR, 1.04; 95% CI, 0.89-1.22; P=0.62 and six months (42.6% vs. 43.9%; RR, 0.98; 95% CI, 0.76-1.25; P=0.85), as well as between prone and supine patients with severe hypoxemia at 28 days (37.8% vs. 46.1%; RR, 0.87; 95% CI, 0.66-1.14; P=0.31) and six months (52.7% vs. 63.2%; RR, 0.78; 95% CI, 0.53-1.14; P=0.19). Researchers did note a favorable, but statistically non-significant, 10% difference for patients with severe hypoxemia who were prone, compared to those who were supine.

There’s no apparent survival advantage to using prone positioning in patients with ARDS, though there was a favorable trend toward its use in severely hypoxemic patients, the authors concluded. Prone position is therefore not indicated as a treatment in most of the unselected ARDS population, though further study is warranted for patients with severe hypoxemia, they said.

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Heart failure

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Thirty-day heart failure readmissions unchanged between 2004 and 2006

Hospital readmissions for heart failure hovered around 24% in 2004, 2005 and 2006, virtually unchanged from previous years, a new study found.

Researchers used 2004-2006 Medicare data to identify fee-for-service patients admitted and discharged with a diagnosis of heart failure between Jan. 1, 2004 and Dec. 31, 2006. The main outcome was patient readmission to the hospital for any reason within 30 days of discharge after an index heart failure hospitalization. The study was published in the Nov. 10 online issue of Circulation: Heart Failure.

The data comprised 570,996 heart failure hospitalizations among 4,728 hospitals in 2004, 544,550 hospitalizations among 4,694 hospitals in 2005, and 501,234 hospitalizations among 4,674 hospitals in 2006. The average patient age was 80.1 years, and a majority of patients had multiple chronic diseases. Unadjusted, hospital-specific 30-day all-cause readmission rates were 23% in 2004, 23.3% in 2005, and 22.9% in 2006. The mean risk-standardized readmission rates were 23.7% in 2004, 23.9% in 2005 and 23.8% in 2006—statistically different (P<0.001), but not clinically significant, the authors noted. Annual estimates of between-hospital variation in patient risk of readmission were also similar (0.021 for 2004, 0.024 for 2005 and 0.025 for 2006).

There’s been no regional or national improvement in readmission rates after heart failure hospitalization in recent years, the authors said. The data also suggest little variability between hospitals in managing transitions of care among patients discharged after heart failure hospitalization, they said. Observed hospital performance is likely a function of the current fee-for-service payment system, the authors added, which rewards patient volume over outcomes. “Readmitting nearly a quarter of patients after HF hospitalization within 30 days is not likely to represent optimal care for patients and suggests there is substantial room and a clear opportunity for improvement…,” they wrote.

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Pulmonary embolism

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Handheld devices help diagnose PE in the ED

Using mobile, hand-held clinical decision-support systems in the emergency department improved diagnostic decision making and reduced unnecessary tests for patients with suspected pulmonary embolism, a study found.

Researchers conducted a cluster randomized trial in 20 emergency departments in France, which were randomly assigned to use either handheld electronic decision-support devices or posters and pocket cards showing guidelines for diagnosing pulmonary embolism (PE). Both groups improved their percentage of appropriate diagnostic workups but the increase was 19.3% higher in the handheld device group (P=0.023). Physicians assigned to mobile devices also ordered fewer inappropriate tests than those assigned to paper guidelines (P<0.001). The results appear in the Nov. 17 Annals of Internal Medicine.

Mobile devices gave physicians real-time access to the probability of PE at each stage of the diagnostic workup, whereas physicians using paper had to search for information, the authors noted. The devices prompted physicians to assess initial pretest probability and helped them order appropriate tests, taking into account the clinical situation, availability and previous test results. Physicians using the devices were told to stop their workups after a PE diagnosis was excluded or confirmed and were less likely to stop their investigations prematurely if, for example, the patient had a positive D-dimer test result.

The authors concluded that handheld electronic decision-support systems have the potential to significantly improve decision making in the emergency department. Physician acceptance of the devices may increase as software becomes more sophisticated and efficient, predicted an accompanying editorial. For now, the findings are a promising start toward the goal of bringing evidence to practice, the editorial concluded.

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FDA update

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Class 1 recall issued for aortic catheter

The FDA last week announced a class 1 recall of CardioVations EndoClamp Aortic Catheter, Model Numbers EC1001 and EC65, because the balloon catheters may spontaneously rupture during surgery, an FDA alert said.

This product was manufactured from August 2008 through August 2009, and distributed from November 2008 through September 2009. The catheter is used to block off the aorta, monitor aortic pressure and deliver solution to stop the heart during cardiopulmonary bypass procedures.

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Liposyn II and III and Propofol Injectable Emulsion recalled

Dozens of lots of Liposyn II and III and Propofol Injectable Emulsion have been recalled because some may contain particulate matter that impedes blood flow, an FDA alert said.

The recall comprises 85 lots of Liposyn II 10%, Liposyn II 20%, Liposyn III 10%, Liposyn III 20%, and Liposyn III 30%, and 73 lots of Propofol Injectable Emulsion 1% products that begin with the lot numbers 79 and 80. The affected lots were distributed between July and October of 2009.

The particulate matter has been traced to stainless steel equipment used in the manufacturing process, the alert said. The contaminants could potentially act as emboli and impede blood flow, which could lead to stroke, respiratory failure, kidney failure, liver failure, heart attack and/or death, it said.

