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ACP HospitalistWeekly 2-10-10

Highlights

• Using no sedation lowers number of days on ventilator vs. daily sedation interruption
• Withholding anticoagulation after negative compression ultrasound carries low VTE risk

Cardiology

• Heart failure patients discharged from ED often have significant mortality risks
• AHA, ACC issue statement on prevention of in-hospital torsade de pointes

Mental health

• Federal government expands mental health parity coverage

FDA update

• Didanosine gets labeling change
• Hemodialysis system recalled
• Some H1N1 vaccine to expire next week

Cartoon caption contest

• Put words in our mouth

Physician editor: A. Scott Keller, FACP

Highlights

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Using no sedation lowers number of days on ventilator vs. daily sedation interruption

Critically ill patients on mechanical ventilators who don't receive sedation spend fewer days on the ventilators than patients who are sedated with daily interruption, a new study found.

Danish researchers performed a randomized, prospective study of 140 critically ill patients on mechanical ventilators who were expected to need ventilation for more than 24 hours. Seventy patients received no sedation. The other 70 patients received 20 mg/mL of propofol for 48 hours and 1 mg/mL of midazolam after 48 hours, with daily interruption until they were awake. All patients were given bolus doses of 2.5 or 5 mg of morphine. The study was published in the Feb. 6 The Lancet.

Twenty-seven patients were excluded from the study because they died or were successfully extubated within 48 hours. Of the remainder, patients who weren't sedated had significantly more days without ventilation in a 28-day period than patients who had interrupted sedation (13.8 days without ventilation vs. 9.6 days, mean difference of 4.2 days; 95% CI, 0.3 to 8.1; P=0.0191). As a group, patients without sedation stayed 9.7 fewer days in the ICU (hazard ratio, 1.86; 95% CI, 1.05 to 3.23; P=0.0316) and 24 fewer days in the hospital for the first 30 days studied (HR, 3.57; CI, 1.52 to 9.09; P=0.0039). Sedation had no effect on length of stay after 30 days. There was no significant difference in mortality, though there were more deaths in the sedation group.

There was no difference in the number of complications (cases of ventilator-associated pneumonia, accidental extubations or need for reintubation, or the need for CT or MRI brain scans). Patients with no sedation experienced agitated delirium more often than those with interrupted sedation (20% vs. 7%; P=0.04). Haloperidol was used more often in the no sedation group, but doses were very low for both groups. An extra person was needed to comfort more patients in the no sedation than the sedation group (11 patients vs. 3 patients; P=0.025). Physical restraints were never used.

A strength of the study was its inclusion of both medical and surgical patients, where previous studies had used only medical patients, the authors noted. Limitations included the fact that patients came from a single center; the study was unblinded; and the ICU had a nurse-to-patient ratio of 1:1, which is unattainable in many units, they said. Also, 18% of the no sedation group didn't tolerate the strategy, they said. An editorialist suggested that patients who aren't sedated may need supplemental drugs to address an increased risk of delirium, and may also need an extra person for comfort. While long-term follow-up of patients for psychological effects will be important, the overall results are "impressive and promising," the editorialist said.

To read more about sedation protocols in the ICU, see the September 2009 cover story of ACP Hospitalist.

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Withholding anticoagulation after negative compression ultrasound carries low VTE risk

Withholding anticoagulation following a single negative whole-leg compression ultrasound (CUS) posed a low risk for venous thromboembolism (VTE) during three-month follow-up in patients with suspected deep vein thrombosis (DVT), according to a meta-analysis.

CUS is typically the first test to confirm or exclude proximal DVT, but its accuracy for distal (below-the-knee) DVT has been questioned. Because up to 25% of distal DVTs may propagate into proximal veins, patients with a negative exam often require repeat exams five to seven days later. Researchers examined whether a single whole-leg CUS would exclude suspected proximal and distal DVT just as well among patients not treated with anticoagulation.

Researchers conducted a meta-analysis of seven studies totaling 4,731 patients with negative whole-leg CUS examinations who did not receive anticoagulation. Most participants were identified from an ambulatory setting. All were followed for 90 days. Results were reported in the Feb. 3 Journal of the American Medical Association.

VTE or suspected VTE-related death occurred in 34 patients (0.7%), including 11 patients with distal DVT (32.4%), seven patients with proximal DVT (20.6%), seven patients with nonfatal pulmonary emboli (20.6%), and nine patients (26.5%) who died possibly due to VTE. Isolated distal DVT represented 52.1% of all DVTs diagnosed by the initial whole-leg CUS.

A random-effects model with inverse variance weighting found the combined VTE rate at three months was 0.57% (95% CI, 0.25% to 0.89%). The exact binomial method calculated individual VTE rates among the studies as low as 0.24% (95% CI, 0.01% to 1.34%) and as high as 1.95% (95% CI, 0.94% to 3.56%) at three-month follow-up. The pooled incidence rate was 0.57% (95% CI, 0.25% to 0.89%).

Researchers wrote that because many distal thrombi appear to resolve without anticoagulants, detection and treatment of distal DVT may be unnecessary. This could potentially improve patient outcomes as there is an estimated 1.1% annual risk for major bleeding with treatment. However, current clinical practice guidelines recommend 3 months of anticoagulation for distal DVT.

Whole-leg CUS has a low failure rate and is more convenient than repeated evaluations, the researchers said, and bilateral whole-leg CUS requires only 10 to 15 minutes to perform compared to venography, which requires 30 to 90 minutes. Whole-leg CUS may not be widely available, however, they cautioned.

Limitations include that techniques varied slightly across all the studies. The study population also had few pregnant or postpartum patients, and few with cancer. More study is needed in patients with intermediate or high pretest probability for VTE, the authors said.

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Cardiology

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Heart failure patients discharged from ED often have significant mortality risks

Heart failure patients who are discharged from the emergency department often have significant mortality risks that, for some, exceed those of hospitalized patients, a new study found.

Researchers in Ontario, Canada examined outcomes of 50,816 patients who visited an ED from April 2004 to March 2007, using data from the National Ambulatory Care Reporting System Database. Patients aged 20 years and older with a primary diagnosis of heart failure were studied. In patients with multiple ED visits in the study period, the first episode was used as the index heart failure visit. Results were published in the January Circulation: Heart Failure.

Nearly 32% of patients studied were discharged without admission; 4% of these died within 30 days and 1.3% died within a week of ED discharge. Factors that increased the risk of 30-day death included two or more prior heart failure admissions (odds ratio, 1.64; 95% CI, 1.14 to 2.31), valvular heart disease (OR, 1.37; 95% CI, 1.00 to 1.84), peripheral vascular disease (OR, 1.41; 95% CI, 1.00 to 1.93), and respiratory disease (OR, 1.33; 95% CI, 1.08 to 1.63). These same conditions didn't increase the likelihood of hospital admission, however. Instead, patients were more likely to be admitted if they arrived by ambulance (OR, 2.02; 95% CI, 1.93 to 2.12), were older (OR, 1.08; 95% CI, 1.06 to 1.10 per decade), had higher triage acuity score (OR, 4.12; 95% CI, 3.84 to 4.42), or got resuscitation in the ED (OR, 2.85; 95% CI, 2.68 to 3.04). Patients with comparable predicted mortality risks were more likely to die if they were discharged than if they were admitted (11.9% mortality vs. 9.5%; log rank, P=0.016), and had higher rates of repeated ED visits within 90 days.

For every 25 heart failure patients discharged, one patient died within 30 days, and more than 1 of 80 discharged patients died within one week. This amounts to thousands of early deaths after ED discharge each year in North America, the authors noted. Their results suggest that decisions to discharge are based largely on clinical judgment, and a validated tool is needed to better determine the risk of death for heart failure patients who present to the ED, and to help guide decision-making, they said.

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AHA, ACC issue statement on prevention of in-hospital torsade de pointes

The American Heart Association and American College of Cardiology Foundation issued a scientific statement this week on preventing torsade de pointes in hospitalized patients, including risk factors, exacerbating conditions and immediate management.

Hospitalized patients who are given a QT-prolonging drug could be more likely to develop torsade de pointes and cardiac arrest than those in the general population, due to underlying risk factors. The scientific statement was aimed at discussing and raising awareness of drug-induced long-QT syndrome in the hospital.

Drugs associated with torsade de pointes include quinidine, disopyramide and sotalol, among others, but carry varying arrhythmia risks. The statement recommended that physicians check online for an updated list of potentially problematic drugs. Risk factors for drug-induced torsade de pointes include genetic predisposition, older age, female sex, heart disease, electrolyte disorders, renal or hepatic dysfunction, bradycardia or rhythms with long pauses, and treatment with more than one QT-prolonging drug. Patients should be evaluated individually to determine whether a drug's potential therapeutic benefit is greater than the risk for torsade de pointes.