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Genzyme Corp. medications may contain foreign particles

Five medications for rare and serious diseases made by Genzyme Corporation may be contaminated by foreign particles, including stainless steel fragments, non-latex rubber and fiber-like material, according to an FDA notice.

The affected medications include all of the following products with lot numbers that start with “A” (eg: Lot A12345): imiglucerase (Cerezyme), an IV infusion for Gaucher disease; agalsidase beta (Fabrazyme), an IV infusion for Fabry disease; alglucosidase alpha (Myozyme), an IV infusion for Pompe disease; laronidase (Aldurazyme), an IV infusion for Mucopolysaccharidosis Type I; and thyrotropin alpha (Thyrogen), an intramuscular injection used as an adjunctive diagnostic tool and treatment for thyroid cancer.

The foreign particles could potentially cause “serious adverse events” in patients, including damage to blood vessels or embolic events, and anaphylactic, allergic and immune-mediated reactions, the notice said. Less serious reactions could include local pain, swelling and inflammation. No adverse events have been reported. The contaminants are thought to be found in less than 1% of the products, based on product lots assessed thus far.

Laronidase is supplied as a liquid solution, while the other four products are supplied as lyophilized powders requiring reconstitution before administration. To reduce the risk of administering a contaminated product, health care professionals should:

• Visually inspect the powder in the vial for the presence of particles before reconstitution.
• Visually inspect the reconstituted powder (in solution) and the laronidase solution for the presence of particles.
• Not administer any product with visualized particles. The product should be returned to Genzyme Corporation (1-800-745-4447, option 2).
• Continue to use an in-line, low protein-binding 0.2 or 0.22 micrometer filter as recommended in the drug labeling. Note that at this time, the FDA has not determined whether using an in-line, low protein-binding 0.2 or 0.22 micrometer filter will remove all foreign particles or whether foreign particles might affect the integrity of the in-line filter.
• Observe for local or systemic infusion reactions after administration.

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Romidepsin approved for CTCL

The FDA last week approved injectable romidepsin (Istodax) to treat patients with cutaneous T-cell lymphoma (CTCL).

Romidepsin, which interferes with cell replication, is meant to be used when CTCL gets worse or comes back after at least one other type of chemotherapy has been used, the FDA said in a news release.

The drug was evaluated based on two clinical studies with 167 patients. About 35% of patients in both trials experienced tumor responses, indicating a reduction of tumor size. Six percent of those studied had complete responses, indicating no apparent evidence of the tumor on physical, laboratory and X-ray examinations. Responses lasted a median of 15 months in one study and 11 months in the other study, the release said.

Side effects of romidepsin may include nausea, fatigue, infections, vomiting, decreased appetite, decreased red blood cell count, decreased platelet count, and decreases in the components of white blood cells. The drug may cause changes in an electrocardiogram (ECG), so periodic ECG monitoring should be considered in patients at risk for certain heart rhythm abnormalities. Periodic blood tests should also be done to monitor electrolytes. Women shouldn’t become pregnant while taking the drug, as it may harm a fetus.

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FDA investigates external biphasic defibrillators

The FDA is investigating energy levels in external biphasic defibrillators with shocks < 200 J due to 14 reports of the devices being ineffective, an FDA notice said.

In the 14 events, which occurred since 2006, a 200 J biphasic defibrillator was ineffective in providing defibrillation/cardioversion therapy to a patient, whereas a subsequent shock from a different 360 J biphasic defibrillator resulted in immediate defibrillation/cardioversion. The majority of events occurred during attempts at cardioversion of atrial fibrillation, but there was at least one instance with defibrillation of a ventricular arrhythmia as well, the FDA said. The events involved multiple shocks from defibrillators from different manufacturers, the agency added, noting that the scientific literature doesn’t provide clarity on the question of optimal energy delivery.

The agency doesn’t recommend any changes to clinical practice at this time. It is seeking additional information in order to interpret the significance of these 14 events, and to determine whether FDA activities are advised. If you suspect a problem with a defibrillator, such as a situation where a patient received shocks from multiple devices, the problem should be reported to the FDA's MedWatch Safety Information and Adverse Event Reporting Program online or by calling 1-800-332-1088.

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From ACP Hospitalist

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Second annual 'Top Docs' issue now online

The November ACP Hospitalist is now online, including the second annual Top Hospitalists feature.

The issue also features the following:

Is it observation or inpatient? The question has perplexed hospital physicians for some time, but it’s recently acquired greater financial significance.

A deviant approach to hospital challenges. Positive deviance is a bottom-up, rather than top-down, approach to solving seemingly intractable problems in an institution or a community.

Success story: Homemade computer program improves glucose control. The Medical University of South Carolina Medical Center in Charleston, S.C., developed a nurse-driven Web-based insulin infusion protocol to manage blood glucose.

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Cartoon caption contest

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Vote for your favorite entry

ACP HospitalistWeekly's cartoon caption contest continues. Readers can vote for their favorite caption to determine the winner.

"I'm the new CAT scanner."
"And then Timmy says to me, 'Jump, girl. You can make it.'"
"Doc says my gait disturbance is caused by Barkinson's disease."

Go online to pick the winner, who receives a $50 gift certificate good toward any ACP program, product or service. Voting continues through Nov. 23, with the winner announced in the Nov. 25 issue.

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ACP Hospitalist provides news and information for internists about the practice of medicine and reports on the policies, products and activities of ACP. All published material, which is covered by copyright, represents the views of the contributor and does not reflect the opinion of the American College of Physicians or any other institution unless clearly stated