QT intervals should be monitored with the same method before and after a drug is administered, the statement said. In patients who have received a drug associated with torsade de pointes, the following ECG signs indicate risk for arrhythmia:

• An increase in QTc from predrug baseline of 60 ms,
• Marked QTc interval prolongation of more than 500 ms,
• T-U wave distortion that becomes more exaggerated in the beat after a pause,
• Visible (macroscopic) T-wave alternans,
• New-onset ventricular ectopy, and
• Couplets and nonsustained polymorphic ventricular tachycardia initiated in the beat after a pause.

When an ECG indicates impending torsade de pointes, the statement recommended the following actions:

• Withdraw the drug,
• Replace potassium,
• Administer magnesium,
• Consider temporary pacing to prevent bradycardia and long pauses, and
• Transfer the patient to a hospital unit with the highest level of ECG monitoring surveillance where immediate defibrillation is available.

The statement was published online Feb. 8 by Circulation and by the Journal of the American College of Cardiology.

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Mental health

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Federal government expands mental health parity coverage

Group health plans will be required to provide coverage for mental and substance use disorders that is equivalent to their medical benefits under a new rule issued by the Obama administration.

The rule, which was jointly issued by the Departments of Health and Human Services, Labor and the Treasury last week, prohibits group health insurance plans from restricting access to care by limiting benefits and requiring higher patient contributions, according to an HHS press release. The rules implement the Paul Wellstone and Pete Domenici Mental Health Parity and Addiction Equity Act of 2008 (MHPAEA).

MHPAEA expands on an earlier law, the Mental Health Parity Act of 1996, which required parity only in aggregate lifetime and annual dollar limits between the categories of benefits and did not extend to substance use disorder benefits. The new law, which applies to employers of 50 or more workers, requires that any group plan that includes mental health and substance use disorder benefits along with standard medical and surgical coverage must treat them equally in terms of out-of-pocket costs, benefit limits, and practices such as prior authorization and utilization review.

The mental health and substance use coverage must be based on the same level of scientific evidence used by the insurer for medical and surgical benefits. For example, a plan may not apply separate deductibles for treatment related to mental health or substance use.

The new rules will come into effect for plan years beginning on or after July 1, 2010. Comments on the interim final rules are being solicited for the next 90 days. Sections where further comments are being specifically sought include non-quantitative treatment limits, such as those that pertain to the scope and duration of covered benefits, drug formularies, and the coverage of step-therapies. Comments are also being specifically requested on the regulation's section on scope of benefits or continuum of care. Comments may be e-mailed through the federal rulemaking portal.

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FDA update

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Didanosine gets labeling change

Patients taking didanosine (Videx/Videx EC) have a newly recognized risk of non-cirrhotic portal hypertension, the FDA notified health care providers last week.

The medication, which is used to treat HIV infection, has been found to be associated with the liver problem based on reports submitted to the FDA's Adverse Event Reporting System. Because of the potential severity of portal hypertension, including death from hemorrhaging esophageal varices, the FDA has revised the warning and precautions section of the drug label.

The FDA believes the clinical benefits of didanosine for certain patients with HIV continue to outweigh its potential risks. The decision to use this drug, however, must be made on an individual basis between the treating physician and the patient, the agency said.

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Hemodialysis system recalled

The Aquarius Hemodialysis System is being recalled due to reports of clinically significant fluid imbalance and the potential for users to repeatedly override the fluid imbalance alarm, the FDA announced last week.

The class I recall includes model numbers GEF08200, GEF09500, GEF09600, GEF09700, and GEF09800, using Software version 6.00.04. The product was distributed from July 12, 2007 through March 18, 2009. A software upgrade will be made to prevent users from bypassing the fluid balance alarm more than five times in a 20-minute period.

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Some H1N1 vaccine to expire next week

The expiration date for Sanofi Pasteur’s 2009 H1N1 influenza vaccine in pre-filled syringes has been moved up to Feb. 15, 2010, the CDC announced last week.

The expiration date is being changed to ensure that the vaccine meets potency standards, according to the CDC. The vaccine does not pose any safety concerns and people who received vaccine from the lots with shortened shelf life do not need to take any action. The lots had previous expiration dates ranging from March to June, 2011. The change does not include Sanofi Pasteur’s 2009 H1N1 influenza vaccine in multi-dose vials. A full list of affected vaccine is online.

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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 three finalists and post them online for an online vote by readers. The winner will appear in an upcoming edition.

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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